[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2023 Edition]
[From the U.S. Government Publishing Office]



[[Page i]]

          

                                              Title 21

                                            Food and Drugs


                                       ________________________

                                            Parts 800 to 1299

                                     Revised as of April 1, 2023

          Containing a codification of documents of general 
          applicability and future effect

          As of April 1, 2023
                    Published by the Office of the Federal Register 
                    National Archives and Records Administration as a 
                    Special Edition of the Federal Register

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                            Table of Contents



                                                                    Page
  Explanation.................................................       v

  Title 21:
          Chapter I--Food and Drug Administration, Department 
          of Health and Human Services (Continued)                   3
  Finding Aids:
      Table of CFR Titles and Chapters........................    1105
      Alphabetical List of Agencies Appearing in the CFR......    1125
      List of CFR Sections Affected...........................    1135

[[Page iv]]





                     ----------------------------

                     Cite this Code: CFR
                     To cite the regulations in 
                       this volume use title, 
                       part and section number. 
                       Thus, 21 CFR 800.10 refers 
                       to title 21, part 800, 
                       section 10.

                     ----------------------------

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                               EXPLANATION

    The Code of Federal Regulations is a codification of the general and 
permanent rules published in the Federal Register by the Executive 
departments and agencies of the Federal Government. The Code is divided 
into 50 titles which represent broad areas subject to Federal 
regulation. Each title is divided into chapters which usually bear the 
name of the issuing agency. Each chapter is further subdivided into 
parts covering specific regulatory areas.
    Each volume of the Code is revised at least once each calendar year 
and issued on a quarterly basis approximately as follows:

Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1

    The appropriate revision date is printed on the cover of each 
volume.

LEGAL STATUS

    The contents of the Federal Register are required to be judicially 
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie 
evidence of the text of the original documents (44 U.S.C. 1510).

HOW TO USE THE CODE OF FEDERAL REGULATIONS

    The Code of Federal Regulations is kept up to date by the individual 
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    To determine whether a Code volume has been amended since its 
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EFFECTIVE AND EXPIRATION DATES

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OMB CONTROL NUMBERS

    The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires 
Federal agencies to display an OMB control number with their information 
collection request.

[[Page vi]]

Many agencies have begun publishing numerous OMB control numbers as 
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PAST PROVISIONS OF THE CODE

    Provisions of the Code that are no longer in force and effect as of 
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``[RESERVED]'' TERMINOLOGY

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INCORPORATION BY REFERENCE

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This material, like any other properly issued regulation, has the force 
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    (b) The matter incorporated is in fact available to the extent 
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    An index to the text of ``Title 3--The President'' is carried within 
that volume.

[[Page vii]]

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    Oliver A. Potts,
    Director,
    Office of the Federal Register
    April 1, 2023







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                               THIS TITLE

    Title 21--Food and Drugs is composed of nine volumes. The parts in 
these volumes are arranged in the following order: Parts 1-99, 100-169, 
170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300 to end. 
The first eight volumes, containing parts 1-1299, comprise Chapter I--
Food and Drug Administration, Department of Health and Human Services. 
The ninth volume, containing part 1300 to end, includes Chapter II--Drug 
Enforcement Administration, Department of Justice, and Chapter III--
Office of National Drug Control Policy. The contents of these volumes 
represent all current regulations codified under this title of the CFR 
as of April 1, 2023.

    For this volume, Robert J. Sheehan, III was Chief Editor. The Code 
of Federal Regulations publication program is under the direction of 
John Hyrum Martinez, assisted by Stephen J. Frattini.

[[Page 1]]



                        TITLE 21--FOOD AND DRUGS




                 (This book contains Parts 800 to 1299)

  --------------------------------------------------------------------
                                                                    Part

chapter i--Food and Drug Administration, Department of 
  Health and Human Services (Continued).....................         800

[[Page 3]]



CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)




  --------------------------------------------------------------------


  Editorial Note: Nomenclature changes to chapter I appear at 59 FR 
14366, Mar. 28, 1994; 68 FR 24879, May 9, 2003; and 69 FR 13717, Mar. 
24, 2004.

                      SUBCHAPTER H--MEDICAL DEVICES
Part                                                                Page
800             General.....................................           7
801             Labeling....................................          28
803             Medical device reporting....................          64
806             Medical devices; reports of corrections and 
                    removals................................          81
807             Establishment registration and device 
                    listing for manufacturers and initial 
                    importers of devices....................          85
808             Exemptions from Federal preemption of State 
                    and local medical device requirements...         103
809             In vitro diagnostic products for human use..         109
810             Medical device recall authority.............         118
812             Investigational device exemptions...........         125
813

[Reserved]

814             Premarket approval of medical devices.......         146
820             Quality system regulation...................         170
821             Medical device tracking requirements........         184
822             Postmarket surveillance.....................         191
830             Unique device identification................         199
860             Medical device classification procedures....         208
861             Procedures for performance standards 
                    development.............................         229
862             Clinical chemistry and clinical toxicology 
                    devices.................................         233
864             Hematology and pathology devices............         285
866             Immunology and microbiology devices.........         317
868             Anesthesiology devices......................         425
870             Cardiovascular devices......................         450
872             Dental devices..............................         493
874             Ear, nose, and throat devices...............         522
876             Gastroenterology-urology devices............         539
878             General and plastic surgery devices.........         576

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880             General hospital and personal use devices...         611
882             Neurological devices........................         640
884             Obstetrical and gynecological devices.......         675
886             Ophthalmic devices..........................         705
888             Orthopedic devices..........................         735
890             Physical medicine devices...................         768
892             Radiology devices...........................         793
895             Banned devices..............................         812
898             Performance standard for electrode lead 
                    wires and patient cables................         818
             SUBCHAPTER I--MAMMOGRAPHY QUALITY STANDARDS ACT
900             Mammography.................................         820
                    SUBCHAPTER J--RADIOLOGICAL HEALTH
1000            General.....................................         860
1002            Records and reports.........................         863
1003            Notification of defects or failure to comply         871
1004            Repurchase, repairs, or replacement of 
                    electronic products.....................         875
1005            Importation of electronic products..........         877
1010            Performance standards for electronic 
                    products: General.......................         880
1020            Performance standards for ionizing radiation 
                    emitting products.......................         886
1030            Performance standards for microwave and 
                    radio frequency emitting products.......         918
1040            Performance standards for light-emitting 
                    products................................         921
                     SUBCHAPTER K--TOBACCO PRODUCTS
1100            General.....................................         946
1105            General.....................................         948
1107            Exemption requests and substantial 
                    equivalence reports.....................         949
1114            Premarket tobacco product applications......         987
1140            Cigarettes, smokeless tobacco, and covered 
                    tobacco products........................        1026
1141            Cigarette package and advertising warnings 
                    (eff. until 11-6-23)....................        1032
1141            Required warnings for cigarette packages and 
                    advertisements (eff. 11-6-23)...........        1036
1143            Minimum required warning statements.........        1039
1150            User fees...................................        1044
 SUBCHAPTER L--REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE 
                      FOOD AND DRUG ADMINISTRATION
1210            Regulations under the Federal Import Milk 
                    Act.....................................        1048

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1230            Regulations under the Federal Caustic Poison 
                    Act.....................................        1051
1240            Control of communicable diseases............        1058
1250            Interstate conveyance sanitation............        1063
1251-1270

 [Reserved]

1271            Human cells, tissues, and cellular and 
                    tissue-based products...................        1074
1272-1299

 [Reserved]

[[Page 7]]



                      SUBCHAPTER H_MEDICAL DEVICES





PART 800_GENERAL--Table of Contents



Subpart A [Reserved]

           Subpart B_Requirements for Specific Medical Devices

Sec.
800.10 Contact lens solutions; sterility.
800.12 Contact lens solutions and tablets; tamper-resistant packaging.
800.20 Patient examination gloves and surgeons' gloves; sample plans and 
          test method for leakage defects; adulteration.
800.30 Over-the-counter hearing aid controls.

            Subpart C_Administrative Practices and Procedures

800.55 Administrative detention.
800.75 Requests for supervisory review of certain decisions made by the 
          Center for Devices and Radiological Health.

    Authority: 21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360j, 
360k, 361, 362, 371.
    Section 800.30 also issued under Sec. 709, Pub. L. 115-52, 131 Stat. 
1065-67.

Subpart A [Reserved]



           Subpart B_Requirements for Specific Medical Devices



Sec. 800.10  Contact lens solutions; sterility.

    (a)(1) Informed medical opinion is in agreement that all 
preparations offered or intended for ophthalmic use, including contact 
lens solutions, should be sterile. It is further evident that such 
preparations purport to be of such purity and quality as to be suitable 
for safe use in the eye.
    (2) The Food and Drug Administration concludes that all such 
preparations, if they are not sterile, fall below their professed 
standard of purity or quality and may be unsafe. In a statement of 
policy issued on September 1, 1964, the Food and Drug Administration 
ruled that liquid preparations offered or intended for ophthalmic use 
that are not sterile may be regarded as adulterated within the meaning 
of section 501(c) of the Federal Food, Drug, and Cosmetic Act (the act), 
and, further, may be deemed misbranded within the meaning of section 
502(j) of the act. By this regulation, this ruling is applicable to all 
preparations for ophthalmic use that are regulated as medical devices, 
i.e., contact lens solutions. By the regulation in Sec. 200.50 of this 
chapter, this ruling is applicable to ophthalmic preparations that are 
regulated as drugs.
    (3) The containers shall be sterile at the time of filling and 
closing, and the container or individual carton shall be so sealed that 
the contents cannot be used without destroying the seal. The packaging 
and labeling of these solutions shall also comply with Sec. 800.12 on 
tamper-resistant packaging requirements.
    (b) Liquid ophthalmic preparations packed in multiple-dose 
containers should:
    (1) Contain one or more suitable and harmless substances that will 
inhibit the growth of microorganisms; or
    (2) Be so packaged as to volume and type of container and so labeled 
as to duration of use and with such necessary warnings as to afford 
adequate protection and minimize the hazard of injury resulting from 
contamination during use.
    (c) Eye cups, eye droppers, and other dispensers intended for 
ophthalmic use should be sterile, and may be regarded as falling below 
their professed standard of purity or quality if they are not sterile. 
These articles, which are regulated as medical devices unless packaged 
with the drugs with which they are to be used, should be packaged so as 
to maintain sterility until the package is opened and be labeled, on or 
within the retail package, so as to afford adequate directions and 
necessary warnings to minimize the hazard of injury resulting from 
contamination during use.

[47 FR 50455, Nov. 5, 1982]



Sec. 800.12  Contact lens solutions and tablets; tamper-resistant packaging.

    (a) General. Unless contact lens solutions used, for example, to 
clean, disinfect, wet, lubricate, rinse, soak, or store contact lenses 
and salt tablets or

[[Page 8]]

other dosage forms to be used to make any such solutions are packaged in 
tamper-resistant retail packages, there is the opportunity for the 
malicious adulteration of these products with risks both to individuals 
who unknowingly purchase adulterated products and with loss of consumer 
confidence in the security of the packages of over-the-counter (OTC) 
health care products. The Food and Drug Administration has the authority 
and responsibility under the Federal Food, Drug, and Cosmetic Act (the 
act) to establish a uniform national standard for tamper-resistant 
packaging of those OTC products vulnerable to malicious adulteration 
that will improve the security of OTC packaging and help assure the 
safety and effectiveness of the products contained therein. A contact 
lens solution or tablet or other dosage form to be used to make such a 
solution for retail sale that is not packaged in a tamper-resistant 
package and labeled in accordance with this section is adulterated under 
section 501 of the act or misbranded under section 502 of the act, or 
both.
    (b) Requirement for tamper-resistant package. Each manufacturer and 
packer who packages for retail sale a product regulated as a medical 
device that is a solution intended for use with contact lenses, e.g., 
for cleaning, disinfecting, wetting, lubricating, rinsing, soaking, or 
storing contact lenses or tablets or other dosage forms to be used to 
make any such solution shall package the product in a tamper-resistant 
package, if this product is accessible to the public while held for 
sale. A tamper-resistant package is one having an indicator or barrier 
to entry which, if breached or missing, can reasonably be expected to 
provide visible evidence to consumers that tampering has occurred. To 
reduce the likelihood of substitution of a tamper-resistant feature 
after tampering, the indicator or barrier to entry is required to be 
distinctive by design or by the use of an identifying characteristic 
(e.g., a pattern, name, registered trademark, logo, or picture). For 
purposes of this section, the term ``distinctive by design'' means the 
package cannot be duplicated with commonly available material or through 
commonly available processes. A tamper-resistant package may involve an 
immediate-container and closure system or secondary-container or carton 
system or any combination of systems intended to provide a visual 
indication of package integrity. The tamper-resistant feature shall be 
designed to and shall remain intact when handled in a reasonable manner 
during manufacture, distribution, and retail display.
    (c) Labeling. Each retail package of a product covered by this 
section is required to bear a statement that is prominently placed so 
that consumers are alerted to the tamper-resistant feature of the 
package. The labeling statement is also required to be so placed that it 
will be unaffected if the tamper-resistant feature of the package is 
breached or missing. If the tamper-resistant feature chosen to meet the 
requirement in paragraph (b) of this section is one that uses an 
identifying characteristic, that characteristic is required to be 
referred to in the labeling statement. For example, the labeling 
statement on a bottle with a shrink band could say ``For your 
protection, this bottle has an imprinted seal around the neck.''
    (d) Requests for exemptions from packaging and labeling 
requirements. A manufacturer or packer may request an exemption from the 
packaging and labeling requirements of this section. A request for an 
exemption is required to be submitted in the form of a citizen petition 
under Sec. 10.30 of this chapter and should be clearly identified on 
the envelope as a ``Request for Exemption from Tamper-resistant Rule.'' 
A petition for an exemption from a requirement of this section is 
required to contain the same kind of information about the product as is 
specified for OTC drugs in Sec. 211.132(d) of this chapter.
    (e) Products subject to approved premarket approval applications. 
Holders of approved premarket approval applications for products subject 
to this section are required to submit supplements to provide for 
changes in packaging to comply with the requirement of paragraph (b) of 
this section unless these changes do not affect the composition of the 
container, the torque (tightness) of the container, or the

[[Page 9]]

composition of the closure component in contact with the contents (cap 
liner or innerseal) as these features are described in the approved 
premarket approval application. Any supplemental premarket approval 
application under this paragraph is required to include data sufficient 
to show that these changes do not adversely affect the product.
    (f) Effective date. Each product subject to this section is required 
to comply with the requirements of this section on the dates listed 
below except to the extent that a product's manufacturer or packer has 
obtained an exemption from a packaging or labeling requirement:
    (1) Initial effective date for packaging requirements. (i) The 
packaging requirement in paragraph (b) of this section is effective on 
February 7, 1983 for each contact lens solution packaged for retail sale 
on or after that date, except for the requirement in paragraph (b) of 
this section for a distinctive indicator or barrier to entry.
    (ii) The packaging requirement in paragraph (b) of this section is 
effective on May 5, 1983 for each tablet that is to be used to make a 
contact lens solution and that is packaged for retail sale on or after 
that date.
    (2) Initial effective date for labeling requirements. The 
requirement in paragraph (b) of this section that the indicator or 
barrier to entry be distinctive by design and the requirement in 
paragraph (c) of this section for a labeling statement are effective on 
May 5, 1983 for each product subject to this section packaged for retail 
sale on or after that date, except that the requirement for a specific 
label reference to any identifying characteristic is effective on 
February 6, 1984 for each affected product subject to this section 
packaged for retail sale on or after that date.
    (3) Retail level effective date. The tamper-resistant packaging 
requirement of paragraph (b) of this section is effective on February 6, 
1984 for each product subject to this section that is held for sale at 
retail level on or after that date that was packaged for retail sale 
before May 5, 1983. This does not include the requirement in paragraph 
(b) of this section that the indicator or barrier to entry be 
distinctive by design. Products packaged for retail sale after May 5, 
1983, are required to be in compliance with all aspects of the 
regulations without regard to the retail level effective date.

[47 FR 50455, Nov. 5, 1982; 48 FR 1706, Jan. 14, 1983, as amended at 48 
FR 16666, Apr. 19, 1983; 48 FR 37625, Aug. 19, 1983; 53 FR 11252, Apr. 
6, 1988; 73 FR 34859, June 19, 2008]

    Effective Date Note: A document published at 48 FR 41579, Sept. 16, 
1983, stayed the effective date of Sec. 800.12(f)(3) until further 
notice.



Sec. 800.20  Patient examination gloves and surgeons' gloves;
sample plans and test method for leakage defects; adulteration.

    (a) Purpose. The prevalence of human immunodeficiency virus (HIV), 
which causes acquired immune deficiency syndrome (AIDS), and its risk of 
transmission in the health care context, have caused the Food and Drug 
Administration (FDA) to look more closely at the quality control of 
barrier devices, such as surgeons' gloves and patient examination gloves 
(collectively known as medical gloves) to reduce the risk of 
transmission of HIV and other blood-borne infectious diseases. The 
Centers for Disease Control (CDC) recommend that health care workers 
wear medical gloves to reduce the risk of transmission of HIV and other 
blood-borne infectious deseases. The CDC recommends that health care 
workers wear medical gloves when touching blood or other body fluids, 
mucous membranes, or nonintact skin of all patients; when handling items 
or surfaces soiled with blood or other body fluids; and when performing 
venipuncture and other vascular access procedures. Among other things, 
CDC's recommendation that health care providers wear medical gloves 
demonstrates the proposition that devices labeled as medical gloves 
purport to be and are represented to be effective barriers against the 
transmission of blood- and fluid-borne pathogens. Therefore, FDA, 
through this regulation, is defining adulteration for patient 
examination and surgeons' gloves as a means of assuring safe and 
effective devices.
    (1) For a description of a patient examination glove, see Sec. 
880.6250. Finger

[[Page 10]]

cots, however, are excluded from the test method and sample plans in 
paragraphs (b) and (c) of this section.
    (2) For a description of a surgeons' glove, see Sec. 878.4460 of 
this chapter.
    (b)(1) General test method. For the purposes of this part, FDA's 
analysis of gloves for leaks and visual defects will be conducted by a 
visual examination and by a water leak test method, using 1,000 
milliliters (ml) of water.
    (i) Units examined. Each medical glove will be analyzed 
independently. When packaged as pairs, each glove is considered 
separately, and both gloves will be analyzed.
    (ii) Identification of defects. For this test, defects include leaks 
detected when tested in accordance with paragraph (b)(3) of this 
section. A leak is defined as the appearance of water on the outside of 
the glove. This emergence of water from the glove constitutes a 
watertight barrier failure. Other defects include tears, embedded 
foreign objects, extrusions of glove material on the exterior or 
interior surface of the glove, gloves that are fused together so that 
individual glove separation is impossible, gloves that adhere to each 
other and tear when separated, or other visual defects that are likely 
to affect the barrier integrity.
    (iii) Factors for counting defects. One defect in one glove is 
counted as one defect. A defect in both gloves in a pair of gloves is 
counted as two defects. If multiple defects, as defined in paragraph 
(b)(1)(ii) of this section, are found in one glove, they are counted as 
one defect. Visual defects and leaks that are observed in the top 40 
millimeters (mm) of a glove will not be counted as a defect for the 
purposes of this part.
    (2) Leak test materials. FDA considers the following to be the 
minimum materials required for this test :
    (i) A 60 mm by 380 mm (clear) plastic cylinder with a hook on one 
end and a mark scored 40 mm from the other end (a cylinder of another 
size may be used if it accommodates both cuff diameter and any water 
above the glove capacity);
    (ii) Elastic strapping with velcro or other fastening material;
    (iii) Automatic water-dispensing apparatus or manual device capable 
of delivering 1,000 ml of water;
    (iv) Stand with horizontal rod for hanging the hook end of the 
plastic tube. The horizontal support rod must be capable of holding the 
weight of the total number of gloves that will be suspended at any one 
time, e.g., five gloves suspended will weigh about 5 kilograms (kg);
    (v) Timer capable of measuring two minute intervals.
    (3) Visual defects and leak test procedures. Examine the sample and 
identify code/lot number, size, and brand as appropriate. Continue the 
visual examination using the following procedures:
    (i) Visual defects examination. Inspect the gloves for visual 
defects by carefully removing the glove from the wrapper, box, or 
package. Visually examine each glove for defects. As noted in paragraph 
(b)(1)(iii) of this section, a visual defect observed in the top 40 mm 
of a glove will not be counted as a defect for the purpose of this part. 
Visually defective gloves do not require further testing, although they 
must be included in the total number of defective gloves counted for the 
sample.
    (ii) Leak test set-up. (A) During this procedure, ensure that the 
exterior of the glove remains dry. Attach the glove to the plastic fill 
tube by bringing the cuff end to the 40 mm mark and fastening with 
elastic strapping to make a watertight seal.
    (B) Add 1,000 ml of room temperature water (i.e., 20 (deg)C to 30 
(deg)C) into the open end of the fill tube. The water should pass freely 
into the glove. (With some larger sizes of long-cuffed surgeons' gloves, 
the water level may reach only the base of the thumb. With some smaller 
gloves, the water level may extend several inches up the fill tube.)
    (iii) Leak test examination. Immediately after adding the water, 
examine the glove for water leaks. Do not squeeze the glove; use only 
minimum manipulation to spread the fingers to check for leaks. Water 
drops may be blotted to confirm leaking.
    (A) If the glove does not leak immediately, keep the glove/filling 
tube assembly upright and hang the assembly vertically from the 
horizontal rod,

[[Page 11]]

using the wire hook on the open end of the fill tube (do not support the 
filled glove while transferring).
    (B) Make a second observation for leaks 2 minutes after the water is 
added to the glove. Use only minimum manipulation of the fingers to 
check for leaks.
    (C) Record the number of defective gloves.
    (c) Sampling, inspection, acceptance, and adulteration. In 
performing the test for leaks and other visual defects described in 
paragraph (b) of this section, FDA will collect and inspect samples of 
medical gloves, and determine when the gloves are acceptable as set out 
in paragraphs (c)(1) through (c)(3) of this section.
    (1) Sample plans. FDA will collect samples from lots of medical 
gloves in accordance with agency sampling plans. These plans are based 
on sample sizes, levels of sample inspection, and acceptable quality 
levels (AQLs) found in the International Standard Organization's 
standard ISO 2859, ``Sampling Procedures For Inspection By Attributes.''
    (2) Sample sizes, inspection levels, and minimum AQLs. FDA will use 
single normal sampling for lots of 1,200 gloves or less and multiple 
normal sampling for all larger lots. FDA will use general inspection 
level II in determining the sample size for any lot size. As shown in 
the tables following paragraph (c)(3) of this section, FDA considers a 
1.5 AQL to be the minimum level of quality acceptable for surgeons' 
gloves and a 2.5 AQL to be the minimum level of quality acceptable for 
patient examination gloves.
    (3) Adulteration levels and accept/reject criteria. FDA considers a 
lot of medical gloves to be adulterated when the number of defective 
gloves found in the tested sample meets or exceeds the applicable 
rejection number at the 1.5 AQL for surgeons' gloves or the 2.5 AQL for 
patient examination gloves. These acceptance and rejection numbers are 
identified in the tables following paragraph (c)(3) of this section as 
follows:

                             Accept/Reject Criteria at 1.5 AQL for Surgeons' Gloves
----------------------------------------------------------------------------------------------------------------
                                                                                      Number Defective
     Lot Size            Sample          Sample Size      Number Examined  -------------------------------------
                                                                                  Accept             Reject
----------------------------------------------------------------------------------------------------------------
8 to 90                Single sample  .................                  8                  0                  1
----------------------------------------------------------------------------------------------------------------
91 to 280              Single sample  .................                 32                  1                  2
----------------------------------------------------------------------------------------------------------------
281 to 500             Single sample  .................                 50                  2                  3
----------------------------------------------------------------------------------------------------------------
501 to 1,200           Single sample  .................                 80                  3                  4
----------------------------------------------------------------------------------------------------------------
1,201 to 3,200                 First                 32                 32                 --                  4
                              Second                 32                 64                  1                  5
                               Third                 32                 96                  2                  6
                              Fourth                 32                128                  3                  7
                               Fifth                 32                160                  5                  8
                               Sixth                 32                192                  7                  9
                             Seventh                 32                224                  9                 10
----------------------------------------------------------------------------------------------------------------
3,201 to 10,000                First                 50                 50                  0                  4
                              Second                 50                100                  1                  6
                               Third                 50                150                  3                  8
                              Fourth                 50                200                  5                 10
                               Fifth                 50                250                  7                 11
                               Sixth                 50                300                 10                 12
                             Seventh                 50                350                 13                 14
----------------------------------------------------------------------------------------------------------------
10,001 to 35,000               First                 80                 80                  0                  5
                              Second                 80                160                  3                  8
                               Third                 80                240                  6                 10
                              Fourth                 80                320                  8                 13
                               Fifth                 80                400                 11                 15
                               Sixth                 80                480                 14                 17
                             Seventh                 80                560                 18                 19
----------------------------------------------------------------------------------------------------------------
35,000                         First                125                125                  1                  7
                              Second                125                250                  4                 10

[[Page 12]]

 
                               Third                125                375                  8                 13
                              Fourth                125                500                 12                 17
                               Fifth                125                625                 17                 20
                               Sixth                125                750                 21                 23
                             Seventh                125                875                 25                 26
----------------------------------------------------------------------------------------------------------------


                        Accept/Reject Criteria at 2.5 AQL for Patient Examination Gloves
----------------------------------------------------------------------------------------------------------------
                                                                                      Number Defective
     Lot Size            Sample          Sample Size      Number Examined  -------------------------------------
                                                                                  Accept             Reject
----------------------------------------------------------------------------------------------------------------
5 to 50                Single sample  .................                  5                  0                  1
----------------------------------------------------------------------------------------------------------------
51 to 150              Single sample  .................                 20                  1                  2
----------------------------------------------------------------------------------------------------------------
151 to 280             Single sample  .................                 32                  2                  3
----------------------------------------------------------------------------------------------------------------
281 to 500             Single sample  .................                 50                  3                  4
----------------------------------------------------------------------------------------------------------------
501 to 1,200           Single sample  .................                 80                  5                  6
----------------------------------------------------------------------------------------------------------------
1,201 to 3,200                 First                 32                 32                  0                  4
                              Second                 32                 64                  1                  6
                               Third                 32                 96                  3                  8
                              Fourth                 32                128                  5                 10
                               Fifth                 32                160                  7                 11
                               Sixth                 32                192                 10                 12
                             Seventh                 32                224                 13                 14
----------------------------------------------------------------------------------------------------------------
3,201 to 10,000                First                 50                 50                  0                  5
                              Second                 50                100                  3                  8
                               Third                 50                150                  6                 10
                              Fourth                 50                200                  8                 13
                               Fifth                 50                250                 11                 15
                               Sixth                 50                300                 14                 17
                             Seventh                 50                350                 18                 19
----------------------------------------------------------------------------------------------------------------
10,001 to 35,000               First                 80                 80                  1                  7
                              Second                 80                160                  4                 10
                               Third                 80                240                  8                 13
                              Fourth                 80                320                 12                 17
                               Fifth                 80                400                 17                 20
                               Sixth                 80                480                 21                 23
                             Seventh                 80                560                 25                 26
----------------------------------------------------------------------------------------------------------------
35,000 and above               First                125                125                  2                  9
                              Second                125                250                  7                 14
                               Third                125                375                 13                 19
                              Fourth                125                500                 19                 25
                               Fifth                125                625                 25                 29
                               Sixth                125                750                 31                 33
                             Seventh                125                875                 37                 38
----------------------------------------------------------------------------------------------------------------

    (d) Compliance. Lots of gloves that are sampled, tested, and 
rejected using procedures in paragraphs (b) and (c) of this section, are 
considered adulterated within the meaning of section 501(c) of the act.
    (1) Detention and seizure. Lots of gloves that are adulterated under 
section 501(c) of the act are subject to administrative and judicial 
action, such as detention of imported products and seizure of domestic 
products.
    (2) Reconditioning. FDA may authorize the owner of the product, or 
the owner's representative, to attempt to recondition, i.e., bring into 
compliance with the act, a lot or part of a lot of foreign gloves 
detained at importation, or a lot or part of a lot of seized domestic 
gloves.

[[Page 13]]

    (i) Modified sampling, inspection, and acceptance. If FDA authorizes 
reconditioning of a lot or portion of a lot of adulterated gloves, 
testing to confirm that the reconditioned gloves meet AQLs must be 
performed by an independent testing facility. The following tightened 
sampling plan must be followed, as described in ISO 2859 ``Sampling 
Procedures for Inspection by Attributes:''
    (A) General inspection level II,
    (B) Single sampling plans for tightened inspection,
    (C) 1.5 AQL for surgeons' gloves, and
    (D) 2.5 AQL for patient examination gloves.
    (ii) Adulteration levels and acceptance criteria for reconditioned 
gloves. (A) FDA considers a lot or part of a lot of adulterated gloves, 
that is reconditioned in accordance with paragraph (d)(2)(i) of this 
section, to be acceptable when the number of defective gloves found in 
the tested sample does not exceed the acceptance number in the 
appropriate tables in paragraph (d)(2)(ii)(B) of this section for 
reconditioned surgeons' gloves or patient examination gloves.
    (B) FDA considers a reconditioned lot of medical gloves to be 
adulterated within the meaning of section 501(c) of the act when the 
number of defective gloves found in the tested sample meets or exceeds 
the applicable rejection number in the tables following paragraph 
(d)(2)(ii)(B) of this section:

                      Accept/Reject Criteria at 1.5 AQL for Reconditioned Surgeons' Gloves
----------------------------------------------------------------------------------------------------------------
                                                                                      Number Defective
              Lot Size                      Sample          Sample Size    -------------------------------------
                                                                                  Accept             Reject
----------------------------------------------------------------------------------------------------------------
13 to 90                                  Single sample                 13                  0                  1
----------------------------------------------------------------------------------------------------------------
91 to 500                                 Single sample                 50                  1                  2
----------------------------------------------------------------------------------------------------------------
501 to 1,200                              Single sample                 80                  2                  3
----------------------------------------------------------------------------------------------------------------
1,201 to 3,200                            Single sample                125                  3                  4
----------------------------------------------------------------------------------------------------------------
3,201 to 10,000                           Single sample                200                  5                  6
----------------------------------------------------------------------------------------------------------------
10,001 to 35,000                          Single sample                315                  8                  9
----------------------------------------------------------------------------------------------------------------
35,000 and above                          Single sample                500                 12                 13
----------------------------------------------------------------------------------------------------------------


                 Accept/Reject Criteria at 2.5 AQL for Reconditioned Patient Examination Gloves
----------------------------------------------------------------------------------------------------------------
                                                                                      Number Defective
              Lot Size                      Sample          Sample Size    -------------------------------------
                                                                                  Accept             Reject
----------------------------------------------------------------------------------------------------------------
8 to 50                                   Single sample                  8                  0                  1
----------------------------------------------------------------------------------------------------------------
51 to 280                                 Single sample                 32                  1                  2
----------------------------------------------------------------------------------------------------------------
281 to 500                                Single sample                 50                  2                  3
----------------------------------------------------------------------------------------------------------------
501 to 1,200                              Single sample                 80                  3                  4
----------------------------------------------------------------------------------------------------------------
1,201 to 3,200                            Single sample                125                  5                  6
----------------------------------------------------------------------------------------------------------------
3,201 to 10,000                           Single sample                200                  8                  9
----------------------------------------------------------------------------------------------------------------
10,001 to 35,000                          Single sample                315                 12                 13
----------------------------------------------------------------------------------------------------------------
35,000 and above                          Single sample                500                 18                 19
----------------------------------------------------------------------------------------------------------------


[55 FR 51256, Dec. 12, 1990, as amended at 71 FR 75876, Dec. 19, 2006]



Sec. 800.30  Over-the-counter hearing aid controls.

    (a) Scope. This section specifies the requirements for over-the-
counter (OTC) air-conduction hearing aids. Air-

[[Page 14]]

conduction hearing aids that satisfy the requirements in paragraphs (c) 
through (f) of this section are considered ``available'' over the 
counter as section 520(q)(1)(A)(v) of the Federal Food, Drug, and 
Cosmetic Act uses the term. Air-conduction hearing aids that do not meet 
the definition in section 520(q) of the Federal Food, Drug, and Cosmetic 
Act or do not satisfy the following requirements are prescription 
hearing aids. Unless otherwise specified, the requirements in this 
section are in addition to other applicable requirements, including but 
not limited to special controls found in the applicable classification 
regulation in part 874 of this chapter.
    (b) Definitions for the purposes of this section. This section uses 
the following definitions:
    Air-conduction hearing aid. An air-conduction hearing aid is a 
hearing aid that conducts sound to the ear through the air.
    Hearing aid. A hearing aid is any wearable device designed for, 
offered for the purpose of, or represented as aiding persons with or 
compensating for, impaired hearing.
    Licensed person. A licensed person is a person as defined in section 
201(e) of the Federal Food, Drug, and Cosmetic Act that holds a license 
or degree for the diagnosis, assessment, or treatment of hearing loss; 
or that holds a license to sell or distribute hearing aids. A person 
that must meet generally applicable licensing or operating requirements 
such as annual health and safety inspections, provided the generally 
applicable licensing or operating requirement is consistent with this 
section and other applicable requirements under the Federal Food, Drug, 
and Cosmetic Act, is not a ``licensed person'' solely for that reason. A 
person that represents as a marketer, seller, dispenser, distributor, or 
customer support representative (or an equivalent description) is not a 
``licensed person'' solely by making such representations.
    Over-the-counter hearing aid. An over-the-counter (OTC) hearing aid 
is an air-conduction hearing aid that does not require implantation or 
other surgical intervention, and is intended for use by a person age 18 
or older to compensate for perceived mild to moderate hearing 
impairment. The device, through tools, tests, or software, allows the 
user to control the hearing aid and customize it to the user's hearing 
needs. The device may use wireless technology or may include tests for 
self-assessment of hearing loss. The device is available over-the-
counter, without the supervision, prescription, or other order, 
involvement, or intervention of a licensed person, to consumers through 
in-person transactions, by mail, or online, provided that the device 
satisfies the requirements in this section.
    Prescription hearing aid. A prescription hearing aid is a hearing 
aid that is not an OTC hearing aid as defined in this section or a 
hearing aid that does not satisfy the requirements in this section.
    Rebuilt hearing aid. An OTC hearing aid is ``rebuilt'' if the 
manufacturer has inspected and tested the device, made any necessary 
modifications to ensure it meets applicable regulatory requirements, 
including the requirements in this section to be available OTC, and 
adequately reprocessed the device for the next user.
    Sale. Sale includes a lease, rental, or any other purchase or 
exchange for value.
    Tools, tests, or software. Tools, tests, or software are components 
of the device that, individually or in combination, allow a lay user to 
control the device and customize it sufficiently, such as the device's 
output, to meet the user's hearing needs.
    Used hearing aid. A hearing aid is ``used'' if a user has worn it 
for any period of time. However, a hearing aid shall not be ``used'' 
merely because a prospective user wore it as part of a bona fide hearing 
aid evaluation to determine whether to select that particular hearing 
aid for that prospective user. A hearing aid evaluation is ``bona fide'' 
if it was conducted in the presence of the dispenser or a hearing health 
professional selected by the dispenser to assist the prospective user in 
making a determination.
    (c) Labeling. An OTC hearing aid shall bear all of the following in 
the labeling:
    (1) Outside package labeling. The outside package of an OTC hearing 
aid shall bear all of the following:

[[Page 15]]

    (i) Warnings and other important information. All of the following 
shall appear on the outside package:
    (A) (A) Warning against use in people younger than 18.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.000
    
    (B) Symptoms suggesting perceived mild to moderate hearing loss.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.001
    
    (C) Advice of availability of professional services.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.002
    
    (D) ``Red flag'' conditions.

[[Page 16]]

[GRAPHIC] [TIFF OMITTED] TR17AU22.003

    (E) Notice of contact information.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.004
    
    (F) Notice of manufacturer's return policy.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.005
    
    (ii) Statement of build condition. If the OTC hearing aid is used or 
rebuilt, the outside package shall declare that fact. A sticker under 
and visible through the outer wrapper will suffice to declare such fact.
    (iii) Statement of OTC availability. The principal display panel 
shall bear the marks ``OTC'' and ``hearing aid'' with the same 
prominence required under Sec. 801.61(c) of this chapter for the 
device's statement of identity. The device's common name on the 
principal display panel may satisfy all or part of this requirement to 
the extent the common name includes the marks.
    (iv) Indication of battery information. The outside package shall 
indicate the type and number of batteries and whether batteries are 
included in the package.
    (v) Indication of control platform. The outside package shall 
indicate whether a mobile device or other non-included

[[Page 17]]

control platform is required. The indication must include the type of 
platform and how the platform connects to the device.
    (2) Labeling, inside the package. The manufacturer or distributor of 
an OTC hearing aid shall include a user instructional brochure inside 
the package and shall make an electronic version available for download 
without site or customer registration and without requiring purchase of 
any product or service. The user instructional brochure shall include 
all of the following:
    (i) The following warnings, which shall appear in the following 
order and prior to any content except the cover page:
    (A) Warning against use in people younger than 18.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.006
    
    (B) ``Red flag'' conditions.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.007
    
    (C) Warning about pain from device placement.

[[Page 18]]

[GRAPHIC] [TIFF OMITTED] TR17AU22.008

    (ii) Any additional warnings the manufacturer may include prior to 
the cautions and notices to users in paragraph (c)(2)(iii) of this 
section.
    (iii) The following cautions and notices for users, which shall 
appear prior to any content except the cover page and the warnings under 
paragraphs (c)(2)(i) and (ii) of this section:
    (A) Caution about hearing protection.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.009
    
    (B) Caution about excessive sound output.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.010
    
    (C) Caution about components lodging in ear.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.011
    
    (D) Advice to seek professional services.

[[Page 19]]

[GRAPHIC] [TIFF OMITTED] TR17AU22.012

    (E) Note about user expectations.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.013
    
    (E) Note about reporting adverse events to FDA.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.014
    
    (iv) An illustration(s) of the OTC hearing aid that indicates 
operating controls, user adjustments, and the battery compartment.
    (v) Information on the function of all controls intended for user 
adjustment.
    (vi) A description of any accessory that accompanies the OTC hearing 
aid, including but not limited to wax guards and accessories for use 
with a computer, television, or telephone.
    (vii) Specific instructions for all of the following:
    (A) Instructions for sizing or inserting the eartip of the OTC 
hearing aid to prevent insertion past the depth limit and damage to the 
tympanic membrane.
    (B) The tools, tests, or software that allow the user to control the 
OTC hearing aid, including self-selection and self-checking the 
performance of the OTC hearing aid, and customize it to

[[Page 20]]

the user's hearing needs, including information about properly fitting 
eartips.
    (C) Use of the OTC hearing aid with any accompanying accessories.
    (D) Maintenance and care of the OTC hearing aid, including how a lay 
user can clean, disinfect, and replace parts or how to seek 
replacements, as well as how to store the hearing aid when it will not 
be used for an extended period of time.
    (E) If the battery is replaceable or rechargeable, how to replace or 
recharge the battery, including a generic designation of replacement 
batteries.
    (F) Expected battery life.
    (G) Any other information necessary for adequate directions for use 
as defined in Sec. 801.5 of this chapter.
    (viii) Identification of any known physiological side effects 
associated with the use of the OTC hearing aid that may warrant 
consultation with a physician, referring to an ear-nose-throat doctor 
when preferable, including if applicable, skin irritation and 
accelerated accumulation of cerumen (ear wax).
    (ix) The technical specifications required by paragraph (c)(4) of 
this section.
    (x) A description of commonly occurring, avoidable events that could 
adversely affect or damage the OTC hearing aid, including but not 
limited to, as applicable, ear wax buildup, drops, immersion in water, 
or exposure to excessive heat.
    (xi) If the hearing aid incorporates wireless technology in its 
programming or use, appropriate warnings, instructions, and information 
relating to electromagnetic compatibility and wireless technology and 
human exposure to non-ionizing radiation.
    (xii) Information on how and where to obtain repair service or 
replacements, including at least one specific address where the user can 
go or send the OTC hearing aid to obtain such repair service or 
replacements.
    (xiii) If clinical or non-clinical studies were conducted by or for 
the manufacturer to support the performance of the OTC hearing aid, a 
summary of all such studies.
    (3) Labeling on the device. The labeling on an OTC hearing aid 
itself shall bear all of the following clearly and permanently, except 
as provided in paragraph (c)(3)(iii) of this section:
    (i) The serial number.
    (ii) If the battery is removable, a ``+'' symbol to indicate the 
positive terminal for battery insertion unless the battery's physical 
design prevents inserting the battery in the reversed position.
    (iii) If the OTC hearing aid is used or rebuilt, the manufacturer 
shall physically attach a removable tag to the hearing aid declaring 
that fact.
    (4) Technical specifications. All of the following technical 
specifications shall appear in the user instructional brochure that 
accompanies the device. You may additionally include it on the outside 
package:
    (i) The maximum output limit value (Output Sound Pressure Level 90 
(OSPL90)).
    (ii) The full-on gain value, which is the gain with a 50 decibel 
(dB) Sound Pressure Level (SPL) pure-tone input and volume set to full 
on.
    (iii) The total harmonic distortion value.
    (iv) The self-generated noise value.
    (v) The latency value.
    (vi) The upper and lower cutoff frequencies for bandwidth.
    (5) Software device labeling. OTC hearing aid software that is not 
distributed with the hearing aid or amplification platform shall meet 
all of the following labeling requirements. With respect to the 
information required under paragraphs (c)(1) through (4) of this 
section, the information must be provided in the software device 
labeling, as specified in paragraphs (c)(5)(i) through (v) of this 
section, rather than the locations (e.g., outside package labeling) 
specified in paragraphs (c)(1) through (4):
    (i) Prior to first use of the software or obtaining payment 
information for the software, whichever occurs first, the labeling must 
clearly and prominently present all of the following to the prospective 
user. For each, the labeling must remain visible until the user 
dismisses it or proceeds to the next step:
    (A) Compatibility and minimum operating requirements for the 
software device.

[[Page 21]]

    (B) Disclosures of any fees or payments after first use or initial 
payment, including but not limited to any fees or payments relating to 
subscriptions, add-on features, or continued access to features or 
services. The disclosures must name and briefly describe what each fee 
or payment covers.
    (C) The information required under paragraphs (c)(1)(i), (iii), and 
(v) of this section.
    (ii) Prior to first use of the software, the labeling must clearly 
and prominently present all of the following to the prospective user:
    (A) The information required under paragraph (c)(2)(i)(A) of this 
section, and it must remain visible until the user acknowledges it.
    (B) The information required under paragraphs (c)(2)(i)(B) and (C), 
(c)(2)(ii), (iii), and (v), (c)(2)(vii)(B) and (G), and (c)(2)(viii) and 
(ix) of this section, and the information must remain visible until the 
user dismisses it or proceeds to the next step.
    (C) All other information required under paragraph (c)(2) of this 
section, to the extent applicable, and the information must remain 
visible until the user dismisses it or proceeds to the next step.
    (iii) The software device labeling must include the information 
required under paragraphs (c)(3)(i) and (c)(4) of this section.
    (iv) All of the software device labeling must be accessible for 
review after acknowledgment, dismissal, or proceeding to the next step.
    (v) If there are changes to any of the labeling required under 
paragraph (c)(5) of this section, the labeling with the changed 
information must be presented to the user until the user dismisses it.
    (d) Output limits. The output limit for an OTC hearing aid shall be 
the device maximum acoustic output sound pressure level (SPL) with an 
acoustic coupler as described in paragraph (e)(6) of this section when 
the device input is a 90 dB SPL pure-tone, and the gain/volume control 
is full on. An OTC hearing aid shall not exceed the following limits at 
any of the frequencies at which the device is intended to operate:
    (1) General output limit. An OTC hearing aid shall not exceed an 
output limit of 111 dB SPL at any frequency except as provided in 
paragraph (d)(2) of this section.
    (2) Output limit for a device with activated input-controlled 
compression. An OTC hearing aid that has input-controlled compression 
activated shall not exceed an output limit of 117 dB SPL at any 
frequency.
    (e) Electroacoustic performance limits. An OTC hearing aid shall 
perform within all of the following electroacoustic limits. Measure each 
electroacoustic performance characteristic using an acoustic coupler as 
described in paragraph (e)(6) of this section, where applicable:
    (1) Output distortion control limits. Test the output distortion of 
the OTC hearing aid as follows to ensure that it does not exceed the 
limit specified in paragraphs (e)(1)(i) through (iii) of this section.
    (i) The total harmonic distortion plus noise shall not exceed 5 
percent for output levels within one of the following sets of levels, 
depending on the test method:
    (A) Using sine wave-based testing, measure at 70 dB SPL and 100 dB 
SPL; or
    (B) Using a 500-hertz (Hz) one-third-octave pulsed-noise signal, 
measure at 67 dB SPL and 97 dB SPL.
    (ii) You must measure the total harmonic distortion using a 500-Hz 
input tone with an analyzer that has a bandwidth at least as wide as the 
frequency limits of the OTC hearing aid.
    (iii) You must measure the output distortion at the OTC hearing 
aid's maximum volume and the input sound level to the OTC hearing aid 
adjusted to produce the required outputs.
    (2) Self-generated noise level limits. Self-generated noise shall 
not exceed 32 dBA. You must disable any methods that artificially lower 
the apparent noise floor for the measurement. Such methods would include 
but are not limited to auto-muting and downward expansion.
    (3) Latency. Latency shall not exceed 15 ms. You must measure the 
latency with a method that is accurate and repeatable to within 1.5 ms.
    (4) Frequency response bandwidth. The lower cutoff frequency shall 
extend to 250 Hz or below, and the upper cutoff

[[Page 22]]

frequency shall extend to 5 kHz or greater. You must measure the 
frequency response bandwidth as specified in the Method for clause 4.1 
in ANSI/CTA-2051:2017.
    (5) Frequency response smoothness. No single peak in the one-third-
octave frequency response shall exceed 12 dB relative to the average 
levels of the one-third-octave bands, two-thirds octave above and below 
the peak. You must measure the frequency response smoothness using 
values for a diffuse field and the corrected one-third-octave frequency 
insertion response as specified in the Method for clause 4.1 in ANSI/
CTA-2051:2017.
    (6) Acoustic coupler choice. Where applicable, use one of the 
following acoustic couplers to measure electroacoustic performance:
    (i) When compatible with the device design, a 2-cubic centimeter 
(cm\3\) acoustic coupler; or
    (ii) When a 2-cm\3\ acoustic coupler is not compatible with the 
device design, an acoustic coupler that is a scientifically valid and 
technically equivalent alternative. You must document the rationale for 
using an alternative acoustic coupler.
    (f) Design requirements. An OTC hearing aid must conform to all of 
the following design requirements:
    (1) Insertion depth. The design of an OTC hearing aid shall limit 
the insertion of the most medial component so that, when inserted, the 
component is reasonably expected to remain at least 10 millimeters (mm) 
from the tympanic membrane.
    (2) Use of atraumatic materials. The material for the eartip of an 
OTC hearing aid shall be atraumatic.
    (3) Proper physical fit. The design of an OTC hearing aid shall 
enable consumers to readily achieve a safe, customized, acoustically 
favorable, and comfortable physical fit in the ear canal and/or external 
ear.
    (4) Tools, tests, or software. The OTC hearing aid shall, through 
tools, tests, or software, permit a lay user to control the device and 
customize it to the user's hearing needs.
    (5) User-adjustable volume control. The OTC hearing aid shall have a 
user-adjustable volume control.
    (6) Adequate reprocessing. If the OTC hearing aid is used or 
rebuilt, it must be adequately reprocessed for the next user prior to 
sale.
    (g) Conditions for sale of an OTC hearing aid. The sale of an OTC 
hearing aid is subject to all of the following conditions:
    (1) Age minimum. Sale to or for a person younger than 18 years of 
age is prohibited.
    (2) Statement of OTC availability. Sale of an OTC hearing aid is 
prohibited unless its labeling bears the statement of OTC availability 
required under paragraph (c)(1)(iii) of this section.
    (h) Effect on State law. Any State or local government requirement 
for an OTC hearing aid is preempted to the following extent:
    (1) Preemption. No State or local government shall establish or 
continue in effect any law, regulation, order, or other requirement 
specifically related to hearing products that would restrict or 
interfere with the servicing, marketing, sale, dispensing, use, customer 
support, or distribution of OTC hearing aids through in-person 
transactions, by mail, or online, that is different from, in addition 
to, or otherwise not identical to, the regulations promulgated under 
section 709(b) of the FDA Reauthorization Act of 2017, including any 
State or local requirement for the supervision, prescription, or other 
order, involvement, or intervention of a licensed person for consumers 
to access OTC hearing aids.
    (2) Professional requirements--(i) General rule. The servicing, 
marketing, sale, dispensing, customer support, or distribution of OTC 
hearing aids, or an equivalent activity, whether through in-person 
transactions, by mail, or online, shall not cause, require, or otherwise 
obligate a person providing such services to obtain specialized 
licensing, certification, or any other State or local sanction unless 
such requirement is generally applicable to the sale of any product or 
to all places of business regardless of whether they sell OTC hearing 
aids. However, although a State or local government may not require the 
order, involvement, or intervention of a licensed person for consumers 
to access OTC hearing aids, a licensed person may service, market,

[[Page 23]]

sell, dispense, provide customer support for, or distribute OTC hearing 
aids.
    (ii) Sale of OTC hearing aids is not an exemption. The servicing, 
marketing, sale, dispensing, customer support, or distribution of OTC 
hearing aids does not exempt a person from any State or local 
government's professional or establishment requirements that are 
consistent with this section.
    (iii) Representations may create professional obligations. A person 
shall not incur specialized obligations by representing as a servicer, 
marketer, seller, dispenser, customer support representative, or 
distributor (or an equivalent description) of OTC hearing aids. However, 
a person representing as any other defined professional or 
establishment, or as a State licensed dispenser, is subject to 
applicable State and local requirements even if the person undertakes 
commercial or professional activities only in relation to OTC hearing 
aids.
    (3) Private remedies. This section does not modify or otherwise 
affect the ability of any person to exercise a private right of action 
under any State or Federal product liability, tort, warranty, contract, 
or consumer protection law.
    (i) Incorporation by reference. ANSI/CTA-2051, ``Personal Sound 
Amplification Performance Criteria,'' dated January 2017 (ANSI/CTA-
2051:2017), is incorporated by reference into this section with the 
approval of the Director of the Office of the Federal Register under 5 
U.S.C. 552(a) and 1 CFR part 51. This material is available for 
inspection at the Food and Drug Administration and at the National 
Archives and Records Administration (NARA). Contact the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500. For information on the availability of this material at NARA, 
email: [email protected], or go to: www.archives.gov/federal-
register/cfr/ibr-locations.html. The material may be obtained from 
Consumer Technology Association (CTA), Technology & Standards 
Department, 1919 S Eads Street, Arlington, VA 22202; phone: 703-907-
7600; fax: (703) 907-7693; email: [email protected], website: 
www.cta.tech.

[87 FR 50748, Aug. 17, 2022]



            Subpart C_Administrative Practices and Procedures



Sec. 800.55  Administrative detention.

    (a) General. This section sets forth the procedures for detention of 
medical devices intended for human use believed to be adulterated or 
misbranded. Administrative detention is intended to protect the public 
by preventing distribution or use of devices encountered during 
inspections that may be adulterated or misbranded, until the Food and 
Drug Administration (FDA) has had time to consider what action it should 
take concerning the devices, and to initiate legal action, if 
appropriate. Devices that FDA orders detained may not be used, moved, 
altered, or tampered with in any manner by any person during the 
detention period, except as authorized under paragraph (h) of this 
section, until FDA terminates the detention order under paragraph (j) of 
this section, or the detention period expires, whichever occurs first.
    (b) Criteria for ordering detention. Administrative detention of 
devices may be ordered in accordance with this section when an 
authorized FDA representative, during an inspection under section 704 of 
the Federal Food, Drug, and Cosmetic Act (the act), has reason to 
believe that a device, as defined in section 201(h) of the act, is 
adulterated or misbranded.
    (c) Detention period. The detention is to be for a reasonable period 
that may not exceed 20 calendar days after the detention order is 
issued, unless the FDA Division Director in whose division the devices 
are located determines that a greater period is required to seize the 
devices, to institute injunction proceedings, or to evaluate the need 
for legal action, in which case the Division Director may authorize 
detention for 10 additional calendar days. The additional 10-calendar-
day detention period may be ordered at the time the detention order is 
issued or at any time thereafter. The entire detention period may not 
exceed 30 calendar days, except when the detention period is extended 
under paragraph (g)(6) of this section. An authorized FDA representative 
may, in accordance with paragraph (j) of this section, terminate

[[Page 24]]

a detention before the expiration of the detention period.
    (d) Issuance of detention order. (1) The detention order shall be 
issued in writing, in the form of a detention notice, signed by the 
authorized FDA representative who has reason to believe that the devices 
are adulterated or misbranded, and issued to the owner, operator, or 
agent in charge of the place where the devices are located. If the owner 
or the user of the devices is different from the owner, operator, or 
agent in charge of the place where the devices are detained, a copy of 
the detention order shall be provided to the owner or user of the 
devices if the owner's or user's identity can be readily determined.
    (2) If detention of devices in a vehicle or other carrier is 
ordered, a copy of the detention order shall be provided to the shipper 
of record and the owner of the vehicle or other carrier, if their 
identities can be readily determined.
    (3) The detention order shall include the following information:
    (i) A statement that the devices identified in the order are 
detained for the period shown;
    (ii) A brief, general statement of the reasons for the detention;
    (iii) The location of the devices;
    (iv) A statement that these devices are not to be used, moved, 
altered, or tampered with in any manner during that period, except as 
permitted under paragraph (h) of this section, without the written 
permission of an authorized FDA representative;
    (v) Identification of the detained devices;
    (vi) The detention order number;
    (vii) The date and hour of the detention order;
    (viii) The period of the detention;
    (ix) The text of section 304(g) of the act and paragraph (g) (1) and 
(2) of this section;
    (x) A statement that any informal hearing on an appeal of a 
detention order shall be conducted as a regulatory hearing under part 16 
of this chapter, with certain exceptions described in paragraph (g)(3) 
of this section; and
    (xi) The mailing address, telephone number, and name of the FDA 
Division Director.
    (e) Approval of detention order. A detention order, before issuance, 
shall be approved by the FDA Division Director in whose division the 
devices are located. If prior written approval is not feasible, prior 
oral approval shall be obtained and confirmed by written memorandum 
within FDA as soon as possible.
    (f) Labeling or marking a detained device. An FDA representative 
issuing a detention order under paragraph (d) of this section shall 
label or mark the devices with official FDA tags that include the 
following information:
    (1) A statement that the devices are detained by the United States 
Government in accordance with section 304(g) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 334(g)).
    (2) A statement that the devices shall not be used, moved, altered, 
or tampered with in any manner for the period shown, without the written 
permission of an authorized FDA representative, except as authorized in 
paragraph (h) of this section.
    (3) A statement that the violation of a detention order or the 
removal or alteration of the tag is punishable by fine or imprisonment 
or both (section 303 of the act, 21 U.S.C. 333).
    (4) The detention order number, the date and hour of the detention 
order, the detention period, and the name of the FDA representative who 
issued the detention order.
    (g) Appeal of a detention order. (1) A person who would be entitled 
to claim the devices, if seized, may appeal a detention order. Any 
appeal shall be submitted in writing to the FDA Division Director in 
whose division the devices are located within 5 working days of receipt 
of a detention order. If the appeal includes a request for an informal 
hearing, as defined in section 201(x) of the act, the appellant shall 
request either that a hearing be held within 5 working days after the 
appeal is filed or that the hearing be held at a later date, which shall 
not be later than 20 calendar days after receipt of a detention order.
    (2) The appellant of a detention order shall state the ownership or 
proprietary interest the appellant has in the detained devices. If the 
detained devices are located at a place other than

[[Page 25]]

an establishment owned or operated by the appellant, the appellant shall 
include documents showing that the appellant would have legitimate 
authority to claim the devices if seized.
    (3) Any informal hearing on an appeal of a detention order shall be 
conducted as a regulatory hearing pursuant to regulation in accordance 
with part 16 of this chapter, except that:
    (i) The detention order under paragraph (d) of this section, rather 
than the notice under Sec. 16.22(a) of this chapter, provides notice of 
opportunity for a hearing under this section and is part of the 
administrative record of the regulatory hearing under Sec. 16.80(a) of 
this chapter.
    (ii) A request for a hearing under this section should be addressed 
to the FDA Division Director.
    (iii) The last sentence of Sec. 16.24(e) of this chapter, stating 
that a hearing may not be required to be held at a time less than 2 
working days after receipt of the request for a hearing, does not apply 
to a hearing under this section.
    (iv) Paragraph (g)(4) of this section, rather than Sec. 16.42(a) of 
this chapter, describes the FDA employees who preside at hearings under 
this section.
    (4) The presiding officer of a regulatory hearing on an appeal of a 
detention order, who also shall decide the appeal, shall be an Office of 
Regulatory Affairs Program Director or another FDA official senior to an 
FDA Division Director who is permitted by Sec. 16.42(a) of this chapter 
to preside over the hearing.
    (5) If the appellant requests a regulatory hearing and requests that 
the hearing be held within 5 working days after the appeal is filed, the 
presiding officer shall, within 5 working days, hold the hearing and 
render a decision affirming or revoking the detention.
    (6) If the appellant requests a regulatory hearing and requests that 
the hearing be held at a date later than within 5 working days after the 
appeal is filed, but not later than 20 calendar days after receipt of a 
detention order, the presiding officer shall hold the hearing at a date 
agreed upon by FDA and the appellant. The presiding officer shall decide 
whether to affirm or revoke the detention within 5 working days after 
the conclusion of the hearing. The detention period extends to the date 
of the decision even if the 5-working-day period for making the decision 
extends beyond the otherwise applicable 20-calendar-day or 30-calendar-
day detention period.
    (7) If the appellant appeals the detention order but does not 
request a regulatory hearing, the presiding officer shall render a 
decision on the appeal affirming or revoking the detention within 5 
working days after the filing of the appeal.
    (8) If the presiding officer affirms a detention order, the devices 
continue to be detained until FDA terminates the detention under 
paragraph (j) of this section or the detention period expires, whichever 
occurs first.
    (9) If the presiding officer revokes a detention order, FDA shall 
terminate the detention under paragraph (j) of this section.
    (h) Movement of detained devices. (1) Except as provided in this 
paragraph (h), no person shall move detained devices within or from the 
place where they have been ordered detained until FDA terminates the 
detention under paragraph (j) of this section or the detention period 
expires, whichever occurs first.
    (2) If detained devices are not in final form for shipment, the 
manufacturer may move them within the establishment where they are 
detained to complete the work needed to put them in final form. As soon 
as the devices are moved for the purpose of the preceding sentence, the 
individual responsible for their movement shall orally notify the FDA 
representative who issued the detention order, or another responsible 
division office official, of the movement of the devices. As soon as the 
devices are put in final form, they shall be segregated from other 
devices, and the individual responsible for their movement shall orally 
notify the FDA representative who issued the detention order, or another 
responsible division office official, of their new location. The devices 
put in final form shall not be moved further without FDA approval.
    (3) The FDA representative who issued the detention order, or 
another responsible division office official, may

[[Page 26]]

approve, in writing, the movement of detained devices for any of the 
following purposes:
    (i) To prevent interference with an establishment's operations or 
harm to the devices.
    (ii) To destroy the devices.
    (iii) To bring the devices into compliance.
    (iv) For any other purpose that the FDA representative who issued 
the detention order, or other responsible division office official, 
believes is appropriate in the case.
    (4) If an FDA representative approves the movement of detained 
devices under paragraph (h)(3) of this section, the detained devices 
shall remain segregated from other devices and the person responsible 
for their movement shall immediately orally notify the official who 
approved the movement of the devices, or another responsible FDA 
division office official, of the new location of the detained devices.
    (5) Unless otherwise permitted by the FDA representative who is 
notified of, or who approves, the movement of devices under this 
paragraph, the required tags shall accompany the devices during and 
after movement and shall remain with the devices until FDA terminates 
the detention or the detention period expires, whichever occurs first.
    (i) Actions involving adulterated or misbranded devices. If FDA 
determines that the detained devices, including any that have been put 
in final form, are adulterated or misbranded, or both, it may initiate 
legal action against the devices or the responsible individuals, or 
both, or request that the devices be destroyed or otherwise brought into 
compliance with the act under FDA's supervision.
    (j) Detention termination. If FDA decides to terminate a detention 
or when the detention period expires, whichever occurs first, an FDA 
representative authorized to terminate a detention will issue a 
detention termination notice releasing the devices to any person who 
received the original detention order or that person's representative 
and will remove, or authorize in writing the removal of, the required 
labels or tags.
    (k) Recordkeeping requirements. (1) After issuance of a detention 
order under paragraph (d) of this section, the owner, operator, or agent 
in charge of any factory, warehouse, other establishment, or consulting 
laboratory where detained devices are manufactured, processed, packed, 
or held shall have, or establish, and maintain adequate records relating 
to how the detained devices may have become adulterated or misbranded, 
records on any distribution of the devices before and after the 
detention period, records on the correlation of any in-process detained 
devices that are put in final form under paragraph (h) of this section 
to the completed devices, records of any changes in, or processing of, 
the devices permitted under the detention order, and records of any 
other movement under paragraph (h) of this section. Records required 
under this paragraph shall be provided to the FDA on request for review 
and copying. Any FDA request for access to records required under this 
paragraph shall be made at a reasonable time, shall state the reason or 
purpose for the request, and shall identify to the fullest extent 
practicable the information or type of information sought in the records 
to which access is requested.
    (2) Records required under this paragraph shall be maintained for a 
maximum period of 2 years after the issuance of the detention order or 
for such other shorter period as FDA directs. When FDA terminates the 
detention or when the detention period expires, whichever occurs first, 
FDA will advise all persons required under this paragraph to keep 
records concerning that detention whether further recordkeeping is 
required for the remainder of the 2-year, or shorter, period. FDA 
ordinarily will not require further recordkeeping if the agency 
determines that the devices are not adulterated or misbranded or that 
recordkeeping is not necessary to protect the public health, unless the 
records are required under other regulations in this chapter (e.g., the 
good manufacturing practice regulation in part 820 of this chapter).

[44 FR 13239, Mar. 9, 1979, as amended at 49 FR 3174, Jan. 26, 1984; 69 
FR 17292, Apr. 2, 2004; 79 FR 9412, Feb. 19, 2014; 82 FR 14147, Mar. 17, 
2017; 85 FR 16555, Mar. 25, 2020]

[[Page 27]]



Sec. 800.75  Requests for supervisory review of certain decisions
made by the Center for Devices and Radiological Health.

    (a) Definitions. The following definitions shall apply to this 
section:
    (1) FDA means the Food and Drug Administration.
    (2) 517A decision means a significant decision made by the Center 
for Devices and Radiological Health, as set forth in section 517A of the 
Federal Food, Drug, and Cosmetic Act, and includes one of the following 
decisions:
    (i) A substantially equivalent order under Sec. 807.100(a)(1) of 
this chapter, or a not substantially equivalent order under Sec. 
807.100(a)(2) of this chapter;
    (ii) An approval order under Sec. 814.44(d) of this chapter, an 
approvable letter under Sec. 814.44(e) of this chapter, a not 
approvable letter under Sec. 814.44(f) of this chapter, or an order 
denying approval under Sec. 814.45 of this chapter;
    (iii) An approval order under Sec. 814.116(b) of this chapter, an 
approvable letter under Sec. 814.116(c) of this chapter, a not 
approvable letter under Sec. 814.116(d) of this chapter, or an order 
denying approval under Sec. 814.118 of this chapter;
    (iv) A grant or denial of a request for breakthrough device 
designation under section 515B of the Federal Food, Drug, and Cosmetic 
Act;
    (v) An approval order under Sec. 812.30(a) of this chapter or a 
disapproval order under Sec. 812.30(c) of this chapter;
    (vi) A failure to reach agreement letter under section 520(g)(7) of 
the Federal Food, Drug, and Cosmetic Act; or
    (vii) A clinical hold determination under section 520(g)(8) of the 
Federal Food, Drug, and Cosmetic Act.
    (3) CDRH means the Center for Devices and Radiological Health.
    (b) Submission of request--(1) Review of 517A decisions. (i) An 
initial or sequential request for supervisory review within CDRH of a 
517A decision under Sec. 10.75 of this chapter must be addressed to the 
next organizational level or higher above the individual who made the 
decision; submitted in electronic format in accordance with section 
745A(b) of the Federal Food, Drug, and Cosmetic Act; marked ``Appeal: 
Request for Supervisory Review''; and received by CDRH no later than 30 
days after the date of the decision involved. Any such request for 
supervisory review not received by CDRH within 30 days after the date of 
the decision involved is not eligible for review. Except as provided in 
paragraph (b)(1)(ii) or (iii) of this section, FDA will render a 
decision within 45 days of the request for supervisory review.
    (ii) A person requesting supervisory review under paragraph 
(b)(1)(i) may request an in-person meeting or teleconference with the 
supervisor reviewing the request for supervisory review. Except as 
provided in paragraph (b)(1)(iii) of this section, if a request for in-
person meeting or teleconference is included in the request for 
supervisory review to CDRH, CDRH will schedule the meeting or 
teleconference to occur within 30 days of receipt of the request. Except 
as provided in paragraph (b)(1)(iii) of this section, a decision will be 
rendered within 30 days of such meeting or teleconference.
    (iii) The timeframes for CDRH to render a decision provided in 
(b)(1)(i) and (ii) of this section, and the timeframe to schedule an in-
person meeting or teleconference review in (b)(1)(ii) of this section, 
do not apply if a matter related to the 517A decision under review is 
referred by CDRH to external experts, such as an advisory committee, as 
provided in Sec. 10.75(b) of this chapter.
    (2) Supervisory review. An initial or sequential request for 
supervisory review within CDRH under Sec. 10.75 of this chapter of a 
decision other than a 517A decision that is not received by CDRH within 
60 days after the date of the decision involved will be denied as 
untimely, unless CDRH, for good cause, permits the request to be filed 
after 60 days. An initial or sequential request for supervisory review 
within CDRH of a decision other than a 517A decision must be addressed 
to the next organizational level or higher above the individual who made 
the decision; submitted in electronic format in accordance with section 
745A(b) of the Federal Food, Drug, and Cosmetic Act, when applicable; 
marked, ``Appeal: Request for Supervisory Review'' in the subject line 
of the electronic request;

[[Page 28]]

and sent to the CDRH Ombudsman at [email protected].

[84 FR 31477, July 2, 2019]



PART 801_LABELING--Table of Contents



                  Subpart A_General Labeling Provisions

Sec.
801.1 Medical devices; name and place of business of manufacturer, 
          packer or distributor.
801.3 Definitions.
801.4 Meaning of intended uses.
801.5 Medical devices; adequate directions for use.
801.6 Medical devices; misleading statements.
801.15 Medical devices; prominence of required label statements.
801.16 Medical devices; Spanish-language version of certain required 
          statements.
801.18 Format of dates provided on a medical device label.

    Subpart B_Labeling Requirements for Unique Device Identification

801.20 Label to bear a unique device identifier.
801.30 General exceptions from the requirement for the label of a device 
          to bear a unique device identifier.
801.35 Voluntary labeling of a device with a unique device identifier.
801.40 Form of a unique device identifier.
801.45 Devices that must be directly marked with a unique device 
          identifier.
801.50 Labeling requirements for stand-alone software.
801.55 Request for an exception from or alternative to a unique device 
          identifier requirement.
801.57 Discontinuation of legacy FDA identification numbers assigned to 
          devices.

      Subpart C_Labeling Requirements for Over-the-Counter Devices

801.60 Principal display panel.
801.61 Statement of identity.
801.62 Declaration of net quantity of contents.
801.63 Medical devices; warning statements for devices containing or 
          manufactured with chlorofluorocarbons and other class I ozone-
          depleting substances.

          Subpart D_Exemptions From Adequate Directions for Use

801.109 Prescription devices.
801.110 Retail exemption for prescription devices.
801.116 Medical devices having commonly known directions.
801.119 In vitro diagnostic products.
801.122 Medical devices for processing, repacking, or manufacturing.
801.125 Medical devices for use in teaching, law enforcement, research, 
          and analysis.
801.127 Medical devices; expiration of exemptions.
801.128 Exceptions or alternatives to labeling requirements for medical 
          devices held by the Strategic National Stockpile.

                       Subpart E_Other Exemptions

801.150 Medical devices; processing, labeling, or repacking.

Subparts F-G [Reserved]

           Subpart H_Special Requirements for Specific Devices

801.405 Labeling of articles intended for lay use in the repairing and/
          or refitting of dentures.
801.410 Use of impact-resistant lenses in eyeglasses and sunglasses.
801.415 Maximum acceptable level of ozone.
800.417 Chlorofluorocarbon propellants.
801.422 Prescription hearing aid labeling.
801.430 User labeling for menstrual tampons.
801.433 Warning statements for prescription and restricted device 
          products containing or manufactured with chlorofluorocarbons 
          or other ozone-depleting substances.
801.435 User labeling for latex condoms.
801.437 User labeling for devices that contain natural rubber.

    Authority: 21 U.S.C. 321, 331-334, 351, 352, 360d, 360i, 360j, 371, 
374.

    Source: 41 FR 6896, Feb. 13, 1976, unless otherwise noted.



                  Subpart A_General Labeling Provisions



Sec. 801.1  Medical devices; name and place of business of
manufacturer, packer or distributor.

    (a) The label of a device in package form shall specify 
conspicuously the name and place of business of the manufacturer, 
packer, or distributor.
    (b) The requirement for declaration of the name of the manufacturer, 
packer, or distributor shall be deemed to be satisfied, in the case of a 
corporation, only by the actual corporate name which may be preceded or 
followed by the name of the particular division of the corporation. 
Abbreviations for ``Company,'' ``Incorporated,'' etc., may

[[Page 29]]

be used and ``The'' may be omitted. In the case of an individual, 
partnership, or association, the name under which the business is 
conducted shall be used.
    (c) Where a device is not manufactured by the person whose name 
appears on the label, the name shall be qualified by a phrase that 
reveals the connection such person has with such device; such as, 
``Manufactured for ___'', ``Distributed by _____'', or any other wording 
that expresses the facts.
    (d) The statement of the place of business shall include the street 
address, city, State, and Zip Code; however, the street address may be 
omitted if it is shown in a current city directory or telephone 
directory. The requirement for inclusion of the ZIP Code shall apply 
only to consumer commodity labels developed or revised after the 
effective date of this section. In the case of nonconsumer packages, the 
ZIP Code shall appear on either the label or the labeling (including the 
invoice).
    (e) If a person manufactures, packs, or distributes a device at a 
place other than his principal place of business, the label may state 
the principal place of business in lieu of the actual place where such 
device was manufactured or packed or is to be distributed, unless such 
statement would be misleading.



Sec. 801.3  Definitions.

    As used in this part:
    Automatic identification and data capture (AIDC) means any 
technology that conveys the unique device identifier or the device 
identifier of a device in a form that can be entered into an electronic 
patient record or other computer system via an automated process.
    Center Director means the Director of the Center for Devices and 
Radiological Health or the Director of the Center for Biologics 
Evaluation and Research, depending on which Center has been assigned 
lead responsibility for the device.
    Combination product has the meaning set forth in Sec. 3.2(e) of 
this chapter.
    Convenience kit means two or more different medical devices packaged 
together for the convenience of the user.
    Device package means a package that contains a fixed quantity of a 
particular version or model of a device.
    Expiration date means the date by which the label of a device states 
the device must or should be used.
    FDA, we, or us means the Food and Drug Administration.
    Finished device means any device or accessory to any device that is 
suitable for use or capable of functioning.
    Global Unique Device Identification Database (GUDID) means the 
database that serves as a repository of information to facilitate the 
identification of medical devices through their distribution and use.
    Human cells, tissues, or cellular or tissue-based product (HCT/P) 
regulated as a device means an HCT/P as defined in Sec. 1271.3(d) of 
this chapter that does not meet the criteria in Sec. 1271.10(a) and 
that is also regulated as a device.
    Implantable device means a device that is intended to be placed in a 
surgically or naturally formed cavity of the human body. A device is 
regarded as an implantable device for the purpose of this part only if 
it is intended to remain implanted continuously for a period of 30 days 
or more, unless the Commissioner of Food and Drugs determines otherwise 
in order to protect human health.
    Label has the meaning set forth in section 201(k) of the Federal 
Food, Drug, and Cosmetic Act.
    Labeler means:
    (1) Any person who causes a label to be applied to a device with the 
intent that the device will be commercially distributed without any 
intended subsequent replacement or modification of the label; and
    (2) Any person who causes the label of a device to be replaced or 
modified with the intent that the device will be commercially 
distributed without any subsequent replacement or modification of the 
label, except that the addition of the name of, and contact information 
for, a person who distributes the device, without making any other 
changes to the label, is not a modification for the purposes of 
determining whether a person is a labeler.
    Lot or batch means one finished device or more that consist of a 
single type,

[[Page 30]]

model, class, size, composition, or software version that are 
manufactured under essentially the same conditions and that are intended 
to have uniform characteristics and quality within specified limits.
    Shipping container means a container used during the shipment or 
transportation of devices, and whose contents may vary from one shipment 
to another.
    Specification means any requirement with which a device must 
conform.
    Unique device identifier (UDI) means an identifier that adequately 
identifies a device through its distribution and use by meeting the 
requirements of Sec. 830.20 of this chapter. A unique device identifier 
is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies the specific version or model of a device and the labeler of 
that device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured;
    (v) For an HCT/P regulated as a device, the distinct identification 
code required by Sec. 1271.290(c) of this chapter.
    Universal product code (UPC) means the product identifier used to 
identify an item sold at retail in the United States.
    Version or model means all devices that have specifications, 
performance, size, and composition, within limits set by the labeler.

[78 FR 58817, Sept. 24, 2013]



Sec. 801.4  Meaning of intended uses.

    The words intended uses or words of similar import in Sec. Sec. 
801.5, 801.119, 801.122, and 1100.5 of this chapter refer to the 
objective intent of the persons legally responsible for the labeling of 
an article (or their representatives). The intent may be shown by such 
persons' expressions, the design or composition of the article, or by 
the circumstances surrounding the distribution of the article. This 
objective intent may, for example, be shown by labeling claims, 
advertising matter, or oral or written statements by such persons or 
their representatives. Objective intent may be shown, for example, by 
circumstances in which the article is, with the knowledge of such 
persons or their representatives, offered or used for a purpose for 
which it is neither labeled nor advertised; provided, however, that a 
firm would not be regarded as intending an unapproved new use for a 
device approved, cleared, granted marketing authorization, or exempted 
from premarket notification based solely on that firm's knowledge that 
such device was being prescribed or used by health care providers for 
such use. The intended uses of an article may change after it has been 
introduced into interstate commerce by its manufacturer. If, for 
example, a packer, distributor, or seller intends an article for 
different uses than those intended by the person from whom he or she 
received the article, such packer, distributor, or seller is required to 
supply adequate labeling in accordance with the new intended uses.

[86 FR 41401, Aug. 2, 2021]

    Effective Date Note: At 82 FR 2217, Jan. 9, 2017, Sec. 801.4 was 
revised, effective Feb. 8, 2017. At 82 FR 9501, Feb. 7, 2017, this 
amendment was delayed until Mar. 21, 2017. At 82 FR 14319, Mar. 20, 
2017, this amendment was further delayed until Mar. 19, 2018. At 83 FR 
11639, Mar. 16, 2018 this amendment was delayed indefinitely. For the 
convenience of the user, the revised text is set forth as follows:



Sec. 801.4  Meaning of intended uses.

    The words intended uses or words of similar import in Sec. Sec. 
801.5, 801.119, 801.122, and 1100.5 of this chapter refer to the 
objective intent of the persons legally responsible for the labeling of 
devices. The intent is determined by such persons' expressions or may be 
shown by the circumstances surrounding the distribution of the article. 
This objective intent may, for example, be shown by labeling claims, 
advertising matter, or oral or written statements by such persons or 
their representatives. It may be shown, for example, by circumstances in 
which the article is, with the knowledge of such persons or their 
representatives, offered and used for a purpose for which it is neither 
labeled nor advertised. The intended uses of an article may change after 
it has been introduced into

[[Page 31]]

interstate commerce by its manufacturer. If, for example, a packer, 
distributor, or seller intends an article for different uses than those 
intended by the person from whom he received the device, such packer, 
distributor, or seller is required to supply adequate labeling in 
accordance with the new intended uses. And if the totality of the 
evidence establishes that a manufacturer objectively intends that a 
device introduced into interstate commerce by him is to be used for 
conditions, purposes, or uses other than ones for which it has been 
approved, cleared, granted marketing authorization, or is exempt from 
premarket notification requirements (if any), he is required, in 
accordance with section 502(f) of the Federal Food, Drug, and Cosmetic 
Act, or, as applicable, duly promulgated regulations exempting the 
device from the requirements of section 502(f)(1), to provide for such 
device adequate labeling that accords with such other intended uses.



Sec. 801.5  Medical devices; adequate directions for use.

    Adequate directions for use means directions under which the layman 
can use a device safely and for the purposes for which it is intended. 
Section 801.4 defines intended use. Directions for use may be inadequate 
because, among other reasons, of omission, in whole or in part, or 
incorrect specification of:
    (a) Statements of all conditions, purposes, or uses for which such 
device is intended, including conditions, purposes, or uses for which it 
is prescribed, recommended, or suggested in its oral, written, printed, 
or graphic advertising, and conditions, purposes, or uses for which the 
device is commonly used; except that such statements shall not refer to 
conditions, uses, or purposes for which the device can be safely used 
only under the supervision of a practitioner licensed by law and for 
which it is advertised solely to such practitioner.
    (b) Quantity of dose, including usual quantities for each of the 
uses for which it is intended and usual quantities for persons of 
different ages and different physical conditions.
    (c) Frequency of administration or application.
    (d) Duration of administration or application.
    (e) Time of administration or application, in relation to time of 
meals, time of onset of symptoms, or other time factors.
    (f) Route or method of administration or application.
    (g) Preparation for use, i.e., adjustment of temperature, or other 
manipulation or process.



Sec. 801.6  Medical devices; misleading statements.

    Among representations in the labeling of a device which render such 
device misbranded is a false or misleading representation with respect 
to another device or a drug or food or cosmetic.



Sec. 801.15  Medical devices; prominence of required label statements;
use of symbols in labeling.

    (a) A word, statement, or other information required by or under 
authority of the act to appear on the label may lack that prominence and 
conspicuousness required by section 502(c) of the act by reason, among 
other reasons, of:
    (1) The failure of such word, statement, or information to appear on 
the part or panel of the label which is presented or displayed under 
customary conditions of purchase;
    (2) The failure of such word, statement, or information to appear on 
two or more parts or panels of the label, each of which has sufficient 
space therefor, and each of which is so designed as to render it likely 
to be, under customary conditions of purchase, the part or panel 
displayed;
    (3) The failure of the label to extend over the area of the 
container or package available for such extension, so as to provide 
sufficient label space for the prominent placing of such word, 
statement, or information;
    (4) Insufficiency of label space for the prominent placing of such 
word, statement, or information, resulting from the use of label space 
for any word, statement, design, or device which is not required by or 
under authority of the act to appear on the label;
    (5) Insufficiency of label space for the placing of such word, 
statement, or information, resulting from the use of label space to give 
materially greater conspicuousness to any other word, statement, or 
information, or to any design or device; or

[[Page 32]]

    (6) Smallness or style of type in which such word, statement, or 
information appears, insufficient background contrast, obscuring designs 
or vignettes, or crowding with other written, printed, or graphic 
matter.
    (b) No exemption depending on insufficiency of label space, as 
prescribed in regulations promulgated under section 502(b) of the act, 
shall apply if such insufficiency is caused by:
    (1) The use of label space for any word, statement, design, or 
device which is not required by or under authority of the act to appear 
on the label;
    (2) The use of label space to give greater conspicuousness to any 
word, statement, or other information than is required by section 502(c) 
of the act; or
    (3) The use of label space for any representation in a foreign 
language.
    (c)(1)(i) All words, statements, and other information required by 
or under authority of the act to appear on the label or labeling for a 
device shall appear thereon in one or more of the following formats:
    (A) The English language;
    (B) In the case of articles distributed solely in Puerto Rico or in 
a Territory where the predominant language is one other than English, 
the predominant language may be substituted for English;
    (C) A symbol accompanied by adjacent explanatory English text, or 
text in the predominant language of the Territory, in the case of 
articles distributed solely in Puerto Rico or in a Territory where the 
predominant language is one other than English;
    (D) A symbol not accompanied by adjacent explanatory text that:
    (1) Is contained in a standard that FDA recognizes under its 
authority in section 514(c) of the act;
    (2) Is used according to the specifications for use of the symbol 
set forth in FDA's section 514(c) recognition; and
    (3) Is explained in a paper or electronic symbols glossary that is 
included in the labeling for the device and the labeling on or within 
the package containing the device bears a prominent and conspicuous 
statement identifying the location of the symbols glossary that is 
written in English or, in the case of articles distributed solely in 
Puerto Rico or in a Territory where the predominant language is one 
other than English, the predominant language may be used;
    (E) A symbol not accompanied by adjacent explanatory text that:
    (1) Is established in a standard developed by a standards 
development organization (SDO);
    (2) Is not contained in a standard that is recognized by FDA under 
its authority in section 514(c) of the act or is contained in a standard 
that is recognized by FDA but is not used according to the 
specifications for use of the symbol set forth in FDA's section 514(c) 
recognition;
    (3) Is determined by the manufacturer to be likely to be read and 
understood by the ordinary individual under customary conditions of 
purchase and use in compliance with section 502(c) of the act;
    (4) Is used according to the specifications for use of the symbol 
set forth in the SDO-developed standard; and
    (5) Is explained in a paper or electronic symbols glossary that is 
included in the labeling for the device and the labeling on or within 
the package containing the device bears a prominent and conspicuous 
statement identifying the location of the symbols glossary that is 
written in English or, in the case of articles distributed solely in 
Puerto Rico or in a Territory where the predominant language is one 
other than English, the predominant language may be used;
    (F) The symbol statement ``Rx only'' or ``[rx] only'' may be used as 
provided under Sec. 801.109(b)(1).
    (ii) The use of symbols in device labeling which do not meet the 
requirements of paragraph (c)(1)(i) of this section renders a device 
misbranded under section 502(c) of the act.
    (iii) For purposes of paragraph (c)(1)(i) of this section:
    (A) An SDO is an organization that is nationally or internationally 
recognized and that follows a process for standard development that is 
transparent, (i.e., open to public scrutiny), where the participation is 
balanced, where an appeals process is included, where the standard is 
not in conflict with any statute, regulation, or policy

[[Page 33]]

under which FDA operates, and where the standard is national or 
international in scope.
    (B) The term ``symbols glossary'' means a compiled listing of:
    (1) Each SDO-established symbol used in the labeling for the device;
    (2) The title and designation number of the SDO-developed standard 
containing the symbol;
    (3) The title of the symbol and its reference number, if any, in the 
standard; and
    (4) The meaning or explanatory text for the symbol as provided in 
the FDA recognition or, if FDA has not recognized the standard or 
portion of the standard in which the symbol is located or the symbol is 
not used according to the specifications for use of the symbol set forth 
in FDA's section 514(c) recognition, the explanatory text as provided in 
the standard.
    (2) If the label contains any representation in a foreign language, 
all words, statements, and other information required by or under 
authority of the act to appear on the label shall appear thereon in the 
foreign language.
    (3) If the labeling contains any representation in a foreign 
language, all words, statements, and other information required by or 
under authority of the act to appear on the label or labeling shall 
appear on the labeling in the foreign language.

[41 FR 6896, Feb. 13, 1976, as amended at 81 FR 38930, June 15, 2016]



Sec. 801.16  Medical devices; Spanish-language version of certain 
required statements.

    If devices restricted to prescription use only are labeled solely in 
Spanish for distribution in the Commonwealth of Puerto Rico where 
Spanish is the predominant language, such labeling is authorized under 
Sec. 801.15(c).



Sec. 801.18  Format of dates provided on a medical device label.

    (a) In general. Whenever the label of a medical device includes a 
printed expiration date, date of manufacture, or any other date intended 
to be brought to the attention of the user of the device, the date must 
be presented in the following format: The year, using four digits; 
followed by the month, using two digits; followed by the day, using two 
digits; each separated by hyphens. For example, January 2, 2014, must be 
presented as 2014-01-02.
    (b) Exceptions. (1) A combination product that properly bears a 
National Drug Code (NDC) number is not subject to the requirements of 
paragraph (a) of this section.
    (2) If the device is an electronic product to which a standard is 
applicable under subchapter J of this chapter, Radiological Health, the 
date of manufacture shall be presented as required by Sec. 
1010.3(a)(2)(ii) of this chapter.

[78 FR 58818, Sept. 24, 2013]



    Subpart B_Labeling Requirements for Unique Device Identification



Sec. 801.20  Label to bear a unique device identifier.

    (a) In general. (1) The label of every medical device shall bear a 
unique device identifier (UDI) that meets the requirements of this 
subpart and part 830 of this chapter.
    (2) Every device package shall bear a UDI that meets the 
requirements of this subpart and part 830 of this chapter.
    (b) Exceptions. Exceptions to the general rule of paragraph (a) of 
this section are provided by Sec. Sec. 801.30, 801.45, and 
801.128(f)(2), and Sec. 801.55 provides a means to request an exception 
or alternative not provided by those provisions.

[78 FR 58818, Sept. 24, 2013]



Sec. 801.30  General exceptions from the requirement for the 
label of a device to bear a unique device identifier.

    (a) In general. The following types of devices are excepted from the 
requirement of Sec. 801.20; a device within one or more of the 
following exceptions is not required to bear a unique device identifier 
(UDI):
    (1) A finished device manufactured and labeled prior to the 
compliance date established by FDA for Sec. 801.20 regarding the 
device. This exception expires with regard to a particular device 3 
years after the compliance date established by FDA for the device.

[[Page 34]]

    (2) A class I device that FDA has by regulation exempted from the 
good manufacturing practice requirements of part 820 of this chapter, 
exclusive of any continuing requirement for recordkeeping under 
Sec. Sec. 820.180 and 820.198.
    (3) Individual single-use devices, all of a single version or model, 
that are distributed together in a single device package, intended to be 
stored in that device package until removed for use, and which are not 
intended for individual commercial distribution. This exception is not 
available for any implantable device. The device package containing 
these individual devices is not excepted from the requirement of Sec. 
801.20, and must bear a UDI.
    (4) A device used solely for research, teaching, or chemical 
analysis, and not intended for any clinical use.
    (5) A custom device within the meaning of Sec. 812.3(b) of this 
chapter.
    (6) An investigational device within the meaning of part 812 of this 
chapter.
    (7) A veterinary medical device not intended for use in the 
diagnosis of disease or other conditions in man, in the cure, 
mitigation, treatment, or prevention of disease in man, or intended to 
affect the structure or any function of the body of man.
    (8) A device intended for export from the United States.
    (9) A device held by the Strategic National Stockpile and granted an 
exception or alternative under Sec. 801.128(f)(2).
    (10) A device for which FDA has established a performance standard 
under section 514(b) of the Federal Food, Drug, and Cosmetic Act and has 
provided therein an exception from the requirement of Sec. 801.20, or 
for which FDA has recognized all or part of a performance standard under 
section 514(c) of the Federal Food, Drug, and Cosmetic Act and has 
included an exception from the requirement of Sec. 801.20 within the 
scope of that recognition.
    (11) A device packaged within the immediate container of a 
combination product or convenience kit, provided that the label of the 
combination product or convenience kit bears a UDI.
    (b) National Drug Code (NDC) Numbers. If a combination product 
properly bears an NDC number on its label--
    (1) The combination product is not subject to the requirements of 
Sec. 801.20.
    (2) A device constituent of such a combination product whose 
components are physically, chemically, or otherwise combined or mixed 
and produced as a single entity as described by Sec. 3.2(e)(1) of this 
chapter is not subject to the requirements of Sec. 801.20.
    (3) Each device constituent of such a combination product, other 
than one described by Sec. 3.2(e)(1) of this chapter, must bear a UDI 
on its label unless paragraph (a)(11) of this section applies.
    (c) Exception for shipping containers. This rule does not require a 
UDI to be placed on any shipping container.
    (d) The UDI of a class I device is not required to include a 
production identifier.

[78 FR 58818, Sept. 24, 2013]



Sec. 801.35  Voluntary labeling of a device with a unique device identifier.

    (a) The labeler of a device that is not required to bear a unique 
device identifier (UDI) may voluntarily comply with Sec. 801.20. If a 
labeler voluntarily includes a UDI for a device, the labeler may 
voluntarily provide information concerning the device under subpart E of 
part 830 of this chapter.
    (b) A device may bear both a Universal Product Code (UPC) and a UDI 
on its label and packages.

[78 FR 58818, Sept. 24, 2013]



Sec. 801.40  Form of a unique device identifier.

    (a) Every unique device identifier (UDI) must meet the technical 
requirements of Sec. 830.20 of this chapter. The UDI must be presented 
in two forms:
    (1) Easily readable plain-text, and
    (2) Automatic identification and data capture (AIDC) technology.
    (b) The UDI must include a device identifier segment. Whenever a 
device label includes a lot or batch number, a serial number, a 
manufacturing date, an expiration date, or for a human cell, tissue, or 
cellular or tissue-based product (HCT/P) regulated as a device, a 
distinct identification code as required by Sec. 1271.290(c) of this 
chapter, the UDI must include a production identifier segment that 
conveys such information.

[[Page 35]]

    (c) If the AIDC technology is not evident upon visual examination of 
the label or device package, the label or device package must disclose 
the presence of AIDC technology.
    (d) A class I device that bears a Universal Product Code (UPC) on 
its label and device packages is deemed to meet all requirements of 
subpart B of this part. The UPC will serve as the unique device 
identifier required by Sec. 801.20.

[78 FR 58818, Sept. 24, 2013]



Sec. 801.45  Devices that must be directly marked with a unique
device identifier.

    (a) In general. A device that must bear a unique device identifier 
(UDI) on its label must also bear a permanent marking providing the UDI 
on the device itself if the device is intended to be used more than once 
and intended to be reprocessed before each use.
    (b) UDI for direct marking. The UDI provided through a direct 
marking on a device may be:
    (1) Identical to the UDI that appears on the label of the device, or
    (2) A different UDI used to distinguish the unpackaged device from 
any device package containing the device.
    (c) Form of a UDI when provided as a direct marking. When a device 
must bear a UDI as a direct marking, the UDI may be provided through 
either or both of the following:
    (1) Easily readable plain-text;
    (2) Automatic identification and data capture (AIDC) technology, or 
any alternative technology, that will provide the UDI of the device on 
demand.
    (d) Exceptions. The requirement of paragraph (a) of this section 
shall not apply to any device that meets any of the following criteria:
    (1) Any type of direct marking would interfere with the safety or 
effectiveness of the device;
    (2) The device cannot be directly marked because it is not 
technologically feasible;
    (3) The device is a single-use device and is subjected to additional 
processing and manufacturing for the purpose of an additional single 
use.
    (4) The device has been previously marked under paragraph (a) of 
this section.
    (e) Exception to be noted in design history file. A labeler that 
decides to make use of an exception under paragraph (d of this section) 
must document the basis of that decision in the design history file 
required by Sec. 820.30(j) of this chapter.

[78 FR 58818, Sept. 24, 2013]



Sec. 801.50  Labeling requirements for stand-alone software.

    (a) Stand-alone software that is not distributed in packaged form 
(e.g., when downloaded from a Web site) is deemed to meet the UDI 
labeling requirements of this subpart if it complies with the 
requirements of paragraph (b) of this section and conveys the version 
number in its production identifier.
    (b) Regardless of whether it is or is not distributed in packaged 
form, stand-alone software regulated as a medical device must provide 
its unique device identifier through either or both of the following:
    (1) An easily readable plain-text statement displayed whenever the 
software is started;
    (2) An easily readable plain-text statement displayed through a menu 
command (e.g., an ``About * * *'' command).
    (c) Stand-alone software that is distributed in both packaged form 
and in a form that is not packaged (e.g., when downloaded from a Web 
site) may be identified with the same device identifier.

[78 FR 58818, Sept. 24, 2013]



Sec. 801.55  Request for an exception from or alternative to a
unique device identifier requirement.

    (a) A labeler may submit a request for an exception from or 
alternative to the requirement of Sec. 801.20 or any other requirement 
of this subpart for a specified device or a specified type of device. A 
written request for an exception or alternative must:
    (1) Identify the device or devices that would be subject to the 
exception or alternative;
    (2) Identify the provisions of this subpart that are the subject of 
the request for an exception or alternative;

[[Page 36]]

    (3) If requesting an exception, explain why you believe the 
requirements of this subpart are not technologically feasible;
    (4) If requesting an alternative, describe the alternative and 
explain why it would provide for more accurate, precise, or rapid device 
identification than the requirements of this subpart or how the 
alternative would better ensure the safety or effectiveness of the 
device that would be subject to the alternative;
    (5) Provide, if known, the number of labelers and the number of 
devices that would be affected if we grant the requested exception or 
alternative; and
    (6) Provide other requested information that the Center Director 
needs to clarify the scope and effects of the requested exception or 
alternative.
    (b) A written request for an exception or alternative must be 
submitted by sending it:
    (1) If the device is regulated by the Center for Biologics 
Evaluation and Research (CBER), by email to: [email protected] 
or by correspondence to: Food and Drug Administration, Center for 
Biologics Evaluation and Research, Document Control Center, 10903 New 
Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993.
    (2) In all other cases, by email to: [email protected], or by 
correspondence to: UDI Regulatory Policy Support, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 3293, Silver Spring, MD 20993-0002.
    (c) The Center Director may grant an exception or alternative, 
either in response to a request or on his or her own initiative, if the 
Center Director determines that an exception is appropriate because the 
requirements of this subpart are not technologically feasible, or that 
an alternative would provide for more accurate, precise, or rapid device 
identification than the requirements of this subpart or would better 
ensure the safety or effectiveness of the device that would be subject 
to the alternative. If we grant an exception or alternative, we may 
include any safeguards or conditions deemed appropriate to ensure the 
adequate identification of the device through its distribution and use. 
Any labeler may make use of an exception or alternative granted under 
this section, provided that such use satisfies all safeguards or 
conditions that are part of the exception or alternative.
    (d) FDA may initiate and grant an exception or alternative if we 
determine that the exception or alternative is in the best interest of 
the public health. Any such exception or alternative will remain in 
effect only so long as there remains a public health need for the 
exception or alternative.
    (e) The Center Director may rescind an exception or alternative 
granted under this section if, after providing an opportunity for an 
informal hearing as defined in section 201(x) of the Federal Food, Drug, 
and Cosmetic Act and under part 16 of this chapter, the Center Director 
determines that the exception or alternative no longer satisfies the 
criteria described in this paragraph (e) or that any safeguard or 
condition required under this paragraph (e) has not been met.

[78 FR 58818, Sept. 24, 2013, as amended at 80 FR 18093, Apr. 3, 2015; 
81 FR 11428, Mar. 4, 2016; 85 FR 18441, Apr. 2, 2020]



Sec. 801.57  Discontinuation of legacy FDA identification
numbers assigned to devices.

    (a) On the date your device must bear a unique device identifier 
(UDI) on its label, any National Health-Related Item Code (NHRIC) or 
National Drug Code (NDC) number assigned to that device is rescinded, 
and you may no longer provide an NHRIC or NDC number on the label of 
your device or on any device package.
    (b) If your device is not required to bear a UDI on its label, any 
NHRIC or NDC number assigned to that device is rescinded as of September 
24, 2018, and beginning on that date, you may no longer provide an NHRIC 
or NDC number of the label of your device or on any device package.
    (c) A labeler who has been assigned an FDA labeler code to 
facilitate use of NHRIC or NDC numbers may continue to use that labeler 
code under a system for the issuance of UDIs, provided that--

[[Page 37]]

    (1) Such use is consistent with the framework of the issuing agency 
that operates that system; and
    (2) No later than September 24, 2014, the labeler submits, and 
obtains FDA approval of, a request for continued use of the assigned 
labeler code. A request for continued use of an assigned labeler code 
must be submitted by email to: [email protected], or by 
correspondence to: UDI Regulatory Policy Support, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 3293, Silver Spring, MD 20993-0002.
    (d) Each request for continued use of an assigned labeler code must 
provide--
    (1) The name, mailing address, email address, and phone number of 
the labeler who is currently using the labeler code;
    (2) The owner/operator account identification used by the labeler to 
submit registration and listing information using FDA's Unified 
Registration and Listing System (FURLS).
    (3) The FDA labeler code that the labeler wants to continue using.

[78 FR 58820, Sept. 24, 2013, as amended at 81 FR 11428, Mar. 4, 2016; 
85 FR 18441, Apr. 2, 2020]



      Subpart C_Labeling Requirements for Over-the-Counter Devices



Sec. 801.60  Principal display panel.

    The term principal display panel, as it applies to over-the-counter 
devices in package form and as used in this part, means the part of a 
label that is most likely to be displayed, presented, shown, or examined 
under customary conditions of display for retail sale. The principal 
display panel shall be large enough to accommodate all the mandatory 
label information required to be placed thereon by this part with 
clarity and conspicuousness and without obscuring designs, vignettes, or 
crowding. Where packages bear alternate principal display panels, 
information required to be placed on the principal display panel shall 
be duplicated on each principal display panel. For the purpose of 
obtaining uniform type size in declaring the quantity of contents for 
all packages of substantially the same size, the term area of the 
principal display panel means the area of the side or surface that bears 
the principal display panel, which area shall be:
    (a) In the case of a rectangular package where one entire side 
properly can be considered to be the principal display panel side, the 
product of the height times the width of that side;
    (b) In the case of a cylindrical or nearly cylindrical container, 40 
percent of the product of the height of the container times the 
circumference; and
    (c) In the case of any other shape of container, 40 percent of the 
total surface of the container: Provided, however, That where such 
container presents an obvious ``principal display panel'' such as the 
top of a triangular or circular package, the area shall consist of the 
entire top surface.

In determining the area of the principal display panel, exclude tops, 
bottoms, flanges at the tops and bottoms of cans, and shoulders and 
necks of bottles or jars. In the case of cylindrical or nearly 
cylindrical containers, information required by this part to appear on 
the principal display panel shall appear within that 40 percent of the 
circumference which is most likely to be displayed, presented, shown, or 
examined under customary conditions of display for retail sale.



Sec. 801.61  Statement of identity.

    (a) The principal display panel of an over-the-counter device in 
package form shall bear as one of its principal features a statement of 
the identity of the commodity.
    (b) Such statement of identity shall be in terms of the common name 
of the device followed by an accurate statement of the principal 
intended action(s) of the device. Such statement shall be placed in 
direct conjunction with the most prominent display of the name and shall 
employ terms descriptive of the principal intended action(s). The 
indications for use shall be included in the directions for use of the 
device, as required by section 502(f)(1) of the act and by the 
regulations in this part.

[[Page 38]]

    (c) The statement of identity shall be presented in bold face type 
on the principal display panel, shall be in a size reasonably related to 
the most prominent printed matter on such panel, and shall be in lines 
generally parallel to the base on which the package rests as it is 
designed to be displayed.



Sec. 801.62  Declaration of net quantity of contents.

    (a) The label of an over-the-counter device in package form shall 
bear a declaration of the net quantity of contents. This shall be 
expressed in the terms of weight, measure, numerical count, or a 
combination of numerical count and weight, measure, or size: Provided, 
That:
    (1) In the case of a firmly established general consumer usage and 
trade custom of declaring the quantity of a device in terms of linear 
measure or measure of area, such respective term may be used. Such term 
shall be augmented when necessary for accuracy of information by a 
statement of the weight, measure, or size of the individual units or of 
the entire device.
    (2) If the declaration of contents for a device by numerical count 
does not give accurate information as to the quantity of the device in 
the package, it shall be augmented by such statement of weight, measure, 
or size of the individual units or of the total weight, measure, or size 
of the device as will give such information; for example, ``100 tongue 
depressors, adult size'', ``1 rectal syringe, adult size'', etc. 
Whenever the Commissioner determines for a specific packaged device that 
an existing practice of declaring net quantity of contents by weight, 
measure, numerical count, or a combination of these does not facilitate 
value comparisions by consumers, he shall by regulation designate the 
appropriate term or terms to be used for such article.
    (b) Statements of weight of the contents shall be expressed in terms 
of avoirdupois pound and ounce. A statement of liquid measure of the 
contents shall be expressed in terms of the U.S. gallon of 231 cubic 
inches and quart, pint, and fluid-ounce subdivisions thereof, and shall 
express the volume at 68 [deg]F (20 [deg]C). See also paragraph (p) of 
this section.
    (c) The declaration may contain common or decimal fractions. A 
common fraction shall be in terms of halves, quarters, eighths, 
sixteenths, or thirty-seconds; except that if there exists a firmly 
established, general consumer usage and trade custom of employing 
different common fractions in the net quantity declaration of a 
particular commodity, they may be employed. A common fraction shall be 
reduced to its lowest terms; a decimal fraction shall not be carried out 
to more than two places. A statement that includes small fractions of an 
ounce shall be deemed to permit smaller variations than one which does 
not include such fractions.
    (d) The declaration shall be located on the principal display panel 
of the label, and with respect to packages bearing alternate principal 
panels it shall be duplicated on each principal display panel.
    (e) The declaration shall appear as a distinct item on the principal 
display panel, shall be separated, by at least a space equal to the 
height of the lettering used in the declaration, from other printed 
label information appearing above or below the declaration and, by at 
least a space equal to twice the width of the letter ``N'' of the style 
of type used in the quantity of contents statement, from other printed 
label information appearing to the left or right of the declaration. It 
shall not include any term qualifying a unit of weight, measure, or 
count, such as ``giant pint'' and ``full quart'', that tends to 
exaggerate. It shall be placed on the principal display panel within the 
bottom 30 percent of the area of the label panel in lines generally 
parallel to the base on which the package rests as it is designed to be 
displayed: Provided, That:
    (1) On packages having a principal display panel of 5 square inches 
or less the requirement for placement within the bottom 30 percent of 
the area of the label panel shall not apply when the declaration of net 
quantity of contents meets the other requirements of this part; and
    (2) In the case of a device that is marketed with both outer and 
inner retail containers bearing the mandatory label

[[Page 39]]

information required by this part and the inner container is not 
intended to be sold separately, the net quantity of contents placement 
requirement of this section applicable to such inner container is 
waived.
    (3) The principal display panel of a device marketed on a display 
card to which the immediate container is affixed may be considered to be 
the display panel of the card, and the type size of the net quantity of 
contents statement is governed by the dimensions of the display card.
    (f) The declaration shall accurately reveal the quantity of device 
in the package exclusive of wrappers and other material packed 
therewith.
    (g) The declaration shall appear in conspicuous and easily legible 
boldface print or type in distinct contrast (by typography, layout, 
color, embossing, or molding) to other matter on the package; except 
that a declaration of net quantity blown, embossed, or molded on a glass 
or plastic surface is permissible when all label information is so 
formed on the surface. Requirements of conspicuousness and legibility 
shall include the specifications that:
    (1) The ratio of height to width of the letter shall not exceed a 
differential of 3 units to 1 unit, i.e., no more than 3 times as high as 
it is wide.
    (2) Letter heights pertain to upper case or capital letters. When 
upper and lower case or all lower case letters are used, it is the lower 
case letter ``o'' or its equivalent that shall meet the minimum 
standards.
    (3) When fractions are used, each component numeral shall meet one-
half the minimum height standards.
    (h) The declaration shall be in letters and numerals in a type size 
established in relationship to the area of the principal display panel 
of the package and shall be uniform for all packages of substantially 
the same size by complying with the following type specifications:
    (1) Not less than one-sixteenth inch in height on packages the 
principal display panel of which has an area of 5 square inches or less.
    (2) Not less than one-eighth inch in height on packages the 
principal display panel of which has an area of more than 5 but not more 
than 25 square inches.
    (3) Not less than three-sixteenths inch in height on packages the 
principal display panel of which has an area of more than 25 but not 
more than 100 square inches.
    (4) Not less than one-fourth inch in height on packages the 
principal display panel of which has an area of more than 100 square 
inches, except not less than one-half inch in height if the area is more 
than 400 square inches.


Where the declaration is blown, embossed, or molded on a glass or 
plastic surface rather than by printing, typing, or coloring, the 
lettering sizes specified in paragraphs (h)(1) through (4) of this 
section shall be increased by one-sixteenth of an inch.
    (i) On packages containing less than 4 pounds or 1 gallon and 
labeled in terms of weight or fluid measure:
    (1) The declaration shall be expressed both in ounces, with 
identification by weight or by liquid measure and, if applicable (1 
pound or 1 pint or more) followed in parentheses by a declaration in 
pounds for weight units, with any remainder in terms of ounces or common 
or decimal fractions of the pound (see examples set forth in paragraphs 
(k) (1) and (2) of this section), or in the case of liquid measure, in 
the largest whole units (quarts, quarts and pints, or pints, as 
appropriate) with any remainder in terms of fluid ounces or common or 
decimal fractions of the pint or quart (see examples set forth in 
paragraphs (k) (3) and (4) of this section). If the net weight of the 
package is less than 1 ounce avoirdupois or the net fluid measure is 
less than 1 fluid ounce, the declaration shall be in terms of common or 
decimal fractions of the respective ounce and not in terms of drams.
    (2) The declaration may appear in more than one line. The term ``net 
weight'' shall be used when stating the net quantity of contents in 
terms of weight. Use of the terms ``net'' or ``net contents'' in terms 
of fluid measure or numerical count is optional. It is sufficient to 
distinguish avoirdupois ounce from fluid ounce through association of 
terms; for example, ``Net wt. 6 oz'' or ``6 oz net wt.,'' and ``6 fl 
oz'' or ``net contents 6 fl oz.''

[[Page 40]]

    (j) On packages containing 4 pounds or 1 gallon or more and labeled 
in terms of weight or fluid measure, the declaration shall be expressed 
in pounds for weight units with any remainder in terms of ounces or 
common or decimal fractions of the pound; in the case of fluid measure, 
it shall be expressed in the largest whole unit, i.e., gallons, followed 
by common or decimal fractions of a gallon or by the next smaller whole 
unit or units (quarts or quarts and pints), with any remainder in terms 
of fluid ounces or common or decimal fractions of the pint or quart; see 
paragraph (k)(5) of this section.
    (k) Examples: (1) A declaration of 1\1/2\ pounds weight shall be 
expressed as ``net wt. 24 oz (1 lb 8 oz),'' or ``Net wt. 24 oz (1\1/2\ 
lb)'' or ``Net wt. 24 oz (1.5 lb).''
    (2) A declaration of three-fourths pound avoirdupois weight shall be 
expressed as ``Net wt. 12 oz.''.
    (3) A declaration of 1 quart liquid measure shall be expressed as 
``Net contents 32 fl oz (1 qt)'' or ``32 fl oz (1 qt).''
    (4) A declaration of 1\3/4\ quarts liquid measure shall be expressed 
as, ``Net contents 56 fl oz (1 qt 1 pt 8 oz)'' or ``Net contents 56 fl 
oz (1 qt 1.5 pt),'' but not in terms of quart and ounce such as ``Net 
contents 56 fl oz (1 qt 24 oz).''
    (5) A declaration of 2\1/2\ gallons liquid measure shall be 
expressed as ``Net contents 2 gal 2 qt'', ``Net contents 2.5 gallons,'' 
or ``Net contents 2\1/2\ gal'' but not as ``2 gal 4 pt''.
    (l) For quantities, the following abbreviations and none other may 
be employed. Periods and plural forms are optional:

gallon gal                            liter l
milliliter ml                         cubic centimeter cc
quart qt                              yard yd
pint pt                               feet or foot ft
ounce oz                              inch in
pound lb                              meter m
grain gr                              centimeter cm
kilogram kg                           millimeter mm
gram g                                fluid fl
milligram mg                          square sq
microgram mcg                         weight wt
 

    (m) On packages labeled in terms of linear measure, the declaration 
shall be expressed both in terms of inches and, if applicable (1 foot or 
more), the largest whole units (yards, yards and feet, feet). The 
declaration in terms of the largest whole units shall be in parentheses 
following the declaration in terms of inches and any remainder shall be 
in terms of inches or common or decimal fractions of the foot or yard; 
if applicable, as in the case of adhesive tape, the initial declaration 
in linear inches shall be preceded by a statement of the width. Examples 
of linear measure are ``86 inches (2 yd 1 ft 2 in)'', ``90 inches (2\1/
2\ yd)'', ``30 inches (2.5 ft)'', ``\3/4\ inch by 36 in (1 yd)'', etc.
    (n) On packages labeled in terms of area measure, the declaration 
shall be expressed both in terms of square inches and, if applicable (1 
square foot or more), the largest whole square unit (square yards, 
square yards and square feet, square feet). The declaration in terms of 
the largest whole units shall be in parentheses following the 
declaration in terms of square inches and any remainder shall be in 
terms of square inches or common or decimal fractions of the square foot 
or square yard; for example, ``158 sq inches (1 sq ft 14 sq in)''.
    (o) Nothing in this section shall prohibit supplemental statements 
at locations other than the principal display panel(s) describing in 
nondeceptive terms the net quantity of contents, provided that such 
supplemental statements of net quantity of contents shall not include 
any term qualifying a unit of weight, measure, or count that tends to 
exaggerate the amount of the device contained in the package; for 
example, ``giant pint'' and ``full quart''. Dual or combination 
declarations of net quantity of contents as provided for in paragraphs 
(a) and (i) of this section are not regarded as supplemental net 
quantity statements and shall be located on the principal display panel.
    (p) A separate statement of net quantity of contents in terms of the 
metric system of weight or measure is not regarded as a supplemental 
statement and an accurate statement of the net quantity of contents in 
terms of the metric system of weight or measure may also appear on the 
principal display panel or on other panels.
    (q) The declaration of net quantity of contents shall express an 
accurate statement of the quantity of contents of the package. 
Reasonable variations caused by loss or gain of moisture during the 
course of good distribution

[[Page 41]]

practice or by unavoidable deviations in good manufacturing practice 
will be recognized. Variations from stated quantity of contents shall 
not be unreasonably large.



Sec. 801.63  Medical devices; warning statements for devices
containing or manufactured with chlorofluorocarbons and other
class I ozone-depleting substances.

    (a) All over-the-counter devices containing or manufactured with 
chlorofluorocarbons, halons, carbon tetrachloride, methyl chloride, or 
any other class I substance designated by the Environmental Protection 
Agency (EPA) shall carry one of the following warnings:
    (1) The EPA warning statement:

    Warning: Contains [or Manufactured with, if applicable] [insert name 
of substance], a substance which harms public health and environment by 
destroying ozone in the upper atmosphere.

    (2) The alternative statement:

    Note: The indented statement below is required by the Federal 
government's Clean Air Act for all products containing or manufactured 
with chlorofluorocarbons (CFC's) [or other class I substance, if 
applicable]:

    Warning: Contains [or Manufactured with, if applicable] [insert name 
of substance], a substance which harms public health and environment by 
destroying ozone in the upper atmosphere.

    CONSULT WITH YOUR PHYSICIAN, HEALTH PROFESSIONAL, OR SUPPLIER IF YOU 
HAVE ANY QUESTION ABOUT THE USE OF THIS PRODUCT.

    (b) The warning statement shall be clearly legible and conspicuous 
on the product, its immediate container, its outer packaging, or other 
labeling in accordance with the requirements of 40 CFR part 82 and 
appear with such prominence and conspicuousness as to render it likely 
to be read and understood by consumers under normal conditions of 
purchase. This provision does not replace or relieve a person from any 
requirements imposed under 40 CFR part 82.

[61 FR 20101, May 3, 1996]



          Subpart D_Exemptions From Adequate Directions for Use



Sec. 801.109  Prescription devices.

    A device which, because of any potentiality for harmful effect, or 
the method of its use, or the collateral measures necessary to its use 
is not safe except under the supervision of a practitioner licensed by 
law to direct the use of such device, and hence for which ``adequate 
directions for use'' cannot be prepared, shall be exempt from section 
502(f)(1) of the act if all the following conditions are met:
    (a) The device is:
    (1)(i) In the possession of a person, or his agents or employees, 
regularly and lawfully engaged in the manufacture, transportation, 
storage, or wholesale or retail distribution of such device; or
    (ii) In the possession of a practitioner, such as physicians, 
dentists, and veterinarians, licensed by law to use or order the use of 
such device; and
    (2) Is to be sold only to or on the prescription or other order of 
such practitioner for use in the course of his professional practice.
    (b) The label of the device, other than surgical instruments, bears:
    (1) The symbol statement ``Rx only'' or ``[rx] only'' or the 
statement ``Caution: Federal law restricts this device to sale by or on 
the order of a ___'', the blank to be filled with the word 
``physician'', ``dentist'', ``veterinarian'', or with the descriptive 
designation of any other practitioner licensed by the law of the State 
in which the practitioner practices to use or order the use of the 
device; and
    (2) The method of its application or use.
    (c) Labeling on or within the package from which the device is to be 
dispensed bears information for use, including indications, effects, 
routes, methods, and frequency and duration of administration, and any 
relevant hazards, contraindications, side effects, and precautions under 
which practitioners licensed by law to administer the device can use the 
device safely and for the purpose for which it is intended, including 
all purposes for which it is advertised or represented:

[[Page 42]]

Provided, however, That such information may be omitted from the 
dispensing package if, but only if, the article is a device for which 
directions, hazards, warnings, and other information are commonly known 
to practitioners licensed by law to use the device. Upon written 
request, stating reasonable grounds therefor, the Commissioner will 
offer an opinion on a proposal to omit such information from the 
dispensing package under this proviso.
    (d) Any labeling, as defined in section 201(m) of the act, whether 
or not it is on or within a package from which the device is to be 
dispensed, distributed by or on behalf of the manufacturer, packer, or 
distributor of the device, that furnishes or purports to furnish 
information for use of the device contains adequate information for such 
use, including indications, effects, routes, methods, and frequency and 
duration of administration and any relevant hazards, contraindications, 
side effects, and precautions, under which practitioners licensed by law 
to employ the device can use the device safely and for the purposes for 
which it is intended, including all purposes for which it is advertised 
or represented. This information will not be required on so-called 
reminder--piece labeling which calls attention to the name of the device 
but does not include indications or other use information.
    (e) All labeling, except labels and cartons, bearing information for 
use of the device also bears the date of the issuance or the date of the 
latest revision of such labeling.

[41 FR 6896, Feb. 13, 1976, as amended at 81 FR 38930, June 15, 2016]



Sec. 801.110  Retail exemption for prescription devices.

    A device subject to Sec. 801.109 shall be exempt at the time of 
delivery to the ultimate purchaser or user from section 502(f)(1) of the 
act if it is delivered by a licensed practitioner in the course of his 
professional practice or upon a prescription or other order lawfully 
issued in the course of his professional practice, with labeling bearing 
the name and address of such licensed practitioner and the directions 
for use and cautionary statements, if any, contained in such order.



Sec. 801.116  Medical devices having commonly known directions.

    A device shall be exempt from section 502(f)(1) of the act insofar 
as adequate directions for common uses thereof are known to the ordinary 
individual.



Sec. 801.119  In vitro diagnostic products.

    A product intended for use in the diagnosis of disease and which is 
an in vitro diagnostic product as defined in Sec. 809.3(a) of this 
chapter shall be deemed to be in compliance with the requirements of 
this part and section 502(f)(1) of the Federal Food, Drug, and Cosmetic 
Act if it meets the requirements of subpart B of this part and the 
requirements of Sec. 809.10 of this chapter.

[78 FR 58820, Sept. 24, 2013]



Sec. 801.122  Medical devices for processing, repacking, or manufacturing.

    A device intended for processing, repacking, or use in the 
manufacture of another drug or device shall be exempt from section 
502(f)(1) of the act if its label bears the statement ``Caution: For 
manufacturing, processing, or repacking''.



Sec. 801.125  Medical devices for use in teaching, law enforcement, 
research, and analysis.

    A device subject to Sec. 801.109 shall be exempt from section 
502(f)(1) of this act if shipped or sold to, or in the possession of, 
persons regularly and lawfully engaged in instruction in pharmacy, 
chemistry, or medicine not involving clinical use, or engaged in law 
enforcement, or in research not involving clinical use, or in chemical 
analysis, or physical testing, and is to be used only for such 
instruction, law enforcement, research, analysis, or testing.



Sec. 801.127  Medical devices; expiration of exemptions.

    (a) If a shipment or delivery, or any part thereof, of a device 
which is exempt under the regulations in this section is made to a 
person in whose possession the article is not exempt, or is made for any 
purpose other than those

[[Page 43]]

specified, such exemption shall expire, with respect to such shipment or 
delivery or part thereof, at the beginning of that shipment or delivery. 
The causing of an exemption to expire shall be considered an act which 
results in such device being misbranded unless it is disposed of under 
circumstances in which it ceases to be a drug or device.
    (b) The exemptions conferred by Sec. Sec. 801.119, 801.122, and 
801.125 shall continue until the devices are used for the purposes for 
which they are exempted, or until they are relabeled to comply with 
section 502(f)(1) of the act. If, however, the device is converted, or 
manufactured into a form limited to prescription dispensing, no 
exemption shall thereafter apply to the article unless the device is 
labeled as required by Sec. 801.109.



Sec. 801.128  Exceptions or alternatives to labeling requirements 
for medical devices held by the Strategic National Stockpile.

    (a) The appropriate FDA Center Director may grant an exception or 
alternative to any provision listed in paragraph (f) of this section and 
not explicitly required by statute, for specified lots, batches, or 
other units of a medical device, if the Center Director determines that 
compliance with such labeling requirement could adversely affect the 
safety, effectiveness, or availability of such devices that are or will 
be included in the Strategic National Stockpile.
    (b)(1)(i) A Strategic National Stockpile official or any entity that 
manufactures (including labeling, packing, relabeling, or repackaging), 
distributes, or stores devices that are or will be included in the 
Strategic National Stockpile may submit, with written concurrence from a 
Strategic National Stockpile official, a written request for an 
exception or alternative described in paragraph (a) of this section to 
the Center Director.
    (ii) The Center Director may grant an exception or alternative 
described in paragraph (a) of this section on his or her own initiative.
    (2) A written request for an exception or alternative described in 
paragraph (a) of this section must:
    (i) Identify the specified lots, batches, or other units of the 
medical device that would be subject to the exception or alternative;
    (ii) Identify the labeling provision(s) listed in paragraph (f) of 
this section that are the subject of the exception or alternative 
request;
    (iii) Explain why compliance with the labeling provision(s) could 
adversely affect the safety, effectiveness, or availability of the 
specified lots, batches, or other units of a medical device that are or 
will be held in the Strategic National Stockpile;
    (iv) Describe any proposed safeguards or conditions that will be 
implemented so that the labeling of the device includes appropriate 
information necessary for the safe and effective use of the device, 
given the anticipated circumstances of use of the device;
    (v) Provide a draft of the proposed labeling of the specified lots, 
batches, or other units of the medical device subject to the exception 
or alternative; and
    (vi) Provide any other information requested by the Center Director 
in support of the request.
    (c) The Center Director must respond in writing to all requests 
under this section. The Center Director may impose appropriate 
conditions when granting such an exception or alternative under this 
section.
    (d) A grant of an exception or alternative under this section will 
include any safeguards or conditions deemed appropriate by the Center 
Director so that the labeling of devices subject to the exception or 
alternative includes the information necessary for the safe and 
effective use of the device, given the anticipated circumstances of use.
    (e) If the Center Director grants a request for an exception or 
alternative to the labeling requirements under this section:
    (1) The Center Director may determine that the submission and grant 
of a written request under this section satisfies the provisions 
relating to premarket notification submissions under Sec. 807.81(a)(3) 
of this chapter.
    (2)(i) For a Premarket Approval Application (PMA)-approved device, 
the submission and grant of a written request under this section 
satisfies the

[[Page 44]]

provisions relating to submission of PMA supplements under Sec. 814.39 
of this chapter; however,
    (ii) The grant of the request must be identified in a periodic 
report under Sec. 814.84 of this chapter.
    (f) The Center Director may grant an exception or alternative under 
this section to the following provisions of this chapter, to the extent 
that the requirements in these provisions are not explicitly required by 
statute:
    (1) Sec. 801.1(d);
    (2) Subpart B of this part and part 830 of this chapter in its 
entirety;
    (3) Sec. 801.60;
    (4) Sec. 801.61;
    (5) Sec. 801.62;
    (6) Sec. 801.63;
    (7) Sec. 801.109; and
    (8) Part 801, subpart H.

[72 FR 73601, Dec. 28, 2007, as amended at 78 FR 58820, Sept. 24, 2013]



                       Subpart E_Other Exemptions



Sec. 801.150  Medical devices; processing, labeling, or repacking.

    (a) Except as provided by paragraphs (b) and (c) of this section, a 
shipment or other delivery of a device which is, in accordance with the 
practice of the trade, to be processed, labeled, or repacked, in 
substantial quantity at an establishment other than that where 
originally processed or packed, shall be exempt, during the time of 
introduction into and movement in interstate commerce and the time of 
holding in such establishment, from compliance with the labeling and 
packaging requirements of section 502(b) and (f) of the act if:
    (1) The person who introduced such shipment or delivery into 
interstate commerce is the operator of the establishment where such 
device is to be processed, labeled, or repacked; or
    (2) In case such person is not such operator, such shipment or 
delivery is made to such establishment under a written agreement, signed 
by and containing the post office addresses of such person and such 
operator, and containing such specifications for the processing, 
labeling, or repacking, as the case may be, of such device in such 
establishment as will insure, if such specifications are followed, that 
such device will not be adulterated or misbranded within the meaning of 
the act upon completion of such processing, labeling, or repacking. Such 
person and such operator shall each keep a copy of such agreement until 
2 years after the final shipment or delivery of such device from such 
establishment, and shall make such copies available for inspection at 
any reasonable hour to any officer or employee of the Department who 
requests them.
    (b) An exemption of a shipment or other delivery of a device under 
paragraph (a)(1) of this section shall, at the beginning of the act of 
removing such shipment or delivery, or any part thereof, from such 
establishment, become void ab initio if the device comprising such 
shipment, delivery, or part is adulterated or misbranded within the 
meaning of the act when so removed.
    (c) An exemption of a shipment or other delivery of a device under 
paragraph (a)(2) of this section shall become void ab initio with 
respect to the person who introduced such shipment or delivery into 
interstate commerce upon refusal by such person to make available for 
inspection a copy of the agreement, as required by such paragraph 
(a)(2).
    (d) An exemption of a shipment or other delivery of a device under 
paragraph (a)(2) of this section shall expire:
    (1) At the beginning of the act of removing such shipment or 
delivery, or any part thereof, from such establishment if the device 
comprising such shipment, delivery, or part is adulterated or misbranded 
within the meaning of the act when so removed; or
    (2) Upon refusal by the operator of the establishment where such 
device is to be processed, labeled, or repacked, to make available for 
inspection a copy of the agreement, as required by such clause.
    (e) As it is a common industry practice to manufacture and/or 
assemble, package, and fully label a device as sterile at one 
establishment and then ship such device in interstate commerce to 
another establishment or to a contract sterilizer for sterilization, the 
Food and Drug Administration will initiate no regulatory action against 
the device as misbranded or adulterated

[[Page 45]]

when the nonsterile device is labeled sterile, provided all the 
following conditions are met:
    (1) There is in effect a written agreement which:
    (i) Contains the names and post office addresses of the firms 
involved and is signed by the person authorizing such shipment and the 
operator or person in charge of the establishment receiving the devices 
for sterilization.
    (ii) Provides instructions for maintaining proper records or 
otherwise accounting for the number of units in each shipment to insure 
that the number of units shipped is the same as the number received and 
sterilized.
    (iii) Acknowledges that the device is nonsterile and is being 
shipped for further processing, and
    (iv) States in detail the sterilization process, the gaseous mixture 
or other media, the equipment, and the testing method or quality 
controls to be used by the contract sterilizer to assure that the device 
will be brought into full compliance with the Federal Food, Drug, and 
Cosmetic Act.
    (2) Each pallet, carton, or other designated unit is conspicuously 
marked to show its nonsterile nature when it is introduced into and is 
moving in interstate commerce, and while it is being held prior to 
sterilization. Following sterilization, and until such time as it is 
established that the device is sterile and can be released from 
quarantine, each pallet, carton, or other designated unit is 
conspicuously marked to show that it has not been released from 
quarantine, e.g., ``sterilized--awaiting test results'' or an equivalent 
designation.

Subparts F-G [Reserved]



           Subpart H_Special Requirements for Specific Devices



Sec. 801.405  Labeling of articles intended for lay use in the 
repairing and/or refitting of dentures.

    (a) The American Dental Association and leading dental authorities 
have advised the Food and Drug Administration of their concern regarding 
the safety of denture reliners, repair kits, pads, cushions, and other 
articles marketed and labeled for lay use in the repairing, refitting, 
or cushioning of ill-fitting, broken, or irritating dentures. It is the 
opinion of dental authorities and the Food and Drug Administration that 
to properly repair and properly refit dentures a person must have 
professional knowledge and specialized technical skill. Laymen cannot be 
expected to maintain the original vertical dimension of occlusion and 
the centric relation essential in the proper repairing or refitting of 
dentures. The continued wearing of improperly repaired or refitted 
dentures may cause acceleration of bone resorption, soft tissue 
hyperplasia, and other irreparable damage to the oral cavity. Such 
articles designed for lay use should be limited to emergency or 
temporary situations pending the services of a licensed dentist.
    (b) The Food and Drug Administration therefore regards such articles 
as unsafe and misbranded under the Federal Food, Drug, and Cosmetic Act, 
unless the labeling:
    (1)(i) Limits directions for use for denture repair kits to 
emergency repairing pending unavoidable delay in obtaining professional 
reconstruction of the denture;
    (ii) Limits directions for use for denture reliners, pads, and 
cushions to temporary refitting pending unavoidable delay in obtaining 
professional reconstruction of the denture;
    (2) Contains in a conspicuous manner the word ``emergency'' 
preceding and modifying each indication-for-use statement for denture 
repair kits and the word ``temporary'' preceding and modifying each 
indication-for-use statement for reliners, pads, and cushions; and
    (3) Includes a conspicuous warning statement to the effect:
    (i) For denture repair kits: ``Warning--For emergency repairs only. 
Long term use of home-repaired dentures may cause faster bone loss, 
continuing irritation, sores, and tumors. This kit for emergency use 
only. See Dentist Without Delay.''
    (ii) For denture reliners, pads, and cushions: ``Warning--For 
temporary use only. Longterm use of this product may lead to faster bone 
loss, continuing irritation, sores, and tumors. For Use Only Until a 
Dentist Can Be Seen.''

[[Page 46]]

    (c) Adequate directions for use require full information of the 
temporary and emergency use recommended in order for the layman to 
understand the limitations of usefulness, the reasons therefor, and the 
importance of adhering to the warnings. Accordingly, the labeling should 
contain substantially the following information:
    (1) For denture repair kits: Special training and tools are needed 
to repair dentures to fit properly. Home-repaired dentures may cause 
irritation to the gums and discomfort and tiredness while eating. Long 
term use may lead to more troubles, even permanent changes in bones, 
teeth, and gums, which may make it impossible to wear dentures in the 
future. For these reasons, dentures repaired with this kit should be 
used only in an emergency until a dentist can be seen. Dentures that 
don't fit properly cause irritation and injury to the gums and faster 
bone loss, which is permanent. Dentures that don't fit properly cause 
gum changes that may require surgery for correction. Continuing 
irritation and injury may lead to cancer in the mouth. You must see your 
dentist as soon as possible.
    (2) For denture reliners, pads, and cushions: Use of these 
preparations or devices may temporarily decrease the discomfort; 
however, their use will not make the denture fit properly. Special 
training and tools are needed to repair a denture to fit properly. 
Dentures that do not fit properly cause irritation and injury to the 
gums and faster bone loss, which is permanent and may require a 
completely new denture. Changes in the gums caused by dentures that do 
not fit properly may require surgery for correction. Continuing 
irritation and injury may lead to cancer in the mouth. You must see your 
dentist as soon as possible.
    (3) If the denture relining or repairing material forms a permanent 
bond with the denture, a warning statement to the following effect 
should be included: ``This reliner becomes fixed to the denture and a 
completely new denture may be required because of its use.''
    (d) Labeling claims exaggerating the usefulness or the safety of the 
material or failing to disclose all facts relevant to the claims of 
usefulness will be regarded as false and misleading under sections 
201(n) and 502(a) of the Federal Food, Drug, and Cosmetic Act.
    (e) Regulatory action may be initiated with respect to any article 
found within the jurisdiction of the act contrary to the provisions of 
this policy statement after 90 days following the date of publication of 
this section in the Federal Register.



Sec. 801.410  Use of impact-resistant lenses in eyeglasses and sunglasses.

    (a) Examination of data available on the frequency of eye injuries 
resulting from the shattering of ordinary crown glass lenses indicates 
that the use of such lenses constitutes an avoidable hazard to the eye 
of the wearer.
    (b) The consensus of the ophthalmic community is that the number of 
eye injuries would be substantially reduced by the use in eyeglasses and 
sunglasses of impact-resistant lenses.
    (c)(1) To protect the public more adequately from potential eye 
injury, eyeglasses and sunglasses must be fitted with impact-resistant 
lenses, except in those cases where the physician or optometrist finds 
that such lenses will not fulfill the visual requirements of the 
particular patient, directs in writing the use of other lenses, and 
gives written notification thereof to the patient.
    (2) The physician or optometrist shall have the option of ordering 
glass lenses, plastic lenses, or laminated glass lenses made impact 
resistant by any method; however, all such lenses shall be capable of 
withstanding the impact test described in paragraph (d)(2) of this 
section.
    (3) Each finished impact-resistant glass lens for prescription use 
shall be individually tested for impact resistance and shall be capable 
of withstanding the impact test described in paragraph (d)(2) of this 
section. Raised multifocal lenses shall be impact resistant but need not 
be tested beyond initial design testing. Prism segment multifocal, slab-
off prism, lenticular cataract, iseikonic, depressed segment one-piece 
multifocal, bioconcave, myodisc and minus lenticular, custom laminate 
and cemented assembly lenses shall be impact resistant but

[[Page 47]]

need not be subjected to impact testing. To demonstrate that all other 
types of impact-resistant lenses, including impact-resistant laminated 
glass lenses (i.e., lenses other than those described in the three 
preceding sentences of this paragraph (c)(3)), are capable of 
withstanding the impact test described in this regulation, the 
manufacturer of these lenses shall subject to an impact test a 
statistically significant sampling of lenses from each production batch, 
and the lenses so tested shall be representative of the finished forms 
as worn by the wearer, including finished forms that are of minimal lens 
thickness and have been subjected to any treatment used to impart impact 
resistance. All nonprescription lenses and plastic prescription lenses 
tested on the basis of statistical significance shall be tested in 
uncut-finished or finished form.
    (d)(1) For the purpose of this regulation, the impact test described 
in paragraph (d)(2) of this section shall be the ``referee test,'' 
defined as ``one which will be utilized to determine compliance with a 
regulation.'' The referee test provides the Food and Drug Administration 
with the means of examining a medical device for performance and does 
not inhibit the manufacturer from using equal or superior test methods. 
A lens manufacturer shall conduct tests of lenses using the impact test 
described in paragraph (d)(2) of this section or any equal or superior 
test. Whatever test is used, the lenses shall be capable of withstanding 
the impact test described in paragraph (d)(2) of this section if the 
Food and Drug Administration examines them for performance.
    (2) In the impact test, a \5/8\-inch steel ball weighing 
approximately 0.56 ounce is dropped from a height of 50 inches upon the 
horizontal upper surface of the lens. The ball shall strike within a \5/
8\-inch diameter circle located at the geometric center of the lens. The 
ball may be guided but not restricted in its fall by being dropped 
through a tube extending to within approximately 4 inches of the lens. 
To pass the test, the lens must not fracture; for the purpose of this 
section, a lens will be considered to have fractured if it cracks 
through its entire thickness, including a laminar layer, if any, and 
across a complete diameter into two or more separate pieces, or if any 
lens material visible to the naked eyes becomes detached from the ocular 
surface. The test shall be conducted with the lens supported by a tube 
(1-inch inside diameter, 1\1/4\-inch outside diameter, and approximately 
1-inch high) affixed to a rigid iron or steel base plate. The total 
weight of the base plate and its rigidly attached fixtures shall be not 
less than 27 pounds. For lenses of small minimum diameter, a support 
tube having an outside diameter of less than 1\1/4\ inches may be used. 
The support tube shall be made of rigid acrylic plastic, steel, or other 
suitable substance and shall have securely bonded on the top edge a \1/
8\- by \1/8\-inch neoprene gasket having a hardness of 40 5, as determined by ASTM Method D 1415-88, ``Standard 
Test Method for Rubber Property--International Hardness'' a minimum 
tensile strength of 1,200 pounds, as determined by ASTM Method D 412-
98A, ``Standard Test Methods for Vulcanized Rubber and Thermoplastic 
Elastomers--Tension,'' and a minimum ultimate elongation of 400 percent, 
as determined by ASTM Method D 412-68 (Both methods are incorporated by 
reference and are available from the American Society for Testing 
Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 
19428, or available for inspection at the Center for Devices and 
Radiological Health's Library, 9200 Corporate Blvd., Rockville, MD 
20850, or at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html. The diameter or contour 
of the lens support may be modified as necessary so that the \1/8\- by 
\1/8\-inch neoprene gasket supports the lens at its periphery.
    (e) Copies of invoice(s), shipping document(s), and records of sale 
or distribution of all impact resistant lenses, including finished 
eyeglasses and sunglasses, shall be kept and maintained for a period of 
3 years; however, the names and addresses of individuals purchasing 
nonprescription eyeglasses and

[[Page 48]]

sunglasses at the retail level need not be kept and maintained by the 
retailer. The records kept in compliance with this paragraph shall be 
made available upon request at all reasonable hours by any officer or 
employee of the Food and Drug Administration or by any other officer or 
employee acting on behalf of the Secretary of Health and Human Services 
and such officer or employee shall be permitted to inspect and copy such 
records, to make such inventories of stock as he deems necessary, and 
otherwise to check the correctness of such inventories.
    (f) In addition, those persons conducting tests in accordance with 
paragraph (d) of this section shall maintain the results thereof and a 
description of the test method and of the test apparatus for a period of 
3 years. These records shall be made available upon request at any 
reasonable hour by any officer or employee acting on behalf of the 
Secretary of Health and Human Services. The persons conducting tests 
shall permit the officer or employee to inspect and copy the records, to 
make such inventories of stock as the officer or employee deems 
necessary, and otherwise to check the correctness of the inventories.
    (g) For the purpose of this section, the term ``manufacturer'' 
includes an importer for resale. Such importer may have the tests 
required by paragraph (d) of this section conducted in the country of 
origin but must make the results thereof available, upon request, to the 
Food and Drug Administration, as soon as practicable.
    (h) All lenses must be impact-resistant except when the physician or 
optometrist finds that impact-resistant lenses will not fulfill the 
visual requirements for a particular patient.
    (i) This statement of policy does not apply to contact lenses.

[41 FR 6896, Feb. 13, 1976, as amended at 44 FR 20678, Apr. 6, 1979; 47 
FR 9397, Mar. 5, 1982; 65 FR 3586, Jan. 24, 2000; 65 FR 44436, July 18, 
2000; 69 FR 18803, Apr. 9, 2004]



Sec. 801.415  Maximum acceptable level of ozone.

    (a) Ozone is a toxic gas with no known useful medical application in 
specific, adjunctive, or preventive therapy. In order for ozone to be 
effective as a germicide, it must be present in a concentration far 
greater than that which can be safely tolerated by man and animals.
    (b) Although undesirable physiological effects on the central 
nervous system, heart, and vision have been reported, the predominant 
physiological effect of ozone is primary irritation of the mucous 
membranes. Inhalation of ozone can cause sufficient irritation to the 
lungs to result in pulmonary edema. The onset of pulmonary edema is 
usually delayed for some hours after exposure; thus, symptomatic 
response is not a reliable warning of exposure to toxic concentrations 
of ozone. Since olfactory fatigue develops readily, the odor of ozone is 
not a reliable index of atmospheric ozone concentration.
    (c) A number of devices currently on the market generate ozone by 
design or as a byproduct. Since exposure to ozone above a certain 
concentration can be injurious to health, any such device will be 
considered adulterated and/or misbranded within the meaning of sections 
501 and 502 of the act if it is used or intended for use under the 
following conditions:
    (1) In such a manner that it generates ozone at a level in excess of 
0.05 part per million by volume of air circulating through the device or 
causes an accumulation of ozone in excess of 0.05 part per million by 
volume of air (when measured under standard conditions at 25 [deg]C (77 
[deg]F) and 760 millimeters of mercury) in the atmosphere of enclosed 
space intended to be occupied by people for extended periods of time, 
e.g., houses, apartments, hospitals, and offices. This applies to any 
such device, whether portable or permanent or part of any system, which 
generates ozone by design or as an inadvertent or incidental product.
    (2) To generate ozone and release it into the atmosphere in 
hospitals or other establishments occupied by the ill or infirm.
    (3) To generate ozone and release it into the atmosphere and does 
not indicate in its labeling the maximum acceptable concentration of 
ozone which may be generated (not to exceed 0.05 part per million by 
volume of air circulating through the device) as established herein and 
the smallest area in

[[Page 49]]

which such device can be used so as not to produce an ozone accumulation 
in excess of 0.05 part per million.
    (4) In any medical condition for which there is no proof of safety 
and effectiveness.
    (5) To generate ozone at a level less than 0.05 part per million by 
volume of air circulating through the device and it is labeled for use 
as a germicide or deodorizer.
    (d) This section does not affect the present threshold limit value 
of 0.10 part per million (0.2 milligram per cubic meter) of ozone 
exposure for an 8-hour-day exposure of industrial workers as recommended 
by the American Conference of Governmental Industrial Hygienists.
    (e) The method and apparatus specified in 40 CFR part 50, or any 
other equally sensitive and accurate method, may be employed in 
measuring ozone pursuant to this section.



Sec. 801.417  Chlorofluorocarbon propellants.

    The use of chlorofluorocarbon in devices as propellants in self-
pressurized containers is generally prohibited except as provided in 
Sec. 2.125 of this chapter.

[43 FR 11318, Mar. 17, 1978]



Sec. 801.422  Prescription hearing aid labeling.

    (a) Scope. This section specifies the labeling requirements for 
prescription hearing aids. Any hearing aid that does not satisfy the 
requirements of Sec. 800.30 of this chapter shall be a prescription 
device. Unless otherwise specified, the requirements in this section are 
in addition to other applicable requirements, including but not limited 
to special controls found in the applicable classification regulation in 
part 874 of this chapter. This section does not apply to group auditory 
trainers.
    (b) Definitions for the purposes of this section. This section uses 
the following definitions:
    Dispenser. A dispenser is any person, as defined in section 201(e) 
of the Federal Food, Drug, and Cosmetic Act, engaged in the sale of 
hearing aids to any member of the consuming public or any employee, 
agent, salesperson, and/or representative of such a person.
    Hearing aid. A hearing aid is any wearable device designed for, 
offered for the purpose of, or represented as aiding persons with or 
compensating for, impaired hearing.
    Prescription hearing aid. A prescription hearing aid is a hearing 
aid that is not an over-the-counter (OTC) hearing aid as defined in 
Sec. 800.30 of this chapter or a hearing aid that does not satisfy the 
requirements in Sec. 800.30 of this chapter.
    Rebuilt hearing aid. A prescription hearing aid is ``rebuilt'' if 
the manufacturer has inspected and tested the device, made any necessary 
modifications to ensure it meets applicable regulatory requirements, 
including the requirements in this section, and adequately reprocessed 
the device for the next user.
    Sale. Sale includes a lease, rental, or any other purchase or 
exchange for value.
    Used hearing aid. A hearing aid is ``used'' if a user has worn it 
for any period of time. However, a hearing aid shall not be ``used'' 
merely because a prospective user wore it as part of a bona fide hearing 
aid evaluation to determine whether to select that particular hearing 
aid for that prospective user. A hearing aid evaluation is ``bona fide'' 
if it was conducted in the presence of the dispenser or a hearing health 
professional selected by the dispenser to assist the prospective user in 
making a determination.
    (c) Labeling. A prescription hearing aid shall bear all of the 
following labeling:
    (1) Outside package labeling. The outside package of a prescription 
hearing aid shall bear all of the following:
    (i) Warnings and other important information. All of the following 
shall appear on the outside package:
    (A) Warning against use in people younger than 18 without prior 
medical evaluation.

[[Page 50]]

[GRAPHIC] [TIFF OMITTED] TR17AU22.015

    (B) ``Red flag'' conditions.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.016
    
    (C) Note about device trial options.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.017
    
    (ii) Statement of build condition. If the prescription hearing aid 
is used or rebuilt, the outside package shall declare that fact. A 
sticker under and visible through the outer wrapper will suffice to 
declare such fact.
    (iii) Indication of battery information. The outside package shall 
indicate the type and number of batteries and whether batteries are 
included in the package.
    (iv) Indication of control platform. That outside package shall 
indicate

[[Page 51]]

whether a mobile device or other non-included control platform is 
required. The indication must include the type of platform and how the 
platform connects to the device.
    (2) Labeling, inside the package. The manufacturer or distributor of 
a prescription hearing aid shall include a user instructional brochure 
inside the package and shall make an electronic version available for 
download without site or customer registration and without requiring 
purchase of any product or service. The user instructional brochure 
shall include all of the following:
    (i) The following warnings, which shall appear in the following 
order and prior to any content except the cover page:
    (A) Warning against use in people younger than 18 without prior 
medical evaluation.
[GRAPHIC] [TIFF OMITTED] TR17AU22.018

    (B) ``Red flag'' conditions, addressed to dispensers.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.019
    

[[Page 52]]


    (C) Warning to dispensers about very high-output devices.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.020
    
    (D) Additional warnings. Any additional warnings the manufacturer 
may include prior to the cautions and notices to users in paragraph 
(c)(2)(ii) of this section.
    (ii) The following cautions and notices for users, which shall 
appear prior to any content, except the cover page and the warnings 
under paragraph (c)(2)(i) of this section:
    (A) Caution about hearing protection.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.021
    
    (B) Caution about excessive sound output.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.022
    
    (C) Caution about components lodging in ear.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.023
    
    (D) Note about user expectations.

[[Page 53]]

[GRAPHIC] [TIFF OMITTED] TR17AU22.024

    (E) Note about reporting adverse events to FDA.
    [GRAPHIC] [TIFF OMITTED] TR17AU22.025
    
    (F) Note about hearing loss in people younger than 18 and fitting 
devices.

[[Page 54]]

[GRAPHIC] [TIFF OMITTED] TR17AU22.026

    (iii) An illustration(s) of the prescription hearing aid that 
indicates operating controls, user adjustments, and the battery 
compartment.
    (iv) Information on the function of all controls intended for user 
adjustment.
    (v) A description of any accessory that accompanies the prescription 
hearing aid, including but not limited to wax guards, and accessories 
for use with a computer, television, or telephone.
    (vi) Specific instructions for all of the following:
    (A) Use of the prescription hearing aid with any accompanying 
accessories.
    (B) Maintenance and care of the prescription hearing aid, including 
how a user can clean, disinfect, and replace parts or how to seek 
replacements, as well as how to store the hearing aid when it will not 
be used for an extended period of time.
    (C) If the battery is replaceable or rechargeable, how to replace or 
recharge the battery, including a generic designation of replacement 
batteries.
    (D) Expected battery life.
    (vii) Identification of any known physiological side effects 
associated with the use of the prescription hearing aid that may warrant 
consultation with a physician, referring to an ear-nose-throat doctor 
when preferable, including if applicable, skin irritation and 
accelerated accumulation of cerumen (ear wax).

[[Page 55]]

    (viii) The technical specifications required by paragraph (c)(4) of 
this section unless such specifications appear in separate labeling 
accompanying the prescription hearing aid.
    (ix) A description of commonly occurring, avoidable events that 
could adversely affect or damage the prescription hearing aid, including 
but not limited to, as applicable, ear wax buildup, drops, immersion in 
water, or exposure to excessive heat.
    (x) If the hearing aid incorporates wireless technology in its 
programming or use, appropriate warnings, instructions, and information 
relating to electromagnetic compatibility and wireless technology and 
human exposure to non-ionizing radiation.
    (xi) Information on how and where to obtain repair service or 
replacements, including at least one specific address where the user can 
go or send the prescription hearing aid to obtain such repair service or 
replacements.
    (xii) If clinical or non-clinical studies were conducted by or for 
the manufacturer to support the performance of the prescription hearing 
aid, a summary of all such studies.
    (3) Labeling on the device. The labeling on a prescription hearing 
aid itself shall bear all of the following clearly and permanently, 
except as provided in paragraph (c)(3)(iii) of this section:
    (i) The serial number.
    (ii) If the battery is removable, a ``+'' symbol to indicate the 
positive terminal for battery insertion unless the battery's physical 
design prevents inserting the battery in the reversed position.
    (iii) If the prescription hearing aid is used or rebuilt, the 
manufacturer shall physically attach a removable tag to the hearing aid 
declaring that fact.
    (4) Technical specifications. You must determine the technical 
specification values for the prescription hearing aid labeling in 
accordance with the test procedures of ANSI/ASA S3.22-2014 (R2020), 
except as provided in paragraph (c)(4)(ix) of this section for latency. 
Technical specifications and their associated values that are useful in 
selecting, fitting, and checking the performance of the prescription 
hearing aid shall appear in the user instructional brochure or in 
separate labeling that accompanies the device, including all of the 
following:
    (i) Saturation output curve (Saturation Sound Pressure Level (SSPL) 
90 curve).
    (ii) Frequency response curve.
    (iii) Average saturation output (High Frequency (HF)-Average SSPL 
90).
    (iv) Average full-on gain (HF-Average full-on gain).
    (v) Reference test gain.
    (vi) Frequency range.
    (vii) Total harmonic distortion.
    (viii) Equivalent input noise.
    (ix) Latency, measured using a method that is accurate and 
repeatable to within 1.5 ms.
    (x) Battery current drain.
    (xi) Induction coil sensitivity (telephone coil aids only).
    (xii) Input-output curve (only for hearing aids with automatic gain 
control).
    (xiii) Attack and release times (only for hearing aids with 
automatic gain control).
    (5) Software device labeling. Prescription hearing aid software that 
is not distributed with the hearing aid or amplification platform shall 
meet all of the following labeling requirements. With respect to the 
information required under paragraphs (c)(1) through (4) of this 
section, the information must be provided in the software device 
labeling, as specified in paragraphs (c)(5)(i) through (v) of this 
section, rather than the locations (e.g., outside package labeling) 
specified in paragraphs (c)(1) through (4).
    (i) Prior to first use of the software or obtaining payment 
information for the software, whichever occurs first, the labeling must 
clearly and prominently present all of the following to the prospective 
user. For each, the labeling must remain visible until the user 
dismisses it or proceeds to the next step:
    (A) Compatibility and minimum operating requirements for the 
software device.
    (B) Disclosures of any fees or payments after first use or initial 
payment, including but not limited to any

[[Page 56]]

fees or payments relating to subscriptions, add-on features, or 
continued access to features or services. The disclosures must name and 
briefly describe what each fee or payment covers.
    (C) The information required under paragraphs (c)(1)(i) and (iv) of 
this section.
    (ii) Prior to first use of the software, the labeling must clearly 
and prominently present all of the following to the prospective user:
    (A) The information required under paragraph (c)(2)(i)(A) of this 
section, and it must remain visible until the user acknowledges it.
    (B) The information required under paragraphs (c)(2)(i)(B) through 
(D) and (c)(2)(ii), (iv), (vii), and (viii) of this section, and the 
information must remain visible until the user dismisses it or proceeds 
to the next step.
    (C) All other information required under paragraph (c)(2) of this 
section, to the extent applicable, and the information must remain 
visible until the user dismisses it or proceeds to the next step.
    (iii) The software device labeling must include the information 
required under paragraphs (c)(3)(i) and (c)(4) of this section.
    (iv) All of the software device labeling must be accessible for 
review after acknowledgment, dismissal, or proceeding to the next step.
    (v) If there are changes to any of the labeling required under 
paragraph (c)(5) of this section, the labeling with the changed 
information must be presented to the user until the user dismisses it.
    (6) Misbranding. A prescription hearing aid that is not labeled as 
required under this section and Sec. 801.109 is misbranded under 
sections 201(n), 502(a), and/or 502(f) of the Federal Food, Drug, and 
Cosmetic Act.
    (d) Incorporation by reference. ANSI/ASA S3.22-2014 (R2020), 
``AMERICAN NATIONAL STANDARD Specification of Hearing Aid 
Characteristics,'' dated June 5, 2020, is incorporated by reference into 
this section with the approval of the Director of the Office of the 
Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. This material 
is available for inspection at the Food and Drug Administration and at 
the National Archives and Records Administration (NARA). Contact the 
Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852, 240-402-7500. For information on the availability of this 
material at NARA, email: [email protected], or go to: 
www.archives.gov/federal-register/cfr/ibr-locations.html. The material 
may be obtained from the Acoustical Society of America (ASA), 1305 Walt 
Whitman Road, Suite 300, Melville, NY 11747; phone: (631) 390-0215; fax: 
(631) 923-2875; email: [email protected].

[87 FR 50755, Aug. 17, 2022]



Sec. 801.430  User labeling for menstrual tampons.

    (a) This section applies to scented or scented deodorized menstrual 
tampons as identified in Sec. 884.5460 and unscented menstrual tampons 
as identified in Sec. 884.5470 of this chapter.
    (b) Data show that toxic shock syndrome (TSS), a rare but serious 
and sometimes fatal disease, is associated with the use of menstrual 
tampons. To protect the public and to minimize the serious adverse 
effects of TSS, menstrual tampons shall be labeled as set forth in 
paragraphs (c), (d), and (e) of this section and tested for absorbency 
as set forth in paragraph (f) of this section.
    (c) If the information specified in paragraph (d) of this section is 
to be included as a package insert, the following alert statement shall 
appear prominently and legibly on the package label:

    Attention: Tampons are associated with Toxic Shock Syndrome (TSS). 
TSS is a rare but serious disease that may cause death. Read and save 
the enclosed information.

    (d) The labeling of menstrual tampons shall contain the following 
consumer information prominently and legibly, in such terms as to render 
the information likely to be read and understood by the ordinary 
individual under customary conditions of purchase and use:
    (1)(i) Warning signs of TSS, e.g., sudden fever (usually 102[deg] or 
more) and vomiting, diarrhea, fainting or near fainting when standing 
up, dizziness, or a rash that looks like a sunburn;

[[Page 57]]

    (ii) What to do if these or other signs of TSS appear, including the 
need to remove the tampon at once and seek medical attention 
immediately;
    (2) The risk of TSS to all women using tampons during their 
menstrual period, especially the reported higher risks to women under 30 
years of age and teenage girls, the estimated incidence of TSS of 1 to 
17 per 100,000 menstruating women and girls per year, and the risk of 
death from contracting TSS;
    (3) The advisability of using tampons with the minimum absorbency 
needed to control menstrual flow in order to reduce the risk of 
contracting TSS;
    (4) Avoiding the risk of getting tampon-associated TSS by not using 
tampons, and reducing the risk of getting TSS by alternating tampon use 
with sanitary napkin use during menstrual periods; and
    (5) The need to seek medical attention before again using tampons if 
TSS warning signs have occurred in the past, or if women have any 
questions about TSS or tampon use.
    (e) The statements required by paragraph (e) of this section shall 
be prominently and legibly placed on the package label of menstrual 
tampons in conformance with section 502(c) of the Federal Food, Drug, 
and Cosmetic Act (the act) (unless the menstrual tampons are exempt 
under paragraph (g) of this section).
    (1) Menstrual tampon package labels shall bear one of the following 
absorbency terms representing the absorbency of the production run, lot, 
or batch as measured by the test described in paragraph (f)(2) of this 
section;

------------------------------------------------------------------------
 Ranges of absorbency in grams \1\     Corresponding term of absorbency
------------------------------------------------------------------------
6 and under                          Light absorbency
------------------------------------------------------------------------
6 to 9                               Regular absorbency
------------------------------------------------------------------------
9 to 12                              Super absorbency
------------------------------------------------------------------------
12 to 15                             Super plus absorbency
------------------------------------------------------------------------
15 to 18                             Ultra absorbency
------------------------------------------------------------------------
Above 18                             No term
------------------------------------------------------------------------
\1\These ranges are defined, respectively, as follows: Less than or
  equal to 6 grams (g); greater than 6 g up to and including 9 g;
  greater than 9 g up to and including 12 g; greater than 12 g up to and
  including 15 g; greater than 15 g up to and including 18 g; and
  greater than 18 g.

    (2) The package label shall include an explanation of the ranges of 
absorbency and a description of how consumers can use a range of 
absorbency, and its corresponding absorbency term, to make comparisons 
of absorbency of tampons to allow selection of the tampons with the 
minimum absorbency needed to control menstrual flow in order to reduce 
the risk of contracting TSS.
    (f) A manufacturer shall measure the absorbency of individual 
tampons using the test method specified in paragraph (f)(2) of this 
section and calculate the mean absorbency of a production run, lot, or 
batch by rounding to the nearest 0.1 gram.
    (1) A manufacturer shall design and implement a sampling plan that 
includes collection of probability samples of adequate size to yield 
consistent tolerance intervals such that the probability is 90 percent 
that at least 90 percent of the absorbencies of individual tampons 
within a brand and type are within the range of absorbency stated on the 
package label.
    (2) In the absorbency test, an unlubricated condom, with tensile 
strength between 17 Mega Pascals (MPa) and 30 MPa, as measured according 
to the procedure in the American Society for Testing and Materials 
(ASTM) D 3492-97, ``Standard Specification for Rubber Contraceptives 
(Male Condoms)'' \1\ for determining tensile strength, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a), is 
attached to the large end of a glass chamber (or a chamber made from 
hard transparent plastic) with a rubber band (see figure 1) and pushed

[[Page 58]]

through the small end of the chamber using a smooth, finished rod. The 
condom is pulled through until all slack is removed. The tip of the 
condom is cut off and the remaining end of the condom is stretched over 
the end of the tube and secured with a rubber band. A preweighed (to the 
nearest 0.01 gram) tampon is placed within the condom membrane so that 
the center of gravity of the tampon is at the center of the chamber. An 
infusion needle (14 gauge) is inserted through the septum created by the 
condom tip until it contacts the end of the tampon. The outer chamber is 
filled with water pumped from a temperature-controlled waterbath to 
maintain the average temperature at 271 [deg]C. 
The water returns to the waterbath as shown in figure 2. Syngyna fluid 
(10 grams sodium chloride, 0.5 gram Certified Reagent Acid Fushsin, 
1,000 milliliters distilled water) is then pumped through the infusion 
needle at a rate of 50 milliliters per hour. The test shall be 
terminated when the tampon is saturated and the first drop of fluid 
exits the apparatus. (The test result shall be discarded if fluid is 
detected in the folds of the condom before the tampon is saturated). The 
water is then drained and the tampon is removed and immediately weighed 
to the nearest 0.01 gram. The absorbency of the tampon is determined by 
subtracting its dry weight from this value. The condom shall be replaced 
after 10 tests or at the end of the day during which the condom is used 
in testing, whichever occurs first.
---------------------------------------------------------------------------

    \1\The Director of the Federal Register approves this incorporation 
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You 
may obtain a copy from the American Society for Testing and Materials 
International, 100 Barr Harbor Dr., P.O. Box C700, West Conshohocken, PA 
19428-2959, 610-832-9578, www.astm.org. You may inspect a copy at the 
FDA Main Library, 10903 New Hampshire Ave., Bldg. 2, 3d floor, Silver 
Spring, MD 20993-0002, 301-796-2039, or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-2139, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

---------------------------------------------------------------------------

[[Page 59]]

[GRAPHIC] [TIFF OMITTED] TR01FE93.026


[[Page 60]]


[GRAPHIC] [TIFF OMITTED] TR01FE93.027

    (3) The Food and Drug Administration may permit the use of an 
absorbency test method different from the test method specified in this 
section if each of the following conditions is met:
    (i) The manufacturer presents evidence, in the form of a citizen 
petition

[[Page 61]]

submitted in accordance with the requirements of Sec. 10.30 of this 
chapter, demonstrating that the alternative test method will yield 
results that are equivalent to the results yielded by the test method 
specified in this section; and
    (ii) FDA approves the method and has published notice of its 
approval of the alternative test method in the Federal Register.
    (g) Any menstrual tampon intended to be dispensed by a vending 
machine is exempt from the requirements of this section.
    (h) Any menstrual tampon that is not labeled as required by 
paragraphs (c), (d), and (e) of this section and that is initially 
introduced or initially delivered for introduction into commerce after 
March 1, 1990, is misbranded under sections 201(n), 502 (a) and (f) of 
the act.

(Information collection requirements contained in paragraphs (e) and (f) 
were approved by the Office of Management and Budget under control 
number 0910-0257)

[47 FR 26989, June 22, 1982, as amended at 54 FR 43771, Oct. 26, 1989; 
55 FR 17600, Apr. 26, 1990; 65 FR 3586, Jan. 24, 2000; 65 FR 44436, July 
18, 2000; 65 FR 62284, Oct. 18, 2000; 69 FR 18803, Apr. 9, 2004; 69 FR 
52171, Aug. 25, 2004; 75 FR 20914, Apr. 22, 2010]



Sec. 801.433  Warning statements for prescription and restricted
device products containing or manufactured with chlorofluorocarbons
or other ozone-depleting 
          substances.

    (a)(1) All prescription and restricted device products containing or 
manufactured with chlorofluorocarbons, halons, carbon tetrachloride, 
methyl chloride, or any other class I substance designated by the 
Environmental Protection Agency (EPA) shall, except as provided in 
paragraph (b) of this section, bear the following warning statement:

    Warning: Contains [or Manufactured with, if applicable] [insert name 
of substance], a substance which harms public health and environment by 
destroying ozone in the upper atmosphere.

    (2) The warning statement shall be clearly legible and conspicuous 
on the product, its immediate container, its outer packaging, or other 
labeling in accordance with the requirements of 40 CFR part 82 and 
appear with such prominence and conspicuousness as to render it likely 
to be read and understood by consumers under normal conditions of 
purchase.
    (b)(1) For prescription and restricted device products, the 
following alternative warning statement may be used:

    Note: The indented statement below is required by the Federal 
government's Clean Air Act for all products containing or manufactured 
with chlorofluorocarbons (CFC's) [or name of other class I substance, if 
applicable]:

    This product contains [or is manufactured with, if applicable] 
[insert name of substance], a substance which harms the environment by 
destroying ozone in the upper atmosphere.
    Your physician has determined that this product is likely to help 
your personal health. USE THIS PRODUCT AS DIRECTED, UNLESS INSTRUCTED TO 
DO OTHERWISE BY YOUR PHYSICIAN. If you have any questions about 
alternatives, consult with your physician.
    (2) The warning statement shall be clearly legible and conspicuous 
on the product, its immediate container, its outer packaging, or other 
labeling in accordance with the requirements of 40 CFR part 82 and 
appear with such prominence and conspicuousness as to render it likely 
to be read and understood by consumers under normal conditions of 
purchase.
    (3) If the warning statement in paragraph (b)(1) of this section is 
used, the following warning statement must be placed on the package 
labeling intended to be read by the physician (physician package insert) 
after the ``How supplied'' section, which describes special handling and 
storage conditions on the physician labeling:
    Note: The indented statement below is required by the Federal 
government's Clean Air Act for all products containing or manufactured 
with chlorofluorocarbons (CFC's) [or name of other class I substance, if 
applicable]:

    Warning: Contains [or Manufactured with, if applicable] [insert name 
of substance], a substance which harms public health and environment by 
destroying ozone in the upper atmosphere.

    A notice similar to the above WARNING has been placed in the 
information for the patient [or patient information leaflet, if 
applicable] of this product under Environmental Protection Agency (EPA) 
regulations. The patient's warning states that the

[[Page 62]]

patient should consult his or her physician if there are questions about 
alternatives.

    (c) This section does not replace or relieve a person from any 
requirements imposed under 40 CFR part 82.

[61 FR 20101, May 3, 1996]



Sec. 801.435  User labeling for latex condoms.

    (a) This section applies to the subset of condoms as identified in 
Sec. 884.5300 of this chapter, and condoms with spermicidal lubricant 
as identified in Sec. 884.5310 of this chapter, which products are 
formed from latex films.
    (b) Data show that the material integrity of latex condoms degrade 
over time. To protect the public health and minimize the risk of device 
failure, latex condoms must bear an expiration date which is supported 
by testing as described in paragraphs (d) and (h) of this section.
    (c) The expiration date, as demonstrated by testing procedures 
required by paragraphs (d) and (h) of this section, must be displayed 
prominently and legibly on the primary packaging (i.e., individual 
package), and higher levels of packaging (e.g., boxes of condoms), in 
order to ensure visibility of the expiration date by consumers.
    (d) Except as provided under paragraph (f) of this section, the 
expiration date must be supported by data demonstrating physical and 
mechanical integrity of the product after three discrete and 
representative lots of the product have been subjected to each of the 
following conditions:
    (1) Storage of unpackaged bulk product for the maximum amount of 
time the manufacturer allows the product to remain unpackaged, followed 
by storage of the packaged product at 70 [deg]C (plus or minus 2 [deg]C) 
for 7 days;
    (2) Storage of unpackaged bulk product for the maximum amount of 
time the manufacturer allows the product to remain unpackaged, followed 
by storage of the packaged product at a selected temperature between 40 
and 50 [deg]C (plus or minus 2 [deg]C) for 90 days; and
    (3) Storage of unpackaged bulk product for the maximum amount of 
time the manufacturer allows the product to remain unpackaged, followed 
by storage of the packaged product at a monitored or controlled 
temperature between 15 and 30 [deg]C for the lifetime of the product 
(real time storage).
    (e) If a product fails the physical and mechanical integrity tests 
commonly used by industry after the completion of the accelerated 
storage tests described in paragraphs (d)(1) and (d)(2) of this section, 
the product expiration date must be demonstrated by real time storage 
conditions described in paragraph (d)(3) of this section. If all of the 
products tested after storage at temperatures as described in paragraphs 
(d)(1) and (d)(2) of this section pass the manufacturer's physical and 
mechanical integrity tests, the manufacturer may label the product with 
an expiration date of up to 5 years from the date of product packaging. 
If the extrapolated expiration date under paragraphs (d)(1) and (d)(2) 
of this section is used, the labeled expiration date must be confirmed 
by physical and mechanical integrity tests performed at the end of the 
stated expiration period as described in paragraph (d)(3) of this 
section. If the data from tests following real time storage described in 
paragraph (d)(3) of this section fails to confirm the extrapolated 
expiration date, the manufacturer must, at that time, relabel the 
product to reflect the actual shelf life.
    (f) Products that already have established shelf life data based 
upon real time storage and testing and have such storage and testing 
data available for inspection are not required to confirm such data 
using accelerated and intermediate aging data described in paragraphs 
(d)(1) and (d)(2) of this section. If, however, such real time 
expiration dates were based upon testing of products that were not first 
left unpackaged for the maximum amount of time as described in paragraph 
(d)(3) of this section, the real time testing must be confirmed by 
testing products consistent with the requirements of paragraph (d)(3) of 
this section. This testing shall be initiated no later than the 
effective date of this regulation. Until the confirmation testing in 
accordance with paragraph (d)(3) of this section is completed, the 
product may remain on the market labeled with the expiration date based 
upon previous real time testing.

[[Page 63]]

    (g) If a manufacturer uses testing data from one product to support 
expiration dating on any variation of that product, the manufacturer 
must document and provide, upon request, an appropriate justification 
for the application of the testing data to the variation of the tested 
product.
    (h) If a latex condom contains a spermicide, and the expiration date 
based on spermicidal stability testing is different from the expiration 
date based upon latex integrity testing, the product shall bear only the 
earlier expiration date.
    (i) The time period upon which the expiration date is based shall 
start with the date of packaging.
    (j) As provided in part 820 of this chapter, all testing data must 
be retained in each company's files, and shall be made available upon 
request for inspection by the Food and Drug Administration.
    (k) Any latex condom not labeled with an expiration date as required 
by paragraph (c) of this section, and initially delivered for 
introduction into interstate commerce after the effective date of this 
regulation is misbranded under sections 201(n) and 502(a) and (f) of 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(n) and 352(a) and 
(f)).

[62 FR 50501, Sept. 26, 1997]



Sec. 801.437  User labeling for devices that contain natural rubber.

    (a) Data in the Medical Device Reporting System and the scientific 
literature indicate that some individuals are at risk of severe 
anaphylactic reactions to natural latex proteins. This labeling 
regulation is intended to minimize the risk to individuals sensitive to 
natural latex proteins and protect the public health.
    (b) This section applies to all devices composed of or containing, 
or having packaging or components that are composed of, or contain, 
natural rubber that contacts humans. The term ``natural rubber'' 
includes natural rubber latex, dry natural rubber, and synthetic latex 
or synthetic rubber that contains natural rubber in its formulation.
    (1) The term ``natural rubber latex'' means rubber that is produced 
by the natural rubber latex process that involves the use of natural 
latex in a concentrated colloidal suspension. Products are formed from 
natural rubber latex by dipping, extruding, or coating.
    (2) The term ``dry natural rubber'' means rubber that is produced by 
the dry natural rubber process that involves the use of coagulated 
natural latex in the form of dried or milled sheets. Products are formed 
from dry natural rubber by compression molding, extrusion, or by 
converting the sheets into a solution for dipping.
    (3) The term ``contacts humans'' means that the natural rubber 
contained in a device is intended to contact or is likely to contact the 
user or patient. This includes contact when the device that contains 
natural rubber is connected to the patient by a liquid path or an 
enclosed gas path; or the device containing the natural rubber is fully 
or partially coated with a powder, and such powder may carry natural 
rubber proteins that may contaminate the environment of the user or 
patient.
    (c) Devices containing natural rubber shall be labeled as set forth 
in paragraphs (d) through (h) of this section. Each required labeling 
statement shall be prominently and legibly displayed in conformance with 
section 502(c) of the Federal Food, Drug, and Cosmetic Act (the act) (21 
U.S.C. 352(c)).
    (d) Devices containing natural rubber latex that contacts humans, as 
described in paragraph (b) of this section, shall bear the following 
statement in bold print on the device labeling:
    ``Caution: This Product Contains Natural Rubber Latex Which May 
Cause Allergic Reactions.''

This statement shall appear on all device labels, and other labeling, 
and shall appear on the principal display panel of the device packaging, 
the outside package, container or wrapper, and the immediate device 
package, container, or wrapper.
    (e) Devices containing dry natural rubber that contacts humans, as 
described in paragraph (b) of this section, that are not already subject 
to paragraph (d) of this section, shall bear the following statement in 
bold print on the device labeling:
    ``This Product Contains Dry Natural Rubber.''

[[Page 64]]


This statement shall appear on all device labels, and other labeling, 
and shall appear on the principal display panel of the device packaging, 
the outside package, container or wrapper, and the immediate device 
package, container, or wrapper.
    (f) Devices that have packaging containing natural rubber latex that 
contacts humans, as described in paragraph (b) of this section, shall 
bear the following statement in bold print on the device labeling:
    ``Caution: The Packaging of This Product Contains Natural Rubber 
Latex Which May Cause Allergic Reactions.''

This statement shall appear on the packaging that contains the natural 
rubber, and the outside package, container, or wrapper.
    (g) Devices that have packaging containing dry natural rubber that 
contacts humans, as described in paragraph (b) of this section, shall 
bear the following statement in bold print on the device labeling:
    ``The Packaging of This Product Contains Dry Natural Rubber.''

This statement shall appear on the packaging that contains the natural 
rubber, and the outside package, container, or wrapper.
    (h) Devices that contain natural rubber that contacts humans, as 
described in paragraph (b) of this section, shall not contain the term 
``hypoallergenic'' on their labeling.
    (i) Any affected person may request an exemption or variance from 
the requirements of this section by submitting a citizen petition in 
accordance with Sec. 10.30 of this chapter.
    (j) Any device subject to this section that is not labeled in 
accordance with paragraphs (d) through (h) of this section and that is 
initially introduced or initially delivered for introduction into 
interstate commerce after the effective date of this regulation is 
misbranded under sections 201(n) and 502(a), (c), and (f) of the act (21 
U.S.C. 321(n) and 352(a), (c), and (f)).

    Note to Sec. 801.437: Paragraphs (f) and (g) are stayed until June 
27, 1999, as those regulations relate to device packaging that uses 
``cold seal'' adhesives.

[62 FR 51029, Sept. 30, 1997, as amended at 63 FR 46175, Aug. 31, 1998]



PART 803_MEDICAL DEVICE REPORTING--Table of Contents



                      Subpart A_General Provisions

Sec.
803.1 What does this part cover?
803.3 How does FDA define the terms used in this part?
803.9 What information from the reports do we disclose to the public?
803.10 Generally, what are the reporting requirements that apply to me?
803.11 What form should I use to submit reports of individual adverse 
          events and where do I obtain these forms?
803.12 How do I submit initial and supplemental or followup reports?
803.13 Do I need to submit reports in English?
803.15 How will I know if you require more information about my medical 
          device report?
803.16 When I submit a report, does the information in my report 
          constitute an admission that the device caused or contributed 
          to the reportable event?
803.17 What are the requirements for developing, maintaining, and 
          implementing written MDR procedures that apply to me?
803.18 What are the requirements for establishing and maintaining MDR 
          files or records that apply to me?
803.19 Are there exemptions, variances, or alternative forms of adverse 
          event reporting requirements?

Subpart B_Generally Applicable Requirements for Individual Adverse Event 
                                 Reports

803.20 How do I complete and submit an individual adverse event report?
803.21 Where can I find the reporting codes for adverse events that I 
          use with medical device reports?
803.22 What are the circumstances in which I am not required to file a 
          report?
803.23 Where can I find information on how to prepare and submit an MDR 
          in electronic format?

             Subpart C_User Facility Reporting Requirements

803.30 If I am a user facility, what reporting requirements apply to me?
803.32 If I am a user facility, what information must I submit in my 
          individual adverse event reports?

[[Page 65]]

803.33 If I am a user facility, what must I include when I submit an 
          annual report?

                Subpart D_Importer Reporting Requirements

803.40 If I am an importer, what reporting requirements apply to me?
803.42 If I am an importer, what information must I submit in my 
          individual adverse event reports?

              Subpart E_Manufacturer Reporting Requirements

803.50 If I am a manufacturer, what reporting requirements apply to me?
803.52 If I am a manufacturer, what information must I submit in my 
          individual adverse event reports?
803.53 If I am a manufacturer, in which circumstances must I submit a 5-
          day report?
803.56 If I am a manufacturer, in what circumstances must I submit a 
          supplemental or followup report and what are the requirements 
          for such reports?
803.58 Foreign manufacturers.

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

    Source: 79 FR 8846, Feb. 14, 2014, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 803.1  What does this part cover?

    (a) This part establishes the requirements for medical device 
reporting for device user facilities, manufacturers, importers, and 
distributors. If you are a device user facility, you must report deaths 
and serious injuries that a device has or may have caused or contributed 
to, establish and maintain adverse event files, and submit summary 
annual reports. If you are a manufacturer or importer, you must report 
deaths and serious injuries that your device has or may have caused or 
contributed to, you must report certain device malfunctions, and you 
must establish and maintain adverse event files. If you are a 
manufacturer, you must also submit specified followup. These reports 
help us to protect the public health by helping to ensure that devices 
are not adulterated or misbranded and are safe and effective for their 
intended use. If you are a medical device distributor, you must maintain 
records (files) of incidents, but you are not required to report these 
incidents.
    (b) This part supplements and does not supersede other provisions of 
this chapter, including the provisions of part 820 of this chapter.
    (c) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.



Sec. 803.3  How does FDA define the terms used in this part?

    Some of the terms we use in this part are specific to medical device 
reporting and reflect the language used in the statute (law). Other 
terms are more general and reflect our interpretation of the law. This 
section defines the following terms as used in this part:
    (a) Ambulatory surgical facility (ASF) means a distinct entity that 
operates for the primary purpose of furnishing same day outpatient 
surgical services to patients. An ASF may be either an independent 
entity (i.e., not a part of a provider of services or any other 
facility) or operated by another medical entity (e.g., under the common 
ownership, licensure, or control of an entity). An ASF is subject to 
this regulation regardless of whether it is licensed by a Federal, 
State, municipal, or local government or regardless of whether it is 
accredited by a recognized accreditation organization. If an adverse 
event meets the criteria for reporting, the ASF must report that event 
regardless of the nature or location of the medical service provided by 
the ASF.
    (b) Become aware means that an employee of the entity required to 
report has acquired information that reasonably suggests a reportable 
adverse event has occurred.
    (1) If you are a device user facility, you are considered to have 
``become aware'' when medical personnel, as defined in this section, who 
are employed by or otherwise formally affiliated with your facility, 
obtain information about a reportable event.
    (2) If you are a manufacturer, you are considered to have become 
aware of an event when any of your employees becomes aware of a 
reportable event that is required to be reported within 30 calendar days 
or that is required to be reported within 5 work days because we had 
requested reports in accordance with Sec. 803.53(b). You are also 
considered

[[Page 66]]

to have become aware of an event when any of your employees with 
management or supervisory responsibilities over persons with regulatory, 
scientific, or technical responsibilities, or whose duties relate to the 
collection and reporting of adverse events, becomes aware, from any 
information, including any trend analysis, that a reportable MDR event 
or events necessitates remedial action to prevent an unreasonable risk 
of substantial harm to the public health.
    (3) If you are an importer, you are considered to have become aware 
of an event when any of your employees becomes aware of a reportable 
event that is required to be reported by you within 30 days.
    (c) Caused or contributed means that a death or serious injury was 
or may have been attributed to a medical device, or that a medical 
device was or may have been a factor in a death or serious injury, 
including events occurring as a result of:
    (1) Failure,
    (2) Malfunction,
    (3) Improper or inadequate design,
    (4) Manufacture,
    (5) Labeling, or
    (6) User error.
    (d) Device user facility means a hospital, ambulatory surgical 
facility, nursing home, outpatient diagnostic facility, or outpatient 
treatment facility as defined in this section, which is not a 
physician's office, as defined in this section. School nurse offices and 
employee health units are not device user facilities.
    (e) Distributor means any person (other than the manufacturer or 
importer) who furthers the marketing of a device from the original place 
of manufacture to the person who makes final delivery or sale to the 
ultimate user, but who does not repackage or otherwise change the 
container, wrapper, or labeling of the device or device package. If you 
repackage or otherwise change the container, wrapper, or labeling, you 
are considered a manufacturer as defined in this section.
    (f) Expected life of a device means the time that a device is 
expected to remain functional after it is placed into use. Certain 
implanted devices have specified ``end of life'' (EOL) dates. Other 
devices are not labeled as to their respective EOL, but are expected to 
remain operational through activities such as maintenance, repairs, or 
upgrades, for an estimated period of time.
    (g) FDA, we, us, or Agency means the Food and Drug Administration.
    (h) Five-day report means a medical device report that must be 
submitted by a manufacturer to us under Sec. 803.53 within 5 work days.
    (i) Hospital means a distinct entity that operates for the primary 
purpose of providing diagnostic, therapeutic (such as medical, 
occupational, speech, physical), surgical, and other patient services 
for specific and general medical conditions. Hospitals include general, 
chronic disease, rehabilitative, psychiatric, and other special-purpose 
facilities. A hospital may be either independent (e.g., not a part of a 
provider of services or any other facility) or may be operated by 
another medical entity (e.g., under the common ownership, licensure, or 
control of another entity). A hospital is covered by this regulation 
regardless of whether it is licensed by a Federal, State, municipal or 
local government or whether it is accredited by a recognized 
accreditation organization. If an adverse event meets the criteria for 
reporting, the hospital must report that event regardless of the nature 
or location of the medical service provided by the hospital.
    (j) Importer means any person who imports a device into the United 
States and who furthers the marketing of a device from the original 
place of manufacture to the person who makes final delivery or sale to 
the ultimate user, but who does not repackage or otherwise change the 
container, wrapper, or labeling of the device or device package. If you 
repackage or otherwise change the container, wrapper, or labeling, you 
are considered a manufacturer as defined in this section.
    (k) Malfunction means the failure of a device to meet its 
performance specifications or otherwise perform as intended. Performance 
specifications include all claims made in the labeling for the device. 
The intended performance of a device refers to the intended use for 
which the device is labeled or

[[Page 67]]

marketed, as defined in Sec. 801.4 of this chapter.
    (l) Manufacturer means any person who manufactures, prepares, 
propagates, compounds, assembles, or processes a device by chemical, 
physical, biological, or other procedure. The term includes any person 
who either:
    (1) Repackages or otherwise changes the container, wrapper, or 
labeling of a device in furtherance of the distribution of the device 
from the original place of manufacture;
    (2) Initiates specifications for devices that are manufactured by a 
second party for subsequent distribution by the person initiating the 
specifications;
    (3) Manufactures components or accessories that are devices that are 
ready to be used and are intended to be commercially distributed and 
intended to be used as is, or are processed by a licensed practitioner 
or other qualified person to meet the needs of a particular patient; or
    (4) Is the U.S. agent of a foreign manufacturer.
    (m) Manufacturer or importer report number. This number uniquely 
identifies each individual adverse event report submitted by a 
manufacturer or importer. This number consists of the following three 
parts:
    (1) The FDA registration number for the manufacturing site of the 
reported device, or the registration number for the importer. If the 
manufacturing site or the importer does not have an establishment 
registration number, we will assign a temporary MDR reporting number 
until the site is registered in accordance with part 807 of this 
chapter. We will inform the manufacturer or importer of the temporary 
MDR reporting number;
    (2) The four-digit calendar year in which the report is submitted; 
and
    (3) The five-digit sequence number of the reports submitted during 
the year, starting with 00001. (For example, the complete number will 
appear as follows: 1234567-2011-00001.)
    (n) MDR means medical device report.
    (o) MDR reportable event (or reportable event) means:
    (1) An event that user facilities become aware of that reasonably 
suggests that a device has or may have caused or contributed to a death 
or serious injury or
    (2) An event that manufacturers or importers become aware of that 
reasonably suggests that one of their marketed devices:
    (i) May have caused or contributed to a death or serious injury, or
    (ii) Has malfunctioned and that the device or a similar device 
marketed by the manufacturer or importer would be likely to cause or 
contribute to a death or serious injury if the malfunction were to 
recur.
    (p) Medical personnel means an individual who:
    (1) Is licensed, registered, or certified by a State, territory, or 
other governing body, to administer health care;
    (2) Has received a diploma or a degree in a professional or 
scientific discipline;
    (3) Is an employee responsible for receiving medical complaints or 
adverse event reports; or
    (4) Is a supervisor of these persons.
    (q) Nursing home means:
    (1) An independent entity (i.e., not a part of a provider of 
services or any other facility) or one operated by another medical 
entity (e.g., under the common ownership, licensure, or control of an 
entity) that operates for the primary purpose of providing:
    (i) Skilled nursing care and related services for persons who 
require medical or nursing care;
    (ii) Hospice care to the terminally ill; or
    (iii) Services for the rehabilitation of the injured, disabled, or 
sick.
    (2) A nursing home is subject to this regulation regardless of 
whether it is licensed by a Federal, State, municipal, or local 
government or whether it is accredited by a recognized accreditation 
organization. If an adverse event meets the criteria for reporting, the 
nursing home must report that event regardless of the nature or location 
of the medical service provided by the nursing home.
    (r) Outpatient diagnostic facility means:
    (1) A distinct entity that:
    (i) Operates for the primary purpose of conducting medical 
diagnostic tests on patients,

[[Page 68]]

    (ii) Does not assume ongoing responsibility for patient care, and
    (iii) Provides its services for use by other medical personnel.
    (2) Outpatient diagnostic facilities include outpatient facilities 
providing radiography, mammography, ultrasonography, 
electrocardiography, magnetic resonance imaging, computerized axial 
tomography, and in vitro testing. An outpatient diagnostic facility may 
be either independent (i.e., not a part of a provider of services or any 
other facility) or operated by another medical entity (e.g., under the 
common ownership, licensure, or control of an entity). An outpatient 
diagnostic facility is covered by this regulation regardless of whether 
it is licensed by a Federal, State, municipal, or local government or 
whether it is accredited by a recognized accreditation organization. If 
an adverse event meets the criteria for reporting, the outpatient 
diagnostic facility must report that event regardless of the nature or 
location of the medical service provided by the outpatient diagnostic 
facility.
    (s) Outpatient treatment facility means a distinct entity that 
operates for the primary purpose of providing nonsurgical therapeutic 
(medical, occupational, or physical) care on an outpatient basis or in a 
home health care setting. Outpatient treatment facilities include 
ambulance providers, rescue services, and home health care groups. 
Examples of services provided by outpatient treatment facilities include 
the following: Cardiac defibrillation, chemotherapy, radiotherapy, pain 
control, dialysis, speech or physical therapy, and treatment for 
substance abuse. An outpatient treatment facility may be either 
independent (i.e., not a part of a provider of services or any other 
facility) or operated by another medical entity (e.g., under the common 
ownership, licensure, or control of an entity). An outpatient treatment 
facility is covered by this regulation regardless of whether it is 
licensed by a Federal, State, municipal, or local government or whether 
it is accredited by a recognized accreditation organization. If an 
adverse event meets the criteria for reporting, the outpatient treatment 
facility must report that event regardless of the nature or location of 
the medical service provided by the outpatient treatment facility.
    (t) Patient of the facility means any individual who is being 
diagnosed or treated and/or receiving medical care at or under the 
control or authority of the facility. This includes employees of the 
facility or individuals affiliated with the facility who, in the course 
of their duties, suffer a device-related death or serious injury that 
has or may have been caused or contributed to by a device used at the 
facility.
    (u) Physician's office means a facility that operates as the office 
of a physician or other health care professional for the primary purpose 
of examination, evaluation, and treatment or referral of patients. 
Examples of physician offices include: Dentist offices, chiropractor 
offices, optometrist offices, nurse practitioner offices, school nurse 
offices, school clinics, employee health clinics, or freestanding care 
units. A physician's office may be independent, a group practice, or 
part of a Health Maintenance Organization.
    (v) Remedial action means any action other than routine maintenance 
or servicing of a device where such action is necessary to prevent 
recurrence of a reportable event.
    (w) Serious injury means an injury or illness that:
    (1) Is life-threatening,
    (2) Results in permanent impairment of a body function or permanent 
damage to a body structure, or
    (3) Necessitates medical or surgical intervention to preclude 
permanent impairment of a body function or permanent damage to a body 
structure. Permanent means irreversible impairment or damage to a body 
structure or function, excluding trivial impairment or damage.
    (x) User facility report number means the number that uniquely 
identifies each report submitted by a user facility to manufacturers and 
to us. This number consists of the following three parts:
    (1) The user facility's 10-digit Centers for Medicare and Medicaid 
Services (CMS) number (if the CMS number has fewer than 10 digits, fill 
the remaining spaces with zeros);

[[Page 69]]

    (2) The four-digit calendar year in which the report is submitted; 
and
    (3) The four-digit sequence number of the reports submitted for the 
year, starting with 0001. (For example, a complete user facility report 
number will appear as follows: 1234560000-2011-0001. If a user facility 
has more than one CMS number, it must select one that will be used for 
all of its MDR reports. If a user facility has no CMS number, it should 
use all zeros in the appropriate space in its initial report (e.g., 
0000000000-2011-0001). We will assign a number for future use and send 
that number to the user facility. This number is used in our record of 
the initial report, in subsequent reports, and in any correspondence 
with the user facility. If a facility has multiple sites, the primary 
site may submit reports for all sites and use one reporting number for 
all sites if the primary site provides the name, address, and CMS number 
for each respective site.)
    (y) Work day means Monday through Friday, except Federal holidays.
    (z) [Reserved]
    (aa) Human cell, tissue, or cellular or tissue-based product (HCT/P) 
regulated as a device means an HCT/P as defined in Sec. 1271.3(d) of 
this chapter that does not meet the criteria in Sec. 1271.10(a) and 
that is also regulated as a device.
    (bb) Unique device identifier (UDI) means an identifier that 
adequately identifies a device through its distribution and use by 
meeting the requirements of Sec. 830.20 of this chapter. A unique 
device identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies the specific version or model of a device and the labeler of 
that device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (v) For an HCT/P regulated as a device, the distinct identification 
code required by Sec. 1271.290(c) of this chapter.

[79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015]



Sec. 803.9  What information from the reports do we disclose 
to the public?

    (a) We may disclose to the public any report, including any FDA 
record of a telephone report, submitted under this part. Our disclosures 
are governed by part 20 of this chapter.
    (b) Before we disclose a report to the public, we will delete the 
following:
    (1) Any information that constitutes trade secret or confidential 
commercial or financial information under Sec. 20.61 of this chapter;
    (2) Any personal, medical, and similar information, including the 
serial number of implanted devices, which would constitute an invasion 
of personal privacy under Sec. 20.63 of this chapter. However, if a 
patient requests a report, we will disclose to that patient all the 
information in the report concerning that patient, as provided in Sec. 
20.61 of this chapter; and
    (3) Any names and other identifying information of a third party 
that voluntarily submitted an adverse event report.
    (c) We may not disclose the identity of a device user facility that 
makes a report under this part except in connection with:
    (1) An action brought to enforce section 301(q) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 331(q)), including the failure or 
refusal to furnish material or information required by section 519 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i));
    (2) A communication to a manufacturer of a device that is the 
subject of a report required to be submitted by a user facility under 
Sec. 803.30; or
    (3) A disclosure to employees of the Department of Health and Human 
Services, to the Department of Justice, or to the duly authorized 
committees and subcommittees of the Congress.

[[Page 70]]



Sec. 803.10  Generally, what are the reporting requirements
that apply to me?

    (a) If you are a device user facility, you must submit reports 
(described in subpart C of this part), as follows:
    (1) Submit reports of individual adverse events no later than 10 
work days after the day that you become aware of a reportable event:
    (i) Submit reports of device-related deaths to us and to the 
manufacturer, if known, or
    (ii) Submit reports of device-related serious injuries to the 
manufacturers or, if the manufacturer is unknown, submit reports to us.
    (2) Submit annual reports (described in Sec. 803.33) to us.
    (b) If you are an importer, you must submit reports (described in 
subpart D of this part), as follows:
    (1) Submit reports of individual adverse events no later than 30 
calendar days after the day that you become aware of a reportable event:
    (i) Submit reports of device-related deaths or serious injuries to 
us and to the manufacturer or
    (ii) Submit reports of device-related malfunctions to the 
manufacturer.
    (2) [Reserved]
    (c) If you are a manufacturer, you must submit reports (described in 
subpart E of this part) to us, as follows:
    (1) Submit reports of individual adverse events no later than 30 
calendar days after the day that you become aware of a reportable death, 
serious injury, or malfunction.
    (2) Submit reports of individual adverse events no later than 5 work 
days after the day that you become aware of:
    (i) A reportable event that requires remedial action to prevent an 
unreasonable risk of substantial harm to the public health or
    (ii) A reportable event for which we made a written request.
    (3) Submit supplemental reports if you obtain information that you 
did not submit in an initial report.



Sec. 803.11  What form should I use to submit reports of individual
adverse events and where do I obtain these forms?

    (a) If you are a manufacturer or importer, you must submit reports 
of individual adverse events to FDA in an electronic format in 
accordance with Sec. 803.12(a) and Sec. 803.20, unless granted an 
exemption under Sec. 803.19.
    (b) Importer reports submitted to device manufacturers may be in 
paper format or an electronic format that includes all required data 
fields to ensure that the manufacturer has all required information.
    (c) If you are a user facility, you must submit reports of 
individual adverse events in accordance with Sec. 803.12(b) and Sec. 
803.20.
    (d) Form FDA 3500A is available on the internet at https://
www.accessdata.fda.gov/scripts/medwatch/index.cfm.

[79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015; 85 
FR 18441, Apr. 2, 2020]



Sec. 803.12  How do I submit initial and supplemental or followup reports?

    (a) Manufacturers and importers must submit initial and supplemental 
or followup reports to FDA in an electronic format that FDA can process, 
review, and archive.
    (b) User facilities that submit their reports and additional 
information to FDA electronically must use an electronic format that FDA 
can process, review, and archive. User facilities that submit their 
reports to FDA on paper must submit any written report or additional 
information required under this part to FDA, CDRH, Medical Device 
Reporting, P.O. Box 3002, Rockville, MD 20847-3002, using Form FDA 
3500A. Each report must be identified (e.g., ``User Facility Report'' or 
``Annual Report'').
    (c) If you are confronted with a public health emergency, this can 
be brought to FDA's attention by contacting FDA's Office of Crisis 
Management, Emergency Operations Center by telephone, 24-hours a day, at 
301-796-8240 or toll free at 866-300-4374, followed by the submission of 
an email to: [email protected].

[[Page 71]]

    Note: This action does not satisfy your obligation to report under 
part 803.
    (d) You may submit a voluntary telephone report to the MedWatch 
office at 800-FDA-1088. You may also obtain information regarding 
voluntary reporting from the MedWatch office at 800-FDA-1088. You may 
also find the voluntary Form FDA 3500 and instructions to complete it 
at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/
default.htm.



Sec. 803.13  Do I need to submit reports in English?

    Yes. You must submit all reports required by this part in English.



Sec. 803.15  How will I know if you require more information 
about my medical device report?

    (a) We will notify you in writing if we require additional 
information and will tell you what information we need. We will require 
additional information if we determine that protection of the public 
health requires additional or clarifying information for medical device 
reports submitted to us and in cases when the additional information is 
beyond the scope of FDA reporting forms or is not readily accessible to 
us.
    (b) In any request under this section, we will state the reason or 
purpose for the information request, specify the due date for submitting 
the information, and clearly identify the reported event(s) related to 
our request. If we verbally request additional information, we will 
confirm the request in writing.



Sec. 803.16  When I submit a report, does the information in my 
report constitute an admission that the device caused or
contributed to the reportable event?

    No. A report or other information submitted by you, and our release 
of that report or information, is not necessarily an admission that the 
device, or you or your employees, caused or contributed to the 
reportable event. You do not have to admit and may deny that the report 
or information submitted under this part constitutes an admission that 
the device, you, or your employees, caused or contributed to a 
reportable event.



Sec. 803.17  What are the requirements for developing, maintaining,
and implementing written MDR procedures that apply to me?

    If you are a user facility, importer, or manufacturer, you must 
develop, maintain, and implement written MDR procedures for the 
following:
    (a) Internal systems that provide for:
    (1) Timely and effective identification, communication, and 
evaluation of events that may be subject to MDR requirements;
    (2) A standardized review process or procedure for determining when 
an event meets the criteria for reporting under this part; and
    (3) Timely transmission of complete medical device reports to 
manufacturers or to us, or to both if required.
    (b) Documentation and recordkeeping requirements for:
    (1) Information that was evaluated to determine if an event was 
reportable;
    (2) All medical device reports and information submitted to 
manufacturers and/or us;
    (3) Any information that was evaluated for the purpose of preparing 
the submission of annual reports; and
    (4) Systems that ensure access to information that facilitates 
timely followup and inspection by us.



Sec. 803.18  What are the requirements for establishing and
maintaining MDR files or records that apply to me?

    (a) If you are a user facility, importer, or manufacturer, you must 
establish and maintain MDR event files. You must clearly identify all 
MDR event files and maintain them to facilitate timely access.
    (b)(1) For purposes of this part, ``MDR event files'' are written or 
electronic files maintained by user facilities, importers, and 
manufacturers. MDR event files may incorporate references to other 
information (e.g., medical records, patient files, engineering reports), 
in lieu of copying and maintaining duplicates in this file. Your MDR 
event files must contain:
    (i) Information in your possession or references to information 
related to the adverse event, including all documentation of your 
deliberations and

[[Page 72]]

decision making processes used to determine if a device-related death, 
serious injury, or malfunction was or was not reportable under this 
part;
    (ii) Copies of all reports submitted under this part (whether paper 
or electronic), and of all other information related to the event that 
you submitted to us or other entities such as an importer, distributor, 
or manufacturer; and
    (iii) Copies of all electronic acknowledgments FDA sends you in 
response to electronic MDR submissions.
    (2) If you are a user facility, importer, or manufacturer, you must 
permit any authorized FDA employee, at all reasonable times, to access, 
to copy, and to verify the records required by this part.
    (c) If you are a user facility, you must retain an MDR event file 
relating to an adverse event for a period of 2 years from the date of 
the event. If you are a manufacturer or importer, you must retain an MDR 
event file relating to an adverse event for a period of 2 years from the 
date of the event or a period of time equivalent to the expected life of 
the device, whichever is greater. If the device is no longer 
distributed, you still must maintain MDR event files for the time 
periods described in this paragraph (c).
    (d)(1) If you are a device distributor, you must establish and 
maintain device complaint records (files). Your records must contain any 
incident information, including any written, electronic, or oral 
communication, either received or generated by you, that alleges 
deficiencies related to the identity (e.g., labeling), quality, 
durability, reliability, safety, effectiveness, or performance of a 
device. You must also maintain information about your evaluation of the 
allegations, if any, in the incident record. You must clearly identify 
the records as device incident records and file these records by device 
name. You may maintain these records in written or electronic format. 
You must back up any file maintained in electronic format.
    (2) You must retain copies of the required device incident records 
for a period of 2 years from the date of inclusion of the record in the 
file or for a period of time equivalent to the expected life of the 
device, whichever is greater. You must maintain copies of these records 
for this period even if you no longer distribute the device.
    (3) You must maintain the device complaint files established under 
this section at your principal business establishment. If you are also a 
manufacturer, you may maintain the file at the same location as you 
maintain your complaint file under part 820 of this chapter. You must 
permit any authorized FDA employee, at all reasonable times, to access, 
to copy, and to verify the records required by this part.
    (e) If you are a manufacturer, you may maintain MDR event files as 
part of your complaint file, under part 820 of this chapter, if you 
prominently identify these records as MDR reportable events. We will not 
consider your submitted MDR report to comply with this part unless you 
evaluate an event in accordance with the quality system requirements 
described in part 820 of this chapter. You must document and maintain in 
your MDR event files an explanation of why you did not submit or could 
not obtain any information required by this part, as well as the results 
of your evaluation of each event.



Sec. 803.19  Are there exemptions, variances, or alternative forms
of adverse event reporting requirements?

    (a) We exempt the following persons from the adverse event reporting 
requirements in this part:
    (1) A licensed practitioner who prescribes or administers devices 
intended for use in humans and manufactures or imports devices solely 
for use in diagnosing and treating persons with whom the practitioner 
has a ``physician-patient'' relationship;
    (2) An individual who manufactures devices intended for use in 
humans solely for this person's use in research or teaching and not for 
sale. This includes any person who is subject to alternative reporting 
requirements under the investigational device exemption regulations 
(described in part 812 of this chapter), which require reporting of all 
adverse device effects; and
    (3) Dental laboratories or optical laboratories.

[[Page 73]]

    (b) If you are a manufacturer, importer, or user facility, you may 
request an exemption or variance from any or all of the reporting 
requirements in this part, including the requirements of Sec. 803.12. 
You must submit the request to the Center for Devices and Radiological 
Health (CDRH) in writing at [email protected]. Your request must 
include information necessary to identify you and the device; a complete 
statement of the request for exemption, variance, or alternative 
reporting; and an explanation why your request is justified. If you are 
requesting an exemption from the requirement to submit reports to FDA in 
electronic format under Sec. 803.12(a), your request should indicate 
for how long you will require this exemption.
    (c) If you are a manufacturer, importer, or user facility, we may 
grant in writing an exemption or variance from, or alternative to, any 
or all of the reporting requirements in this part, and may change the 
frequency of reporting to quarterly, semiannually, annually or other 
appropriate time period. We may grant these modifications in response to 
your request, as described in paragraph (b) of this section, or at our 
discretion. When we grant modifications to the reporting requirements, 
we may impose other reporting requirements to ensure the protection of 
public health.
    (d) We may revoke or modify in writing an exemption, variance, or 
alternative reporting requirement if we determine that revocation or 
modification is necessary to protect the public health.
    (e) If we grant your request for a reporting modification, you must 
submit any reports or information required in our approval of the 
modification. The conditions of the approval will replace and supersede 
the regular reporting requirement specified in this part until such time 
that we revoke or modify the alternative reporting requirements in 
accordance with paragraph (d) of this section or until the date 
specified in our response granting your variance, at which time the 
provisions of this part will again apply.

[79 FR 8846, Feb. 14, 2014, as amended at 85 FR 18441, Apr. 2, 2020; 88 
FR 16879, Mar. 21, 2023]



Subpart B_Generally Applicable Requirements for Individual Adverse Event 
                                 Reports



Sec. 803.20  How do I complete and submit an individual adverse event report?

    (a) What form must I complete and submit?
    (1) If you are a health professional or consumer or other entity, 
you may submit voluntary reports to FDA regarding devices or other FDA-
regulated products using the Form FDA 3500.
    (2) To submit a mandatory report in written form, a user facility 
must use Form FDA 3500A.
    (3) An electronic submission of a mandatory report from a user 
facility, importer, or manufacturer must contain the information from 
the applicable blocks of Form FDA 3500A. All electronic submissions must 
include information about the patient, the event, the device, and the 
``initial reporter.'' An electronic submission from a user facility or 
importer must include the information from block F. An electronic 
submission from a manufacturer must include the information from blocks 
G and H. If you are a manufacturer and you receive a report from a user 
facility or importer, you must incorporate that information in your 
electronic submission and include any corrected or missing information.
    (b) To whom must I submit reports and when?
    (1) If you are a user facility, you must submit MDR reports to:
    (i) The manufacturer and to us no later than 10 work days after the 
day that you become aware of information that reasonably suggests that a 
device has or may have caused or contributed to a death or
    (ii) The manufacturer no later than 10 work days after the day that 
you become aware of information that reasonably suggests that a device 
has or may have caused or contributed to a serious injury. If the 
manufacturer is not known, you must submit this report to us.
    (2) If you are an importer, you must submit MDR reports to:
    (i) The manufacturer and to us, no later than 30 calendar days after 
the day that you become aware of information that reasonably suggests 
that a

[[Page 74]]

device has or may have caused or contributed to a death or serious 
injury or
    (ii) The manufacturer, no later than 30 calendar days after 
receiving information that a device you market has malfunctioned and 
that this device or a similar device that you market would be likely to 
cause or contribute to a death or serious injury if the malfunction were 
to recur.
    (3) If you are a manufacturer, you must submit MDR reports to us:
    (i) No later than 30 calendar days after the day that you become 
aware of information that reasonably suggests that a device may have 
caused or contributed to a death or serious injury or
    (ii) No later than 30 calendar days after the day that you become 
aware of information that reasonably suggests a device has malfunctioned 
and that this device or a similar device that you market would be likely 
to cause or contribute to a death or serious injury if the malfunction 
were to recur; or
    (iii) Within 5 work days if required by Sec. 803.53.
    (c) What kind of information reasonably suggests that a reportable 
event has occurred?
    (1) Any information, including professional, scientific, or medical 
facts, observations, or opinions, may reasonably suggest that a device 
has caused or may have caused or contributed to an MDR reportable event. 
An MDR reportable event is a death, a serious injury, or, if you are a 
manufacturer or importer, a malfunction that would be likely to cause or 
contribute to a death or serious injury if the malfunction were to 
recur.
    (2) If you are a user facility, importer, or manufacturer, you do 
not have to report an adverse event if you have information that would 
lead a person who is qualified to make a medical judgment reasonably to 
conclude that a device did not cause or contribute to a death or serious 
injury, or that a malfunction would not be likely to cause or contribute 
to a death or serious injury if it were to recur. Persons qualified to 
make a medical judgment include physicians, nurses, risk managers, and 
biomedical engineers. You must keep in your MDR event files (described 
in Sec. 803.18) the information that the qualified person used to 
determine whether or not a device-related event was reportable.



Sec. 803.21  Where can I find the reporting codes for adverse events
that I use with medical device reports?

    (a) The MedWatch Medical Device Reporting Code Instruction Manual 
contains adverse event codes for use with Form FDA 3500A. You may obtain 
the coding manual from FDA's website at: https://www.fda.gov/medical-
devices/mandatory-reporting-requirements-manufacturers-importers-and-
device-user-facilities/mdr-adverse-event-codes.
    (b) We may sometimes use additional coding of information on the 
reporting forms or modify the existing codes. If we do make 
modifications, we will ensure that we make the new coding information 
available to all reporters.

[79 FR 8846, Feb. 14, 2014, as amended at 85 FR 18441, Apr. 2, 2020]



Sec. 803.22  What are the circumstances in which I am not
required to file a report?

    (a) If you become aware of information from multiple sources 
regarding the same patient and same reportable event, you may submit one 
medical device report.
    (b) You are not required to submit a medical device report if:
    (1) You are a user facility, importer, or manufacturer, and you 
determine that the information received is erroneous in that a device-
related adverse event did not occur. You must retain documentation of 
these reports in your MDR files for the time periods specified in Sec. 
803.18.
    (2) You are a manufacturer or importer and you did not manufacture 
or import the device about which you have adverse event information. 
When you receive reportable event information in error, you must forward 
this information to us with a cover letter explaining that you did not 
manufacture or import the device in question.



Sec. 803.23  Where can I find information on how to prepare and 
submit an MDR in electronic format?

    (a) You may obtain information on how to prepare and submit reports 
in an electronic format that FDA can process, review, and archive at: 
http://

[[Page 75]]

www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm.
    (b) We may sometimes update information on how to prepare and submit 
reports electronically. If we do make modifications, we will ensure that 
we alert reporters by updating the eMDR Web page.



             Subpart C_User Facility Reporting Requirements



Sec. 803.30  If I am a user facility, what reporting requirements
apply to me?

    (a) You must submit reports to the manufacturer or to us, or both, 
as specified in paragraphs (a)(1) and (a)(2) of this section as follows:
    (1) Reports of death. You must submit a report to us as soon as 
practicable but no more than 10 work days after the day that you become 
aware of information, from any source, that reasonably suggests that a 
device has or may have caused or contributed to the death of a patient 
of your facility. You must also submit the report to the device 
manufacturer, if known. You must submit the information required by 
Sec. 803.32. Reports sent to the Agency must be submitted in accordance 
with the requirements of Sec. 803.12(b).
    (2) Reports of serious injury. You must submit a report to the 
manufacturer of the device no later than 10 work days after the day that 
you become aware of information, from any source, that reasonably 
suggests that a device has or may have caused or contributed to a 
serious injury to a patient of your facility. If the manufacturer is not 
known, you must submit the report to us. You must report information 
required by Sec. 803.32. Reports sent to the Agency must be submitted 
in accordance with the requirements of Sec. 803.12 (b).
    (b) What information does FDA consider ``reasonably known'' to me? 
You must submit all information required in this subpart C that is 
reasonably known to you. This information includes information found in 
documents that you possess and any information that becomes available as 
a result of reasonable followup within your facility. You are not 
required to evaluate or investigate the event by obtaining or evaluating 
information that you do not reasonably know.



Sec. 803.32  If I am a user facility, what information must I submit
in my individual adverse event reports?

    You must include the following information in your report, if 
reasonably known to you, as described in Sec. 803.30(b). These types of 
information correspond generally to the elements of Form FDA 3500A:
    (a) Patient information (Form FDA 3500A, Block A). You must submit 
the following:
    (1) Patient name or other identifier;
    (2) Patient age at the time of event, or date of birth;
    (3) Patient gender; and
    (4) Patient weight.
    (b) Adverse event or product problem (Form FDA 3500A, Block B). You 
must submit the following:
    (1) Identification of adverse event or product problem;
    (2) Outcomes attributed to the adverse event (e.g., death or serious 
injury). An outcome is considered a serious injury if it is:
    (i) A life-threatening injury or illness;
    (ii) A disability resulting in permanent impairment of a body 
function or permanent damage to a body structure; or
    (iii) An injury or illness that requires intervention to prevent 
permanent impairment of a body structure or function;
    (3) Date of event;
    (4) Date of this report;
    (5) Description of event or problem, including a discussion of how 
the device was involved, nature of the problem, patient followup or 
required treatment, and any environmental conditions that may have 
influenced the event;
    (6) Description of relevant tests, including dates and laboratory 
data; and
    (7) Description of other relevant history, including preexisting 
medical conditions.
    (c) Device information (Form FDA 3500A, Block D). You must submit 
the following:
    (1) Brand name;
    (2) Product Code, if known, and Common Device Name;

[[Page 76]]

    (3) Manufacturer name, city, and state;
    (4) Model number, catalog number, serial number, lot number, or 
other identifying number; expiration date; and unique device identifier 
(UDI) that appears on the device label or on the device package;
    (5) Operator of the device (health professional, lay user/patient, 
other);
    (6) Date of device implantation (month, day, year), if applicable;
    (7) Date of device explantation (month, day, year), if applicable;
    (8) Whether the device is a single-use device that was reprocessed 
and reused on a patient (Yes, No)?
    (9) If the device is a single-use device that was reprocessed and 
reused on a patient (yes to paragraph (c)(8) of this section), the name 
and address of the reprocessor;
    (10) Whether the device was available for evaluation and whether the 
device was returned to the manufacturer; if so, the date it was returned 
to the manufacturer; and
    (11) Concomitant medical products and therapy dates. (Do not report 
products that were used to treat the event.)
    (d) Initial reporter information (Form FDA 3500A, Block E). You must 
submit the following:
    (1) Name, address, and telephone number of the reporter who 
initially provided information to you, or to the manufacturer or 
distributor;
    (2) Whether the initial reporter is a health professional;
    (3) Occupation; and
    (4) Whether the initial reporter also sent a copy of the report to 
us, if known.
    (e) User facility information (Form FDA 3500A, Block F). You must 
submit the following:
    (1) An indication that this is a user facility report (by marking 
the user facility box on the form);
    (2) Your user facility number;
    (3) Your address;
    (4) Your contact person;
    (5) Your contact person's telephone number;
    (6) Date that you became aware of the event (month, day, year);
    (7) Type of report (initial or followup); if it is a followup, you 
must include the report number of the initial report;
    (8) Date of your report (month, day, year);
    (9) Approximate age of device;
    (10) Event problem codes--patient code and device code (refer to the 
``MedWatch Medical Device Reporting Code Instructions'');
    (11) Whether a report was sent to us and the date it was sent 
(month, day, year);
    (12) Location where the event occurred;
    (13) Whether the report was sent to the manufacturer and the date it 
was sent (month, day, year); and
    (14) Manufacturer name and address, if available.

[79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015]



Sec. 803.33  If I am a user facility, what must I include when
I submit an annual report?

    (a) You must submit to us an annual report on Form FDA 3419. You 
must submit an annual report by January 1, of each year. You may obtain 
this form on the internet at: https://www.fda.gov/media/72292/download.
    (b) You must clearly identify your annual report as such. You must 
submit your annual report to FDA, CDRH, Medical Device Reporting, P.O. 
Box 3002, Rockville, MD 20847-3002. Your annual report must include:
    (1) Your CMS provider number used for medical device reports, or the 
number assigned by us for reporting purposes in accordance with Sec. 
803.3;
    (2) Reporting year;
    (3) Your name and complete address;
    (4) Total number of reports attached or summarized;
    (5) Date of the annual report and report numbers identifying the 
range of medical device reports that you submitted during the report 
period (e.g., 1234567890-2011-0001 through 1000);
    (6) Name, position title, and complete address of the individual 
designated as your contact person responsible for reporting to us and 
whether that person is a new contact for you; and
    (7) Information for each reportable event that occurred during the 
annual reporting period including:

[[Page 77]]

    (i) Report number;
    (ii) Name and address of the device manufacturer;
    (iii) Device brand name and common name;
    (iv) Product model, catalog, serial, and lot number and unique 
device identifier (UDI) that appears on the device label or on the 
device package;
    (v) A brief description of the event reported to the manufacturer 
and/or us; and
    (vi) Where the report was submitted, i.e., to the manufacturer, 
importer, or us.
    (c) In lieu of submitting the information in paragraph (b)(7) of 
this section, you may submit a copy of each medical device report that 
you submitted to the manufacturers and/or to us during the reporting 
period.
    (d) If you did not submit any medical device reports to 
manufacturers or us during the time period, you do not need to submit an 
annual report.

[79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015; 85 
FR 18442, Apr. 2, 2020]



                Subpart D_Importer Reporting Requirements



Sec. 803.40  If I am an importer, what reporting requirements
apply to me?

    (a) Reports of deaths or serious injuries. You must submit a report 
to us, and a copy of this report to the manufacturer, as soon as 
practicable, but no later than 30 calendar days after the day that you 
receive or otherwise become aware of information from any source, 
including user facilities, individuals, or medical or scientific 
literature, whether published or unpublished, that reasonably suggests 
that one of your marketed devices may have caused or contributed to a 
death or serious injury. You must submit the information required by 
Sec. 803.42. Reports sent to the Agency must be submitted in accordance 
with the requirements of Sec. 803.12(a).
    (b) Reports of malfunctions. You must submit a report to the 
manufacturer as soon as practicable but no later than 30 calendar days 
after the day that you receive or otherwise become aware of information 
from any source, including user facilities, individuals, or through your 
own research, testing, evaluation, servicing, or maintenance of one of 
your devices, that reasonably suggests that one of your devices has 
malfunctioned and that this device or a similar device that you market 
would be likely to cause or contribute to a death or serious injury if 
the malfunction were to recur. You must submit the information required 
by Sec. 803.42. Reports to manufacturers may be made in accordance with 
Sec. 803.11(b).



Sec. 803.42  If I am an importer, what information must I submit
in my individual adverse event reports?

    You must include the following information in your report, if the 
information is known or should be known to you, as described in Sec. 
803.40. These types of information correspond generally to the format of 
Form FDA 3500A:
    (a) Patient information (Form FDA 3500A, Block A). You must submit 
the following:
    (1) Patient name or other identifier;
    (2) Patient age at the time of event, or date of birth;
    (3) Patient gender; and
    (4) Patient weight.
    (b) Adverse event or product problem (Form FDA 3500A, Block B). You 
must submit the following:
    (1) Identification of adverse event or product problem;
    (2) Outcomes attributed to the adverse event (e.g., death or serious 
injury). An outcome is considered a serious injury if it is:
    (i) A life-threatening injury or illness;
    (ii) A disability resulting in permanent impairment of a body 
function or permanent damage to a body structure; or
    (iii) An injury or illness that requires intervention to prevent 
permanent impairment of a body structure or function;
    (3) Date of event;
    (4) Date of this report;
    (5) Description of the event or problem, including a discussion of 
how the device was involved, nature of the problem, patient followup or 
required treatment, and any environmental conditions that may have 
influenced the event;

[[Page 78]]

    (6) Description of relevant tests, including dates and laboratory 
data; and
    (7) Description of other relevant patient history, including 
preexisting medical conditions.
    (c) Device information (Form FDA 3500A, Block D). You must submit 
the following:
    (1) Brand name;
    (2) Product Code, if known, and Common Device Name;
    (3) Manufacturer name, city, and state;
    (4) Model number, catalog number, serial number, lot number, or 
other identifying number; expiration date; and unique device identifier 
(UDI) that appears on the device label or on the device package;
    (5) Operator of the device (health professional, lay user/patient, 
other);
    (6) Date of device implantation (month, day, year), if applicable;
    (7) Date of device explanation (month, day, year), if applicable;
    (8) Whether the device is a single-use device that was reprocessed 
and reused on a patient (Yes, No)?
    (9) If the device is a single-use device that was reprocessed and 
reused on a patient (yes to paragraph (c)(8) of this section), the name 
and address of the reprocessor;
    (10) Whether the device was available for evaluation, and whether 
the device was returned to the manufacturer, and if so, the date it was 
returned to the manufacturer; and
    (11) Concomitant medical products and therapy dates. (Do not report 
products that were used to treat the event.)
    (d) Initial reporter information (Form FDA 3500A, Block E). You must 
submit the following:
    (1) Name, address, and telephone number of the reporter who 
initially provided information to the manufacturer, user facility, or 
distributor;
    (2) Whether the initial reporter is a health professional;
    (3) Occupation; and
    (4) Whether the initial reporter also sent a copy of the report to 
us, if known.
    (e) Importer information (Form FDA 3500A, Block F). You must submit 
the following:
    (1) An indication that this is an importer report (by marking the 
importer box on the form);
    (2) Your importer report number;
    (3) Your address;
    (4) Your contact person;
    (5) Your contact person's telephone number;
    (6) Date that you became aware of the event (month, day, year);
    (7) Type of report (initial or followup). If it is a followup 
report, you must include the report number of your initial report;
    (8) Date of your report (month, day, year);
    (9) Approximate age of device;
    (10) Event problem codes--patient code and device code (refer to FDA 
MedWatch Medical Device Reporting Code Instructions);
    (11) Whether a report was sent to us and the date it was sent 
(month, day, year);
    (12) Location where event occurred;
    (13) Whether a report was sent to the manufacturer and the date it 
was sent (month, day, year); and
    (14) Manufacturer name and address, if available.

[79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015]



              Subpart E_Manufacturer Reporting Requirements



Sec. 803.50  If I am a manufacturer, what reporting requirements
apply to me?

    (a) If you are a manufacturer, you must report to us the information 
required by Sec. 803.52 in accordance with the requirements of Sec. 
803.12(a), no later than 30 calendar days after the day that you receive 
or otherwise become aware of information, from any source, that 
reasonably suggests that a device that you market:
    (1) May have caused or contributed to a death or serious injury or
    (2) Has malfunctioned and this device or a similar device that you 
market would be likely to cause or contribute to a death or serious 
injury, if the malfunction were to recur.
    (b) What information does FDA consider ``reasonably known'' to me?

[[Page 79]]

    (1) You must submit all information required in this subpart E that 
is reasonably known to you. We consider the following information to be 
reasonably known to you:
    (i) Any information that you can obtain by contacting a user 
facility, importer, or other initial reporter;
    (ii) Any information in your possession; or
    (iii) Any information that you can obtain by analysis, testing, or 
other evaluation of the device.
    (2) You are responsible for obtaining and submitting to us 
information that is incomplete or missing from reports submitted by user 
facilities, importers, and other initial reporters.
    (3) You are also responsible for conducting an investigation of each 
event and evaluating the cause of the event. If you cannot submit 
complete information on a report, you must provide a statement 
explaining why this information was incomplete and the steps you took to 
obtain the information. If you later obtain any required information 
that was not available at the time you filed your initial report, you 
must submit this information in a supplemental report under Sec. 803.56 
in accordance with the requirements of Sec. 803.12(a).



Sec. 803.52  If I am a manufacturer, what information must I submit 
in my individual adverse event reports?

    You must include the following information in your reports, if known 
or reasonably known to you, as described in Sec. 803.50(b). These types 
of information correspond generally to the format of Form FDA 3500A:
    (a) Patient information (Form FDA 3500A, Block A). You must submit 
the following:
    (1) Patient name or other identifier;
    (2) Patient age at the time of event, or date of birth;
    (3) Patient gender; and
    (4) Patient weight.
    (b) Adverse event or product problem (Form FDA 3500A, Block B). You 
must submit the following:
    (1) Identification of adverse event or product problem;
    (2) Outcomes attributed to the adverse event (e.g., death or serious 
injury). An outcome is considered a serious injury if it is:
    (i) A life-threatening injury or illness;
    (ii) A disability resulting in permanent impairment of a body 
function or permanent damage to a body structure; or
    (iii) An injury or illness that requires intervention to prevent 
permanent impairment of a body structure or function;
    (3) Date of event;
    (4) Date of this report;
    (5) Description of the event or problem, including a discussion of 
how the device was involved, nature of the problem, patient followup or 
required treatment, and any environmental conditions that may have 
influenced the event;
    (6) Description of relevant tests, including dates and laboratory 
data; and
    (7) Other relevant patient history including preexisting medical 
conditions.
    (c) Device information (Form FDA 3500A, Block D). You must submit 
the following:
    (1) Brand name;
    (2) Product Code, if known, and Common Device Name;
    (3) Manufacturer name, city, and state;
    (4) Model number, catalog number, serial number, lot number, or 
other identifying number; expiration date; and unique device identifier 
(UDI) that appears on the device label or on the device package;
    (5) Operator of the device (health professional, lay user/patient, 
other);
    (6) Date of device implantation (month, day, year), if applicable;
    (7) Date of device explantation (month, day, year), if applicable;
    (8) Whether the device is a single-use device that was reprocessed 
and reused on a patient (Yes, No)?
    (9) If the device is a single-use device that was reprocessed and 
reused on a patient (yes to paragraph (c)(8) of this section), the name 
and address of the reprocessor;
    (10) Whether the device was available for evaluation, and whether 
the device was returned to the manufacturer, and if so, the date it was 
returned to the manufacturer; and

[[Page 80]]

    (11) Concomitant medical products and therapy dates. (Do not report 
products that were used to treat the event.)
    (d) Initial reporter information (Form FDA 3500A, Block E). You must 
submit the following:
    (1) Name, address, and telephone number of the reporter who 
initially provided information to you, or to the user facility or 
importer;
    (2) Whether the initial reporter is a health professional;
    (3) Occupation; and
    (4) Whether the initial reporter also sent a copy of the report to 
us, if known.
    (e) Reporting information for all manufacturers (Form FDA 3500A, 
Block G). You must submit the following:
    (1) Your reporting office's contact name and address and device 
manufacturing site;
    (2) Your contact person's telephone number;
    (3) Your report sources;
    (4) Date received by you (month, day, year);
    (5) PMA/510k Number and whether or not the product is a combination 
product;
    (6) Type of report being submitted (e.g., 5-day, initial, followup); 
and
    (7) Your report number.
    (f) Device manufacturer information (Form FDA 3500A, Block H). You 
must submit the following:
    (1) Type of reportable event (death, serious injury, malfunction, 
etc.);
    (2) Type of followup report, if applicable (e.g., correction, 
response to FDA request, etc);
    (3) If the device was returned to you and evaluated by you, you must 
include a summary of the evaluation. If you did not perform an 
evaluation, you must explain why you did not perform an evaluation;
    (4) Device manufacture date (month, day, year);
    (5) Whether the device was labeled for single use;
    (6) Evaluation codes (including event codes, method of evaluation, 
result, and conclusion codes) (refer to FDA MedWatch Medical Device 
Reporting Code Instructions);
    (7) Whether remedial action was taken and the type of action;
    (8) Whether the use of the device was initial, reuse, or unknown;
    (9) Whether remedial action was reported as a removal or correction 
under section 519(f) of the Federal Food, Drug, and Cosmetic Act, and if 
it was, provide the correction/removal report number; and
    (10) Your additional narrative; and/or
    (11) Corrected data, including:
    (i) Any information missing on the user facility report or importer 
report, including any event codes that were not reported, or information 
corrected on these forms after your verification;
    (ii) For each event code provided by the user facility under Sec. 
803.32(e)(10) or the importer under Sec. 803.42(e)(10), you must 
include a statement of whether the type of the event represented by the 
code is addressed in the device labeling; and
    (iii) If your report omits any required information, you must 
explain why this information was not provided and the steps taken to 
obtain this information.

[79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015]



Sec. 803.53  If I am a manufacturer, in which circumstances 
must I submit a 5-day report?

    You must submit a 5-day report to us with the information required 
by Sec. 803.52 in accordance with the requirements of Sec. 803.12(a) 
no later than 5 work days after the day that you become aware that:
    (a) An MDR reportable event necessitates remedial action to prevent 
an unreasonable risk of substantial harm to the public health. You may 
become aware of the need for remedial action from any information, 
including any trend analysis or
    (b) We have made a written request for the submission of a 5-day 
report. If you receive such a written request from us, you must submit, 
without further requests, a 5-day report for all subsequent events of 
the same nature that involve substantially similar devices for the time 
period specified in the written request. We may extend the time period 
stated in the original written request if we determine it is in the 
interest of the public health.

[[Page 81]]



Sec. 803.56  If I am a manufacturer, in what circumstances must I submit
a supplemental or followup report and what are the requirements for such reports?

    If you are a manufacturer, when you obtain information required 
under this part that you did not provide because it was not known or was 
not available when you submitted the initial report, you must submit the 
supplemental information to us within 30 calendar days of the day that 
you receive this information. You must submit the supplemental or 
followup report in accordance with the requirements of Sec. 803.12(a). 
On a supplemental or followup report, you must:
    (a) Indicate that the report being submitted is a supplemental or 
followup report;
    (b) Submit the appropriate identification numbers of the report that 
you are updating with the supplemental information (e.g., your original 
manufacturer report number and the user facility or importer report 
number of any report on which your report was based), if applicable; and
    (c) Include only the new, changed, or corrected information.



Sec. 803.58  Foreign manufacturers.

    (a) Every foreign manufacturer whose devices are distributed in the 
United States shall designate a U.S. agent to be responsible for 
reporting in accordance with Sec. 807.40 of this chapter. The U.S. 
designated agent accepts responsibility for the duties that such 
designation entails. Upon the effective date of this regulation, foreign 
manufacturers shall inform FDA, by letter, of the name and address of 
the U.S. agent designated under this section and Sec. 807.40 of this 
chapter, and shall update this information as necessary. Such updated 
information shall be submitted to FDA, within 5 days of a change in the 
designated agent information.
    (b) U.S.-designated agents of foreign manufacturers are required to:
    (1) Report to FDA in accordance with Sec. Sec. 803.50, 803.52, 
803.53, and 803.56;
    (2) Conduct, or obtain from the foreign manufacturer the necessary 
information regarding, the investigation and evaluation of the event to 
comport with the requirements of Sec. 803.50;
    (3) Forward MDR complaints to the foreign manufacturer and maintain 
documentation of this requirement;
    (4) Maintain complaint files in accordance with Sec. 803.18; and
    (5) Register, list, and submit premarket notifications in accordance 
with part 807 of this chapter.

    Effective Date Note: At 79 FR 8846, Feb. 14, 2014, part 803 was 
revised. At 79 FR 8855, Feb. 14, 2014, Sec. 803.58 was stayed 
indefinitely.



PART 806_MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS--
Table of Contents



                      Subpart A_General Provisions

Sec.
806.1 Scope.
806.2 Definitions.

                      Subpart B_Reports and Records

806.10 Reports of corrections and removals.
806.20 Records of corrections and removals not required to be reported.
806.30 FDA access to records.
806.40 Public availability of reports.

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

    Source: 62 FR 27191, May 19, 1997, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 806.1  Scope.

    (a) This part implements the provisions of section 519(g) of the 
Federal Food, Drug, and Cosmetic Act (the act) requiring device 
manufacturers and importers to report promptly to the Food and Drug 
Administration (FDA) certain actions concerning device corrections and 
removals, and to maintain records of all corrections and removals 
regardless of whether such corrections and removals are required to be 
reported to FDA.
    (b) The following actions are exempt from the reporting requirements 
of this part:
    (1) Actions taken by device manufacturers or importers to improve 
the performance or quality of a device but that do not reduce a risk to 
health posed by the device or remedy a violation of the act caused by 
the device.

[[Page 82]]

    (2) Market withdrawal as defined in Sec. 806.2(i)
    (3) Routine servicing as defined in Sec. 806.2(l).
    (4) Stock recovery as defined in Sec. 806.2(m).

[62 FR 27191, May 19, 1997, as amended at 63 FR 42232, Aug. 7, 1998; 84 
FR 12083, Apr. 1, 2019]



Sec. 806.2  Definitions.

    As used in this part:
    (a) Act means the Federal Food, Drug, and Cosmetic Act.
    (b) Agency or FDA means the Food and Drug Administration.
    (c) Consignee means any person or firm that has received, purchased, 
or used a device subject to correction or removal.
    (d) Correction means the repair, modification, adjustment, 
relabeling, destruction, or inspection (including patient monitoring) of 
a device without its physical removal from its point of use to some 
other location.
    (e) Correction or removal report number means the number that 
uniquely identifies each report submitted.
    (f) Human cell, tissue, or cellular or tissue-based product (HCT/P) 
regulated as a device means an HCT/P as defined in Sec. 1271.3(d) of 
this chapter that does not meet the criteria in Sec. 1271.10(a) and 
that is also regulated as a device.
    (g) Importer means, for the purposes of this part, any person who 
imports a device into the United States.
    (h) Manufacturer means any person who manufactures, prepares, 
propagates, compounds, assembles, or processes a device by chemical, 
physical, biological, or other procedures. The term includes any person 
who:
    (1) Repackages or otherwise changes the container, wrapper, or 
labeling of a device in furtherance of the distribution of the device 
from the original place of manufacture to the person who makes final 
delivery or sale to the ultimate user or consumer;
    (2) Initiates specifications for devices that are manufactured by a 
second party for subsequent distribution by the person initiating the 
specifications; or
    (3) Manufactures components or accessories which are devices that 
are ready to be used and are intended to be commercially distributed and 
are intended to be used as is, or are processed by a licensed 
practitioner or other qualified person to meet the needs of a particular 
patient.
    (i) Market withdrawal means a correction or removal of a distributed 
device that involves a minor violation of the act that would not be 
subject to legal action by FDA or that involves no violation of the act, 
e.g., normal stock rotation practices.
    (j) Removal means the physical removal of a device from its point of 
use to some other location for repair, modification, adjustment, 
relabeling, destruction, or inspection.
    (k) Risk to health means
    (1) A reasonable probability that use of, or exposure to, the 
product will cause serious adverse health consequences or death; or
    (2) That use of, or exposure to, the product may cause temporary or 
medically reversible adverse health consequences, or an outcome where 
the probability of serious adverse health consequences is remote.
    (l) Routine servicing means any regularly scheduled maintenance of a 
device, including the replacement of parts at the end of their normal 
life expectancy, e.g., calibration, replacement of batteries, and 
responses to normal wear and tear. Repairs of an unexpected nature, 
replacement of parts earlier than their normal life expectancy, or 
identical repairs or replacements of multiple units of a device are not 
routine servicing.
    (m) Stock recovery means the correction or removal of a device that 
has not been marketed or that has not left the direct control of the 
manufacturer, i.e., the device is located on the premises owned, or 
under the control of, the manufacturer, and no portion of the lot, 
model, code, or other relevant unit involved in the corrective or 
removal action has been released for sale or use.
    (n) Unique device identifier (UDI) means an identifier that 
adequately identifies a device through its distribution and use by 
meeting the requirements of Sec. 830.20 of this chapter. A UDI is 
composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies

[[Page 83]]

the specific version or model of a device and the labeler of that 
device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (v) For an HCT/P regulated as a device, the distinct identification 
code required by Sec. 1271.290(c) of this chapter.

[62 FR 27191, May 19, 1997, as amended at 63 FR 42232, Aug. 7, 1998; 78 
FR 58821, Sept. 24, 2013]



                      Subpart B_Reports and Records



Sec. 806.10  Reports of corrections and removals.

    (a) Each device manufacturer or importer shall submit a written 
report to FDA of any correction or removal of a device initiated by such 
manufacturer or importer if the correction or removal was initiated:
    (1) To reduce a risk to health posed by the device; or
    (2) To remedy a violation of the act caused by the device which may 
present a risk to health unless the information has already been 
provided as set forth in paragraph (f) of this section or the corrective 
or removal action is exempt from the reporting requirements under Sec. 
806.1(b).
    (b) The manufacturer or importer shall submit any report required by 
paragraph (a) of this section within 10-working days of initiating such 
correction or removal.
    (c) The manufacturer or importer shall include the following 
information in the report:
    (1) The seven digit registration number of the entity responsible 
for submission of the report of corrective or removal action (if 
applicable), the month, day, and year that the report is made, and a 
sequence number (i.e., 001 for the first report, 002 for the second 
report, 003 etc.), and the report type designation ``C'' or ``R''. For 
example, the complete number for the first correction report submitted 
on June 1, 1997, will appear as follows for a firm with the registration 
number 1234567: 1234567-6/1/97-001-C. The second correction report 
number submitted by the same firm on July 1, 1997, would be 1234567-7/1/
97-002-C etc. For removals, the number will appear as follows: 1234567-
6/1/97-001-R and 1234567-7/1/97-002-R, etc. Firms that do not have a 
seven digit registration number may use seven zeros followed by the 
month, date, year, and sequence number (i.e. 0000000-6/1/97-001-C for 
corrections and 0000000-7/1/97-001-R for removals). Reports received 
without a seven digit registration number will be assigned a seven digit 
central file number by the district office reviewing the reports.
    (2) The name, address, and telephone number of the manufacturer or 
importer, and the name, title, address, and telephone number of the 
manufacturer or importer representative responsible for conducting the 
device correction or removal.
    (3) The brand name and the common name, classification name, or 
usual name of the device and the intended use of the device.
    (4) Marketing status of the device, i.e., any applicable premarket 
notification number, premarket approval number, or indication that the 
device is a preamendments device, and the device listing number. A 
manufacturer or importer that does not have an FDA establishment 
registration number shall indicate in the report whether it has ever 
registered with FDA.
    (5) The unique device identifier (UDI) that appears on the device 
label or on the device package, or the device identifier, universal 
product code (UPC), model, catalog, or code number of the device and the 
manufacturing lot or serial number of the device or other identification 
number.
    (6) The manufacturer's name, address, telephone number, and contact 
person if different from that of the person submitting the report.
    (7) A description of the event(s) giving rise to the information 
reported and the corrective or removal actions that have been, and are 
expected to be taken.

[[Page 84]]

    (8) Any illness or injuries that have occurred with use of the 
device. If applicable, include the medical device report numbers.
    (9) The total number of devices manufactured or distributed subject 
to the correction or removal and the number in the same batch, lot, or 
equivalent unit of production subject to the correction or removal.
    (10) The date of manufacture or distribution and the device's 
expiration date or expected life.
    (11) The names, addresses, and telephone numbers of all domestic and 
foreign consignees of the device and the dates and number of devices 
distributed to each such consignee.
    (12) A copy of all communications regarding the correction or 
removal and the names and addresses of all recipients of the 
communications not provided in accordance with paragraph (c)(11) of this 
section.
    (13) If any required information is not immediately available, a 
statement as to why it is not available and when it will be submitted.
    (d) If, after submitting a report under this part, a manufacturer or 
importer determines that the same correction or removal should be 
extended to additional lots or batches of the same device, the 
manufacturer or importer shall within 10-working days of initiating the 
extension of the correction or removal, amend the report by submitting 
an amendment citing the original report number assigned according to 
paragraph (c)(1) of this section, all of the information required by 
paragraph (c)(2), and any information required by paragraphs (c)(3) 
through (c)(12) of this section that is different from the information 
submitted in the original report. The manufacturer or importer shall 
also provide a statement in accordance with paragraph (c)(13) of this 
section for any required information that is not readily available.
    (e) A report submitted by a manufacturer or importer under this 
section (and any release by FDA of that report or information) does not 
necessarily reflect a conclusion by the manufacturer, importer, or FDA 
that the report or information constitutes an admission that the device 
caused or contributed to a death or serious injury. A manufacturer or 
importer need not admit, and may deny, that the report or information 
submitted under this section constitutes an admission that the device 
caused or contributed to a death or serious injury.
    (f) No report of correction or removal is required under this part, 
if a report of the correction or removal is required and has been 
submitted under parts 803 or 1004 of this chapter.

[62 FR 27191, May 19, 1997, as amended at 63 FR 42232, Aug. 7, 1998; 69 
FR 11311, Mar. 10, 2004; 78 FR 58821, Sept. 24, 2013]



Sec. 806.20  Records of corrections and removals not required 
to be reported.

    (a) Each device manufacturer or importer who initiates a correction 
or removal of a device that is not required to be reported to FDA under 
Sec. 806.10 shall keep a record of such correction or removal.
    (b) Records of corrections and removals not required to be reported 
to FDA under Sec. 806.10 shall contain the following information:
    (1) The brand name, common or usual name, classification, name and 
product code if known, and the intended use of the device.
    (2) The unique device identifier (UDI) of the device, or the device 
identifier, universal product code (UPC), model, catalog, or code number 
of the device and the manufacturing lot or serial number of the device 
or other identification number.
    (3) A description of the event(s) giving rise to the information 
reported and the corrective or removal action that has been, and is 
expected to be taken.
    (4) Justification for not reporting the correction or removal action 
to FDA, which shall contain conclusions and any followups, and be 
reviewed and evaluated by a designated person.
    (5) A copy of all communications regarding the correction or 
removal.
    (c) The manufacturer or importer shall retain records required under 
this section for a period of 2 years beyond the expected life of the 
device, even if the manufacturer or importer has ceased to manufacture 
or import the device. Records required to be maintained under paragraph 
(b) of this section must be transferred to the new

[[Page 85]]

manufacturer or importer of the device and maintained for the required 
period of time.

[62 FR 27191, May 19, 1997, as amended at 63 FR 42233, Aug. 7, 1998; 78 
FR 58821, Sept. 24, 2013]



Sec. 806.30  FDA access to records.

    Each device manufacturer or importer required under this part to 
maintain records and every person who is in charge or custody of such 
records shall, upon request of an officer or employee designated by FDA 
and under section 704(e) of the act, permit such officer or employee at 
all reasonable times to have access to, and to copy and verify, such 
records and reports.

[63 FR 42233, Aug. 7, 1998]



Sec. 806.40  Public availability of reports.

    (a) Any report submitted under this part is available for public 
disclosure in accordance with part 20 of this chapter.
    (b) Before public disclosure of a report, FDA will delete from the 
report:
    (1) Any information that constitutes trade secret or confidential 
commercial or financial information under Sec. 20.61 of this chapter; 
and
    (2) Any personnel, medical, or similar information, including the 
serial numbers of implanted devices, which would constitute a clearly 
unwarranted invasion of personal privacy under Sec. 20.63 of this 
chapter or 5 U.S.C. 552(b)(6); provided, that except for the information 
under Sec. 20.61 of this chapter or 5 U.S.C. 552(b)(4), FDA will 
disclose to a patient who requests a report all the information in the 
report concerning that patient.



PART 807_ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR
MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES--Table of Contents



                      Subpart A_General Provisions

Sec.
807.3 Definitions.

             Subpart B_Procedures for Device Establishments

807.20 Who must register and submit a device list?
807.21 How to register establishments and list devices.
807.22 Times for establishment registration and device listing.
807.25 Information required for device establishment registration and 
          device listing.
807.26 Additional listing information.
807.28 Updating device listing information.
807.34 Summary of requirements for owners or operators granted a waiver 
          from submitting required information electronically.
807.35 Notification of registrant.
807.37 Public availability of establishment registration and device 
          listing information.
807.39 Misbranding by reference to establishment registration or to 
          registration number.

         Subpart C_Procedures for Foreign Device Establishments

807.40 Establishment registration and device listing for foreign 
          establishments importing or offering for import devices into 
          the United States.
807.41 Identification of importers and persons who import or offer for 
          import.

                          Subpart D_Exemptions

807.65 Exemptions for device establishments.

               Subpart E_Premarket Notification Procedures

807.81 When a premarket notification submission is required.
807.85 Exemption from premarket notification.
807.87 Information required in a premarket notification submission.
807.90 Format of a premarket notification submission.
807.92 Content and format of a 510(k) summary.
807.93 Content and format of a 510(k) statement.
807.94 Format of class III certification.
807.95 Confidentiality of information.
807.97 Misbranding by reference to premarket notification.
807.100 FDA action on a premarket notification.

    Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i, 
360j, 360bbb-8b, 371, 374, 379k-1, 381, 393; 42 U.S.C. 264, 271.

    Source: 42 FR 42526, Aug. 23, 1977, unless otherwise noted.

[[Page 86]]



                      Subpart A_General Provisions



Sec. 807.3  Definitions.

    (a) Act means the Federal Food, Drug, and Cosmetic Act.
    (b) Commercial distribution means any distribution of a device 
intended for human use which is held or offered for sale but does not 
include the following:
    (1) Internal or interplant transfer of a device between 
establishments within the same parent, subsidiary, and/or affiliate 
company;
    (2) Any distribution of a device intended for human use which has in 
effect an approved exemption for investigational use under section 
520(g) of the act and part 812 of this chapter;
    (3) Any distribution of a device, before the effective date of part 
812 of this chapter, that was not introduced or delivered for 
introduction into interstate commerce for commercial distribution before 
May 28, 1976, and that is classified into class III under section 513(f) 
of the act: Provided, That the device is intended solely for 
investigational use, and under section 501(f)(2)(A) of the act the 
device is not required to have an approved premarket approval 
application as provided in section 515 of the act; or
    (4) For foreign establishments, the distribution of any device that 
is neither imported nor offered for import into the United States.
    (c) Establishment means a place of business under one management at 
one general physical location at which a device is manufactured, 
assembled, or otherwise processed.
    (d) Manufacture, preparation, propagation, compounding, assembly, or 
processing of a device means the making by chemical, physical, 
biological, or other procedures of any article that meets the definition 
of device in section 201(h) of the act. These terms include the 
following activities:
    (1) Repackaging or otherwise changing the container, wrapper, or 
labeling of any device package in furtherance of the distribution of the 
device from the original place of manufacture to the person who makes 
final delivery or sale to the ultimate consumer;
    (2) Initial importation of devices manufactured in foreign 
establishments; or
    (3) Initiation of specifications for devices that are manufactured 
by a second party for subsequent commercial distribution by the person 
initiating specifications.
    (e) Official correspondent means the person designated by the owner 
or operator of an establishment as responsible for the following:
    (1) The annual registration of the establishment;
    (2) Contact with the Food and Drug Administration for device 
listing;
    (3) Maintenance and submission of a current list of officers and 
directors to the Food and Drug Administration upon the request of the 
Commissioner; and
    (4) The receipt of pertinent correspondence from the Food and Drug 
Administration directed to and involving the owner or operator and/or 
any of the firm's establishments.
    (f) Owner or operator means the corporation, subsidiary, affiliated 
company, partnership, or proprietor directly responsible for the 
activities of the registering establishment.
    (g) Initial importer means any importer who furthers the marketing 
of a device from a foreign manufacturer to the person who makes the 
final delivery or sale of the device to the ultimate consumer or user, 
but does not repackage, or otherwise change the container, wrapper, or 
labeling of the device or device package.
    (h) Any term defined in section 201 of the act shall have that 
meaning.
    (i) Restricted device means a device for which a requirement 
restricting sale, distribution, or use has been established by a 
regulation issued under section 520(e) of the act, by order as a 
condition of premarket approval under section 515(d)(1)(B)(ii) of the 
act, or by a performance standard issued in accordance with sections 
514(a)(2)(B)(v) and 514(b) of the act.
    (j) Classification name means the term used by the Food and Drug 
Administration and its classification panels to describe a device or 
class of devices for purposes of classifying devices under section 513 
of the act.
    (k) Product code means the code used by FDA to identify the generic 
category of a device.

[[Page 87]]

    (l) Representative sampling of advertisements means typical 
advertising material that gives the promotional claims made for the 
device.
    (m) Representative sampling of any other labeling means typical 
labeling material (excluding labels and package inserts) that gives the 
promotional claims made for the device.
    (n) Material change includes any change or modification in the 
labeling or advertisements that affects the identity or safety and 
effectiveness of the device. These changes may include, but are not 
limited to, changes in the common or usual or proprietary name, declared 
ingredients or components, intended use, contraindications, warnings, or 
instructions for use. Changes that are not material may include graphic 
layouts, grammar, or correction of typographical errors which do not 
change the content of the labeling, changes in lot number, and, for 
devices where the biological activity or known composition differs with 
each lot produced, the labeling containing the actual values for each 
lot.
    (o) 510(k) summary (summary of any information respecting safety and 
effectiveness) means a summary, submitted under section 513(i) of the 
act, of the safety and effectiveness information contained in a 
premarket notification submission upon which a determination of 
substantial equivalence can be based. Safety and effectiveness 
information refers to safety and effectiveness data and information 
supporting a finding of substantial equivalence, including all adverse 
safety and effectiveness information.
    (p) 510(k) statement means a statement, made under section 513(i) of 
the act, asserting that all information in a premarket notification 
submission regarding safety and effectiveness will be made available 
within 30 days of request by any person if the device described in the 
premarket notification submission is determined to be substantially 
equivalent. The information to be made available will be a duplicate of 
the premarket notification submission, including any adverse safety and 
effectiveness information, but excluding all patient identifiers, and 
trade secret or confidential commercial information, as defined in Sec. 
20.61 of this chapter.
    (q) Class III certification means a certification that the submitter 
of the 510(k) has conducted a reasonable search of all known information 
about the class III device and other similar, legally marketed devices.
    (r) Class III summary means a summary of the types of safety and 
effectiveness problems associated with the type of device being compared 
and a citation to the information upon which the summary is based. The 
summary must be comprehensive and describe the problems to which the 
type of device is susceptible and the causes of such problems.
    (s) United States agent means a person residing or maintaining a 
place of business in the United States whom a foreign establishment 
designates as its agent. This definition excludes mailboxes, answering 
machines or services, or other places where an individual acting as the 
foreign establishment's agent is not physically present.
    (t) Wholesale distributor means any person (other than the 
manufacturer or the initial importer) who distributes a device from the 
original place of manufacture to the person who makes the final delivery 
or sale of the device to the ultimate consumer or user.
    (u) Fiscal year means the FDA fiscal year, which runs from October 1 
through September 30.
    (v) FURLS means the Food and Drug Administration's Unified
    Registration and Listing System,
    (w) FDA premarket submission number means the number assigned by FDA 
to a premarket device submission, such as a Premarket Approval 
Application (PMA); Humanitarian Device Exemption (HDE); New Drug 
Application (NDA); Biologics License Application (BLA); de novo 
classification petition; or Premarket Notification (510(k)).
    (x) Importer means, for purposes of this part, a company or 
individual in the United States that is an owner, consignee, or 
recipient, even if not the initial owner, consignee, or recipient, of 
the foreign establishment's device that is imported into the United 
States. An importer does not include the consumer or patient who 
ultimately purchases, receives, or uses the

[[Page 88]]

device, unless the foreign establishment ships the device directly to 
the consumer or patient.
    (y) Person who imports or offers for import means, for purposes of 
this part, an agent, broker, or other entity, other than a carrier, that 
the foreign establishment uses to facilitate the import of its device 
into the United States.

[42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37997, Aug. 25, 1978; 
57 FR 18066, Apr. 28, 1992; 58 FR 46522, Sept. 1, 1993; 59 FR 64295, 
Dec. 14, 1994; 60 FR 63606, Dec. 11, 1995; 63 FR 51826, Sept. 29, 1998; 
66 FR 59159, Nov. 27, 2001; 77 FR 45940, Aug. 2, 2012]



             Subpart B_Procedures for Device Establishments



Sec. 807.20  Who must register and submit a device list?

    (a) An owner or operator of an establishment not exempt under 
section 510(g) of the Federal Food, Drug, and Cosmetic Act or subpart D 
of this part who is engaged in the manufacture, preparation, 
propagation, compounding, assembly, or processing of a device intended 
for human use shall register and submit listing information for those 
devices in commercial distribution, except that registration and listing 
information may be submitted by the parent, subsidiary, or affiliate 
company for all the domestic or foreign establishments under the control 
of one of these organizations when operations are conducted at more than 
one establishment and there exists joint ownership and control among all 
the establishments. The term ``device'' includes all in vitro diagnostic 
products and in vitro diagnostic biological products not subject to 
licensing under section 351 of the Public Health Service Act. An owner 
or operator of an establishment located in any State as defined in 
section 201(a)(1) of the Federal Food, Drug, and Cosmetic Act shall 
register its name, places of business, and all establishments and list 
the devices whether or not the output of the establishments or any 
particular device so listed enters interstate commerce. The registration 
and listing requirements shall pertain to any person who is engaged in 
the manufacture, preparation, propagation, compounding, assembly, or 
processing of a device intended for human use, including any person who:
    (1) Initiates or develops specifications for a device that is to be 
manufactured by a second party;
    (2) Sterilizes or otherwise makes a device for or on behalf of a 
specifications developer or any other person;
    (3) Repackages or relabels a device;
    (4) Reprocesses a single use device that has previously been used on 
a patient;
    (5) Acts as an initial importer as defined in Sec. 807.3(g), except 
that initial importers may fulfill their listing obligation for any 
device for which they did not initiate or develop the specifications for 
the device or repackage or relabel the device by submitting the name and 
address of the manufacturer. Initial importers shall also be prepared to 
submit, when requested by FDA, the proprietary name, if any, and the 
common or usual name of each device for which they are the initial 
importer;
    (6) Manufactures components or accessories that are ready to be used 
for any intended health-related purpose and are packaged or labeled for 
commercial distribution for such health-related purpose, e.g. blood 
filters, hemodialysis tubing, or devices which of necessity must be 
further processed by a licensed practitioner or other qualified person 
to meet the needs of a particular patient, e.g., a manufacturer of 
ophthalmic lens blanks.
    (b) Registration or listing does not constitute an admission or 
agreement or determination that a product is a device within the meaning 
of section 201(h) of the Federal Food, Drug, and Cosmetic Act.
    (c) Registration and listing requirements shall not pertain to any 
person who acts as a wholesale distributor, as defined in Sec. 
807.3(t), and who does not manufacture, repackage, process, or relabel a 
device.
    (d) Owners and operators of establishments or persons engaged in the 
recovery, screening, testing, processing, storage, or distribution of 
human cells, tissues, and cellular and tissue-based products, as defined 
in Sec. 1271.3(d) of this chapter, that are regulated under the Federal 
Food, Drug, and Cosmetic Act must register and list those human cells, 
tissues, and cellular and tissue-

[[Page 89]]

based products with the Center for Biologics Evaluation and Research on 
Form FDA 3356 following the procedures set out in subpart B of part 1271 
of this chapter, instead of the procedures for registration and listing 
contained in this part, except that the additional listing information 
requirements of Sec. 807.26 remain applicable.
    (e) Owners and operators of establishments that manufacture devices 
licensed under section 351 of the Public Health Service Act as well as 
licensed biological products used in the manufacture of a licensed 
device must register and list following the procedures set out in part 
607 of this chapter, instead of the procedures for registration and 
listing contained in this part.

[77 FR 45941, Aug. 2, 2012]



Sec. 807.21  How to register establishments and list devices.

    (a) Owners or operators of establishments that are subject to the 
registration and listing requirements of this part must provide the 
following information to us using our electronic device registration and 
listing system, except as provided in paragraphs (b), (c), and (d) of 
this section:
    (1) Initial establishment registration information as required by 
Sec. Sec. 807.22(a) and 807.25;
    (2) Updates to registration information as required by Sec. Sec. 
807.22(b) and 807.25;
    (3) Initial device listing information as required by Sec. Sec. 
807.22(a), 807.25, and 807.28;
    (4) Updates to device listing information as required by Sec. Sec. 
807.22(b), 807.25, and 807.28, including updates to reflect the 
discontinuance or resumption of the commercial distribution of a 
previously-listed device as specified at paragraphs (d) and (e) of Sec. 
807.28.
    (b) If the information under Sec. 807.21(a) cannot be submitted 
electronically, a waiver may be requested. Waivers will be granted only 
if use of electronic means is not reasonable for the person requesting 
the waiver. To request a waiver, applicants must send a letter to the 
Imports and Registration and Listing Team, Division of Regulatory 
Programs 2, Office of Regulatory Programs, Office of Product Evaluation 
and Quality, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.1432, Silver 
Spring, MD 20993-0002, that includes the following information:
    (1) The name and address of the device establishment(s) to be 
registered, a contact person for the owner or operator of the 
establishment, and the telephone number at which that person can be 
reached. If the establishment has already registered in the past, the 
letter should also include the owner or operator number, registration 
number, and any listing numbers previously assigned by FDA for devices 
manufactured at that establishment.
    (2) Information about whether the company is an initial importer as 
defined in Sec. 807.3(g) and, if so, whether it also conducts any other 
activities or operations relating to devices.
    (3) A statement that use of the Internet is not reasonable for the 
person requesting the waiver, and an explanation of why such use is not 
reasonable. The statement must be signed by the owner or operator of the 
establishment, or by a person employed by the owner or operator who is 
authorized to make the declaration on behalf of the owner or operator.
    (c) Those owners or operators who have obtained a waiver from filing 
registration and listing information electronically should refer to 
Sec. 807.34 for information on how to submit such information by postal 
mail.
    (d) When additional device listing information (e.g., copies of 
labeling or advertisements) is requested by FDA as described at Sec. 
807.26(e), such information may be submitted by postal mail or 
electronically by email, but will not be submitted using the FDA 
electronic device registration and listing system.

[77 FR 45941, Aug. 2, 2012, as amended at 85 FR 18442, Apr. 2, 2020]



Sec. 807.22  Times for establishment registration and device listing.

    (a) Initial registration and listing. An owner or operator of an 
establishment who has not previously entered into an operation described 
in Sec. 807.20(a) shall register within 30 days after entering into 
such an operation and submit device listing information at that time.

[[Page 90]]

    (b) Registration and listing updates. Owners or operators shall 
review and update all of their establishment registration and device 
listing information that is on file at FDA, documenting any changes that 
were not previously reported as follows:
    (1) Annual registration for each fiscal year is required for all 
establishments. Annual registration shall take place during the period 
beginning on October 1 and ending on December 31 of each fiscal year;
    (2) Updates to the registration information as described in Sec. 
807.25(b) shall be made within 30 days of any change to such 
information;
    (3) Every fiscal year, during the period beginning on October 1 and 
ending on December 31, owners or operators shall review and update all 
of their device listing information that is on file at FDA, reporting 
any changes or deletions to listings and any new listings that were not 
previously reported. The accuracy of all information on file must be 
confirmed each year regardless of whether any changes were made to the 
owner or operator's list of devices; and
    (4) Changes to listing information may also be made at other times, 
such as when a device is introduced into commercial distribution, when a 
change is made to a previously-listed device, or when a previously-
listed device is removed from commercial distribution.
    (c) Failure to submit required information. Failure to submit any of 
the required information on time, as specified in paragraphs (a) and (b) 
of this section, will put the establishment in a ``failed to register'' 
or ``failed to list'' status as applicable. The establishment will not 
be considered active and the establishment registration and device 
listing information may not appear on the FDA Web site until such time 
as the owner or operator submits and FDA processes the required 
information.

[77 FR 45942, Aug. 2, 2012]



Sec. 807.25  Information required for device establishment
registration and device listing.

    (a) All owners or operators that are subject to the registration and 
listing requirements of this part shall provide such information to us 
by using the FDA electronic device registration and listing system, 
unless granted a waiver from electronic submission in accordance with 
Sec. 807.21(b). Electronic submissions of registration and listing 
information must comply with part 11 of this chapter, except for the 
requirements in Sec. 11.10(b), (c), and (e), and the corresponding 
requirements in Sec. 11.30 of this chapter. Those owners or operators 
granted a waiver from electronic submission should refer to paragraphs 
(c) and (g) of this section and Sec. 807.34 for instructions on how to 
submit device registration and listing information.
    (b) Registration information required to be submitted includes: The 
name and mailing address of the device establishment; the Web site 
address of the device establishment, if any; the name, address, phone 
number, fax number, and email address of the owner or operator; the 
name, address, phone number, fax number, and email address of the 
establishment's official correspondent; and all trade names used by the 
establishment.
    (c) Owners or operators who have been granted a waiver from 
electronic filing must submit the establishment registration information 
described in paragraph (b) of this section, except for the Web site and 
email address information, in paper form using the procedures set forth 
in Sec. 807.34.
    (d) Each owner or operator is required to maintain a listing of all 
officers, directors, and partners for each establishment registered by 
the owner or operator and to furnish this information to FDA upon 
request.
    (e) For each establishment, an official correspondent must be 
designated by the owner or operator to serve as a point of contact with 
FDA on matters relating to the registration of device establishments and 
the listing of device products. Each owner or operator shall also 
provide FDA with the name of a contact person at the owner or operator's 
offices who will be responsible for identifying the official 
correspondent for each establishment. The owner or operator contact 
person will be the official correspondent in the event no one else has 
been properly

[[Page 91]]

designated. The official correspondent is responsible for:
    (1) Providing FDA with all required registration and listing 
information electronically unless a waiver from electronic submission 
has been granted in accordance with Sec. 807.21(b);
    (2) Receiving all correspondence from FDA concerning registration 
and listing;
    (3) Supplying, when requested by FDA, the names of all officers, 
directors, and partners; and
    (4) Receiving communications from FDA by email, or by postal mail if 
the owner or operator has been granted a waiver from the requirement to 
file registration and listing information electronically.
    (f) The designation of an official correspondent does not in any 
manner affect the liability of the owner or operator of the 
establishment or any other individual under section 301(p) or any other 
provision of the Federal Food, Drug, and Cosmetic Act.
    (g) Device listing information must be submitted to FDA 
electronically unless a waiver from electronic submission has been 
granted in accordance with Sec. 807.21(b). Owners or operators who have 
been granted a waiver must submit the required device listing 
information, including information required by this paragraph, Sec. 
807.28, and any listing information requested by FDA under Sec. 
807.26(e), in paper form using the procedures set forth in Sec. 807.34. 
The information required for each device listed includes:
    (1) The current registration number and name of each establishment 
under the ownership and control of the owner or operator where the 
device is manufactured, repackaged, relabeled, or otherwise processed, 
or where specifications are developed.
    (2) The product code for each device that is exempt from premarket 
notification and approval or which was in commercial distribution prior 
to May 28, 1976.
    (3) The proprietary or brand name(s) under which each device is 
marketed.
    (4) The FDA-assigned premarket submission number of the approved 
application, cleared premarket notification, granted de novo 
classification petition, or approved humanitarian device exemption for 
each device listed that is subject to sections 505, 510(k), 513(f)(2), 
515, or 520(m) of the Federal Food, Drug, and Cosmetic Act, which 
includes devices that are not exempt from premarket notification and 
approval.
    (5) Each activity or process that is conducted on or done to the 
device at each establishment, such as manufacturing, repacking, 
relabeling, developing specifications, remanufacturing, single-use 
device reprocessing, contract manufacturing, contract sterilizing, or 
manufacturing for export only.

[77 FR 45942, Aug. 2, 2012]



Sec. 807.26  Additional listing information.

    (a) Each owner or operator shall maintain a historical file 
containing the labeling and advertisements in use on the date of initial 
listing, and in use after October 10, 1978, but before the date of 
initial listing, as follows:
    (1) For each device subject to section 514 or 515 of the act that is 
not a restricted device, a copy of all labeling for the device;
    (2) For each restricted device, a copy of all labeling and 
advertisements for the device;
    (3) For each device that is neither restricted nor subject to 
section 514 or 515 of the act, a copy of all labels, package inserts, 
and a representative sampling of any other labeling.
    (b) In addition to the requirements set forth in paragraph (a) of 
this section, each owner or operator shall maintain in the historical 
file any labeling or advertisements in which a material change has been 
made anytime after initial listing.
    (c) Each owner or operator may discard labeling and advertisements 
from the historical file 3 years after the date of the last shipment of 
a discontinued device by an owner or operator.
    (d) Location of the file:
    (1) Currently existing systems for maintenance of labeling and 
advertising may be used for the purpose of maintaining the historical 
file as long as the information included in the systems fulfills the 
requirements of this section, but only if the labeling and 
advertisements are retrievable in a timely manner.

[[Page 92]]

    (2) The contents of the historical file may be physically located in 
more than one place in the establishment or in more than one 
establishment provided there exists joint ownership and control among 
all the establishments maintaining the historical file. If no joint 
ownership and control exists, the registered establishment must provide 
the Food and Drug Administration with a letter authorizing the 
establishment outside its control to maintain the historical file.
    (3) A copy of the certification and disclosure statements as 
required by part 54 of this chapter shall be retained and physically 
located at the establishment maintaining the historical file.
    (e) Each owner or operator shall be prepared to submit to the Food 
and Drug Administration, only upon specific request, the following 
information:
    (1) For a device subject to section 514 or 515 of the act that is 
not a restricted device, a copy of all labeling for the device.
    (2) For a device that is a restricted device, a copy of all labeling 
for the device, a representative sampling of advertisements for the 
device, and for good cause, a copy of all advertisements for a 
particular device. A request for all advertisements will, where 
feasible, be accompanied by an explanation of the basis for such 
request.
    (3) For a device that is neither a restricted device, nor subject to 
section 514 of 515 of the act, the label and package insert for the 
device and a representative sampling of any other labeling for the 
device.
    (4) For a particular device, a statement of the basis upon which the 
registrant has determined that the device is not subject to section 514 
or 515 of the act.
    (5) For a particular device, a statement of the basis upon which the 
registrant has determined the device is not a restricted device.
    (6) For a particular device, a statement of the basis for 
determining that the product is a device rather than a drug.
    (7) For a device that the owner or operator has manufactured for 
distribution under a label other than its own, the names of all 
distributors for whom it has been manufactured.
    (f) Labeling, advertisements, and other information to be submitted 
upon request in accordance with paragraph (e) of this section may be 
submitted by postal mail or electronically by email, but will not be 
submitted using the FDA electronic device registration and listing 
system. Electronic submissions of such information must comply with part 
11 of this chapter, except for the requirements in Sec. 11.10 (a), (c) 
through (h), and (k), and the corresponding requirements in Sec. 11.30 
of this chapter. The information provided in electronic format must be 
in a form that we can process, review, and archive.

[43 FR 37999, Aug. 25, 1978, as amended at 51 FR 33033, Sept. 18, 1986; 
63 FR 5253, Feb. 2, 1998. Redesignated and amended at 77 FR 45943, Aug. 
2, 2012]



Sec. 807.28  Updating device listing information.

    (a) Updating of device listing information is required if an 
additional establishment begins to engage in any of the activities 
described in Sec. 807.3(d) with respect to a listed device, such as 
manufacturing, developing specifications, repackaging, relabeling, or 
otherwise processing the device. Updating of the listing is also 
required if an establishment begins performing another activity on or to 
the device, or ceases to perform an activity on or to the device that 
had previously been identified on the device listing.
    (b) An owner or operator shall create a new device listing using the 
FDA electronic device registration and listing system:
    (1) If introducing into commercial distribution an exempt device 
identified with a product code that is not currently listed by the owner 
or operator; or
    (2) If introducing into commercial distribution a non-exempt device 
with an FDA premarket submission number that is not currently listed by 
the owner or operator.
    (c) All device listings for foreign establishments must be submitted 
before the device may be imported or offered for import into the United 
States.

[[Page 93]]

    (d) An owner or operator who discontinues commercial distribution of 
a device shall discontinue the device listing using the FDA electronic 
device registration and listing system. A device listing is considered 
discontinued if:
    (1) All devices under an exempt product code have been discontinued 
or
    (2) All devices associated with an FDA premarket submission number 
have been discontinued.
    (e) If commercial distribution of a discontinued device is resumed, 
the owner or operator must reactivate the previously-discontinued 
listing using the electronic device registration and listing system. Any 
changes to the listing information for the product that is the subject 
of the listing such as a new establishment, new activity, or new 
proprietary name must be made using the electronic device registration 
and listing system at the time the listing is reactivated.
    (f) FDA will assign one listing number for all devices exempt from 
premarket notification requirements under a single product code. For 
products not exempt from premarket notification requirements, a single 
listing number will be assigned by FDA for each FDA premarket submission 
number.

[77 FR 45943, Aug. 2, 2012]



Sec. 807.34  Summary of requirements for owners or operators
granted a waiver from submitting required information electronically.

    (a) For initial registration and listing, owners or operators who 
have been granted a waiver from electronic filing using the procedures 
set forth in Sec. 807.21(b) must send a letter containing all of the 
registration and listing information described in Sec. Sec. 807.22, 
807.25 (and Sec. 807.26 when such information is requested by FDA), at 
the times described in Sec. 807.22, to: The Imports and Registration 
and Listing Team, Division of Regulatory Programs 2, Office of 
Regulatory Programs, Office of Product Evaluation and Quality, Center 
for Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 1432, Silver Spring, MD 20993-0002.
    (b) As specified in Sec. 807.22(b)(1) and (b)(3), all owners or 
operators shall update their establishment registration and device 
listings annually during the period beginning on October 1 and ending on 
December 31 of each fiscal year.
    (c) Failure to submit any of the required information on time, as 
specified in Sec. 807.22(a) and (b), will put the establishment in a 
``failed to register'' or ``failed to list'' status as applicable.
    The establishment will not be considered active and the 
establishment registration and device listing information may not appear 
on the FDA Web site until the required information is submitted to and 
processed by FDA.

[77 FR 45943, Aug. 2, 2012, as amended at 85 FR 18442, Apr. 2, 2020]



Sec. 807.35  Notification of registrant.

    (a) The Food and Drug Administration will assign each device 
establishment a registration number after verifying the initial 
establishment registration information that has been submitted. The 
owner or operator of the establishment will also be assigned an 
identifying number. Both numbers will be sent to the official 
correspondent by email, or by postal mail if the owner or operator has 
been granted a waiver from the requirement to file registration and 
listing information electronically.
    (b) Owners or operators of device establishments who also 
manufacture or process biological products (including devices licensed 
under section 351 of the Public Health Service Act) or drug products at 
the same establishment must also register and list those products under 
part 607 or part 207 of this chapter, as appropriate. Registration and 
listing for human blood and blood products, devices licensed under 
section 351 of the Public Health Service Act, and licensed biological 
products used in the manufacture of a device licensed under section 351 
of the Public Health Service Act, are subject to part 607 of this 
chapter; registration and listing for all other drug products (including 
other biological products that are also regulated as drug products) are 
subject to part 207 of this chapter.
    (c) Although establishment registration and device listing are 
required to

[[Page 94]]

engage in the device activities described in Sec. 807.20, validation of 
registration and the assignment of a device listing number in itself 
does not establish that the holder of the registration is legally 
qualified to deal in such devices and does not represent a determination 
by the Food and Drug Administration as to the status of any device.

[69 FR 11312, Mar. 10, 2004, as amended at 77 FR 45943, Aug. 2, 2012]



Sec. 807.37  Public availability of establishment registration 
and device listing information.

    (a) Establishment registration and device listing information is 
available for public inspection in accordance with section 510(f) of the 
Federal Food, Drug, and Cosmetic Act and will be posted on the FDA 
website, with the exception of the information identified in paragraph 
(b) of this section. Requests for information by persons who do not have 
access to the internet should be directed to the Imports and 
Registration and Listing Team, Division of Regulatory Programs 2, Office 
of Regulatory Programs, Office of Product Evaluation and Quality, Center 
for Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm.1432, Silver Spring, MD 20993-0002. In 
addition, there will be available for inspection at each of the Food and 
Drug Administration district offices the same information for firms 
within the geographical area of such district offices. Upon request, 
verification of a registration number or location of a registered 
establishment will be provided.
    (b) The following listing information will not be available for 
public inspection or posted on the FDA Web site:
    (1) For contract manufacturers, contract sterilizers, and private 
label manufacturers, the proprietary or brand name(s) under which a 
device is marketed and the FDA-assigned premarket submission number, if 
this information would reveal a confidential business relationship;
    (2) FDA-assigned listing numbers.

[77 FR 45943, Aug. 2, 2012, as amended at 85 FR 18442, Apr. 2, 2020]



Sec. 807.39  Misbranding by reference to establishment registration
or to registration number.

    Registration of a device establishment or assignment of a 
registration number does not in any way denote approval of the 
establishment or its products. Any representation that creates an 
impression of official approval because of registration or possession of 
a registration number is misleading and constitutes misbranding.



         Subpart C_Procedures for Foreign Device Establishments



Sec. 807.40  Establishment registration and device listing for 
foreign establishments importing or offering for import devices
into the United States.

    (a) Any establishment within any foreign country engaged in the 
manufacture, preparation, propagation, compounding, or processing of a 
device that is imported or offered for import into the United States 
shall register such establishment and list such devices using the FDA 
electronic device registration and listing system in conformance with 
the procedures in this section, Sec. 807.41, and subpart B of this 
part. The official correspondent for the foreign establishment shall 
facilitate communication between the foreign establishment's management 
and representatives of FDA for matters relating to the registration of 
device establishments and the listing of device products.
    (b) Each foreign establishment required to register under paragraph 
(a) of this section shall submit the name, address, and phone number of 
its United States agent as part of its initial and updated registration 
information in accordance with subpart B of this part. Each foreign 
establishment shall designate only one United States agent and may 
designate the United States agent to act as its official correspondent.
    (1) The United States agent shall reside or maintain a place of 
business in the United States.
    (2) Upon request from FDA, the United States agent shall assist FDA

[[Page 95]]

in communications with the foreign establishment, respond to questions 
concerning the foreign establishment's products that are imported or 
offered for import into the United States, and assist FDA in scheduling 
inspections of the foreign establishment. If the agency is unable to 
contact the foreign establishment directly or expeditiously, FDA may 
provide information or documents to the United States agent, and such an 
action shall be considered to be equivalent to providing the same 
information or documents to the foreign establishment.
    (3) The foreign establishment or the United States agent shall 
report changes in the United States agent's name, address, or phone 
number to FDA within 10-business days of the change.
    (c) No device may be imported or offered for import into the United 
States unless it is the subject of a device listing as required under 
subpart B of this part and is manufactured, prepared, propagated, 
compounded, or processed at a registered foreign establishment; however, 
this restriction does not apply to devices imported or offered for 
import under the investigational use provisions of part 812 of this 
chapter.
    (d) The device establishment registration and device listing 
information shall be in the English language.

[66 FR 59160, Nov. 27, 2001, as amended at 77 FR 45944, Aug. 2, 2012]



Sec. 807.41  Identification of importers and persons who import
or offer for import.

    (a) Upon initial registration, annually, and at the time of any 
changes, each foreign establishment required to register and list as 
provided in Sec. 807.40(a) must, using the FDA electronic device 
registration and listing system, submit the name, address, telephone and 
fax numbers, email address, and registration number, if any has been 
assigned, of any importer (defined in Sec. 807.3(x)) of the 
establishment's devices that is known to the foreign establishment. The 
foreign establishment must also specify which of the establishment's 
listed products each importer receives from the foreign establishment.
    (b) Upon initial registration, annually, and at the time of any 
changes, each foreign establishment required to register and list as 
provided in Sec. 807.40(a) must, using the FDA electronic device 
registration and listing system, submit the name, address, telephone and 
fax numbers, email address, and registration number, if any has been 
assigned, of each person who imports or offers for import the 
establishment's devices into the United States. The term ``person who 
imports or offers for import,'' which is defined in Sec. 807.3(y), 
includes agents, brokers, or other parties used by the foreign 
establishment to facilitate the import of its device into the United 
States.
    (c) For each individual or organization identified by the foreign 
establishment under paragraphs (a) and (b) of this section, the foreign 
establishment must submit to FDA electronically the current FDA 
premarket submission number and any other identifying information that 
is known to the establishment for each device being imported or offered 
for import by the named individuals or organizations.

[77 FR 45944, Aug. 2, 2012]



                          Subpart D_Exemptions



Sec. 807.65  Exemptions for device establishments.

    The following classes of persons are exempt from registration in 
accordance with Sec. 807.20 under the provisions of section 510(g)(1), 
(g)(2), and (g)(3) of the act, or because the Commissioner of Food and 
Drugs has found, under section 510(g)(5) of the act, that such 
registration is not necessary for the protection of the public health. 
The exemptions in paragraphs (d), (e), (f), and (i) of this section are 
limited to those classes of persons located in any State as defined in 
section 201(a)(1) of the act.
    (a) A manufacturer of raw materials or components to be used in the 
manufacture or assembly of a device who would otherwise not be required 
to register under the provisions of this part.
    (b) A manufacturer of devices to be used solely for veterinary 
purposes.
    (c) A manufacturer of general purpose articles such as chemical 
reagents or laboratory equipment whose uses

[[Page 96]]

are generally known by persons trained in their use and which are not 
labeled or promoted for medical uses.
    (d) Licensed practitioners, including physicians, dentists, and 
optometrists, who manufacture or otherwise alter devices solely for use 
in their practice.
    (e) Pharmacies, surgical supply outlets, or other similar retail 
establishments making final delivery or sale to the ultimate user. This 
exemption also applies to a pharmacy or other similar retail 
establishment that purchases a device for subsequent distribution under 
its own name, e.g., a properly labeled health aid such as an elastic 
bandage or crutch, indicating ``distributed by'' or ``manufactured for'' 
followed by the name of the pharmacy.
    (f) Persons who manufacture, prepare, propagate, compound, or 
process devices solely for use in research, teaching, or analysis and do 
not introduce such devices into commercial distribution.
    (g) [Reserved]
    (h) Carriers by reason of their receipt, carriage, holding or 
delivery of devices in the usual course of business as carriers.
    (i) Persons who dispense devices to the ultimate consumer or whose 
major responsibility is to render a service necessary to provide the 
consumer (i.e., patient, physician, layman, etc.) with a device or the 
benefits to be derived from the use of a device; for example, a hearing 
aid dispenser, optician, clinical laboratory, assembler of diagnostic x-
ray systems, and personnel from a hospital, clinic, dental laboratory, 
orthotic or prosthetic retail facility, whose primary responsibility to 
the ultimate consumer is to dispense or provide a service through the 
use of a previously manufactured device.

[42 FR 42526, Aug. 23, 1977, as amended at 58 FR 46523, Sept. 1, 1993; 
61 FR 44615, Aug. 28, 1996; 65 FR 17136, Mar. 31, 2000; 66 FR 59160, 
Nov. 27, 2001]



               Subpart E_Premarket Notification Procedures



Sec. 807.81  When a premarket notification submission is required.

    (a) Except as provided in paragraph (b) of this section, each person 
who is required to register his establishment pursuant to Sec. 807.20 
must submit a premarket notification submission to the Food and Drug 
Administration at least 90 days before he proposes to begin the 
introduction or delivery for introduction into interstate commerce for 
commercial distribution of a device intended for human use which meets 
any of the following criteria:
    (1) The device is being introduced into commercial distribution for 
the first time; that is, the device is not of the same type as, or is 
not substantially equivalent to, (i) a device in commercial distribution 
before May 28, 1976, or (ii) a device introduced for commercial 
distribution after May 28, 1976, that has subsequently been reclassified 
into class I or II.
    (2) The device is being introduced into commercial distribution for 
the first time by a person required to register, whether or not the 
device meets the criteria in paragraph (a)(1) of this section.
    (3) The device is one that the person currently has in commercial 
distribution or is reintroducing into commercial distribution, but that 
is about to be significantly changed or modified in design, components, 
method of manufacture, or intended use. The following constitute 
significant changes or modifications that require a premarket 
notification:
    (i) A change or modification in the device that could significantly 
affect the safety or effectiveness of the device, e.g., a significant 
change or modification in design, material, chemical composition, energy 
source, or manufacturing process.
    (ii) A major change or modification in the intended use of the 
device.
    (b)(1) A premarket notification under this subpart is not required 
for a device for which a premarket approval application under section 
515 of the act, or for which a petition to reclassify under section 
513(f)(2) of the act, is pending before the Food and Drug 
Administration.
    (2) The appropriate FDA Center Director may determine that the 
submission and grant of a written request for an exception or 
alternative under Sec. 801.128 or Sec. 809.11 of this chapter 
satisfies the requirement in paragraph (a)(3) of this section.

[[Page 97]]

    (c) In addition to complying with the requirements of this part, 
owners or operators of device establishments that manufacture radiation-
emitting electronic products, as defined in Sec. 1000.3 of this 
chapter, shall comply with the reporting requirements of part 1002 of 
this chapter.

[42 FR 42526, Aug. 23, 1977, as amended at 72 FR 73601, Dec. 28, 2007]



Sec. 807.85  Exemption from premarket notification.

    (a) A custom device is exempt from premarket notification 
requirements of this subpart if the device is within the meaning of 
section 520(b) of the Federal Food, Drug, and Cosmetic Act.
    (1) It is intended for use by a patient named in the order of the 
physician or dentist (or other specially qualified person); or
    (2) It is intended solely for use by a physician or dentist (or 
other specially qualified person) and is not generally available to, or 
generally used by, other physicians or dentists (or other specially 
qualified persons).
    (b) A distributor who places a device into commercial distribution 
for the first time under his own name and a repackager who places his 
own name on a device and does not change any other labeling or otherwise 
affect the device shall be exempted from the premarket notification 
requirements of this subpart if:
    (1) The device was in commercial distribution before May 28, 1976; 
or
    (2) A premarket notification submission was filed by another person.

[42 FR 42526, Aug. 23, 1977, as amended at 81 FR 70340, Oct. 12, 2016]



Sec. 807.87  Information required in a premarket notification submission.

    Each premarket notification submission shall contain the following 
information:
    (a) The device name, including both the trade or proprietary name 
and the common or usual name or classification name of the device.
    (b) The establishment registration number, if applicable, of the 
owner or operator submitting the premarket notification submission.
    (c) The class in which the device has been put under section 513 of 
the act and, if known, its appropriate panel; or, if the owner or 
operator determines that the device has not been classified under such 
section, a statement of that determination and the basis for the 
person's determination that the device is not so classified.
    (d) Action taken by the person required to register to comply with 
the requirements of the act under section 514 for performance standards.
    (e) Proposed labels, labeling, and advertisements sufficient to 
describe the device, its intended use, and the directions for its use. 
Where applicable, photographs or engineering drawings should be 
supplied.
    (f) A statement indicating the device is similar to and/or different 
from other products of comparable type in commercial distribution, 
accompanied by data to support the statement. This information may 
include an identification of similar products, materials, design 
considerations, energy expected to be used or delivered by the device, 
and a description of the operational principles of the device.
    (g) Where a person required to register intends to introduce into 
commercial distribution a device that has undergone a significant change 
or modification that could significantly affect the safety or 
effectiveness of the device, or the device is to be marketed for a new 
or different indication for use, the premarket notification submission 
must include appropriate supporting data to show that the manufacturer 
has considered what consequences and effects the change or modification 
or new use might have on the safety and effectiveness of the device.
    (h) A 510(k) summary as described in Sec. 807.92 or a 510(k) 
statement as described in Sec. 807.93.
    (i) A financial certification or disclosure statement or both, as 
required by part 54 of this chapter.
    (j) For a submission supported by clinical data:
    (1) If the data are from clinical investigations conducted in the 
United States, a statement that each investigation was conducted in 
compliance with applicable requirements in the

[[Page 98]]

protection of human subjects regulations in part 50 of this chapter, the 
institutional review boards regulations in part 56 of this chapter, or 
was not subject to the regulations under Sec. 56.104 or Sec. 56.105, 
and the investigational device exemptions regulations in part 812 of 
this chapter, or if the investigation was not conducted in compliance 
with those regulations, a brief statement of the reason for the 
noncompliance.
    (2) If the data are from clinical investigations conducted outside 
the United States, the requirements under Sec. 812.28 of this chapter 
apply. If any such investigation was not conducted in accordance with 
good clinical practice (GCP) as described in Sec. 812.28(a) of this 
chapter, include either a waiver request in accordance with Sec. 
812.28(c) of the chapter or a brief statement of the reason for not 
conducting the investigation in accordance with GCP and a description of 
steps taken to ensure that the data and results are credible and 
accurate and that the rights, safety, and well-being of subjects have 
been adequately protected.
    (k) For submissions claiming substantial equivalence to a device 
which has been classified into class III under section 513(b) of the 
act:
    (1) Which was introduced or delivered for introduction into 
interstate commerce for commercial distribution before December 1, 1990; 
and
    (2) For which no final regulation requiring premarket approval has 
been issued under section 515(b) of the act, a summary of the types of 
safety and effectiveness problems associated with the type of devices 
being compared and a citation to the information upon which the summary 
is based (class III summary). The 510(k) submitter shall also certify 
that a reasonable search of all information known or otherwise available 
about the class III device and other similar legally marketed devices 
has been conducted (class III certification), as described in Sec. 
807.94. This information does not refer to information that already has 
been submitted to the Food and Drug Administration (FDA) under section 
519 of the act. FDA may require the submission of the adverse safety and 
effectiveness data described in the class III summary or citation.
    (l) A statement that the submitter believes, to the best of his or 
her knowledge, that all data and information submitted in the premarket 
notification are truthful and accurate and that no material fact has 
been omitted.
    (m) Any additional information regarding the device requested by the 
Commissioner that is necessary for the Commissioner to make a finding as 
to whether or not the device is substantially equivalent to a device in 
commercial distribution. A request for additional information will 
advise the owner or operator that there is insufficient information 
contained in the original premarket notification submission for the 
Commissioner to make this determination and that the owner or operator 
may either submit the requested data or a new premarket notification 
containing the requested information at least 90 days before the owner 
or operator intends to market the device, or submit a premarket approval 
application in accordance with section 515 of the act. If the additional 
information is not submitted within 30 days following the date of the 
request, the Commissioner will consider the premarket notification to be 
withdrawn.

(Information collection requirements in this section were approved by 
the Office of Management and Budget (OMB) and assigned OMB control 
number 0910-0281)

[42 FR 42526, Aug. 23, 1977, as amended at 57 FR 18066, Apr. 28, 1992; 
59 FR 64295, Dec. 14, 1994; 63 FR 5253, Feb. 2, 1998; 83 FR 7385, Feb. 
21, 2018]



Sec. 807.90  Format of a premarket notification submission.

    Each premarket notification submission pursuant to this part shall 
be submitted in accordance with this section. Each submission shall:
    (a)(1) For devices regulated by the Center for Devices and 
Radiological Health, be addressed to the current address displayed on 
the website https://www.fda.gov/cdrhsubmissionaddress.
    (2) For devices regulated by the Center for Biologics Evaluation and 
Research, be addressed to the current address displayed on the website 
https://www.fda.gov/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/

[[Page 99]]

CBER/ucm385240.htm; or for devices regulated by the Center for Drug 
Evaluation and Research, be addressed to the Central Document Room, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
5901-B Ammendale Rd., Beltsville, MD 20705-1266. Information about 
devices regulated by the Center for Biologics Evaluation and Research is 
available at https://www.fda.gov/BiologicsBloodVaccines/
BloodBloodProducts/ApprovedProducts/default.htm.
    (3) All inquiries regarding a premarket notification submission 
should be sent to the address in this section or one of the current 
addresses displayed on the Food and Drug Administration's website.
    (b) [Reserved]
    (c) Be submitted as a single version in electronic format.
    (d) Be submitted separately for each product the manufacturer 
intends to market.
    (e) Designated ``510(k) Notification'' in the cover letter.

[42 FR 42526, Aug. 23, 1977, as amended at 53 FR 11252, Apr. 6, 1988; 55 
FR 11169, Mar. 27, 1990; 65 FR 17137, Mar. 31, 2000; 70 FR 14986, Mar. 
24, 2005; 75 FR 20915, Apr. 22, 2010; 80 FR 18094, Apr. 3, 2015; 84 FR 
68339, Dec. 16, 2019]



Sec. 807.92  Content and format of a 510(k) summary.

    (a) A 510(k) summary shall be in sufficient detail to provide an 
understanding of the basis for a determination of substantial 
equivalence. FDA will accept summaries as well as amendments thereto 
until such time as FDA issues a determination of substantial 
equivalence. All 510(k) summaries shall contain the following 
information:
    (1) The submitter's name, address, telephone number, a contact 
person, and the date the summary was prepared;
    (2) The name of the device, including the trade or proprietary name 
if applicable, the common or usual name, and the classification name, if 
known;
    (3) An identification of the legally marketed device to which the 
submitter claims equivalence. A legally marketed device to which a new 
device may be compared for a determination regarding substantial 
equivalence is a device that was legally marketed prior to May 28, 1976, 
or a device which has been reclassified from class III to class II or I 
(the predicate), or a device which has been found to be substantially 
equivalent through the 510(k) premarket notification process;
    (4) A description of the device that is the subject of the premarket 
notification submission, such as might be found in the labeling or 
promotional material for the device, including an explanation of how the 
device functions, the scientific concepts that form the basis for the 
device, and the significant physical and performance characteristics of 
the device, such as device design, material used, and physical 
properties;
    (5) A statement of the intended use of the device that is the 
subject of the premarket notification submission, including a general 
description of the diseases or conditions that the device will diagnose, 
treat, prevent, cure, or mitigate, including a description, where 
appropriate, of the patient population for which the device is intended. 
If the indication statements are different from those of the legally 
marketed device identified in paragraph (a)(3) of this section, the 
510(k) summary shall contain an explanation as to why the differences 
are not critical to the intended therapeutic, diagnostic, prosthetic, or 
surgical use of the device, and why the differences do not affect the 
safety and effectiveness of the device when used as labeled; and
    (6) If the device has the same technological characteristics (i.e., 
design, material, chemical composition, energy source) as the predicate 
device identified in paragraph (a)(3) of this section, a summary of the 
technological characteristics of the new device in comparison to those 
of the predicate device. If the device has different technological 
characteristics from the predicate device, a summary of how the 
technological characteristics of the device compare to a legally 
marketed device identified in paragraph (a)(3) of this section.
    (b) 510(k) summaries for those premarket submissions in which a 
determination of substantial equivalence is

[[Page 100]]

also based on an assessment of performance data shall contain the 
following information:
    (1) A brief discussion of the nonclinical tests submitted, 
referenced, or relied on in the premarket notification submission for a 
determination of substantial equivalence;
    (2) A brief discussion of the clinical tests submitted, referenced, 
or relied on in the premarket notification submission for a 
determination of substantial equivalence. This discussion shall include, 
where applicable, a description of the subjects upon whom the device was 
tested, a discussion of the safety or effectiveness data obtained from 
the testing, with specific reference to adverse effects and 
complications, and any other information from the clinical testing 
relevant to a determination of substantial equivalence; and
    (3) The conclusions drawn from the nonclinical and clinical tests 
that demonstrate that the device is as safe, as effective, and performs 
as well as or better than the legally marketed device identified in 
paragraph (a)(3) of this section.
    (c) The summary should be in a separate section of the submission, 
beginning on a new page and ending on a page not shared with any other 
section of the premarket notification submission, and should be clearly 
identified as a ``510(k) summary.''
    (d) Any other information reasonably deemed necessary by the agency.

[57 FR 18066, Apr. 28, 1992, as amended at 59 FR 64295, Dec. 14, 1994]



Sec. 807.93  Content and format of a 510(k) statement.

    (a)(1) A 510(k) statement submitted as part of a premarket 
notification shall state as follows:

    I certify that, in my capacity as (the position held in company by 
person required to submit the premarket notification, preferably the 
official correspondent in the firm), of (company name), I will make 
available all information included in this premarket notification on 
safety and effectiveness within 30 days of request by any person if the 
device described in the premarket notification submission is determined 
to be substantially equivalent. The information I agree to make 
available will be a duplicate of the premarket notification submission, 
including any adverse safety and effectiveness information, but 
excluding all patient identifiers, and trade secret and confidential 
commercial information, as defined in 21 CFR 20.61.

    (2) The statement in paragraph (a)(1) of this section should be 
signed by the certifier, made on a separate page of the premarket 
notification submission, and clearly identified as ``510(k) statement.''
    (b) All requests for information included in paragraph (a) of this 
section shall be made in writing to the certifier, whose name will be 
published by FDA on the list of premarket notification submissions for 
which substantial equivalence determinations have been made.
    (c) The information provided to requestors will be a duplicate of 
the premarket notification submission, including any adverse 
information, but excluding all patient identifiers, and trade secret and 
confidential commercial information as defined in Sec. 20.61 of this 
chapter.

[59 FR 64295, Dec. 14, 1994]



Sec. 807.94  Format of a class III certification.

    (a) A class III certification submitted as part of a premarket 
notification shall state as follows:

    I certify, in my capacity as (position held in company), of (company 
name), that I have conducted a reasonable search of all information 
known or otherwise available about the types and causes of safety or 
effectiveness problems that have been reported for the (type of device). 
I further certify that I am aware of the types of problems to which the 
(type of device) is susceptible and that, to the best of my knowledge, 
the following summary of the types and causes of safety or effectiveness 
problems about the (type of device) is complete and accurate.

    (b) The statement in paragraph (a) of this section should be signed 
by the certifier, clearly identified as ``class III certification,'' and 
included at the beginning of the section of the premarket notification 
submission that sets forth the class III summary.

[59 FR 64296, Dec. 14, 1994]



Sec. 807.95  Confidentiality of information.

    (a) The Food and Drug Administration will disclose publicly whether

[[Page 101]]

there exists a premarket notification submission under this part:
    (1) Where the device is on the market, i.e., introduced or delivered 
for introduction into interstate commerce for commercial distribution;
    (2) Where the person submitting the premarket notification 
submission has disclosed, through advertising or any other manner, his 
intent to market the device to scientists, market analysts, exporters, 
or other individuals who are not employees of, or paid consultants to, 
the establishment and who are not in an advertising or law firm pursuant 
to commercial arrangements with appropriate safeguards for secrecy; or
    (3) Where the device is not on the market and the intent to market 
the device has not been so disclosed, except where the submission is 
subject to an exception under paragraph (b) or (c) of this section.
    (b) The Food and Drug Administration will not disclose publicly the 
existence of a premarket notification submission for a device that is 
not on the market and where the intent to market the device has not been 
disclosed for 90 days from the date of receipt of the submission, if:
    (1) The person submitting the premarket notification submission 
requests in the submission that the Food and Drug Administration hold as 
confidential commercial information the intent to market the device and 
submits a certification to the Commissioner:
    (i) That the person considers his intent to market the device to be 
confidential commercial information;
    (ii) That neither the person nor, to the best of his knowledge, 
anyone else, has disclosed through advertising or any other manner, his 
intent to market the device to scientists, market analysts, exporters, 
or other individuals, except employees of, or paid consultants to, the 
establishment or individuals in an advertising or law firm pursuant to 
commercial arrangements with appropriate safeguards for secrecy;
    (iii) That the person will immediately notify the Food and Drug 
Administration if he discloses the intent to market the device to 
anyone, except employees of, or paid consultants to, the establishment 
or individuals in an advertising or law firm pursuant to commercial 
arrangements with appropriate safeguards for secrecy;
    (iv) That the person has taken precautions to protect the 
confidentiality of the intent to market the device; and
    (v) That the person understands that the submission to the 
government of false information is prohibited by 18 U.S.C. 1001 and 21 
U.S.C. 331(q); and
    (2) The Commissioner agrees that the intent to market the device is 
confidential commercial information.
    (c) Where the Commissioner determines that the person has complied 
with the procedures described in paragraph (b) of this section with 
respect to a device that is not on the market and where the intent to 
market the device has not been disclosed, and the Commissioner agrees 
that the intent to market the device is confidential commercial 
information, the Commissioner will not disclose the existence of the 
submission for 90 days from the date of its receipt by the agency. In 
addition, the Commissioner will continue not to disclose the existence 
of such a submission for the device for an additional time when any of 
the following occurs:
    (1) The Commissioner requests in writing additional information 
regarding the device pursuant to Sec. 807.87(h), in which case the 
Commissioner will not disclose the existence of the submission until 90 
days after the Food and Drug Administration's receipt of a complete 
premarket notification submission;
    (2) The Commissioner determines that the device intended to be 
introduced is a class III device and cannot be marketed without 
premarket approval or reclassification, in which case the Commissioner 
will not disclose the existence of the submission unless a petition for 
reclassification is submitted under section 513(f)(2) of the act and its 
existence can be disclosed under Sec. 860.5(d) of this chapter; or
    (d) FDA will make a 510(k) summary of the safety and effectiveness 
data available to the public within 30 days of the issuance of a 
determination that the device is substantially equivalent to another 
device. Accordingly, even when a 510(k) submitter has complied

[[Page 102]]

with the conditions set forth in paragraphs (b) and (c) of this section, 
confidentiality for a premarket notification submission cannot be 
granted beyond 30 days after FDA issues a determination of equivalency.
    (e) Data or information submitted with, or incorporated by reference 
in, a premarket notification submission (other than safety and 
effectiveness data that have not been disclosed to the public) shall be 
available for disclosure by the Food and Drug Administration when the 
intent to market the device is no longer confidential in accordance with 
this section, unless exempt from public disclosure in accordance with 
part 20 of this chapter. Upon final classification, data and information 
relating to safety and effectiveness of a device classified in class I 
(general controls) or class II (performance standards) shall be 
available for public disclosure. Data and information relating to safety 
and effectiveness of a device classified in class III (premarket 
approval) that have not been released to the public shall be retained as 
confidential unless such data and information become available for 
release to the public under Sec. 860.5(d) or other provisions of this 
chapter.

[42 FR 42526, Aug. 23, 1977, as amended at 53 FR 11252, Apr. 6, 1988; 57 
FR 18067, Apr. 28, 1992; 59 FR 64296, Dec. 14, 1994; 84 FR 68339, Dec. 
16, 2019]



Sec. 807.97  Misbranding by reference to premarket notification.

    Submission of a premarket notification in accordance with this 
subpart, and a subsequent determination by the Commissioner that the 
device intended for introduction into commercial distribution is 
substantially equivalent to a device in commercial distribution before 
May 28, 1976, or is substantially equivalent to a device introduced into 
commercial distribution after May 28, 1976, that has subsequently been 
reclassified into class I or II, does not in any way denote official 
approval of the device. Any representation that creates an impression of 
official approval of a device because of complying with the premarket 
notification regulations is misleading and constitutes misbranding.



Sec. 807.100  FDA action on a premarket notification.

    (a) After review of a premarket notification, FDA will:
    (1) Issue an order declaring the device to be substantially 
equivalent to a legally marketed predicate device;
    (2) Issue an order declaring the device to be not substantially 
equivalent to any legally marketed predicate device;
    (3) Request additional information; or
    (4) Withhold the decision until a certification or disclosure 
statement is submitted to FDA under part 54 of this chapter.
    (5) Advise the applicant that the premarket notification is not 
required. Until the applicant receives an order declaring a device 
substantially equivalent, the applicant may not proceed to market the 
device.
    (b) FDA will determine that a device is substantially equivalent to 
a predicate device using the following criteria:
    (1) The device has the same intended use as the predicate device; 
and
    (2) The device:
    (i) Has the same technological characteristics as the predicate 
device; or
    (ii)(A) Has different technological characteristics, such as a 
significant change in the materials, design, energy source, or other 
features of the device from those of the predicate device;
    (B) The data submitted establishes that the device is substantially 
equivalent to the predicate device and contains information, including 
clinical data if deemed necessary by the Commissioner, that demonstrates 
that the device is as safe and as effective as a legally marketed 
device; and
    (C) Does not raise different questions of safety and effectiveness 
than the predicate device.
    (3) The predicate device has not been removed from the market at the 
initiative of the Commissioner of Food and Drugs or has not been 
determined to be misbranded or adulterated by a judicial order.

[57 FR 58403, Dec. 10, 1992, as amended at 63 FR 5253, Feb. 2, 1998]

[[Page 103]]



PART 808_EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND
LOCAL MEDICAL DEVICE REQUIREMENTS--Table of Contents



                      Subpart A_General Provisions

Sec.
808.1 Scope.
808.3 Definitions.
808.5 Advisory opinions.

                     Subpart B_Exemption Procedures

808.20 Application.
808.25 Procedures for processing an application.
808.35 Revocation of an exemption.

        Subpart C_Listing of Specific State and Local Exemptions

808.53 [Reserved]
808.55 California
808.57--808.101 [Reserved]

    Authority: 21 U.S.C. 360j, 360k, 371.
    Section 808.1 also issued under Sec. 709, Public Law 115-52, 131 
Stat. 1065-67.

    Source: 43 FR 18665, May 2, 1978, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 808.1  Scope.

    (a) Introduction. This part prescribes procedures for the 
submission, review, and approval of applications for exemption from 
Federal preemption of State and local requirements applicable to medical 
devices under section 521 of the Federal Food, Drug, and Cosmetic Act.
    (b) General rule for State and local requirements respecting 
devices. Section 521(a) of the Federal Food, Drug, and Cosmetic Act 
contains special provisions governing the regulation of devices by 
States and localities. That section prescribes a general rule that after 
May 28, 1976, no State or political subdivision of a State may establish 
or continue in effect any requirement with respect to a medical device 
intended for human use having the force and effect of law (whether 
established by statute, ordinance, regulation, or court decision), which 
is different from, or in addition to, any requirement applicable to such 
device under any provision of the Federal Food, Drug, and Cosmetic Act 
and which relates to the safety or effectiveness of the device or to any 
other matter included in a requirement applicable to the device under 
the Federal Food, Drug, and Cosmetic Act.
    (c) Exempting from preemption certain State or local requirements 
respecting devices. Section 521(b) of the Federal Food, Drug, and 
Cosmetic Act contains a provision whereby the Commissioner of Food and 
Drugs may, upon application by a State or political subdivision, allow 
imposition of a requirement which is different from, or in addition to, 
any requirement applicable under the Federal Food, Drug, and Cosmetic 
Act to the device (and which is thereby preempted) by promulgating a 
regulation in accordance with this part exempting the State or local 
requirement from preemption. The granting of an exemption does not 
affect the applicability to the device of any requirements under the 
Federal Food, Drug, and Cosmetic Act. The Commissioner may promulgate an 
exemption regulation for the preempted requirement if he makes either of 
the following findings:
    (1) That the requirement is more stringent than a requirement under 
the Federal Food, Drug, and Cosmetic Act applicable to the device; or
    (2) That the requirement is required by compelling local conditions 
and compliance with the requirement would not cause the device to be in 
violation of any applicable requirement under the Federal Food, Drug, 
and Cosmetic Act.
    (d) Meaning of ``requirements applicable to a device.'' State or 
local requirements are preempted only when the Food and Drug 
Administration has established specific counterpart regulations or there 
are other specific requirements applicable to a particular device under 
the Federal Food, Drug, and Cosmetic Act, thereby making any existing 
divergent State or local requirements applicable to the device different 
from, or in addition to, the specific Food and Drug Administration 
requirements. There are other State or local requirements that affect 
devices that are not preempted by section 521(a) of the Federal Food, 
Drug, and Cosmetic Act because they are not ``requirements applicable to 
a device''

[[Page 104]]

within the meaning of section 521(a) of the Federal Food, Drug, and 
Cosmetic Act. The following are examples of State or local requirements 
that are not regarded as preempted by section 521 of the Federal Food, 
Drug, and Cosmetic Act:
    (1) Section 521(a) does not preempt State or local requirements of 
general applicability where the purpose of the requirement relates 
either to other products in addition to devices (e.g., requirements such 
as general electrical codes, and the Uniform Commercial Code (warranty 
of fitness)), or to unfair trade practices in which the requirements are 
not limited to devices.
    (2) Section 521(a) does not preempt State or local requirements that 
are equal to, or substantially identical to, requirements imposed by or 
under the Federal Food, Drug, and Cosmetic Act.
    (3) Section 521(a) does not preempt State or local permits, 
licensing, registration, certification, or other requirements relating 
to the approval or sanction of the practice of medicine, dentistry, 
optometry, pharmacy, nursing, podiatry, or any other of the healing arts 
or allied medical sciences or related professions or occupations that 
administer, dispense, or sell devices. However, regulations issued under 
section 520(e) or (g) of the Federal Food, Drug, and Cosmetic Act may 
impose restrictions on the sale, distribution, or use of a device beyond 
those prescribed in State or local requirements. If there is a conflict 
between such restrictions and State or local requirements, the Federal 
regulations shall prevail.
    (4) Section 521(a) does not preempt specifications in contracts 
entered into by States or localities for procurement of devices.
    (5) Section 521(a) does not preempt criteria for payment of State or 
local obligations under Medicaid and similar Federal, State or local 
health-care programs.
    (6)(i) Section 521(a) does not preempt State or local requirements 
respecting general enforcement, e.g., requirements that State inspection 
be permitted of factory records concerning all devices, registration, 
and licensing requirements for manufacturers and others, and prohibition 
of manufacture of devices in unlicensed establishments. However, Federal 
regulations issued under sections 519 and 520(f) of the Federal Food, 
Drug, and Cosmetic Act may impose requirements for records and reports 
and good manufacturing practices beyond those prescribed in State or 
local requirements. If there is a conflict between such regulations and 
State or local requirements, the Federal regulations shall prevail.
    (ii) Generally, section 521(a) does not preempt a State or local 
requirement prohibiting the manufacture of adulterated or misbranded 
devices. Where, however, such a prohibition has the effect of 
establishing a substantive requirement for a specific device, e.g., a 
specific labeling requirement, then the prohibition will be preempted if 
the requirement is different from, or in addition to, a Federal 
requirement established under the Federal Food, Drug, and Cosmetic Act. 
In determining whether such a requirement is preempted, the 
determinative factor is how the requirement is interpreted and enforced 
by the State or local government and not the literal language of the 
statute, which may be identical to a provision in the Federal Food, 
Drug, and Cosmetic Act.
    (7) Section 521(a) does not preempt State or local provisions 
respecting delegations of authority and related administrative matters 
relating to devices.
    (8) Section 521(a) does not preempt a State or local requirement 
whose sole purpose is raising revenue or charging fees for services, 
registration, or regulatory programs.
    (9) Section 521(a) does not preempt State or local requirements of 
the types that have been developed under the Atomic Energy Act of 1954 
(42 U.S.C. 2011 note), as amended, Subchapter C--Electronic Product 
Radiation Control of the Federal Food, Drug, and Cosmetic Act (formerly 
the Radiation Control for Health and Safety Act of 1968), and other 
Federal statutes, until such time as the Food and Drug Administration 
issues specific requirements under the Federal Food, Drug, and Cosmetic 
Act applicable to these types of devices.

[[Page 105]]

    (10) Part 820 of this chapter (21 CFR part 820) (CGMP requirements) 
does not preempt remedies created by States or Territories of the United 
States, the District of Columbia, or the Commonwealth of Puerto Rico.
    (e) Determination of equivalence or difference of requirements 
applicable to a device. It is the responsibility of the Food and Drug 
Administration, subject to review by Federal courts, to determine 
whether a State or local requirement is equal to, or substantially 
identical to, requirements imposed by or under the Federal Food, Drug, 
and Cosmetic Act, or is different from, or in addition to, such 
requirements, in accordance with the procedures provided by this part. 
However, it is the responsibility of States and political subdivisions 
to determine initially whether to seek exemptions from preemption. Any 
State or political subdivision whose requirements relating to devices 
are preempted by section 521(a) may petition the Commissioner of Food 
and Drugs for exemption from preemption, in accordance with the 
procedures provided by this part.
    (f) Applicability of Federal requirements respecting devices. The 
Federal requirement with respect to a device applies whether or not a 
corresponding State or local requirement is preempted or exempted from 
preemption. As a result, if a State or local requirement that the Food 
and Drug Administration has exempted from preemption is not as broad in 
its application as the Federal requirement, the Federal requirement 
applies to all circumstances not covered by the State or local 
requirement.
    (g) Exemptions not applicable to certain State or local government 
requirements specifically related to hearing products. An exemption 
under this part shall not apply to any State or local government law, 
regulation, order, or other requirement specifically related to hearing 
products, including any requirement for the supervision, prescription, 
or other order, involvement, or intervention of a licensed person for 
consumers to access over-the-counter hearing aids, that:
    (1) Would restrict or interfere with the servicing, marketing, sale, 
dispensing, use, customer support, or distribution of over-the-counter 
hearing aids, as defined under section 520(q) of the Federal Food, Drug, 
and Cosmetic Act, through in-person transactions, by mail, or online; 
and
    (2) Is different from, in addition to, or otherwise not identical 
to, the regulations issued under section 709(b) of the FDA 
Reauthorization Act of 2017.

[43 FR 18665, May 2, 1978, as amended at 45 FR 67336, Oct. 10, 1980; 61 
FR 52654, Oct. 7, 1996; 73 FR 34859, June 19, 2008; 87 FR 50761, Aug. 
17, 2022]



Sec. 808.3  Definitions.

    Compelling local conditions includes any factors, considerations, or 
circumstances prevailing in, or characteristic of, the geographic area 
or population of the State or political subdivision that justify 
exemption from preemption.
    More stringent refers to a requirement of greater restrictiveness or 
one that is expected to afford to those who may be exposed to a risk of 
injury from a device a higher degree of protection than is afforded by a 
requirement applicable to the device under the Federal Food, Drug, and 
Cosmetic Act.
    Political subdivision or locality means any lawfully established 
local governmental unit within a State which unit has the authority to 
establish or continue in effect any requirement having the force and 
effect of law with respect to a device intended for human use.
    State means any State or Territory of the United States, including 
but not limited to, the District of Columbia and the Commonwealth of 
Puerto Rico.
    Substantially identical to refers to the fact that a State or local 
requirement does not significantly differ in effect from a Federal 
requirement.

[87 FR 50762, Aug. 17, 2022]



Sec. 808.5  Advisory opinions.

    (a) Any State, political subdivision, or other interested person may 
request an advisory opinion from the Commissioner with respect to any 
general matter concerning preemption of State or local device 
requirements or with respect to whether the Food and Drug Administration 
regards particular State or local requirements, or proposed 
requirements, as preempted.

[[Page 106]]

    (1) Such an advisory opinion may be requested and may be granted in 
accordance with Sec. 10.85 of this chapter.
    (2) The Food and Drug Administration, in its discretion and after 
consultation with the State or political subdivision, may treat a 
request by a State or political subdivision for an advisory opinion as 
an application for exemption from preemption under Sec. 808.20.
    (b) The Commissioner may issue an advisory opinion relating to a 
State or local requirement on his own initiative when he makes one of 
the following determinations:
    (1) A requirement with respect to a device for which an application 
for exemption from preemption has been submitted under Sec. 808.20 is 
not preempted by section 521(a) of the Federal Food, Drug, and Cosmetic 
Act because it is: (i) Equal to or substantially identical to a 
requirement under the Federal Food, Drug, and Cosmetic Act applicable to 
the device, or (ii) is not a requirement within the meaning of section 
521 of the Federal Food, Drug, and Cosmetic Act and therefore is not 
preempted;
    (2) A proposed State or local requirement with respect to a device 
is not eligible for exemption from preemption because the State or local 
requirement has not been issued in final form. In such a case, the 
advisory opinion may indicate whether the proposed requirement would be 
preempted and, if it would be preempted, whether the Food and Drug 
Administration would propose to grant an exemption from preemption;
    (3) Issuance of such an advisory opinion is in the public interest.

[43 FR 18665, May 2, 1978, as amended at 87 FR 50761, Aug. 17, 2022]



                     Subpart B_Exemption Procedures



Sec. 808.20  Application.

    (a) Any State or political subdivision may apply to the Food and 
Drug Administration for an exemption from preemption for any requirement 
that it has enacted and that is preempted. An exemption may only be 
granted for a requirement that has been enacted, promulgated, or issued 
in final form by the authorized body or official of the State or 
political subdivision so as to have the force and effect of law. 
However, an application for exemption may be submitted before the 
effective date of the requirement.
    (b) An application for exemption shall be in the form of a letter to 
the Commissioner of Food and Drugs and shall be signed by an individual 
who is authorized to request the exemption on behalf of the State or 
political subdivision. An original and two copies of the letter and any 
accompanying material, as well as any subsequent reports or 
correspondence concerning an application, shall be submitted to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The outside wrapper of 
any application, report, or correspondence should indicate that it 
concerns an application for exemption from preemption of device 
requirements.
    (c) For each requirement for which an exemption is sought, the 
application shall include the following information to the fullest 
extent possible, or an explanation of why such information has not been 
included:
    (1) Identification and a current copy of any statute, rule, 
regulation, or ordinance of the State or political subdivision 
considered by the State or political subdivision to be a requirement 
which is preempted, with a reference to the date of enactment, 
promulgation, or issuance in final form. The application shall also 
include, where available, copies of any legislative history or 
background materials pertinent to enactment, promulgation, or issuance 
of the requirement, including hearing reports or studies concerning 
development or consideration of the requirement. If the requirement has 
been subject to any judicial or administrative interpretations, the 
State or political subdivision shall furnish copies of such judicial or 
administrative interpretations.
    (2) A comparison of the requirement of the State or political 
subdivision and any applicable Federal requirements to show similarities 
and differences.
    (3) Information on the nature of the problem addressed by the 
requirement of the State or political subdivision.

[[Page 107]]

    (4) Identification of which (or both) of the following bases is 
relied upon for seeking an exemption from preemption:
    (i) The requirement is more stringent than a requirement applicable 
to a device under the Federal Food, Drug, and Cosmetic Act. If the State 
or political subdivision relies upon this basis for exemption from 
preemption, the application shall include information, data, or material 
showing how and why the requirement of the State or political 
subdivision is more stringent than requirements under the Federal Food, 
Drug, and Cosmetic Act.
    (ii) The requirement is required by compelling local conditions, and 
compliance with the requirement would not cause the device to be in 
violation of any applicable requirement under the Federal Food, Drug, 
and Cosmetic Act. If the State or political subdivision relies upon this 
basis for exemption from preemption, the application shall include 
information, data, or material showing why compliance with the 
requirement of the State or political subdivision would not cause a 
device to be in violation of any applicable requirement under the 
Federal Food, Drug, and Cosmetic Act and why the requirement is required 
by compelling local conditions. The application shall also explain in 
detail the compelling local conditions that justify the requirement.
    (5) The title of the chief administrative or legal officers of that 
State or local agency that has primary responsibility for administration 
of the requirement.
    (6) When requested by the Food and Drug Administration, any records 
concerning administration of any requirement which is the subject of an 
exemption or an application for an exemption from preemption.
    (7) Information on how the public health may be benefitted and how 
interstate commerce may be affected, if an exemption is granted.
    (8) Any other pertinent information respecting the requirement 
voluntarily submitted by the applicant.
    (d) If litigation regarding applicability of the requirement is 
pending, the State or political subdivision may so indicate in its 
application and request expedited action on such application.

[43 FR 18665, May 2, 1978; 43 FR 22010, May 23, 1978, as amended at 49 
FR 3646, Jan. 30, 1984; 59 FR 14365, Mar. 28, 1994; 87 FR 50761, Aug. 
17, 2022]



Sec. 808.25  Procedures for processing an application.

    (a) Upon receipt of an application for an exemption from preemption 
submitted in accordance with Sec. 808.20, the Commissioner shall notify 
the State or political subdivision of the date of such receipt.
    (b) If the Commissioner finds that an application does not meet the 
requirements of Sec. 808.20, he shall notify the State or political 
subdivision of the deficiencies in the application and of the 
opportunity to correct such deficiencies. A deficient application may be 
corrected at any time.
    (c) After receipt of an application meeting the requirements of 
Sec. 808.20, the Commissioner shall review such application and 
determine whether to grant or deny an exemption from preemption for each 
requirement which is the subject of the application. The Commissioner 
shall then issue in the Federal Register a proposed regulation either to 
grant or to deny an exemption from preemption. The Commissioner shall 
also issue in the Federal Register a notice of opportunity to request an 
oral hearing before the Commissioner or the Commissioner's designee.
    (d) A request for an oral hearing may be made by the State or 
political subdivision or any other interested person. Such request shall 
be submitted to the Division of Dockets Management within the period of 
time prescribed in the notice and shall include an explanation of why an 
oral hearing, rather than submission of written comments only, is 
essential to the presentation of views on the application for exemption 
from preemption and the proposed regulation.
    (e) If a timely request for an oral hearing is made, the 
Commissioner shall review such a request and may grant a legislative-
type informal oral hearing pursuant to part 15 of this chapter by 
publishing in the Federal

[[Page 108]]

Register a notice of the hearing in accordance with Sec. 15.20 of this 
chapter. The scope of the oral hearing shall be limited to matters 
relevant to the application for exemption from preemption and the 
proposed regulation. Oral or written presentations at the oral hearing 
which are not relevant to the application shall be excluded from the 
administrative record of the hearing.
    (f) If a request for hearing is not timely made or a notice of 
appearance is not filed pursuant to Sec. 15.21 of this chapter, the 
Commissioner shall consider all written comments submitted and publish a 
final rule in accordance with paragraph (g) of this section.
    (g)(1) The Commissioner shall review all written comments submitted 
on the proposed rule and the administrative record of the oral hearing, 
if an oral hearing has been granted, and shall publish in the Federal 
Register a final rule in subpart C of this part identifying any 
requirement in the application for which exemption from preemption is 
granted, or conditionally granted, and any requirement in the 
application for which exemption from preemption is not granted.
    (2) The Commissioner may issue a regulation granting or 
conditionally granting an application for an exemption from preemption 
for any requirement if the Commissioner makes either of the following 
findings:
    (i) The requirement is more stringent than a requirement applicable 
to the device under the Federal Food, Drug, and Cosmetic Act;
    (ii) The requirement is required by compelling local conditions, and 
compliance with the requirement would not cause the device to be in 
violation of any requirement applicable to the device under the Federal 
Food, Drug, and Cosmetic Act.
    (3) The Commissioner may not grant an application for an exemption 
from preemption for any requirement with respect to a device if the 
Commissioner determines that the granting of an exemption would not be 
in the best interest of public health, taking into account the potential 
burden on interstate commerce.
    (h) An advisory opinion pursuant to Sec. 808.5 or a regulation 
pursuant to paragraph (g) of this section constitutes final agency 
action.

[43 FR 18665, May 2, 1978, as amended at 87 FR 50761, Aug. 17, 2022]



Sec. 808.35  Revocation of an exemption.

    (a) An exemption from preemption pursuant to a regulation under this 
part shall remain effective until the Commissioner revokes such 
exemption.
    (b) The Commissioner may by regulation, in accordance with Sec. 
808.25, revoke an exemption from preemption for any of the following 
reasons:
    (1) An exemption may be revoked upon the effective date of a newly 
established requirement under the Federal Food, Drug, and Cosmetic Act 
which, in the Commissioner's view, addresses the objectives of an exempt 
requirement and which is described, when issued, as preempting a 
previously exempt State or local requirement.
    (2) An exemption may be revoked upon a finding that there has 
occurred a change in the bases listed in Sec. 808.20(c)(4) upon which 
the exemption was granted.
    (3) An exemption may be revoked if it is determined that a condition 
placed on the exemption by the regulation under which the exemption was 
granted has not been met or is no longer being met.
    (4) An exemption may be revoked if a State or local jurisdiction 
fails to submit records as provided in Sec. 808.20(c)(6).
    (5) An exemption may be revoked if a State or local jurisdiction to 
whom the exemption was originally granted requests revocation.
    (6) An exemption may be revoked if it is determined that it is no 
longer in the best interests of the public health to continue the 
exemption.
    (c) An exemption that has been revoked may be reinstated, upon 
request from the State or political subdivision, if the Commissioner, in 
accordance with the procedures in Sec. 808.25, determines that the 
grounds for revocation are no longer applicable except that the 
Commissioner may permit abbreviated submissions of the documents and 
materials normally required for an

[[Page 109]]

application for exemption under Sec. 808.20.

[43 FR 18665, May 2, 1978, as amended at 87 FR 50761, Aug. 17, 2022]



        Subpart C_Listing of Specific State and Local Exemptions



Sec. 808.53  [Reserved]



Sec. 808.55  California.

    The following California medical device requirements are preempted 
under section 521(a) of the Federal Food, Drug, and Cosmetic Act, and 
FDA has denied them exemption from preemption:
    (a) Medical devices; general provisions. Sherman Food, Drug, and 
Cosmetic Law, Division 21 of the California Health and Safety Code, 
sections 26207, 26607, 26614, 26615, 26618, 26631, 26640, and 26441, to 
the extent that they apply to devices; and
    (b) Ophthalmic devices; quality standards. California Business and 
Professions Code, section 2541.3 to the extent that it requires adoption 
of the American National Standards Institute standards Z-80.1 and Z-
80.2.

[87 FR 50762, Aug. 17, 2022]



Sec. Sec. 808.57--808.101  [Reserved]



PART 809_IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE--Table of Contents



                      Subpart A_General Provisions

Sec.
809.3 Definitions.
809.4 Confidentiality of submitted information.

                           Subpart B_Labeling

809.10 Labeling for in vitro diagnostic products.
809.11 Exceptions or alternatives to labeling requirements for in vitro 
          diagnostic products for human use held by the Strategic 
          National Stockpile.

         Subpart C_Requirements for Manufacturers and Producers

809.20 General requirements for manufacturers and producers of in vitro 
          diagnostic products.
809.30 Restrictions on the sale, distribution and use of analyte 
          specific reagents.
809.40 Restrictions on the sale, distribution, and use of OTC test 
          sample collection systems for drugs of abuse testing.

    Authority: 21 U.S.C. 331, 351, 352, 355, 360b, 360c, 360d, 360h, 
360i, 360j, 371, 372, 374, 381.



                      Subpart A_General Provisions



Sec. 809.3  Definitions.

    (a) In vitro diagnostic products are those reagents, instruments, 
and systems intended for use in the diagnosis of disease or other 
conditions, including a determination of the state of health, in order 
to cure, mitigate, treat, or prevent disease or its sequelae. Such 
products are intended for use in the collection, preparation, and 
examination of specimens taken from the human body. These products are 
devices as defined in section 201(h) of the Federal Food, Drug, and 
Cosmetic Act (the act), and may also be biological products subject to 
section 351 of the Public Health Service Act.
    (b) A product class is all those products intended for use for a 
particular determination or for a related group of determinations or 
products with common or related characteristics or those intended for 
common or related uses. A class may be further divided into subclasses 
when appropriate.
    (c) [Reserved]
    (d) Act means the Federal Food, Drug, and Cosmetic Act.

[41 FR 6903, Feb. 13, 1976, as amended at 45 FR 7484, Feb. 1, 1980]



Sec. 809.4  Confidentiality of submitted information.

    Data and information submitted under Sec. 809.10(c) that are shown 
to fall within the exemption established in Sec. 20.61 of this chapter 
shall be treated as confidential by the Food and Drug Administration and 
any person to whom the data and information are referred. The Food and 
Drug Administration will determine whether information submitted will be 
treated as confidential in accordance with the provisions of part 20 of 
this chapter.

[45 FR 7484, Feb. 1, 1980]

[[Page 110]]



                           Subpart B_Labeling



Sec. 809.10  Labeling for in vitro diagnostic products.

    (a) The label for an in vitro diagnostic product shall state the 
following information, except where such information is not applicable, 
or as otherwise specified in a standard for a particular product class 
or as provided in paragraph (e) of this section. Section 201(k) of the 
act provides that ``a requirement made by or under authority of this act 
that any word, statement, or other information appear on the label shall 
not be considered to be complied with unless such word, statement, or 
other information also appears on the outside container or wrapper, if 
any there be, of the retail package of such article, or is easily 
legible through the outside container or wrapper.''
    (1) The proprietary name and established name (common or usual 
name), if any.
    (2) The intended use or uses of the product.
    (3) For a reagent, a declaration of the established name (common or 
usual name), if any, and quantity, proportion or concentration of each 
reactive ingredient; and for a reagent derived from biological material, 
the source and a measure of its activity. The quantity, proportion, 
concentration, or activity shall be stated in the system generally used 
and recognized by the intended user, e.g., metric, international units, 
etc.
    (4) A statement of warnings or precautions for users as established 
in the regulations contained in 16 CFR part 1500 and any other warnings 
appropriate to the hazard presented by the product; and a statement 
``For In Vitro Diagnostic Use'' and any other limiting statements 
appropriate to the intended use of the product. The limiting statement 
appropriate to the intended use of a prescription in vitro diagnostic 
product shall bear the symbol statement ``Rx only'' or ``[rx] only'' or 
the statement ``Caution: Federal law restricts this device to sale by or 
on the order of a ___'', the blank to be filled with the word 
``physician'', ``dentist'', ``veterinarian'', or with the descriptive 
designation of any other practitioner licensed by the law of the State 
in which the practitioner practices to use or order the use of the 
device.
    (5) For a reagent, appropriate storage instructions adequate to 
protect the stability of the product. When applicable, these 
instructions shall include such information as conditions of 
temperature, light, humidity, and other pertinent factors. For products 
requiring manipulation, such as reconstitution and/or mixing before use, 
appropriate storage instructions shall be provided for the reconstituted 
or mixed product which is to be stored in the original container. The 
basis for such instructions shall be determined by reliable, meaningful, 
and specific test methods such as those described in Sec. 211.166 of 
this chapter.
    (6) For a reagent, a means by which the user may be assured that the 
product meets appropriate standards of identity, strength, quality and 
purity at the time of use. This shall be provided, both for the product 
as provided and for any resultant reconstituted or mixed product, by 
including on the label one or more of the following:
    (i) An expiration date based upon the stated storage instructions.
    (ii) A statement of an observable indication of an alteration of the 
product, e.g., turbidity, color change, precipitate, beyond its 
appropriate standards.
    (iii) Instructions for a simple method by which the user can 
reasonably determine that the product meets its appropriate standards.
    (7) For a reagent, a declaration of the net quantity of contents, 
expressed in terms of weight or volume, numerical count, or any 
combination of these or other terms which accurately reflect the 
contents of the package. The use of metric designations is encouraged, 
wherever appropriate. If more than a single determination may be 
performed using the product, any statement of the number of tests shall 
be consistent with instructions for use and amount of material provided.
    (8) Name and place of business of manufacturer, packer, or 
distributor.
    (9) A lot or control number, identified as such, from which it is 
possible to determine the complete manufacturing history of the product.

[[Page 111]]

    (i) If it is a multiple unit product, the lot or control number 
shall permit tracing the identity of the individual units.
    (ii) For an instrument, the lot or control number shall permit 
tracing the identity of all functional subassemblies.
    (iii) For multiple unit products which require the use of included 
units together as a system, all units should bear the same lot or 
control number, if appropriate, or other suitable uniform identification 
should be used.
    (10) Except that for items in paragraphs (a) (1) through (9) of this 
section: (i) In the case of immediate containers too small or otherwise 
unable to accommodate a label with sufficient space to bear all such 
information and which are packaged within an outer container from which 
they are removed for use, the information required by paragraphs (a) 
(2), (3), (4), (5), (6) (ii), (iii) and (7) of this section may appear 
in the outer container labeling only.
    (ii) In any case in which the presence of this information on the 
immediate container will interfere with the test, the information may 
appear on the outside container or wrapper rather than on the immediate 
container label.
    (b) Labeling accompanying each product, e.g., a package insert, 
shall state in one place the following information in the format and 
order specified below, except where such information is not applicable, 
or as specified in a standard for a particular product class. The 
labeling for a multiple-purpose instrument used for diagnostic purposes, 
and not committed to specific diagnostic procedures or systems, may bear 
only the information indicated in paragraphs (b) (1), (2), (6), (14), 
and (15) of this section. The labeling for a reagent intended for use as 
a replacement in a diagnostic system may be limited to that information 
necessary to identify the reagent adequately and to describe its proper 
use in the system.
    (1) The proprietary name and established name, i.e., common or usual 
name, if any.
    (2) The intended use or uses of the product and the type of 
procedure, e.g., qualitative or quantitative.
    (3) Summary and explanation of the test. Include a short history of 
the methodology, with pertinent references and a balanced statement of 
the special merits and limitations of this method or product. If the 
product labeling refers to any other procedure, appropriate literature 
citations shall be included and the labeling shall explain the nature of 
any differences from the original and their effect on the results.
    (4) The chemical, physical, physiological, or biological principles 
of the procedure. Explain concisely, with chemical reactions and 
techniques involved, if applicable.
    (5) Reagents:
    (i) A declaration of the established name (common or usual name), if 
any, and quantity, proportion or concentration or each reactive 
ingredient; and for biological material, the source and a measure of its 
activity. The quantity, proportion, concentration or activity shall be 
stated in the system generally used and recognized by the intended user, 
e.g., metric, international units, etc. A statement indicating the 
presence of and characterizing any catalytic or nonreactive ingredients, 
e.g., buffers, preservatives, stabilizers.
    (ii) A statement of warnings or precautions for users as established 
in the regulations contained in 16 CFR part 1500 and any other warnings 
appropriate to the hazard presented by the product; and a statement 
``For In Vitro Diagnostic Use'' and any other limiting statements 
appropriate to the intended use of the product. The limiting statement 
appropriate to the intended use of a prescription in vitro diagnostic 
product shall bear the symbol statement ``Rx only'' or ``[rx] only'' or 
the statement ``Caution: Federal law restricts this device to sale by or 
on the order of a ___'', the blank to be filled with the word 
``physician'', ``dentist'', ``veterinarian'', or with the descriptive 
designation of any other practitioner licensed by the law of the State 
in which the practitioner practices to use or order the use of the 
device.
    (iii) Adequate instructions for reconstitution, mixing, dilution, 
etc.
    (iv) Appropriate storage instructions adequate to protect the 
stability of the

[[Page 112]]

product. When applicable, these instructions shall include such 
information as conditions of temperature, light, humidity, and other 
pertinent factors. For products requiring manipulation, such as 
reconstitution and/or mixing before use, appropriate storage 
instructions shall be provided for the reconstituted or mixed product. 
The basis for such instructions shall be determined by reliable, 
meaningful, and specific test methods such as those described in Sec. 
211.166 of this chapter.
    (v) A statement of any purification or treatment required for use.
    (vi) Physical, biological, or chemical indications of instability or 
deterioration.
    (6) Instruments:
    (i) Use or function.
    (ii) Installation procedures and special requirements.
    (iii) Principles of operation.
    (iv) Performance characteristics and specifications.
    (v) Operating instructions.
    (vi) Calibration procedures including materials and/or equipment to 
be used.
    (vii) Operational precautions and limitations.
    (viii) Hazards.
    (ix) Service and maintenance information.
    (7) Specimen collection and preparation for analysis, including a 
description of:
    (i) Special precautions regarding specimen collection including 
special preparation of the patient as it bears on the validity of the 
test.
    (ii) Additives, preservatives, etc., necessary to maintain the 
integrity of the specimen.
    (iii) Known interfering substances.
    (iv) Recommended storage, handling or shipping instructions for the 
protection and maintenance of stability of the specimen.
    (8) Procedure: A step-by-step outline of recommended procedures from 
reception of the specimen to obtaining results. List any points that may 
be useful in improving precision and accuracy.
    (i) A list of all materials provided, e.g., reagents, instruments 
and equipment, with instructions for their use.
    (ii) A list of all materials required but not provided. Include such 
details as sizes, numbers, types, and quality.
    (iii) A description of the amounts of reagents necessary, times 
required for specific steps, proper temperatures, wavelengths, etc.
    (iv) A statement describing the stability of the final reaction 
material to be measured and the time within which it shall be measured 
to assure accurate results.
    (v) Details of calibration: Identify reference material. Describe 
preparation of reference sample(s), use of blanks, preparation of the 
standard curve, etc. The description of the range of calibration should 
include the highest and the lowest values measurable by the procedure.
    (vi) Details of kinds of quality control procedures and materials 
required. If there is need for both positive and negative controls, this 
should be stated. State what are considered satisfactory limits of 
performance.
    (9) Results: Explain the procedure for calculating the value of the 
unknown. Give an explanation for each component of the formula used for 
the calculation of the unknown. Include a sample calculation, step-by-
step, explaining the answer. The values shall be expressed to the 
appropriate number of significant figures. If the test provides other 
than quantitative results, provide an adequate description of expected 
results.
    (10) Limitation of the procedure: Include a statement of limitations 
of the procedure. State known extrinsic factors or interfering 
substances affecting results. If further testing, either more specific 
or more sensitive, is indicated in all cases where certain results are 
obtained, the need for the additional test shall be stated.
    (11) Expected values: State the range(s) of expected values as 
obtained with the product from studies of various populations. Indicate 
how the range(s) was established and identify the population(s) on which 
it was established.

[[Page 113]]

    (12) Specific performance characteristics: Include, as appropriate, 
information describing such things as accuracy, precision, specificity, 
and sensitivity. These shall be related to a generally accepted method 
using biological specimens from normal and abnormal populations. Include 
a statement summarizing the data upon which the specific performance 
characteristics are based.
    (13) Bibliography: Include pertinent references keyed to the text.
    (14) Name and place of business of manufacturer, packer, or 
distributor.
    (15) Date of issuance of the last revision of the labeling 
identified as such.
    (c) A shipment or other delivery of an in vitro diagnostic product 
shall be exempt from the requirements of paragraphs (a) and (b) of this 
section and from a standard promulgated under part 861 provided that the 
following conditions are met:
    (1) In the case of a shipment or delivery for an investigation 
subject to part 812, if there has been compliance with part 812; or
    (2) In the case of a shipment or delivery for an investigation that 
is not subject to part 812 (see Sec. 812.2(c)), if the following 
conditions are met:
    (i) For a product in the laboratory research phase of development, 
and not represented as an effective in vitro diagnostic product, all 
labeling bears the statement, prominently placed: ``For Research Use 
Only. Not for use in diagnostic procedures.''
    (ii) For a product being shipped or delivered for product testing 
prior to full commercial marketing (for example, for use on specimens 
derived from humans to compare the usefulness of the product with other 
products or procedures which are in current use or recognized as 
useful), all labeling bears the statement, prominently placed: ``For 
Investigational Use Only. The performance characteristics of this 
product have not been established.''
    (d) The labeling of general purpose laboratory reagents (e.g., 
hydrochloric acid) and equipment (e.g., test tubes and pipettes) whose 
uses are generally known by persons trained in their use need not bear 
the directions for use required by Sec. 809.10(a) and (b), if their 
labeling meets the requirements of this paragraph.
    (1) The label of a reagent shall bear the following information:
    (i) The proprietary name and established name (common or usual 
name), if any, of the reagent.
    (ii) A declaration of the established name (common or usual name), 
if any, and quantity, proportion or concentration of the reagent 
ingredient (e.g., hydrochloric acid: Formula weight 36.46, assay 37.9 
percent, specific gravity 1.192 at 60 [deg]F); and for a reagent derived 
from biological material, the source and where applicable a measure of 
its activity. The quantity, proportion, concentration or activity shall 
be stated in the system generally used and recognized by the intended 
user, e.g., metric, international units, etc.
    (iii) A statement of the purity and quality of the reagent, 
including a quantitative declaration of any impurities present. The 
requirement for this information may be met by a statement of conformity 
with a generally recognized and generally available standard which 
contains the same information, e.g., those established by the American 
Chemical Society, U.S. Pharmacopeia, National Formulary, National 
Research Council.
    (iv) A statement of warnings or precautions for users as established 
in the regulations contained in 16 CFR part 1500 and any other warnings 
appropriate to the hazard presented by the product; and a statement 
``For Laboratory Use.''
    (v) Appropriate storage instructions adequate to protect the 
stability of the product. When applicable, these instructions shall 
include such information as conditions of temperature, light, humidity, 
and other pertinent factors. The basis for such information shall be 
determined by reliable, meaningful, and specific test methods such as 
those described in Sec. 211.166 of this chapter.
    (vi) A declaration of the net quantity of contents, expressed in 
terms of weight or volume, numerical count, or any combination of these 
or other terms which accurately reflect the contents of the package. The 
use of metric designations is encouraged, wherever appropriate.

[[Page 114]]

    (vii) Name and place of business of manufacturer, packer, or 
distributor.
    (viii) A lot or control number, identified as such, from which it is 
possible to determine the complete manufacturing history of the product.
    (ix) In the case of immediate containers too small or otherwise 
unable to accommodate a label with sufficient space to bear all such 
information, and which are packaged within an outer container from which 
they are removed for use, the information required by paragraphs 
(d)(1)(ii), (iii), (iv), (v), and (vi) of this section may appear in the 
outer container labeling only.
    (2) The label of general purpose laboratory equipment, e.g., a 
beaker or a pipette, shall bear a statement adequately describing the 
product, its composition, and physical characteristics if necessary for 
its proper use.
    (e)(1) The labeling for analyte specific reagents (e.g., monoclonal 
antibodies, deoxyribonucleic acid (DNA) probes, viral antigens, ligands) 
shall bear the following information:
    (i) The proprietary name and established name (common or usual 
name), if any, of the reagent;
    (ii) A declaration of the established name (common or usual name), 
if any;
    (iii) The quantity, proportion, or concentration of the reagent 
ingredient; and for a reagent derived from biological material, the 
source and where applicable, a measure of its activity. The quantity, 
proportion, concentration, or activity shall be stated in the system 
generally used and recognized by the intended user, e.g., metric, 
international units, etc.;
    (iv) A statement of the purity and quality of the reagent, including 
a quantitative declaration of any impurities present and method of 
analysis or characterization. The requirement for this information may 
be met by a statement of conformity with a generally recognized and 
generally available standard that contains the same information, e.g., 
those established by the American Chemical Society, U.S. Pharmacopeia, 
National Formulary, and National Research Council. The labeling may also 
include information concerning chemical/molecular composition, nucleic 
acid sequence, binding affinity, cross-reactivities, and interaction 
with substances of known clinical significance;
    (v) A statement of warnings or precautions for users as established 
in the regulations contained in 16 CFR part 1500 and any other warnings 
appropriate to the hazard presented by the product;
    (vi) The date of manufacture and appropriate storage instructions 
adequate to protect the stability of the product. When applicable, these 
instructions shall include such information as conditions of 
temperature, light, humidity, date of expiration, and other pertinent 
factors. The basis for such instructions shall be determined by 
reliable, meaningful, and specific test methods, such as those described 
in Sec. 211.166 of this chapter;
    (vii) A declaration of the net quantity of contents, expressed in 
terms of weight or volume, numerical count, or any combination of these 
or other terms that accurately reflect the contents of the package. The 
use of metric designations is encouraged, wherever appropriate;
    (viii) The name and place of business of manufacturer, packer, or 
distributor;
    (ix) A lot or control number, identified as such, from which it is 
possible to determine the complete manufacturing history of the product;
    (x) For class I exempt ASR's, the statement: ``Analyte Specific 
Reagent. Analytical and performance characteristics are not 
established''; and
    (xi) For class II and III ASR's, the statement: ``Analyte Specific 
Reagent. Except as a component of the approved/cleared test (Name of 
approved/cleared test), analytical and performance characteristics of 
this ASR are not established.''
    (2) In the case of immediate containers too small or otherwise 
unable to accommodate a label with sufficient space to bear all such 
information, and which are packaged within an outer container from which 
they are removed for use, the information required by paragraphs (e)(1) 
through (e)(6) of this section may appear in the outer container 
labeling only.
    (f) The labeling for over-the-counter (OTC) test sample collection 
systems for drugs of abuse testing shall bear

[[Page 115]]

the following information in language appropriate for the intended 
users:
    (1) Adequate instructions for specimen collection and handling, and 
for preparation and mailing of the specimen to the laboratory for 
testing.
    (2) An identification system to ensure that specimens are not mixed 
up or otherwise misidentified at the laboratory, and that user anonymity 
is maintained.
    (3) The intended use or uses of the product, including what drugs 
are to be identified in the specimen, a quantitative description of the 
performance characteristics for those drugs (e.g., sensitivity and 
specificity) in terms understandable to lay users, and the detection 
period.
    (4) A statement that confirmatory testing will be conducted on all 
samples that initially test positive.
    (5) A statement of warnings or precautions for users as established 
in the regulations contained in 16 CFR part 1500 and any other warnings 
appropriate to the hazard presented by the product.
    (6) Adequate instructions on how to obtain test results from a 
person who can explain their meaning, including the probability of false 
positive and false negative results, as well as how to contact a trained 
health professional if additional information on interpretation of test 
results from the laboratory or followup counseling is desired.
    (7) Name and place of business of the manufacturer, packer, or 
distributor.
    (g)(1) The applicant may provide the labeling information referenced 
in this section in the form of:
    (i) A symbol accompanied by explanatory text adjacent to the symbol;
    (ii) A symbol not accompanied by adjacent explanatory text that:
    (A) Is contained in a standard that FDA recognizes under its 
authority in section 514(c) of the act;
    (B) Is used according to the specifications for use of the symbol 
set forth in FDA's section 514(c) recognition; and
    (C) Is explained in a paper or electronic symbols glossary that is 
included in the labeling for the device and the labeling on or within 
the package containing the device bears a prominent and conspicuous 
statement identifying the location of the symbols glossary that is 
written in English or, in the case of articles distributed solely in 
Puerto Rico or in a Territory where the predominant language is one 
other than English, the predominant language may be used;
    (iii) A symbol not accompanied by adjacent explanatory text that:
    (A) Is established in a standard developed by a standards 
development organization (SDO);
    (B) Is not contained in a standard that is recognized by FDA under 
its authority in section 514(c) of the act or is contained in a standard 
that is recognized by FDA but is not used according to the 
specifications for use of the symbol set forth in FDA's section 514(c) 
recognition;
    (C) Is determined by the manufacturer to be likely to be read and 
understood by the ordinary individual under customary conditions of 
purchase and use in compliance with section 502(c) of the act;
    (D) Is used according to the specifications for use of the symbol 
set forth in the SDO-developed standard; and
    (E) Is explained in a paper or electronic symbols glossary that is 
included in the labeling for the device and the labeling on or within 
the package containing the device bears a prominent and conspicuous 
statement identifying the location of the symbols glossary that is 
written in English or, in the case of articles distributed solely in 
Puerto Rico or in a Territory where the predominant language is one 
other than English, the predominant language may be used; or
    (iv) The symbol statement ``Rx only'' or ``[rx] only'' used as 
provided under paragraphs (a)(4) and (b)(5)(ii) of this section.
    (2) The use of symbols in device labeling which do not meet the 
requirements of paragraph (g)(1) of this section renders a device 
misbranded under section 502(c) of the act.
    (3) For purposes of paragraph (g)(1) of this section:
    (i) An SDO is an organization that is nationally or internationally 
recognized and that follows a process for standard development that is 
transparent, (i.e., open to public scrutiny), where the participation is 
balanced, where an appeals process is included,

[[Page 116]]

where the standard is not in conflict with any statute, regulation, or 
policy under which FDA operates, and where the standard is national or 
international in scope.
    (ii) The term ``symbols glossary'' means a compiled listing of:
    (A) Each SDO-established symbol used in the labeling for the device;
    (B) The title and designation number of the SDO-developed standard 
containing the symbol;
    (C) The title of the symbol and its reference number, if any, in the 
standard; and
    (D) The meaning or explanatory text for the symbol as provided in 
the FDA recognition or, if FDA has not recognized the standard or 
portion of the standard in which the symbol is located or the symbol is 
not used according to the specifications for use of the symbol set forth 
in FDA's section 514(c) recognition, the explanatory text as provided in 
the standard.

[41 FR 6903, Feb. 13, 1976, as amended at 45 FR 3750, Jan. 18, 1980; 45 
FR 7484, Feb. 1, 1980; 47 FR 41107, Sept. 17, 1982; 47 FR 51109, Nov. 
12, 1982; 48 FR 34470, July 29, 1983; 62 FR 62259, Nov. 21, 1997; 65 FR 
18234, Apr. 7, 2000; 81 FR 38391, June 15, 2016]



Sec. 809.11  Exceptions or alternatives to labeling requirements for
in vitro diagnostic products for human use held by the Strategic
National Stockpile.

    (a) The appropriate FDA Center Director may grant an exception or 
alternative to any provision listed in paragraph (f) of this section and 
not explicitly required by statute, for specified lots, batches, or 
other units of an in vitro diagnostic product for human use, if the 
Center Director determines that compliance with such labeling 
requirement could adversely affect the safety, effectiveness, or 
availability of such products that are or will be included in the 
Strategic National Stockpile.
    (b)(1)(i) A Strategic National Stockpile official or any entity that 
manufactures (including labeling, packing, relabeling, or repackaging), 
distributes, or stores an in vitro diagnostic product for human use that 
is or will be included in the Strategic National Stockpile may submit, 
with written concurrence from a Strategic National Stockpile official, a 
written request for an exception or alternative described in paragraph 
(a) of this section to the Center Director.
    (ii) The Center Director may grant an exception or alternative 
described in paragraph (a) of this section on his or her own initiative.
    (2) A written request for an exception or alternative described in 
paragraph (a) of this section must:
    (i) Identify the specified lots, batches, or other units of an in 
vitro diagnostic product for human use that would be subject to the 
exception or alternative;
    (ii) Identify the labeling provision(s) listed in paragraph (f) of 
this section that are the subject of the exception or alternative 
request;
    (iii) Explain why compliance with such labeling provision(s) could 
adversely affect the safety, effectiveness, or availability of the 
specified lots, batches, or other units of the in vitro diagnostic 
product for human use that are or will be held in the Strategic National 
Stockpile;
    (iv) Describe any proposed safeguards or conditions that will be 
implemented so that the labeling of the product includes appropriate 
information necessary for the safe and effective use of the product, 
given the anticipated circumstances of use of the product;
    (v) Provide a draft of the proposed labeling of the specified lots, 
batches, or other units of the in vitro diagnostic products for human 
use subject to the exception or alternative; and
    (vi) Provide any other information requested by the Center Director 
in support of the request.
    (c) The Center Director must respond in writing to all requests 
under this section. The Center Director may impose appropriate 
conditions or safeguards when granting such an exception or alternative 
under this section.
    (d) A grant of an exception or alternative under this section will 
include any safeguards or conditions deemed appropriate by the Center 
Director to ensure that the labeling of the product subject to the 
exception or alternative includes the information necessary for the safe 
and effective use of the product, given the anticipated circumstances of 
use.

[[Page 117]]

    (e) If the Center Director grants a request for an exception or 
alternative to the labeling requirements under this section:
    (1) The Center Director may determine that the submission and grant 
of a written request under this section satisfies the provisions 
relating to premarket notification submissions under Sec. 807.81(a)(3) 
of this chapter.
    (2)(i) For a Premarket Approval Application (PMA)-approved in vitro 
diagnostic product for human use, the submission and grant of a written 
request under this section satisfies the provisions relating to 
submission of PMA supplements under Sec. 814.39 of this chapter; 
however,
    (ii) The grant of the request must be identified in a periodic 
report under Sec. 814.84 of this chapter.
    (f) The Center Director may grant an exception or alternative under 
this section to the following provisions of this part, to the extent 
that the requirements in these provisions are not explicitly required by 
statute:
    (1) Sec. 809.10(a)(1) through (a)(6) and (a)(9);
    (2) Sec. 809.10(b);
    (3) Sec. 809.10(c)(2);
    (4) Sec. 809.10(d)(1)(i) through (d)(1)(v), (d)(1)(viii), and 
(d)(2); and
    (5) Sec. 809.10(e)(1)(i) through (e)(1)(vi) and (e)(1)(ix) through 
(e)(1)(xi).

[72 FR 73601, Dec. 28, 2007]



         Subpart C_Requirements for Manufacturers and Producers



Sec. 809.20  General requirements for manufacturers and producers
of in vitro diagnostic products.

    (a) [Reserved]
    (b) Compliance with good manufacturing practices. In vitro 
diagnostic products shall be manufactured in accordance with the good 
manufacturing practices requirements found in part 820 of this chapter 
and, if applicable, with Sec. 610.44 of this chapter.

[41 FR 6903, Feb. 13, 1976, as amended at 42 FR 42530, Aug. 23, 1977; 43 
FR 31527, July 21, 1978; 66 FR 31165, June 11, 2001]



Sec. 809.30  Restrictions on the sale, distribution and use 
of analyte specific reagents.

    (a) Analyte specific reagents (ASR's) (Sec. 864.4020 of this 
chapter) are restricted devices under section 520(e) of the Federal 
Food, Drugs, and Cosmetic Act (the act) subject to the restrictions set 
forth in this section.
    (b) ASR's may only be sold to:
    (1) In vitro diagnostic manufacturers;
    (2) Clinical laboratories regulated under the Clinical Laboratory 
Improvement Amendments of 1988 (CLIA), as qualified to perform high 
complexity testing under 42 CFR part 493 or clinical laboratories 
regulated under VHA Directive 1106 (available from Department of 
Veterans Affairs, Veterans Health Administration, Washington, DC 20420); 
and
    (3) Organizations that use the reagents to make tests for purposes 
other than providing diagnostic information to patients and 
practitioners, e.g., forensic, academic, research, and other nonclinical 
laboratories.
    (c) ASR's must be labeled in accordance with Sec. 809.10(e).
    (d) Advertising and promotional materials for ASR's:
    (1) Shall include the identity and purity (including source and 
method of acquisition) of the analyte specific reagent and the identity 
of the analyte;
    (2) Shall include the statement for class I exempt ASR's: ``Analyte 
Specific Reagent. Analytical and performance characteristics are not 
established'';
    (3) Shall include the statement for class II or III ASR's: ``Analyte 
Specific Reagent. Except as a component of the approved/cleared test 
(name of approved/cleared test), analytical and performance 
characteristics are not established''; and
    (4) Shall not make any statement regarding analytical or clinical 
performance.
    (e) The laboratory that develops an in-house test using the ASR 
shall inform the ordering person of the test result by appending to the 
test report the statement: ``This test was developed and its performance 
characteristics determined by (Laboratory Name). It has not been cleared 
or approved by the U.S. Food and Drug Administration.''

[[Page 118]]

This statement would not be applicable or required when test results are 
generated using the test that was cleared or approved in conjunction 
with review of the class II or III ASR.
    (f) Ordering in-house tests that are developed using analyte 
specific reagents is limited under section 520(e) of the act to 
physicians and other persons authorized by applicable State law to order 
such tests.
    (g) The restrictions in paragraphs (c) through (f) of this section 
do not apply when reagents that otherwise meet the analyte specific 
reagent definition are sold to:
    (1) In vitro diagnostic manufacturers; or
    (2) Organizations that use the reagents to make tests for purposes 
other than providing diagnostic information to patients and 
practitioners, e.g., forensic, academic, research, and other nonclinical 
laboratories.

[62 FR 62259, Nov. 21, 1997]



Sec. 809.40  Restrictions on the sale, distribution, and use of OTC
test sample collection systems for drugs of abuse testing.

    (a) Over-the-counter (OTC) test sample collection systems for drugs 
of abuse testing (Sec. 864.3260 of this chapter) are restricted devices 
under section 520(e) of the Act subject to the restrictions set forth in 
this section.
    (b) Sample testing shall be performed in a laboratory using 
screening tests that have been approved, cleared, or otherwise 
recognized by the Food and Drug Administration as accurate and reliable 
for the testing of such specimens for identifying drugs of abuse or 
their metabolites.
    (c) The laboratory performing the test(s) shall have, and shall be 
recognized as having, adequate capability to reliably perform the 
necessary screening and confirmatory tests, including adequate 
capability to perform integrity checks of the biological specimens for 
possible adulteration.
    (d) All OTC test sample collection systems for drugs of abuse 
testing shall be labeled in accordance with Sec. 809.10(f) and shall 
provide an adequate system to communicate the proper interpretation of 
test results from the laboratory to the lay purchaser.

[65 FR 18234, Apr. 7, 2000]



PART 810_MEDICAL DEVICE RECALL AUTHORITY--Table of Contents



                      Subpart A_General Provisions

Sec.
810.1 Scope.
810.2 Definitions.
810.3 Computation of time.
810.4 Service of orders.

          Subpart B_Mandatory Medical Device Recall Procedures

810.10 Cease distribution and notification order.
810.11 Regulatory hearing.
810.12 Written request for review of cease distribution and notification 
          order.
810.13 Mandatory recall order.
810.14 Cease distribution and notification or mandatory recall strategy.
810.15 Communications concerning a cease distribution and notification 
          or mandatory recall order.
810.16 Cease distribution and notification or mandatory recall order 
          status reports.
810.17 Termination of a cease distribution and notification or mandatory 
          recall order.
810.18 Public notice.

    Authority: 21 U.S.C. 321, 331, 332, 333, 334, 351, 352, 355, 360h, 
360i, 371, 374, 375.

    Source: 61 FR 59018, Nov. 20, 1996, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 810.1  Scope.

    Part 810 describes the procedures that the Food and Drug 
Administration will follow in exercising its medical device recall 
authority under section 518(e) of the Federal Food, Drug, and Cosmetic 
Act.



Sec. 810.2  Definitions.

    As used in this part:
    (a) Act means the Federal Food, Drug, and Cosmetic Act.
    (b) Agency or FDA means the Food and Drug Administration.
    (c) Cease distribution and notification strategy or mandatory recall 
strategy means a planned, specific course of action to be taken by the 
person named in a cease distribution and notification

[[Page 119]]

order or in a mandatory recall order, which addresses the extent of the 
notification or recall, the need for public warnings, and the extent of 
effectiveness checks to be conducted.
    (d) Consignee means any person or firm that has received, purchased, 
or used a device that is subject to a cease distribution and 
notification order or a mandatory recall order. Consignee does not mean 
lay individuals or patients, i.e., nonhealth professionals.
    (e) Correction means repair, modification, adjustment, relabeling, 
destruction, or inspection (including patient monitoring) of a device, 
without its physical removal from its point of use to some other 
location.
    (f) Device user facility means a hospital, ambulatory surgical 
facility, nursing home, or outpatient treatment or diagnostic facility 
that is not a physician's office.
    (g) Health professionals means practitioners, including physicians, 
nurses, pharmacists, dentists, respiratory therapists, physical 
therapists, technologists, or any other practitioners or allied health 
professionals that have a role in using a device for human use.
    (h) Human cell, tissue, or cellular or tissue-based product (HCT/P) 
regulated as a device means an HCT/P as defined in Sec. 1271.3(d) of 
this chapter that does not meet the criteria in Sec. 1271.10(a) and 
that is also regulated as a device.
    (i) Reasonable probability means that it is more likely than not 
that an event will occur.
    (j) Serious, adverse health consequence means any significant 
adverse experience, including those that may be either life-threatening 
or involve permanent or long-term injuries, but excluding injuries that 
are nonlife-threatening and that are temporary and reasonably 
reversible.
    (k) Recall means the correction or removal of a device for human use 
where FDA finds that there is a reasonable probability that the device 
would cause serious, adverse health consequences or death.
    (l) Removal means the physical removal of a device from its point of 
use to some other location for repair, modification, adjustment, 
relabeling, destruction, or inspection.
    (m) Unique device identifier (UDI) means an identifier that 
adequately identifies a device through its distribution and use by 
meeting the requirements of Sec. 830.20 of this chapter. A unique 
device identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies the specific version or model of a device and the labeler of 
that device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (v) For an HCT/P regulated as a device, the distinct identification 
code required by Sec. 1271.290(c) of this chapter.

[61 FR 59018, Nov. 20, 1996, as amended at 78 FR 58821, Sept. 24, 2013]



Sec. 810.3  Computation of time.

    In computing any period of time prescribed or allowed by this part, 
the day of the act or event from which the designated period of time 
begins to run shall not be included. The computation of time is based 
only on working days.



Sec. 810.4  Service of orders.

    Orders issued under this part will be served in person by a 
designated employee of FDA, or by certified or registered mail or 
similar mail delivery service with a return receipt record reflecting 
receipt, to the named person or designated agent at the named person's 
or designated agent's last known address in FDA's records.



          Subpart B_Mandatory Medical Device Recall Procedures



Sec. 810.10  Cease distribution and notification order.

    (a) If, after providing the appropriate person with an opportunity 
to consult with the agency, FDA finds that there is a reasonable 
probability that a device intended for human use would

[[Page 120]]

cause serious, adverse health consequences or death, the agency may 
issue a cease distribution and notification order requiring the person 
named in the order to immediately:
    (1) Cease distribution of the device;
    (2) Notify health professionals and device user facilities of the 
order; and
    (3) Instruct these professionals and device user facilities to cease 
use of the device.
    (b) FDA will include the following information in the order:
    (1) The requirements of the order relating to cessation of 
distribution and notification of health professionals and device user 
facilities;
    (2) Pertinent descriptive information to enable accurate and 
immediate identification of the device subject to the order, including, 
where known:
    (i) The brand name of the device;
    (ii) The common name, classification name, or usual name of the 
device;
    (iii) The model, catalog, or product code numbers of the device;
    (iv) The manufacturing lot numbers or serial numbers of the device 
or other identification numbers; and
    (v) The unique device identifier (UDI) that appears on the device 
label or on the device package; and
    (3) A statement of the grounds for FDA's finding that there is a 
reasonable probability that the device would cause serious, adverse 
health consequences or death.
    (c) FDA may also include in the order a model letter for notifying 
health professionals and device user facilities of the order and a 
requirement that notification of health professionals and device user 
facilities be completed within a specified timeframe. The model letter 
will include the key elements of information that the agency in its 
discretion has determined, based on the circumstances surrounding the 
issuance of each order, are necessary to inform health professionals and 
device user facilities about the order.
    (d) FDA may also require that the person named in the cease 
distribution and notification order submit any or all of the following 
information to the agency by a time specified in the order:
    (1) The total number of units of the device produced and the 
timespan of the production;
    (2) The total number of units of the device estimated to be in 
distribution channels;
    (3) The total number of units of the device estimated to be 
distributed to health professionals and device user facilities;
    (4) The total number of units of the device estimated to be in the 
hands of home users;
    (5) Distribution information, including the names and addresses of 
all consignees;
    (6) A copy of any written communication used by the person named in 
the order to notify health professionals and device user facilities;
    (7) A proposed strategy for complying with the cease distribution 
and notification order;
    (8) Progress reports to be made at specified intervals, showing the 
names and addresses of health professionals and device user facilities 
that have been notified, names of specific individuals contacted within 
device user facilities, and the dates of such contacts; and
    (9) The name, address, and telephone number of the person who should 
be contacted concerning implementation of the order.
    (e) FDA will provide the person named in a cease distribution and 
notification order with an opportunity for a regulatory hearing on the 
actions required by the cease distribution and notification order and on 
whether the order should be modified, or vacated, or amended to require 
a mandatory recall of the device.
    (f) FDA will also provide the person named in the cease distribution 
and notification order with an opportunity, in lieu of a regulatory 
hearing, to submit a written request to FDA asking that the order be 
modified, or vacated, or amended.
    (g) FDA will include in the cease distribution and notification 
order the name, address, and telephone number of an agency employee to 
whom any request for a regulatory hearing or agency review is to be 
addressed.

[61 FR 59018, Nov. 20, 1996, as amended at 78 FR 58821, Sept. 24, 2013]

[[Page 121]]



Sec. 810.11  Regulatory hearing.

    (a) Any request for a regulatory hearing shall be submitted in 
writing to the agency employee identified in the order within the 
timeframe specified by FDA. Under Sec. 16.22(b) of this chapter, this 
timeframe ordinarily will not be fewer than 3 working days after receipt 
of the cease distribution and notification order. However, as provided 
in Sec. 16.60(h) of this chapter, the Commissioner of Food and Drugs or 
presiding officer may waive, suspend, or modify any provision of part 16 
under Sec. 10.19 of this chapter, including those pertaining to the 
timing of the hearing. As provided in Sec. 16.26(a), the Commissioner 
or presiding officer may deny a request for a hearing, in whole or in 
part, if he or she determines that no genuine and substantial issue of 
fact is raised by the material submitted in the request.
    (b) If a request for a regulatory hearing is granted, the regulatory 
hearing shall be limited to:
    (1) Reviewing the actions required by the cease distribution and 
notification order, determining if FDA should affirm, modify, or vacate 
the order, and addressing an appropriate cease distribution and 
notification strategy; and
    (2) Determining whether FDA should amend the cease distribution and 
notification order to require a recall of the device that was the 
subject of the order. The hearing may also address the actions that 
might be required by a recall order, including an appropriate recall 
strategy, if FDA later orders a recall.
    (c) If a request by the person named in a cease distribution and 
notification order for a regulatory hearing is granted, the regulatory 
hearing will be conducted in accordance with the procedures set out in 
section 201(x) of the act (21 U.S.C. 321(x)) and part 16 of this 
chapter, except that the order issued under Sec. 810.10, rather than a 
notice under Sec. 16.22(a) of this chapter, provides the notice of 
opportunity for a hearing and is part of the administrative record of 
the regulatory hearing under Sec. 16.80(a) of this chapter. As provided 
in Sec. 16.60(h) of this chapter, the Commissioner of Food and Drugs or 
presiding officer may waive, suspend, or modify any provision of part 16 
under Sec. 10.19 of this chapter. As provided in Sec. 16.26(b), after 
the hearing commences, the presiding officer may issue a summary 
decision on any issue if the presiding officer determines that there is 
no genuine and substantial issue of fact respecting that issue.
    (d) If the person named in the cease distribution and notification 
order does not request a regulatory hearing within the timeframe 
specified by FDA in the cease distribution and notification order, that 
person will be deemed to have waived his or her right to request a 
hearing.
    (e) The presiding officer will ordinarily hold any regulatory 
hearing requested under paragraph (a) of this section no fewer than 2 
working days after receipt of the request for a hearing, under Sec. 
16.24(e) of this chapter, and no later than 10 working days after the 
date of issuance of the cease distribution and notification order. 
However, FDA and the person named in the order may agree to a later date 
or the presiding officer may determine that the hearing should be held 
in fewer than 2 days. Moreover, as provided for in Sec. 16.60(h) of 
this chapter, the Commissioner of Food and Drugs or presiding officer 
may waive, suspend, or modify any provision of part 16 under Sec. 10.19 
of this chapter, including those pertaining to the timing of the 
hearing. After the presiding officer prepares a written report of the 
hearing and the agency issues a final decision based on the report, the 
presiding officer shall provide the requestor written notification of 
the final decision to affirm, modify, or vacate the order or to amend 
the order to require a recall of the device within 15 working days of 
conducting a regulatory hearing.



Sec. 810.12  Written request for review of cease distribution and notification order.

    (a) In lieu of requesting a regulatory hearing under Sec. 810.11, 
the person named in a cease distribution and notification order may 
submit a written request to FDA asking that the order be modified or 
vacated. Such person shall address the written request to the agency 
employee identified in the order and shall submit the request

[[Page 122]]

within the timeframe specified in the order, unless FDA and the person 
named in the order agree to a later date.
    (b) A written request for review of a cease distribution and 
notification order shall identify each ground upon which the requestor 
relies in asking that the order be modified or vacated, as well as 
addressing an appropriate cease distribution and notification strategy, 
and shall address whether the order should be amended to require a 
recall of the device that was the subject of the order and the actions 
required by such a recall order, including an appropriate recall 
strategy.
    (c) The agency official who issued the cease distribution and 
notification order shall provide the requestor written notification of 
the agency's decision to affirm, modify, or vacate the order or amend 
the order to require a recall of the device within 15 working days of 
receipt of the written request. The agency official shall include in 
this written notification:
    (1) A statement of the grounds for the decision to affirm, modify, 
vacate, or amend the order; and
    (2) The requirements of any modified or amended order.



Sec. 810.13  Mandatory recall order.

    (a) If the person named in a cease distribution and notification 
order does not request a regulatory hearing or submit a request for 
agency review of the order, or, if the Commissioner of Food and Drugs or 
the presiding officer denies a request for a hearing, or, if after 
conducting a regulatory hearing under Sec. 810.11 or completing agency 
review of a cease distribution and notification order under Sec. 
810.12, FDA determines that the order should be amended to require a 
recall of the device with respect to which the order was issued, FDA 
shall amend the order to require such a recall. FDA shall amend the 
order to require such a recall within 15 working days of issuance of a 
cease distribution and notification order if a regulatory hearing or 
agency review of the order is not requested, or within 15 working days 
of denying a request for a hearing, or within 15 working days of 
completing a regulatory hearing under Sec. 810.11, or within 15 working 
days of receipt of a written request for review of a cease distribution 
and notification order under Sec. 810.12.
    (b) In a mandatory recall order, FDA may:
    (1) Specify that the recall is to extend to the wholesale, retail, 
or user level;
    (2) Specify a timetable in accordance with which the recall is to 
begin and be completed;
    (3) Require the person named in the order to submit to the agency a 
proposed recall strategy, as described in Sec. 810.14, and periodic 
reports describing the progress of the mandatory recall, as described in 
Sec. 810.16; and
    (4) Provide the person named in the order with a model recall 
notification letter that includes the key elements of information that 
FDA has determined are necessary to inform health professionals and 
device user facilities.
    (c) FDA will not include in a mandatory recall order a requirement 
for:
    (1) Recall of a device from individuals; or
    (2) Recall of a device from device user facilities, if FDA 
determines that the risk of recalling the device from the facilities 
presents a greater health risk than the health risk of not recalling the 
device from use, unless the device can be replaced immediately with an 
equivalent device.
    (d) FDA will include in a mandatory recall order provisions for 
notification to individuals subject to the risks associated with use of 
the device. If a significant number of such individuals cannot be 
identified, FDA may notify such individuals under section 705(b) of the 
act.



Sec. 810.14  Cease distribution and notification or mandatory recall strategy.

    (a) General. The person named in a cease distribution and 
notification order issued under Sec. 810.10 shall comply with the 
order, which FDA will fashion as appropriate for the individual 
circumstances of the case. The person named in a cease distribution and 
notification order modified under Sec. 810.11(e) or Sec. 810.12(c) or 
a mandatory recall order issued under Sec. 810.13 shall develop a 
strategy for complying with the

[[Page 123]]

order that is appropriate for the individual circumstances and that 
takes into account the following factors:
    (1) The nature of the serious, adverse health consequences related 
to the device;
    (2) The ease of identifying the device;
    (3) The extent to which the risk presented by the device is obvious 
to a health professional or device user facility; and
    (4) The extent to which the device is used by health professionals 
and device user facilities.
    (b) Submission and review. (1) The person named in the cease 
distribution and notification order modified under Sec. 810.11(e) or 
Sec. 810.12(c) or mandatory recall order shall submit a copy of the 
proposed strategy to the agency within the timeframe specified in the 
order.
    (2) The agency will review the proposed strategy and make any 
changes to the strategy that it deems necessary within 7 working days of 
receipt of the proposed strategy. The person named in the order shall 
act in accordance with a strategy determined by FDA to be appropriate.
    (c) Elements of the strategy. A proposed strategy shall meet all of 
the following requirements:
    (1)(i) The person named in the order shall specify the level in the 
chain of distribution to which the cease distribution and notification 
order or mandatory recall order is to extend as follows:
    (A) Consumer or user level, e.g., health professionals, consignee, 
or device user facility level, including any intermediate wholesale or 
retail level; or
    (B) Retail level, to the level immediately preceding the consumer or 
user level, and including any intermediate level; or
    (C) Wholesale level.
    (ii) The person named in the order shall not recall a device from 
individuals; and
    (iii) The person named in the order shall not recall a device from 
device user facilities if FDA notifies the person not to do so because 
of a risk determination under Sec. 810.13(c)(2).
    (2) The person named in a recall order shall ensure that the 
strategy provides for notice to individuals subject to the risks 
associated with use of the recalled device. The notice may be provided 
through the individuals' health professionals if FDA determines that 
such consultation is appropriate and would be the most effective method 
of notifying patients.
    (3) Effectiveness checks by the person named in the order are 
required to verify that all health professionals, device user 
facilities, consignees, and individuals, as appropriate, have been 
notified of the cease distribution and notification order or mandatory 
recall order and of the need to take appropriate action. The person 
named in the cease distribution and notification order or the mandatory 
recall order shall specify in the strategy the method(s) to be used in 
addition to written communications as required by Sec. 810.15, i.e., 
personal visits, telephone calls, or a combination thereof to contact 
all health professionals, device user facilities, consignees, and 
individuals, as appropriate. The agency may conduct additional audit 
checks where appropriate.



Sec. 810.15  Communications concerning a cease distribution and 
notification or mandatory recall order.

    (a) General. The person named in a cease distribution and 
notification order issued under Sec. 810.10 or a mandatory recall order 
issued under Sec. 810.13 is responsible for promptly notifying each 
health professional, device user facility, consignee, or individual, as 
appropriate, of the order. In accordance with Sec. 810.10(c) or Sec. 
810.13(b)(4), FDA may provide the person named in the cease distribution 
and notification or mandatory recall order with a model letter for 
notifying each health professional, device user facility, consignee, or 
individual, as appropriate, of the order. However, if FDA does not 
provide the person named in the cease distribution and notification or 
mandatory recall order with a model letter, the person named in a cease 
distribution and notification order issued under Sec. 810.10, or a 
mandatory recall order issued under Sec. 810.13, is responsible for 
providing such notification. The purpose of the communication is to 
convey:

[[Page 124]]

    (1) That FDA has found that there is a reasonable probability that 
use of the device would cause a serious, adverse health consequence or 
death;
    (2) That the person named in the order has ceased distribution of 
the device;
    (3) That health professionals and device user facilities should 
cease use of the device immediately;
    (4) Where appropriate, that the device is subject to a mandatory 
recall order; and
    (5) Specific instructions on what should be done with the device.
    (b) Implementation. The person named in a cease distribution and 
notification order, or a mandatory recall order, shall notify the 
appropriate person(s) of the order by verified written communication, 
e.g., telegram, mailgram, or fax. The written communication and any 
envelope in which it is sent or enclosed shall be conspicuously marked, 
preferably in bold red ink: ``URGENT--[DEVICE CEASE DISTRIBUTION AND 
NOTIFICATION ORDER] or [MANDATORY DEVICE RECALL ORDER].'' Telephone 
calls or other personal contacts may be made in addition to, but not as 
a substitute for, the verified written communication, and shall be 
documented in an appropriate manner.
    (c) Contents. The person named in the order shall ensure that the 
notice of a cease distribution and notification order or mandatory 
recall order:
    (1) Is brief and to the point;
    (2) Identifies clearly the device, size, lot number(s), code(s), or 
serial number(s), and any other pertinent descriptive information to 
facilitate accurate and immediate identification of the device;
    (3) Explains concisely the serious, adverse health consequences that 
may occur if use of the device were continued;
    (4) Provides specific instructions on what should be done with the 
device;
    (5) Provides a ready means for the recipient of the communication to 
confirm receipt of the communication and to notify the person named in 
the order of the actions taken in response to the communication. Such 
means may include, but are not limited to, the return of a postage-paid, 
self-addressed post card or a toll-free call to the person named in the 
order; and
    (6) Does not contain irrelevant qualifications, promotional 
materials, or any other statement that may detract from the message.
    (d) Followup communications. The person named in the cease 
distribution and notification order or mandatory recall order shall 
ensure that followup communications are sent to all who fail to respond 
to the initial communication.
    (e) Responsibility of the recipient. Health professionals, device 
user facilities, and consignees who receive a communication concerning a 
cease distribution and notification order or a mandatory recall order 
should immediately follow the instructions set forth in the 
communication. Where appropriate, these recipients should immediately 
notify their consignees of the order in accordance with paragraphs (b) 
and (c) of this section.



Sec. 810.16  Cease distribution and notification or mandatory 
recall order status reports.

    (a) The person named in a cease distribution and notification order 
issued under Sec. 810.10 or a mandatory recall order issued under Sec. 
810.13 shall submit periodic status reports to FDA to enable the agency 
to assess the person's progress in complying with the order. The 
frequency of such reports and the agency official to whom such reports 
shall be submitted will be specified in the order.
    (b) Unless otherwise specified in the order, each status report 
shall contain the following information:
    (1) The number and type of health professionals, device user 
facilities, consignees, or individuals notified about the order and the 
date and method of notification;
    (2) The number and type of health professionals, device user 
facilities, consignees, or individuals who have responded to the 
communication and the quantity of the device on hand at these locations 
at the time they received the communication;
    (3) The number and type of health professionals, device user 
facilities, consignees, or individuals who have not responded to the 
communication;

[[Page 125]]

    (4) The number of devices returned or corrected by each health 
professional, device user facility, consignee, or individual contacted, 
and the quantity of products accounted for;
    (5) The number and results of effectiveness checks that have been 
made; and
    (6) Estimated timeframes for completion of the requirements of the 
cease distribution and notification order or mandatory recall order.
    (c) The person named in the cease distribution and notification 
order or recall order may discontinue the submission of status reports 
when the agency terminates the order in accordance with Sec. 810.17.



Sec. 810.17  Termination of a cease distribution and notification
or mandatory recall order.

    (a) The person named in a cease distribution and notification order 
issued under Sec. 810.10 or a mandatory recall order issued under Sec. 
810.13 may request termination of the order by submitting a written 
request to FDA. The person submitting a request shall certify that he or 
she has complied in full with all of the requirements of the order and 
shall include a copy of the most current status report submitted to the 
agency under Sec. 810.16. A request for termination of a recall order 
shall include a description of the disposition of the recalled device.
    (b) FDA may terminate a cease distribution and notification order 
issued under Sec. 810.10 or a mandatory recall order issued under Sec. 
810.13 when the agency determines that the person named in the order:
    (1) Has taken all reasonable efforts to ensure and to verify that 
all health professionals, device user facilities, consignees, and, where 
appropriate, individuals have been notified of the cease distribution 
and notification order, and to verify that they have been instructed to 
cease use of the device and to take other appropriate action; or
    (2) Has removed the device from the market or has corrected the 
device so that use of the device would not cause serious, adverse health 
consequences or death.
    (c) FDA will provide written notification to the person named in the 
order when a request for termination of a cease distribution and 
notification order or a mandatory recall order has been granted or 
denied. FDA will respond to a written request for termination of a cease 
distribution and notification or recall order within 30 working days of 
its receipt.



Sec. 810.18  Public notice.

    The agency will make available to the public in the weekly FDA 
Enforcement Report a descriptive listing of each new mandatory recall 
issued under Sec. 810.13. The agency will delay public notification of 
orders when the agency determines that such notification may cause 
unnecessary and harmful anxiety in individuals and that initial 
consultation between individuals and their health professionals is 
essential.



PART 812_INVESTIGATIONAL DEVICE EXEMPTIONS--Table of Contents



                      Subpart A_General Provisions

Sec.
812.1 Scope.
812.2 Applicability.
812.3 Definitions.
812.5 Labeling of investigational devices.
812.7 Prohibition of promotion and other practices.
812.10 Waivers.
812.18 Import and export requirements.
812.19 Address for IDE correspondence.

             Subpart B_Application and Administrative Action

812.20 Application.
812.25 Investigational plan.
812.27 Report of prior investigations.
812.28 xxx
812.30 FDA action on applications.
812.35 Supplemental applications.
812.36 Treatment use of an investigational device.
812.38 Confidentiality of data and information.

                 Subpart C_Responsibilities of Sponsors

812.40 General responsibilities of sponsors.
812.42 FDA and IRB approval.
812.43 Selecting investigators and monitors.
812.45 Informing investigators.
812.46 Monitoring investigations.

[[Page 126]]

812.47 Emergency research under Sec. 50.24 of this chapter.

                    Subpart D_IRB Review and Approval

812.60 IRB composition, duties, and functions.
812.62 IRB approval.
812.64 IRB's continuing review.
812.65 [Reserved]
812.66 Significant risk device determinations.

               Subpart E_Responsibilities of Investigators

812.100 General responsibilities of investigators.
812.110 Specific responsibilities of investigators.
812.119 Disqualification of a clinical investigator.

Subpart F [Reserved]

                      Subpart G_Records and Reports

812.140 Records.
812.145 Inspections.
812.150 Reports.

    Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-
360j, 360bbb-8b, 371, 372, 374, 379e, 379k-1, 381, 382, 383; 42 U.S.C. 
216, 241, 262, 263b-263n.

    Source: 45 FR 3751, Jan. 18, 1980, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 812.1  Scope.

    (a) The purpose of this part is to encourage, to the extent 
consistent with the protection of public health and safety and with 
ethical standards, the discovery and development of useful devices 
intended for human use, and to that end to maintain optimum freedom for 
scientific investigators in their pursuit of this purpose. This part 
provides procedures for the conduct of clinical investigations of 
devices. An approved investigational device exemption (IDE) permits a 
device that otherwise would be required to comply with a performance 
standard or to have premarket approval to be shipped lawfully for the 
purpose of conducting investigations of that device. An IDE approved 
under Sec. 812.30 or considered approved under Sec. 812.2(b) exempts a 
device from the requirements of the following sections of the Federal 
Food, Drug, and Cosmetic Act (the act) and regulations issued 
thereunder: Misbranding under section 502 of the act, registration, 
listing, and premarket notification under section 510, performance 
standards under section 514, premarket approval under section 515, a 
banned device regulation under section 516, records and reports under 
section 519, restricted device requirements under section 520(e), good 
manufacturing practice requirements under section 520(f) except for the 
requirements found in Sec. 820.30, if applicable (unless the sponsor 
states an intention to comply with these requirements under Sec. 
812.20(b)(3) or Sec. 812.140(b)(4)(v)) and color additive requirements 
under section 721.
    (b) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.

[45 FR 3751, Jan. 18, 1980, as amended at 59 FR 14366, Mar. 28, 1994; 61 
FR 52654, Oct. 7, 1996]



Sec. 812.2  Applicability.

    (a) General. This part applies to all clinical investigations of 
devices to determine safety and effectiveness, except as provided in 
paragraph (c) of this section.
    (b) Abbreviated requirements. The following categories of 
investigations are considered to have approved applications for IDE's, 
unless FDA has notified a sponsor under Sec. 812.20(a) that approval of 
an application is required:
    (1) An investigation of a device other than a significant risk 
device, if the device is not a banned device and the sponsor:
    (i) Labels the device in accordance with Sec. 812.5;
    (ii) Obtains IRB approval of the investigation after presenting the 
reviewing IRB with a brief explanation of why the device is not a 
significant risk device, and maintains such approval;
    (iii) Ensures that each investigator participating in an 
investigation of the device obtains from each subject under the 
investigator's care, informed consent under part 50 and documents it, 
unless documentation is waived by an IRB under Sec. 56.109(c).
    (iv) Complies with the requirements of Sec. 812.46 with respect to 
monitoring investigations;
    (v) Maintains the records required under Sec. 812.140(b) (4) and 
(5) and makes

[[Page 127]]

the reports required under Sec. 812.150(b) (1) through (3) and (5) 
through (10);
    (vi) Ensures that participating investigators maintain the records 
required by Sec. 812.140(a)(3)(i) and make the reports required under 
Sec. 812.150(a) (1), (2), (5), and (7); and
    (vii) Complies with the prohibitions in Sec. 812.7 against 
promotion and other practices.
    (2) An investigation of a device other than one subject to paragraph 
(e) of this section, if the investigation was begun on or before July 
16, 1980, and to be completed, and is completed, on or before January 
19, 1981.
    (c) Exempted investigations. This part, with the exception of Sec. 
812.119, does not apply to investigations of the following categories of 
devices:
    (1) A device, other than a transitional device, in commercial 
distribution immediately before May 28, 1976, when used or investigated 
in accordance with the indications in labeling in effect at that time.
    (2) A device, other than a transitional device, introduced into 
commercial distribution on or after May 28, 1976, that FDA has 
determined to be substantially equivalent to a device in commercial 
distribution immediately before May 28, 1976, and that is used or 
investigated in accordance with the indications in the labeling FDA 
reviewed under subpart E of part 807 in determining substantial 
equivalence.
    (3) A diagnostic device, if the sponsor complies with applicable 
requirements in Sec. 809.10(c) and if the testing:
    (i) Is noninvasive,
    (ii) Does not require an invasive sampling procedure that presents 
significant risk,
    (iii) Does not by design or intention introduce energy into a 
subject, and
    (iv) Is not used as a diagnostic procedure without confirmation of 
the diagnosis by another, medically established diagnostic product or 
procedure.
    (4) A device undergoing consumer preference testing, testing of a 
modification, or testing of a combination of two or more devices in 
commercial distribution, if the testing is not for the purpose of 
determining safety or effectiveness and does not put subjects at risk.
    (5) A device intended solely for veterinary use.
    (6) A device shipped solely for research on or with laboratory 
animals and labeled in accordance with Sec. 812.5(c).
    (7) A custom device as defined in Sec. 812.3(b), unless the device 
is being used to determine safety or effectiveness for commercial 
distribution.
    (d) Limit on certain exemptions. In the case of class II or class 
III device described in paragraph (c)(1) or (2) of this section, this 
part applies beginning on the date stipulated in an FDA regulation or 
order that calls for the submission of premarket approval applications 
for an unapproved class III device, or establishes a performance 
standard for a class II device.
    (e) Investigations subject to IND's. A sponsor that, on July 16, 
1980, has an effective investigational new drug application (IND) for an 
investigation of a device shall continue to comply with the requirements 
of part 312 until 90 days after that date. To continue the investigation 
after that date, a sponsor shall comply with paragraph (b)(1) of this 
section, if the device is not a significant risk device, or shall have 
obtained FDA approval under Sec. 812.30 of an IDE application for the 
investigation of the device.

[45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8956, Jan. 27, 1981; 46 
FR 14340, Feb. 27, 1981; 53 FR 11252, Apr. 6, 1988; 62 FR 4165, Jan. 29, 
1997; 62 FR 12096, Mar. 14, 1997]



Sec. 812.3  Definitions.

    (a) Act means the Federal Food, Drug, and Cosmetic Act (sections 
201-901, 52 Stat. 1040 et seq., as amended (21 U.S.C. 301-392)).
    (b) A custom device means a device within the meaning of section 
520(b) of the Federal Food, Drug, and Cosmetic Act.
    (c) FDA means the Food and Drug Administration.
    (d) Implant means a device that is placed into a surgically or 
naturally formed cavity of the human body if it is intended to remain 
there for a period of 30 days or more. FDA may, in order to protect 
public health, determine that devices placed in subjects for shorter 
periods are also ``implants'' for purposes of this part.

[[Page 128]]

    (e) Institution means a person, other than an individual, who 
engages in the conduct of research on subjects or in the delivery of 
medical services to individuals as a primary activity or as an adjunct 
to providing residential or custodial care to humans. The term includes, 
for example, a hospital, retirement home, confinement facility, academic 
establishment, and device manufacturer. The term has the same meaning as 
``facility'' in section 520(g) of the act.
    (f) Institutional review board (IRB) means any board, committee, or 
other group formally designated by an institution to review biomedical 
research involving subjects and established, operated, and functioning 
in conformance with part 56. The term has the same meaning as 
``institutional review committee'' in section 520(g) of the act.
    (g) Investigational device means a device, including a transitional 
device, that is the object of an investigation.
    (h) Investigation means a clinical investigation or research 
involving one or more subjects to determine the safety or effectiveness 
of a device.
    (i) Investigator means an individual who actually conducts a 
clinical investigation, i.e., under whose immediate direction the test 
article is administered or dispensed to, or used involving, a subject, 
or, in the event of an investigation conducted by a team of individuals, 
is the responsible leader of that team.
    (j) Monitor, when used as a noun, means an individual designated by 
a sponsor or contract research organization to oversee the progress of 
an investigation. The monitor may be an employee of a sponsor or a 
consultant to the sponsor, or an employee of or consultant to a contract 
research organization. Monitor, when used as a verb, means to oversee an 
investigation.
    (k) Noninvasive, when applied to a diagnostic device or procedure, 
means one that does not by design or intention: (1) Penetrate or pierce 
the skin or mucous membranes of the body, the ocular cavity, or the 
urethra, or (2) enter the ear beyond the external auditory canal, the 
nose beyond the nares, the mouth beyond the pharynx, the anal canal 
beyond the rectum, or the vagina beyond the cervical os. For purposes of 
this part, blood sampling that involves simple venipuncture is 
considered noninvasive, and the use of surplus samples of body fluids or 
tissues that are left over from samples taken for noninvestigational 
purposes is also considered noninvasive.
    (l) Person includes any individual, partnership, corporation, 
association, scientific or academic establishment, Government agency or 
organizational unit of a Government agency, and any other legal entity.
    (m) Significant risk device means an investigational device that:
    (1) Is intended as an implant and presents a potential for serious 
risk to the health, safety, or welfare of a subject;
    (2) Is purported or represented to be for a use in supporting or 
sustaining human life and presents a potential for serious risk to the 
health, safety, or welfare of a subject;
    (3) Is for a use of substantial importance in diagnosing, curing, 
mitigating, or treating disease, or otherwise preventing impairment of 
human health and presents a potential for serious risk to the health, 
safety, or welfare of a subject; or
    (4) Otherwise presents a potential for serious risk to the health, 
safety, or welfare of a subject.
    (n) Sponsor means a person who initiates, but who does not actually 
conduct, the investigation, that is, the investigational device is 
administered, dispensed, or used under the immediate direction of 
another individual. A person other than an individual that uses one or 
more of its own employees to conduct an investigation that it has 
initiated is a sponsor, not a sponsor-investigator, and the employees 
are investigators.
    (o) Sponsor-investigator means an individual who both initiates and 
actually conducts, alone or with others, an investigation, that is, 
under whose immediate direction the investigational device is 
administered, dispensed, or used. The term does not include any person 
other than an individual. The obligations of a sponsor-investigator 
under this part include those of an investigator and those of a sponsor.
    (p) Subject means a human who participates in an investigation, 
either as an individual on whom or on whose

[[Page 129]]

specimen an investigational device is used or as a control. A subject 
may be in normal health or may have a medical condition or disease.
    (q) Termination means a discontinuance, by sponsor or by withdrawal 
of IRB or FDA approval, of an investigation before completion.
    (r) Transitional device means a device subject to section 520(l) of 
the act, that is, a device that FDA considered to be a new drug or an 
antibiotic drug before May 28, 1976.
    (s) Unanticipated adverse device effect means any serious adverse 
effect on health or safety or any life-threatening problem or death 
caused by, or associated with, a device, if that effect, problem, or 
death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious 
problem associated with a device that relates to the rights, safety, or 
welfare of subjects.
    (t) Independent ethics committee (IEC) means an independent review 
panel that is responsible for ensuring the protection of the rights, 
safety, and well-being of subjects involved in a clinical investigation 
and is adequately constituted to ensure that protection. An 
institutional review board (IRB), as defined in paragraph (f) of this 
section and subject to the requirements of part 56 of this chapter, is 
one type of IEC.

[45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8956, Jan. 27, 1981; 48 
FR 15622, Apr. 12, 1983; 81 FR 70340, Oct. 12, 2016; 83 FR 7385, Feb. 
21, 2018; 83 FR 7385, Feb. 21, 2018]



Sec. 812.5  Labeling of investigational devices.

    (a) Contents. An investigational device or its immediate package 
shall bear a label with the following information: the name and place of 
business of the manufacturer, packer, or distributor (in accordance with 
Sec. 801.1), the quantity of contents, if appropriate, and the 
following statement: ``CAUTION--Investigational device. Limited by 
Federal (or United States) law to investigational use.'' The label or 
other labeling shall describe all relevant contraindications, hazards, 
adverse effects, interfering substances or devices, warnings, and 
precautions.
    (b) Prohibitions. The labeling of an investigational device shall 
not bear any statement that is false or misleading in any particular and 
shall not represent that the device is safe or effective for the 
purposes for which it is being investigated.
    (c) Animal research. An investigational device shipped solely for 
research on or with laboratory animals shall bear on its label the 
following statement: ``CAUTION--Device for investigational use in 
laboratory animals or other tests that do not involve human subjects.''
    (d) The appropriate FDA Center Director, according to the procedures 
set forth in Sec. 801.128 or Sec. 809.11 of this chapter, may grant an 
exception or alternative to the provisions in paragraphs (a) and (c) of 
this section, to the extent that these provisions are not explicitly 
required by statute, for specified lots, batches, or other units of a 
device that are or will be included in the Strategic National Stockpile.

[45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58842, Sept. 5, 1980; 72 
FR 73602, Dec. 28, 2007]



Sec. 812.7  Prohibition of promotion and other practices.

    A sponsor, investigator, or any person acting for or on behalf of a 
sponsor or investigator shall not:
    (a) Promote or test market an investigational device, until after 
FDA has approved the device for commercial distribution.
    (b) Commercialize an investigational device by charging the subjects 
or investigators for a device a price larger than that necessary to 
recover costs of manufacture, research, development, and handling.
    (c) Unduly prolong an investigation. If data developed by the 
investigation indicate in the case of a class III device that premarket 
approval cannot be justified or in the case of a class II device that it 
will not comply with an applicable performance standard or an amendment 
to that standard, the sponsor shall promptly terminate the 
investigation.
    (d) Represent that an investigational device is safe or effective 
for the purposes for which it is being investigated.

[[Page 130]]



Sec. 812.10  Waivers.

    (a) Request. A sponsor may request FDA to waive any requirement of 
this part. A waiver request, with supporting documentation, may be 
submitted separately or as part of an application to the address in 
Sec. 812.19.
    (b) FDA action. FDA may by letter grant a waiver of any requirement 
that FDA finds is not required by the act and is unnecessary to protect 
the rights, safety, or welfare of human subjects.
    (c) Effect of request. Any requirement shall continue to apply 
unless and until FDA waives it.



Sec. 812.18  Import and export requirements.

    (a) Imports. In addition to complying with other requirements of 
this part, a person who imports or offers for importation an 
investigational device subject to this part shall be the agent of the 
foreign exporter with respect to investigations of the device and shall 
act as the sponsor of the clinical investigation, or ensure that another 
person acts as the agent of the foreign exporter and the sponsor of the 
investigation.
    (b) Exports. A person exporting an investigational device subject to 
this part shall obtain FDA's prior approval, as required by section 
801(e) of the act or comply with section 802 of the act.

[45 FR 3751, Jan. 18, 1980, as amended at 62 FR 26229, May 13, 1997]



Sec. 812.19  Address for IDE correspondence.

    (a) If you are sending an application, supplemental application, 
report, request for waiver, request for import or export approval, or 
other correspondence relating to matters covered by this part, you must 
send the submission to the appropriate address as follows:
    (1) For devices regulated by the Center for Devices and Radiological 
Health, send it to the current address displayed on the website https://
www.fda.gov/cdrhsubmissionaddress.
    (2) For devices regulated by the Center for Biologics Evaluation and 
Research, send it to the current address displayed on the website 
https://www.fda.gov/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm.
    (3) For devices regulated by the Center for Drug Evaluation and 
Research, send it to Central Document Control Room, Center for Drug 
Evaluation and Research, Food and Drug Administration, 5901-B Ammendale 
Rd., Beltsville, MD 20705-1266.
    (b) You must state on the outside wrapper of each submission what 
the submission is, for example, an ``IDE application,'' a ``supplemental 
IDE application,'' or a ``correspondence concerning an IDE (or an IDE 
application).''

[71 FR 42048, July 25, 2006, as amended at 75 FR 20915, Apr. 22, 2010; 
80 FR 18094, Apr. 3, 2015; 84 FR 68339, Dec. 16, 2019]



             Subpart B_Application and Administrative Action



Sec. 812.20  Application.

    (a) Submission. (1) A sponsor shall submit an application to FDA if 
the sponsor intends to use a significant risk device in an 
investigation, intends to conduct an investigation that involves an 
exception from informed consent under Sec. 50.24 of this chapter, or if 
FDA notifies the sponsor that an application is required for an 
investigation.
    (2) A sponsor shall not begin an investigation for which FDA's 
approval of an application is required until FDA has approved the 
application.
    (3) A sponsor shall submit a signed ``Application for an 
Investigational Device Exemption'' (IDE application), together with 
accompanying materials in electronic format, to one of the addresses in 
Sec. 812.19, and if eCopy by registered mail or by hand. Subsequent 
correspondence concerning an application or a supplemental application 
shall be submitted in electronic format and if eCopy by registered mail 
or by hand.
    (4)(i) A sponsor shall submit a separate IDE for any clinical 
investigation involving an exception from informed consent under Sec. 
50.24 of this chapter. Such a clinical investigation is not permitted to 
proceed without the prior written authorization of FDA. FDA shall 
provide a written determination

[[Page 131]]

30 days after FDA receives the IDE or earlier.
    (ii) If the investigation involves an exception from informed 
consent under Sec. 50.24 of this chapter, the sponsor shall prominently 
identify on the cover sheet that the investigation is subject to the 
requirements in Sec. 50.24 of this chapter.
    (b) Contents. An IDE application shall include, in the following 
order:
    (1) The name and address of the sponsor.
    (2) A complete report of prior investigations of the device and an 
accurate summary of those sections of the investigational plan described 
in Sec. 812.25(a) through (e) or, in lieu of the summary, the complete 
plan. The sponsor shall submit to FDA a complete investigational plan 
and a complete report of prior investigations of the device if no IRB 
has reviewed them, if FDA has found an IRB's review inadequate, or if 
FDA requests them.
    (3) A description of the methods, facilities, and controls used for 
the manufacture, processing, packing, storage, and, where appropriate, 
installation of the device, in sufficient detail so that a person 
generally familiar with good manufacturing practices can make a 
knowledgeable judgment about the quality control used in the manufacture 
of the device.
    (4) An example of the agreements to be entered into by all 
investigators to comply with investigator obligations under this part, 
and a list of the names and addresses of all investigators who have 
signed the agreement.
    (5) A certification that all investigators who will participate in 
the investigation have signed the agreement, that the list of 
investigators includes all the investigators participating in the 
investigation, and that no investigators will be added to the 
investigation until they have signed the agreement.
    (6) A list of the name, address, and chairperson of each IRB that 
has been or will be asked to review the investigation and a 
certification of the action concerning the investigation taken by each 
such IRB.
    (7) The name and address of any institution at which a part of the 
investigation may be conducted that has not been identified in 
accordance with paragraph (b)(6) of this section.
    (8) If the device is to be sold, the amount to be charged and an 
explanation of why sale does not constitute commercialization of the 
device.
    (9) A claim for categorical exclusion under Sec. 25.30 or Sec. 
25.34 or an environmental assessment under Sec. 25.40.
    (10) Copies of all labeling for the device.
    (11) Copies of all forms and informational materials to be provided 
to subjects to obtain informed consent.
    (12) Any other relevant information FDA requests for review of the 
application.
    (c) Additional information. FDA may request additional information 
concerning an investigation or revision in the investigational plan. The 
sponsor may treat such a request as a disapproval of the application for 
purposes of requesting a hearing under part 16.
    (d) Information previously submitted. Information previously 
submitted to the Center for Devices and Radiological Health, the Center 
for Biologics Evaluation and Research, or the Center for Drug Evaluation 
and Research, as applicable, in accordance with this chapter ordinarily 
need not be resubmitted, but may be incorporated by reference.

[45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8956, Jan. 27, 1981; 50 
FR 16669, Apr. 26, 1985; 53 FR 11252, Apr. 6, 1988; 61 FR 51530, Oct. 2, 
1996; 62 FR 40600, July 29, 1997; 64 FR 10942, Mar. 8, 1999; 73 FR 
49942, Aug. 25, 2008; 84 FR 68339, Dec. 16, 2019]



Sec. 812.25  Investigational plan.

    The investigational plan shall include, in the following order:
    (a) Purpose. The name and intended use of the device and the 
objectives and duration of the investigation.
    (b) Protocol. A written protocol describing the methodology to be 
used and an analysis of the protocol demonstrating that the 
investigation is scientifically sound.
    (c) Risk analysis. A description and analysis of all increased risks 
to which subjects will be exposed by the investigation; the manner in 
which these risks will be minimized; a justification for the 
investigation; and a description

[[Page 132]]

of the patient population, including the number, age, sex, and 
condition.
    (d) Description of device. A description of each important 
component, ingredient, property, and principle of operation of the 
device and of each anticipated change in the device during the course of 
the investigation.
    (e) Monitoring procedures. The sponsor's written procedures for 
monitoring the investigation and the name and address of any monitor.
    (f) Labeling. Copies of all labeling for the device.
    (g) Consent materials. Copies of all forms and informational 
materials to be provided to subjects to obtain informed consent.
    (h) IRB information. A list of the names, locations, and 
chairpersons of all IRB's that have been or will be asked to review the 
investigation, and a certification of any action taken by any of those 
IRB's with respect to the investigation.
    (i) Other institutions. The name and address of each institution at 
which a part of the investigation may be conducted that has not been 
identified in paragraph (h) of this section.
    (j) Additional records and reports. A description of records and 
reports that will be maintained on the investigation in addition to 
those prescribed in subpart G.



Sec. 812.27  Report of prior investigations.

    (a) General. The report of prior investigations shall include 
reports of all prior clinical, animal, and laboratory testing of the 
device and shall be comprehensive and adequate to justify the proposed 
investigation.
    (b) Specific contents. The report also shall include:
    (1) A bibliography of all publications, whether adverse or 
supportive, that are relevant to an evaluation of the safety or 
effectiveness of the device, copies of all published and unpublished 
adverse information, and, if requested by an IRB or FDA, copies of other 
significant publications.
    (2) A summary of all other unpublished information (whether adverse 
or supportive) in the possession of, or reasonably obtainable by, the 
sponsor that is relevant to an evaluation of the safety or effectiveness 
of the device.
    (3) If information on nonclinical laboratory studies is provided, a 
statement that all such studies have been conducted in compliance with 
applicable requirements in the good laboratory practice regulations in 
part 58, or if any such study was not conducted in compliance with such 
regulations, a brief statement of the reason for the noncompliance. 
Failure or inability to comply with this requirement does not justify 
failure to provide information on a relevant nonclinical test study.
    (4)(i) If data from clinical investigations conducted in the United 
States are provided, a statement that each investigation was conducted 
in compliance with applicable requirements in the protection of human 
subjects regulations in part 50 of this chapter, the institutional 
review boards regulations in part 56 of this chapter, or was not subject 
to the regulations under Sec. 56.104 or Sec. 56.105, and the 
investigational device exemptions regulations in this part, or if any 
such investigation was not conducted in compliance with those 
regulations, a brief statement of the reason for the noncompliance. 
Failure or inability to comply with these requirements does not justify 
failure to provide information on a relevant clinical investigation.
    (ii) If data from clinical investigations conducted outside the 
United States are provided to support the IDE, the requirements under 
Sec. 812.28 apply. If any such investigation was not conducted in 
accordance with good clinical practice (GCP) as described in Sec. 
812.28(a), the report of prior investigations shall include either a 
waiver request in accordance with Sec. 812.28(c) or a brief statement 
of the reason for not conducting the investigation in accordance with 
GCP and a description of steps taken to ensure that the data and results 
are credible and accurate and that the rights, safety, and well-being of 
subjects have been adequately protected. Failure or inability to comply 
with these requirements does not justify failure to provide information 
on a relevant clinical investigation.

[45 FR 3751, Jan. 18, 1980, as amended at 50 FR 7518, Feb. 22, 1985; 83 
FR 7385, Feb. 21, 2018]

[[Page 133]]



Sec. 812.28  Acceptance of data from clinical investigations 
conducted outside the United States.

    (a) Acceptance of data from clinical investigations conducted 
outside the United States to support an IDE or a device marketing 
application or submission (an application under section 515 or 520(m) of 
the Federal Food, Drug, and Cosmetic Act, a premarket notification 
submission under section 510(k) of the Federal Food, Drug, and Cosmetic 
Act, or a request for De Novo classification under section 513(f)(2) of 
the Federal Food, Drug, and Cosmetic Act). FDA will accept information 
on a clinical investigation conducted outside the United States to 
support an IDE or a device marketing application or submission if the 
investigation is well-designed and well-conducted and the following 
conditions are met:
    (1) A statement is provided that the investigation was conducted in 
accordance with good clinical practice (GCP). For the purposes of this 
section, GCP is defined as a standard for the design, conduct, 
performance, monitoring, auditing, recording, analysis, and reporting of 
clinical investigations in a way that provides assurance that the data 
and results are credible and accurate and that the rights, safety, and 
well-being of subjects are protected. GCP includes review and approval 
(or provision of a favorable opinion) by an independent ethics committee 
(IEC) before initiating an investigation, continuing review of an 
ongoing investigation by an IEC, and obtaining and documenting the 
freely given informed consent of the subject (or a subject's legally 
authorized representative, if the subject is unable to provide informed 
consent) before initiating an investigation. GCP does not require 
informed consent in life-threatening situations when the IEC reviewing 
the investigation finds, before initiation of the investigation, that 
informed consent is not feasible and either that the conditions present 
are consistent with those described in Sec. 50.23 or Sec. 50.24(a) of 
this chapter, or that the measures described in the protocol or 
elsewhere will protect the rights, safety, and well-being of subjects.
    (2) In addition to the information required elsewhere in parts 807, 
812, and 814 of this chapter, as applicable, the information in 
paragraph (b) of this section is submitted, as follows:
    (i) For an investigation of a significant risk device, as defined in 
Sec. 812.3(m), the supporting information as described in paragraph (b) 
of this section is submitted.
    (ii) For an investigation of a device, other than a significant risk 
device, the supporting information as described in paragraphs (b)(1), 
(4), (5), (7) through (9), and (11) of this section is submitted, and 
the supporting information as described in paragraph (b)(10) of this 
section and the rationale for determining the investigation is of a 
device other than a significant risk device are made available for 
agency review upon request by FDA.
    (iii) For a device investigation that meets the exemption criteria 
in Sec. 812.2(c), the supporting information as described in paragraphs 
(b)(1), (4), (5), (7) through (11) of this section and the rationale for 
determining the investigation meets the exemption criteria in Sec. 
812.2(c) are made available for agency review upon request by FDA.
    (3) FDA is able to validate the data from the investigation through 
an onsite inspection, or through other appropriate means, if the agency 
deems it necessary.
    (b) Supporting information. A sponsor or applicant who submits data 
from a clinical investigation conducted outside the United States to 
support an IDE or a device marketing application or submission, in 
addition to information required elsewhere in parts 807, 812, and 814 of 
this chapter, as applicable, shall provide a description of the actions 
the sponsor or applicant took to ensure that the research conformed to 
GCP as described in paragraph (a)(1) of this section. The description is 
not required to duplicate information already submitted in the 
application or submission. Instead, the description must provide either 
the following information, as specified in paragraph (a)(2) of this 
section, or a cross-reference to another section of the application or 
submission where the information is located:
    (1) The names of the investigators and the names and addresses of 
the research facilities and sites where

[[Page 134]]

records relating to the investigation are maintained;
    (2) The investigator's qualifications;
    (3) A description of the research facility(ies);
    (4) A detailed summary of the protocol and results of the 
investigation and, should FDA request, case records maintained by the 
investigator or additional background data such as hospital or other 
institutional records;
    (5) Either a statement that the device used in the investigation 
conducted outside the United States is identical to the device that is 
the subject of the submission or application, or a detailed description 
of the device and each important component (including all materials and 
specifications), ingredient, property, and principle of operation of the 
device used in the investigation conducted outside the United States and 
a comparison to the device that is the subject of the submission or 
application that indicates how the device used in the investigation is 
similar to and/or different from the device that is the subject of the 
submission or application;
    (6) If the investigation is intended to support the safety and 
effectiveness of a device, a discussion demonstrating that the data and 
information constitute valid scientific evidence within the meaning of 
Sec. 860.7 of this chapter;
    (7) The name and address of the IEC that reviewed the investigation 
and a statement that the IEC meets the definition in Sec. 812.3(t). The 
sponsor or applicant must maintain records supporting such statement, 
including records describing the qualifications of IEC members, and make 
these records available for agency review upon request;
    (8) A summary of the IEC's decision to approve or modify and approve 
the investigation, or to provide a favorable opinion;
    (9) A description of how informed consent was obtained;
    (10) A description of what incentives, if any, were provided to 
subjects to participate in the investigation;
    (11) A description of how the sponsor(s) monitored the investigation 
and ensured that the investigation was carried out consistently with the 
protocol; and
    (12) A description of how investigators were trained to comply with 
GCP (as described in paragraph (a)(1) of this section) and to conduct 
the investigation in accordance with the protocol, and a statement on 
whether written commitments by investigators to comply with GCP and the 
protocol were obtained. Any signed written commitments by investigators 
must be maintained by the sponsor or applicant and made available for 
agency review upon request.
    (c) Waivers. (1) A sponsor or applicant may ask FDA to waive any 
applicable requirements under paragraphs (a)(1) and (b) of this section. 
A waiver request may be submitted in an IDE or in an amendment or 
supplement to an IDE, in a device marketing application or submission 
(an application under section 515 or 520(m) of the Federal Food, Drug, 
and Cosmetic Act, a premarket notification submission under section 
510(k) of the Federal Food, Drug, and Cosmetic Act, or a request for De 
Novo classification under section 513(f)(2) of the Federal Food, Drug, 
and Cosmetic Act) or in an amendment or supplement to a device marketing 
application or submission, or in a pre-submission. A waiver request is 
required to contain at least one of the following:
    (i) An explanation why the sponsor's or applicant's compliance with 
the requirement is unnecessary or cannot be achieved;
    (ii) A description of an alternative submission or course of action 
that satisfies the purpose of the requirement; or
    (iii) Other information justifying a waiver.
    (2) FDA may grant a waiver if it finds that doing so would be in the 
interest of the public health.
    (d) Records. A sponsor or applicant must retain the records required 
by this section for a clinical investigation conducted outside the 
United States as follows:
    (1) If the investigation is submitted in support of an IDE, for 2 
years after the termination or completion of the IDE; and
    (2) If the investigation is submitted in support of a premarket 
approval application, a notice of completion of a

[[Page 135]]

product development protocol, a humanitarian device exemption 
application, a premarket notification submission, or a request for De 
Novo classification, for 2 years after an agency decision on that 
submission or application.
    (e) Clinical investigations conducted outside of the United States 
that do not meet conditions. For clinical investigations conducted 
outside the United States that do not meet the conditions under 
paragraph (a) of this section, FDA may accept the information from such 
clinical investigations to support an IDE or a device marketing 
application or submission if FDA believes that the data and results from 
such clinical investigation are credible and accurate and that the 
rights, safety, and well-being of subjects have been adequately 
protected.

[83 FR 7386, Feb. 21, 2018]



Sec. 812.30  FDA action on applications.

    (a) Approval or disapproval. FDA will notify the sponsor in writing 
of the date it receives an application. FDA may approve an investigation 
as proposed, approve it with modifications, or disapprove it. An 
investigation may not begin until:
    (1) Thirty days after FDA receives the application at the address in 
Sec. 812.19 for the investigation of a device other than a banned 
device, unless FDA notifies the sponsor that the investigation may not 
begin; or
    (2) FDA approves, by order, an IDE for the investigation.
    (b) Grounds for disapproval or withdrawal. FDA may disapprove or 
withdraw approval of an application if FDA finds that:
    (1) There has been a failure to comply with any requirement of this 
part or the act, any other applicable regulation or statute, or any 
condition of approval imposed by an IRB or FDA.
    (2) The application or a report contains an untrue statement of a 
material fact, or omits material information required by this part.
    (3) The sponsor fails to respond to a request for additional 
information within the time prescribed by FDA.
    (4) There is reason to believe that the risks to the subjects are 
not outweighed by the anticipated benefits to the subjects and the 
importance of the knowledge to be gained, or informed consent is 
inadequate, or the investigation is scientifically unsound, or there is 
reason to believe that the device as used is ineffective.
    (5) It is otherwise unreasonable to begin or to continue the 
investigation owing to the way in which the device is used or the 
inadequacy of:
    (i) The report of prior investigations or the investigational plan;
    (ii) The methods, facilities, and controls used for the 
manufacturing, processing, packaging, storage, and, where appropriate, 
installation of the device; or
    (iii) Monitoring and review of the investigation.
    (c) Notice of disapproval or withdrawal. If FDA disapproves an 
application or proposes to withdraw approval of an application, FDA will 
notify the sponsor in writing.
    (1) A disapproval order will contain a complete statement of the 
reasons for disapproval and a statement that the sponsor has an 
opportunity to request a hearing under part 16.
    (2) A notice of a proposed withdrawal of approval will contain a 
complete statement of the reasons for withdrawal and a statement that 
the sponsor has an opportunity to request a hearing under part 16. FDA 
will provide the opportunity for hearing before withdrawal of approval, 
unless FDA determines in the notice that continuation of testing under 
the exemption will result in an unreasonble risk to the public health 
and orders withdrawal of approval before any hearing.

[45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58842, Sept. 5, 1980]



Sec. 812.35  Supplemental applications.

    (a) Changes in investigational plan--(1) Changes requiring prior 
approval. Except as described in paragraphs (a)(2) through (a)(4) of 
this section, a sponsor must obtain approval of a supplemental 
application under Sec. 812.30(a), and IRB approval when appropriate 
(see Sec. Sec. 56.110 and 56.111 of this chapter), prior to 
implementing a change to an investigational plan. If a sponsor intends 
to conduct an investigation that involves an exception to informed 
consent under Sec. 50.24 of this chapter, the

[[Page 136]]

sponsor shall submit a separate investigational device exemption (IDE) 
application in accordance with Sec. 812.20(a).
    (2) Changes effected for emergency use. The requirements of 
paragraph (a)(1) of this section regarding FDA approval of a supplement 
do not apply in the case of a deviation from the investigational plan to 
protect the life or physical well-being of a subject in an emergency. 
Such deviation shall be reported to FDA within 5-working days after the 
sponsor learns of it (see Sec. 812.150(a)(4)).
    (3) Changes effected with notice to FDA within 5 days. A sponsor may 
make certain changes without prior approval of a supplemental 
application under paragraph (a)(1) of this section if the sponsor 
determines that these changes meet the criteria described in paragraphs 
(a)(3)(i) and (a)(3)(ii) of this section, on the basis of credible 
information defined in paragraph (a)(3)(iii) of this section, and the 
sponsor provides notice to FDA within 5-working days of making these 
changes.
    (i) Developmental changes. The requirements in paragraph (a)(1) of 
this section regarding FDA approval of a supplement do not apply to 
developmental changes in the device (including manufacturing changes) 
that do not constitute a significant change in design or basic 
principles of operation and that are made in response to information 
gathered during the course of an investigation.
    (ii) Changes to clinical protocol. The requirements in paragraph 
(a)(1) of this section regarding FDA approval of a supplement do not 
apply to changes to clinical protocols that do not affect:
    (A) The validity of the data or information resulting from the 
completion of the approved protocol, or the relationship of likely 
patient risk to benefit relied upon to approve the protocol;
    (B) The scientific soundness of the investigational plan; or
    (C) The rights, safety, or welfare of the human subjects involved in 
the investigation.
    (iii) Definition of credible information. (A) Credible information 
to support developmental changes in the device (including manufacturing 
changes) includes data generated under the design control procedures of 
Sec. 820.30, preclinical/animal testing, peer reviewed published 
literature, or other reliable information such as clinical information 
gathered during a trial or marketing.
    (B) Credible information to support changes to clinical protocols is 
defined as the sponsor's documentation supporting the conclusion that a 
change does not have a significant impact on the study design or planned 
statistical analysis, and that the change does not affect the rights, 
safety, or welfare of the subjects. Documentation shall include 
information such as peer reviewed published literature, the 
recommendation of the clinical investigator(s), and/or the data gathered 
during the clinical trial or marketing.
    (iv) Notice of IDE change. Changes meeting the criteria in 
paragraphs (a)(3)(i) and (a)(3)(ii) of this section that are supported 
by credible information as defined in paragraph (a)(3)(iii) of this 
section may be made without prior FDA approval if the sponsor submits a 
notice of the change to the IDE not later than 5-working days after 
making the change. Changes to devices are deemed to occur on the date 
the device, manufactured incorporating the design or manufacturing 
change, is distributed to the investigator(s). Changes to a clinical 
protocol are deemed to occur when a clinical investigator is notified by 
the sponsor that the change should be implemented in the protocol or, 
for sponsor-investigator studies, when a sponsor-investigator 
incorporates the change in the protocol. Such notices shall be 
identified as a ``notice of IDE change.''
    (A) For a developmental or manufacturing change to the device, the 
notice shall include a summary of the relevant information gathered 
during the course of the investigation upon which the change was based; 
a description of the change to the device or manufacturing process 
(cross-referenced to the appropriate sections of the original device 
description or manufacturing process); and, if design controls were used 
to assess the change, a statement that no new risks were identified by 
appropriate risk analysis and that the verification and validation 
testing, as

[[Page 137]]

appropriate, demonstrated that the design outputs met the design input 
requirements. If another method of assessment was used, the notice shall 
include a summary of the information which served as the credible 
information supporting the change.
    (B) For a protocol change, the notice shall include a description of 
the change (cross-referenced to the appropriate sections of the original 
protocol); an assessment supporting the conclusion that the change does 
not have a significant impact on the study design or planned statistical 
analysis; and a summary of the information that served as the credible 
information supporting the sponsor's determination that the change does 
not affect the rights, safety, or welfare of the subjects.
    (4) Changes submitted in annual report. The requirements of 
paragraph (a)(1) of this section do not apply to minor changes to the 
purpose of the study, risk analysis, monitoring procedures, labeling, 
informed consent materials, and IRB information that do not affect:
    (i) The validity of the data or information resulting from the 
completion of the approved protocol, or the relationship of likely 
patient risk to benefit relied upon to approve the protocol;
    (ii) The scientific soundness of the investigational plan; or
    (iii) The rights, safety, or welfare of the human subjects involved 
in the investigation. Such changes shall be reported in the annual 
progress report for the IDE, under Sec. 812.150(b)(5).
    (b) IRB approval for new facilities. A sponsor shall submit to FDA a 
certification of any IRB approval of an investigation or a part of an 
investigation not included in the IDE application. If the investigation 
is otherwise unchanged, the supplemental application shall consist of an 
updating of the information required by Sec. 812.20(b) and (c) and a 
description of any modifications in the investigational plan required by 
the IRB as a condition of approval. A certification of IRB approval need 
not be included in the initial submission of the supplemental 
application, and such certification is not a precondition for agency 
consideration of the application. Nevertheless, a sponsor may not begin 
a part of an investigation at a facility until the IRB has approved the 
investigation, FDA has received the certification of IRB approval, and 
FDA, under Sec. 812.30(a), has approved the supplemental application 
relating to that part of the investigation (see Sec. 56.103(a)).

[50 FR 25909, June 24, 1985; 50 FR 28932, July 17, 1985, as amended at 
61 FR 51531, Oct. 2, 1996; 63 FR 64625, Nov. 23, 1998]



Sec. 812.36  Treatment use of an investigational device.

    (a) General. A device that is not approved for marketing may be 
under clinical investigation for a serious or immediately life-
threatening disease or condition in patients for whom no comparable or 
satisfactory alternative device or other therapy is available. During 
the clinical trial or prior to final action on the marketing 
application, it may be appropriate to use the device in the treatment of 
patients not in the trial under the provisions of a treatment 
investigational device exemption (IDE). The purpose of this section is 
to facilitate the availability of promising new devices to desperately 
ill patients as early in the device development process as possible, 
before general marketing begins, and to obtain additional data on the 
device's safety and effectiveness. In the case of a serious disease, a 
device ordinarily may be made available for treatment use under this 
section after all clinical trials have been completed. In the case of an 
immediately life-threatening disease, a device may be made available for 
treatment use under this section prior to the completion of all clinical 
trials. For the purpose of this section, an ``immediately life-
threatening'' disease means a stage of a disease in which there is a 
reasonable likelihood that death will occur within a matter of months or 
in which premature death is likely without early treatment. For purposes 
of this section, ``treatment use''of a device includes the use of a 
device for diagnostic purposes.
    (b) Criteria. FDA shall consider the use of an investigational 
device under a treatment IDE if:
    (1) The device is intended to treat or diagnose a serious or 
immediately life-threatening disease or condition;

[[Page 138]]

    (2) There is no comparable or satisfactory alternative device or 
other therapy available to treat or diagnose that stage of the disease 
or condition in the intended patient population;
    (3) The device is under investigation in a controlled clinical trial 
for the same use under an approved IDE, or such clinical trials have 
been completed; and
    (4) The sponsor of the investigation is actively pursuing marketing 
approval/clearance of the investigational device with due diligence.
    (c) Applications for treatment use. (1) A treatment IDE application 
shall include, in the following order:
    (i) The name, address, and telephone number of the sponsor of the 
treatment IDE;
    (ii) The intended use of the device, the criteria for patient 
selection, and a written protocol describing the treatment use;
    (iii) An explanation of the rationale for use of the device, 
including, as appropriate, either a list of the available regimens that 
ordinarily should be tried before using the investigational device or an 
explanation of why the use of the investigational device is preferable 
to the use of available marketed treatments;
    (iv) A description of clinical procedures, laboratory tests, or 
other measures that will be used to evaluate the effects of the device 
and to minimize risk;
    (v) Written procedures for monitoring the treatment use and the name 
and address of the monitor;
    (vi) Instructions for use for the device and all other labeling as 
required under Sec. 812.5(a) and (b);
    (vii) Information that is relevant to the safety and effectiveness 
of the device for the intended treatment use. Information from other 
IDE's may be incorporated by reference to support the treatment use;
    (viii) A statement of the sponsor's commitment to meet all 
applicable responsibilities under this part and part 56 of this chapter 
and to ensure compliance of all participating investigators with the 
informed consent requirements of part 50 of this chapter;
    (ix) An example of the agreement to be signed by all investigators 
participating in the treatment IDE and certification that no 
investigator will be added to the treatment IDE before the agreement is 
signed; and
    (x) If the device is to be sold, the price to be charged and a 
statement indicating that the price is based on manufacturing and 
handling costs only.
    (2) A licensed practitioner who receives an investigational device 
for treatment use under a treatment IDE is an ``investigator'' under the 
IDE and is responsible for meeting all applicable investigator 
responsibilities under this part and parts 50 and 56 of this chapter.
    (d) FDA action on treatment IDE applications--(1) Approval of 
treatment IDE's. Treatment use may begin 30 days after FDA receives the 
treatment IDE submission at the address specified in Sec. 812.19, 
unless FDA notifies the sponsor in writing earlier than the 30 days that 
the treatment use may or may not begin. FDA may approve the treatment 
use as proposed or approve it with modifications.
    (2) Disapproval or withdrawal of approval of treatment IDE's. FDA 
may disapprove or withdraw approval of a treatment IDE if:
    (i) The criteria specified in Sec. 812.36(b) are not met or the 
treatment IDE does not contain the information required in Sec. 
812.36(c);
    (ii) FDA determines that any of the grounds for disapproval or 
withdrawal of approval listed in Sec. 812.30(b)(1) through (b)(5) 
apply;
    (iii) The device is intended for a serious disease or condition and 
there is insufficient evidence of safety and effectiveness to support 
such use;
    (iv) The device is intended for an immediately life-threatening 
disease or condition and the available scientific evidence, taken as a 
whole, fails to provide a reasonable basis for concluding that the 
device:
    (A) May be effective for its intended use in its intended 
population; or
    (B) Would not expose the patients to whom the device is to be 
administered to an unreasonable and significant additional risk of 
illness or injury;
    (v) There is reasonable evidence that the treatment use is impeding 
enrollment in, or otherwise interfering with

[[Page 139]]

the conduct or completion of, a controlled investigation of the same or 
another investigational device;
    (vi) The device has received marketing approval/clearance or a 
comparable device or therapy becomes available to treat or diagnose the 
same indication in the same patient population for which the 
investigational device is being used;
    (vii) The sponsor of the controlled clinical trial is not pursuing 
marketing approval/clearance with due diligence;
    (viii) Approval of the IDE for the controlled clinical investigation 
of the device has been withdrawn; or
    (ix) The clinical investigator(s) named in the treatment IDE are not 
qualified by reason of their scientific training and/or experience to 
use the investigational device for the intended treatment use.
    (3) Notice of disapproval or withdrawal. If FDA disapproves or 
proposes to withdraw approval of a treatment IDE, FDA will follow the 
procedures set forth in Sec. 812.30(c).
    (e) Safeguards. Treatment use of an investigational device is 
conditioned upon the sponsor and investigators complying with the 
safeguards of the IDE process and the regulations governing informed 
consent (part 50 of this chapter) and institutional review boards (part 
56 of this chapter).
    (f) Reporting requirements. The sponsor of a treatment IDE shall 
submit progress reports on a semi-annual basis to all reviewing IRB's 
and FDA until the filing of a marketing application. These reports shall 
be based on the period of time since initial approval of the treatment 
IDE and shall include the number of patients treated with the device 
under the treatment IDE, the names of the investigators participating in 
the treatment IDE, and a brief description of the sponsor's efforts to 
pursue marketing approval/clearance of the device. Upon filing of a 
marketing application, progress reports shall be submitted annually in 
accordance with Sec. 812.150(b)(5). The sponsor of a treatment IDE is 
responsible for submitting all other reports required under Sec. 
812.150.

[62 FR 48947, Sept. 18, 1997]



Sec. 812.38  Confidentiality of data and information.

    (a) Existence of IDE. FDA will not disclose the existence of an IDE 
unless its existence has previously been publicly disclosed or 
acknowledged, until FDA approves an application for premarket approval 
of the device subject to the IDE; or a notice of completion of a product 
development protocol for the device has become effective.
    (b) Availability of summaries or data. (1) FDA will make publicly 
available, upon request, a detailed summary of information concerning 
the safety and effectiveness of the device that was the basis for an 
order approving, disapproving, or withdrawing approval of an application 
for an IDE for a banned device. The summary shall include information on 
any adverse effect on health caused by the device.
    (2) If a device is a banned device or if the existence of an IDE has 
been publicly disclosed or acknowledged, data or information contained 
in the file is not available for public disclosure before approval of an 
application for premarket approval or the effective date of a notice of 
completion of a product development protocol except as provided in this 
section. FDA may, in its discretion, disclose a summary of selected 
portions of the safety and effectiveness data, that is, clinical, 
animal, or laboratory studies and tests of the device, for public 
consideration of a specific pending issue.
    (3) If the existence of an IDE file has not been publicly disclosed 
or acknowledged, no data or information in the file are available for 
public disclosure except as provided in paragraphs (b)(1) and (c) of 
this section.
    (4) Notwithstanding paragraph (b)(2) of this section, FDA will make 
available to the public, upon request, the information in the IDE that 
was required to be filed in Docket Number FDA-1995-S-0036 in the Dockets 
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852, for investigations involving an 
exception from informed consent under Sec. 50.24 of this chapter. 
Persons wishing to request this information shall submit a request under 
the Freedom of Information Act.

[[Page 140]]

    (c) Reports of adverse effects. Upon request or on its own 
initiative, FDA shall disclose to an individual on whom an 
investigational device has been used a copy of a report of adverse 
device effects relating to that use.
    (d) Other rules. Except as otherwise provided in this section, the 
availability for public disclosure of data and information in an IDE 
file shall be handled in accordance with Sec. 814.9.

[45 FR 3751, Jan. 18, 1980, as amended at 53 FR 11253, Apr. 6, 1988; 61 
FR 51531, Oct. 2, 1996; 88 FR 16880, Mar. 21, 2023]



                 Subpart C_Responsibilities of Sponsors



Sec. 812.40  General responsibilities of sponsors.

    Sponsors are responsible for selecting qualified investigators and 
providing them with the information they need to conduct the 
investigation properly, ensuring proper monitoring of the investigation, 
ensuring that IRB review and approval are obtained, submitting an IDE 
application to FDA, and ensuring that any reviewing IRB and FDA are 
promptly informed of significant new information about an investigation. 
Additional responsibilities of sponsors are described in subparts B and 
G.



Sec. 812.42  FDA and IRB approval.

    A sponsor shall not begin an investigation or part of an 
investigation until an IRB and FDA have both approved the application or 
supplemental application relating to the investigation or part of an 
investigation.

[46 FR 8957, Jan. 27, 1981]



Sec. 812.43  Selecting investigators and monitors.

    (a) Selecting investigators. A sponsor shall select investigators 
qualified by training and experience to investigate the device.
    (b) Control of device. A sponsor shall ship investigational devices 
only to qualified investigators participating in the investigation.
    (c) Obtaining agreements. A sponsor shall obtain from each 
participating investigator a signed agreement that includes:
    (1) The investigator's curriculum vitae.
    (2) Where applicable, a statement of the investigator's relevant 
experience, including the dates, location, extent, and type of 
experience.
    (3) If the investigator was involved in an investigation or other 
research that was terminated, an explanation of the circumstances that 
led to termination.
    (4) A statement of the investigator's commitment to:
    (i) Conduct the investigation in accordance with the agreement, the 
investigational plan, this part and other applicable FDA regulations, 
and conditions of approval imposed by the reviewing IRB or FDA;
    (ii) Supervise all testing of the device involving human subjects; 
and
    (iii) Ensure that the requirements for obtaining informed consent 
are met.
    (5) Sufficient accurate financial disclosure information to allow 
the sponsor to submit a complete and accurate certification or 
disclosure statement as required under part 54 of this chapter. The 
sponsor shall obtain a commitment from the clinical investigator to 
promptly update this information if any relevant changes occur during 
the course of the investigation and for 1 year following completion of 
the study. This information shall not be submitted in an investigational 
device exemption application, but shall be submitted in any marketing 
application involving the device.
    (d) Selecting monitors. A sponsor shall select monitors qualified by 
training and experience to monitor the investigational study in 
accordance with this part and other applicable FDA regulations.

[45 FR 3751, Jan. 18, 1980, as amended at 63 FR 5253, Feb. 2, 1998]



Sec. 812.45  Informing investigators.

    A sponsor shall supply all investigators participating in the 
investigation with copies of the investigational plan and the report of 
prior investigations of the device.



Sec. 812.46  Monitoring investigations.

    (a) Securing compliance. A sponsor who discovers that an 
investigator is

[[Page 141]]

not complying with the signed agreement, the investigational plan, the 
requirements of this part or other applicable FDA regulations, or any 
conditions of approval imposed by the reviewing IRB or FDA shall 
promptly either secure compliance, or discontinue shipments of the 
device to the investigator and terminate the investigator's 
participation in the investigation. A sponsor shall also require such an 
investigator to dispose of or return the device, unless this action 
would jeopardize the rights, safety, or welfare of a subject.
    (b) Unanticipated adverse device effects. (1) A sponsor shall 
immediately conduct an evaluation of any unanticipated adverse device 
effect.
    (2) A sponsor who determines that an unanticipated adverse device 
effect presents an unreasonable risk to subjects shall terminate all 
investigations or parts of investigations presenting that risk as soon 
as possible. Termination shall occur not later than 5 working days after 
the sponsor makes this determination and not later than 15 working days 
after the sponsor first received notice of the effect.
    (c) Resumption of terminated studies. If the device is a significant 
risk device, a sponsor may not resume a terminated investigation without 
IRB and FDA approval. If the device is not a significant risk device, a 
sponsor may not resume a terminated investigation without IRB approval 
and, if the investigation was terminated under paragraph (b)(2) of this 
section, FDA approval.



Sec. 812.47  Emergency research under Sec. 50.24 of this chapter.

    (a) The sponsor shall monitor the progress of all investigations 
involving an exception from informed consent under Sec. 50.24 of this 
chapter. When the sponsor receives from the IRB information concerning 
the public disclosures under Sec. 50.24(a)(7)(ii) and (iii) of this 
chapter, the sponsor shall promptly submit to the IDE file and to Docket 
Number FDA-1995-S-0036 in the Dockets Management Staff (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852, copies of the information that was disclosed, identified by the 
IDE number.
    (b) The sponsor also shall monitor such investigations to determine 
when an IRB determines that it cannot approve the research because it 
does not meet the criteria in the exception in Sec. 50.24(a) of this 
chapter or because of other relevant ethical concerns. The sponsor 
promptly shall provide this information in writing to FDA, investigators 
who are asked to participate in this or a substantially equivalent 
clinical investigation, and other IRB's that are asked to review this or 
a substantially equivalent investigation.

[61 FR 51531, Oct. 2, 1996, as amended at 64 FR 10943, Mar. 8, 1999; 88 
FR 16880, Mar. 21, 2023]



                    Subpart D_IRB Review and Approval



Sec. 812.60  IRB composition, duties, and functions.

    An IRB reviewing and approving investigations under this part shall 
comply with the requirements of part 56 in all respects, including its 
composition, duties, and functions.

[46 FR 8957, Jan. 27, 1981]



Sec. 812.62  IRB approval.

    (a) An IRB shall review and have authority to approve, require 
modifications in (to secure approval), or disapprove all investigations 
covered by this part.
    (b) If no IRB exists or if FDA finds that an IRB's review is 
inadequate, a sponsor may submit an application to FDA.

[46 FR 8957, Jan. 27, 1981]



Sec. 812.64  IRB's continuing review.

    The IRB shall conduct its continuing review of an investigation in 
accordance with part 56.

[46 FR 8957, Jan. 27, 1981]



Sec. 812.65  [Reserved]



Sec. 812.66  Significant risk device determinations.

    If an IRB determines that an investigation, presented for approval 
under Sec. 812.2(b)(1)(ii), involves a significant risk device, it 
shall so notify the investigator and, where appropriate, the sponsor. A 
sponsor may not begin the

[[Page 142]]

investigation except as provided in Sec. 812.30(a).

[46 FR 8957, Jan. 27, 1981]



               Subpart E_Responsibilities of Investigators



Sec. 812.100  General responsibilities of investigators.

    An investigator is responsible for ensuring that an investigation is 
conducted according to the signed agreement, the investigational plan 
and applicable FDA regulations, for protecting the rights, safety, and 
welfare of subjects under the investigator's care, and for the control 
of devices under investigation. An investigator also is responsible for 
ensuring that informed consent is obtained in accordance with part 50 of 
this chapter. Additional responsibilities of investigators are described 
in subpart G.

[45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8957, Jan. 27, 1981]



Sec. 812.110  Specific responsibilities of investigators.

    (a) Awaiting approval. An investigator may determine whether 
potential subjects would be interested in participating in an 
investigation, but shall not request the written informed consent of any 
subject to participate, and shall not allow any subject to participate 
before obtaining IRB and FDA approval.
    (b) Compliance. An investigator shall conduct an investigation in 
accordance with the signed agreement with the sponsor, the 
investigational plan, this part and other applicable FDA regulations, 
and any conditions of approval imposed by an IRB or FDA.
    (c) Supervising device use. An investigator shall permit an 
investigational device to be used only with subjects under the 
investigator's supervision. An investigator shall not supply an 
investigational device to any person not authorized under this part to 
receive it.
    (d) Financial disclosure. A clinical investigator shall disclose to 
the sponsor sufficient accurate financial information to allow the 
applicant to submit complete and accurate certification or disclosure 
statements required under part 54 of this chapter. The investigator 
shall promptly update this information if any relevant changes occur 
during the course of the investigation and for 1 year following 
completion of the study.
    (e) Disposing of device. Upon completion or termination of a 
clinical investigation or the investigator's part of an investigation, 
or at the sponsor's request, an investigator shall return to the sponsor 
any remaining supply of the device or otherwise dispose of the device as 
the sponsor directs.

[45 FR 3751, Jan. 18, 1980, as amended at 63 FR 5253, Feb. 2, 1998]



Sec. 812.119  Disqualification of a clinical investigator.

    (a) If FDA has information indicating that an investigator 
(including a sponsor-investigator) has repeatedly or deliberately failed 
to comply with the requirements of this part, part 50, or part 56 of 
this chapter, or has repeatedly or deliberately submitted to FDA or to 
the sponsor false information in any required report, the Center for 
Devices and Radiological Health, the Center for Biologics Evaluation and 
Research, or the Center for Drug Evaluation and Research will furnish 
the investigator written notice of the matter complained of and offer 
the investigator an opportunity to explain the matter in writing, or, at 
the option of the investigator, in an informal conference. If an 
explanation is offered and accepted by the applicable Center, the Center 
will discontinue the disqualification proceeding. If an explanation is 
offered but not accepted by the applicable Center, the investigator will 
be given an opportunity for a regulatory hearing under part 16 of this 
chapter on the question of whether the investigator is eligible to 
receive test articles under this part and eligible to conduct any 
clinical investigation that supports an application for a research or 
marketing permit for products regulated by FDA.
    (b) After evaluating all available information, including any 
explanation presented by the investigator, if the Commissioner 
determines that the investigator has repeatedly or deliberately failed 
to comply with the requirements of this part, part 50, or part 56 of 
this chapter, or has repeatedly or

[[Page 143]]

deliberately submitted to FDA or to the sponsor false information in any 
required report, the Commissioner will notify the investigator, the 
sponsor of any investigation in which the investigator has been named as 
a participant, and the reviewing investigational review boards (IRBs) 
that the investigator is not eligible to receive test articles under 
this part. The notification to the investigator, sponsor and IRBs will 
provide a statement of the basis for such determination. The 
notification also will explain that an investigator determined to be 
ineligible to receive test articles under this part will be ineligible 
to conduct any clinical investigation that supports an application for a 
research or marketing permit for products regulated by FDA, including 
drugs, biologics, devices, new animal drugs, foods, including dietary 
supplements, that bear a nutrient content claim or a health claim, 
infant formulas, food and color additives, and tobacco products.
    (c) Each application or submission to FDA under the provisions of 
this chapter containing data reported by an investigator who has been 
determined to be ineligible to receive FDA-regulated test articles is 
subject to examination to determine whether the investigator has 
submitted unreliable data that are essential to the continuation of an 
investigation or essential to the clearance or approval of a marketing 
application, or essential to the continued marketing of an FDA-regulated 
product.
    (d) If the Commissioner determines, after the unreliable data 
submitted by the investigator are eliminated from consideration, that 
the data remaining are inadequate to support a conclusion that it is 
reasonably safe to continue the investigation, the Commissioner will 
notify the sponsor, who shall have an opportunity for a regulatory 
hearing under part 16 of this chapter. If a danger to the public health 
exists, however, the Commissioner shall terminate the investigational 
device exemption (IDE) immediately and notify the sponsor and the 
reviewing IRBs of the termination. In such case, the sponsor shall have 
an opportunity for a regulatory hearing before FDA under part 16 of this 
chapter on the question of whether the IDE should be reinstated. The 
determination that an investigation may not be considered in support of 
a research or marketing application or a notification or petition 
submission does not, however, relieve the sponsor of any obligation 
under any other applicable regulation to submit to FDA the results of 
the investigation.
    (e) If the Commissioner determines, after the unreliable data 
submitted by the investigator are eliminated from consideration, that 
the continued clearance or approval of the product for which the data 
were submitted cannot be justified, the Commissioner will proceed to 
rescind clearance or withdraw approval of the product in accordance with 
the applicable provisions of the relevant statutes.
    (f) An investigator who has been determined to be ineligible under 
paragraph (b) of this section may be reinstated as eligible when the 
Commissioner determines that the investigator has presented adequate 
assurances that the investigator will employ all test articles, and will 
conduct any clinical investigation that supports an application for a 
research or marketing permit for products regulated by FDA, solely in 
compliance with the applicable provisions of this chapter.

[77 FR 25360, Apr. 30, 2012]

Subpart F [Reserved]



                      Subpart G_Records and Reports



Sec. 812.140  Records.

    (a) Investigator records. A participating investigator shall 
maintain the following accurate, complete, and current records relating 
to the investigator's participation in an investigation:
    (1) All correspondence with another investigator, an IRB, the 
sponsor, a monitor, or FDA, including required reports.
    (2) Records of receipt, use or disposition of a device that relate 
to:
    (i) The type and quantity of the device, the dates of its receipt, 
and the batch number or code mark.
    (ii) The names of all persons who received, used, or disposed of 
each device.

[[Page 144]]

    (iii) Why and how many units of the device have been returned to the 
sponsor, repaired, or otherwise disposed of.
    (3) Records of each subject's case history and exposure to the 
device. Case histories include the case report forms and supporting data 
including, for example, signed and dated consent forms and medical 
records including, for example, progress notes of the physician, the 
individual's hospital chart(s), and the nurses' notes. Such records 
shall include:
    (i) Documents evidencing informed consent and, for any use of a 
device by the investigator without informed consent, any written 
concurrence of a licensed physician and a brief description of the 
circumstances justifying the failure to obtain informed consent. The 
case history for each individual shall document that informed consent 
was obtained prior to participation in the study.
    (ii) All relevant observations, including records concerning adverse 
device effects (whether anticipated or unanticipated), information and 
data on the condition of each subject upon entering, and during the 
course of, the investigation, including information about relevant 
previous medical history and the results of all diagnostic tests.
    (iii) A record of the exposure of each subject to the 
investigational device, including the date and time of each use, and any 
other therapy.
    (4) The protocol, with documents showing the dates of and reasons 
for each deviation from the protocol.
    (5) Any other records that FDA requires to be maintained by 
regulation or by specific requirement for a category of investigations 
or a particular investigation.
    (b) Sponsor records. A sponsor shall maintain the following 
accurate, complete, and current records relating to an investigation:
    (1) All correspondence with another sponsor, a monitor, an 
investigator, an IRB, or FDA, including required reports.
    (2) Records of shipment and disposition. Records of shipment shall 
include the name and address of the consignee, type and quantity of 
device, date of shipment, and batch number or code mark. Records of 
disposition shall describe the batch number or code marks of any devices 
returned to the sponsor, repaired, or disposed of in other ways by the 
investigator or another person, and the reasons for and method of 
disposal.
    (3) Signed investigator agreements including the financial 
disclosure information required to be collected under Sec. 812.43(c)(5) 
in accordance with part 54 of this chapter.
    (4) For each investigation subject to Sec. 812.2(b)(1) of a device 
other than a significant risk device, the records described in paragraph 
(b)(5) of this section and the following records, consolidated in one 
location and available for FDA inspection and copying:
    (i) The name and intended use of the device and the objectives of 
the investigation;
    (ii) A brief explanation of why the device is not a significant risk 
device:
    (iii) The name and address of each investigator:
    (iv) The name and address of each IRB that has reviewed the 
investigation:
    (v) A statement of the extent to which the good manufacturing 
practice regulation in part 820 will be followed in manufacturing the 
device; and
    (vi) Any other information required by FDA.
    (5) Records concerning adverse device effects (whether anticipated 
or unanticipated) and complaints and
    (6) Any other records that FDA requires to be maintained by 
regulation or by specific requirement for a category of investigation or 
a particular investigation.
    (c) IRB records. An IRB shall maintain records in accordance with 
part 56 of this chapter.
    (d) Retention period. An investigator or sponsor shall maintain the 
records required by this subpart during the investigation and for a 
period of 2 years after the latter of the following two dates: The date 
on which the investigation is terminated or completed, or the date that 
the records are no longer required for purposes of supporting a 
premarket approval application, a notice of completion of a product 
development protocol, a humanitarian device exemption application, a 
premarket

[[Page 145]]

notification submission, or a request for De Novo classification.
    (e) Records custody. An investigator or sponsor may withdraw from 
the responsibility to maintain records for the period required in 
paragraph (d) of this section and transfer custody of the records to any 
other person who will accept responsibility for them under this part, 
including the requirements of Sec. 812.145. Notice of a transfer shall 
be given to FDA not later than 10 working days after transfer occurs.

[45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58843, Sept. 5, 1980; 46 
FR 8957, Jan. 27, 1981; 61 FR 57280, Nov. 5, 1996; 63 FR 5253, Feb. 2, 
1998; 83 FR 7387, Feb. 21, 2018; 83 FR 7387, Feb. 21, 2018]



Sec. 812.145  Inspections.

    (a) Entry and inspection. A sponsor or an investigator who has 
authority to grant access shall permit authorized FDA employees, at 
reasonable times and in a reasonable manner, to enter and inspect any 
establishment where devices are held (including any establishment where 
devices are manufactured, processed, packed, installed, used, or 
implanted or where records of results from use of devices are kept).
    (b) Records inspection. A sponsor, IRB, or investigator, or any 
other person acting on behalf of such a person with respect to an 
investigation, shall permit authorized FDA employees, at reasonable 
times and in a reasonable manner, to inspect and copy all records 
relating to an investigation.
    (c) Records identifying subjects. An investigator shall permit 
authorized FDA employees to inspect and copy records that identify 
subjects, upon notice that FDA has reason to suspect that adequate 
informed consent was not obtained, or that reports required to be 
submitted by the investigator to the sponsor or IRB have not been 
submitted or are incomplete, inaccurate, false, or misleading.



Sec. 812.150  Reports.

    (a) Investigator reports. An investigator shall prepare and submit 
the following complete, accurate, and timely reports:
    (1) Unanticipated adverse device effects. An investigator shall 
submit to the sponsor and to the reviewing IRB a report of any 
unanticipated adverse device effect occurring during an investigation as 
soon as possible, but in no event later than 10 working days after the 
investigator first learns of the effect.
    (2) Withdrawal of IRB approval. An investigator shall report to the 
sponsor, within 5 working days, a withdrawal of approval by the 
reviewing IRB of the investigator's part of an investigation.
    (3) Progress. An investigator shall submit progress reports on the 
investigation to the sponsor, the monitor, and the reviewing IRB at 
regular intervals, but in no event less often than yearly.
    (4) Deviations from the investigational plan. An investigator shall 
notify the sponsor and the reviewing IRB (see Sec. 56.108(a) (3) and 
(4)) of any deviation from the investigational plan to protect the life 
or physical well-being of a subject in an emergency. Such notice shall 
be given as soon as possible, but in no event later than 5 working days 
after the emergency occurred. Except in such an emergency, prior 
approval by the sponsor is required for changes in or deviations from a 
plan, and if these changes or deviations may affect the scientific 
soundness of the plan or the rights, safety, or welfare of human 
subjects, FDA and IRB in accordance with Sec. 812.35(a) also is 
required.
    (5) Informed consent. If an investigator uses a device without 
obtaining informed consent, the investigator shall report such use to 
the sponsor and the reviewing IRB within 5 working days after the use 
occurs.
    (6) Final report. An investigator shall, within 3 months after 
termination or completion of the investigation or the investigator's 
part of the investigation, submit a final report to the sponsor and the 
reviewing IRB.
    (7) Other. An investigator shall, upon request by a reviewing IRB or 
FDA, provide accurate, complete, and current information about any 
aspect of the investigation.
    (b) Sponsor reports. A sponsor shall prepare and submit the 
following complete, accurate, and timely reports:
    (1) Unanticipated adverse device effects. A sponsor who conducts an 
evaluation

[[Page 146]]

of an unanticipated adverse device effect under Sec. 812.46(b) shall 
report the results of such evaluation to FDA and to all reviewing IRB's 
and participating investigators within 10 working days after the sponsor 
first receives notice of the effect. Thereafter the sponsor shall submit 
such additional reports concerning the effect as FDA requests.
    (2) Withdrawal of IRB approval. A sponsor shall notify FDA and all 
reviewing IRB's and participating investigators of any withdrawal of 
approval of an investigation or a part of an investigation by a 
reviewing IRB within 5 working days after receipt of the withdrawal of 
approval.
    (3) Withdrawal of FDA approval. A sponsor shall notify all reviewing 
IRB's and participating investigators of any withdrawal of FDA approval 
of the investigation, and shall do so within 5 working days after 
receipt of notice of the withdrawal of approval.
    (4) Current investigator list. A sponsor shall submit to FDA, at 6-
month intervals, a current list of the names and addresses of all 
investigators participating in the investigation. The sponsor shall 
submit the first such list 6 months after FDA approval.
    (5) Progress reports. At regular intervals, and at least yearly, a 
sponsor shall submit progress reports to all reviewing IRB's. In the 
case of a significant risk device, a sponsor shall also submit progress 
reports to FDA. A sponsor of a treatment IDE shall submit semi-annual 
progress reports to all reviewing IRB's and FDA in accordance with Sec. 
812.36(f) and annual reports in accordance with this section.
    (6) Recall and device disposition. A sponsor shall notify FDA and 
all reviewing IRB's of any request that an investigator return, repair, 
or otherwise dispose of any units of a device. Such notice shall occur 
within 30 working days after the request is made and shall state why the 
request was made.
    (7) Final report. In the case of a significant risk device, the 
sponsor shall notify FDA within 30 working days of the completion or 
termination of the investigation and shall submit a final report to FDA 
and all reviewing the IRB's and participating investigators within 6 
months after completion or termination. In the case of a device that is 
not a significant risk device, the sponsor shall submit a final report 
to all reviewing IRB's within 6 months after termination or completion.
    (8) Informed consent. A sponsor shall submit to FDA a copy of any 
report by an investigator under paragraph (a)(5) of this section of use 
of a device without obtaining informed consent, within 5 working days of 
receipt of notice of such use.
    (9) Significant risk device determinations. If an IRB determines 
that a device is a significant risk device, and the sponsor had proposed 
that the IRB consider the device not to be a significant risk device, 
the sponsor shall submit to FDA a report of the IRB's determination 
within 5 working days after the sponsor first learns of the IRB's 
determination.
    (10) Other. A sponsor shall, upon request by a reviewing IRB or FDA, 
provide accurate, complete, and current information about any aspect of 
the investigation.

[45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58843, Sept. 5, 1980; 48 
FR 15622, Apr. 12, 1983; 62 FR 48948, Sept. 18, 1997]

                           PART 813 [RESERVED]



PART 814_PREMARKET APPROVAL OF MEDICAL DEVICES--Table of Contents



                            Subpart A_General

Sec.
814.1 Scope.
814.2 Purpose.
814.3 Definitions.
814.9 Confidentiality of data and information in a premarket approval 
          application (PMA) file.
814.15 Research conducted outside the United States.
814.17 Service of orders.
814.19 Product development protocol (PDP).

             Subpart B_Premarket Approval Application (PMA)

814.20 Application.
814.37 PMA amendments and resubmitted PMAs.
814.39 PMA supplements.

                      Subpart C_FDA Action on a PMA

814.40 Time frames for reviewing a PMA.
814.42 Filing a PMA.
814.44 Procedures for review of a PMA.

[[Page 147]]

814.45 Denial of approval of a PMA.
814.46 Withdrawal of approval of a PMA.
814.47 Temporary suspension of approval of a PMA.

Subpart D--Administrative Review [Reserved]

                   Subpart E_Postapproval Requirements

814.80 General.
814.82 Postapproval requirements.
814.84 Reports.

Subparts F-G [Reserved]

                   Subpart H_Humanitarian Use Devices

814.100 Purpose and scope.
814.102 Designation of HUD status.
814.104 Original applications.
814.106 HDE amendments and resubmitted HDE's.
814.108 Supplemental applications.
814.110 New indications for use.
814.112 Filing an HDE.
814.114 Timeframes for reviewing an HDE.
814.116 Procedures for review of an HDE.
814.118 Denial of approval or withdrawal of approval of an HDE.
814.120 Temporary suspension of approval of an HDE.
814.122 Confidentiality of data and information.
814.124 Institutional Review Board requirements.
814.126 Postapproval requirements and reports.

    Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b, 371, 
372, 373, 374, 375, 379, 379e, 379k-1, 381.

    Source: 51 FR 26364, July 22, 1986, unless otherwise noted.



                            Subpart A_General



Sec. 814.1  Scope.

    (a) This section implements sections 515 and 515A of the act by 
providing procedures for the premarket approval of medical devices 
intended for human use.
    (b) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.
    (c) This part applies to any class III medical device, unless exempt 
under section 520(g) of the act, that:
    (1) Was not on the market (introduced or delivered for introduction 
into commerce for commercial distribution) before May 28, 1976, and is 
not substantially equivalent to a device on the market before May 28, 
1976, or to a device first marketed on, or after that date, which has 
been classified into class I or class II; or
    (2) Is required to have an approved premarket approval application 
(PMA) or a declared completed product development protocol under a 
regulation issued under section 515(b) of the act; or
    (3) Was regulated by FDA as a new drug or antibiotic drug before May 
28, 1976, and therefore is governed by section 520(1) of the act.
    (d) This part amends the conditions to approval for any PMA approved 
before the effective date of this part. Any condition to approval for an 
approved PMA that is inconsistent with this part is revoked. Any 
condition to approval for an approved PMA that is consistent with this 
part remains in effect.

[51 FR 26364, July 22, 1986, as amended at 79 FR 1740, Jan. 10, 2014]



Sec. 814.2  Purpose.

    The purpose of this part is to establish an efficient and thorough 
device review process--
    (a) To facilitate the approval of PMA's for devices that have been 
shown to be safe and effective and that otherwise meet the statutory 
criteria for approval; and
    (b) To ensure the disapproval of PMA's for devices that have not 
been shown to be safe and effective or that do not otherwise meet the 
statutory criteria for approval. This part shall be construed in light 
of these objectives.



Sec. 814.3  Definitions.

    For the purposes of this part:
    (a) Act means the Federal Food, Drug, and Cosmetic Act (sections 
201-902, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321-392)).
    (b) FDA means the Food and Drug Administration.
    (c) IDE means an approved or considered approved investigational 
device exemption under section 520(g) of the act and parts 812 and 813.
    (d) Master file means a reference source that a person submits to 
FDA. A

[[Page 148]]

master file may contain detailed information on a specific manufacturing 
facility, process, methodology, or component used in the manufacture, 
processing, or packaging of a medical device.
    (e) PMA means any premarket approval application for a class III 
medical device, including all information submitted with or incorporated 
by reference therein. ``PMA'' includes a new drug application for a 
device under section 520(1) of the act.
    (f) PMA amendment means information an applicant submits to FDA to 
modify a pending PMA or a pending PMA supplement.
    (g) PMA supplement means a supplemental application to an approved 
PMA for approval of a change or modification in a class III medical 
device, including all information submitted with or incorporated by 
reference therein.
    (h) Person includes any individual, partnership, corporation, 
association, scientific or academic establishment, Government agency, or 
organizational unit thereof, or any other legal entity.
    (i) Statement of material fact means a representation that tends to 
show that the safety or effectiveness of a device is more probable than 
it would be in the absence of such a representation. A false affirmation 
or silence or an omission that would lead a reasonable person to draw a 
particular conclusion as to the safety or effectiveness of a device also 
may be a false statement of material fact, even if the statement was not 
intended by the person making it to be misleading or to have any 
probative effect.
    (j) 30-day PMA supplement means a supplemental application to an 
approved PMA in accordance with Sec. 814.39(e).
    (k) Reasonable probability means that it is more likely than not 
that an event will occur.
    (l) Serious, adverse health consequences means any significant 
adverse experience, including those which may be either life-threatening 
or involve permanent or long term injuries, but excluding injuries that 
are nonlife-threatening and that are temporary and reasonably 
reversible.
    (m) HDE means a premarket approval application submitted pursuant to 
this subpart seeking a humanitarian device exemption from the 
effectiveness requirements of sections 514 and 515 of the act as 
authorized by section 520(m)(2) of the act.
    (n) HUD (humanitarian use device) means a medical device intended to 
benefit patients in the treatment or diagnosis of a disease or condition 
that affects or is manifested in not more than 8,000 individuals in the 
United States per year.
    (o) Newly acquired information means data, analyses, or other 
information not previously submitted to the agency, which may include 
(but are not limited to) data derived from new clinical studies, reports 
of adverse events, or new analyses of previously submitted data (e.g., 
meta-analyses) if the studies, events or analyses reveal risks of a 
different type or greater severity or frequency than previously included 
in submissions to FDA.
    (p) Human cell, tissue, or cellular or tissue-based product (HCT/P) 
regulated as a device means an HCT/P as defined in Sec. 1271.3(d) of 
this chapter that does not meet the criteria in Sec. 1271.10(a) and 
that is also regulated as a device.
    (q) Unique device identifier (UDI) means an identifier that 
adequately identifies a device through its distribution and use by 
meeting the requirements of Sec. 830.20 of this chapter. A unique 
device identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies the specific version or model of a device and the labeler of 
that device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (v) For an HCT/P regulated as a device, the distinct identification 
code required by Sec. 1271.290(c) of this chapter.

[[Page 149]]

    (r) Universal product code (UPC) means the product identifier used 
to identify an item sold at retail in the United States.
    (s) Pediatric patients means patients who are 21 years of age or 
younger (that is, from birth through the twenty-first year of life, up 
to but not including the twenty-second birthday) at the time of the 
diagnosis or treatment.
    (t) Readily available means available in the public domain through 
commonly used public resources for conducting biomedical, regulatory, 
and medical product research.

[51 FR 26364, July 22, 1986, as amended at 61 FR 15190, Apr. 5, 1996; 61 
FR 33244, June 26, 1996; 73 FR 49610, Aug. 22, 2008; 78 FR 58821, Sept. 
24, 2013; 79 FR 1740, Jan. 10, 2014; 82 FR 26349, June 7, 2017]



Sec. 814.9  Confidentiality of data and information in a premarket
approval application (PMA) file.

    (a) A ``PMA file'' includes all data and information submitted with 
or incorporated by reference in the PMA, any IDE incorporated into the 
PMA, any PMA supplement, any report under Sec. 814.82, any master file, 
or any other related submission. Any record in the PMA file will be 
available for public disclosure in accordance with the provisions of 
this section and part 20. The confidentiality of information in a color 
additive petition submitted as part of a PMA is governed by Sec. 71.15.
    (b) The existence of a PMA file may not be disclosed by FDA before 
an approval order is issued to the applicant unless it previously has 
been publicly disclosed or acknowledged.
    (c) If the existence of a PMA file has not been publicly disclosed 
or acknowledged, data or information in the PMA file are not available 
for public disclosure.
    (d)(1) If the existence of a PMA file has been publicly disclosed or 
acknowledged before an order approving, or an order denying approval of 
the PMA is issued, data or information contained in the file are not 
available for public disclosure before such order issues. FDA may, 
however, disclose a summary of portions of the safety and effectiveness 
data before an approval order or an order denying approval of the PMA 
issues if disclosure is relevant to public consideration of a specific 
pending issue.
    (2) Notwithstanding paragraph (d)(1) of this section, FDA will make 
available to the public upon request the information in the IDE that was 
required to be filed in Docket Number 95S-0158 in the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857, for investigations 
involving an exception from informed consent under Sec. 50.24 of this 
chapter. Persons wishing to request this information shall submit a 
request under the Freedom of Information Act.
    (e) Upon issuance of an order approving, or an order denying 
approval of any PMA, FDA will make available to the public the fact of 
the existence of the PMA and a detailed summary of information submitted 
to FDA respecting the safety and effectiveness of the device that is the 
subject of the PMA and that is the basis for the order.
    (f) After FDA issues an order approving, or an order denying 
approval of any PMA, the following data and information in the PMA file 
are immediately available for public disclosure:
    (1) All safety and effectiveness data and information previously 
disclosed to the public, as such disclosure is defined in Sec. 20.81.
    (2) Any protocol for a test or study unless the protocol is shown to 
constitute trade secret or confidential commercial or financial 
information under Sec. 20.61.
    (3) Any adverse reaction report, product experience report, consumer 
complaint, and other similar data and information, after deletion of:
    (i) Any information that constitutes trade secret or confidential 
commercial or financial information under Sec. 20.61; and
    (ii) Any personnel, medical, and similar information disclosure of 
which would constitute a clearly unwarranted invasion of personal 
privacy under Sec. 20.63; provided, however, that except for the 
information that constitutes trade secret or confidential commercial or 
financial information under Sec. 20.61, FDA will disclose to a patient 
who requests a report all the information in the report concerning that 
patient.

[[Page 150]]

    (4) A list of components previously disclosed to the public, as such 
disclosure is defined in Sec. 20.81.
    (5) An assay method or other analytical method, unless it does not 
serve any regulatory purpose and is shown to fall within the exemption 
in Sec. 20.61 for trade secret or confidential commercial or financial 
information.
    (6) All correspondence and written summaries of oral discussions 
relating to the PMA file, in accordance with the provisions of 
Sec. Sec. 20.103 and 20.104.
    (g) All safety and effectiveness data and other information not 
previously disclosed to the public are available for public disclosure 
if any one of the following events occurs and the data and information 
do not constitute trade secret or confidential commercial or financial 
information under Sec. 20.61:
    (1) The PMA has been abandoned. FDA will consider a PMA abandoned 
if:
    (i)(A) The applicant fails to respond to a request for additional 
information within 180 days after the date FDA issues the request or
    (B) Other circumstances indicate that further work is not being 
undertaken with respect to it, and
    (ii) The applicant fails to communicate with FDA within 7 days after 
the date on which FDA notifies the applicant that the PMA appears to 
have been abandoned.
    (2) An order denying approval of the PMA has issued, and all legal 
appeals have been exhausted.
    (3) An order withdrawing approval of the PMA has issued, and all 
legal appeals have been exhausted.
    (4) The device has been reclassified.
    (5) The device has been found to be substantially equivalent to a 
class I or class II device.
    (6) The PMA is considered voluntarily withdrawn under Sec. 
814.44(g).
    (h) The following data and information in a PMA file are not 
available for public disclosure unless they have been previously 
disclosed to the public, as such disclosure is defined in Sec. 20.81, 
or they relate to a device for which a PMA has been abandoned and they 
no longer represent a trade secret or confidential commercial or 
financial information as defined in Sec. 20.61:
    (1) Manufacturing methods or processes, including quality control 
procedures.
    (2) Production, sales, distribution, and similar data and 
information, except that any compilation of such data and information 
aggregated and prepared in a way that does not reveal data or 
information which are not available for public disclosure under this 
provision is available for public disclosure.
    (3) Quantitative or semiquantitative formulas.

[51 FR 26364, July 22, 1986, as amended at 61 FR 51531, Oct. 2, 1996]



Sec. 814.15  Research conducted outside the United States.

    (a) Data to support PMA. If data from clinical investigations 
conducted outside the United States are submitted to support a PMA, the 
applicant shall comply with the provisions in Sec. 812.28 of this 
chapter, as applicable.
    (b) As sole basis for marketing approval. A PMA based solely on 
foreign clinical data and otherwise meeting the criteria for approval 
under this part may be approved if:
    (1) The foreign data are applicable to the U.S. population and U.S. 
medical practice;
    (2) The studies have been performed by clinical investigators of 
recognized competence; and
    (3) The data may be considered valid without the need for an on-site 
inspection by FDA or, if FDA considers such an inspection to be 
necessary, FDA can validate the data through an on-site inspection or 
other appropriate means.
    (c) Consultation between FDA and applicants. Applicants are 
encouraged to meet with FDA officials in a ``presubmission'' meeting 
when approval based solely on foreign data will be sought.

[51 FR 26364, July 22, 1986; 51 FR 40415, Nov. 7, 1986, as amended at 51 
FR 43344, Dec. 2, 1986; 83 FR 7387, Feb. 21, 2018]



Sec. 814.17  Service of orders.

    Orders issued under this part will be served in person by a 
designated officer or employee of FDA on, or by registered mail to, the 
applicant or the designated agent at the applicant's or

[[Page 151]]

designated agent's last known address in FDA's records.



Sec. 814.19  Product development protocol (PDP).

    A class III device for which a product development protocol has been 
declared completed by FDA under this chapter will be considered to have 
an approved PMA.



             Subpart B_Premarket Approval Application (PMA)



Sec. 814.20  Application.

    (a) The applicant or an authorized representative shall sign the 
PMA. If the applicant does not reside or have a place of business within 
the United States, the PMA shall be countersigned by an authorized 
representative residing or maintaining a place of business in the United 
States and shall identify the representative's name and address.
    (b) Unless the applicant justifies an omission in accordance with 
paragraph (d) of this section, a PMA shall include in electronic format:
    (1) The name and address of the applicant.
    (2) A table of contents that specifies the volume and page number 
for each item referred to in the table. A PMA shall include separate 
sections on nonclinical laboratory studies and on clinical 
investigations involving human subjects. A PMA shall be submitted as a 
single version. The applicant shall include information that it believes 
to be trade secret or confidential commercial or financial information 
in the PMA and identify the information that it believes to be trade 
secret or confidential commercial or financial information.
    (3) A summary in sufficient detail that the reader may gain a 
general understanding of the data and information in the application. 
The summary shall contain the following information:
    (i) Indications for use. A general description of the disease or 
condition the device will diagnose, treat, prevent, cure, or mitigate, 
including a description of the patient population for which the device 
is intended.
    (ii) Device description. An explanation of how the device functions, 
the basic scientific concepts that form the basis for the device, and 
the significant physical and performance characteristics of the device. 
A brief description of the manufacturing process should be included if 
it will significantly enhance the reader's understanding of the device. 
The generic name of the device as well as any proprietary name or trade 
name should be included.
    (iii) Alternative practices and procedures. A description of 
existing alternative practices or procedures for diagnosing, treating, 
preventing, curing, or mitigating the disease or condition for which the 
device is intended.
    (iv) Marketing history. A brief description of the foreign and U.S. 
marketing history, if any, of the device, including a list of all 
countries in which the device has been marketed and a list of all 
countries in which the device has been withdrawn from marketing for any 
reason related to the safety or effectiveness of the device. The 
description shall include the history of the marketing of the device by 
the applicant and, if known, the history of the marketing of the device 
by any other person.
    (v) Summary of studies. An abstract of any information or report 
described in the PMA under paragraph (b)(8)(ii) of this section and a 
summary of the results of technical data submitted under paragraph 
(b)(6) of this section. Such summary shall include a description of the 
objective of the study, a description of the experimental design of the 
study, a brief description of how the data were collected and analyzed, 
and a brief description of the results, whether positive, negative, or 
inconclusive. This section shall include the following:
    (A) A summary of the nonclinical laboratory studies submitted in the 
application;
    (B) A summary of the clinical investigations involving human 
subjects submitted in the application including a discussion of subject 
selection and exclusion criteria, study population, study period, safety 
and effectiveness data, adverse reactions and complications, patient 
discontinuation, patient complaints, device failures and replacements, 
results of statistical analyses of

[[Page 152]]

the clinical investigations, contraindications and precautions for use 
of the device, and other information from the clinical investigations as 
appropriate (any investigation conducted under an IDE shall be 
identified as such).
    (vi) Conclusions drawn from the studies. A discussion demonstrating 
that the data and information in the application constitute valid 
scientific evidence within the meaning of Sec. 860.7 and provide 
reasonable assurance that the device is safe and effective for its 
intended use. A concluding discussion shall present benefit and risk 
considerations related to the device including a discussion of any 
adverse effects of the device on health and any proposed additional 
studies or surveillance the applicant intends to conduct following 
approval of the PMA.
    (4) A complete description of:
    (i) The device, including pictorial representations;
    (ii) Each of the functional components or ingredients of the device 
if the device consists of more than one physical component or 
ingredient;
    (iii) The properties of the device relevant to the diagnosis, 
treatment, prevention, cure, or mitigation of a disease or condition;
    (iv) The principles of operation of the device; and
    (v) The methods used in, and the facilities and controls used for, 
the manufacture, processing, packing, storage, and, where appropriate, 
installation of the device, in sufficient detail so that a person 
generally familiar with current good manufacturing practice can make a 
knowledgeable judgment about the quality control used in the manufacture 
of the device.
    (5) Reference to any performance standard under section 514 of the 
Federal Food, Drug, and Cosmetic Act or under section 534 of Subchapter 
C--Electronic Product Radiation Control of the Federal Food, Drug, and 
Cosmetic Act (formerly the Radiation Control for Health and Safety Act 
of 1968) in effect or proposed at the time of the submission and to any 
voluntary standard that is relevant to any aspect of the safety or 
effectiveness of the device and that is known to or that should 
reasonably be known to the applicant. The applicant shall--
    (i) Provide adequate information to demonstrate how the device 
meets, or justify any deviation from, any performance standard 
established under section 514 of the Federal Food, Drug, and Cosmetic 
Act or under section 534 of Subchapter C--Electronic Product Radiation 
Control of the Federal Food, Drug, and Cosmetic Act (formerly the 
Radiation Control for Health and Safety Act of 1968); and
    (ii) Explain any deviation from a voluntary standard.
    (6) The following technical sections which shall contain data and 
information in sufficient detail to permit FDA to determine whether to 
approve or deny approval of the application:
    (i) A section containing results of the nonclinical laboratory 
studies with the device including microbiological, toxicological, 
immunological, biocompatibility, stress, wear, shelf life, and other 
laboratory or animal tests as appropriate. Information on nonclinical 
laboratory studies shall include a statement that each such study was 
conducted in compliance with part 58, or, if the study was not conducted 
in compliance with such regulations, a brief statement of the reason for 
the noncompliance.
    (ii) A section containing results of the clinical investigations 
involving human subjects with the device including clinical protocols, 
number of investigators and subjects per investigator, subject selection 
and exclusion criteria, study population, study period, safety and 
effectiveness data, adverse reactions and complications, patient 
discontinuation, patient complaints, device failures and replacements, 
tabulations of data from all individual subject report forms and copies 
of such forms for each subject who died during a clinical investigation 
or who did not complete the investigation, results of statistical 
analyses of the clinical investigations, device failures and 
replacements, contraindications and precautions for use of the device, 
and any other appropriate information from the clinical investigations. 
Any investigation conducted under an IDE shall be

[[Page 153]]

identified as such. Information on clinical investigations involving 
human subjects shall include the following:
    (A) For clinical investigations conducted in the United States, a 
statement with respect to each investigation that it either was 
conducted in compliance with the institutional review board regulations 
in part 56 of this chapter, or was not subject to the regulations under 
Sec. 56.104 or Sec. 56.105, and that it was conducted in compliance 
with the informed consent regulations in part 50 of this chapter; or if 
the investigation was not conducted in compliance with those 
regulations, a brief statement of the reason for the noncompliance. 
Failure or inability to comply with these requirements does not justify 
failure to provide information on a relevant clinical investigation.
    (B) For clinical investigations conducted in the United States, a 
statement that each investigation was conducted in compliance with part 
812 of this chapter concerning sponsors of clinical investigations and 
clinical investigators, or if the investigation was not conducted in 
compliance with those regulations, a brief statement of the reason for 
the noncompliance. Failure or inability to comply with these 
requirements does not justify failure to provide information on a 
relevant clinical investigation.
    (C) For clinical investigations conducted outside the United States 
that are intended to support the PMA, the requirements under Sec. 
812.28 of this chapter apply. If any such investigation was not 
conducted in accordance with good clinical practice (GCP) as described 
in Sec. 812.28(a), include either a waiver request in accordance with 
Sec. 812.28(c) or a brief statement of the reason for not conducting 
the investigation in accordance with GCP and a description of steps 
taken to ensure that the data and results are credible and accurate and 
that the rights, safety, and well-being of subjects have been adequately 
protected. Failure or inability to comply with these requirements does 
not justify failure to provide information on a relevant clinical 
investigation.
    (7) For a PMA supported solely by data from one investigation, a 
justification showing that data and other information from a single 
investigator are sufficient to demonstrate the safety and effectiveness 
of the device and to ensure reproducibility of test results.
    (8)(i) A bibliography of all published reports not submitted under 
paragraph (b)(6) of this section, whether adverse or supportive, known 
to or that should reasonably be known to the applicant and that concern 
the safety or effectiveness of the device.
    (ii) An identification, discussion, and analysis of any other data, 
information, or report relevant to an evaluation of the safety and 
effectiveness of the device known to or that should reasonably be known 
to the applicant from any source, foreign or domestic, including 
information derived from investigations other than those proposed in the 
application and from commercial marketing experience.
    (iii) Copies of such published reports or unpublished information in 
the possession of or reasonably obtainable by the applicant if an FDA 
advisory committee or FDA requests.
    (9) One or more samples of the device and its components, if 
requested by FDA. If it is impractical to submit a requested sample of 
the device, the applicant shall name the location at which FDA may 
examine and test one or more devices.
    (10) Copies of all proposed labeling for the device. Such labeling 
may include, e.g., instructions for installation and any information, 
literature, or advertising that constitutes labeling under section 
201(m) of the Federal Food, Drug, and Cosmetic Act.
    (11) An environmental assessment under Sec. 25.20(n) prepared in 
the applicable format in Sec. 25.40, unless the action qualifies for 
exclusion under Sec. 25.30 or Sec. 25.34. If the applicant believes 
that the action qualifies for exclusion, the PMA shall under Sec. 
25.15(a) and (d) provide information that establishes to FDA's 
satisfaction that the action requested is included within the excluded 
category and meets the criteria for the applicable exclusion.
    (12) A financial certification or disclosure statement or both as 
required by part 54 of this chapter.

[[Page 154]]

    (13) Information concerning uses in pediatric patients. The 
application must include the following information, if readily 
available:
    (i) A description of any pediatric subpopulations (neonates, 
infants, children, adolescents) that suffer from the disease or 
condition that the device is intended to treat, diagnose, or cure; and
    (ii) The number of affected pediatric patients.
    (14) Such other information as FDA may request. If necessary, FDA 
will obtain the concurrence of the appropriate FDA advisory committee 
before requesting additional information.
    (c) Pertinent information in FDA files specifically referred to by 
an applicant may be incorporated into a PMA by reference. Information in 
a master file or other information submitted to FDA by a person other 
than the applicant will not be considered part of a PMA unless such 
reference is authorized in a record submitted to FDA by the person who 
submitted the information or the master file. If a master file is not 
referenced within 5 years after the date that it is submitted to FDA, 
FDA will return the master file to the person who submitted it.
    (d) If the applicant believes that certain information required 
under paragraph (b) of this section to be in a PMA is not applicable to 
the device that is the subject of the PMA, and omits any such 
information from its PMA, the applicant shall submit a statement that 
identifies the omitted information and justifies the omission. The 
statement shall be submitted as a separate section in the PMA and 
identified in the table of contents. If the justification for the 
omission is not accepted by the agency, FDA will so notify the 
applicant.
    (e) The applicant shall periodically update its pending application 
with new safety and effectiveness information learned about the device 
from ongoing or completed studies that may reasonably affect an 
evaluation of the safety or effectiveness of the device or that may 
reasonably affect the statement of contraindications, warnings, 
precautions, and adverse reactions in the draft labeling. The update 
report shall be consistent with the data reporting provisions of the 
protocol. The applicant shall submit any update report in electronic 
format and shall include in the report the number assigned by FDA to the 
PMA. These updates are considered to be amendments to the PMA. The time 
frame for review of a PMA will not be extended due to the submission of 
an update report unless the update is a major amendment under Sec. 
814.37(c)(1). The applicant shall submit these reports--
    (1) 3 months after the filing date;
    (2) Following receipt of an approvable letter; and
    (3) At any other time as requested by FDA.
    (f) If a color additive subject to section 721 of the Federal Food, 
Drug, and Cosmetic Act is used in or on the device and has not 
previously been listed for such use, then, in lieu of submitting a color 
additive petition under part 71 of this chapter, at the option of the 
applicant, the information required to be submitted under part 71 may be 
submitted as part of the PMA. When submitted as part of the PMA, the 
information shall be submitted in electronic format. A PMA for a device 
that contains a color additive that is subject to section 721 of the 
Federal Food, Drug, and Cosmetic Act will not be approved until the 
color additive is listed for use in or on the device.
    (g) Additional information on FDA policies and procedures, as well 
as links to PMA guidance documents, is available on the Internet at 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/
default.htm.
    (h) If you are sending a PMA, PMA amendment, PMA supplement, or 
correspondence with respect to a PMA, you must send the submission to 
the appropriate address as follows:
    (1) For devices regulated by the Center for Devices and Radiological 
Health, send it to the current address displayed on the website https://
www.fda.gov/cdrhsubmissionaddress.
    (2) For devices regulated by the Center for Biologics Evaluation and 
Research, send it to the current address displayed on the website 
https://

[[Page 155]]

www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/
CBER/ucm385240.htm.
    (3) For devices regulated by the Center for Drug Evaluation and 
Research, send it to: Central Document Control Room, Center for Drug 
Evaluation and Research, Food and Drug Administration, 5901-B Ammendale 
Rd., Beltsville, MD 20705-1266.

[51 FR 26364, July 22, 1986; 51 FR 40415, Nov. 7, 1986, as amended at 51 
FR 43344, Dec. 2, 1986; 55 FR 11169, Mar. 27, 1990; 62 FR 40600, July 
29, 1997; 63 FR 5253, Feb. 2, 1998; 65 FR 17137, Mar. 31, 2000; 65 FR 
56480, Sept. 19, 2000; 67 FR 9587, Mar. 4, 2002; 71 FR 42048, July 25, 
2006; 72 FR 17399, Apr. 9, 2007; 73 FR 34859, June 19, 2008; 74 FR 
14478, Mar. 31, 2009; 75 FR 20915, Apr. 22, 2010; 78 FR 18233, Mar. 26, 
2013; 79 FR 1740, Jan. 10, 2014; 80 FR 18094, Apr. 3, 2015; 83 FR 7387, 
Feb. 21, 2018; 84 FR 68339, Dec. 16, 2019]



Sec. 814.37  PMA amendments and resubmitted PMAs.

    (a) An applicant may amend a pending PMA or PMA supplement to revise 
existing information or provide additional information.
    (b)(1) FDA may request the applicant to amend a PMA or PMA 
supplement with any information regarding the device that is necessary 
for FDA or the appropriate advisory committee to complete the review of 
the PMA or PMA supplement.
    (2) FDA may request the applicant to amend a PMA or PMA supplement 
with information concerning pediatric uses as required under Sec. Sec. 
814.20(b)(13) and 814.39(c)(2).
    (c) A PMA amendment submitted to FDA shall include the PMA or PMA 
supplement number assigned to the original submission and, if submitted 
on the applicant's own initiative, the reason for submitting the 
amendment. FDA may extend the time required for its review of the PMA, 
or PMA supplement, as follows:
    (1) If the applicant on its own initiative or at FDA's request 
submits a major PMA amendment (e.g., an amendment that contains 
significant new data from a previously unreported study, significant 
updated data from a previously reported study, detailed new analyses of 
previously submitted data, or significant required information 
previously omitted), the review period may be extended up to 180 days.
    (2) If an applicant declines to submit a major amendment requested 
by FDA, the review period may be extended for the number of days that 
elapse between the date of such request and the date that FDA receives 
the written response declining to submit the requested amendment.
    (d) An applicant may on its own initiative withdraw a PMA or PMA 
supplement. If FDA requests an applicant to submit a PMA amendment and a 
written response to FDA's request is not received within 180 days of the 
date of the request, FDA will consider the pending PMA or PMA supplement 
to be withdrawn voluntarily by the applicant.
    (e) An applicant may resubmit a PMA or PMA supplement after 
withdrawing it or after it is considered withdrawn under paragraph (d) 
of this section, or after FDA has refused to accept it for filing, or 
has denied approval of the PMA or PMA supplement. A resubmitted PMA or 
PMA supplement shall comply with the requirements of Sec. 814.20 or 
Sec. 814.39, respectively, and shall include the PMA number assigned to 
the original submission and the applicant's reasons for resubmission of 
the PMA or PMA supplement.

[51 FR 26364, July 22, 1986, as amended at 79 FR 1740, Jan. 10, 2014]



Sec. 814.39  PMA supplements.

    (a) After FDA's approval of a PMA, an applicant shall submit a PMA 
supplement for review and approval by FDA before making a change 
affecting the safety or effectiveness of the device for which the 
applicant has an approved PMA, unless the change is of a type for which 
FDA, under paragraph (e) of this section, has advised that an alternate 
submission is permitted or is of a type which, under section 
515(d)(6)(A) of the act and paragraph (f) of this section, does not 
require a PMA supplement under this paragraph. While the burden for 
determining whether a supplement is required is primarily on the PMA 
holder, changes for which an applicant shall submit a PMA supplement 
include, but are not limited to, the following types of

[[Page 156]]

changes if they affect the safety or effectiveness of the device:
    (1) New indications for use of the device.
    (2) Labeling changes.
    (3) The use of a different facility or establishment to manufacture, 
process, or package the device.
    (4) Changes in sterilization procedures.
    (5) Changes in packaging.
    (6) Changes in the performance or design specifications, circuits, 
components, ingredients, principle of operation, or physical layout of 
the device.
    (7) Extension of the expiration date of the device based on data 
obtained under a new or revised stability or sterility testing protocol 
that has not been approved by FDA. If the protocol has been approved, 
the change shall be reported to FDA under paragraph (b) of this section.
    (b) An applicant may make a change in a device after FDA's approval 
of a PMA for the device without submitting a PMA supplement if the 
change does not affect the device's safety or effectiveness and the 
change is reported to FDA in postapproval periodic reports required as a 
condition to approval of the device, e.g., an editorial change in 
labeling which does not affect the safety or effectiveness of the 
device.
    (c)(1) All procedures and actions that apply to an application under 
Sec. 814.20 also apply to PMA supplements except that the information 
required in a supplement is limited to that needed to support the 
change. A summary under Sec. 814.20(b)(3) is required for only a 
supplement submitted for new indications for use of the device, 
significant changes in the performance or design specifications, 
circuits, components, ingredients, principles of operation, or physical 
layout of the device, or when otherwise required by FDA. The applicant 
shall submit a PMA supplement in electronic format and shall include 
information relevant to the proposed changes in the device. A PMA 
supplement shall include a separate section that identifies each change 
for which approval is being requested and explains the reason for each 
such change. The applicant shall submit additional information, if 
requested by FDA, in electronic format. The time frames for review of, 
and FDA action on, a PMA supplement are the same as those provided in 
Sec. 814.40 for a PMA.
    (2) The supplement must include the following information:
    (i) Information concerning pediatric uses as required under Sec. 
814.20(b)(13).
    (ii) If information concerning the device that is the subject of the 
supplement was previously submitted under Sec. 814.20(b)(13) or under 
this section in a previous supplement, that information may be included 
by referencing a previous application or submission that contains the 
information. However, if additional information required under Sec. 
814.20(b)(13) has become readily available to the applicant since the 
previous submission, the applicant must submit that information as part 
of the supplement.
    (d)(1) After FDA approves a PMA, any change described in paragraph 
(d)(2) of this section to reflect newly acquired information that 
enhances the safety of the device or the safety in the use of the device 
may be placed into effect by the applicant prior to the receipt under 
Sec. 814.17 of a written FDA order approving the PMA supplement 
provided that:
    (i) The PMA supplement and its mailing cover are plainly marked 
``Special PMA Supplement--Changes Being Effected'';
    (ii) The PMA supplement provides a full explanation of the basis for 
the changes;
    (iii) The applicant has received acknowledgement from FDA of receipt 
of the supplement; and
    (iv) The PMA supplement specifically identifies the date that such 
changes are being effected.
    (2) The following changes are permitted by paragraph (d)(1) of this 
section:
    (i) Labeling changes that add or strengthen a contraindication, 
warning, precaution, or information about an adverse reaction for which 
there is reasonable evidence of a causal association.
    (ii) Labeling changes that add or strengthen an instruction that is 
intended to enhance the safe use of the device.

[[Page 157]]

    (iii) Labeling changes that delete misleading, false, or unsupported 
indications.
    (iv) Changes in quality controls or manufacturing process that add a 
new specification or test method, or otherwise provide additional 
assurance of purity, identity, strength, or reliability of the device.
    (e)(1) FDA will identify a change to a device for which an applicant 
has an approved PMA and for which a PMA supplement under paragraph (a) 
is not required. FDA will identify such a change in an advisory opinion 
under Sec. 10.85, if the change applies to a generic type of device, or 
in correspondence to the applicant, if the change applies only to the 
applicant's device. FDA will require that a change for which a PMA 
supplement under paragraph (a) is not required be reported to FDA in:
    (i) A periodic report under Sec. 814.84 or
    (ii) A 30-day PMA supplement under this paragraph.
    (2) FDA will identify, in the advisory opinion or correspondence, 
the type of information that is to be included in the report or 30-day 
PMA supplement. If the change is required to be reported to FDA in a 
periodic report, the change may be made before it is reported to FDA. If 
the change is required to be reported in a 30-day PMA supplement, the 
change may be made 30 days after FDA files the 30-day PMA supplement 
unless FDA requires the PMA holder to provide additional information, 
informs the PMA holder that the supplement is not approvable, or 
disapproves the supplement. The 30-day PMA supplement shall follow the 
instructions in the correspondence or advisory opinion. Any 30-day PMA 
supplement that does not meet the requirements of the correspondence or 
advisory opinion will not be filed and, therefore, will not be deemed 
approved 30 days after receipt.
    (f) Under section 515(d) of the act, modifications to manufacturing 
procedures or methods of manufacture that affect the safety and 
effectiveness of a device subject to an approved PMA do not require 
submission of a PMA supplement under paragraph (a) of this section and 
are eligible to be the subject of a 30-day notice. A 30-day notice shall 
describe in detail the change, summarize the data or information 
supporting the change, and state that the change has been made in 
accordance with the requirements of part 820 of this chapter. The 
manufacturer may distribute the device 30 days after the date on which 
FDA receives the 30-day notice, unless FDA notifies the applicant within 
30 days from receipt of the notice that the notice is not adequate. If 
the notice is not adequate, FDA shall inform the applicant in writing 
that a 135-day PMA supplement is needed and shall describe what further 
information or action is required for acceptance of such change. The 
number of days under review as a 30-day notice shall be deducted from 
the 135-day PMA supplement review period if the notice meets appropriate 
content requirements for a PMA supplement.
    (g) The submission and grant of a written request for an exception 
or alternative under Sec. 801.128 or Sec. 809.11 of this chapter 
satisfies the requirement in paragraph (a) of this section.

[51 FR 26364, July 22, 1986, as amended at 51 FR 43344, Dec. 2, 1986; 63 
FR 54044, Oct. 8, 1998; 67 FR 9587, Mar. 4, 2002; 69 FR 11313, Mar. 10, 
2004; 72 FR 73602, Dec. 28, 2007; 73 FR 49610, Aug. 22, 2008; 79 FR 
1740, Jan. 10, 2014; 84 FR 68340, Dec. 16, 2019]



                      Subpart C_FDA Action on a PMA



Sec. 814.40  Time frames for reviewing a PMA.

    Within 180 days after receipt of an application that is accepted for 
filing and to which the applicant does not submit a major amendment, FDA 
will review the PMA and, after receiving the report and recommendation 
of the appropriate FDA advisory committee, send the applicant an 
approval order under Sec. 814.44(d), an approvable letter under Sec. 
814.44(e), a not approvable letter under Sec. 814.44(f), or an order 
denying approval under Sec. 814.45. The approvable letter and the not 
approvable letter will provide an opportunity for the applicant to amend 
or withdraw the application, or to consider the letter to be a denial of 
approval of the PMA

[[Page 158]]

under Sec. 814.45 and to request administrative review under section 
515 (d)(4) and (g) of the act.

[51 FR 26364, July 22, 1986, as amended at 87 FR 2045, Jan. 13, 2022]



Sec. 814.42  Filing a PMA.

    (a) The filing of an application means that FDA has made a threshold 
determination that the application is sufficiently complete to permit a 
substantive review. Within 45 days after a PMA is received by FDA, the 
agency will notify the applicant whether the application has been filed.
    (b) If FDA does not find that any of the reasons in paragraph (e) of 
this section for refusing to file the PMA applies, the agency will file 
the PMA and will notify the applicant in writing of the filing. The 
notice will include the PMA reference number and the date FDA filed the 
PMA. The date of filing is the date that a PMA accepted for filing was 
received by the agency. The 180-day period for review of a PMA starts on 
the date of filing.
    (c) If FDA refuses to file a PMA, the agency will notify the 
applicant of the reasons for the refusal. This notice will identify the 
deficiencies in the application that prevent filing and will include the 
PMA reference number.
    (d) If FDA refuses to file the PMA, the applicant may:
    (1) Resubmit the PMA with additional information necessary to comply 
with the requirements of section 515(c)(1) (A)-(G) of the act and Sec. 
814.20. A resubmitted PMA shall include the PMA reference number of the 
original submission. If the resubmitted PMA is accepted for filing, the 
date of filing is the date FDA receives the resubmission;
    (2) Request in writing within 10 working days of the date of receipt 
of the notice refusing to file the PMA, an informal conference with the 
Director of the associated Office of Health Technology to review FDA's 
decision not to file the PMA. FDA will hold the informal conference 
within 10 working days of its receipt of the request and will render its 
decision on filing within 5 working days after the informal conference. 
If, after the informal conference, FDA accepts the PMA for filing, the 
date of filing will be the date of the decision to accept the PMA for 
filing. If FDA does not reverse its decision not to file the PMA, the 
applicant may request reconsideration of the decision from the Director 
of the Office of Product Evaluation and Quality, the Director of the 
Center for Biologics Evaluation and Research, or the Director of the 
Center for Drug Evaluation and Research, as applicable. The Director's 
decision will constitute final administrative action for the purpose of 
judicial review.
    (e) FDA may refuse to file a PMA if any of the following applies:
    (1) The application is incomplete because it does not on its face 
contain all the information required under section 515(c)(1) (A)-(G) of 
the act;
    (2) The PMA does not contain each of the items required under Sec. 
814.20 and justification for omission of any item is inadequate;
    (3) The applicant has a pending premarket notification under section 
510(k) of the act with respect to the same device, and FDA has not 
determined whether the device falls within the scope of Sec. 814.1(c).
    (4) The PMA contains a false statement of material fact.
    (5) The PMA is not accompanied by a statement of either 
certification or disclosure as required by part 54 of this chapter.

[51 FR 26364, July 22, 1986, as amended at 63 FR 5254, Feb. 2, 1998; 73 
FR 49942, Aug. 25, 2008; 85 FR 18442, Apr. 2, 2020]



Sec. 814.44  Procedures for review of a PMA.

    (a) FDA will begin substantive review of a PMA after the PMA is 
accepted for filing under Sec. 814.42. FDA may refer the PMA to a panel 
on its own initiative, and will do so upon request of an applicant, 
unless FDA determines that the application substantially duplicates 
information previously reviewed by a panel. If FDA refers an application 
to a panel, FDA will forward the PMA, or relevant portions thereof, to 
each member of the appropriate FDA panel for review. During the review 
process, FDA may communicate with the applicant as set forth under Sec. 
814.37(b), or with a panel to respond to questions that may be posed by 
panel members or to provide additional information to

[[Page 159]]

the panel. FDA will maintain a record of all communications with the 
applicant and with the panel.
    (b) The advisory committee shall submit a report to FDA which 
includes the committee's recommendation and the basis for such 
recommendation on the PMA. Before submission of this report, the 
committee shall hold a public meeting to review the PMA in accordance 
with part 14. This meeting may be held by a telephone conference under 
Sec. 14.22(g). The advisory committee report and recommendation may be 
in the form of a meeting transcript signed by the chairperson of the 
committee.
    (c) FDA will complete its review of the PMA and the advisory 
committee report and recommendation and, within the later of 180 days 
from the date of filing of the PMA under Sec. 814.42 or the number of 
days after the date of filing as determined under Sec. 814.37(c), issue 
an approval order under paragraph (d) of this section, an approvable 
letter under paragraph (e) of this section, a not approvable letter 
under paragraph (f) of this section, or an order denying approval of the 
application under Sec. 814.45(a).
    (d)(1) FDA will issue to the applicant an order approving a PMA if 
none of the reasons in Sec. 814.45 for denying approval of the 
application applies. FDA will approve an application on the basis of 
draft final labeling if the only deficiencies in the application concern 
editorial or similar minor deficiencies in the draft final labeling. 
Such approval will be conditioned upon the applicant incorporating the 
specified labeling changes exactly as directed and upon the applicant 
submitting to FDA a copy of the final printed labeling before marketing. 
FDA will also give the public notice of the order, including notice of 
and opportunity for any interested persons to request review under 
section 515(d)(4) of the act. The notice of approval will be placed on 
FDA's home page on the Internet (http://www.fda.gov), and it will state 
that a detailed summary of information respecting the safety and 
effectiveness of the device, which was the basis for the order approving 
the PMA, including information about any adverse effects of the device 
on health, is available on the Internet and has been placed on public 
display, and that copies are available upon request. When a notice of 
approval is published, data and information in the PMA file will be 
available for public disclosure in accordance with Sec. 814.9.
    (2) A request for copies of the current PMA approvals and denials 
document and for copies of summaries of safety and effectiveness shall 
be sent in writing to the Freedom of Information Staff's address listed 
on the Agency's website at https://www.fda.gov.
    (e) FDA will send the applicant an approvable letter if the 
application substantially meets the requirements of this part and the 
agency believes it can approve the application if specific additional 
information is submitted or specific conditions are agreed to by the 
applicant.
    (1) The approvable letter will describe the information FDA requires 
to be provided by the applicant or the conditions the applicant is 
required to meet to obtain approval. For example, FDA may require, as a 
condition to approval:
    (i) The submission of certain information identified in the 
approvable letter, e.g., final labeling;
    (ii) The submission of additional information concerning pediatric 
uses required by Sec. 814.20(b)(13);
    (iii) An FDA inspection that finds the manufacturing facilities, 
methods, and controls in compliance with part 820 and, if applicable, 
that verifies records pertinent to the PMA;
    (iv) Restrictions imposed on the device under section 
515(d)(1)(B)(ii) or 520(e) of the act;
    (v) Postapproval requirements as described in subpart E of this 
part.
    (2) In response to an approvable letter the applicant may:
    (i) Amend the PMA as requested in the approvable letter; or
    (ii) Consider the approvable letter to be a denial of approval of 
the PMA under Sec. 814.45 and request administrative review under 
section 515(d)(4) of the act by filing a petition in the form of a 
petition for reconsideration under Sec. 10.33; or
    (iii) Withdraw the PMA.
    (f) FDA will send the applicant a not approvable letter if the 
agency believes

[[Page 160]]

that the application may not be approved for one or more of the reasons 
given in Sec. 814.45(a). The not approvable letter will describe the 
deficiencies in the application, including each applicable ground for 
denial under section 515(d)(2) (A)-(E) of the act, and, where practical, 
will identify measures required to place the PMA in approvable form. In 
response to a not approvable letter, the applicant may:
    (1) Amend the PMA as requested in the not approvable letter (such an 
amendment will be considered a major amendment under Sec. 
814.37(c)(1)); or
    (2) Consider the not approvable letter to be a denial of approval of 
the PMA under Sec. 814.45 and request administrative review under 
section 515(d)(4) of the act by filing a petition in the form of a 
petition for reconsideration under Sec. 10.33; or
    (3) Withdraw the PMA.
    (g) FDA will consider a PMA to have been withdrawn voluntarily if:
    (1) The applicant fails to respond in writing to a written request 
for an amendment within 180 days after the date FDA issues such request;
    (2) The applicant fails to respond in writing to an approvable or 
not approvable letter within 180 days after the date FDA issues such 
letter; or
    (3) The applicant submits a written notice to FDA that the PMA has 
been withdrawn.

[51 FR 26364, July 22, 1986, as amended at 57 FR 58403, Dec. 10, 1992; 
63 FR 4572, Jan. 30, 1998; 79 FR 1740, Jan. 10, 2014; 87 FR 2045, Jan. 
13, 2022]



Sec. 814.45  Denial of approval of a PMA.

    (a) FDA may issue an order denying approval of a PMA if the 
applicant fails to follow the requirements of this part or if, upon the 
basis of the information submitted in the PMA or any other information 
before the agency, FDA determines that any of the grounds for denying 
approval of a PMA specified in section 515(d)(2) (A)-(E) of the act 
applies. In addition, FDA may deny approval of a PMA for any of the 
following reasons:
    (1) The PMA contains a false statement of material fact;
    (2) The device's proposed labeling does not comply with the 
requirements in part 801 or part 809;
    (3) The applicant does not permit an authorized FDA employee an 
opportunity to inspect at a reasonable time and in a reasonable manner 
the facilities, controls, and to have access to and to copy and verify 
all records pertinent to the application;
    (4) A nonclinical laboratory study that is described in the PMA and 
that is essential to show that the device is safe for use under the 
conditions prescribed, recommended, or suggested in its proposed 
labeling, was not conducted in compliance with the good laboratory 
practice regulations in part 58 and no reason for the noncompliance is 
provided or, if it is, the differences between the practices used in 
conducting the study and the good laboratory practice regulations do not 
support the validity of the study; or
    (5) Any clinical investigation involving human subjects described in 
the PMA, subject to the institutional review board regulations in part 
56 of this chapter or informed consent regulations in part 50 of this 
chapter or GCP referenced in Sec. 814.15(a) and described in Sec. 
812.28(a) of this chapter, was not conducted in compliance with those 
regulations such that the rights or safety of human subjects were not 
adequately protected or the supporting data were determined to be 
otherwise unreliable.
    (b) FDA will issue any order denying approval of the PMA in 
accordance with Sec. 814.17. The order will inform the applicant of the 
deficiencies in the PMA, including each applicable ground for denial 
under section 515(d)(2) of the act and the regulations under this part, 
and, where practical, will identify measures required to place the PMA 
in approvable form. The order will include a notice of an opportunity to 
request review under section 515(d)(4) of the act.
    (c) FDA will use the criteria specified in Sec. 860.7 to determine 
the safety and effectiveness of a device in deciding whether to approve 
or deny approval of a PMA. FDA may use information other than that 
submitted by the applicant in making such determination.
    (d)(1) FDA will give the public notice of an order denying approval 
of the PMA. The notice will be placed on the FDA's home page on the 
Internet

[[Page 161]]

(http://www.fda.gov), and it will state that a detailed summary of 
information respecting the safety and effectiveness of the device, 
including information about any adverse effects of the device on health, 
is available on the Internet and has been placed on public display and 
that copies are available upon request. When a notice of denial of 
approval is made publicly available, data and information in the PMA 
file will be available for public disclosure in accordance with Sec. 
814.9.
    (2) A request for copies of the current PMA approvals and denials 
document and copies of summaries of safety and effectiveness shall be 
sent in writing to the Freedom of Information Staff's address listed on 
the Agency's Web site at http://www.fda.gov.
    (e) FDA will issue an order denying approval of a PMA after an 
approvable or not approvable letter has been sent and the applicant:
    (1) Submits a requested amendment but any ground for denying 
approval of the application under section 515(d)(2) of the act still 
applies; or
    (2) Notifies FDA in writing that the requested amendment will not be 
submitted; or
    (3) Petitions for review under section 515(d)(4) of the act by 
filing a petition in the form of a petition for reconsideration under 
Sec. 10.33.

[51 FR 26364, July 22, 1986, as amended at 63 FR 4572, Jan. 30, 1998; 73 
FR 34859, June 19, 2008; 76 FR 31470, June 1, 2011; 79 FR 68115, Nov. 
14, 2014; 83 FR 7387, Feb. 21, 2018; 87 FR 2045, Jan. 13, 2022]



Sec. 814.46  Withdrawal of approval of a PMA.

    (a) FDA may issue an order withdrawing approval of a PMA if, from 
any information available to the agency, FDA determines that:
    (1) Any of the grounds under section 515(e)(1) (A)-(G) of the act 
applies.
    (2) Any postapproval requirement imposed by the PMA approval order 
or by regulation has not been met.
    (3) A nonclinical laboratory study that is described in the PMA and 
that is essential to show that the device is safe for use under the 
conditions prescribed, recommended, or suggested in its proposed 
labeling, was not conducted in compliance with the good laboratory 
practice regulations in part 58 and no reason for the noncompliance is 
provided or, if it is, the differences between the practices used in 
conducting the study and the good laboratory practice regulations do not 
support the validity of the study.
    (4) Any clinical investigation involving human subjects described in 
the PMA, subject to the institutional review board regulations in part 
56 of this chapter or informed consent regulations in part 50 of this 
chapter or GCP referenced in Sec. 814.15(a) and described in Sec. 
812.28(a) of this chapter, was not conducted in compliance with those 
regulations such that the rights or safety of human subjects were not 
adequately protected or the supporting data were determined to be 
otherwise unreliable.
    (b)(1) FDA may seek advice on scientific matters from any 
appropriate FDA advisory committee in deciding whether to withdraw 
approval of a PMA.
    (2) FDA may use information other than that submitted by the 
applicant in deciding whether to withdraw approval of a PMA.
    (c) Before issuing an order withdrawing approval of a PMA, FDA will 
issue the holder of the approved application a notice of opportunity for 
an informal hearing under part 16.
    (d) If the applicant does not request a hearing or if after the part 
16 hearing is held the agency decides to proceed with the withdrawal, 
FDA will issue to the holder of the approved application an order 
withdrawing approval of the application. The order will be issued under 
Sec. 814.17, will state each ground for withdrawing approval, and will 
include a notice of an opportunity for administrative review under 
section 515(e)(2) of the act.
    (e) FDA will give the public notice of an order withdrawing approval 
of a PMA. The notice will be published in the Federal Register and will 
state that a detailed summary of information respecting the safety and 
effectiveness of the device, including information about any adverse 
effects of the device on health, has been placed on public display and 
that copies are available upon request. When a notice of withdrawal of 
approval is published,

[[Page 162]]

data and information in the PMA file will be available for public 
disclosure in accordance with Sec. 814.9.

[51 FR 26364, July 22, 1986, as amended at 83 FR 7387, Feb. 21, 2018]



Sec. 814.47  Temporary suspension of approval of a PMA.

    (a) Scope. (1) This section describes the procedures that FDA will 
follow in exercising its authority under section 515(e)(3) of the act 
(21 U.S.C. 360e(e)(3)). This authority applies to the original PMA, as 
well as any PMA supplement(s), for a medical device.
    (2) FDA will issue an order temporarily suspending approval of a PMA 
if FDA determines that there is a reasonable probability that continued 
distribution of the device would cause serious, adverse health 
consequences or death.
    (b) Regulatory hearing. (1) If FDA believes that there is a 
reasonable probability that the continued distribution of a device 
subject to an approved PMA would cause serious, adverse health 
consequences or death, FDA may initiate and conduct a regulatory hearing 
to determine whether to issue an order temporarily suspending approval 
of the PMA.
    (2) Any regulatory hearing to determine whether to issue an order 
temporarily suspending approval of a PMA shall be initiated and 
conducted by FDA pursuant to part 16 of this chapter. If FDA believes 
that immediate action to remove a dangerous device from the market is 
necessary to protect the public health, the agency may, in accordance 
with Sec. 16.60(h) of this chapter, waive, suspend, or modify any part 
16 procedure pursuant to Sec. 10.19 of this chapter.
    (3) FDA shall deem the PMA holder's failure to request a hearing 
within the timeframe specified by FDA in the notice of opportunity for 
hearing to be a waiver.
    (c) Temporary suspension order. If the PMA holder does not request a 
regulatory hearing or if, after the hearing, and after consideration of 
the administrative record of the hearing, FDA determines that there is a 
reasonable probability that the continued distribution of a device under 
an approved PMA would cause serious, adverse health consequences or 
death, the agency shall, under the authority of section 515(e)(3) of the 
act, issue an order to the PMA holder temporarily suspending approval of 
the PMA.
    (d) Permanent withdrawal of approval of the PMA. If FDA issues an 
order temporarily suspending approval of a PMA, the agency shall proceed 
expeditiously, but within 60 days, to hold a hearing on whether to 
permanently withdraw approval of the PMA in accordance with section 
515(e)(1) of the act and the procedures set out in Sec. 814.46.

[61 FR 15190, Apr. 5, 1996]

Subpart D--Administrative Review [Reserved]



                   Subpart E_Postapproval Requirements



Sec. 814.80  General.

    A device may not be manufactured, packaged, stored, labeled, 
distributed, or advertised in a manner that is inconsistent with any 
conditions to approval specified in the PMA approval order for the 
device.



Sec. 814.82  Postapproval requirements.

    (a) FDA may impose postapproval requirements in a PMA approval order 
or by regulation at the time of approval of the PMA or by regulation 
subsequent to approval. Postapproval requirements may include as a 
condition to approval of the device:
    (1) Restriction of the sale, distribution, or use of the device as 
provided by section 515(d)(1)(B)(ii) or 520(e) of the act.
    (2) Continuing evaluation and periodic reporting on the safety, 
effectiveness, and reliability of the device for its intended use. FDA 
will state in the PMA approval order the reason or purpose for such 
requirement and the number of patients to be evaluated and the reports 
required to be submitted.
    (3) Prominent display in the labeling of a device and in the 
advertising of any restricted device of warnings, hazards, or 
precautions important for the device's safe and effective use, including 
patient information, e.g., information provided to the patient on 
alternative modes of therapy and on risks

[[Page 163]]

and benefits associated with the use of the device.
    (4) Inclusion of identification codes on the device or its labeling, 
or in the case of an implant, on cards given to patients if necessary to 
protect the public health.
    (5) Maintenance of records that will enable the applicant to submit 
to FDA information needed to trace patients if such information is 
necessary to protect the public health. Under section 519(a)(4) of the 
act, FDA will require that the identity of any patient be disclosed in 
records maintained under this paragraph only to the extent required for 
the medical welfare of the individual, to determine the safety or 
effectiveness of the device, or to verify a record, report, or 
information submitted to the agency.
    (6) Maintenance of records for specified periods of time and 
organization and indexing of records into identifiable files to enable 
FDA to determine whether there is reasonable assurance of the continued 
safety and effectiveness of the device.
    (7) Submission to FDA at intervals specified in the approval order 
of periodic reports containing the information required by Sec. 
814.84(b).
    (8) Batch testing of the device.
    (9) Such other requirements as FDA determines are necessary to 
provide reasonable assurance, or continued reasonable assurance, of the 
safety and effectiveness of the device.
    (b) An applicant shall grant to FDA access to any records and 
reports required under the provisions of this part, and shall permit 
authorized FDA employees to copy and verify such records and reports and 
to inspect at a reasonable time and in a reasonable manner all 
manufacturing facilities to verify that the device is being 
manufactured, stored, labeled, and shipped under approved conditions.
    (c) Failure to comply with any postapproval requirement constitutes 
a ground for withdrawal of approval of a PMA.

(Approved by the Office of Management and Budget under control number 
0910-0231)

[51 FR 26364, July 22, 1986, as amended at 51 FR 43344, Dec. 2, 1986]



Sec. 814.84  Reports.

    (a) The holder of an approved PMA shall comply with the requirements 
of part 803 and with any other requirements applicable to the device by 
other regulations in this subchapter or by order approving the device.
    (b) Unless FDA specifies otherwise, any periodic report shall:
    (1) Identify changes described in Sec. 814.39(a) and changes 
required to be reported to FDA under Sec. 814.39(b).
    (2) Contain a summary and bibliography of the following information 
not previously submitted as part of the PMA:
    (i) Unpublished reports of data from any clinical investigations or 
nonclinical laboratory studies involving the device or related devices 
and known to or that reasonably should be known to the applicant.
    (ii) Reports in the scientific literature concerning the device and 
known to or that reasonably should be known to the applicant. If, after 
reviewing the summary and bibliography, FDA concludes that the agency 
needs a copy of the unpublished or published reports, FDA will notify 
the applicant that copies of such reports shall be submitted.
    (3) Identify changes made pursuant to an exception or alternative 
granted under Sec. 801.128 or Sec. 809.11 of this chapter.
    (4) Identify each device identifier currently in use for the device, 
and each device identifier for the device that has been discontinued 
since the previous periodic report. It is not necessary to identify any 
device identifier discontinued prior to December 23, 2013.

[51 FR 26364, July 22, 1986, as amended at 51 FR 43344, Dec. 2, 1986; 67 
FR 9587, Mar. 4, 2002; 72 FR 73602, Dec. 28, 2007; 78 FR 58822, Sept. 
24, 2013]

Subparts F-G [Reserved]



                   Subpart H_Humanitarian Use Devices

    Source: 61 FR 33244, June 26, 1996, unless otherwise noted.

[[Page 164]]



Sec. 814.100  Purpose and scope.

    (a) This subpart H implements sections 515A and 520(m) of the act.
    (b) The purpose of section 520(m) is, to the extent consistent with 
the protection of the public health and safety and with ethical 
standards, to encourage the discovery and use of devices intended to 
benefit patients in the treatment or diagnosis of diseases or conditions 
that affect or are manifested in not more than 8,000 individuals in the 
United States per year. This subpart provides procedures for obtaining:
    (1) HUD designation of a medical device; and
    (2) Marketing approval for the HUD notwithstanding the absence of 
reasonable assurance of effectiveness that would otherwise be required 
under sections 514 and 515 of the act.
    (c) Section 515A of the act is intended to ensure the submission of 
readily available information concerning:
    (1) Any pediatric subpopulations (neonates, infants, children, 
adolescents) that suffer from the disease or condition that the device 
is intended to treat, diagnose, or cure; and
    (2) The number of affected pediatric patients.
    (d) Although a HUD may also have uses that differ from the 
humanitarian use, applicants seeking approval of any non-HUD use shall 
submit a PMA as required under Sec. 814.20, or a premarket notification 
as required under part 807 of this chapter.
    (e) Obtaining marketing approval for a HUD involves two steps:
    (1) Obtaining designation of the device as a HUD from FDA's Office 
of Orphan Products Development, and
    (2) Submitting an HDE to the Office of Product Evaluation and 
Quality (OPEQ), Center for Devices and Radiological Health (CDRH), the 
Center for Biologics Evaluation and Research (CBER), or the Center for 
Drug Evaluation and Research (CDER), as applicable.
    (f) A person granted an exemption under section 520(m) of the act 
shall submit periodic reports as described in Sec. 814.126(b).
    (g) FDA may suspend or withdraw approval of an HDE after providing 
notice and an opportunity for an informal hearing.

[61 FR 33244, June 26, 1996, as amended at 63 FR 59220, Nov. 3, 1998; 73 
FR 49942, Aug. 25, 2008; 79 FR 1740, Jan. 10, 2014; 82 FR 26349, June 7, 
2017; 85 FR 18442, Apr. 2, 2020]



Sec. 814.102  Designation of HUD status.

    (a) Request for designation. Prior to submitting an HDE application, 
the applicant shall submit a request for HUD designation to FDA's Office 
of Orphan Products Development. The request shall contain the following:
    (1) A statement that the applicant requests HUD designation for a 
rare disease or condition or a valid subset of a disease or condition 
which shall be identified with specificity;
    (2) The name and address of the applicant, the name of the 
applicant's primary contact person and/or resident agent, including 
title, address, and telephone number;
    (3) A description of the rare disease or condition for which the 
device is to be used, the proposed indication or indications for use of 
the device, and the reasons why such therapy is needed. If the device is 
proposed for an indication that represents a subset of a common disease 
or condition, a demonstration that the subset is medically plausible 
should be included;
    (4) A description of the device and a discussion of the scientific 
rationale for the use of the device for the rare disease or condition; 
and
    (5) Documentation, with appended authoritative references, to 
demonstrate that the device is designed to treat or diagnose a disease 
or condition that affects or is manifested in not more than 8,000 people 
in the United States per year. If the device is for diagnostic purposes, 
the documentation must demonstrate that not more than 8,000 patients per 
year would be subjected to diagnosis by the device in the United States. 
Authoritative references include literature citations in specialized 
medical journals, textbooks, specialized medical society proceedings, or 
governmental statistics publications. When no such studies or literature 
citations exist, the applicant may be able to demonstrate the prevalence 
of the disease or condition in the United States by providing credible

[[Page 165]]

conclusions from appropriate research or surveys.
    (b) FDA action. Within 45 days of receipt of a request for HUD 
designation, FDA will take one of the following actions:
    (1) Approve the request and notify the applicant that the device has 
been designated as a HUD based on the information submitted;
    (2) Return the request to the applicant pending further review upon 
submission of additional information. This action will ensue if the 
request is incomplete because it does not on its face contain all of the 
information required under Sec. 814.102(a). Upon receipt of this 
additional information, the review period may be extended up to 45 days; 
or
    (3) Disapprove the request for HUD designation based on a 
substantive review of the information submitted. FDA may disapprove a 
request for HUD designation if:
    (i) There is insufficient evidence to support the estimate that the 
disease or condition for which the device is designed to treat or 
diagnose affects or is manifested in not more than 8,000 people in the 
United States per year;
    (ii) FDA determines that, for a diagnostic device, more than 8,000 
patients in the United States would be subjected to diagnosis using the 
device per year; or
    (iii) FDA determines that the patient population defined in the 
request is not a medically plausible subset of a larger population.
    (c) Revocation of designation. FDA may revoke a HUD designation if 
the agency finds that:
    (1) The request for designation contained an untrue statement of 
material fact or omitted material information; or
    (2) Based on the evidence available, the device is not eligible for 
HUD designation.
    (d) Submission. The applicant shall submit two copies of a 
completed, dated, and signed request for HUD designation to: Office of 
Orphan Products Development (HF-35), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857.

[61 FR 33244, June 26, 1996, as amended at 82 FR 26349, June 7, 2017]



Sec. 814.104  Original applications.

    (a) United States applicant or representative. The applicant or an 
authorized representative shall sign the HDE. If the applicant does not 
reside or have a place of business within the United States, the HDE 
shall be countersigned by an authorized representative residing or 
maintaining a place of business in the United States and shall identify 
the representative's name and address.
    (b) Contents. Unless the applicant justifies an omission in 
accordance with paragraph (d) of this section, an HDE shall include:
    (1) A copy of or reference to the determination made by FDA's Office 
of Orphan Products Development (in accordance with Sec. 814.102) that 
the device qualifies as a HUD;
    (2) An explanation of why the device would not be available unless 
an HDE were granted and a statement that no comparable device (other 
than another HUD approved under this subpart or a device under an 
approved IDE) is available to treat or diagnose the disease or 
condition. The application also shall contain a discussion of the risks 
and benefits of currently available devices or alternative forms of 
treatment in the United States;
    (3) An explanation of why the probable benefit to health from the 
use of the device outweighs the risk of injury or illness from its use, 
taking into account the probable risks and benefits of currently 
available devices or alternative forms of treatment. Such explanation 
shall include a description, explanation, or theory of the underlying 
disease process or condition, and known or postulated mechanism(s) of 
action of the device in relation to the disease process or condition;
    (4) All of the information required to be submitted under Sec. 
814.20(b), except that:
    (i) In lieu of the summaries, conclusions, and results from clinical 
investigations required under Sec. 814.20(b)(3)(v)(B), (b)(3)(vi), and 
the introductory text of (b)(6)(ii), the applicant shall include the 
summaries, conclusions, and results of all clinical experience or 
investigations (whether adverse or supportive) reasonably obtainable by 
the applicant that are relevant

[[Page 166]]

to an assessment of the risks and probable benefits of the device and to 
the extent the applicant includes data from clinical investigations, the 
applicant shall include the statements described in Sec. 
814.20(b)(6)(ii)(A) and (B) with respect to clinical investigations 
conducted in the United States and the information described in Sec. 
814.20(b)(6)(ii)(C) with respect to clinical investigations conducted 
outside the United States; and
    (ii) In addition to the proposed labeling requirement set forth in 
Sec. 814.20(b)(10), the labeling shall bear the following statement: 
Humanitarian Device. Authorized by Federal law for use in the [treatment 
or diagnosis] of [specify disease or condition]. The effectiveness of 
this device for this use has not been demonstrated;
    (5) The amount to be charged for the device and, if the amount is 
more than $250, a report by an independent certified public accountant, 
made in accordance with the Statement on Standards for Attestation 
established by the American Institute of Certified Public Accountants, 
or in lieu of such a report, an attestation by a responsible individual 
of the organization, verifying that the amount charged does not exceed 
the costs of the device's research, development, fabrication, and 
distribution. If the amount charged is $250 or less, the requirement for 
a report by an independent certified public accountant or an attestation 
by a responsible individual of the organization is waived; and
    (6) Information concerning pediatric uses of the device, as required 
by Sec. 814.20(b)(13).
    (c) Omission of information. If the applicant believes that certain 
information required under paragraph (b) of this section is not 
applicable to the device that is the subject of the HDE, and omits any 
such information from its HDE, the applicant shall submit a statement 
that identifies and justifies the omission. The statement shall be 
submitted as a separate section in the HDE and identified in the table 
of contents. If the justification for the omission is not accepted by 
the agency, FDA will so notify the applicant.
    (d) Address for submissions and correspondence. All original HDEs, 
amendments and supplements, as well as any correspondence relating to an 
HDE, must be provided in electronic format. These materials must be sent 
or delivered to one of the following:
    (1) For devices regulated by the Center for Devices and Radiological 
Health, send it to the current address found on the website https://
www.fda.gov/cdrhsubmissionaddress.
    (2) For devices regulated by the Center for Biologics Evaluation and 
Research, send it to the current address displayed on the website 
https://www.fda.gov/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm.
    (3) For devices regulated by the Center for Drug Evaluation and 
Research, send this information to the Central Document Control Room, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
5901-B Ammendale Rd., Beltsville, MD 20705-1266.

[61 FR 33244, June 26, 1996, as amended at 63 FR 59220, Nov. 3, 1998; 73 
FR 49942, Aug. 25, 2008; 75 FR 20915, Apr. 22, 2010; 79 FR 1740, Jan. 
10, 2014; 80 FR 18094, Apr. 3, 2015; 83 FR 7388, Feb. 21, 2018; 84 FR 
68340, Dec. 16, 2019]



Sec. 814.106  HDE amendments and resubmitted HDE's.

    An HDE or HDE supplement may be amended or resubmitted upon an 
applicant's own initiative, or at the request of FDA, for the same 
reasons and in the same manner as prescribed for PMA's in Sec. 814.37, 
except that the timeframes set forth in Sec. 814.37(c)(1) and (d) do 
not apply. If FDA requests an HDE applicant to submit an HDE amendment, 
and a written response to FDA's request is not received within 75 days 
of the date of the request, FDA will consider the pending HDE or HDE 
supplement to be withdrawn voluntarily by the applicant. Furthermore, if 
the HDE applicant, on its own initiative or at FDA's request, submits a 
major amendment as described in Sec. 814.37(c)(1), the review period 
may be extended up to 75 days.

[63 FR 59220, Nov. 3, 1998]

[[Page 167]]



Sec. 814.108  Supplemental applications.

    After FDA approval of an original HDE, an applicant shall submit 
supplements in accordance with the requirements for PMA's under Sec. 
814.39, except that a request for a new indication for use of a HUD 
shall comply with requirements set forth in Sec. 814.110. The 
timeframes for review of, and FDA action on, an HDE supplement are the 
same as those provided in Sec. 814.114 for an HDE.

[63 FR 59220, Nov. 3, 1998]



Sec. 814.110  New indications for use.

    (a) An applicant seeking a new indication for use of a HUD approved 
under this subpart H shall obtain a new designation of HUD status in 
accordance with Sec. 814.102 and shall submit an original HDE in 
accordance with Sec. 814.104.
    (b) An application for a new indication for use made under Sec. 
814.104 may incorporate by reference any information or data previously 
submitted to the agency under an HDE.



Sec. 814.112  Filing an HDE.

    (a) The filing of an HDE means that FDA has made a threshold 
determination that the application is sufficiently complete to permit 
substantive review. Within 30 days from the date an HDE is received by 
FDA, the agency will notify the applicant whether the application has 
been filed. FDA may refuse to file an HDE if any of the following 
applies:
    (1) The application is incomplete because it does not on its face 
contain all the information required under Sec. 814.104(b);
    (2) FDA determines that there is a comparable device available 
(other than another HUD approved under this subpart or a device under an 
approved IDE) to treat or diagnose the disease or condition for which 
approval of the HUD is being sought; or
    (3) The application contains an untrue statement of material fact or 
omits material information.
    (4) The HDE is not accompanied by a statement of either 
certification or disclosure, or both, as required by part 54 of this 
chapter.
    (b) The provisions contained in Sec. 814.42(b), (c), and (d) 
regarding notification of filing decisions, filing dates, the start of 
the 75-day review period, and applicant's options in response to FDA 
refuse to file decisions shall apply to HDE's.

[61 FR 33244, June 26, 1996, as amended at 63 FR 5254, Feb. 2, 1998; 63 
FR 59221, Nov. 3, 1998]



Sec. 814.114  Timeframes for reviewing an HDE.

    Within 75 days after receipt of an HDE that is accepted for filing 
and to which the applicant does not submit a major amendment, FDA shall 
send the applicant an approval order, an approvable letter, a not 
approvable letter (under Sec. 814.116), or an order denying approval 
(under Sec. 814.118).

[63 FR 59221, Nov. 3, 1998]



Sec. 814.116  Procedures for review of an HDE.

    (a) Substantive review. FDA will begin substantive review of an HDE 
after the HDE is accepted for filing under Sec. 814.112. FDA may refer 
an original HDE application to a panel on its own initiative, and shall 
do so upon the request of an applicant, unless FDA determines that the 
application substantially duplicates information previously reviewed by 
a panel. If the HDE is referred to a panel, the agency shall follow the 
procedures set forth under Sec. 814.44, with the exception that FDA 
will complete its review of the HDE and the advisory committee report 
and recommendations within 75 days from receipt of an HDE that is 
accepted for filing under Sec. 814.112 or the date of filing as 
determined under Sec. 814.106, whichever is later. Within the later of 
these two timeframes, FDA will issue an approval order under paragraph 
(b) of this section, an approvable letter under paragraph (c) of this 
section, a not approvable letter under paragraph (d) of this section, or 
an order denying approval of the application under Sec. 814.118(a).
    (b) Approval order. FDA will issue to the applicant an order 
approving an HDE if none of the reasons in Sec. 814.118 for denying 
approval of the application applies. FDA will approve an application on 
the basis of draft final labeling if the only deficiencies in the 
application concern editorial or similar minor

[[Page 168]]

deficiencies in the draft final labeling. Such approval will be 
conditioned upon the applicant incorporating the specified labeling 
changes exactly as directed and upon the applicant submitting to FDA a 
copy of the final printed labeling before marketing. The notice of 
approval of an HDE will be placed on the FDA's home page on the internet 
(https://www.fda.gov) in accordance with the rules and policies 
applicable to PMAs submitted under Sec. 814.20. Following the issuance 
of an approval order, data and information in the HDE file will be 
available for public disclosure in accordance with Sec. 814.9(b) 
through (h), as applicable.
    (c) Approvable letter. FDA will send the applicant an approvable 
letter if the application substantially meets the requirements of this 
subpart and the agency believes it can approve the application if 
specific additional information is submitted or specific conditions are 
agreed to by the applicant. The approvable letter will describe the 
information FDA requires to be provided by the applicant or the 
conditions the applicant is required to meet to obtain approval. For 
example, FDA may require as a condition to approval:
    (1) The submission of certain information identified in the 
approvable letter, e.g., final labeling;
    (2) The submission of additional information concerning pediatric 
uses of the device, as required by Sec. 814.20(b)(13);
    (3) Restrictions imposed on the device under section 520(e) of the 
act;
    (4) Postapproval requirements as described in subpart E of this 
part; and
    (5) An FDA inspection that finds the manufacturing facilities, 
methods, and controls in compliance with part 820 of this chapter and, 
if applicable, that verifies records pertinent to the HDE.
    (d) Not approvable letter. FDA will send the applicant a not 
approvable letter if the agency believes that the application may not be 
approved for one or more of the reasons given in Sec. 814.118. The not 
approvable letter will describe the deficiencies in the application and, 
where practical, will identify measures required to place the HDE in 
approvable form. The applicant may respond to the not approvable letter 
in the same manner as permitted for not approvable letters for PMA's 
under Sec. 814.44(f), with the exception that if a major HDE amendment 
is submitted, the review period may be extended up to 75 days.
    (e) FDA will consider an HDE to have been withdrawn voluntarily if:
    (1) The applicant fails to respond in writing to a written request 
for an amendment within 75 days after the date FDA issues such request;
    (2) The applicant fails to respond in writing to an approvable or 
not approvable letter within 75 days after the date FDA issues such 
letter; or
    (3) The applicant submits a written notice to FDA that the HDE has 
been withdrawn.

[61 FR 33244, June 26, 1996, as amended at 63 FR 59221, Nov. 3, 1998; 79 
FR 1741, Jan. 10, 2014; 87 FR 2045, Jan. 13, 2022]



Sec. 814.118  Denial of approval or withdrawal of approval of an HDE.

    (a) FDA may deny approval or withdraw approval of an application if 
the applicant fails to meet the requirements of section 520(m) of the 
act or of this part, or of any condition of approval imposed by an IRB 
or by FDA, or any postapproval requirements imposed under Sec. 814.126. 
In addition, FDA may deny approval or withdraw approval of an 
application if, upon the basis of the information submitted in the HDE 
or any other information before the agency, FDA determines that:
    (1) There is a lack of a showing of reasonable assurance that the 
device is safe under the conditions of use prescribed, recommended, or 
suggested in the labeling thereof;
    (2) The device is ineffective under the conditions of use 
prescribed, recommended, or suggested in the labeling thereof;
    (3) The applicant has not demonstrated that there is a reasonable 
basis from which to conclude that the probable benefit to health from 
the use of the device outweighs the risk of injury or illness, taking 
into account the probable risks and benefits of currently available 
devices or alternative forms of treatment;
    (4) The application or a report submitted by or on behalf of the 
applicant contains an untrue statement of material fact, or omits 
material information;

[[Page 169]]

    (5) The device's labeling does not comply with the requirements in 
part 801 or part 809 of this chapter;
    (6) A nonclinical laboratory study that is described in the HDE and 
that is essential to show that the device is safe for use under the 
conditions prescribed, recommended, or suggested in its proposed 
labeling, was not conducted in compliance with the good laboratory 
practice regulations in part 58 of this chapter and no reason for the 
noncompliance is provided or, if it is, the differences between the 
practices used in conducting the study and the good laboratory practice 
regulations do not support the validity of the study;
    (7) Any clinical investigation involving human subjects described in 
the HDE, subject to the institutional review board regulations in part 
56 of this chapter or the informed consent regulations in part 50 of 
this chapter, was not conducted in compliance with those regulations 
such that the rights or safety of human subjects were not adequately 
protected;
    (8) The applicant does not permit an authorized FDA employee an 
opportunity to inspect at a reasonable time and in a reasonable manner 
the facilities and controls, and to have access to and to copy and 
verify all records pertinent to the application; or
    (9) The device's HUD designation should be revoked in accordance 
with Sec. 814.102(c).
    (b) If FDA issues an order denying approval of an application, the 
agency will comply with the same notice and disclosure provisions 
required for PMA's under Sec. 814.45(b) and (d), as applicable.
    (c) FDA will issue an order denying approval of an HDE after an 
approvable or not approvable letter has been sent and the applicant:
    (1) Submits a requested amendment but any ground for denying 
approval of the application under Sec. 814.118(a) still applies;
    (2) Notifies FDA in writing that the requested amendment will not be 
submitted; or
    (3) Petitions for review under section 515(d)(4) of the act by 
filing a petition in the form of a petition for reconsideration under 
Sec. 10.33 of this chapter.
    (d) Before issuing an order withdrawing approval of an HDE, FDA will 
provide the applicant with notice and an opportunity for a hearing as 
required for PMA's under Sec. 814.46(c) and (d), and will provide the 
public with notice in accordance with Sec. 814.46(e), as applicable.

[61 FR 33244, June 26, 1996, as amended at 63 FR 59221, Nov. 3, 1998; 87 
FR 2045, Jan. 13, 2022]



Sec. 814.120  Temporary suspension of approval of an HDE.

    An HDE or HDE supplement may be temporarily suspended for the same 
reasons and in the same manner as prescribed for PMA's in Sec. 814.47.

[63 FR 59221, Nov. 3, 1998]



Sec. 814.122  Confidentiality of data and information.

    (a) Requirement for disclosure. The ``HDE file'' includes all data 
and information submitted with or referenced in the HDE, any IDE 
incorporated into the HDE, any HDE amendment or supplement, any report 
submitted under Sec. 814.126, any master file, or any other related 
submission. Any record in the HDE file will be available for public 
disclosure in accordance with the provisions of this section and part 20 
of this chapter.
    (b) Extent of disclosure. Disclosure by FDA of the existence and 
contents of an HDE file shall be subject to the same rules that pertain 
to PMA's under Sec. 814.9(b) through (h), as applicable.



Sec. 814.124  Institutional Review Board requirements.

    (a) IRB approval. The HDE holder is responsible for ensuring that a 
HUD approved under this subpart is administered only in facilities 
having oversight by an Institutional Review Board (IRB) constituted and 
acting pursuant to part 56 of this chapter, including continuing review 
of use of the device. In addition, a HUD may be administered only if 
such use has been approved by an IRB. If, however, a physician in an 
emergency situation determines that approval from an IRB cannot be 
obtained in time to prevent serious harm or death to a patient, a HUD

[[Page 170]]

may be administered without prior approval by an IRB. In such an 
emergency situation, the physician shall, within 5 days after the use of 
the device, provide written notification to the chairman of the IRB of 
such use. Such written notification shall include the identification of 
the patient involved, the date on which the device was used, and the 
reason for the use.
    (b) Withdrawal of IRB approval. A holder of an approved HDE shall 
notify FDA of any withdrawal of approval for the use of a HUD by a 
reviewing IRB within 5 working days after being notified of the 
withdrawal of approval.

[61 FR 33244, June 26, 1996, as amended at 63 FR 59221, Nov. 3, 1998; 82 
FR 26349, June 7, 2017]



Sec. 814.126  Postapproval requirements and reports.

    (a) An HDE approved under this subpart H shall be subject to the 
postapproval requirements and reports set forth under subpart E of this 
part, as applicable, with the exception of Sec. 814.82(a)(7). In 
addition, medical device reports submitted to FDA in compliance with the 
requirements of part 803 of this chapter shall also be submitted to the 
IRB of record.
    (b) In addition to the reports identified in paragraph (a) of this 
section, the holder of an approved HDE shall prepare and submit the 
following complete, accurate, and timely reports:
    (1) Periodic reports. An HDE applicant is required to submit reports 
in accordance with the approval order. Unless FDA specifies otherwise, 
any periodic report shall include:
    (i) An update of the information required under Sec. 814.102(a) in 
a separately bound volume;
    (ii) An update of the information required under Sec. 
814.104(b)(2), (b)(3), and (b)(5);
    (iii) The number of devices that have been shipped or sold since 
initial marketing approval under this subpart H and, if the number 
shipped or sold exceeds 8,000, an explanation and estimate of the number 
of devices used per patient. If a single device is used on multiple 
patients, the applicant shall submit an estimate of the number of 
patients treated or diagnosed using the device together with an 
explanation of the basis for the estimate;
    (iv) Information describing the applicant's clinical experience with 
the device since the HDE was initially approved. This information shall 
include safety information that is known or reasonably should be known 
to the applicant, medical device reports made under part 803 of this 
chapter, any data generated from the postmarketing studies, and 
information (whether published or unpublished) that is known or 
reasonably expected to be known by the applicant that may affect an 
evaluation of the safety of the device or that may affect the statement 
of contraindications, warnings, precautions, and adverse reactions in 
the device's labeling; and
    (v) A summary of any changes made to the device in accordance with 
supplements submitted under Sec. 814.108. If information provided in 
the periodic reports, or any other information in the possession of FDA, 
gives the agency reason to believe that a device raises public health 
concerns or that the criteria for exemption are no longer met, the 
agency may require the HDE holder to submit additional information to 
demonstrate continued compliance with the HDE requirements.
    (2) Other. An HDE holder shall maintain records of the names and 
addresses of the facilities to which the HUD has been shipped, 
correspondence with reviewing IRB's, as well as any other information 
requested by a reviewing IRB or FDA. Such records shall be maintained in 
accordance with the HDE approval order.

[61 FR 33244, June 26, 1996, as amended at 63 FR 59221, Nov. 3, 1998; 71 
FR 16228, Mar. 31, 2006; 82 FR 26349, June 7, 2017]



PART 820_QUALITY SYSTEM REGULATION--Table of Contents



                      Subpart A_General Provisions

Sec.
820.1 Scope.
820.3 Definitions.
820.5 Quality system.

                  Subpart B_Quality System Requirements

820.20 Management responsibility.
820.22 Quality audit.

[[Page 171]]

820.25 Personnel.

                        Subpart C_Design Controls

820.30 Design controls.

                       Subpart D_Document Controls

820.40 Document controls.

                      Subpart E_Purchasing Controls

820.50 Purchasing controls.

                Subpart F_Identification and Traceability

820.60 Identification.
820.65 Traceability.

                Subpart G_Production and Process Controls

820.70 Production and process controls.
820.72 Inspection, measuring, and test equipment.
820.75 Process validation.

                     Subpart H_Acceptance Activities

820.80 Receiving, in-process, and finished device acceptance.
820.86 Acceptance status.

                     Subpart I_Nonconforming Product

820.90 Nonconforming product.

               Subpart J_Corrective and Preventive Action

820.100 Corrective and preventive action.

                Subpart K_Labeling and Packaging Control

820.120 Device labeling.
820.130 Device packaging.

       Subpart L_Handling, Storage, Distribution, and Installation

820.140 Handling.
820.150 Storage.
820.160 Distribution.
820.170 Installation.

                            Subpart M_Records

820.180 General requirements.
820.181 Device master record.
820.184 Device history record.
820.186 Quality system record.
820.198 Complaint files.

                           Subpart N_Servicing

820.200 Servicing.

                    Subpart O_Statistical Techniques

820.250 Statistical techniques.

    Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 
360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.

    Source: 61 FR 52654, Oct. 7, 1996, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 820.1  Scope.

    (a) Applicability. (1) Current good manufacturing practice (CGMP) 
requirements are set forth in this quality system regulation. The 
requirements in this part govern the methods used in, and the facilities 
and controls used for, the design, manufacture, packaging, labeling, 
storage, installation, and servicing of all finished devices intended 
for human use. The requirements in this part are intended to ensure that 
finished devices will be safe and effective and otherwise in compliance 
with the Federal Food, Drug, and Cosmetic Act (the act). This part 
establishes basic requirements applicable to manufacturers of finished 
medical devices. If a manufacturer engages in only some operations 
subject to the requirements in this part, and not in others, that 
manufacturer need only comply with those requirements applicable to the 
operations in which it is engaged. With respect to class I devices, 
design controls apply only to those devices listed in Sec. 
820.30(a)(2). This regulation does not apply to manufacturers of 
components or parts of finished devices, but such manufacturers are 
encouraged to use appropriate provisions of this regulation as guidance. 
Manufacturers of blood and blood components used for transfusion or for 
further manufacturing are not subject to this part, but are subject to 
subchapter F of this chapter. Manufacturers of human cells, tissues, and 
cellular and tissue-based products (HCT/Ps), as defined in Sec. 
1271.3(d) of this chapter, that are medical devices (subject to 
premarket review or notification, or exempt from notification, under an 
application submitted under the device provisions of the act or under a 
biological product license application under section 351 of the Public 
Health Service Act) are subject to this part and are

[[Page 172]]

also subject to the donor-eligibility procedures set forth in part 1271 
subpart C of this chapter and applicable current good tissue practice 
procedures in part 1271 subpart D of this chapter. In the event of a 
conflict between applicable regulations in part 1271 and in other parts 
of this chapter, the regulation specifically applicable to the device in 
question shall supersede the more general.
    (2) The provisions of this part shall be applicable to any finished 
device as defined in this part, intended for human use, that is 
manufactured, imported, or offered for import in any State or Territory 
of the United States, the District of Columbia, or the Commonwealth of 
Puerto Rico.
    (3) In this regulation the term ``where appropriate'' is used 
several times. When a requirement is qualified by ``where appropriate,'' 
it is deemed to be ``appropriate'' unless the manufacturer can document 
justification otherwise. A requirement is ``appropriate'' if 
nonimplementation could reasonably be expected to result in the product 
not meeting its specified requirements or the manufacturer not being 
able to carry out any necessary corrective action.
    (b) The quality system regulation in this part supplements 
regulations in other parts of this chapter except where explicitly 
stated otherwise. In the event of a conflict between applicable 
regulations in this part and in other parts of this chapter, the 
regulations specifically applicable to the device in question shall 
supersede any other generally applicable requirements.
    (c) Authority. Part 820 is established and issued under authority of 
sections 501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 
801, 803 of the act (21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 
360i, 360j, 360l, 371, 374, 381, 383). The failure to comply with any 
applicable provision in this part renders a device adulterated under 
section 501(h) of the act. Such a device, as well as any person 
responsible for the failure to comply, is subject to regulatory action.
    (d) Foreign manufacturers. If a manufacturer who offers devices for 
import into the United States refuses to permit or allow the completion 
of a Food and Drug Administration (FDA) inspection of the foreign 
facility for the purpose of determining compliance with this part, it 
shall appear for purposes of section 801(a) of the act, that the methods 
used in, and the facilities and controls used for, the design, 
manufacture, packaging, labeling, storage, installation, or servicing of 
any devices produced at such facility that are offered for import into 
the United States do not conform to the requirements of section 520(f) 
of the act and this part and that the devices manufactured at that 
facility are adulterated under section 501(h) of the act.
    (e) Exemptions or variances. (1) Any person who wishes to petition 
for an exemption or variance from any device quality system requirement 
is subject to the requirements of section 520(f)(2) of the Federal Food, 
Drug, and Cosmetic Act. Petitions for an exemption or variance shall be 
submitted according to the procedures set forth in Sec. 10.30 of this 
chapter, the FDA's administrative procedures. For guidance on how to 
proceed for a request for a variance, contact Division of Regulatory 
Programs 2, Office of Regulatory Programs, Office of Product Evaluation 
and Quality, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1438, Silver 
Spring, MD 20993-0002.
    (2) FDA may initiate and grant a variance from any device quality 
system requirement when the agency determines that such variance is in 
the best interest of the public health. Such variance will remain in 
effect only so long as there remains a public health need for the device 
and the device would not likely be made sufficiently available without 
the variance.

[61 FR 52654, Oct. 7, 1996, as amended at 65 FR 17136, Mar. 31, 2000; 65 
FR 66636, Nov. 7, 2000; 69 FR 29829, May 25, 2005; 72 FR 17399, Apr. 9, 
2007; 75 FR 20915, Apr. 22, 2010; 80 FR 29906, May 22, 2015; 85 FR 
18442, Apr. 2, 2020]



Sec. 820.3  Definitions.

    (a) Act means the Federal Food, Drug, and Cosmetic Act, as amended 
(secs. 201-903, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321-394)). 
All definitions in section 201 of the act shall apply to the regulations 
in this part.

[[Page 173]]

    (b) Complaint means any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, 
reliability, safety, effectiveness, or performance of a device after it 
is released for distribution.
    (c) Component means any raw material, substance, piece, part, 
software, firmware, labeling, or assembly which is intended to be 
included as part of the finished, packaged, and labeled device.
    (d) Control number means any distinctive symbols, such as a 
distinctive combination of letters or numbers, or both, from which the 
history of the manufacturing, packaging, labeling, and distribution of a 
unit, lot, or batch of finished devices can be determined.
    (e) Design history file (DHF) means a compilation of records which 
describes the design history of a finished device.
    (f) Design input means the physical and performance requirements of 
a device that are used as a basis for device design.
    (g) Design output means the results of a design effort at each 
design phase and at the end of the total design effort. The finished 
design output is the basis for the device master record. The total 
finished design output consists of the device, its packaging and 
labeling, and the device master record.
    (h) Design review means a documented, comprehensive, systematic 
examination of a design to evaluate the adequacy of the design 
requirements, to evaluate the capability of the design to meet these 
requirements, and to identify problems.
    (i) Device history record (DHR) means a compilation of records 
containing the production history of a finished device.
    (j) Device master record (DMR) means a compilation of records 
containing the procedures and specifications for a finished device.
    (k) Establish means define, document (in writing or electronically), 
and implement.
    (l) Finished device means any device or accessory to any device that 
is suitable for use or capable of functioning, whether or not it is 
packaged, labeled, or sterilized.
    (m) Lot or batch means one or more components or finished devices 
that consist of a single type, model, class, size, composition, or 
software version that are manufactured under essentially the same 
conditions and that are intended to have uniform characteristics and 
quality within specified limits.
    (n) Management with executive responsibility means those senior 
employees of a manufacturer who have the authority to establish or make 
changes to the manufacturer's quality policy and quality system.
    (o) Manufacturer means any person who designs, manufactures, 
fabricates, assembles, or processes a finished device. Manufacturer 
includes but is not limited to those who perform the functions of 
contract sterilization, installation, relabeling, remanufacturing, 
repacking, or specification development, and initial distributors of 
foreign entities performing these functions.
    (p) Manufacturing material means any material or substance used in 
or used to facilitate the manufacturing process, a concomitant 
constituent, or a byproduct constituent produced during the 
manufacturing process, which is present in or on the finished device as 
a residue or impurity not by design or intent of the manufacturer.
    (q) Nonconformity means the nonfulfillment of a specified 
requirement.
    (r) Product means components, manufacturing materials, in- process 
devices, finished devices, and returned devices.
    (s) Quality means the totality of features and characteristics that 
bear on the ability of a device to satisfy fitness-for-use, including 
safety and performance.
    (t) Quality audit means a systematic, independent examination of a 
manufacturer's quality system that is performed at defined intervals and 
at sufficient frequency to determine whether both quality system 
activities and the results of such activities comply with quality system 
procedures, that these procedures are implemented effectively, and that 
these procedures are suitable to achieve quality system objectives.
    (u) Quality policy means the overall intentions and direction of an 
organization with respect to quality, as established by management with 
executive responsibility.

[[Page 174]]

    (v) Quality system means the organizational structure, 
responsibilities, procedures, processes, and resources for implementing 
quality management.
    (w) Remanufacturer means any person who processes, conditions, 
renovates, repackages, restores, or does any other act to a finished 
device that significantly changes the finished device's performance or 
safety specifications, or intended use.
    (x) Rework means action taken on a nonconforming product so that it 
will fulfill the specified DMR requirements before it is released for 
distribution.
    (y) Specification means any requirement with which a product, 
process, service, or other activity must conform.
    (z) Validation means confirmation by examination and provision of 
objective evidence that the particular requirements for a specific 
intended use can be consistently fulfilled.
    (1) Process validation means establishing by objective evidence that 
a process consistently produces a result or product meeting its 
predetermined specifications.
    (2) Design validation means establishing by objective evidence that 
device specifications conform with user needs and intended use(s).
    (aa) Verification means confirmation by examination and provision of 
objective evidence that specified requirements have been fulfilled.
    (bb) Human cell, tissue, or cellular or tissue-based product (HCT/P) 
regulated as a device means an HCT/P as defined in Sec. 1271.3(d) of 
this chapter that does not meet the criteria in Sec. 1271.10(a) and 
that is also regulated as a device.
    (cc) Unique device identifier (UDI) means an identifier that 
adequately identifies a device through its distribution and use by 
meeting the requirements of Sec. 830.20 of this chapter. A unique 
device identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies the specific version or model of a device and the labeler of 
that device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (v) For an HCT/P regulated as a device, the distinct identification 
code required by Sec. 1271.290(c) of this chapter.
    (dd) Universal product code (UPC) means the product identifier used 
to identify an item sold at retail in the United States.

[61 FR 52654, Oct. 7, 1996, as amended at 78 FR 58822, Sept. 24, 2013]



Sec. 820.5  Quality system.

    Each manufacturer shall establish and maintain a quality system that 
is appropriate for the specific medical device(s) designed or 
manufactured, and that meets the requirements of this part.



                  Subpart B_Quality System Requirements



Sec. 820.20  Management responsibility.

    (a) Quality policy. Management with executive responsibility shall 
establish its policy and objectives for, and commitment to, quality. 
Management with executive responsibility shall ensure that the quality 
policy is understood, implemented, and maintained at all levels of the 
organization.
    (b) Organization. Each manufacturer shall establish and maintain an 
adequate organizational structure to ensure that devices are designed 
and produced in accordance with the requirements of this part.
    (1) Responsibility and authority. Each manufacturer shall establish 
the appropriate responsibility, authority, and interrelation of all 
personnel who manage, perform, and assess work affecting quality, and 
provide the independence and authority necessary to perform these tasks.
    (2) Resources. Each manufacturer shall provide adequate resources, 
including the assignment of trained personnel, for management, 
performance

[[Page 175]]

of work, and assessment activities, including internal quality audits, 
to meet the requirements of this part.
    (3) Management representative. Management with executive 
responsibility shall appoint, and document such appointment of, a member 
of management who, irrespective of other responsibilities, shall have 
established authority over and responsibility for:
    (i) Ensuring that quality system requirements are effectively 
established and effectively maintained in accordance with this part; and
    (ii) Reporting on the performance of the quality system to 
management with executive responsibility for review.
    (c) Management review. Management with executive responsibility 
shall review the suitability and effectiveness of the quality system at 
defined intervals and with sufficient frequency according to established 
procedures to ensure that the quality system satisfies the requirements 
of this part and the manufacturer's established quality policy and 
objectives. The dates and results of quality system reviews shall be 
documented.
    (d) Quality planning. Each manufacturer shall establish a quality 
plan which defines the quality practices, resources, and activities 
relevant to devices that are designed and manufactured. The manufacturer 
shall establish how the requirements for quality will be met.
    (e) Quality system procedures. Each manufacturer shall establish 
quality system procedures and instructions. An outline of the structure 
of the documentation used in the quality system shall be established 
where appropriate.



Sec. 820.22  Quality audit.

    Each manufacturer shall establish procedures for quality audits and 
conduct such audits to assure that the quality system is in compliance 
with the established quality system requirements and to determine the 
effectiveness of the quality system. Quality audits shall be conducted 
by individuals who do not have direct responsibility for the matters 
being audited. Corrective action(s), including a reaudit of deficient 
matters, shall be taken when necessary. A report of the results of each 
quality audit, and reaudit(s) where taken, shall be made and such 
reports shall be reviewed by management having responsibility for the 
matters audited. The dates and results of quality audits and reaudits 
shall be documented.



Sec. 820.25  Personnel.

    (a) General. Each manufacturer shall have sufficient personnel with 
the necessary education, background, training, and experience to assure 
that all activities required by this part are correctly performed.
    (b) Training. Each manufacturer shall establish procedures for 
identifying training needs and ensure that all personnel are trained to 
adequately perform their assigned responsibilities. Training shall be 
documented.
    (1) As part of their training, personnel shall be made aware of 
device defects which may occur from the improper performance of their 
specific jobs.
    (2) Personnel who perform verification and validation activities 
shall be made aware of defects and errors that may be encountered as 
part of their job functions.



                        Subpart C_Design Controls



Sec. 820.30  Design controls.

    (a) General. (1) Each manufacturer of any class III or class II 
device, and the class I devices listed in paragraph (a)(2) of this 
section, shall establish and maintain procedures to control the design 
of the device in order to ensure that specified design requirements are 
met.
    (2) The following class I devices are subject to design controls:
    (i) Devices automated with computer software; and
    (ii) The devices listed in the following chart.

------------------------------------------------------------------------
              Section                              Device
------------------------------------------------------------------------
868.6810..........................  Catheter, Tracheobronchial Suction.
878.4460..........................  Glove, Surgeon's.
880.6760..........................  Restraint, Protective.
892.5650..........................  System, Applicator, Radionuclide,
                                     Manual.
892.5740..........................  Source, Radionuclide Teletherapy.
------------------------------------------------------------------------

    (b) Design and development planning. Each manufacturer shall 
establish and

[[Page 176]]

maintain plans that describe or reference the design and development 
activities and define responsibility for implementation. The plans shall 
identify and describe the interfaces with different groups or activities 
that provide, or result in, input to the design and development process. 
The plans shall be reviewed, updated, and approved as design and 
development evolves.
    (c) Design input. Each manufacturer shall establish and maintain 
procedures to ensure that the design requirements relating to a device 
are appropriate and address the intended use of the device, including 
the needs of the user and patient. The procedures shall include a 
mechanism for addressing incomplete, ambiguous, or conflicting 
requirements. The design input requirements shall be documented and 
shall be reviewed and approved by a designated individual(s). The 
approval, including the date and signature of the individual(s) 
approving the requirements, shall be documented.
    (d) Design output. Each manufacturer shall establish and maintain 
procedures for defining and documenting design output in terms that 
allow an adequate evaluation of conformance to design input 
requirements. Design output procedures shall contain or make reference 
to acceptance criteria and shall ensure that those design outputs that 
are essential for the proper functioning of the device are identified. 
Design output shall be documented, reviewed, and approved before 
release. The approval, including the date and signature of the 
individual(s) approving the output, shall be documented.
    (e) Design review. Each manufacturer shall establish and maintain 
procedures to ensure that formal documented reviews of the design 
results are planned and conducted at appropriate stages of the device's 
design development. The procedures shall ensure that participants at 
each design review include representatives of all functions concerned 
with the design stage being reviewed and an individual(s) who does not 
have direct responsibility for the design stage being reviewed, as well 
as any specialists needed. The results of a design review, including 
identification of the design, the date, and the individual(s) performing 
the review, shall be documented in the design history file (the DHF).
    (f) Design verification. Each manufacturer shall establish and 
maintain procedures for verifying the device design. Design verification 
shall confirm that the design output meets the design input 
requirements. The results of the design verification, including 
identification of the design, method(s), the date, and the individual(s) 
performing the verification, shall be documented in the DHF.
    (g) Design validation. Each manufacturer shall establish and 
maintain procedures for validating the device design. Design validation 
shall be performed under defined operating conditions on initial 
production units, lots, or batches, or their equivalents. Design 
validation shall ensure that devices conform to defined user needs and 
intended uses and shall include testing of production units under actual 
or simulated use conditions. Design validation shall include software 
validation and risk analysis, where appropriate. The results of the 
design validation, including identification of the design, method(s), 
the date, and the individual(s) performing the validation, shall be 
documented in the DHF.
    (h) Design transfer. Each manufacturer shall establish and maintain 
procedures to ensure that the device design is correctly translated into 
production specifications.
    (i) Design changes. Each manufacturer shall establish and maintain 
procedures for the identification, documentation, validation or where 
appropriate verification, review, and approval of design changes before 
their implementation.
    (j) Design history file. Each manufacturer shall establish and 
maintain a DHF for each type of device. The DHF shall contain or 
reference the records necessary to demonstrate that the design was 
developed in accordance with the approved design plan and the 
requirements of this part.



                       Subpart D_Document Controls



Sec. 820.40  Document controls.

    Each manufacturer shall establish and maintain procedures to control 
all

[[Page 177]]

documents that are required by this part. The procedures shall provide 
for the following:
    (a) Document approval and distribution. Each manufacturer shall 
designate an individual(s) to review for adequacy and approve prior to 
issuance all documents established to meet the requirements of this 
part. The approval, including the date and signature of the 
individual(s) approving the document, shall be documented. Documents 
established to meet the requirements of this part shall be available at 
all locations for which they are designated, used, or otherwise 
necessary, and all obsolete documents shall be promptly removed from all 
points of use or otherwise prevented from unintended use.
    (b) Document changes. Changes to documents shall be reviewed and 
approved by an individual(s) in the same function or organization that 
performed the original review and approval, unless specifically 
designated otherwise. Approved changes shall be communicated to the 
appropriate personnel in a timely manner. Each manufacturer shall 
maintain records of changes to documents. Change records shall include a 
description of the change, identification of the affected documents, the 
signature of the approving individual(s), the approval date, and when 
the change becomes effective.



                      Subpart E_Purchasing Controls



Sec. 820.50  Purchasing controls.

    Each manufacturer shall establish and maintain procedures to ensure 
that all purchased or otherwise received product and services conform to 
specified requirements.
    (a) Evaluation of suppliers, contractors, and consultants. Each 
manufacturer shall establish and maintain the requirements, including 
quality requirements, that must be met by suppliers, contractors, and 
consultants. Each manufacturer shall:
    (1) Evaluate and select potential suppliers, contractors, and 
consultants on the basis of their ability to meet specified 
requirements, including quality requirements. The evaluation shall be 
documented.
    (2) Define the type and extent of control to be exercised over the 
product, services, suppliers, contractors, and consultants, based on the 
evaluation results.
    (3) Establish and maintain records of acceptable suppliers, 
contractors, and consultants.
    (b) Purchasing data. Each manufacturer shall establish and maintain 
data that clearly describe or reference the specified requirements, 
including quality requirements, for purchased or otherwise received 
product and services. Purchasing documents shall include, where 
possible, an agreement that the suppliers, contractors, and consultants 
agree to notify the manufacturer of changes in the product or service so 
that manufacturers may determine whether the changes may affect the 
quality of a finished device. Purchasing data shall be approved in 
accordance with Sec. 820.40.



                Subpart F_Identification and Traceability



Sec. 820.60  Identification.

    Each manufacturer shall establish and maintain procedures for 
identifying product during all stages of receipt, production, 
distribution, and installation to prevent mixups.



Sec. 820.65  Traceability.

    Each manufacturer of a device that is intended for surgical implant 
into the body or to support or sustain life and whose failure to perform 
when properly used in accordance with instructions for use provided in 
the labeling can be reasonably expected to result in a significant 
injury to the user shall establish and maintain procedures for 
identifying with a control number each unit, lot, or batch of finished 
devices and where appropriate components. The procedures shall 
facilitate corrective action. Such identification shall be documented in 
the DHR.

[[Page 178]]



                Subpart G_Production and Process Controls



Sec. 820.70  Production and process controls.

    (a) General. Each manufacturer shall develop, conduct, control, and 
monitor production processes to ensure that a device conforms to its 
specifications. Where deviations from device specifications could occur 
as a result of the manufacturing process, the manufacturer shall 
establish and maintain process control procedures that describe any 
process controls necessary to ensure conformance to specifications. 
Where process controls are needed they shall include:
    (1) Documented instructions, standard operating procedures (SOP's), 
and methods that define and control the manner of production;
    (2) Monitoring and control of process parameters and component and 
device characteristics during production;
    (3) Compliance with specified reference standards or codes;
    (4) The approval of processes and process equipment; and
    (5) Criteria for workmanship which shall be expressed in documented 
standards or by means of identified and approved representative samples.
    (b) Production and process changes. Each manufacturer shall 
establish and maintain procedures for changes to a specification, 
method, process, or procedure. Such changes shall be verified or where 
appropriate validated according to Sec. 820.75, before implementation 
and these activities shall be documented. Changes shall be approved in 
accordance with Sec. 820.40.
    (c) Environmental control. Where environmental conditions could 
reasonably be expected to have an adverse effect on product quality, the 
manufacturer shall establish and maintain procedures to adequately 
control these environmental conditions. Environmental control system(s) 
shall be periodically inspected to verify that the system, including 
necessary equipment, is adequate and functioning properly. These 
activities shall be documented and reviewed.
    (d) Personnel. Each manufacturer shall establish and maintain 
requirements for the health, cleanliness, personal practices, and 
clothing of personnel if contact between such personnel and product or 
environment could reasonably be expected to have an adverse effect on 
product quality. The manufacturer shall ensure that maintenance and 
other personnel who are required to work temporarily under special 
environmental conditions are appropriately trained or supervised by a 
trained individual.
    (e) Contamination control. Each manufacturer shall establish and 
maintain procedures to prevent contamination of equipment or product by 
substances that could reasonably be expected to have an adverse effect 
on product quality.
    (f) Buildings. Buildings shall be of suitable design and contain 
sufficient space to perform necessary operations, prevent mixups, and 
assure orderly handling.
    (g) Equipment. Each manufacturer shall ensure that all equipment 
used in the manufacturing process meets specified requirements and is 
appropriately designed, constructed, placed, and installed to facilitate 
maintenance, adjustment, cleaning, and use.
    (1) Maintenance schedule. Each manufacturer shall establish and 
maintain schedules for the adjustment, cleaning, and other maintenance 
of equipment to ensure that manufacturing specifications are met. 
Maintenance activities, including the date and individual(s) performing 
the maintenance activities, shall be documented.
    (2) Inspection. Each manufacturer shall conduct periodic inspections 
in accordance with established procedures to ensure adherence to 
applicable equipment maintenance schedules. The inspections, including 
the date and individual(s) conducting the inspections, shall be 
documented.
    (3) Adjustment. Each manufacturer shall ensure that any inherent 
limitations or allowable tolerances are visibly posted on or near 
equipment requiring periodic adjustments or are readily available to 
personnel performing these adjustments.

[[Page 179]]

    (h) Manufacturing material. Where a manufacturing material could 
reasonably be expected to have an adverse effect on product quality, the 
manufacturer shall establish and maintain procedures for the use and 
removal of such manufacturing material to ensure that it is removed or 
limited to an amount that does not adversely affect the device's 
quality. The removal or reduction of such manufacturing material shall 
be documented.
    (i) Automated processes. When computers or automated data processing 
systems are used as part of production or the quality system, the 
manufacturer shall validate computer software for its intended use 
according to an established protocol. All software changes shall be 
validated before approval and issuance. These validation activities and 
results shall be documented.



Sec. 820.72  Inspection, measuring, and test equipment.

    (a) Control of inspection, measuring, and test equipment. Each 
manufacturer shall ensure that all inspection, measuring, and test 
equipment, including mechanical, automated, or electronic inspection and 
test equipment, is suitable for its intended purposes and is capable of 
producing valid results. Each manufacturer shall establish and maintain 
procedures to ensure that equipment is routinely calibrated, inspected, 
checked, and maintained. The procedures shall include provisions for 
handling, preservation, and storage of equipment, so that its accuracy 
and fitness for use are maintained. These activities shall be 
documented.
    (b) Calibration. Calibration procedures shall include specific 
directions and limits for accuracy and precision. When accuracy and 
precision limits are not met, there shall be provisions for remedial 
action to reestablish the limits and to evaluate whether there was any 
adverse effect on the device's quality. These activities shall be 
documented.
    (1) Calibration standards. Calibration standards used for 
inspection, measuring, and test equipment shall be traceable to national 
or international standards. If national or international standards are 
not practical or available, the manufacturer shall use an independent 
reproducible standard. If no applicable standard exists, the 
manufacturer shall establish and maintain an in-house standard.
    (2) Calibration records. The equipment identification, calibration 
dates, the individual performing each calibration, and the next 
calibration date shall be documented. These records shall be displayed 
on or near each piece of equipment or shall be readily available to the 
personnel using such equipment and to the individuals responsible for 
calibrating the equipment.



Sec. 820.75  Process validation.

    (a) Where the results of a process cannot be fully verified by 
subsequent inspection and test, the process shall be validated with a 
high degree of assurance and approved according to established 
procedures. The validation activities and results, including the date 
and signature of the individual(s) approving the validation and where 
appropriate the major equipment validated, shall be documented.
    (b) Each manufacturer shall establish and maintain procedures for 
monitoring and control of process parameters for validated processes to 
ensure that the specified requirements continue to be met.
    (1) Each manufacturer shall ensure that validated processes are 
performed by qualified individual(s).
    (2) For validated processes, the monitoring and control methods and 
data, the date performed, and, where appropriate, the individual(s) 
performing the process or the major equipment used shall be documented.
    (c) When changes or process deviations occur, the manufacturer shall 
review and evaluate the process and perform revalidation where 
appropriate. These activities shall be documented.



                     Subpart H_Acceptance Activities



Sec. 820.80  Receiving, in-process, and finished device acceptance.

    (a) General. Each manufacturer shall establish and maintain 
procedures for acceptance activities. Acceptance activities include 
inspections, tests, or other verification activities.

[[Page 180]]

    (b) Receiving acceptance activities. Each manufacturer shall 
establish and maintain procedures for acceptance of incoming product. 
Incoming product shall be inspected, tested, or otherwise verified as 
conforming to specified requirements. Acceptance or rejection shall be 
documented.
    (c) In-process acceptance activities. Each manufacturer shall 
establish and maintain acceptance procedures, where appropriate, to 
ensure that specified requirements for in-process product are met. Such 
procedures shall ensure that in-process product is controlled until the 
required inspection and tests or other verification activities have been 
completed, or necessary approvals are received, and are documented.
    (d) Final acceptance activities. Each manufacturer shall establish 
and maintain procedures for finished device acceptance to ensure that 
each production run, lot, or batch of finished devices meets acceptance 
criteria. Finished devices shall be held in quarantine or otherwise 
adequately controlled until released. Finished devices shall not be 
released for distribution until:
    (1) The activities required in the DMR are completed;
    (2) the associated data and documentation is reviewed;
    (3) the release is authorized by the signature of a designated 
individual(s); and
    (4) the authorization is dated.
    (e) Acceptance records. Each manufacturer shall document acceptance 
activities required by this part. These records shall include:
    (1) The acceptance activities performed;
    (2) the dates acceptance activities are performed;
    (3) the results;
    (4) the signature of the individual(s) conducting the acceptance 
activities; and
    (5) where appropriate the equipment used. These records shall be 
part of the DHR.



Sec. 820.86  Acceptance status.

    Each manufacturer shall identify by suitable means the acceptance 
status of product, to indicate the conformance or nonconformance of 
product with acceptance criteria. The identification of acceptance 
status shall be maintained throughout manufacturing, packaging, 
labeling, installation, and servicing of the product to ensure that only 
product which has passed the required acceptance activities is 
distributed, used, or installed.



                     Subpart I_Nonconforming Product



Sec. 820.90  Nonconforming product.

    (a) Control of nonconforming product. Each manufacturer shall 
establish and maintain procedures to control product that does not 
conform to specified requirements. The procedures shall address the 
identification, documentation, evaluation, segregation, and disposition 
of nonconforming product. The evaluation of nonconformance shall include 
a determination of the need for an investigation and notification of the 
persons or organizations responsible for the nonconformance. The 
evaluation and any investigation shall be documented.
    (b) Nonconformity review and disposition. (1) Each manufacturer 
shall establish and maintain procedures that define the responsibility 
for review and the authority for the disposition of nonconforming 
product. The procedures shall set forth the review and disposition 
process. Disposition of nonconforming product shall be documented. 
Documentation shall include the justification for use of nonconforming 
product and the signature of the individual(s) authorizing the use.
    (2) Each manufacturer shall establish and maintain procedures for 
rework, to include retesting and reevaluation of the nonconforming 
product after rework, to ensure that the product meets its current 
approved specifications. Rework and reevaluation activities, including a 
determination of any adverse effect from the rework upon the product, 
shall be documented in the DHR.

[[Page 181]]



               Subpart J_Corrective and Preventive Action



Sec. 820.100  Corrective and preventive action.

    (a) Each manufacturer shall establish and maintain procedures for 
implementing corrective and preventive action. The procedures shall 
include requirements for:
    (1) Analyzing processes, work operations, concessions, quality audit 
reports, quality records, service records, complaints, returned product, 
and other sources of quality data to identify existing and potential 
causes of nonconforming product, or other quality problems. Appropriate 
statistical methodology shall be employed where necessary to detect 
recurring quality problems;
    (2) Investigating the cause of nonconformities relating to product, 
processes, and the quality system;
    (3) Identifying the action(s) needed to correct and prevent 
recurrence of nonconforming product and other quality problems;
    (4) Verifying or validating the corrective and preventive action to 
ensure that such action is effective and does not adversely affect the 
finished device;
    (5) Implementing and recording changes in methods and procedures 
needed to correct and prevent identified quality problems;
    (6) Ensuring that information related to quality problems or 
nonconforming product is disseminated to those directly responsible for 
assuring the quality of such product or the prevention of such problems; 
and
    (7) Submitting relevant information on identified quality problems, 
as well as corrective and preventive actions, for management review.
    (b) All activities required under this section, and their results, 
shall be documented.



                Subpart K_Labeling and Packaging Control



Sec. 820.120  Device labeling.

    Each manufacturer shall establish and maintain procedures to control 
labeling activities.
    (a) Label integrity. Labels shall be printed and applied so as to 
remain legible and affixed during the customary conditions of 
processing, storage, handling, distribution, and where appropriate use.
    (b) Labeling inspection. Labeling shall not be released for storage 
or use until a designated individual(s) has examined the labeling for 
accuracy including, where applicable, the correct unique device 
identifier (UDI) or universal product code (UPC), expiration date, 
control number, storage instructions, handling instructions, and any 
additional processing instructions. The release, including the date and 
signature of the individual(s) performing the examination, shall be 
documented in the DHR.
    (c) Labeling storage. Each manufacturer shall store labeling in a 
manner that provides proper identification and is designed to prevent 
mixups.
    (d) Labeling operations. Each manufacturer shall control labeling 
and packaging operations to prevent labeling mixups. The label and 
labeling used for each production unit, lot, or batch shall be 
documented in the DHR.
    (e) Control number. Where a control number is required by Sec. 
820.65, that control number shall be on or shall accompany the device 
through distribution.

[61 FR 52654, Oct. 7, 1996, as amended at 78 FR 58822, Sept. 24, 2013]



Sec. 820.130  Device packaging.

    Each manufacturer shall ensure that device packaging and shipping 
containers are designed and constructed to protect the device from 
alteration or damage during the customary conditions of processing, 
storage, handling, and distribution.



       Subpart L_Handling, Storage, Distribution, and Installation



Sec. 820.140  Handling.

    Each manufacturer shall establish and maintain procedures to ensure 
that mixups, damage, deterioration, contamination, or other adverse 
effects to product do not occur during handling.

[[Page 182]]



Sec. 820.150  Storage.

    (a) Each manufacturer shall establish and maintain procedures for 
the control of storage areas and stock rooms for product to prevent 
mixups, damage, deterioration, contamination, or other adverse effects 
pending use or distribution and to ensure that no obsolete, rejected, or 
deteriorated product is used or distributed. When the quality of product 
deteriorates over time, it shall be stored in a manner to facilitate 
proper stock rotation, and its condition shall be assessed as 
appropriate.
    (b) Each manufacturer shall establish and maintain procedures that 
describe the methods for authorizing receipt from and dispatch to 
storage areas and stock rooms.



Sec. 820.160  Distribution.

    (a) Each manufacturer shall establish and maintain procedures for 
control and distribution of finished devices to ensure that only those 
devices approved for release are distributed and that purchase orders 
are reviewed to ensure that ambiguities and errors are resolved before 
devices are released for distribution. Where a device's fitness for use 
or quality deteriorates over time, the procedures shall ensure that 
expired devices or devices deteriorated beyond acceptable fitness for 
use are not distributed.
    (b) Each manufacturer shall maintain distribution records which 
include or refer to the location of:
    (1) The name and address of the initial consignee;
    (2) The identification and quantity of devices shipped;
    (3) The date shipped; and
    (4) Any control number(s) used.



Sec. 820.170  Installation.

    (a) Each manufacturer of a device requiring installation shall 
establish and maintain adequate installation and inspection 
instructions, and where appropriate test procedures. Instructions and 
procedures shall include directions for ensuring proper installation so 
that the device will perform as intended after installation. The 
manufacturer shall distribute the instructions and procedures with the 
device or otherwise make them available to the person(s) installing the 
device.
    (b) The person installing the device shall ensure that the 
installation, inspection, and any required testing are performed in 
accordance with the manufacturer's instructions and procedures and shall 
document the inspection and any test results to demonstrate proper 
installation.



                            Subpart M_Records



Sec. 820.180  General requirements.

    All records required by this part shall be maintained at the 
manufacturing establishment or other location that is reasonably 
accessible to responsible officials of the manufacturer and to employees 
of FDA designated to perform inspections. Such records, including those 
not stored at the inspected establishment, shall be made readily 
available for review and copying by FDA employee(s). Such records shall 
be legible and shall be stored to minimize deterioration and to prevent 
loss. Those records stored in automated data processing systems shall be 
backed up.
    (a) Confidentiality. Records deemed confidential by the manufacturer 
may be marked to aid FDA in determining whether information may be 
disclosed under the public information regulation in part 20 of this 
chapter.
    (b) Record retention period. All records required by this part shall 
be retained for a period of time equivalent to the design and expected 
life of the device, but in no case less than 2 years from the date of 
release for commercial distribution by the manufacturer.
    (c) Exceptions. This section does not apply to the reports required 
by Sec. 820.20(c) Management review, Sec. 820.22 Quality audits, and 
supplier audit reports used to meet the requirements of Sec. 820.50(a) 
Evaluation of suppliers, contractors, and consultants, but does apply to 
procedures established under these provisions. Upon request of a 
designated employee of FDA, an employee in management with executive 
responsibility shall certify in writing that the management reviews and 
quality audits required under this part, and supplier audits where 
applicable, have been performed and documented, the dates on which they 
were performed,

[[Page 183]]

and that any required corrective action has been undertaken.



Sec. 820.181  Device master record.

    Each manufacturer shall maintain device master records (DMR's). Each 
manufacturer shall ensure that each DMR is prepared and approved in 
accordance with Sec. 820.40. The DMR for each type of device shall 
include, or refer to the location of, the following information:
    (a) Device specifications including appropriate drawings, 
composition, formulation, component specifications, and software 
specifications;
    (b) Production process specifications including the appropriate 
equipment specifications, production methods, production procedures, and 
production environment specifications;
    (c) Quality assurance procedures and specifications including 
acceptance criteria and the quality assurance equipment to be used;
    (d) Packaging and labeling specifications, including methods and 
processes used; and
    (e) Installation, maintenance, and servicing procedures and methods.



Sec. 820.184  Device history record.

    Each manufacturer shall maintain device history records (DHR's). 
Each manufacturer shall establish and maintain procedures to ensure that 
DHR's for each batch, lot, or unit are maintained to demonstrate that 
the device is manufactured in accordance with the DMR and the 
requirements of this part. The DHR shall include, or refer to the 
location of, the following information:
    (a) The dates of manufacture;
    (b) The quantity manufactured;
    (c) The quantity released for distribution;
    (d) The acceptance records which demonstrate the device is 
manufactured in accordance with the DMR;
    (e) The primary identification label and labeling used for each 
production unit; and
    (f) Any unique device identifier (UDI) or universal product code 
(UPC), and any other device identification(s) and control number(s) 
used.

[61 FR 52654, Oct. 7, 1996, as amended at 78 FR 58822, Sept. 24, 2013]



Sec. 820.186  Quality system record.

    Each manufacturer shall maintain a quality system record (QSR). The 
QSR shall include, or refer to the location of, procedures and the 
documentation of activities required by this part that are not specific 
to a particular type of device(s), including, but not limited to, the 
records required by Sec. 820.20. Each manufacturer shall ensure that 
the QSR is prepared and approved in accordance with Sec. 820.40.



Sec. 820.198  Complaint files.

    (a) Each manufacturer shall maintain complaint files. Each 
manufacturer shall establish and maintain procedures for receiving, 
reviewing, and evaluating complaints by a formally designated unit. Such 
procedures shall ensure that:
    (1) All complaints are processed in a uniform and timely manner;
    (2) Oral complaints are documented upon receipt; and
    (3) Complaints are evaluated to determine whether the complaint 
represents an event which is required to be reported to FDA under part 
803 of this chapter, Medical Device Reporting.
    (b) Each manufacturer shall review and evaluate all complaints to 
determine whether an investigation is necessary. When no investigation 
is made, the manufacturer shall maintain a record that includes the 
reason no investigation was made and the name of the individual 
responsible for the decision not to investigate.
    (c) Any complaint involving the possible failure of a device, 
labeling, or packaging to meet any of its specifications shall be 
reviewed, evaluated, and investigated, unless such investigation has 
already been performed for a similar complaint and another investigation 
is not necessary.
    (d) Any complaint that represents an event which must be reported to 
FDA under part 803 of this chapter shall be promptly reviewed, 
evaluated, and investigated by a designated individual(s) and shall be 
maintained in a separate portion of the complaint files or otherwise 
clearly identified. In addition to the information required by Sec. 
820.198(e), records of investigation

[[Page 184]]

under this paragraph shall include a determination of:
    (1) Whether the device failed to meet specifications;
    (2) Whether the device was being used for treatment or diagnosis; 
and
    (3) The relationship, if any, of the device to the reported incident 
or adverse event.
    (e) When an investigation is made under this section, a record of 
the investigation shall be maintained by the formally designated unit 
identified in paragraph (a) of this section. The record of investigation 
shall include:
    (1) The name of the device;
    (2) The date the complaint was received;
    (3) Any unique device identifier (UDI) or universal product code 
(UPC), and any other device identification(s) and control number(s) 
used;
    (4) The name, address, and phone number of the complainant;
    (5) The nature and details of the complaint;
    (6) The dates and results of the investigation;
    (7) Any corrective action taken; and
    (8) Any reply to the complainant.
    (f) When the manufacturer's formally designated complaint unit is 
located at a site separate from the manufacturing establishment, the 
investigated complaint(s) and the record(s) of investigation shall be 
reasonably accessible to the manufacturing establishment.
    (g) If a manufacturer's formally designated complaint unit is 
located outside of the United States, records required by this section 
shall be reasonably accessible in the United States at either:
    (1) A location in the United States where the manufacturer's records 
are regularly kept; or
    (2) The location of the initial distributor.

[61 FR 52654, Oct. 7, 1996, as amended at 69 FR 11313, Mar. 10, 2004; 71 
FR 16228, Mar. 31, 2006; 78 FR 58822, Sept. 24, 2013]



                           Subpart N_Servicing



Sec. 820.200  Servicing.

    (a) Where servicing is a specified requirement, each manufacturer 
shall establish and maintain instructions and procedures for performing 
and verifying that the servicing meets the specified requirements.
    (b) Each manufacturer shall analyze service reports with appropriate 
statistical methodology in accordance with Sec. 820.100.
    (c) Each manufacturer who receives a service report that represents 
an event which must be reported to FDA under part 803 of this chapter 
shall automatically consider the report a complaint and shall process it 
in accordance with the requirements of Sec. 820.198.
    (d) Service reports shall be documented and shall include:
    (1) The name of the device serviced;
    (2) Any unique device identifier (UDI) or universal product code 
(UPC), and any other device identification(s) and control number(s) 
used;
    (3) The date of service;
    (4) The individual(s) servicing the device;
    (5) The service performed; and
    (6) The test and inspection data.

[61 FR 52654, Oct. 7, 1996, as amended at 69 FR 11313, Mar. 10, 2004; 78 
FR 58822, Sept. 24, 2013]



                    Subpart O_Statistical Techniques



Sec. 820.250  Statistical techniques.

    (a) Where appropriate, each manufacturer shall establish and 
maintain procedures for identifying valid statistical techniques 
required for establishing, controlling, and verifying the acceptability 
of process capability and product characteristics.
    (b) Sampling plans, when used, shall be written and based on a valid 
statistical rationale. Each manufacturer shall establish and maintain 
procedures to ensure that sampling methods are adequate for their 
intended use and to ensure that when changes occur the sampling plans 
are reviewed. These activities shall be documented.



PART 821_MEDICAL DEVICE TRACKING REQUIREMENTS--Table of Contents



                      Subpart A_General Provisions

Sec.
821.1 Scope.
821.2 Exemptions and variances.
821.3 Definitions.
821.4 Imported devices.

[[Page 185]]

                     Subpart B_Tracking Requirements

821.20 Devices subject to tracking.
821.25 Device tracking system and content requirements: manufacturer 
          requirements.

         Subpart C_Additional Requirements and Responsibilities

821.30 Tracking obligations of persons other than device manufacturers: 
          distributor requirements.

                    Subpart D_Records and Inspections

821.50 Availability.
821.55 Confidentiality.
821.60 Retention of records.

    Authority: 21 U.S.C. 331, 351, 352, 360, 360e, 360h, 360i, 371, 374.

    Source: 58 FR 43447, Aug. 16, 1993, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 821.1  Scope.

    (a) The regulations in this part implement section 519(e) of the 
Federal Food, Drug, and Cosmetic Act (the act), which provides that the 
Food and Drug Administration may require a manufacturer to adopt a 
method of tracking a class II or class III device, if the device meets 
one of the following three criteria and FDA issues an order to the 
manufacturer: the failure of the device would be reasonably likely to 
have serious adverse health consequences; or the device is intended to 
be implanted in the human body for more than 1 year; or the device is a 
life-sustaining or life-supporting device used outside a device user 
facility. A device that meets one of these criteria and is the subject 
of an FDA order must comply with this part and is referred to, in this 
part, as a ``tracked device.''
    (b) These regulations are intended to ensure that tracked devices 
can be traced from the device manufacturing facility to the person for 
whom the device is indicated, that is, the patient. Effective tracking 
of devices from the manufacturing facility, through the distributor 
network (including distributors, retailers, rental firms and other 
commercial enterprises, device user facilities, and licensed 
practitioners) and, ultimately, to the patient is necessary for the 
effectiveness of remedies prescribed by the act, such as patient 
notification (section 518(a) of the act) or device recall (section 
518(e) of the act). Although these regulations do not preclude a 
manufacturer from involving outside organizations in that manufacturer's 
device tracking effort, the legal responsibility for complying with this 
part rests with manufacturers who are subject to tracking orders, and 
that responsibility cannot be altered, modified, or in any way abrogated 
by contracts or other agreements.
    (c) The primary burden for ensuring that the tracking system works 
rests upon the manufacturer. A manufacturer or any other person, 
including a distributor, final distributor, or multiple distributor, who 
distributes a device subject to tracking, who fails to comply with any 
applicable requirement of section 519(e) of the act or of this part, or 
any person who causes such failure, misbrands the device within the 
meaning of section 502(t)(2) of the act and commits a prohibited act 
within the meaning of sections 301(e) and 301(q)(1)(B) of the act.
    (d) Any person subject to this part who permanently discontinues 
doing business is required to notify FDA at the time the person notifies 
any government agency, court, or supplier, and provide FDA with a 
complete set of its tracking records and information. However, if a 
person ceases distribution of a tracked device but continues to do other 
business, that person continues to be responsible for compliance with 
this part unless another person, affirmatively and in writing, assumes 
responsibility for continuing the tracking of devices previously 
distributed under this part. Further, if a person subject to this part 
goes out of business completely, but other persons acquire the right to 
manufacture or distribute tracked devices, those other persons are 
deemed to be responsible for continuing the tracking responsibility of 
the previous person under this part.

[58 FR 43447, Aug. 16, 1993, as amended at 67 FR 5951, Feb. 8, 2002; 73 
FR 34860, June 19, 2008]

[[Page 186]]



Sec. 821.2  Exemptions and variances.

    (a) A manufacturer, importer, or distributor may seek an exemption 
or variance from one or more requirements of this part.
    (b) A request for an exemption or variance shall be submitted in the 
form of a petition under Sec. 10.30 of this chapter and shall comply 
with the requirements set out therein, except that a response shall be 
issued in 90 days. The Director or Deputy Directors, CDRH, or the 
Director or Principal Deputy Director of the Office of Product 
Evaluation and Quality, CDRH, shall issue responses to requests under 
this section. The petition shall also contain the following:
    (1) The name of the device and device class and representative 
labeling showing the intended use(s) of the device;
    (2) The reasons that compliance with the tracking requirements of 
this part is unnecessary;
    (3) A complete description of alternative steps that are available, 
or that the petitioner has already taken, to ensure that an effective 
tracking system is in place; and
    (4) Other information justifying the exemption or variance.
    (c) An exemption or variance is not effective until the Director or 
Deputy Directors, CDRH, or the Director or Principal Deputy Director of 
the Office of Product Evaluation and Quality, CDRH, approves the request 
under Sec. 10.30(e)(2)(i) of this chapter.

[58 FR 43447, Aug. 16, 1993, as amended at 59 FR 31138, June 17, 1994; 
67 FR 5951, Feb. 8, 2002; 72 FR 17399, Apr. 9, 2007; 85 FR 18443, Apr. 
2, 2020; 86 FR 17065, Apr. 1, 2021]



Sec. 821.3  Definitions.

    The following definitions and terms apply to this part:
    (a) Act means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 
321 et seq., as amended.
    (b) Importer means the initial distributor of an imported device who 
is subject to a tracking order. ``Importer'' does not include anyone who 
only furthers the marketing, e.g., brokers, jobbers, or warehousers.
    (c) Manufacturer means any person, including any importer, repacker 
and/or relabeler, who manufactures, prepares, propagates, compounds, 
assembles, or processes a device or engages in any of the activities 
described in Sec. 807.3(d) of this chapter.
    (d) Device failure means the failure of a device to perform or 
function as intended, including any deviations from the device's 
performance specifications or intended use.
    (e) Serious adverse health consequences means any significant 
adverse experience related to a device, including device-related events 
which are life-threatening or which involve permanent or long-term 
injuries or illnesses.
    (f) Device intended to be implanted in the human body for more than 
1 year means a device that is intended to be placed into a surgically or 
naturally formed cavity of the human body for more than 1 year to 
continuously assist, restore, or replace the function of an organ system 
or structure of the human body throughout the useful life of the device. 
The term does not include a device that is intended and used only for 
temporary purposes or that is intended for explantation in 1 year or 
less.
    (g) Life-supporting or life-sustaining device used outside a device 
user facility means a device which is essential, or yields information 
that is essential, to the restoration or continuation of a bodily 
function important to the continuation of human life that is intended 
for use outside a hospital, nursing home, ambulatory surgical facility, 
or diagnostic or outpatient treatment facility. Physicians' offices are 
not device user facilities and, therefore, devices used therein are 
subject to tracking if they otherwise satisfy the statutory and 
regulatory criteria.
    (h) Distributor means any person who furthers the distribution of a 
device from the original place of manufacture to the person who makes 
delivery or sale to the ultimate user, i.e., the final or multiple 
distributor, but who does not repackage or otherwise change the 
container, wrapper, or labeling of the device or device package.
    (i) Final distributor means any person who distributes a tracked 
device intended for use by a single patient over the useful life of the 
device to the patient. This term includes, but is not

[[Page 187]]

limited to, licensed practitioners, retail pharmacies, hospitals, and 
other types of device user facilities.
    (j) Distributes means any distribution of a tracked device, 
including the charitable distribution of a tracked device. This term 
does not include the distribution of a device under an effective 
investigational device exemption in accordance with section 520(g) of 
the act and part 812 of this chapter or the distribution of a device for 
teaching, law enforcement, research, or analysis as specified in Sec. 
801.125 of this chapter.
    (k) Multiple distributor means any device user facility, rental 
company, or any other entity that distributes a life-sustaining or life-
supporting device intended for use by more than one patient over the 
useful life of the device.
    (l) Licensed practitioner means a physician, dentist, or other 
health care practitioner licensed by the law of the State in which he or 
she practices to use or order the use of the tracked device.
    (m) Any term defined in section 201 of the act shall have the same 
definition in this part.
    (n) Human cell, tissue, or cellular or tissue-based product (HCT/P) 
regulated as a device means an HCT/P as defined in Sec. 1271.3(d) of 
this chapter that does not meet the criteria in Sec. 1271.10(a) and 
that is also regulated as a device.
    (o) Unique device identifier (UDI) means an identifier that 
adequately identifies a device through its distribution and use by 
meeting the requirements of Sec. 830.20 of this chapter. A unique 
device identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies the specific version or model of a device and the labeler of 
that device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (v) For an HCT/P regulated as a device, the distinct identification 
code required by Sec. 1271.290(c) of this chapter.

[58 FR 43447, Aug. 16, 1993, as amended at 67 FR 5951, Feb. 8, 2002; 78 
FR 58822, Sept. 24, 2013]



Sec. 821.4  Imported devices.

    For purposes of this part, the importer of a tracked device shall be 
considered the manufacturer and shall be required to comply with all 
requirements of this part applicable to manufacturers. Importers must 
keep all information required under this part in the United States.



                     Subpart B_Tracking Requirements



Sec. 821.20  Devices subject to tracking.

    (a) A manufacturer of any class II or class III device that fits 
within one of the three criteria within Sec. 821.1(a) must track that 
device in accordance with this part, if FDA issues a tracking order to 
that manufacturer.
    (b) When responding to premarket notification submissions and 
premarket approval applications, FDA will notify the sponsor by issuing 
an order that states that FDA believes the device meets the criteria of 
section 519(e)(1) of the act and, by virtue of the order, the sponsor 
must track the device.

[67 FR 5951, Feb. 8, 2002]



Sec. 821.25  Device tracking system and content requirements:
manufacturer requirements.

    (a) A manufacturer of a tracked device shall adopt a method of 
tracking for each such type of device that it distributes that enables a 
manufacturer to provide FDA with the following information in writing 
for each tracked device distributed:
    (1) Except as required by order under section 518(e) of the act, 
within 3 working days of a request from FDA, prior to the distribution 
of a tracked device to a patient, the name, address, and telephone 
number of the distributor, multiple distributor, or final distributor 
holding the device for distribution and the location of the device;

[[Page 188]]

    (2) Within 10 working days of a request from FDA for tracked devices 
that are intended for use by a single patient over the life of the 
device, after distribution to or implantation in a patient:
    (i) The unique device identifier (UDI), lot number, batch number, 
model number, or serial number of the device or other identifier 
necessary to provide for effective tracking of the devices;
    (ii) The date the device was shipped by the manufacturer;
    (iii) The name, address, telephone number, and social security 
number (if available) of the patient receiving the device, unless not 
released by the patient under Sec. 821.55(a);
    (iv) The date the device was provided to the patient;
    (v) The name, mailing address, and telephone number of the 
prescribing physician;
    (vi) The name, mailing address, and telephone number of the 
physician regularly following the patient if different than the 
prescribing physician; and
    (vii) If applicable, the date the device was explanted and the name, 
mailing address, and telephone number of the explanting physician; the 
date of the patient's death; or the date the device was returned to the 
manufacturer, permanently retired from use, or otherwise permanently 
disposed of.
    (3) Except as required by order under section 518(e) of the act, 
within 10 working days of a request from FDA for tracked devices that 
are intended for use by more than one patient, after the distribution of 
the device to the multiple distributor:
    (i) The unique device identifier (UDI), lot number, batch number, 
model number, or serial number of the device or other identifier 
necessary to provide for effective tracking of the devices;
    (ii) The date the device was shipped by the manufacturer;
    (iii) The name, address, and telephone number of the multiple 
distributor;
    (iv) The name, address, telephone number, and social security number 
(if available) of the patient using the device, unless not released by 
the patient under Sec. 821.55(a);
    (v) The location of the device;
    (vi) The date the device was provided for use by the patient;
    (vii) The name, address, and telephone number of the prescribing 
physician; and
    (viii) If and when applicable, the date the device was returned to 
the manufacturer, permanently retired from use, or otherwise permanently 
disposed of.
    (b) A manufacturer of a tracked device shall keep current records in 
accordance with its standard operating procedure of the information 
identified in paragraphs (a)(1), (a)(2) and (a)(3)(i) through 
(a)(3)(iii) of this section on each tracked device released for 
distribution for as long as such device is in use or in distribution for 
use.
    (c) A manufacturer of a tracked device shall establish a written 
standard operating procedure for the collection, maintenance, and 
auditing of the data specified in paragraphs (a) and (b) of this 
section. A manufacturer shall make this standard operating procedure 
available to FDA upon request. A manufacturer shall incorporate the 
following into the standard operating procedure:
    (1) Data collection and recording procedures, which shall include a 
procedure for recording when data which is required under this part is 
missing and could not be collected and the reason why such required data 
is missing and could not be collected;
    (2) A method for recording all modifications or changes to the 
tracking system or to the data collected and maintained under the 
tracking system, reasons for any modification or change, and dates of 
any modification or change. Modification and changes included under this 
requirement include modifications to the data (including termination of 
tracking), the data format, the recording system, and the file 
maintenance procedures system; and
    (3) A quality assurance program that includes an audit procedure to 
be run for each device product subject to tracking, at not less than 6-
month intervals for the first 3 years of distribution and at least once 
a year thereafter. This audit procedure shall provide for statistically 
relevant sampling of the data collected to ensure the accuracy of data 
and performance testing

[[Page 189]]

of the functioning of the tracking system.
    (d) When a manufacturer becomes aware that a distributor, final 
distributor, or multiple distributor has not collected, maintained, or 
furnished any record or information required by this part, the 
manufacturer shall notify the FDA district office responsible for the 
area in which the distributor, final distributor, or multiple 
distributor is located of the failure of such persons to comply with the 
requirements of this part. Manufacturers shall have taken reasonable 
steps to obtain compliance by the distributor, multiple distributor, or 
final distributor in question before notifying FDA.
    (e) A manufacturer may petition for an exemption or variance from 
one or more requirements of this part according to the procedures in 
Sec. 821.2 of this chapter.

[58 FR 43447, Aug. 16, 1993, as amended at 67 FR 5951, Feb. 8, 2002; 78 
FR 58822, Sept. 24, 2013]



         Subpart C_Additional Requirements and Responsibilities



Sec. 821.30  Tracking obligations of persons other than device
manufacturers: distributor requirements.

    (a) A distributor, final distributor, or multiple distributor of any 
tracked device shall, upon purchasing or otherwise acquiring any 
interest in such a device, promptly provide the manufacturer tracking 
the device with the following information:
    (1) The name and address of the distributor, final distributor or 
multiple distributor;
    (2) The unique device identifier (UDI), lot number, batch number, 
model number, or serial number of the device or other identifier used by 
the manufacturer to track the device;
    (3) The date the device was received;
    (4) The person from whom the device was received;
    (5) If and when applicable, the date the device was explanted, the 
date of the patient's death, or the date the device was returned to the 
distributor, permanently retired from use, or otherwise permanently 
disposed of.
    (b) A final distributor, upon sale or other distribution of a 
tracked device for use in or by the patient, shall promptly provide the 
manufacturer tracking the device with the following information:
    (1) The name and address of the final distributor,
    (2) The unique device identifier (UDI), lot number, batch number, 
model number, or serial number of the device or other identifier used by 
the manufacturer to track the device;
    (3) The name, address, telephone number, and social security number 
(if available) of the patient receiving the device, unless not released 
by the patient under Sec. 821.55(a);
    (4) The date the device was provided to the patient or for use in 
the patient;
    (5) The name, mailing address, and telephone number of the 
prescribing physician;
    (6) The name, mailing address, and telephone number of the physician 
regularly following the patient if different than the prescribing 
physician; and
    (7) When applicable, the date the device was explanted and the name, 
mailing address, and telephone number of the explanting physician, the 
date of the patient's death, or the date the device was returned to the 
manufacturer, permanently retired from use, or otherwise permanently 
disposed of.
    (c)(1) A multiple distributor shall keep written records of the 
following each time such device is distributed for use by a patient:
    (i) The unique device identifier (UDI), lot number, batch number, 
model number, or serial number of the device or other identifier used by 
the manufacturer to track the device;
    (ii) The name, address, telephone number, and social security number 
(if available) of the patient using the device;
    (iii) The location of the device, unless not released by the patient 
under Sec. 821.55(a);
    (iv) The date the device was provided for use by the patient;
    (v) The name, address, and telephone number of the prescribing 
physician;
    (vi) The name, address, and telephone number of the physician 
regularly following the patient if different than the prescribing 
physician; and

[[Page 190]]

    (vii) When applicable, the date the device was permanently retired 
from use or otherwise permanently disposed of.
    (2) Except as required by order under section 518(e) of the act, any 
person who is a multiple distributor subject to the recordkeeping 
requirement of paragraph (c)(1) of this section shall, within 5 working 
days of a request from the manufacturer or within 10 working days of a 
request from FDA for the information identified in paragraph (c)(1) of 
this section, provide such information to the manufacturer or FDA.
    (d) A distributor, final distributor, or multiple distributor shall 
make any records required to be kept under this part available to the 
manufacturer of the tracked device for audit upon written request by an 
authorized representative of the manufacturer.
    (e) A distributor, final distributor, or multiple distributor may 
petition for an exemption or variance from one or more requirements of 
this part according to the procedures in Sec. 821.2.

[58 FR 43447, Aug. 16, 1993, as amended at 67 FR 5951, Feb. 8, 2002; 78 
FR 58822, Sept. 24, 2013]



                    Subpart D_Records and Inspections



Sec. 821.50  Availability.

    (a) Manufacturers, distributors, multiple distributors, and final 
distributors shall, upon the presentation by an FDA representative of 
official credentials and the issuance of Form FDA 482 at the initiation 
of an inspection of an establishment or person under section 704 of the 
act, make each record and all information required to be collected and 
maintained under this part and all records and information related to 
the events and persons identified in such records available to FDA 
personnel.
    (b) Records and information referenced in paragraph (a) of this 
section shall be available to FDA personnel for purposes of reviewing, 
copying, or any other use related to the enforcement of the act and this 
part. Records required to be kept by this part shall be kept in a 
centralized point for each manufacturer or distributor within the United 
States.

[58 FR 43447, Aug. 16, 1993, as amended at 65 FR 43690, July 14, 2000]



Sec. 821.55  Confidentiality.

    (a) Any patient receiving a device subject to tracking requirements 
under this part may refuse to release, or refuse permission to release, 
the patient's name, address, telephone number, and social security 
number, or other identifying information for the purpose of tracking.
    (b) Records and other information submitted to FDA under this part 
shall be protected from public disclosure to the extent permitted under 
part 20 of this chapter, and in accordance with Sec. 20.63 of this 
chapter, information contained in such records that would identify 
patient or research subjects shall not be available for public 
disclosure except as provided in those parts.
    (c) Patient names or other identifiers may be disclosed to a 
manufacturer or other person subject to this part or to a physician when 
the health or safety of the patient requires that such persons have 
access to the information. Such notification will be pursuant to 
agreement that the record or information will not be further disclosed 
except as the health aspects of the patient requires. Such notification 
does not constitute public disclosure and will not trigger the 
availability of the same information to the public generally.

[58 FR 43447, Aug. 16, 1993, as amended at 67 FR 5951, Feb. 8, 2002]



Sec. 821.60  Retention of records.

    Persons required to maintain records under this part shall maintain 
such records for the useful life of each tracked device they manufacture 
or distribute. The useful life of a device is the time a device is in 
use or in distribution for use. For example, a record may be retired if 
the person maintaining the record becomes aware of the fact that the 
device is no longer in use, has been explanted, returned to the 
manufacturer, or the patient has died.

[[Page 191]]



PART 822_POSTMARKET SURVEILLANCE--Table of Contents



                      Subpart A_General Provisions

Sec.
822.1 What does this part cover?
822.2 What is the purpose of this part?
822.3 How do you define the terms used in this part?
822.4 Does this part apply to me?

                         Subpart B_Notification

822.5 How will I know if I must conduct postmarket surveillance?
822.6 When will you notify me that I am required to conduct postmarket 
          surveillance?
822.7 What should I do if I do not agree that postmarket surveillance is 
          appropriate?

                 Subpart C_Postmarket Surveillance Plan

822.8 When, where, and how must I submit my postmarket surveillance 
          plan?
822.9 What must I include in my submission?
822.10 What must I include in my surveillance plan?
822.11 What should I consider when designing my plan to conduct 
          postmarket surveillance?
822.12 Do you have any information that will help me prepare my 
          submission or design my postmarket surveillance plan?
822.13 [Reserved]
822.14 May I reference information previously submitted instead of 
          submitting it again?
822.15 How long must I conduct postmarket surveillance of my device?

                     Subpart D_FDA Review and Action

822.16 What will you consider in the review of my submission?
822.17 How long will your review of my submission take?
822.18 How will I be notified of your decision?
822.19 What kinds of decisions may you make?
822.20 What are the consequences if I fail to submit a postmarket 
          surveillance plan, my plan is disapproved and I fail to submit 
          a new plan, or I fail to conduct surveillance in accordance 
          with my approved plan?
822.21 What must I do if I want to make changes to my postmarket 
          surveillance plan after you have approved it?
822.22 What recourse do I have if I do not agree with your decision?
822.23 Is the information in my submission considered confidential?

               Subpart E_Responsibilities of Manufacturers

822.24 What are my responsibilities once I am notified that I am 
          required to conduct postmarket surveillance?
822.25 What are my responsibilities after my postmarket surveillance 
          plan has been approved?
822.26 If my company changes ownership, what must I do?
822.27 If I go out of business, what must I do?
822.28 If I stop marketing the device subject to postmarket 
          surveillance, what must I do?

                    Subpart F_Waivers and Exemptions

822.29 May I request a waiver of a specific requirement of this part?
822.30 May I request exemption from the requirement to conduct 
          postmarket surveillance?

                      Subpart G_Records and Reports

822.31 What records am I required to keep?
822.32 What records are the investigators in my surveillance plan 
          required to keep?
822.33 How long must we keep the records?
822.34 What must I do with the records if the sponsor of the plan or an 
          investigator in the plan changes?
822.35 Can you inspect my manufacturing site or other sites involved in 
          my postmarket surveillance plan?
822.36 Can you inspect and copy the records related to my postmarket 
          surveillance plan?
822.37 Under what circumstances would you inspect records identifying 
          subjects?
822.38 What reports must I submit to you?

    Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374.

    Source: 67 FR 38887, June 6, 2002, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 822.1  What does this part cover?

    This part implements section 522 of the Federal Food, Drug, and 
Cosmetic Act by providing procedures and requirements for postmarket 
surveillance of class II and class III devices that meet any of the 
following criteria:
    (a) Failure of the device would be reasonably likely to have serious 
adverse health consequences;
    (b) The device is intended to be implanted in the human body for 
more than 1 year;

[[Page 192]]

    (c) The device is intended to be used outside a user facility to 
support or sustain life. If you fail to comply with requirements that we 
order under section 522 of the Federal Food, Drug, and Cosmetic Act and 
this part, your device is considered misbranded under section 502(t)(3) 
of the Federal Food, Drug, and Cosmetic Act and you are in violation of 
section 301(q)(1)(C) of the Federal Food, Drug, and Cosmetic Act; or
    (d) The device is expected to have significant use in pediatric 
populations.

[67 FR 38887, June 6, 2002, as amended at 88 FR 16880, Mar. 21, 2023]



Sec. 822.2  What is the purpose of this part?

    The purpose of this part is to implement our postmarket surveillance 
authority to maximize the likelihood that postmarket surveillance plans 
will result in the collection of useful data. These data can reveal 
unforeseen adverse events, the actual rate of anticipated adverse 
events, or other information necessary to protect the public health.



Sec. 822.3  How do you define the terms used in this part?

    Some of the terms we use in this part are specific to postmarket 
surveillance and reflect the language used in the statute (law). Other 
terms are more general and reflect our interpretation of the law. This 
section of the part defines the following terms:
    (a) Act means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 
301 et seq., as amended.
    (b) Designated person means the individual who conducts or 
supervises the conduct of your postmarket surveillance. If your 
postmarket surveillance plan includes a team of investigators, as 
defined below, the designated person is the responsible leader of that 
team.
    (c) Device failure means a device does not perform or function as 
intended, and includes any deviation from the device's performance 
specifications or intended use.
    (d) General plan guidance means agency guidance that provides 
information about the requirement to conduct postmarket surveillance, 
the submission of a plan to us for approval, the content of the 
submission, and the conduct and reporting requirements of the 
surveillance.
    (e) Human cell, tissue, or cellular or tissue-based product (HCT/P) 
regulated as a device means an HCT/P as defined in Sec. 1271.3(d) of 
this chapter that does not meet the criteria in Sec. 1271.10(a) and 
that is also regulated as a device.
    (f) Investigator means an individual who collects data or 
information in support of a postmarket surveillance plan.
    (g) Life-supporting or life-sustaining device used outside a device 
user facility means that a device is essential to, or yields information 
essential to, the restoration or continuation of a bodily function 
important to the continuation of human life and is used outside a 
hospital, nursing home, ambulatory surgical facility, or diagnostic or 
outpatient treatment facility. A physician's office is not a device user 
facility.
    (h) Manufacturer means any person, including any importer, repacker, 
and/or relabeler, who manufactures, prepares, propagates, compounds, 
assembles, processes a device, or engages in any of the activities 
described in Sec. 807.3(d) of this chapter.
    (i) Postmarket surveillance means the active, systematic, 
scientifically valid collection, analysis, and interpretation of data or 
other information about a marketed device.
    (j) Prospective surveillance means that the subjects are identified 
at the beginning of the surveillance and data or other information will 
be collected from that time forward (as opposed to retrospective 
surveillance).
    (k) Serious adverse health consequences means any significant 
adverse experience related to a device, including device-related events 
that are life-threatening or that involve permanent or long-term 
injuries or illnesses.
    (l) Specific guidance means guidance that provides information 
regarding postmarket surveillance for specific types or categories of 
devices or specific postmarket surveillance issues. This type of 
guidance may be used to supplement general guidance and may address such 
topics as the type of surveillance approach that is appropriate

[[Page 193]]

for the device and the postmarket surveillance question, sample size, or 
specific reporting requirements.
    (m) Surveillance question means the issue or issues to be addressed 
by the postmarket surveillance.
    (n) Unforeseen adverse event means any serious adverse health 
consequence that either is not addressed in the labeling of the device 
or occurs at a rate higher than anticipated.
    (o) Unique device identifier (UDI) means an identifier that 
adequately identifies a device through its distribution and use by 
meeting the requirements of Sec. 830.20 of this chapter. A UDI is 
composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies the specific version or model of a device and the labeler of 
that device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (v) For an HCT/P regulated as a device, the distinct identification 
code required by Sec. 1271.290(c) of this chapter.

[67 FR 38887, June 6, 2002, as amended at 78 FR 58823, Sept. 24, 2013]



Sec. 822.4  Does this part apply to me?

    If we have ordered you to conduct postmarket surveillance of a 
medical device under section 522 of the Federal Food, Drug, and Cosmetic 
Act, this part applies to you. We have the authority to order postmarket 
surveillance of any class II or class III medical device, including a 
device reviewed under the licensing provisions of section 351 of the 
Public Health Service Act, that meets any of the following criteria:
    (a) Failure of the device would be reasonably likely to have serious 
adverse health consequences;
    (b) The device is intended to be implanted in the human body for 
more than 1 year;
    (c) The device is intended to be used to support or sustain life and 
to be used outside a user facility; or
    (d) The device is expected to have significant use in pediatric 
populations.

[67 FR 38887, June 6, 2002, as amended at 88 FR 16880, Mar. 21, 2023]



                         Subpart B_Notification



Sec. 822.5  How will I know if I must conduct postmarket surveillance?

    We will send you a letter (the postmarket surveillance order) 
notifying you of the requirement to conduct postmarket surveillance. 
Before we send the order, or as part of the order, we may require that 
you submit information about your device that will allow us better to 
define the scope of a surveillance order. We will specify the device(s) 
subject to the surveillance order and the reason that we are requiring 
postmarket surveillance of the device under section 522 of the act. We 
will also provide you with any general or specific guidance that is 
available to help you develop your plan for conducting postmarket 
surveillance.



Sec. 822.6  When will you notify me that I am required to conduct
postmarket surveillance?

    We will notify you as soon as we have determined that postmarket 
surveillance of your device is necessary, based on the identification of 
a surveillance question. This may occur during the review of a marketing 
application for your device, as your device goes to market, or after 
your device has been marketed for a period of time.



Sec. 822.7  What should I do if I do not agree that postmarket 
surveillance is appropriate?

    (a) If you do not agree with our decision to order postmarket 
surveillance for a particular device, you may request review of our 
decision by:
    (1) Requesting a meeting with the Director of the Office that issued 
the order for postmarket surveillance;
    (2) Seeking internal review of the order under Sec. 10.75 of this 
chapter;
    (3) Requesting an informal hearing under part 16 of this chapter; or

[[Page 194]]

    (4) Requesting review by the Medical Devices Dispute Resolution 
Panel of the Medical Devices Advisory Committee.
    (b) You may obtain guidance documents that discuss these mechanisms 
from the Center for Devices and Radiological Health's (CDRH's) Web site 
(http://www.fda.gov/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/CDRH/CDRHOmbudsman/default.htm.).

[67 FR 38887, June 6, 2002, as amended at 72 FR 17399, Apr. 9, 2007; 78 
FR 18233, Mar. 26, 2013; 85 FR 18843, Apr. 2, 2020; 88 FR 16880, Mar. 
21, 2023]



                 Subpart C_Postmarket Surveillance Plan



Sec. 822.8  When, where, and how must I submit my postmarket 
surveillance plan?

    You must submit your plan to conduct postmarket surveillance within 
30 days of the date you receive the postmarket surveillance order. For 
devices regulated by the Center for Biologics Evaluation and Research, 
send your submission to the Food and Drug Administration, Center for 
Biologics Evaluation and Research, Document Control Center, 10903 New 
Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002. For 
devices regulated by the Center for Drug Evaluation and Research, send 
your submission to the Central Document Room, Center for Drug Evaluation 
and Research, Food and Drug Administration, 5901-B, Ammendale Rd., 
Beltsville, MD 20705-1266. For devices regulated by the Center for 
Devices and Radiological Health, send your submission to the Document 
Mail Center, 10903 New Hampshire Ave., Bldg. 66, Rm. G609, Silver 
Spring, MD 20993-0002. When we receive your original submission, we will 
send you an acknowledgment letter identifying the unique document number 
assigned to your submission. You must use this number in any 
correspondence related to this submission.

[87 FR 17950, Mar. 29, 2022]



Sec. 822.9  What must I include in my submission?

    Your submission must include the following:
    (a) Organizational/administrative information:
    (1) Your name and address;
    (2) Generic and trade names of your device;
    (3) Name and address of the contact person for the submission;
    (4) Premarket application/submission number and device identifiers 
for your device;
    (5) Table of contents identifying the page numbers for each section 
of the submission;
    (6) Description of the device (this may be incorporated by reference 
to the appropriate premarket application/submission);
    (7) Product codes and a list of all relevant model numbers; and
    (8) Indications for use and claims for the device;
    (b) Postmarket surveillance plan;
    (c) Designated person information;
    (1) Name, address, and telephone number; and
    (2) Experience and qualifications.

[67 FR 38887, June 6, 2002, as amended at 78 FR 58823, Sept. 24, 2013]



Sec. 822.10  What must I include in my surveillance plan?

    Your surveillance plan must include a discussion of:
    (a) The plan objective(s) addressing the surveillance question(s) 
identified in our order;
    (b) The subject of the study, e.g., patients, the device, animals;
    (c) The variables and endpoints that will be used to answer the 
surveillance question, e.g., clinical parameters or outcomes;
    (d) The surveillance approach or methodology to be used;
    (e) Sample size and units of observation;
    (f) The investigator agreement, if applicable;
    (g) Sources of data, e.g., hospital records;
    (h) The data collection plan and forms;
    (i) The consent document, if applicable;

[[Page 195]]

    (j) Institutional Review Board information, if applicable;
    (k) The patient followup plan, if applicable;
    (l) The procedures for monitoring conduct and progress of the 
surveillance;
    (m) An estimate of the duration of surveillance;
    (n) All data analyses and statistical tests planned;
    (o) The content and timing of reports.



Sec. 822.11  What should I consider when designing my plan to 
conduct postmarket surveillance?

    You must design your surveillance to address the postmarket 
surveillance question identified in the order you received. You should 
consider what, if any, patient protection measures should be 
incorporated into your plan. You should also consider the function, 
operating characteristics, and intended use of your device when 
designing a surveillance approach.



Sec. 822.12  Do you have any information that will help me prepare
my submission or design my postmarket surveillance plan?

    Guidance documents that discuss our current thinking on preparing a 
postmarket surveillance submission and designing a postmarket 
surveillance plan are available on the Center for Devices and 
Radiological Health's website, the Food and Drug Administration main 
website, and from the Food and Drug Administration, Center for Devices 
and Radiological Health, Office of Policy, Guidance and Policy 
Development, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver 
Spring, MD 20993-0002. They do not establish legally enforceable rights 
or responsibilities and do not legally bind you or FDA. You may choose 
to use an approach other than the one set forth in a guidance document, 
as long as your alternative approach complies with the relevant statutes 
(laws) and regulations. If you wish, we will meet with you to discuss 
whether an alternative approach you are considering will satisfy the 
requirements of the act and regulations.

[75 FR 20915, Apr. 22, 2010, as amended at 87 FR 17950, Mar. 29, 2022]



Sec. 822.13  [Reserved]



Sec. 822.14  May I reference information previously submitted 
instead of submitting it again?

    Yes, you may reference information that you have submitted in 
premarket submissions as well as other postmarket surveillance 
submissions. You must specify the information to be incorporated and the 
document number and pages where the information is located.



Sec. 822.15  How long must I conduct postmarket surveillance of my device?

    The length of postmarket surveillance will depend on the postmarket 
surveillance question identified in our order. We may order prospective 
surveillance for a period up to 36 months; longer periods require your 
agreement. If we believe that a prospective period of greater than 36 
months is necessary to address the surveillance question, and you do not 
agree, we will use the Medical Devices Dispute Resolution Panel to 
resolve the matter. You may obtain guidance regarding dispute resolution 
procedures from the Center for Devices and Radiological Health's (CDRH') 
Web site (http://www.fda.gov/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/CDRH/CDRHOmbudsman/default.htm.). The 
36-month period refers to the surveillance period, not the length of 
time from the issuance of the order.

[72 FR 17400, Apr. 9, 2007, as amended at 78 FR 18233, Mar. 26, 2013]



                     Subpart D_FDA Review and Action



Sec. 822.16  What will you consider in the review of my submission?

    First, we will determine that the submission is administratively 
complete. Then, in accordance with the law, we must determine whether 
the designated person has appropriate qualifications and experience to 
conduct the

[[Page 196]]

surveillance and whether the surveillance plan will result in the 
collection of useful data that will answer the surveillance question.



Sec. 822.17  How long will your review of my submission take?

    We will review your submission within 60 days of receipt.



Sec. 822.18  How will I be notified of your decision?

    We will send you a letter notifying you of our decision and 
identifying any action you must take.



Sec. 822.19  What kinds of decisions may you make?

----------------------------------------------------------------------------------------------------------------
               If your plan:                      Then we will send you:                 And you must:
----------------------------------------------------------------------------------------------------------------
(a) Should result in the collection of      An approval order, identifying     Conduct postmarket surveillance
 useful data that will address the           any specific requirements          of your device in accordance
 postmarket surveillance question            related to your postmarket         with the approved plan
                                             surveillance
(b) Should result in the collection of      An approvable letter identifying   Revise your postmarket
 useful data that will address the           the specific revisions or          surveillance submission to
 postmarket surveillance question after      information that must be           address the concerns in the
 specific revisions are made or specific     submitted before your plan can     approvable letter and submit it
 information is provided                     be approved                        to us within the specified
                                                                                timeframe. We will determine the
                                                                                timeframe case-by-case, based on
                                                                                the types of revisions or
                                                                                information that you must submit
(c) Does not meet the requirements          A letter disapproving your plan    Revise your postmarket
 specified in this part                      and identifying the reasons for    surveillance submission and
                                             disapproval                        submit it to us within the
                                                                                specified timeframe. We will
                                                                                determine the timeframe case-by-
                                                                                case, based on the types of
                                                                                revisions or information that
                                                                                you must submit
(d) Is not likely to result in the          A letter disapproving your plan    Revise your postmarket
 collection of useful data that will         and identifying the reasons for    surveillance submission and
 address the postmarket surveillance         disapproval                        submit it to us within the
 question                                                                       specified timeframe. We will
                                                                                determine the timeframe case-by-
                                                                                case, based on the types of
                                                                                revisions or information that
                                                                                you must submit
----------------------------------------------------------------------------------------------------------------



Sec. 822.20  What are the consequences if I fail to submit a postmarket
surveillance plan, my plan is disapproved and I fail to submit a new plan
, or I fail to 
          conduct surveillance in accordance with my approved plan?

    The failure to have an approved postmarket surveillance plan or 
failure to conduct postmarket surveillance in accordance with the 
approved plan constitutes failure to comply with section 522 of the act. 
Your failure would be a prohibited act under section 301(q)(1)(C) of the 
act, and your device would be misbranded under section 502(t)(3) of the 
act. We have the authority to initiate actions against products that are 
adulterated or misbranded, and against persons who commit prohibited 
acts. Adulterated or misbranded devices can be seized. Persons who 
commit prohibited acts can be enjoined from committing such acts, 
required to pay civil money penalties, or prosecuted.



Sec. 822.21  What must I do if I want to make changes to my postmarket
surveillance plan after you have approved it?

    You must receive our approval in writing before making changes in 
your plan that will affect the nature or validity of the data collected 
in accordance with the plan. To obtain our approval, you must submit the 
request to make the proposed change and revised postmarket surveillance 
plan to the applicable address listed in Sec. 822.8. You may reference 
information already submitted in accordance with Sec. 822.14. In your 
cover letter, you must identify your submission as a supplement and cite 
the unique document number that we assigned in our acknowledgment letter 
for your original submission,

[[Page 197]]

specifically identify the changes to the plan, and identify the reasons 
and justification for making the changes. You must report changes in 
your plan that will not affect the nature or validity of the data 
collected in accordance with the plan in the next interim report 
required by your approval order.

[87 FR 17950, Mar. 29, 2022]



Sec. 822.22  What recourse do I have if I do not agree with your decision?

    (a) If you disagree with us about the content of your plan or if we 
disapprove your plan, or if you believe there is a less burdensome 
approach that will answer the surveillance question, you may request 
review of our decision by:
    (1) Requesting a meeting with the individual who issued the order 
for postmarket surveillance;
    (2) Seeking internal review of the order under Sec. 10.75 of this 
chapter;
    (3) Requesting an informal hearing under part 16 of this chapter; or
    (4) Requesting review by the Medical Devices Dispute Resolution 
Panel of the Medical Devices Advisory Committee.
    (b) You may obtain guidance documents that discuss these mechanisms 
from the Center for Devices and Radiological Health's (CDRH's) Web site.

[67 FR 38887, June 6, 2002, as amended at 72 FR 17400, Apr. 9, 2007; 85 
FR 18443, Apr. 2, 2020]



Sec. 822.23  Is the information in my submission considered confidential?

    We consider the content of your submission confidential until we 
have approved your postmarket surveillance plan. After we have approved 
your plan, the contents of the original submission and any amendments, 
supplements, or reports may be disclosed in accordance with the Freedom 
of Information Act. We will continue to protect trade secret and 
confidential commercial information after your plan is approved. We will 
not disclose information identifying individual patients. You may wish 
to indicate in your submission which information you consider trade 
secret or confidential commercial.



               Subpart E_Responsibilities of Manufacturers



Sec. 822.24  What are my responsibilities once I am notified that
I am required to conduct postmarket surveillance?

    You must submit your plan to conduct postmarket surveillance to us 
within 30 days from receipt of the order (letter) notifying you that you 
are required to conduct postmarket surveillance of a device. The 
manufacturer shall commence surveillance not later than 15 months after 
the day the order was issued.

[88 FR 16880, Mar. 21, 2023]



Sec. 822.25  What are my responsibilities after my postmarket
surveillance plan has been approved?

    After we have approved your plan, you must conduct the postmarket 
surveillance of your device in accordance with your approved plan. This 
means that you must ensure that:
    (a) Postmarket surveillance is initiated in a timely manner;
    (b) The surveillance is conducted with due diligence;
    (c) The data identified in the plan is collected;
    (d) Any reports required as part of your approved plan are submitted 
to us in a timely manner; and
    (e) Any information that we request prior to your submission of a 
report or in response to our review of a report is provided in a timely 
manner.



Sec. 822.26  If my company changes ownership, what must I do?

    You must notify us within 30 days of any change in ownership of your 
company. Your notification should identify any changes to the name or 
address of the company, the contact person, or the designated person (as 
defined in Sec. 822.3(b)). Your obligation to conduct postmarket 
surveillance will generally transfer to the new owner, unless you and 
the new owner have both agreed that you will continue to conduct the 
surveillance. If you will continue to conduct the postmarket 
surveillance, you still must notify us of the change in ownership.

[[Page 198]]



Sec. 822.27  If I go out of business, what must I do?

    You must notify us within 30 days of the date of your decision to 
close your business. You should provide the expected date of closure and 
discuss your plans to complete or terminate postmarket surveillance of 
your device. You must also identify who will retain the records related 
to the surveillance (described in subpart G of this part) and where the 
records will be kept.



Sec. 822.28  If I stop marketing the device subject to postmarket 
surveillance, what must I do?

    You must continue to conduct postmarket surveillance in accordance 
with your approved plan even if you no longer market the device. You may 
request that we allow you to terminate postmarket surveillance or modify 
your postmarket surveillance because you no longer market the device. We 
will make these decisions on a case-by-case basis, and you must continue 
to conduct the postmarket surveillance unless we notify you that you may 
stop your surveillance study.



                    Subpart F_Waivers and Exemptions



Sec. 822.29  May I request a waiver of a specific requirement
of this part?

    You may request that we waive any specific requirement of this part. 
You may submit your request, with supporting documentation, separately 
or as a part of your postmarket surveillance submission to the address 
in Sec. 822.8.



Sec. 822.30  May I request exemption from the requirement to conduct
postmarket surveillance?

    You may request exemption from the requirement to conduct postmarket 
surveillance for your device or any specific model of that device at any 
time. You must comply with the requirements of this part unless and 
until we grant an exemption for your device. Your request for exemption 
must explain why you believe we should exempt the device or model from 
postmarket surveillance. You should demonstrate why the surveillance 
question does not apply to your device or does not need to be answered 
for the device for which you are requesting exemption. Alternatively, 
you may provide information that answers the surveillance question for 
your device, with supporting documentation, to the address in Sec. 
822.8.



                      Subpart G_Records and Reports



Sec. 822.31  What records am I required to keep?

    You must keep copies of:
    (a) All correspondence with your investigators or FDA, including 
required reports;
    (b) Signed agreements from each of your investigators, if your 
surveillance plan uses investigators, stating the commitment to conduct 
the surveillance in accordance with the approved plan, any applicable 
FDA regulations, and any conditions of approval for your plan, such as 
reporting requirements;
    (c) Your approved postmarket surveillance plan, with documentation 
of the date and reason for any deviation from the plan;
    (d) All data collected and analyses conducted in support of your 
postmarket surveillance plan; and
    (e) Any other records that we require to be maintained by regulation 
or by order, such as copies of signed consent documents, evidence of 
Institutional Review Board review and approval, etc.



Sec. 822.32  What records are the investigators in my surveillance
plan required to keep?

    Your investigator must keep copies of:
    (a) All correspondence between investigators, FDA, the manufacturer, 
and the designated person, including required reports.
    (b) The approved postmarket surveillance plan, with documentation of 
the date and reason for any deviation from the plan.
    (c) All data collected and analyses conducted at that site for 
postmarket surveillance.
    (d) Any other records that we require to be maintained by regulation 
or by order.

[[Page 199]]



Sec. 822.33  How long must we keep the records?

    You, the designated person, and your investigators must keep all 
records for a period of 2 years after we have accepted your final 
report, unless we specify otherwise.



Sec. 822.34  What must I do with the records if the sponsor of the plan
or an investigator in the plan changes?

    If the sponsor of the plan or an investigator in the plan changes, 
you must ensure that all records related to the postmarket surveillance 
have been transferred to the new sponsor or investigator and notify us 
within 10 working days of the effective date of the change. You must 
provide the name, address, and telephone number of the new sponsor or 
investigator, certify that all records have been transferred, and 
provide the date of transfer.



Sec. 822.35  Can you inspect my manufacturing site or other sites 
involved in my postmarket surveillance plan?

    We can review your postmarket surveillance programs during regularly 
scheduled inspections, inspections initiated to investigate recalls or 
other similar actions, and inspections initiated specifically to review 
your postmarket surveillance plan. We may also inspect any other person 
or site involved in your postmarket surveillance, such as investigators 
or contractors. Any person authorized to grant access to a facility must 
permit authorized FDA employees to enter and inspect any facility where 
the device is held or where records regarding postmarket surveillance 
are held.



Sec. 822.36  Can you inspect and copy the records related to my 
postmarket surveillance plan?

    We may, at a reasonable time and in a reasonable manner, inspect and 
copy any records pertaining to the conduct of postmarket surveillance 
that are required to be kept by this regulation. You must be able to 
produce records and information required by this regulation that are in 
the possession of others under contract with you to conduct the 
postmarket surveillance. Those who have signed agreements or are under 
contract with you must also produce the records and information upon our 
request. This information must be produced within 72 hours of the 
initiation of the inspection. We generally will redact information 
pertaining to individual subjects prior to copying those records, unless 
there are extenuating circumstances.



Sec. 822.37  Under what circumstances would you inspect records
identifying subjects?

    We can inspect and copy records identifying subjects under the same 
circumstances that we can inspect any records relating to postmarket 
surveillance. We are likely to be interested in such records if we have 
reason to believe that required reports have not been submitted, or are 
incomplete, inaccurate, false, or misleading.



Sec. 822.38  What reports must I submit to you?

    You must submit interim and final reports as specified in your 
approved postmarket surveillance plan. In addition, we may ask you to 
submit additional information when we believe that the information is 
necessary for the protection of the public health and implementation of 
the act. We will also state the reason or purpose for the request and 
how we will use the information.



PART 830_UNIQUE DEVICE IDENTIFICATION--Table of Contents



                      Subpart A_General Provisions

830.3 Definitions.

          Subpart B_Requirements for a Unique Device Identifier

Sec.
830.10 Incorporation by reference.
830.20 Requirements for a unique device identifier.
830.40 Use and discontinuation of a device identifier.
830.50 Changes that require use of a new device identifier.
830.60 Relabeling of a device that is required to bear a unique device 
          identifier.

[[Page 200]]

            Subpart C_FDA Accreditation of an Issuing Agency

830.100 FDA accreditation of an issuing agency.
830.110 Application for accreditation as an issuing agency.
830.120 Responsibilities of an FDA-accredited issuing agency.
830.130 Suspension or revocation of the accreditation of an issuing 
          agency.

                   Subpart D_FDA as an Issuing Agency

830.200 When FDA will act as an issuing agency.
830.210 Eligibility for use of FDA as an issuing agency.
830.220 Termination of FDA service as an issuing agency.

         Subpart E_Global Unique Device Identification Database

830.300 Devices subject to device identification data submission 
          requirements.
830.310 Information required for unique device identification.
830.320 Submission of unique device identification information.
830.330 Times for submission of unique device identification 
          information.
830.340 Voluntary submission of ancillary device identification 
          information.
830.350 Correction of information submitted to the Global Unique Device 
          Identification Database.
830.360 Records to be maintained by the labeler.

    Authority: 21 U.S.C. 321, 331, 352, 353, 360, 360d, 360i, 360j, 371.

    Source: 78 FR 58823, Sept. 24, 2013, unless otherwise noted.



                      Subpart A_General Provisions

    Source: 78 FR 58825, Sept. 24, 2013, unless otherwise noted.



Sec. 830.3  Definitions.

    As used in this part:
    Automatic identification and data capture (AIDC) means any 
technology that conveys the unique device identifier or the device 
identifier of a device in a form that can be entered into an electronic 
patient record or other computer system via an automated process.
    Center Director means the Director of the Center for Devices and 
Radiological Health or the Director of the Center for Biologics 
Evaluation and Research, depending on which Center has been assigned 
lead responsibility for the device.
    Device package means a package that contains a fixed quantity of a 
particular version or model of a device.
    Expiration date means the date by which the label of a device states 
the device must or should be used.
    FDA, we, or us means the Food and Drug Administration.
    Federal Food, Drug, and Cosmetic Act means 21 U.S.C. 321 et seq., as 
amended.
    Finished device means any device or accessory to any device that is 
suitable for use or capable of functioning.
    Global Unique Device Identification Database (GUDID) means the 
database that serves as a repository of information to facilitate the 
identification of medical devices through their distribution and use.
    Human cell, tissue, or cellular or tissue-based product (HCT/P) 
regulated as a device means an HCT/P as defined in Sec. 1271.3(d) of 
this chapter that does not meet the criteria in Sec. 1271.10(a) and 
that is also regulated as a device.
    Issuing agency means an organization accredited by FDA to operate a 
system for the issuance of unique device identifiers.
    Label has the meaning set forth in section 201(k) of the Federal 
Food, Drug, and Cosmetic Act.
    Labeler means:
    (1) Any person who causes a label to be applied to a device with the 
intent that the device will be commercially distributed without any 
subsequent replacement or modification of the label; and
    (2) Any person who causes the label of a device to be replaced or 
modified with the intent that the device will be commercially 
distributed without any subsequent replacement or modification of the 
label, except that the addition of the name of, and contact information 
for, a person who distributes the device, without making any other 
changes to the label, is not a modification for the purposes of 
determining whether a person is a labeler.
    Lot or batch means one finished device or more that consist of a 
single type, model, class, size, composition, or software version that 
are manufactured under essentially the same conditions

[[Page 201]]

and that are intended to have uniform characteristics and quality within 
specified limits.
    Shipping container means a container used during the shipment or 
transportation of devices, and whose contents may vary from one shipment 
to another.
    Small business means a medical device manufacturer with 500 or fewer 
employees, or a medical device relabeler or repackager with 100 or fewer 
employees.
    Specification means any requirement with which a device must 
conform.
    Unique device identifier (UDI) means an identifier that adequately 
identifies a device through its distribution and use by meeting the 
requirements of Sec. 830.20. A UDI is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies the specific version or model of a device and the labeler of 
that device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (v) For an HCT/P regulated as a device, the distinct identification 
code required by Sec. 1271.290(c) of this chapter.
    Universal product code (UPC) means the product identifier used to 
identify an item sold at retail in the United States.
    Version or model means all devices that have specifications, 
performance, size, and composition, within limits set by the labeler.



          Subpart B_Requirements for a Unique Device Identifier



Sec. 830.10  Incorporation by reference.

    (a) Certain material is incorporated by reference into this part 
with the approval of the Director of the Federal Register in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other 
than that specified in this section, the Food and Drug Administration 
must publish notice of change in the Federal Register and the material 
must be available to the public. All approved material is available for 
inspection at the Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 
301-827-6860, and is available from the source listed in paragraph (b) 
of this section. Copies are also available for purchase from the 
American National Standards Institute (ANSI), mailing address: ANSI, 
Attn: Customer Service Department, 25 West 43rd St., 4th floor, New 
York, NY 10036, phone: 212-642-4980, and may be ordered online at http:/
/webstore.ansi.org/. The material is also available for inspection at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030 or go 
to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
    (b) International Organization for Standardization (ISO), mailing 
address: ISO, Attn: ISO Central Secretariat, 1, ch. de la Voie-Creuse, 
Case postale 56, CH-1211 Geneva 20, Switzerland, phone (dialing from the 
United States): 011-41-22-749-0111, and may be ordered online at http://
www.standardsinfo.net.
    (1) ISO/IEC 646:1991(E), Information technology--ISO 7-bit coded 
character set for information interchange (third edition; December 15, 
1991), into Sec. Sec. 830.20(c) and 830.100(b);
    (2) ISO/IEC 15459-2:2006(E), Information technology--Unique 
identifiers--Part 2: Registration procedures (second edition; March 1, 
2006), into Sec. Sec. 830.20(b) and 830.100(b);
    (3) ISO/IEC 15459-4:2008(E), Information technology--Unique 
identifiers--Part 4: Individual items (second edition; July 15, 2008), 
into Sec. Sec. 830.20(b) and 830.100(b);
    (4) ISO/IEC 15459-6:2007(E), Information technology--Unique 
identifiers--Part 6: Unique identifier for product groupings (first 
edition; June 15, 2007), into Sec. Sec. 830.20(b) and 830.100(b).

[[Page 202]]



Sec. 830.20  Requirements for a unique device identifier.

    A unique device identifier (UDI) must:
    (a) Be issued under a system operated by FDA or an FDA-accredited 
issuing agency;
    (b) Conform to each of the following international standards:
    (1) ISO/IEC 15459-2, which is incorporated by reference at Sec. 
830.10;
    (2) ISO/IEC 15459-4, which is incorporated by reference at Sec. 
830.10; and
    (3) ISO/IEC 15459-6, which is incorporated by reference at Sec. 
830.10.
    (c) Use only characters and numbers from the invariant character set 
of ISO/IEC 646, which is incorporated by reference at Sec. 830.10.

[78 FR 58825, Sept. 24, 2013]



Sec. 830.40  Use and discontinuation of a device identifier.

    (a) Only one device identifier from any particular system for the 
issuance of unique device identifiers (UDIs) may be used to identify a 
particular version or model of a device. A particular version or model 
may be identified by UDIs from two or more systems for the issuance of 
UDIs.
    (b) A device identifier shall be used to identify only one version 
or model.
    (c) In the event that a version or model of a device is 
discontinued, its device identifier may not be reassigned to another 
device. If a discontinued version or model is re-introduced and no 
changes have been made that would require the use of a new device 
identifier, the device identifier that was previously in use may be used 
to identify the device.
    (d) In the event that an issuing agency relinquishes or does not 
renew its accreditation, you may continue to use a previously issued UDI 
until such time as Sec. 830.50 requires you to assign a new device 
identifier.

[78 FR 58825, Sept. 24, 2013]



Sec. 830.50  Changes that require use of a new device identifier.

    (a) Whenever you make a change to a device that is required to bear 
a unique device identifier (UDI) on its label, and the change results in 
a new version or model, you must assign a new device identifier to the 
new version or model.
    (b) Whenever you create a new device package, you must assign a new 
device identifier to the new device package.

[78 FR 58825, Sept. 24, 2013]



Sec. 830.60  Relabeling of a device that is required to bear a
unique device identifier.

    If you relabel a device that is required to bear a unique device 
identifier (UDI), you must:
    (a) Assign a new device identifier to the device, and
    (b) Keep a record showing the relationship of the prior device 
identifier to your new device identifier.

[78 FR 58825, Sept. 24, 2013]



            Subpart C_FDA Accreditation of an Issuing Agency



Sec. 830.100  FDA accreditation of an issuing agency.

    (a) Eligibility. A private organization may apply for accreditation 
as an issuing agency.
    (b) Accreditation criteria. FDA may accredit an organization as an 
issuing agency, if the system it will operate:
    (1) Will employ unique device identifiers (UDIs) that meet the 
requirements of this part to adequately identify a device through its 
distribution and use;
    (2) Conforms to each of the following international standards:
    (i) ISO/IEC 15459-2, which is incorporated by reference at Sec. 
830.10;
    (ii) ISO/IEC 15459-4, which is incorporated by reference at Sec. 
830.10;
    (iii) ISO/IEC 15459-6, which is incorporated by reference at Sec. 
830.10.
    (3) Uses only characters and numbers from the invariant character 
set of ISO/IEC 646, which is incorporated by reference at Sec. 830.10.
    (4) Will be available to all users according to a single set of 
consistent, fair, and reasonable terms and conditions.
    (5) Will protect against conflicts of interest between the issuing 
agency (and its officers, employees, and other agents) and labelers (and 
their officers, employees, and other agents) seeking

[[Page 203]]

to use UDIs that may impede the applicant's ability to independently 
operate a fair and neutral identifier system.



Sec. 830.110  Application for accreditation as an issuing agency.

    (a) Application for initial accreditation. (1) An applicant seeking 
initial FDA accreditation as an issuing agency shall notify FDA of its 
desire to be accredited by sending a notification by email to: 
[email protected], or by correspondence to: UDI Regulatory Policy 
Support, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3293, Silver 
Spring, MD 20993-0002.
    (2) FDA will provide the applicant with additional information to 
aid in submission of an application for approval as an issuing agency, 
together with an email address for submission of an application.
    (3) The applicant shall furnish to FDA, via email to the email 
address provided in paragraph (a)(1) of this section, an application 
containing the following information, materials, and supporting 
documentation:
    (i) Name, address, and phone number of the applicant;
    (ii) Detailed descriptions of any standards or criteria the 
applicant will apply to participating labelers;
    (iii) A detailed description of the guidelines that govern 
assignment of a unique device identifier (UDI) to a device;
    (iv) A detailed description of the review and decisionmaking process 
the applicant will apply when determining whether a particular labeler 
may use the applicant's UDI system, including:
    (A) Copies of the application forms, guidelines, instructions, and 
other materials the applicant will send to medical device labelers who 
wish to use the applicant's unique device identification system;
    (B) Policies and procedures for notifying a labeler of deficiencies 
in its use of UDIs;
    (C) Procedures for monitoring a labeler's correction of deficiencies 
in its use of UDIs;
    (D) Policies and procedures for suspending or revoking a labeler's 
use of the applicant's UDI system, including any appeals process.
    (v) Description of the applicant's electronic data management system 
with respect to its review and decision processes and the applicant's 
ability to provide electronic data in a format compatible with FDA data 
systems;
    (vi) Fee schedules, if any, together with an explanation of any fee 
waivers or reductions that are available;
    (vii) Detailed information regarding any financial or other 
relationship between the applicant and any labeler(s) or governmental 
entity(ies); and
    (viii) Other information required by FDA to clarify the application 
for accreditation.
    (b) Application for renewal of accreditation. An accredited issuing 
agency that intends to continue to serve as an issuing agency beyond its 
current term shall apply to FDA for renewal or notify FDA of its plans 
not to apply for renewal in accordance with the following procedures and 
schedule:
    (1) At least 9 months before the date of expiration of its 
accreditation, an issuing agency shall inform FDA, at the address given 
in paragraph (a)(1) of this section, of its intent to seek renewal.
    (2) FDA will notify the issuing agency of the relevant information, 
materials, and supporting documentation that we will require the issuing 
agency to submit as part of the renewal procedure. We will tailor these 
requirements to reflect our experience with the issuing agency during 
the current and any prior period of accreditation. We will limit our 
request to the types of the information required by paragraph (a)(3) of 
this section, and we will require less information if experience shows 
that we need only a subset of that information.
    (3) At least 6 months before the date of expiration of its 
accreditation, an issuing agency shall furnish to FDA, at the email 
address we provide, a copy of a renewal application containing the 
information, materials, and supporting documentation requested by FDA in 
accordance with paragraph (b)(2) of this section.
    (4) Any issuing agency that does not plan to renew its accreditation 
shall so notify FDA at the address given in

[[Page 204]]

paragraph (a)(1) of this section at least 9 months before the expiration 
of the issuing agency's term of accreditation and shall include a 
description of its plans for allowing continued use of UDIs issued prior 
to the expiration of the current term of accreditation.
    (c) FDA action on an application for initial or renewal 
accreditation. (1) FDA will conduct a review and evaluation to determine 
whether the applicant meets the requirements of this subpart and whether 
the UDI system proposed by the applicant will meet the requirements of 
this subpart.
    (2) Within 60 days of receipt of an application for accreditation, 
FDA will notify the applicant of any deficiencies in its application and 
will request correction of those deficiencies within 60 days. The 
applicant may request an extension if it needs additional time to 
correct deficiencies in its application. If the deficiencies are not 
resolved to FDA's satisfaction within the specified time period, the 
application for accreditation as an issuing agency may be denied.
    (3) FDA shall notify the applicant whether the application for 
accreditation has been granted or denied. That notification shall list 
any conditions of approval or state the reasons for denial.
    (4) If FDA denies an application, we will advise the applicant of 
the circumstances under which a denied application may be resubmitted.
    (5) If FDA does not reach a final decision on a renewal application 
before the expiration of an issuing agency's current accreditation, the 
approval will be deemed extended until FDA reaches a final decision on 
the application.
    (d) Relinquishment of accreditation. If an issuing agency decides to 
relinquish its accreditation before expiration of the current term of 
accreditation, it shall submit a letter of such intent to FDA, at the 
address provided in paragraph (a)(1) of this section, at least 9 months 
before relinquishing its accreditation.
    (e) Notice of termination of accreditation. An issuing agency that 
does not apply for renewal of its accreditation, is denied renewal of 
accreditation by FDA, or relinquishes its accreditation and duties 
before expiration of the current term of accreditation, shall notify all 
labelers that are using the issuing agency's UDI system, in a manner and 
time period approved by FDA, of the date that the issuing agency will 
cease to serve as an FDA-accredited issuing agency.
    (f) Term of accreditation. The initial term of accreditation for an 
issuing agency shall be for a period of 3 years. An issuing agency's 
term of accreditation may be periodically renewed for a period of 7 
years.

[78 FR 58825, Sept. 24, 2013, as amended at 81 FR 11429, Mar. 4, 2016; 
85 FR 18443, Apr. 2, 2020]



Sec. 830.120  Responsibilities of an FDA-accredited issuing agency.

    To maintain its accreditation, an issuing agency must:
    (a) Operate a system for assignment of unique device identifiers 
(UDIs) that meets the requirements of Sec. 830.20;
    (b) Make available information concerning its system for the 
assignment of UDIs;
    (c) Maintain a list of labelers that use its system for the 
assignment of UDIs and provide FDA a copy of such list in electronic 
form by December 31 of each year;
    (d) Upon request, provide FDA with information concerning a labeler 
that is employing the issuing agency's system for assignment of UDIs; 
and
    (e) Remain in compliance with the eligibility and accreditation 
criteria set forth in Sec. 830.100.



Sec. 830.130  Suspension or revocation of the accreditation of
an issuing agency.

    FDA may suspend or revoke the accreditation of an issuing agency if 
FDA finds, after providing the issuing agency with notice and 
opportunity for an informal hearing in accordance with part 16 of this 
chapter, that the issuing agency or any officer, employee, or other 
agent of the issuing agency:
    (a) Has been guilty of misrepresentation or failure to disclose 
required information in obtaining accreditation;
    (b) Has failed to fulfill the responsibilities outlined in Sec. 
830.120;
    (c) Has failed to protect against conflicts of interest that may 
impede the

[[Page 205]]

issuing agency's ability to independently operate a fair and neutral 
identifier system;
    (d) In the operation of the issuing agency, has engaged in any 
anticompetitive activity to restrain trade; or
    (e) Has violated or aided and abetted in the violation of any 
regulation issued under section 510(e) or section 519(f) of the Federal 
Food, Drug, and Cosmetic Act.



                   Subpart D_FDA as an Issuing Agency

    Source: 78 FR 58826, Sept. 24, 2013, unless otherwise noted.



Sec. 830.200  When FDA will act as an issuing agency.

    (a) During any period where there is no accredited issuing agency, 
FDA will act as an issuing agency.
    (b) If FDA determines that a significant number of small businesses 
would be substantially and adversely affected by the fees required by 
all accredited issuing agencies, FDA will act as an issuing agency.
    (c) FDA may, in its discretion, act as an issuing agency if we 
determine it is necessary for us to do so to ensure the continuity or 
the effectiveness of the system for the identification of medical 
devices.
    (d) FDA may, in its discretion, act as an issuing agency if we 
determine it is appropriate for us to do so in order to facilitate or 
implement an alternative granted under Sec. 801.55 of this chapter.



Sec. 830.210  Eligibility for use of FDA as an issuing agency.

    When FDA acts as an issuing agency, any labeler will be permitted to 
use FDA's unique device identification system, regardless of whether the 
labeler is considered a small business.



Sec. 830.220  Termination of FDA service as an issuing agency.

    (a) FDA may end our services as an issuing agency if we determine 
that the conditions that prompted us to act no longer exist and that 
ending our services would not be likely to lead to a return of the 
conditions that prompted us to act.
    (b) If FDA has ended our services as an issuing agency, a labeler 
may continue to use a device identifier assigned under FDA's unique 
device identification system until such time as Sec. 830.50 requires 
the use of a new device identifier.



         Subpart E_Global Unique Device Identification Database

    Source: 78 FR 58826, Sept. 24, 2013, unless otherwise noted.



Sec. 830.300  Devices subject to device identification data 
submission requirements.

    (a) In general. The labeler of a device must provide the information 
required by this subpart for each version or model required to bear a 
unique device identifier (UDI).
    (b) Voluntary submission of information. If a labeler voluntarily 
includes a UDI on the label of a device under Sec. 801.40, the labeler 
may also voluntarily submit information concerning that device under 
this part.
    (c) Exclusions. FDA may reject or remove any device identification 
data where:
    (1) The device identifier submitted does not conform to Sec. 
830.20;
    (2) The information concerns a device that is neither manufactured 
in the United States nor in interstate commerce in the United States,
    (3) The information concerns a product that FDA determines is not a 
device or a combination product that includes a device constituent part,
    (4) The information concerns a device or a combination product that 
requires, but does not have, FDA premarket approval, licensure, or 
clearance;
    (5) A device that FDA has banned under section 516 of the Federal 
Food, Drug, and Cosmetic Act; or
    (6) FDA has suspended the accreditation of the issuing agency that 
operates the system used by the labeler.



Sec. 830.310  Information required for unique device identification.

    The contact for device identification designated under Sec. 
830.320(a) shall provide FDA with the following information concerning 
each version or model

[[Page 206]]

of a device required to bear a unique device identifier (UDI) on its 
label:
    (a) Concerning the labeler:
    (1) The name of the labeler;
    (2) A telephone number or email address that will allow FDA to 
communicate with the contact for device identification designated under 
Sec. 830.320(a); and
    (3) The name of each issuing agency whose system is used by the 
labeler to assign UDIs used by the labeler.
    (b) Concerning each version or model of a device with a UDI on its 
label:
    (1) The device identifier portion of the UDI assigned to the version 
or model;
    (2) When reporting a substitution of a new device identifier that 
will be used in lieu of a previously reported identifier, the device 
identifier that was previously assigned to the version or model;
    (3) If Sec. 801.45 of this chapter requires the device to bear a 
UDI as a permanent marking on the device itself, either:
    (i) A statement that the device identifier that appears as a 
permanent marking on the device is identical to that reported under 
paragraph (b)(1) of this section, or
    (ii) The device identifier portion of the UDI that appears as a 
permanent marking on the device;
    (4) The proprietary, trade, or brand name of the device as it 
appears on the label of the device;
    (5) Any version or model number or similar reference that appears on 
the label of the device;
    (6) If the device is labeled as sterile, a statement to that effect;
    (7) If the device is labeled as containing natural rubber latex that 
contacts humans, or is labeled as having packaging containing natural 
rubber latex that contacts humans, as described by Sec. Sec. 
801.437(b)(1), 801.437(b)(3), and 801.437(f) of this chapter, a 
statement to that effect;
    (8) Whether a patient may be safely exposed to magnetic resonance 
imaging, nuclear magnetic resonance imaging, or magnetic resonance 
tomography while using the device, or while the device is implanted in 
patient.
    (9) If the device is available in more than one size, the size of 
the particular version or model, together with the unit of measure, as 
it appears on the label of the device;
    (10) The type of production identifiers that appear on the label of 
the device;
    (11) The FDA premarket submission number of a cleared or approved 
device, or a statement that FDA has by regulation exempted the device 
from premarket notification;
    (12) The FDA listing number assigned to the device;
    (13) The Global Medical Device Nomenclature (GMDN) term or code for 
the device;
    (14) The total number of individual devices contained in the device 
package.



Sec. 830.320  Submission of unique device identification information.

    (a) Designation of contact for device identification. Each labeler 
must designate an individual to serve as the point of contact with FDA 
on matters relating to the identification of medical devices marketed by 
the labeler. The contact for device information is responsible for 
ensuring FDA is provided with all information required by this part. The 
contact for device information may authorize an issuing agency or any 
other person to provide information to FDA on behalf of the labeler.
    (b) Information shall be submitted via electronic means. All 
information required by this subpart shall be submitted electronically 
to FDA's Global Unique Device Identification Database (GUDID) in a 
format that we can process, review, and archive, unless the labeler has 
obtained a waiver from electronic submission of unique device identifier 
(UDI) data.
    (c) Waiver from electronic submission. (1) A labeler may request a 
waiver from electronic submission of UDI data by submitting a letter 
addressed to the appropriate Center Director explaining why electronic 
submission is not technologically feasible; send the request by email 
to: [email protected], or by correspondence to: UDI Regulatory Policy 
Support, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3293, Silver 
Spring, MD 20993-0002.

[[Page 207]]

    (2) If the establishment where the labeler is located has obtained a 
waiver from electronic submission of registration and listing 
information under section 510(p) of the Federal Food, Drug, and Cosmetic 
Act, the labeler is deemed to have a waiver from electronic submission 
of UDI data.
    (3) A labeler that has a waiver from electronic submission of UDI 
data must send a letter containing all of the information required by 
Sec. 830.310, as well as any ancillary information permitted to be 
submitted under Sec. 830.340 that the labeler wishes to submit, within 
the time permitted by Sec. 830.330, addressed to: UDI Regulatory Policy 
Support, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3293, Silver 
Spring, MD 20993-0002.

[78 FR 58826, Sept. 24, 2013, as amended at 85 FR 18443, Apr. 2, 2020]



Sec. 830.330  Times for submission of unique device identification information.

    (a) The labeler shall submit to FDA the information required by 
Sec. 830.310 no later than the date the label of the device must bear a 
unique device identifier under Sec. 801.20 of this chapter.
    (b) The labeler of a device shall submit to FDA an update to the 
information required by Sec. 830.310 whenever the information changes. 
The updated information must be submitted no later than the date a 
device is first labeled with the changed information. If the information 
does not appear on the label of a device, the updated information must 
be submitted within 10 business days of the change.



Sec. 830.340  Voluntary submission of ancillary device identification 
information.

    (a) You may not submit any information to the Global Unique Device 
Identification Database (GUDID) other than that specified by Sec. 
830.310, except where FDA acts to permit the submission of specified 
additional types of information, termed ancillary information.
    (b) FDA will provide information through the FDA Web site at http://
www.fda.gov/udi/ concerning the types of ancillary information that may 
be submitted to the GUDID.
    (c) FDA may periodically change the types of ancillary information 
that may be submitted to the GUDID. We will announce any change on the 
FDA Web site at http://www.fda.gov/udi/ at least 60 days before making 
the change.



Sec. 830.350  Correction of information submitted to the Global
Unique Device Identification Database.

    (a) If FDA becomes aware that any information submitted to the 
Global Unique Device Identification Database (GUDID) appears to be 
incorrect or potentially misleading, we may notify the labeler of the 
specific information that appears to be incorrect, and request that the 
labeler provide corrected information or explain why the information is 
correct. The labeler must provide corrected information or provide a 
satisfactory explanation of why the information is correct within 30 
days of receipt of FDA's notification.
    (b) If the labeler does not respond to FDA's notification within 30 
days of receipt, or if FDA determines, at any time, that any information 
in the GUDID is incorrect or could be misleading, we may delete or 
correct the information. Any action taken by FDA under this paragraph 
does not relieve the labeler of its responsibility under paragraph (a) 
of this section to provide corrected information or an explanation of 
why the information previously submitted is correct.



Sec. 830.360  Records to be maintained by the labeler.

    (a) Each labeler shall retain, and submit to FDA upon specific 
request, records showing all unique device identifiers (UDIs) used to 
identify devices that must bear a UDI on their label, and the particular 
version or model associated with each device identifier. These records 
must be retained for 3 years from the date the labeler ceases to market 
the version or model.
    (b) Compliance with this section does not relieve the labeler of the 
need to comply with recordkeeping requirements of any other FDA 
regulation.

[[Page 208]]



PART 860_MEDICAL DEVICE CLASSIFICATION PROCEDURES--Table of Contents



                            Subpart A_General

Sec.
860.1 Scope.
860.3 Definitions.
860.5 Confidentiality and use of data and information submitted in 
          connection with classification and reclassification.
860.7 Determination of safety and effectiveness.
860.10 Implants and life-supporting or life-sustaining devices.
860.15 Exemptions from sections 510, 519, and 520(f) of the Federal 
          Food, Drug, and Cosmetic Act.

                        Subpart B_Classification

860.84 Classification procedures for ``preamendments devices.''
860.90 Consultation with panels.

                       Subpart C_Reclassification

860.120 General.
860.123 Reclassification petition: Content and form.
860.125 Consultation with panels.
860.130 General procedures under section 513(e) of the Federal Food, 
          Drug, and Cosmetic Act.
860.132 Procedures when the Commissioner initiates a performance 
          standard or premarket approval proceeding under section 514(b) 
          or 515(b) of the Federal Food, Drug, and Cosmetic Act.
860.133 Procedures when the Commissioner initiates a proceeding to 
          require premarket approval under section 515(b) of the Federal 
          Food, Drug, and Cosmetic Act.
860.134 Procedures for reclassification of ``postamendments devices'' 
          under section 513(f)(3) of the Federal Food, Drug, and 
          Cosmetic Act.
860.136 Procedures for transitional products under section 520(l) of the 
          Federal Food, Drug, and Cosmetic Act.

                    Subpart D_De Novo Classification

860.200 Purpose and applicability.
860.210 De Novo request format.
860.220 De Novo request content.
860.230 Accepting a De Novo request.
860.240 Procedures for review of a De Novo request.
860.250 Withdrawal of a De Novo request.
860.260 Granting or declining a De Novo request.

    Authority: 21 U.S.C. 321(h), 353(g), 360c, 360d, 360e, 360i, 360j, 
371, 374.

    Source: 43 FR 32993, July 28, 1978, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 860 appear at 73 FR 
35341, June 23, 2008 and at 86 FR 54846, Oct. 5, 2021.



                            Subpart A_General



Sec. 860.1  Scope.

    (a) This part implements sections 513, 514(b), 515(b), and 520(l) of 
the Federal Food, Drug, and Cosmetic Act with respect to the 
classification and reclassification of devices intended for human use.
    (b) This part prescribes the criteria and procedures to be used by 
advisory committees, including classification panels, where applicable, 
in making their recommendations, and by the Commissioner in making the 
Commissioner's determinations regarding the class of regulatory control 
(class I, class II, or class III) appropriate for particular devices. 
Supplementing the general Food and Drug Administration procedures 
governing advisory committees (part 14 of this chapter), this part also 
provides procedures for manufacturers, importers, and other interested 
persons to participate in proceedings to classify and reclassify 
devices. This part also describes the type of data required for 
determination of the safety and effectiveness of a device, and the 
circumstances under which information submitted to advisory committees, 
including classification panels, or to the Commissioner in connection 
with classification and reclassification proceedings, will be available 
to the public.

[43 FR 32993, July 28, 1978, as amended at 86 FR 54846, Oct. 5, 2021]



Sec. 860.3  Definitions.

    For the purposes of this part:
    Class means one of the three categories of regulatory control for 
medical devices, defined as follows:
    Class I means the class of devices that are subject only to the 
general controls authorized by or under sections 501 (adulteration), 502 
(misbranding), 510 (registration), 516 (banned devices), 518 
(notification and other remedies), 519 (records and reports), and 520 
(general provisions) of

[[Page 209]]

the Federal Food, Drug, and Cosmetic Act. A device is in class I if:
    (1) General controls are sufficient to provide reasonable assurance 
of the safety and effectiveness of the device, or
    (2) There is insufficient information from which to determine that 
general controls are sufficient to provide reasonable assurance of the 
safety and effectiveness of the device or to establish special controls 
to provide such assurance, but the device is not life-supporting or 
life-sustaining, or for a use which is of substantial importance in 
preventing impairment of human health, and which does not present a 
potential unreasonable risk of illness or injury.
    Class II means the class of devices that is or eventually will be 
subject to special controls. A device is in class II if general controls 
alone are insufficient to provide reasonable assurance of its safety and 
effectiveness and there is sufficient information to establish special 
controls, including the promulgation of performance standards, 
postmarket surveillance, patient registries, development and 
dissemination of guidelines (including guidelines for the submission of 
clinical data in premarket notification submissions in accordance with 
section 510(k) of the Federal Food, Drug, and Cosmetic Act), 
recommendations, and other appropriate actions as the Commissioner deems 
necessary to provide such assurance. For a device that is purported or 
represented to be for use in supporting or sustaining human life, the 
Commissioner shall examine and identify the special controls, if any, 
which are necessary to provide adequate assurance of safety and 
effectiveness, and describe how such controls provide such assurance.
    Class III means the class of devices for which premarket approval is 
or will be required in accordance with section 515 of the Federal Food, 
Drug, and Cosmetic Act. A device is in class III if insufficient 
information exists to determine that general controls are sufficient to 
provide reasonable assurance of its safety and effectiveness, or that 
application of special controls described in the definition of ``Class 
II'' in this section in addition to general controls, would provide such 
assurance, and if, in addition, the device is life-supporting or life-
sustaining, or for a use which is of substantial importance in 
preventing impairment of human health, or if the device presents a 
potential unreasonable risk of illness or injury.
    Classification panel means one of the several advisory committees 
established by the Commissioner under section 513 of the Federal Food, 
Drug, and Cosmetic Act and part 14 of this chapter for the purpose of 
making recommendations to the Commissioner on the classification and 
reclassification of devices and for other purposes prescribed by the 
Federal Food, Drug, and Cosmetic Act or by the Commissioner.
    Classification regulation means a section under parts 862 through 
892 of this chapter that contains the identification (general 
description and intended use) and classification (class I, II or III) of 
a single device type or more than one related device type(s).
    Commissioner means the Commissioner of Food and Drugs, Food and Drug 
Administration, United States Department of Health and Human Services, 
or the Commissioner's designee.
    De Novo request means any submission under section 513(f)(2) of the 
Federal Food, Drug, and Cosmetic Act for a medical device, requesting 
classification into class I or class II, including all information 
submitted with or incorporated by reference therein.
    FDA means the Food and Drug Administration.
    General controls mean the controls authorized by or under sections 
501 (adulteration), 502 (misbranding), 510 (registration, listing, and 
premarket notification), 516 (banned devices), 518 (notification and 
other remedies), 519 (records, reports, and unique device 
identification), and 520 (general provisions) of the Federal Food, Drug, 
and Cosmetic Act.
    Generic type of device means a grouping of devices that do not 
differ significantly in purpose, design, materials, energy source, 
function, or any other feature related to safety and effectiveness, and 
for which similar regulatory

[[Page 210]]

controls are sufficient to provide reasonable assurance of safety and 
effectiveness.
    Implant means a device that is placed into a surgically or naturally 
formed cavity of the human body. A device is regarded as an implant for 
the purpose of this part only if it is intended to remain implanted 
continuously for a period of 30 days or more, unless the Commissioner 
determines otherwise to protect human health.
    Life-supporting or life-sustaining device means a device that is 
essential to, or that yields information that is essential to, the 
restoration or continuation of a bodily function important to the 
continuation of human life.
    Petition means a submission seeking reclassification of a device in 
accordance with Sec. 860.123.
    Special controls mean the controls necessary to provide reasonable 
assurance of safety and effectiveness for a generic type of device that 
is class II. Special controls include performance standards, performance 
testing, postmarket surveillance, patient registries, development and 
dissemination of guidelines (including guidelines for the submission of 
clinical data in premarket notification submissions in accordance with 
section 510(k) of the Federal Food, Drug, and Cosmetic Act), 
recommendations, and other appropriate actions, as the Commissioner 
deems necessary to provide such assurance.

[86 FR 54846, Oct. 5, 2021]



Sec. 860.5  Confidentiality and use of data and information
submitted in connection with classification and reclassification.

    (a) This section governs the availability for public disclosure and 
the use by the Commissioner of data and information submitted to 
classification panels or to the Commissioner in connection with the 
classification or reclassification of devices under this part.
    (b) In general, data and information submitted to classification 
panels in connection with the classification of devices under Sec. 
860.84 will be available immediately for public disclosure upon request. 
However, except as provided by the special rules in paragraph (c) of 
this section, this provision does not apply to data and information 
exempt from public disclosure in accordance with part 20 of this 
chapter: Such data and information will be available only in accordance 
with part 20.
    (c)(1) Safety and effectiveness data submitted to classification 
panels or to the Commissioner in connection with the classification of a 
device under Sec. 860.84, which have not been disclosed previously to 
the public, as described in Sec. 20.81 of this chapter, shall be 
regarded as confidential if the device is classified in to class III. 
Because the classification of a device under Sec. 860.84 may be 
ascertained only upon publication of a final regulation, all safety and 
effectiveness data that have not been disclosed previously are not 
available for public disclosure unless and until the device is 
classified into class I or II, in which case the procedure in paragraph 
(c)(2) of this section applies.
    (2) Thirty days after publication of a final regulation under Sec. 
860.84 classifying a device into class I or class II, safety and 
effectiveness data submitted for that device that had been regarded as 
confidential under paragraph (c)(1) of this section will be available 
for public disclosure and placed on public display in the office of the 
Division of Dockets Management, Food and Drug Administration unless, 
within that 30-day period, the person who submitted the data 
demonstrates that the data still fall within the exemption for trade 
secrets and confidential commercial information described in Sec. 20.61 
of this chapter. Safety and effectiveness data submitted for a device 
that is classified into class III by regulation in accordance with Sec. 
860.84 will remain confidential and unavailable for public disclosure so 
long as such data have not been disclosed to the public as described in 
Sec. 20.81 of this chapter.
    (3) Because device classification affects generic types of devices, 
in making determinations under Sec. 860.84 concerning the initial 
classification of a device, the classification panels and the 
Commissioner may consider safety and effectiveness data developed for 
another device in the same generic type, regardless of whether such data

[[Page 211]]

are regarded currently as confidential under paragraph (c)(1) of this 
section.
    (d)(1) The fact of its existence and the contents of a petition for 
reclassification filed in accordance with Sec. 860.130 or Sec. 860.132 
are available for public disclosure at the time the petition is received 
by the Food and Drug Administration.
    (2) The fact of the existence of a petition for reclassification 
filed in accordance with Sec. 860.134 or Sec. 860.136 is available for 
public disclosure at the time the petition is received by the Food and 
Drug Administration. The contents of such a petition are not available 
for public disclosure for the period of time following its receipt (not 
longer than 30 days) during which the petition is reviewed for any 
deficiencies preventing the Commissioner from making a decision on it. 
Once it is determined that the petition contains no deficiencies 
preventing the Commissioner from making a decision on it, the petition 
will be filed with the Division of Dockets Management and its entire 
contents will be available for public disclosure and subject to 
consideration by classification panels and by the Commissioner in making 
a decision on the petition. If, during this 30-day period of time, the 
petition is found to contain deficiencies that prevent the Commissioner 
from making a decision on it, the petitioner will be so notified and 
afforded an opportunity to correct the deficiencies.

Thirty days after notice to the petitioner of deficiencies in the 
petition, the contents of the petition will be available for public 
disclosure unless, within that 30 days, the petitioner submits 
supplemental material intended to correct the deficiencies in the 
petition. The Commissioner, in the Commissioner's discretion, may allow 
withdrawal of a deficient petition during the 30-day period provided for 
correcting deficiencies. Any supplemental material submitted by the 
petitioner, together with the material in the original petition, is 
considered as a new petition. The new petition is reviewed for 
deficiencies in the same manner as the original petition, and the same 
procedures for notification and correction of deficiencies are followed. 
Once the petitioner has corrected the deficiencies, the entire contents 
of the petition will be available for public disclosure and subject to 
consideration by classification panels and by the Commissioner in making 
a decision on the petition. Deficient petitions which have not been 
corrected within 180 days after notification of deficiency will be 
returned to the petitioner and will not be considered further unless 
resubmitted.
    (e) The Commissioner may not disclose, or use as the basis for 
reclassification of a device from class III to class II, any information 
reported to or otherwise obtained by the Commissioner under section 513, 
514, 515, 516, 518, 519, 520(f), 520(g), or 704 of the Federal Food, 
Drug, and Cosmetic Act that falls within the exemption described in 
Sec. 20.61 of this chapter for trade secrets and confidential 
commercial information. The exemption described in Sec. 20.61 does not 
apply to data or information contained in a petition for 
reclassification submitted in accordance with Sec. 860.130 or Sec. 
860.132, or in a petition submitted in accordance with Sec. 860.134 or 
Sec. 860.136 that has been determined to contain no deficiencies that 
prevent the Commissioner from making a decision on it. Accordingly, all 
data and information contained in such petitions may be disclosed by the 
Commissioner and used as the basis for reclassification of a device from 
class III to class II.
    (f) For purposes of this section, safety and effectiveness data 
include data and results derived from all studies and tests of a device 
on animals and humans and from all studies and tests of the device 
itself intended to establish or determine its safety and effectiveness.
    (g) Confidentiality of data and information in a De Novo file is as 
follows:
    (1) A ``De Novo file'' includes all data and information from the 
requester submitted with or incorporated by reference in the De Novo 
request, any De Novo supplement, or any other related submission 
relevant to the administrative file, as defined in Sec. 10.3(a) of this 
chapter. Any record in the De Novo file will be available for public 
disclosure in accordance with the provisions of this section and part 20 
of this chapter.
    (2) The existence of a De Novo file may not be disclosed by FDA 
before an

[[Page 212]]

order granting the De Novo request is issued unless it previously has 
been publicly disclosed or acknowledged by the De Novo requester.
    (3) Before an order granting the De Novo request is issued, data or 
information contained in the De Novo file is not available for public 
disclosure, except to the extent the existence of the De Novo file is 
disclosable under paragraph (g)(2) of this section and such data or 
information has been publicly disclosed or acknowledged by the De Novo 
requester.
    (4) After FDA issues an order granting a De Novo request, the data 
and information in the De Novo file that are not exempt from release 
under the Freedom of Information Act, 5 U.S.C. 552, are immediately 
available for public disclosure.

[43 FR 32993, July 28, 1978, as amended at 86 FR 54847, Oct. 5, 2021]



Sec. 860.7  Determination of safety and effectiveness.

    (a) The classification panels, in reviewing evidence concerning the 
safety and effectiveness of a device and in preparing advice to the 
Commissioner, and the Commissioner, in making determinations concerning 
the safety and effectiveness of a device, will apply the rules in this 
section.
    (b) In determining the safety and effectiveness of a device for 
purposes of classification, establishment of special controls for class 
II devices, and premarket approval of class III devices, the 
Commissioner and the classification panels will consider the following, 
among other relevant factors:
    (1) The persons for whose use the device is represented or intended;
    (2) The conditions of use for the device, including conditions of 
use prescribed, recommended, or suggested in the labeling or advertising 
of the device, and other intended conditions of use;
    (3) The probable benefit to health from the use of the device 
weighed against any probable injury or illness from such use; and
    (4) The reliability of the device.
    (c)(1) Although the manufacturer may submit any form of evidence to 
the Food and Drug Administration in an attempt to substantiate the 
safety and effectiveness of a device, the agency relies upon only valid 
scientific evidence to determine whether there is reasonable assurance 
that the device is safe and effective. After considering the nature of 
the device and the rules in this section, the Commissioner will 
determine whether the evidence submitted or otherwise available to the 
Commissioner is valid scientific evidence for the purpose of determining 
the safety or effectiveness of a particular device and whether the 
available evidence, when taken as a whole, is adequate to support a 
determination that there is reasonable assurance that the device is safe 
and effective for its conditions of use.
    (2) Valid scientific evidence is evidence from well-controlled 
investigations, partially controlled studies, studies and objective 
trials without matched controls, well-documented case histories 
conducted by qualified experts, and reports of significant human 
experience with a marketed device, from which it can fairly and 
responsibly be concluded by qualified experts that there is reasonable 
assurance of the safety and effectiveness of a device under its 
conditions of use. The evidence required may vary according to the 
characteristics of the device, its conditions of use, the existence and 
adequacy of warnings and other restrictions, and the extent of 
experience with its use. Isolated case reports, random experience, 
reports lacking sufficient details to permit scientific evaluation, and 
unsubstantiated opinions are not regarded as valid scientific evidence 
to show safety or effectiveness. Such information may be considered, 
however, in identifying a device with questionable safety or 
effectiveness.
    (d)(1) There is reasonable assurance that a device is safe when it 
can be determined, based upon valid scientific evidence, that the 
probable benefits to health from use of the device for its intended uses 
and conditions of use, when accompanied by adequate directions and 
warnings against unsafe use, outweigh any probable risks. The valid 
scientific evidence used to determine the safety of a device shall 
adequately demonstrate the absence of unreasonable risk of illness or 
injury associated

[[Page 213]]

with the use of the device for its intended uses and conditions of use.
    (2) Among the types of evidence that may be required, when 
appropriate, to determine that there is reasonable assurance that a 
device is safe are investigations using laboratory animals, 
investigations involving human subjects, nonclinical investigations, and 
analytical studies for in vitro diagnostic devices.
    (e)(1) There is reasonable assurance that a device is effective when 
it can be determined, based upon valid scientific evidence, that in a 
significant portion of the target population, the use of the device for 
its intended uses and conditions of use, when accompanied by adequate 
directions for use and warnings against unsafe use, will provide 
clinically significant results.
    (2) The valid scientific evidence used to determine the 
effectiveness of a device shall consist principally of well-controlled 
investigations, as defined in paragraph (f) of this section, unless the 
Commissioner authorizes reliance upon other valid scientific evidence 
which the Commissioner has determined is sufficient evidence from which 
to determine the effectiveness of a device, even in the absence of well-
controlled investigations. The Commissioner may make such a 
determination where the requirement of well-controlled investigations in 
paragraph (f) of this section is not reasonably applicable to the 
device.
    (f) The following principles have been developed over a period of 
years and are recognized by the scientific community as the essentials 
of a well-controlled clinical investigation. They provide the basis for 
the Commissioner's determination whether there is reasonable assurance 
that a device is effective based upon well-controlled investigations and 
are also useful in assessing the weight to be given to other valid 
scientific evidence permitted under this section.
    (1) The plan or protocol for the study and the report of the results 
of a well-controlled investigation shall include the following:
    (i) A clear statement of the objectives of the study;
    (ii) A method of selection of the subjects that:
    (a) Provides adequate assurance that the subjects are suitable for 
the purposes of the study, provides diagnostic criteria of the condition 
to be treated or diagnosed, provides confirmatory laboratory tests where 
appropriate and, in the case of a device to prevent a disease or 
condition, provides evidence of susceptibility and exposure to the 
condition against which prophylaxis is desired;
    (b) Assigns the subjects to test groups, if used, in such a way as 
to minimize any possible bias;
    (c) Assures comparability between test groups and any control groups 
of pertinent variables such as sex, severity or duration of the disease, 
and use of therapy other than the test device;
    (iii) An explanation of the methods of observation and recording of 
results utilized, including the variables measured, quantitation, 
assessment of any subject's response, and steps taken to minimize any 
possible bias of subjects and observers;
    (iv) A comparison of the results of treatment or diagnosis with a 
control in such a fashion as to permit quantitative evaluation. The 
precise nature of the control must be specified and an explanation 
provided of the methods employed to minimize any possible bias of the 
observers and analysts of the data. Level and methods of ``blinding,'' 
if appropriate and used, are to be documented. Generally, four types of 
comparisons are recognized:
    (a) No treatments. Where objective measurements of effectiveness are 
available and placebo effect is negligible, comparison of the objective 
results in comparable groups of treated and untreated patients;
    (b) Placebo control. Where there may be a placebo effect with the 
use of a device, comparison of the results of use of the device with an 
ineffective device used under conditions designed to resemble the 
conditions of use under investigation as far as possible;
    (c) Active treatment control. Where an effective regimen of therapy 
may be used for comparison, e.g., the condition being treated is such 
that the use of a placebo or the withholding of treatment would be 
inappropriate or contrary to the interest of the patient;

[[Page 214]]

    (d) Historical control. In certain circumstances, such as those 
involving diseases with high and predictable mortality or signs and 
symptoms of predictable duration or severity, or in the case of 
prophylaxis where morbidity is predictable, the results of use of the 
device may be compared quantitatively with prior experience historically 
derived from the adequately documented natural history of the disease or 
condition in comparable patients or populations who received no 
treatment or who followed an established effective regimen (therapeutic, 
diagnostic, prophylactic).
    (v) A summary of the methods of analysis and an evaluation of the 
data derived from the study, including any appropriate statistical 
methods utilized.
    (2) To insure the reliability of the results of an investigation, a 
well-controlled investigation shall involve the use of a test device 
that is standardized in its composition or design and performance.
    (g)(1) It is the responsibility of each manufacturer and importer of 
a device to assure that adequate, valid scientific evidence exists, and 
to furnish such evidence to the Food and Drug Administration to provide 
reasonable assurance that the device is safe and effective for its 
intended uses and conditions of use. The failure of a manufacturer or 
importer of a device to present to the Food and Drug Administration 
adequate, valid scientific evidence showing that there is reasonable 
assurance of the safety and effectiveness of the device, if regulated by 
general controls alone, or by general controls and special controls, may 
support a determination that the device be classified into class III.
    (2) The Commissioner may require that a manufacturer, importer, or 
distributor make reports or provide other information bearing on the 
classification of a device and indicating whether there is reasonable 
assurance of the safety and effectiveness of the device or whether it is 
adulterated or misbranded under the Federal Food, Drug, and Cosmetic 
Act.
    (3) A requirement for a report or other information under this 
paragraph will comply with section 519 of the Federal Food, Drug, and 
Cosmetic Act. Accordingly, the requirement will state the reason or 
purpose for such request; will describe the required report or 
information as clearly as possible; will not be imposed on a 
manufacturer, importer, or distributor of a classified device that has 
been exempted from such a requirement in accordance with Sec. 860.95; 
will prescribe the time for compliance with the requirement; and will 
prescribe the form and manner in which the report or information is to 
be provided.
    (4) Required information that has been submitted previously to the 
Center for Devices and Radiological Health, the Center for Biologics 
Evaluation and Research, or the Center for Drug Evaluation and Research, 
as applicable, need not be resubmitted, but may be incorporated by 
reference.

[43 FR 32993, July 28, 1978, as amended at 53 FR 11253, Apr. 6, 1988; 73 
FR 49942, Aug. 25, 2008; 83 FR 64454, Dec. 17, 2018]



Sec. 860.10  Implants and life-supporting or life-sustaining devices.

    (a) A classification panel will recommend classification into class 
III of any implant or life-supporting or life-sustaining device unless 
the panel determines that such classification is not necessary to 
provide reasonable assurance of the safety and effectiveness of the 
device. If the panel recommends classification or reclassification of 
such a device into a class other than class III, it shall set forth in 
its recommendation the reasons for so doing and an identification of the 
risks to health, if any, presented by the device. In the case of such a 
device being recommended for classification or reclassification into 
class II, the panel shall describe the special controls that, in 
addition to general controls, the panel believes are necessary to 
provide reasonable assurance of safety and effectiveness of the device 
and how such controls provide such assurance.
    (b) The Commissioner will classify an implant or life-supporting or 
life-sustaining device into class III unless the Commissioner determines 
that such classification is not necessary to provide reasonable 
assurance of the safety and effectiveness of the device. If the 
Commissioner proposes to classify or

[[Page 215]]

reclassify such a device into a class other than class III, the 
regulation or order effecting such classification or reclassification 
will be accompanied by a full statement of the reasons for so doing. A 
statement of the reasons for not classifying or retaining the device in 
class III may be in the form of concurrence with the reasons for the 
recommendation of the classification panel, together with supporting 
documentation and data satisfying the requirements of Sec. 860.7 and an 
identification of the risks to health, if any, presented by the device. 
In the case of such a device being classified or reclassified into class 
II, the Commissioner shall describe the special controls that, in 
addition to general controls, the panel believes are necessary to 
provide reasonable assurance of safety and effectiveness of the device 
and how such controls provide such assurance.

[83 FR 64455, Dec. 17, 2018]



Sec. 860.15  Exemptions from sections 510, 519, and 520(f) of the
Federal Food, Drug, and Cosmetic Act.

    (a) A panel recommendation to the Commissioner that a device be 
classified or reclassified into class I will include a recommendation as 
to whether the device should be exempted from some or all of the 
requirements of one or more of the following sections of the Federal 
Food, Drug, and Cosmetic Act: Section 510 (registration, product 
listing, and premarket notification), section 519 (records and reports) 
and section 520(f) (good manufacturing practice requirements of the 
quality system regulation), and, in the case of a recommendation for 
classification into class II, whether the device should be exempted from 
the premarket notification requirement under section 510.
    (b) A regulation or an order classifying or reclassifying a device 
into class I will specify which requirements, if any, of sections 510, 
519, and 520(f) of the Federal Food, Drug, and Cosmetic Act the device 
is to be exempted from or, in the case of a regulation or an order 
classifying or reclassifying a device into class II, whether the device 
is to be exempted from the premarket notification requirement under 
section 510, together with the reasons for such exemption.
    (c) The Commissioner will grant exemptions under this section only 
if the Commissioner determines that the requirements from which the 
device is exempted are not necessary to provide reasonable assurance of 
the safety and effectiveness of the device.

[83 FR 64455, Dec. 17, 2018]



                        Subpart B_Classification



Sec. 860.84  Classification procedures for ``preamendments devices.''

    (a) This subpart sets forth the procedures for the original 
classification of a generic type of device that was in commercial 
distribution before May 28, 1976. Such a device will be classified by 
regulation into either class I (general controls), class II (special 
controls) or class III (premarket approval), depending upon the level of 
regulatory control required to provide reasonable assurance of the 
safety and effectiveness of the device (Sec. 860.3(c)). This subpart 
does not apply to a device that is classified into class III by statute 
under section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act 
because the Food and Drug Administration has determined that the device 
is not ``substantially equivalent'' to any device subject to this 
subpart or under section 520(l)(1) of the Federal Food, Drug, and 
Cosmetic Act because the device was regarded previously as a new drug. 
In classifying a preamendments device to which this section applies, the 
Food and Drug Administration will follow the procedures described in 
paragraphs (b) through (g) of this section.
    (b) The Commissioner refers the device to the appropriate 
classification panel organized and operated in accordance with section 
513 (b) and (c) of the Federal Food, Drug, and Cosmetic Act and part 14 
of this chapter.
    (c) In order to make recommendations to the Commissioner on the 
class of regulatory control (class I, class II, or class III) 
appropriate for the device, the panel reviews the device for safety and 
effectiveness. In so doing, the panel:
    (1) Considers the factors set forth in Sec. 860.7 relating to the 
determination of safety and effectiveness;
    (2) Determines the safety and effectiveness of the device on the 
basis of

[[Page 216]]

the types of scientific evidence set forth in Sec. 860.7; and
    (3) Provides, to the maximum extent practicable, an opportunity for 
interested persons to submit data and views on the classification of the 
device in accordance with part 14 of this chapter.
    (d) Based upon its review of evidence of the safety and 
effectiveness of the device, and applying the definition of each class 
in Sec. 860.3(c), the panel submits to the Commissioner a 
recommendation regarding the classification of the device. The 
recommendation will include:
    (1) A summary of the reasons for the recommendation;
    (2) A summary of the data upon which the recommendation is based;
    (3) An identification of the risks to health (if any) presented by 
the device;
    (4) In the case of a recommendation for classification into class I, 
a recommendation as to whether the device should be exempted from the 
requirements of one or more of the following sections of the Federal 
Food, Drug, and Cosmetic Act: Section 510 (registration, product 
listing, and premarket notification), section 519 (records and reports), 
and section 520(f) (good manufacturing practice requirements of the 
quality system regulation) and, in the case of a recommendation for 
classification into class II, whether the device should be exempted from 
the premarket notification requirement under section 510, in accordance 
with Sec. 860.15;
    (5) In the case of a recommendation for classification into class II 
or class III, to the extent practicable, a recommendation for the 
assignment to the device of a priority for the application of a 
performance standard or a premarket approval requirement, and in the 
case of classification into class II, a recommendation on the 
establishment of special controls and whether the device should be 
exempted from premarket notification in accordance with Sec. 860.15; 
and
    (6) In the case of a recommendation for classification of an implant 
or a life-supporting or life-sustaining device into class I or class II, 
a statement of why premarket approval is not necessary to provide 
reasonable assurance of the safety and effectiveness of the device and 
an identification of the risks to health, if any, presented by the 
device, in accordance with Sec. 860.10.
    (e) A panel recommendation is regarded as preliminary until the 
Commissioner has reviewed it, discussed it with the panel if 
appropriate, and published a proposed regulation classifying the device. 
Preliminary panel recommendations are filed at Dockets Management Staff 
upon receipt and are available to the public at https://
www.regulations.gov.
    (f) The Commissioner publishes the panel's recommendation in the 
Federal Register, together with a proposed regulation classifying the 
device, and other devices of that generic type, and provides interested 
persons an opportunity to submit comments on the recommendation and 
proposed regulation.
    (g) The Commissioner reviews the comments and issues a final 
regulation classifying the device and other devices of that generic 
type. The regulation will:
    (1) If classifying the device into class I, prescribe which, if any, 
of the requirements of sections 510, 519, and 520(f) of the Federal 
Food, Drug, and Cosmetic Act will not apply to the device and state the 
reasons for making the requirements inapplicable, in accordance with 
Sec. 860.95;
    (2) If classifying the device into class II, establish the special 
controls for the device and prescribe whether the premarket notification 
requirement will apply to the device; and
    (3) If classifying an implant, or a life-supporting or life-
sustaining device, comply with Sec. 860.10(b).

[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992; 
64 FR 404, Jan. 5, 1999; 83 FR 64455, Dec. 17, 2018]



Sec. 860.90  Consultation with panels.

    (a) When the Commissioner is required to consult with a panel 
concerning a classification under Sec. 860.84, the Commissioner will 
consult with the panel in one of the following ways:
    (1) Consultation by telephone with at least a majority of current 
voting panel members and, when possible, nonvoting panel members in a 
telephone or video conference call; or
    (2) Discussion at a panel meeting.

[[Page 217]]

    (b) The method of consultation chosen by the Commissioner will 
depend upon the importance and complexity of the subject matter involved 
and the time available for action. When time and circumstances permit, 
the Commissioner will consult with a panel through discussion at a panel 
meeting.

[83 FR 64456, Dec. 17, 2018]



                       Subpart C_Reclassification



Sec. 860.120  General.

    (a) Sections 513(e) and (f), 514(b), 515(b), and 520(l) of the 
Federal Food, Drug, and Cosmetic Act provide for reclassification of a 
device and prescribe the procedures to be followed to effect 
reclassification. The purposes of subpart C are to:
    (1) Set forth the requirements as to form and content of petitions 
for reclassification;
    (2) Describe the circumstances in which each of the five statutory 
reclassification provisions applies; and
    (3) Explain the procedure for reclassification prescribed in the 
five statutory reclassification provisions.
    (b) The criteria for determining the proper class for a device are 
set forth in Sec. 860.3(c). The reclassification of any device within a 
generic type of device causes the reclassification of all devices within 
that generic type. Accordingly, a petition for the reclassification of a 
specific device will be considered a petition for reclassification of 
all devices within the same generic type.
    (c) Any interested person may submit a petition for reclassification 
under section 513(e), 514(b), or 515(b) of the Federal Food, Drug, and 
Cosmetic Act. A manufacturer or importer may submit a petition for 
reclassification under section 513(f) or 520(l) of the Federal Food, 
Drug, and Cosmetic Act. The Commissioner may initiate the 
reclassification of a device under the following sections of the Federal 
Food, Drug, and Cosmetic Act:
    (1) Section 513(e) (for a classified device other than a device 
classified into class III under section 513(f)(1) or 520(l)(1) of the 
Federal Food, Drug, and Cosmetic Act);
    (2) Section 513(f)(3) (for a device classified into class III under 
section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act); or
    (3) Section 520(l)(2) (for a device classified into class III under 
section 520(l)(1) of the Federal Food, Drug, and Cosmetic Act).

[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992; 
83 FR 64456, Dec. 17, 2018]



Sec. 860.123  Reclassification petition: Content and form.

    (a) Unless otherwise provided in writing by the Commissioner, any 
petition for reclassification of a device, regardless of the section of 
the Federal Food, Drug, and Cosmetic Act under which it is filed, shall 
include the following:
    (1) A specification of the type of device for which reclassification 
is requested;
    (2) A statement of the action requested by the petitioner, e.g., 
``It is requested that _ device(s) be reclassified from class III to a 
class II'';
    (3) A statement of the basis for disagreement with the present 
classification status of the device;
    (4) A full statement of the reasons, together with supporting data 
satisfying the requirements of Sec. 860.7, why the device should not be 
classified into its present classification and how the proposed 
classification will provide reasonable assurance of the safety and 
effectiveness of the device;
    (5) Representative data and information known by the petitioner that 
are unfavorable to the petitioner's position;
    (6) If the petition is based upon new information under section 
513(e), 514(b), or 515(b) of the Federal Food, Drug, and Cosmetic Act, a 
summary of the new information;
    (7) Copies of source documents from which new information used to 
support the petition has been obtained (attached as appendices to the 
petition); and
    (8) A financial certification or disclosure statement or both as 
required by part 54 of this chapter.
    (b) Each petition submitted pursuant to this section shall be:
    (1) For devices regulated by the Center for Devices and Radiological

[[Page 218]]

Health, addressed to the Food and Drug Administration, Center for 
Devices and Radiological Health, Office of Policy Staff, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5445, Silver Spring, MD 20993-0002; for 
devices regulated by the Center for Biologics Evaluation and Research, 
addressed to the Food and Drug Administration, Center for Biologics 
Evaluation and Research, Document Control Center, 10903 New Hampshire 
Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002; for devices 
regulated by the Center for Drug Evaluation and Research, addressed to 
the Food and Drug Administration, Center for Drug Evaluation and 
Research, Central Document Control Room, 5901-B Ammendale Rd., 
Beltsville, MD 20705-1266, as applicable.
    (2) Marked clearly with the section of the Federal Food, Drug, and 
Cosmetic Act under which the petition is being submitted, i.e., 
``513(e),'' ``513(f)(3),'' ``514(b),'' ``515(b),'' or ``520(l) 
Petition'';
    (3) Bound in a volume or volumes, where necessary; and
    (4) Submitted in an original and two copies.

[43 FR 32993, July 28, 1978, as amended at 49 FR 14505, Apr. 12, 1984; 
53 FR 11253, Apr. 6, 1988; 55 FR 11169, Mar. 27, 1990; 63 FR 5254, Feb. 
2, 1998; 65 FR 17137, Mar. 31, 2000; 73 FR 49942, Aug. 25, 2008; 75 FR 
20916, Apr. 22, 2010; 79 FR 77388, Dec. 24, 2014; 82 FR 39535, Aug. 21, 
2017; 83 FR 64456, Dec. 17, 2018; 85 FR 18443, Apr. 2, 2020]



Sec. 860.125  Consultation with panels.

    (a) When the Commissioner chooses to refer a reclassification 
petition to a classification panel for its recommendation under Sec. 
860.134(b), or the Commissioner is required to consult with a panel 
concerning a reclassification petition submitted under Sec. 860.130(d) 
or received in a proceeding under Sec. 860.133(b), or the Commissioner 
chooses to consult with a panel with regard to the reclassification of a 
device initiated by the Commissioner under Sec. 860.134(c) or Sec. 
860.136, the Commissioner will distribute a copy of the petition, or its 
relevant portions, if applicable, to each panel member and will consult 
with the panel in one of the following ways:
    (1) Consultation by telephone with at least a majority of current 
voting panel members and, when possible, nonvoting panel members in a 
telephone or video conference call; or
    (2) Discussion at a panel meeting.
    (b) The method of consultation chosen by the Commissioner will 
depend upon the importance and complexity of the subject matter involved 
and the time available for action. When time and circumstances permit, 
the Commissioner will consult with a panel through discussion at a panel 
meeting.
    (c) The Commissioner will consult with a classification panel prior 
to changing the classification of a device in a proceeding under section 
513(e) of the Federal Food, Drug, and Cosmetic Act and Sec. 860.130 
upon the Commissioner's own initiative or upon petition of an interested 
person, and in the latter case, the Commissioner will distribute a copy 
of the petition, or its relevant portions, to each panel member.
    (d) When a petition is submitted under Sec. 860.134 for a 
postamendments, not substantially equivalent, device, if the 
Commissioner chooses to consult with the panel, the Commissioner will 
obtain a recommendation that includes the information described in Sec. 
860.84(d). In consulting with a panel about a petition submitted under 
Sec. 860.130(d), Sec. 860.136(a), or received in a proceeding under 
Sec. 860.133(b), the Commissioner may or may not obtain a formal 
recommendation.

[43 FR 32993, July 28, 1978, as amended at 83 FR 64456, Dec. 17, 2018]



Sec. 860.130  General procedures under section 513(e) of the 
Federal Food, Drug, and Cosmetic Act.

    (a) Section 513(e) of the Federal Food, Drug, and Cosmetic Act 
applies to reclassification proceedings under the Federal Food, Drug, 
and Cosmetic Act based upon new information.
    (b) A proceeding to reclassify a device under section 513(e) may be 
initiated:
    (1) On the initiative of the Commissioner alone;
    (2) On the initiative of the Commissioner in response to a request 
for change in classification based upon new information, under section 
514(b) or 515(b) of the Federal Food, Drug, and Cosmetic Act (see Sec. 
860.132); or

[[Page 219]]

    (3) In response to the petition of an interested person, based upon 
new information, filed in accordance with Sec. 860.123.
    (c) By administrative order published under this section, the 
Commissioner may change the classification from:
    (1) Class I or class II to class III if the Commissioner determines 
that the device meets the criteria set forth in Sec. 860.3(c)(3) for a 
class III device; or
    (2) Class III or class I to class II if the Commissioner determines 
that the device meets the criteria set forth in Sec. 860.3(c)(2) for a 
class II device; or
    (3) Class III or class II to class I if the Commissioner determines 
that the device meets the criteria set forth in Sec. 860.3(c)(1) for a 
class I device.
    (d)(1) The Commissioner shall consult with a classification panel 
and may secure a recommendation with respect to reclassification of a 
device from a classification panel. The panel will consider 
reclassification in accordance with the consultation procedures of Sec. 
860.125. A recommendation submitted to the Commissioner by the panel 
will be published in the Federal Register when the Commissioner 
publishes an administrative order under this section.
    (2) The Commissioner may change the classification of a device by 
administrative order published in the Federal Register following 
publication of a proposed reclassification order in the Federal 
Register, a meeting of a device classification panel described in 
section 513(b) of the Federal Food, Drug, and Cosmetic Act, and 
consideration of comments to a public docket.
    (e) Within 180 days after the filing of a petition for 
reclassification under this section, the Commissioner will either deny 
the petition by order published in the Federal Register or give notice 
of the intent to initiate a change in the classification of the device.
    (f) If a device is reclassified under this section, the 
administrative order effecting the reclassification may revoke any 
special control or premarket approval requirement that previously 
applied to the device but that is no longer applicable because of the 
change in classification.
    (g) An administrative order under this section changing the 
classification of a device to class II may provide that such 
reclassification will not take effect until the effective date of a 
performance standard for the device established under section 514 of the 
Federal Food, Drug, and Cosmetic Act or other special controls 
established under the order. An order under this section changing the 
classification of a device to class II may also establish the special 
controls necessary to provide reasonable assurance of the safety and 
effectiveness of the device.

[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992; 
83 FR 64456, Dec. 17, 2018]



Sec. 860.132  Procedures when the Commissioner initiates a performance
standard or premarket approval proceeding under section 514(b) or 515(b)
of the Federal 
          Food, Drug, and Cosmetic Act.

    (a) Sections 514(b) and 515(b) of the Federal Food, Drug, and 
Cosmetic Act require the Commissioner to provide, by notice in the 
Federal Register, an opportunity for interested parties to petition to 
change the classification of a device based upon new information 
relevant to its classification when the Commissioner initiates a 
proceeding to develop a performance standard for the device if in class 
II or to issue an order requiring premarket approval for the device if 
in class III.
    (b) If the Commissioner agrees that the new information submitted in 
response to a proposed order to require premarket approval of a device 
issued under section 515(b) of the Federal Food, Drug, and Cosmetic Act 
warrants a change in classification, the Commissioner shall follow the 
administrative order procedures under section 513(e) of the Federal 
Food, Drug, and Cosmetic Act and Sec. 860.130 to effect such a change.
    (c) If the Commissioner does not agree that the new information 
submitted in response to a proposed order to require premarket approval 
of a device issued under section 515(b) of the Federal Food, Drug, and 
Cosmetic Act warrants a change in classification, the Commissioner will 
deny the petition.

[[Page 220]]

    (d) The procedures under section 514(b) of the Federal Food, Drug, 
and Cosmetic Act are as follows:
    (1) Within 30 days after publication of the Commissioner's notice 
referred to in paragraph (a) of this section, an interested person files 
a petition for reclassification in accordance with Sec. 860.123.
    (2) The Commissioner consults with the appropriate classification 
panel with regard to the petition in accordance with Sec. 860.125.
    (3) Within 60 days after publication of the notice referred to in 
paragraph (a) of this section, the Commissioner either denies the 
petition or gives notice of the intent to initiate a change in 
classification in accordance with Sec. 860.130.

[43 FR 32993, July 28, 1978, as amended at 83 FR 64457, Dec. 17, 2018]



Sec. 860.133  Procedures when the Commissioner initiates a proceeding
to require premarket approval under section 515(b) of the Federal
Food, Drug, and  Cosmetic Act.

    (a) Section 515(b) of the Federal Food, Drug, and Cosmetic Act 
applies to proceedings to require premarket approval for a class III 
preamendments device.
    (b) The Commissioner may require premarket approval for a class III 
preamendments device by administrative order published in the Federal 
Register following publication of a proposed order in the Federal 
Register, a meeting of a device classification panel described in 
section 513(b) of the Federal Food, Drug, and Cosmetic Act, and 
consideration of comments from all affected stakeholders, including 
patients, payors, and providers. The panel will consider 
reclassification petitions received in the proceeding in accordance with 
section 513(e) of the Federal Food, Drug, and Cosmetic and the 
applicable consultation procedures in Sec. 860.125. A recommendation 
submitted to the Commissioner by the panel will be published in the 
Federal Register when the Commissioner publishes an administrative order 
under this section.

[83 FR 64457, Dec. 17, 2018]



Sec. 860.134  Procedures for reclassification of ``postamendments devices
'' under section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act.

    (a) Section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act 
applies to proceedings for reclassification of a device currently in 
class III by operation of section 513(f)(1) of the Federal Food, Drug, 
and Cosmetic Act. This category includes any device that is to be first 
introduced or delivered for introduction into interstate commerce for 
commercial distribution after May 28, 1976, unless:
    (1) It is substantially equivalent to another device that was in 
commercial distribution before that date and had not been regulated 
before that date as a new drug; or
    (2) It is substantially equivalent to another device that was not in 
commercial distribution before such date but which has been classified 
into class I or class II; or
    (3) The Commissioner has classified the device into class I or class 
II in response to a petition for reclassification under this section; or
    (4) The device is classified under a request for De Novo 
classification under section 513(f)(2) of the Federal Food, Drug, and 
Cosmetic Act.
    (b) The procedures for effecting reclassification under section 
513(f)(3) of the Federal Food, Drug, and Cosmetic Act when initiated by 
a manufacturer or importer are as follows:
    (1) The manufacturer or importer of the device petitions for 
reclassification of the device in accordance with Sec. 860.123.
    (2) Within 30 days after the petition is filed, the Commissioner 
notifies the petitioner of any deficiencies in the petition that prevent 
the Commissioner from making a decision on it and allows the petitioner 
to supplement a deficient petition. Within 30 days after any 
supplemental material is received, the Commissioner notifies the 
petitioner whether the petition, as supplemented, is adequate for 
review.
    (3) After determining that the petition contains no deficiencies 
precluding a decision on it, the Commissioner may for good cause shown 
refer

[[Page 221]]

the petition to the appropriate classification panel for its review and 
recommendation whether to approve or deny the petition.
    (4) Within 90 days after the date the petition is referred to the 
panel, following the review procedures set forth in Sec. 860.84(c) for 
the original classification of a ``preamendments device'', the panel 
submits to the Commissioner its recommendation containing the 
information set forth in Sec. 860.84(d). A panel recommendation is 
regarded as preliminary until the Commissioner has reviewed it, 
discussed it with the panel, if appropriate, and developed a proposed 
reclassification order. Preliminary panel recommendations are filed at 
Dockets Management Staff upon receipt and are available to the public 
and posted at https://www.regulations.gov.
    (5) The panel recommendation is published in the Federal Register as 
soon as practicable and interested persons are provided an opportunity 
to comment on the recommendation.
    (6) Within 90 days after the panel's recommendation is received (and 
no more than 210 days after the date the petition was filed), the 
Commissioner denies or approves the petition by order in the form of a 
letter to the petitioner. If the Commissioner approves the petition, the 
order will classify the device into class I or class II in accordance 
with the criteria set forth in Sec. 860.3(c) and subject to the 
applicable requirements of Sec. 860.10, relating to the classification 
of implants and life-supporting or life-sustaining devices, and Sec. 
860.15, relating to exemptions from certain requirements of the Federal 
Food, Drug, and Cosmetic Act.
    (7) Within a reasonable time after issuance of an order under this 
section, the Commissioner announces the order by notice published in the 
Federal Register.
    (c) By administrative order published under section 513(f)(3) of the 
Federal Food, Drug, and Cosmetic Act, the Commissioner may, on the 
Commissioner's own initiative, change the classification from class III 
under section 513(f)(1) either to class II, if the Commissioner 
determines that special controls in addition to general controls are 
necessary and sufficient to provide reasonable assurance of the safety 
and effectiveness of the device and there is sufficient information to 
establish special controls to provide such assurance, or to class I if 
the Commissioner determines that general controls alone would provide 
reasonable assurance of the safety and effectiveness of the device. The 
procedures for the reclassification proceeding under this paragraph (c) 
are as follows:
    (1) The Commissioner publishes a proposed reclassification order in 
the Federal Register seeking comment on the proposed reclassification.
    (2) The Commissioner may consult with the appropriate classification 
panel with respect to the reclassification of the device. The panel will 
consider reclassification in accordance with the consultation procedures 
of Sec. 860.125.
    (3) Following consideration of comments to a public docket and any 
panel recommendations or comments, the Commissioner may change the 
classification of a device by final administrative order published in 
the Federal Register.
    (d) An administrative order under this section changing the 
classification of a device from class III to class II may establish the 
special controls necessary to provide reasonable assurance of the safety 
and effectiveness of the device.

[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992; 
73 FR 34860, June 19, 2008; 83 FR 64457, Dec. 17, 2018]



Sec. 860.136  Procedures for transitional products under section 520(l)
of the Federal Food, Drug, and Cosmetic Act.

    (a) Section 520(l)(2) of the Federal Food, Drug, and Cosmetic Act 
applies to reclassification proceedings initiated by the Commissioner or 
in response to a request by a manufacturer or importer for 
reclassification of a device currently in class III by operation of 
section 520(l)(1). This section applies only to devices that the Food 
and Drug Administration regarded as ``new drugs'' before May 28, 1976.
    (b) The procedures for effecting reclassification under section 
520(l) of the Federal Food, Drug, and Cosmetic Act

[[Page 222]]

when initiated by a manufacturer or importer are as follows:
    (1) The manufacturer or importer of the device files a petition for 
reclassification of the device in accordance with Sec. 860.123.
    (2) Within 30 days after the petition is filed, the Commissioner 
notifies the petitioner of any deficiencies in the petition that prevent 
the Commissioner from making a decision on it, allowing the petitioner 
to supplement a deficient petition. Within 30 days after any 
supplemental material is received, the Commissioner notifies the 
petitioner whether the petition, as supplemented, is adequate for 
review.
    (3) The Commissioner consults with the appropriate classification 
panel with regard to the petition in accordance with Sec. 860.125.
    (4) Within 180 days after the petition is filed (where the 
Commissioner has determined it to be adequate for review), the 
Commissioner, by order in the form of a letter to the petitioner, either 
denies the petition or classifies the device into class I or class II in 
accordance with the criteria set forth in Sec. 860.3(c).
    (5) Within a reasonable time after issuance of an order under this 
section, the Commissioner announces the order by notice published in the 
Federal Register.
    (c) By administrative order, the Commissioner may, on the 
Commissioner's own initiative, change the classification from class III 
under section 520(l) of the Federal Food, Drug, and Cosmetic Act either 
to class II, if the Commissioner determines that special controls in 
addition to general controls are necessary and sufficient to provide 
reasonable assurance of the safety and effectiveness of the device and 
there is sufficient information to establish special controls to provide 
such assurance, or to class I if the Commissioner determines that 
general controls alone would provide reasonable assurance of the safety 
and effectiveness of the device. The procedures for the reclassification 
proceeding under this paragraph (c) are as follows:
    (1) The Commissioner publishes a proposed reclassification order in 
the Federal Register seeking comment on the proposed reclassification.
    (2) The Commissioner may consult with the appropriate classification 
panel with respect to the reclassification of the device. The panel will 
consider reclassification in accordance with the consultation procedures 
of Sec. 860.125.
    (3) Following consideration of comments to a public docket and any 
panel recommendations or comments, the Commissioner may change the 
classification of a device by final administrative order published in 
the Federal Register.
    (d) An administrative order under this section changing the 
classification of a device from class III to class II may establish the 
special controls necessary to provide reasonable assurance of the safety 
and effectiveness of the device.

[43 FR 32993, July 28, 1978, as amended at 83 FR 64458, Dec. 17, 2018]



                    Subpart D_De Novo Classification

    Source: 86 FR 54847, Oct. 5, 2021, unless otherwise noted.



Sec. 860.200  Purpose and applicability.

    (a) The purpose of this part is to establish an efficient, 
transparent, and thorough process to facilitate De Novo classification 
into class I or class II for devices for which there is no legally 
marketed device on which to base a review of substantial equivalence and 
which meet the definition of class I or class II as described in section 
513(a)(1) of the Federal Food, Drug, and Cosmetic Act and Sec. 860.3.
    (b) De Novo requests can be submitted for a single device type:
    (1) After receiving a not substantially equivalent determination in 
response to a premarket notification (510(k)), or
    (2) If a person determines there is no legally marketed device upon 
which to base a determination of substantial equivalence.



Sec. 860.210  De Novo request format.

    (a) Each De Novo request or information related to a De Novo request 
pursuant to this part must be formatted in accordance with this section. 
Each De

[[Page 223]]

Novo request must be provided as a single version in electronic format. 
These materials must:
    (1)(i) For devices regulated by the Center for Devices and 
Radiological Health, be sent to the current address displayed on the 
website https://www.fda.gov/cdrhsubmissionaddress.
    (ii) For devices regulated by the Center for Biologics Evaluation 
and Research, be sent to the current address displayed on the website 
https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-
cber/regulatory-submissions-electronic-and-paper.
    (2) Be signed by the requester or an authorized representative.
    (3) Be designated ``De Novo Request'' in the cover letter.
    (4) Have all content used to support the request written in, or 
translated into, English.



Sec. 860.220  De Novo request content.

    (a) Unless the requester justifies an omission in accordance with 
paragraph (c) of this section, a De Novo request must include:
    (1) Table of contents. A table of contents that specifies the volume 
(if the De Novo request contains more than one volume) and page number 
for each item.
    (2) Administrative information. The name, address, phone, and email 
address of the requester and U.S. representative, if applicable. The 
establishment registration number, if applicable, of the owner or 
operator submitting the De Novo request.
    (3) Regulatory history. Identify any prior submissions to FDA for 
the device, including, but not limited to, any premarket notifications 
(510(k)s) submitted under part 807 of this chapter; applications for 
premarket approval (PMAs) submitted under part 814 of this chapter; 
applications for humanitarian device exemption (HDE) submitted under 
part 814 of this chapter; applications for investigational device 
exemption (IDEs) submitted under part 812 of this chapter; requests for 
designation (RFD) under Sec. 3.7 of this chapter; requests for 
information under section 513(g) of the Federal Food, Drug, and Cosmetic 
Act; applications for emergency use authorization (EUA) under section 
564 of the Federal Food, Drug, and Cosmetic Act; pre-submissions, or 
previously submitted De Novo requests; or state that there have been no 
prior submissions.
    (4) Device name. The generic name of the device as well as any 
proprietary name or trade name.
    (5) Indications for use. A general description of the disease or 
condition the device is intended to diagnose, treat, prevent, cure or 
mitigate, or affect the structure or function of the body, including a 
description of the patient population for which the device is intended. 
The indications for use include all the labeled patient uses of the 
device, including if it is prescription or over-the-counter.
    (6) Device description. A complete description of:
    (i) The device, including, where applicable, pictorial 
representations, device specifications, and engineering drawings;
    (ii) Each of the functional components or ingredients of the device, 
if the device consists of more than one physical component or 
ingredient;
    (iii) The properties of the device relevant to the diagnosis, 
treatment, prevention, cure, or mitigation of a disease or condition 
and/or the effect of the device on the structure or function of the 
body;
    (iv) The principles of operation of the device; and
    (v) The relevant FDA assigned reference number(s) for any medical 
devices (such as accessories or components) that are intended to be used 
with the device and that are already legally marketed.
    (7) Alternative practices and procedures. A description of existing 
alternative practices or procedures that are used in diagnosing, 
treating, preventing, curing, or mitigating the disease or condition for 
which the device is intended or which similarly affect the structure or 
function of the body and that are known or should reasonably be known to 
the requester.
    (8) Classification summary. (i) For devices not the subject of a 
previous submission under section 510(k) of the Federal Food, Drug, and 
Cosmetic Act, a complete description of:

[[Page 224]]

    (A) The searches used to establish that no legally marketed device 
of the same type exists.
    (B) A list of classification regulations, PMAs, HDEs, premarket 
notifications (510(k)s), EUAs, and/or product codes regarding devices 
that are potentially similar to the subject device.
    (C) A rationale explaining how the device that is the subject of the 
De Novo request is different from the devices covered by the 
classification regulations, PMAs, HDEs, 510(k)s, EUAs, and/or product 
codes identified in paragraph (a)(8)(i)(B) of this section.
    (ii) For devices which were the subject of a previous submission 
under section 510(k) of the Federal Food, Drug, and Cosmetic Act that 
were determined not substantially equivalent (NSE), the relevant 510(k) 
number, along with a summary of the search performed to confirm the 
device has not been classified or reclassified since the date the NSE 
order was issued by FDA pursuant to Sec. 807.100(a) of this chapter.
    (9) Summary of risks and mitigations. A summary of probable risks to 
health associated with use of the device that are known or should 
reasonably be known to the requester and the proposed mitigations, 
including general controls and, if the classification recommendation 
from paragraph (a)(11) of this section is class II, special controls for 
each risk. For each mitigation measure that involves specific 
performance testing or labeling, the De Novo request must provide a 
reference to the associated section or pages for the supporting 
information in the De Novo request.
    (10) Proposed special controls. If the classification recommendation 
from paragraph (a)(11) of this section is class II, then the summary 
must include an initial draft proposal for applicable special controls 
and a description of how those special controls provide reasonable 
assurance of safety and effectiveness.
    (11) Classification recommendation. The recommended class (I or II) 
must be identified and must be supported by a description of why general 
controls, or general and special controls, are adequate to provide 
reasonable assurance of safety and effectiveness.
    (12) Standards. Reference to any published voluntary consensus 
standards that are relevant to any aspect of the safety or effectiveness 
of the device and that are known or should reasonably be known to the 
requester. Such standards include voluntary consensus standards whether 
recognized or not yet recognized under section 514(c) of the Federal 
Food, Drug, and Cosmetic Act. Provide adequate information to 
demonstrate how the device meets, or justify any deviation from, the 
referenced standard.
    (13) Summary of studies. An abstract of any information or report 
described in the De Novo request under paragraph (a)(16)(ii) of this 
section and a summary of the results of technical data submitted under 
paragraph (a)(15) of this section. Each such study summary must include 
a description of the objective of the study, a description of the 
experimental design of the study, a brief description of how the data 
were collected and analyzed, and a brief description of the results, 
whether positive, negative, or inconclusive. This section must also 
include the following:
    (i) A summary of each nonclinical study submitted in the De Novo 
request;
    (ii) A summary of each clinical investigation involving human 
subjects submitted in the De Novo request, including a discussion of 
investigation design, subject selection and exclusion criteria, 
investigation population, investigation period, safety and effectiveness 
data, adverse reactions and complications, subject discontinuation, 
subject complaints, device failures (including unexpected software 
events, if applicable) and replacements, results of statistical analyses 
of the clinical investigations, contraindications and precautions for 
use of the device, and other information from the clinical 
investigations as appropriate. Any investigation conducted under an 
investigational device exemption (IDE) under part 812 of this chapter 
must be identified as such.
    (14) Benefit and risk considerations. A discussion demonstrating 
that:

[[Page 225]]

    (i) The data and information in the De Novo request constitute valid 
scientific evidence within the meaning of Sec. 860.7(c) and
    (ii) Pursuant to Sec. 860.7, when subject to general controls, or 
general and special controls, the probable benefit to health from use of 
the device outweighs any probable injury or illness from such use.
    (15) Technical sections. The following technical sections, which 
must contain data and information in sufficient detail to permit FDA to 
determine whether to grant or decline the De Novo request:
    (i) A section containing the results of the nonclinical studies of 
the device, including, as appropriate, microbiological, toxicological, 
immunological, biocompatibility, stress, wear, shelf life, electrical 
safety, electromagnetic compatibility, and other laboratory or animal 
tests. Information on nonclinical studies must include protocols and 
complete test reports for each study. For those nonclinical studies 
subject to part 58 of this chapter, this section must include a 
statement that each such study was conducted in compliance with such 
regulations, or, if the study was not conducted in compliance with part 
58 of this chapter, a brief statement of the reason for the 
noncompliance.
    (ii) For all devices that incorporate software, a section containing 
all relevant software information and testing, including, but not 
limited to, appropriate device hazard analysis, hardware, and system 
information.
    (iii) A section containing results of each clinical investigation of 
the device involving human subjects, including clinical protocols, 
number of investigators and subjects per investigator, investigation 
design, subject selection and exclusion criteria, investigation 
population, investigation period, safety and effectiveness data, adverse 
reactions and complications, subject discontinuation, subject 
complaints, device failures (including unexpected software events if 
applicable) and replacements, tabulations of data from all individual 
subject report forms and copies of such forms for each subject who died 
during a clinical investigation or who did not complete the 
investigation, results of statistical analyses of the results of the 
clinical investigations, contraindications, warnings, precautions, and 
other limiting statements relevant to the use of the device type, and 
any other appropriate information from the clinical investigations. Any 
investigation conducted under an IDE under part 812 of this chapter must 
be identified as such. Information on clinical investigations involving 
human subjects must include the following:
    (A) For clinical investigations conducted in the United States, a 
statement with respect to each investigation that it either was 
conducted in compliance with the institutional review board regulations 
in part 56 of this chapter, or was not subject to the regulations under 
Sec. 56.104 or Sec. 56.105 of this chapter, and that it was conducted 
in compliance with the informed consent regulations in part 50 of this 
chapter; or if the investigation was not conducted in compliance with 
those regulations, a brief statement of the reason for the 
noncompliance. Failure or inability to comply with these requirements 
does not justify failure to provide information on a relevant clinical 
investigation.
    (B) For clinical investigations conducted in the United States, a 
statement that each investigation was conducted in compliance with part 
812 of this chapter concerning sponsors of clinical investigations and 
clinical investigators, or if the investigation was not conducted in 
compliance with those regulations, a brief statement of the reason for 
the noncompliance. Failure or inability to comply with these 
requirements does not justify failure to provide information on a 
relevant clinical investigation.
    (C) For clinical investigations conducted outside the United States 
that are intended to support the De Novo request, the requirements under 
Sec. 812.28 of this chapter apply. If any such investigation was not 
conducted in accordance with good clinical practice (GCP) as described 
in Sec. 812.28(a) of this chapter, include either a waiver request in 
accordance with Sec. 812.28(c) of this chapter or a brief statement of 
the reason for not conducting the investigation in accordance with GCP 
and a description

[[Page 226]]

of steps taken to ensure that the data and results are credible and 
accurate and that the rights, safety, and well-being of subjects have 
been adequately protected. Failure or inability to comply with these 
requirements does not justify failure to provide information on a 
relevant clinical investigation.
    (D) A statement that each investigation has been completed per the 
protocol or a summary of any protocol deviations.
    (E) A financial certification or disclosure statement or both as 
required by part 54 of this chapter.
    (F) For a De Novo request that relies primarily on data from a 
single investigator at one investigation site, a justification showing 
that these data and other information are sufficient to reasonably 
demonstrate the safety and effectiveness of the device when subject to 
general controls or general and special controls, and to ensure that the 
results from a site are applicable to the intended population.
    (G) A discussion of how the investigation data represent clinically 
significant results, pursuant to Sec. 860.7(e).
    (16) Other information. (i) A bibliography of all published reports 
not submitted under paragraph (a)(15) of this section, whether adverse 
or supportive, known to or that should reasonably be known to the 
requester and that concern the safety or effectiveness of the device.
    (ii) An identification, discussion, and analysis of any other data, 
information, or report relevant to an evaluation of the safety and 
effectiveness of the device known to or that should reasonably be known 
to the requester from any source, foreign or domestic, including 
information derived from investigations other than those in the request 
and from commercial marketing experience.
    (iii) Copies of such published reports or unpublished information in 
the possession of or reasonably obtainable by the requester, if 
requested by FDA.
    (17) Samples. If requested by FDA, one or more samples of the device 
and its components. If it is impractical to submit a requested sample of 
the device, the requester must name the location at which FDA may 
examine and test one or more of the devices.
    (18) Labeling and advertisements. Labels, labeling, and 
advertisements sufficient to describe the device, its intended use, and 
the directions for its use. Where applicable, photographs or engineering 
drawings must be supplied.
    (19) Other information. Such other information as is necessary to 
determine whether general controls or general and special controls 
provide reasonable assurance of safety and effectiveness of the device.
    (b) Pertinent information in FDA files specifically referred to by a 
requester may be incorporated into a De Novo request by reference. 
Information submitted to FDA by a person other than the requester will 
not be considered part of a De Novo request unless such reference is 
authorized in writing by the person who submitted the information.
    (c) If the requester believes that certain information required 
under paragraph (a) of this section to be in a De Novo request is not 
applicable to the device that is the subject of the De Novo request, and 
omits any such information from the De Novo request, the requester must 
submit a statement that specifies the omitted information and justifies 
the omission. The statement must be submitted as a separate section in 
the De Novo request and listed in the table of contents. If the 
justification for the omission is not accepted by FDA, FDA will so 
notify the requester.
    (d) The requester must update the pending De Novo request with new 
safety and effectiveness information learned about the device from 
ongoing or completed studies and investigations that may reasonably 
affect an evaluation of the safety or effectiveness of the device as 
such information becomes available.



Sec. 860.230  Accepting a De Novo request.

    (a) The acceptance of a De Novo request means that FDA has made a 
threshold determination that the De Novo request contains the 
information necessary to permit a substantive review. Within 15 days 
after a De Novo request is received by FDA, FDA will notify the 
requester whether the De Novo request has been accepted.

[[Page 227]]

    (b) If FDA does not find that any of the reasons in paragraph (c)(1) 
of this section for refusing to accept the De Novo request apply or FDA 
fails to complete the acceptance review within 15 days, FDA will accept 
the De Novo request for review and will notify the requester. The notice 
will include the De Novo request reference number and the date FDA 
accepted the De Novo request. The date of acceptance is the date that an 
accepted De Novo request was received by FDA.
    (c)(1) FDA may refuse to accept a De Novo request if any of the 
following applies:
    (i) The requester has an open or pending premarket submission or 
reclassification petition for the device;
    (ii) The De Novo request is incomplete because it does not on its 
face contain all the information required under section 513(f)(2) of the 
Federal Food, Drug, and Cosmetic Act or does not contain each of the 
items required under this part, or a justification for omission of any 
item;
    (iii) The De Novo request is not formatted as required under Sec. 
860.210;
    (iv) The De Novo request is for multiple devices and those devices 
are of more than one type; or
    (v) The requester has not responded to, or has failed to provide a 
rationale for not responding to, deficiencies identified by FDA in 
previous submissions for the same device, including those submissions 
described in Sec. 860.220(a)(3).
    (2) If FDA refuses to accept a De Novo request, FDA will notify the 
requester of the reasons for the refusal. The notice will identify the 
deficiencies in the De Novo request that prevent accepting and will 
include the De Novo request reference number.
    (3) If FDA refuses to accept a De Novo request, the requester may 
submit the additional information necessary to comply with the 
requirements of section 513(f)(2) of the Federal Food, Drug, and 
Cosmetic Act and this part. The additional information must include the 
De Novo request reference number of the original submission. If the De 
Novo request is subsequently accepted, the date of acceptance is the 
date FDA receives the additional information.



Sec. 860.240  Procedures for review of a De Novo request.

    (a) FDA will begin substantive review of a De Novo request after the 
De Novo request is accepted under Sec. 860.230. Within 120 days after 
receipt of a De Novo request or receipt of additional information that 
results in the De Novo request being accepted under Sec. 860.230, FDA 
will review the De Novo request and send the requester an order granting 
the De Novo request under Sec. 860.260(a) or an order declining the De 
Novo request under 860.260(b).
    (b) A requester may supplement or amend a pending De Novo request to 
revise existing information or provide additional information.
    (1) FDA may require additional information regarding the device that 
is necessary for FDA to complete the review of the De Novo request.
    (2) Additional information submitted to FDA must include the 
reference number assigned to the original De Novo request and, if 
submitted on the requester's own initiative, the reason for submitting 
the additional information.
    (c) Prior to granting or declining a De Novo request, FDA may 
inspect relevant facilities to help determine:
    (1) That clinical or nonclinical data were collected in a manner 
that ensures that the data accurately represents the benefits and risks 
of the device; or
    (2) That implementation of Quality System Regulation (part 820 of 
this chapter) requirements, in addition to other general controls and 
any specified special controls, provide adequate assurance that critical 
and/or novel manufacturing processes produce devices that meet 
specifications necessary to ensure reasonable assurance of safety and 
effectiveness.



Sec. 860.250  Withdrawal of a De Novo request.

    (a) FDA considers a De Novo request to have been withdrawn if:
    (1) The requester fails to provide a complete response to a request 
for additional information pursuant to Sec. 860.240(b)(1) within 180 
days after the date FDA issues such request;
    (2) The requester fails to provide a complete response to the 
deficiencies

[[Page 228]]

identified by FDA pursuant to Sec. 860.230(c)(2) within 180 days of the 
date notification was issued by FDA;
    (3) The requester does not permit an authorized FDA employee an 
opportunity to inspect the facilities, pursuant to Sec. 860.240(c), at 
a reasonable time and in a reasonable manner, and to have access to copy 
and verify all records pertinent to the De Novo request; or
    (4) The requester submits a written notice to FDA that the De Novo 
request has been withdrawn.
    (b) If a De Novo request is withdrawn, the Agency will notify the 
requester. The notice will include the De Novo request reference number 
and the date FDA considered the De Novo request withdrawn.



Sec. 860.260  Granting or declining a De Novo request.

    (a)(1) FDA will issue to the requester an order granting a De Novo 
request if none of the reasons in paragraph (c) of this section for 
declining the De Novo request applies.
    (2) If FDA grants a De Novo request, within 30 days after the 
issuance of an order granting the De Novo request, FDA will publish in 
the Federal Register a notice of the classification order, including any 
special controls.
    (b) If FDA declines a De Novo request, FDA will issue a written 
order to the requester.
    (c) FDA may decline a De Novo request if the requester fails to 
follow the requirements of this part or if, upon the basis of the 
information submitted in the De Novo request or any other information 
before FDA, FDA determines:
    (1) The device does not meet the criteria under section 513(a)(1) of 
the Federal Food, Drug, and Cosmetic Act and Sec. 860.3 for 
classification into class I or II;
    (2) The De Novo request contains a false statement of material fact 
or there is a material omission;
    (3) The device's labeling does not comply with the requirements in 
parts 801 and 809 of this chapter, as applicable;
    (4) The product described in the De Novo request does not meet the 
definition of a device under section 201(h) of the Federal Food, Drug, 
and Cosmetic Act and is not a combination product as defined at Sec. 
3.2(e) of this chapter;
    (5) The device is of a type which has already been approved in 
existing applications for premarket approval (PMAs) submitted under part 
814 of this chapter;
    (6) The device is of a type that has already been classified into 
class I, class II, or class III;
    (7) An inspection of a relevant facility under Sec. 860.240(c) 
results in a determination that general or general and special controls 
would not provide reasonable assurance of safety and effectiveness;
    (8) A nonclinical study subject to part 58 of this chapter that is 
described in the De Novo request, and that is essential to show there is 
reasonable assurance of safety, was not conducted in compliance with 
part 58 of this chapter and no reason for the noncompliance is provided 
or, if a reason is provided, the practices used in conducting the study 
do not support the validity of the study;
    (9) A clinical investigation described in the De Novo request 
involving human subjects that is subject to the institutional review 
board regulations in part 56 of this chapter, informed consent 
regulations in part 50 of this chapter, or GCP described in Sec. 
812.28(a) of this chapter, was not conducted in compliance with those 
regulations such that the rights or safety of human subjects were not 
adequately protected or the supporting data were determined to be 
otherwise unreliable;
    (10) A clinical or nonclinical study necessary to demonstrate that 
general controls or general and special controls provide reasonable 
assurance of safety and effectiveness:
    (i) Has not been completed per the study protocol, or
    (ii) Deficiencies related to the investigation and identified in any 
request for additional information under Sec. 860.240(b)(1) have not 
been adequately addressed; or
    (11) After a De Novo request is accepted for review under Sec. 
860.230(b), the requester makes significant unsolicited changes to the 
device's:
    (i) Indications for use; or
    (ii) Technological characteristics.

[[Page 229]]

    (d) An order declining a De Novo request will inform the requester 
of the deficiencies in the De Novo request, including each applicable 
ground for declining the De Novo request.
    (e) FDA will use the criteria specified in Sec. 860.7 to determine 
the safety and effectiveness of a device in deciding whether to grant or 
decline a De Novo request. FDA may use information other than that 
submitted by the requester in making such determination.



PART 861_PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT--
Table of Contents



                            Subpart A_General

Sec.
861.1 Purpose and scope.
861.5 Statement of policy.
861.7 Contents of standards.

     Subpart B_Procedures for Performance Standards Development and 
                               Publication

861.20 Summary of standards development process.
861.24 Existing standard as a proposed standard.
861.30 Development of standards.
861.34 Amendment or revocation of a standard.
861.36 Effective dates.
861.38 Standards advisory committees.

    Authority: 21 U.S.C. 351, 352, 360c, 360d, 360gg-360ss, 371, 374; 42 
U.S.C. 262, 264.

    Source: 45 FR 7484, Feb. 1, 1980, unless otherwise noted.



                            Subpart A_General



Sec. 861.1  Purpose and scope.

    (a) This part implements section 514 of the Federal Food, Drug, and 
Cosmetic Act (the act) with respect to the establishment, amendment, and 
revocation of performance standards applicable to devices intended for 
human use.
    (b) The Food and Drug Administration may determine that a 
performance standard, as described under special controls for class II 
devices in Sec. 860.7(b) of this chapter, is necessary to provide 
reasonable assurance of the safety and effectiveness of the device. 
Performance standards may be established for:
    (1) A class II device;
    (2) A class III device which, upon the effective date of the 
standard, is reclassified into class II; and
    (3) A class III device, as a condition to premarket approval under 
section 515 of the act, to reduce or eliminate a risk or risks 
associated with such device.
    (c) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21 unless otherwise noted.

[45 FR 7484, Feb. 1, 1980, as amended at 45 FR 23686, Apr. 8, 1980; 57 
FR 58404, Dec. 10, 1992]



Sec. 861.5  Statement of policy.

    In carrying out its duties under this section, the Food and Drug 
Administration will, to the maximum extent practical:
    (a) Use personnel, facilities, and other technical support available 
in other Federal agencies;
    (b) Consult with other Federal agencies concerned with standard 
setting and other nationally or internationally recognized standard-
setting entities; and
    (c) Invite participation, through conferences, workshops, or other 
means, by representatives of scientific, professional, industry, or 
consumer organizations who can make a significant contribution.



Sec. 861.7  Contents of standards.

    Any performance standard established under this part will include 
such provisions as the Food and Drug Administration determines are 
necessary to provide reasonable assurance of the safety and 
effectiveness of the device or devices for which it is established. 
Where necessary to provide such assurance, a standard will address (but 
need not be limited to):
    (a) Performance characteristics of the device;
    (b) The design, construction, components, ingredients, and 
properties of the device, and its compatibility with power systems and 
connections to such systems;
    (c) The manufacturing processes and quality control procedures 
applicable to the device;
    (d) Testing of the device on either a sample or a 100-percent basis 
by the manufacturer, or, if it is determined

[[Page 230]]

that no other more practical means are available to the Food and Drug 
Administration to assure the conformity of the device to the standard, 
providing for testing by the Food and Drug Administration or a third 
person to ensure that the device conforms to the standard;
    (e) The publication of the results of each test or of certain tests 
of the device to show that the device conforms to the portions of the 
standard for which the test or tests were required;
    (f) Manufacturers' certification to purchasers or to the Food and 
Drug Administration that the device conforms to the applicable 
performance standard;
    (g) Restrictions on the sale and distribution of the device, but 
only to the extent authorized under section 520(e) of the act;
    (h) The use, and the form and content, of labeling for the proper 
installation, maintenance, operation, and use of the device. Among the 
provisions that may be required in the labeling are warnings; storage 
and transportation information; expiration dates; the date and place of 
manufacture; the results that may be expected if the device is used 
properly; the ranges of accuracy of diagnostic information; instructions 
regarding the proper care of, and the proper components, accessories, or 
other equipment to be used with the device; and statements concerning 
the appropriate patient population, for example, a statement that the 
device is considered safe and effective only when used by, or in the 
treatment of, a patient who has been tested by particular designated 
procedures and found to have an illness or condition for which use of 
the device is indicated by a person skilled in the use of the device.



     Subpart B_Procedures for Performance Standards Development and 
                               Publication



Sec. 861.20  Summary of standards development process.

    The procedure by which a performance standard for a device may be 
established, amended, or revoked is as follows:
    (a) The Food and Drug Administration (FDA) will publish in the 
Federal Register a notice of proposed rulemaking for the establishment, 
amendment, or revocation of any performance standard for a device.
    (1) A notice of proposed rulemaking for the establishment or 
amendment of a performance standard for a device will:
    (i) Set forth a finding, with supporting justification, that the 
performance standard is appropriate and necessary to provide reasonable 
assurance of the safety and effectiveness of the device;
    (ii) Set forth proposed findings with respect to the risk of illness 
or injury that the performance standard is intended to reduce or 
eliminate;
    (iii) Invite interested persons to submit to the Food and Drug 
Administration, within 30 days of the publication of the notice, 
requests for changes in the classification of the device pursuant to 
Sec. 860.132 of this chapter, based on new information relevant to the 
classification; and
    (iv) Invite interested persons to submit an existing performance 
standard for the device, including a draft or proposed performance 
standard, for consideration by the Commissioner of Food and Drugs.
    (2) A notice of proposed rulemaking for the revocation of a 
performance standard will set forth a finding, with supporting 
justification, that the performance standard is no longer necessary to 
provide reasonable assurance of the safety and effectiveness of a 
device.
    (b) A notice under this section will provide for a comment period of 
not less than 60 days.
    (c) If, after publication of a notice under paragraph (a) of this 
section, FDA receives a request to change the classification of the 
device, FDA will, within 60 days of the publication of the notice and 
after consultation with the appropriate panel under Sec. 860.125 of 
this chapter, either deny the request or give notice of its intent to 
initiate a change in the classification under Sec. 860.130.
    (d) If FDA initiates a rulemaking proceeding under paragraph (a) of 
this section, FDA will:

[[Page 231]]

    (1) Complete the proceeding and establish the performance standard 
for the device in accordance with this part and Sec. 10.40 of this 
chapter; or
    (2) Terminate the proceeding by publishing in the Federal Register a 
notice announcing such termination and the reasons therefor and, unless 
the proceeding is terminated because the device is a banned device, 
initiate a proceeding in accordance with section 513(e) of the act to 
reclassify the device; or
    (3) Take other appropriate action.

[57 FR 58404, Dec. 10, 1992]



Sec. 861.24  Existing standard as a proposed standard.

    (a) The Food and Drug Administration may accept an existing standard 
or a proposed or draft standard if it includes:
    (1) A description of the procedures used to develop the standard and 
a list of the persons and organizations that participated in its 
development, to the extent that such information is available or 
reasonably obtainable;
    (2) An identification of the specific portions of the existing 
standard that the person submitting the standard believes are 
appropriate for adoption as, or inclusion in, the proposed standard; and
    (3) A summary of the test data, or, if requested by the Food and 
Drug Administration, all such data or other information supporting the 
specific portions of the standard identified by the person submitting 
the standard.
    (b) The Food and Drug Administration will publish a notice in the 
Federal Register stating either that it has accepted, or accepted with 
modification, as a proposed standard, an existing standard or one that 
has been developed, or that an existing standard is not acceptable, 
together with the reasons therefor.

[45 FR 7484, Feb. 1, 1980, as amended at 57 FR 58405, Dec. 10, 1992]



Sec. 861.30  Development of standards.

    The Food and Drug Administration (FDA), while engaged in the 
development of a proposed standard under this section will:
    (a) Support its proposed performance standard by such test data or 
other documents or materials as may reasonably be required;
    (b) Provide interested persons an opportunity to participate in the 
development of the standard by accepting comments and, where 
appropriate, holding public meetings on issues relating to development 
of the standard. Notice of the opportunity to participate in the 
development of the standard will be furnished in a manner reasonably 
calculated to reach the majority of persons interested in the 
development of the standard. This requirement shall be satisfied by 
publishing such a notice in the Federal Register. Whenever it is 
appropriate, FDA will use the Federal Register to make announcements 
about the standard development process of standard developers other than 
Federal agencies.
    (c) Maintain records disclosing the course of development of the 
proposed standard, the comments and other information submitted by a 
person in connection with such development (including comments and 
information regarding the need for a standard), and such other 
information as may be required to evaluate the standard.

[45 FR 7484, Feb. 1, 1980, as amended at 57 FR 58405, Dec. 10, 1992]



Sec. 861.34  Amendment or revocation of a standard.

    (a) The Food and Drug Administration will provide for periodic 
evaluation of performance standards to determine whether such standards 
should be changed to reflect new medical, scientific, or other 
technological data.
    (b) The Food and Drug Administration may, on its own initiative or 
upon petition of an interested party, amend or revoke by regulation a 
standard established under this part.
    (c) Any petition to amend or revoke a standard shall:
    (1) Identify the specific device and standard for which the 
amendment or revocation is sought; and
    (2) Be submitted in accordance with the requirements of Sec. 10.30.

[[Page 232]]

    (d) Proceedings to amend or revoke a performance standard shall be 
conducted in accordance with the rulemaking procedures of Sec. 10.40. 
In addition, a notice of proposed rulemaking to amend or revoke a 
standard shall set forth proposed findings with respect to the degree of 
risk or illness to be eliminated or reduced and the benefit the public 
will derive from the proposed amendment or revocation.



Sec. 861.36  Effective dates.

    (a) A regulation establishing, amending, or revoking a performance 
standard will set forth the date upon which it will take effect. To the 
extent practical, consistent with the public health and safety, such 
effective date will be established so as to minimize economic loss to, 
and disruption or dislocation of, domestic and international trade.
    (b) Except as provided in paragraph (c) of this section, no 
regulation establishing, amending, or revoking a standard may take 
effect before 1 year after the date of its publication unless:
    (1) The Food and Drug Administration determines that an earlier 
effective date is necessary to protect the public health and safety; or
    (2) The standard has been established for a device that, by the 
effective date of the standard, has been reclassified from class III to 
class II.
    (c) The Food and Drug Administration may declare a proposed 
regulation amending a standard effective on publication in the Federal 
Register if it determines that making the regulation so effective is in 
the public interest. A proposed amendment of a performance standard made 
effective upon publication may not prohibit the introduction or delivery 
for introduction into interstate commerce of a device that conforms to 
the standard without the change or changes provided in the proposed 
amendment until the effective date of any final action on the proposal.

[45 FR 7484, Feb. 1, 1980, as amended at 57 FR 58405, Dec. 10, 1992]



Sec. 861.38  Standards advisory committees.

    (a) The Food and Drug Administration will establish advisory 
committees to which proposed regulations may be referred, and these 
committees shall consider such referrals in accordance with this section 
and part 14 of this chapter. Such advisory committees, which may not be 
classification panels, shall be considered ad hoc advisory committees. 
Their members shall be selected in accordance with Sec. Sec. 14.82 and 
14.84, except that no member may be a regular full-time FDA employee. 
Each advisory committee established under this section shall include as 
nonvoting members a representative of consumer interests and a 
representative of interests of the device manufacturing industry.
    (b) A proposed regulation to establish, amend, or revoke a 
performance standard shall be referred to an advisory committee for a 
report and recommendation with respect to any matter involved in the 
proposed regulation which requires the exercise of scientific judgment 
if:
    (1) The Food and Drug Administration determines that such referral 
is necessary or appropriate under the circumstances; or
    (2) Requested by an interested person, in the form of a citizen 
petition in accordance with Sec. 10.30 of this chapter, which is made 
within the period provided for comment on the proposed regulation and 
which demonstrates good cause for referral.
    (c) When a proposed regulation is referred to an advisory committee, 
the Food and Drug Administration will furnish the committee with the 
data and information upon which the proposed regulation is based. After 
independently reviewing the materials furnished by the Food and Drug 
Administration and any other available data and information, the 
advisory committee shall, within 60 days of the referral, submit a 
report and recommendation on the proposed regulation, together with all 
underlying data and information and a statement of the reason or basis 
for the recommendation. A copy of the report and recommendation will be 
publicly displayed in the office of the Division of Dockets Management, 
Food and Drug Administration.
    (d) Where appropriate, each proposed regulation establishing a 
standard published in the Federal Register will

[[Page 233]]

include a call for nominations to the advisory committee for that 
particular standard.

[45 FR 7484, Feb. 1, 1980, as amended at 57 FR 58405, Dec. 10, 1992]



PART 862_CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES--
Table of Contents



                      Subpart A_General Provisions

Sec.
862.1 Scope.
862.2 Regulation of calibrators.
862.3 Effective dates of requirement for premarket approval.
862.9 Limitations of exemptions from section 510(k) of the Federal Food, 
          Drug, and Cosmetic Act (the act).

                Subpart B_Clinical Chemistry Test Systems

862.1020 Acid phosphatase (total or prostatic) test system.
862.1025 Adrenocorticotropic hormone (ACTH) test system.
862.1030 Alanine amino transferase (ALT/SGPT) test system.
862.1035 Albumin test system.
862.1040 Aldolase test system.
862.1045 Aldosterone test system.
862.1050 Alkaline phosphatase or isoenzymes test system.
862.1055 Newborn screening test system for amino acids, free carnitine, 
          and acylcarnitines using tandem mass spectrometry.
862.1060 Delta-aminolevulinic acid test system.
862.1065 Ammonia test system.
862.1070 Amylase test system.
862.1075 Androstenedione test system.
862.1080 Androsterone test system.
862.1085 Angiotensin I and renin test system.
862.1090 Angiotensin converting enzyme (A.C.E.) test system.
862.1095 Ascorbic acid test system.
862.1100 Aspartate amino transferase (AST/SGOT) test system.
862.1110 Bilirubin (total or direct) test system.
862.1113 Bilirubin (total and unbound) in the neonate test system.
862.1115 Urinary bilirubin and its conjugates (nonquantitative) test 
          system.
862.1117 B-type natriuretic peptide test system.
862.1118 Biotinidase test system.
862.1120 Blood gases (PCO2PO2) and blood pH test 
          system.
862.1130 Blood volume test system.
862.1135 C-peptides of proinsulin test system.
862.1140 Calcitonin test system.
862.1145 Calcium test system.
862.1150 Calibrator.
862.1155 Human chorionic gonadotropin (HCG) test system.
862.1160 Bicarbonate/carbon dioxide test system.
862.1163 Cardiac allograft gene expression profiling test system.
862.1165 Catecholamines (total) test system.
862.1170 Chloride test system.
862.1175 Cholesterol (total) test system.
862.1177 Cholylglycine test system.
862.1180 Chymotrypsin test system.
862.1185 Compound S (11-deoxycortisol) test system.
862.1187 Conjugated sulfolithocholic acid (SLCG) test system.
862.1190 Copper test system.
862.1195 Corticoids test system.
862.1200 Corticosterone test system.
862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test 
          system.
862.1210 Creatine test system.
862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test 
          system.
862.1220 Acute kidney injury test system.
862.1225 Creatinine test system.
862.1230 Cyclic AMP test system.
862.1235 Cyclosporine test system.
862.1240 Cystine test system.
862.1245 Dehydroepiandrosterone (free and sulfate) test system.
862.1250 Desoxycorticosterone test system.
862.1255 2,3-Diphosphoglyceric acid test system.
862.1260 Estradiol test system.
862.1265 Estriol test system.
862.1270 Estrogens (total, in pregnancy) test system.
862.1275 Estrogens (total, nonpregnancy) test system.
862.1280 Estrone test system.
862.1285 Etiocholanolone test system.
862.1290 Fatty acids test system.
862.1295 Folic acid test system.
862.1300 Follicle-stimulating hormone test system.
862.1305 Formiminoglutamic acid (FIGLU) test system.
862.1310 Galactose test system.
862.1315 Galactose-1-phosphate uridyl transferase test system.
862.1320 Gastric acidity test system.
862.1325 Gastrin test system.
862.1330 Globulin test system.
862.1335 Glucagon test system.
862.1340 Urinary glucose (nonquantitative) test system.
862.1345 Glucose test system.
862.1350 Continuous glucose monitor secondary alarm system.
862.1355 Integrated continuous glucose monitoring system.
862.1356 Interoperable automated glycemic controller.
862.1358 Insulin therapy adjustment device.

[[Page 234]]

862.1360 Gamma-glutamyl transpeptidase and isoenzymes test system.
862.1365 Glutathione test system.
862.1370 Human growth hormone test system.
862.1373 Hemoglobin A1c test system.
862.1375 Histidine test system.
862.1377 Urinary homocystine (nonquantitative) test system.
862.1380 Hydroxybutyric dehydrogenase test system.
862.1385 17-Hydroxycorticosteroids (17-ketogenic steroids) test system.
862.1390 5-Hydroxyindole acetic acid/serotonin test system.
862.1395 17-Hydroxyprogesterone test system.
862.1400 Hydroxyproline test system.
862.1405 Immunoreactive insulin test system.
862.1410 Iron (non-heme) test system.
862.1415 Iron-binding capacity test system.
862.1420 Isocitric dehydrogenase test system.
862.1430 17-Ketosteroids test system.
862.1435 Ketones (nonquantitative) test system.
862.1440 Lactate dehydrogenase test system.
862.1445 Lactate dehydrogenase isoenzymes test system.
862.1450 Lactic acid test system.
862.1455 Lecithin/sphingomyelin ratio in amniotic fluid test system.
862.1460 Leucine aminopeptidase test system.
862.1465 Lipase test system.
862.1470 Lipid (total) test system.
862.1475 Lipoprotein test system.
862.1485 Luteinizing hormone test system.
862.1490 Lysozyme (muramidase) test system.
862.1495 Magnesium test system.
862.1500 Malic dehydrogenase test system.
862.1505 Mucopolysaccharides (nonquantitative) test system.
862.1509 Methylmalonic acid (nonquantitative) test system.
862.1510 Nitrite (nonquantitative) test system.
862.1515 Nitrogen (amino-nitrogen) test system.
862.1520 5'-Nucleotidase test system.
862.1530 Plasma oncometry test system.
862.1535 Ornithine carbamyl transferase test system.
862.1540 Osmolality test system.
862.1542 Oxalate test system.
862.1545 Parathyroid hormone test system.
862.1550 Urinary pH (nonquantitative) test system.
862.1555 Phenylalanine test system.
862.1560 Urinary phenylketones (nonquantitative) test system.
862.1565 6-Phosphogluconate dehydrogenase test system.
862.1570 Phosphohexose isomerase test system.
862.1575 Phospholipid test system.
862.1580 Phosphorus (inorganic) test system.
862.1585 Human placental lactogen test system.
862.1590 Porphobilinogen test system.
862.1595 Porphyrins test system.
862.1600 Potassium test system.
862.1605 Pregnanediol test system.
862.1610 Pregnanetriol test system.
862.1615 Pregnenolone test system.
862.1620 Progesterone test system.
862.1622 Prognostic test for assessment of liver related disease 
          progression.
862.1625 Prolactin (lactogen) test system.
862.1630 Protein (fractionation) test system.
862.1635 Total protein test system.
862.1640 Protein-bound iodine test system.
862.1645 Urinary protein or albumin (nonquantitative) test system.
862.1650 Pyruvate kinase test system.
862.1655 Pyruvic acid test system.
862.1660 Quality control material (assayed and unassayed).
862.1665 Sodium test system.
862.1670 Sorbitol dehydrogenase test system.
862.1675 Blood specimen collection device.
862.1678 Tacrolimus test system.
862.1680 Testosterone test system.
862.1685 Thyroxine-binding globulin test system.
862.1690 Thyroid-stimulating hormone test system.
862.1695 Free thyroxine test system.
862.1700 Total thyroxine test system.
862.1705 Triglyceride test system.
862.1710 Total triiodothyronine test system.
862.1715 Triiodothyronine uptake test system.
862.1720 Triose phosphate isomerase test system.
862.1725 Trypsin test system.
862.1730 Free tyrosine test system.
862.1770 Urea nitrogen test system.
862.1775 Uric acid test system.
862.1780 Urinary calculi (stones) test system.
862.1785 Urinary urobilinogen (nonquantitative) test system.
862.1790 Uroporphyrin test system.
862.1795 Vanilmandelic acid test system.
862.1805 Vitamin A test system.
862.1810 Vitamin B12 test system.
862.1815 Vitamin E test system.
862.1820 Xylose test system.
862.1825 Vitamin D test system.
862.1840 Total 25-hydroxyvitamin D mass spectrometry test system.

                Subpart C_Clinical Laboratory Instruments

862.2050 General purpose laboratory equipment labeled or promoted for a 
          specific medical use.
862.2100 Calculator/data processing module for clinical use.
862.2120 Continuous glucose monitor data management system.

[[Page 235]]

862.2140 Centrifugal chemistry analyzer for clinical use.
862.2150 Continuous flow sequential multiple chemistry analyzer for 
          clinical use.
862.2160 Discrete photometric chemistry analyzer for clinical use.
862.2170 Micro chemistry analyzer for clinical use.
862.2230 Chromatographic separation material for clinical use.
862.2250 Gas liquid chromatography system for clinical use.
862.2260 High pressure liquid chromatography system for clinical use.
862.2265 High throughput genomic sequence analyzer for clinical use.
862.2270 Thin-layer chromatography system for clinical use.
862.2300 Colorimeter, photometer, or spectrophotometer for clinical use.
862.2310 Clinical sample concentrator.
862.2320 Beta or gamma counter for clinical use.
862.2400 Densitometer/scanner (integrating, reflectance, TLC, or 
          radiochromatogram) for clinical use.
862.2485 Electrophoresis apparatus for clinical use.
862.2500 Enzyme analyzer for clinical use.
862.2540 Flame emission photometer for clinical use.
862.2560 Fluorometer for clinical use.
862.2570 Instrumentation for clinical multiplex test systems.
862.2680 Microtitrator for clinical use.
862.2700 Nephelometer for clinical use.
862.2720 Plasma oncometer for clinical use.
862.2730 Osmometer for clinical use.
862.2750 Pipetting and diluting system for clinical use.
862.2800 Refractometer for clinical use.
862.2850 Atomic absorption spectrophotometer for clinical use.
862.2860 Mass spectrometer for clinical use.
862.2900 Automated urinalysis system.
862.2920 Plasma viscometer for clinical use.

               Subpart D_Clinical Toxicology Test Systems

862.3030 Acetaminophen test system.
862.3035 Amikacin test system.
862.3040 Alcohol test system.
862.3050 Breath-alcohol test system.
862.3080 Breath nitric oxide test system.
862.3100 Amphetamine test system.
862.3110 Antimony test system.
862.3120 Arsenic test system.
862.3150 Barbiturate test system.
862.3170 Benzodiazepine test system.
862.3200 Clinical toxicology calibrator.
862.3220 Carbon monoxide test system.
862.3240 Cholinesterase test system.
862.3250 Cocaine and cocaine metabolite test system.
862.3270 Codeine test system.
862.3280 Clinical toxicology control material.
862.3300 Digitoxin test system.
862.3320 Digoxin test system.
862.3350 Diphenylhydantoin test system.
862.3360 Drug metabolizing enzyme genotyping system.
862.3380 Ethosuximide test system.
862.3450 Gentamicin test system.
862.3520 Kanamycin test system.
862.3550 Lead test system.
862.3555 Lidocaine test system.
862.3560 Lithium test system.
862.3580 Lysergic acid diethylamide (LSD) test system.
862.3590 Meprobamate test system.
862.3600 Mercury test system.
862.3610 Methamphetamine test system.
862.3620 Methadone test system.
862.3630 Methaqualone test system.
862.3640 Morphine test system.
862.3645 Neuroleptic drugs radioreceptor assay test system.
862.3650 Opiate test system.
862.3652 Organophosphate test system.
862.3660 Phenobarbital test system.
862.3670 Phenothiazine test system.
862.3680 Primidone test system.
862.3700 Propoxyphene test system.
862.3750 Quinine test system.
862.3800 Reagents for molecular diagnostic instrument test systems.
862.3830 Salicylate test system.
862.3840 Sirolimus test system.
862.3850 Sulfonamide test system.
862.3870 Cannabinoid test system.
862.3880 Theophylline test system.
862.3900 Tobramycin test system.
862.3910 Tricyclic antidepressant drugs test system.
862.3950 Vancomycin test system.

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    Source: 52 FR 16122, May 1, 1987, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 862 appear at 73 FR 
35341, June 23, 2008.



                      Subpart A_General Provisions



Sec. 862.1  Scope.

    (a) This part sets forth the classification of clinical chemistry 
and clinical toxicology devices intended for human use that are in 
commercial distribution.
    (b) The identification of a device in a regulation in this part is 
not a precise description of every device that is, or will be, subject 
to the regulation. A manufacturer who submits a premarket notification 
submission for a device under part 807 cannot show

[[Page 236]]

merely that the device is accurately described by the section title and 
identification provisions of a regulation in this part, but shall state 
why the device is substantially equivalent to other devices, as required 
in Sec. 807.87.
    (c) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21 unless otherwise noted.
    (d) Guidance documents referenced in this part are available on the 
Internet at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/default.htm.

[52 FR 16122, May 1, 1987, as amended at 67 FR 58329, Sept. 16, 2002; 78 
FR 18233, Mar. 26, 2013; 79 FR 50552, Aug. 25, 2014]



Sec. 862.2  Regulation of calibrators.

    Many devices classified in this part are intended to be used with a 
calibrator. A calibrator has a reference value assigned to it which 
serves as the basis by which test results of patients are derived or 
calculated. The calibrator for a device may be (a) manufactured and 
distributed separately from the device with which it is intended to be 
used, (b) manufactured and distributed as one of several device 
components, such as in a kit of reagents, or (c) built-in as an integral 
part of the device. Because of the central role that a calibrator plays 
in the measurement process and the critical effect calibrators have on 
accuracy of test results, elsewhere in this part, all three of these 
types of calibrators (Sec. Sec. 862.1150 and 862.3200 of this part) are 
classified into class II, notwithstanding the classification of the 
device with which it is intended to be used. Thus, a device and its 
calibrator may have different classifications, even if the calibrator is 
built into the device.



Sec. 862.3  Effective dates of requirement for premarket approval.

    A device included in this part that is classified into class III 
(premarket approval) shall not be commercially distributed after the 
date shown in the regulation classifying the device unless the 
manufacturer has an approval under section 515 of the act (unless an 
exemption has been granted under section 520(g)(2) of the act). An 
approval under section 515 of the act consists of FDA's issuance of an 
order approving an application for premarket approval (PMA) for the 
device or declaring completed a product development protocol (PDP) for 
the device.
    (a) Before FDA requires that a device commercially distributed 
before the enactment date of the amendments, or a device that has been 
found substantially equivalent to such a device, has an approval under 
section 515 of the act FDA must promulgate a regulation under section 
515(b) of the act requiring such approval, except as provided in 
paragraph (b) of this section. Such a regulation under section 515(b) of 
the act shall not be effective during the grace period ending on the 
90th day after its promulgation or on the last day of the 30th full 
calendar month after the regulation that classifies the device into 
class III is effective, whichever is later. See section 501(f)(2)(B) of 
the act. Accordingly, unless an effective date of the requirement for 
premarket approval is shown in the regulation for a device classified 
into class III in this part, the device may be commercially distributed 
without FDA's issuance of an order approving a PMA or declaring 
completed a PDP for the device. If FDA promulgates a regulation under 
section 515(b) of the act requiring premarket approval for a device, 
section 501(f)(1)(A) of the act applies to the device.
    (b) Any new, not substantially equivalent, device introduced into 
commercial distribution on or after May 28, 1976, including a device 
formerly marketed that has been substantially altered, is classified by 
statute (section 513(f) of the act) into class III without any grace 
period and FDA must have issued an order approving a PMA or declaring 
completed a PDP for the device before the device is commercially 
distributed unless it is reclassified. If FDA knows that a device being 
commercially distributed may be a ``new'' device as defined in this 
section because of any new intended use or other reasons, FDA may codify 
the statutory classification of the device into class III for such new 
use. Accordingly, the regulation for such a class III device states that 
as of the enactment date of

[[Page 237]]

the amendments, May 28, 1976, the device must have an approval under 
section 515 of the act before commercial distribution.



Sec. 862.9  Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).

    The exemption from the requirement of premarket notification 
(section 510(k) of the act) for a generic type of class I or II device 
is only to the extent that the device has existing or reasonably 
foreseeable characteristics of commercially distributed devices within 
that generic type or, in the case of in vitro diagnostic devices, only 
to the extent that misdiagnosis as a result of using the device would 
not be associated with high morbidity or mortality. Accordingly, 
manufacturers of any commercially distributed class I or II device for 
which FDA has granted an exemption from the requirement of premarket 
notification must still submit a premarket notification to FDA before 
introducing or delivering for introduction into interstate commerce for 
commercial distribution the device when:
    (a) The device is intended for a use different from the intended use 
of a legally marketed device in that generic type of device; e.g., the 
device is intended for a different medical purpose, or the device is 
intended for lay use where the former intended use was by health care 
professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro diagnostic 
device detects or identifies infectious agents by using deoxyribonucleic 
acid (DNA) probe or nucleic acid hybridization technology rather than 
culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of neoplastic 
diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial or acquired 
genetic disorders, including inborn errors of metabolism;
    (3) For measuring an analyte that serves as a surrogate marker for 
screening, diagnosis, or monitoring life-threatening diseases such as 
acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, 
tuberculosis, or myocardial infarction or to monitor therapy;
    (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) or IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is intended 
for use in matrices other than serum or plasma;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).

[65 FR 2304, Jan. 14, 2000]



                Subpart B_Clinical Chemistry Test Systems



Sec. 862.1020  Acid phosphatase (total or prostatic) test system.

    (a) Identification. An acid phosphatase (total or prostatic) test 
system is a device intended to measure the activity of the acid 
phosphatase enzyme in plasma and serum.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019]



Sec. 862.1025  Adrenocorticotropic hormone (ACTH) test system.

    (a) Identification. An adrenocorticotropic hormone (ACTH) test 
system is a device intended to measure adrenocorticotropic hormone in 
plasma and serum. ACTH measurements are used in the differential 
diagnosis and treatment of certain disorders of the adrenal glands such 
as

[[Page 238]]

Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH 
syndrome.
    (b) Classification. Class II.



Sec. 862.1030  Alanine amino transferase (ALT/SGPT) test system.

    (a) Identification. An alanine amino transferase (ALT/SGPT) test 
system is a device intended to measure the activity of the enzyme 
alanine amino transferase (ALT) (also known as a serum glutamic pyruvic 
transaminase or SGPT) in serum and plasma. Alanine amino transferase 
measurements are used in the diagnosis and treatment of certain liver 
diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1035  Albumin test system.

    (a) Identification. An albumin test system is a device intended to 
measure the albumin concentration in serum and plasma. Albumin 
measurements are used in the diagnosis and treatment of numerous 
diseases involving primarily the liver or kidneys.
    (b) Classification. Class II.



Sec. 862.1040  Aldolase test system.

    (a) Identification. An aldolase test system is a device intended to 
measure the activity of the enzyme aldolase in serum or plasma. Aldolase 
measurements are used in the diagnosis and treatment of the early stages 
of acute hepatitis and for certain muscle diseases such as progressive 
Duchenne-type muscular dystrophy.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1045  Aldosterone test system.

    (a) Identification. An aldosterone test system is a device intended 
to measure the hormone aldosterone in serum and urine. Aldosterone 
measurements are used in the diagnosis and treatment of primary 
aldosteronism (a disorder caused by the excessive secretion of 
aldosterone by the adrenal gland), hypertension caused by primary 
aldosteronism, selective hypoaldosteronism, edematous states, and other 
conditions of electrolyte imbalance.
    (b) Classification. Class II.



Sec. 862.1050  Alkaline phosphatase or isoenzymes test system.

    (a) Identification. An alkaline phosphatase or isoenzymes test 
system is a device intended to measure alkaline phosphatase or its 
isoenzymes (a group of enzymes with similar biological activity) in 
serum or plasma. Measurements of alkaline phosphatase or its isoenzymes 
are used in the diagnosis and treatment of liver, bone, parathyroid, and 
intestinal diseases.
    (b) Classification. Class II.



Sec. 862.1055  Newborn screening test system for amino acids, free
carnitine, and acylcarnitines using tandem mass spectrometry.

    (a) Identification. A newborn screening test system for amino acids, 
free carnitine, and acylcarnitines using tandem mass spectrometry is a 
device that consists of stable isotope internal standards, control 
materials, extraction solutions, flow solvents, instrumentation, 
software packages, and other reagents and materials. The device is 
intended for the measurement and evaluation of amino acids, free 
carnitine, and acylcarnitine concentrations from newborn whole blood 
filter paper samples. The quantitative analysis of amino acids, free 
carnitine, and acylcarnitines and their relationship with each other 
provides analyte concentration profiles that may aid in screening 
newborns for one or more inborn errors of amino acid, free carnitine, 
and acyl-carnitine metabolism.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance document entitled ``Class II Special Controls Guidance 
Document: Newborn Screening Test Systems for Amino Acids, Free 
Carnitine, and Acylcarnitines Using Tandem Mass

[[Page 239]]

Spectrometry.'' See Sec. 862.1(d) for the availability of this guidance 
document.

[69 FR 68255, Nov. 24, 2004]



Sec. 862.1060  Delta-aminolevulinic acid test system.

    (a) Identification. A delta-aminolevulinic acid test system is a 
device intended to measure the level of delta-aminolevulinic acid (a 
precursor of porphyrin) in urine. Delta-aminolevulinic acid measurements 
are used in the diagnosis and treatment of lead poisoning and certain 
porphyrias (diseases affecting the liver, gastrointestinal, and nervous 
systems that are accompanied by increased urinary excretion of various 
heme compounds including delta-aminolevulinic acid).
    (b) Classification. Class I (general controls). The device is exempt 
from premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1065  Ammonia test system.

    (a) Identification. An ammonia test system is a device intended to 
measure ammonia levels in blood, serum, and plasma, Ammonia measurements 
are used in the diagnosis and treatment of severe liver disorders, such 
as cirrhosis, hepatitis, and Reye's syndrome.
    (b) Classification. Class I.



Sec. 862.1070  Amylase test system.

    (a) Identification. An amylase test system is a device intended to 
measure the activity of the enzyme amylase in serum and urine. Amylase 
measurements are used primarily for the diagnosis and treatment of 
pancreatitis (inflammation of the pancreas).
    (b) Classification. Class II.



Sec. 862.1075  Androstenedione test system.

    (a) Identification. An androstenedione test system is a device 
intended to measure androstenedione (a substance secreted by the testes, 
ovary, and adrenal glands) in serum. Adrostenedione measurements are 
used in the diagnosis and treatment of females with excessive levels of 
androgen (male sex hormone) production.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1080  Androsterone test system.

    (a) Identification. An androsterone test system is a device intended 
to measure the hormone adrosterone in serum, plasma, and urine. 
Androsterone measurements are used in the diagnosis and treatment of 
gonadal and adrenal diseases.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1085  Angiotensin I and renin test system.

    (a) Identification. An angiotensin I and renin test system is a 
device intended to measure the level of angiotensin I generated by renin 
in plasma. Angiotensin I measurements are used in the diagnosis and 
treatment of certain types of hypertension.
    (b) Classification. Class II.



Sec. 862.1090  Angiotensin converting enzyme (A.C.E.) test system.

    (a) Identification. An angiotensin converting enzyme (A.C.E.) test 
system is a device intended to measure the activity of angiotensin 
converting enzyme in serum and plasma. Measurements obtained by this 
device are used in the diagnosis and treatment of diseases such as 
sarcoidosis, a disease characterized by the formation of nodules in the 
lungs, bones, and skin, and Gaucher's disease, a hereditary disorder 
affecting the spleen.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019]

[[Page 240]]



Sec. 862.1095  Ascorbic acid test system.

    (a) Identification. An ascorbic acid test system is a device 
intended to measure the level of ascorbic acid (vitamin C) in plasma, 
serum, and urine. Ascorbic acid measurements are used in the diagnosis 
and treatment of ascorbic acid dietary deficiencies.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1100  Aspartate amino transferase (AST/SGOT) test system.

    (a) Identification. An aspartate amino transferase (AST/SGOT) test 
system is a device intended to measure the activity of the enzyme 
aspartate amino transferase (AST) (also known as a serum glutamic 
oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino 
transferase measurements are used in the diagnosis and treatment of 
certain types of liver and heart disease.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019]



Sec. 862.1110  Bilirubin (total or direct) test system.

    (a) Identification. A bilirubin (total or direct) test system is a 
device intended to measure the levels of bilirubin (total or direct) in 
plasma or serum. Measurements of the levels of bilirubin, an organic 
compound formed during the normal and abnormal distruction of red blood 
cells, if used in the diagnosis and treatment of liver, hemolytic 
hematological, and metabolic disorders, including hepatitis and gall 
bladder block.
    (b) Classification. Class II.



Sec. 862.1113  Bilirubin (total and unbound) in the neonate test system.

    (a) Identification. A bilirubin (total and unbound) in the neonate 
test system is a device intended to measure the levels of bilirubin 
(total and unbound) in the blood (serum) of newborn infants to aid in 
indicating the risk of bilirubin encephalopathy (kernicterus).
    (b) Classification. Class I.

[54 FR 30206, July 19, 1989]



Sec. 862.1115  Urinary bilirubin and its conjugates (nonquantitative)
test system.

    (a) Identification. A urinary bilirubin and its conjugates 
(nonquantitative) test system is a device intended to measure the levels 
of bilirubin conjugates in urine. Measurements of urinary bilirubin and 
its conjugates (nonquantitative) are used in the diagnosis and treatment 
of certain liver diseases.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1117  B-type natriuretic peptide test system.

    (a) Identification. The B-type natriuretic peptide (BNP) test system 
is an in vitro diagnostic device intended to measure BNP in whole blood 
and plasma. Measurements of BNP are used as an aid in the diagnosis of 
patients with congestive heart failure.
    (b) Classification. Class II (special controls). The special control 
is ``Class II Special Control Guidance Document for B-Type Natriuretic 
Peptide Premarket Notifications; Final Guidance for Industry and FDA 
Reviewers.''

[66 FR 12734, Feb. 28, 2001]



Sec. 862.1118  Biotinidase test system.

    (a) Identification. The biotinidase test system is an in vitro 
diagnostic device intended to measure the activity of the enzyme 
biotinidase in blood. Measurements of biotinidase are used in the 
treatment and diagnosis of biotinidase deficiency, an inborn error of 
metabolism in infants, characterized by the inability to utilize dietary 
protein bound vitamin or to recycle endogenous biotin. The deficiency 
may result in irreversible neurological impairment.

[[Page 241]]

    (b) Classification. Class II (special controls). The special control 
is sale, distribution, and use in accordance with the prescription 
device requirements in Sec. 801.109 of this chapter.

[65 FR 16521, Mar. 29, 2000]



Sec. 862.1120  Blood gases (PCO2, PO2) and blood pH test system.

    (a) Identification. A blood gases (PCO2, PO2) 
and blood pH test system is a device intended to measure certain gases 
in blood, serum, plasma or pH of blood, serum, and plasma. Measurements 
of blood gases (PCO2, PO2) and blood pH are used 
in the diagnosis and treatment of life-threatening acid-base 
disturbances.
    (b) Classification. Class II.



Sec. 862.1130  Blood volume test system.

    (a) Identification. A blood volume test system is a device intended 
to measure the circulating blood volume. Blood volume measurements are 
used in the diagnosis and treatment of shock, hemorrhage, and 
polycythemia vera (a disease characterized by an absolute increase in 
erythrocyte mass and total blood volume).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1135  C-peptides of proinsulin test system.

    (a) Identification. A C-peptides of proinsulin test system is a 
device intended to measure C-peptides of proinsulin levels in serum, 
plasma, and urine. Measurements of C-peptides of proinsulin are used in 
the diagnosis and treatment of patients with abnormal insulin secretion, 
including diabetes mellitus.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1140  Calcitonin test system.

    (a) Identification. A calcitonin test system is a device intended to 
measure the thyroid hormone calcitonin (thyrocalcitonin) levels in 
plasma and serum. Calcitonin measurements are used in the diagnosis and 
treatment of diseases involving the thyroid and parathyroid glands, 
including carcinoma and hyperparathyroidism (excessive activity of the 
parathyroid gland).
    (b) Classification. Class II.



Sec. 862.1145  Calcium test system.

    (a) Identification. A calcium test system is a device intended to 
measure the total calcium level in serum. Calcium measurements are used 
in the diagnosis and treatment of parathyroid disease, a variety of bone 
diseases, chronic renal disease and tetany (intermittent muscular 
contractions or spasms).
    (b) Classification. Class II.



Sec. 862.1150  Calibrator.

    (a) Identification. A calibrator is a device intended for medical 
purposes for use in a test system to establish points of reference that 
are used in the determination of values in the measurement of substances 
in human specimens. (See also Sec. 862.2 in this part.)
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019]



Sec. 862.1155  Human chorionic gonadotropin (HCG) test system.

    (a) Human chorionic gonadotropin (HCG) test system intended for the 
early detection of pregnancy--(1) Identification. A human chorionic 
gonadotropin (HCG) test system is a device intended for the early 
detection of pregnancy is intended to measure HCG, a placental hormone, 
in plasma or urine.
    (2) Classification. Class II.
    (b) Human chorionic gonadotropin (HCG) test system intended for any 
uses other than early detection of pregnancy--(1) Identification. A 
human chorionic

[[Page 242]]

goadotropin (HCG) test system is a device intended for any uses other 
than early detection of pregnancy (such as an aid in the diagnosis, 
prognosis, and management of treatment of persons with certain tumors or 
carcinomas) is intended to measure HCG, a placental hormone, in plasma 
or urine.
    (2) Classification. Class III.
    (3) Date PMA or notice of completion of a PDP is required. As of the 
enactment date of the amendments, May 28, 1976, an approval under 
section 515 of the act is required before the device described in 
paragraph (b)(1) may be commercially distributed. See Sec. 862.3.



Sec. 862.1160  Bicarbonate/carbon dioxide test system.

    (a) Identification. A bicarbonate/carbon dioxide test system is a 
device intended to measure bicarbonate/carbon dioxide in plasma, serum, 
and whole blood. Bicarbonate/carbon dioxide measurements are used in the 
diagnosis and treatment of numerous potentially serious disorders 
associated with changes in body acid-base balance.
    (b) Classification. Class II.



Sec. 862.1163  Cardiac allograft gene expression profiling test system.

    (a) Identification. A cardiac allograft gene expression profiling 
test system is a device that measures the ribonucleic acid (RNA) 
expression level of multiple genes and combines this information to 
yield a signature (pattern, classifier, index, score) to aid in the 
identification of a low probability of acute cellular rejection (ACR) in 
heart transplant recipients with stable allograft function.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance document entitled ``Class II Special Controls Guidance 
Document: Cardiac Allograft Gene Expression Profiling Test Systems.'' 
See Sec. 862.1(d) for the availability of this guidance document.

[74 FR 53885, Oct. 21, 2009]



Sec. 862.1165  Catecholamines (total) test system.

    (a) Identification. A catecholamines (total) test system is a device 
intended to determine whether a group of similar compounds (epinephrine, 
norepinephrine, and dopamine) are present in urine and plasma. 
Catecholamine determinations are used in the diagnosis and treatment of 
adrenal medulla and hypertensive disorders, and for catecholamine-
secreting tumors (pheochromo-cytoma, neuroblastoma, ganglioneuroma, and 
retinoblastoma).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1170  Chloride test system.

    (a) Identification. A chloride test system is a device intended to 
measure the level of chloride in plasma, serum, sweat, and urine. 
Chloride measurements are used in the diagnosis and treatment of 
electrolyte and metabolic disorders such as cystic fibrosis and diabetic 
acidosis.
    (b) Classification. Class II.



Sec. 862.1175  Cholesterol (total) test system.

    (a) Identification. A cholesterol (total) test system is a device 
intended to measure cholesterol in plasma and serum. Cholesterol 
measurements are used in the diagnosis and treatment of disorders 
involving excess cholesterol in the blood and lipid and lipoprotein 
metabolism disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1177  Cholylglycine test system.

    (a) Identification. A cholylglycine test system is a device intended 
to measure the bile acid cholylglycine in serum. Measurements obtained 
by this device are used in the diagnosis and treatment of liver 
disorders, such as cirrhosis or obstructive liver disease.
    (b) Classification. Class II.

[[Page 243]]



Sec. 862.1180  Chymotrypsin test system.

    (a) Identification. A chymotrypsin test system is a device intended 
to measure the activity of the enzyme chymotrypsin in blood and other 
body fluids and in feces. Chymotrypsin measurements are used in the 
diagnosis and treatment of pancreatic exocrine insufficiency.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1185  Compound S (11-deoxycortisol) test system.

    (a) Identification. A compound S (11-dioxycortisol) test system is a 
device intended to measure the level of compound S (11-dioxycortisol) in 
plasma. Compound S is a steroid intermediate in the biosynthesis of the 
adrenal hormone cortisol. Measurements of compound S are used in the 
diagnosis and treatment of certain adrenal and pituitary gland disorders 
resulting in clinical symptoms of masculinization and hypertension.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1187  Conjugated sulfolithocholic acid (SLCG) test system.

    (a) Identification. A conjugated sulfolithocholic acid (SLCG) test 
system is a device intended to measure the bile acid SLCG in serum. 
Measurements obtained by this device are used in the diagnosis and 
treatment of liver disorders, such as cirrhosis or obstructive liver 
disease.
    (b) Classification. Class II.



Sec. 862.1190  Copper test system.

    (a) Identification. A copper test system is a device intended to 
measure copper levels in plasma, serum, and urine. Measurements of 
copper are used in the diagnosis and treatment of anemia, infections, 
inflammations, and Wilson's disease (a hereditary disease primarily of 
the liver and nervous system). Test results are also used in monitoring 
patients with Hodgkin's disease (a disease primarily of the lymph 
system).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 
FR 38787, July 25, 2001]



Sec. 862.1195  Corticoids test system.

    (a) Identification. A corticoids test system is a device intended to 
measure the levels of corticoids (hormones of the adrenal cortex) in 
serum and p lasma. Measurements of corticoids are used in the diagnosis 
and treatment of disorders of the cortex of the adrenal glands, 
especially those associated with hypertension and electrolyte 
disturbances.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1200  Corticosterone test system.

    (a) Identification. A corticosterone test system is a device 
intended to measure corticosterone (a steroid secreted by the adrenal 
gland) levels in plasma. Measurements of corticosterone are used in the 
diagnosis and treatment of adrenal disorders such as adrenal cortex 
disorders and blocks in cortisol synthesis.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1205  Cortisol (hydrocortisone and hydroxycorticosterone) test system.

    (a) Identification. A cortisol (hydrocortisone and 
hydroxycorticosterone) test system is a device intended to

[[Page 244]]

measure the cortisol hormones secreted by the adrenal gland in plasma 
and urine. Measurements of cortisol are used in the diagnosis and 
treatment of disorders of the adrenal gland.
    (b) Classification. Class II.



Sec. 862.1210  Creatine test system.

    (a) Identification. A creatine test system is a device intended to 
measure creatine (a substance synthesized in the liver and pancreas and 
found in biological fluids) in plasma, serum, and urine. Measurements of 
creatine are used in the diagnosis and treatment of muscle diseases and 
endocrine disorders including hyperthyroidism.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 
FR 38787, July 25, 2001]



Sec. 862.1215  Creatine phosphokinase/creatine kinase or isoenzymes test system.

    (a) Identification. A creatine phosphokinase/creatine kinase or 
isoenzymes test system is a device intended to measure the activity of 
the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes 
with similar biological activity) in plasma and serum. Measurements of 
creatine phosphokinase and its isoenzymes are used in the diagnosis and 
treatment of myocardial infarction and muscle diseases such as 
progressive, Duchenne-type muscular dystrophy.
    (b) Classification. Class II.



Sec. 862.1220  Acute kidney injury test system.

    (a) Identification. An acute kidney injury test system is a device 
that is intended to measure one or more analytes in human samples as an 
aid in the assessment of a patient's risk for developing acute kidney 
injury. Test results are intended to be used in conjunction with other 
clinical and diagnostic findings, consistent with professional standards 
of practice, including confirmation by alternative methods.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Premarket notification submissions must detail an appropriate 
end user device training program that will be offered while marketing 
the device as part of your efforts to mitigate the risk of incorrect 
interpretation of test results.
    (2) As part of the risk management activities performed as part of 
your 21 CFR 820.30 design controls, you must document the appropriate 
end user device training program provided in your premarket notification 
submission to satisfy special control 21 CFR 862.1220(b)(1) that will be 
offered while marketing the device as part of your efforts to mitigate 
the risk of incorrect interpretation of test results.
    (3) Robust clinical data demonstrating the positive predictive 
value, negative predictive value, sensitivity and specificity of the 
test in the intended use population must be submitted as part of the 
premarket notification submission.

[82 FR 50072, Oct. 30, 2017]



Sec. 862.1225  Creatinine test system.

    (a) Identification. A creatinine test system is a device intended to 
measure creatinine levels in plasma and urine. Creatinine measurements 
are used in the diagnosis and treatment of renal diseases, in monitoring 
renal dialysis, and as a calculation basis for measuring other urine 
analytes.
    (b) Classification. Class II.



Sec. 862.1230  Cyclic AMP test system.

    (a) Identification. A cyclic AMP test system is a device intended to 
measure the level of adenosine 3', 5'-monophosphate (cyclic AMP) in 
plasma, urine, and other body fluids. Cyclic AMP measurements are used 
in the diagnosis and treatment of endocrine disorders, including 
hyperparathyroidism (overactivity of the parathyroid gland). Cyclic AMP 
measurements may also be used in the diagnosis and treatment of Graves' 
disease (a disorder of the thyroid) and in the differentiation of causes 
of hypercalcemia (elevated levels of serum calcium.)
    (b) Classification. Class II.

[[Page 245]]



Sec. 862.1235  Cyclosporine test system.

    (a) Identification. A cyclosporine test system is a device intended 
to quantitatively determine cyclosporine concentrations as an aid in the 
management of transplant patients receiving therapy with this drug. This 
generic type of device includes immunoassays and chromatographic assays 
for cyclosporine.
    (b) Classification. Class II (special controls). The special control 
is ``Class II Special Controls Guidance Document: Cyclosporine and 
Tacrolimus Assays; Guidance for Industry and FDA.'' See Sec. 862.1(d) 
for the availability of this guidance document.

[67 FR 58329, Sept. 16, 2002]



Sec. 862.1240  Cystine test system.

    (a) Identification. A cystine test system is a device intended to 
measure the amino acid cystine in urine. Cystine measurements are used 
in the diagnosis of cystinuria (occurrence of cystine in urine). 
Patients with cystinuria frequently develop kidney calculi (stones).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]



Sec. 862.1245  Dehydroepiandrosterone (free and sulfate) test system.

    (a) Identification. A dehydroepiandrosterone (free and sulfate) test 
system is a device intended to measure dehydroepiandrosterone (DHEA) and 
its sulfate in urine, serum, plasma, and amniotic fluid. 
Dehydroepiandrosterone measurements are used in the diagnosis and 
treatment of DHEA-secreting adrenal carcinomas.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1250  Desoxycorticosterone test system.

    (a) Identification. A desoxycorticosterone test system is a device 
intended to measure desoxycorticosterone (DOC) in plasma and urine. DOC 
measurements are used in the diagnosis and treatment of patients with 
hypermineralocorticoidism (excess retention of sodium and loss of 
potassium) and other disorders of the adrenal gland.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1255  2,3-Diphosphoglyceric acid test system.

    (a) Identification. A 2,3-diphosphoglyceric acid test system is a 
device intended to measure 2,3-diphosphoglyceric acid (2,3-DPG) in 
erythrocytes (red blood cells). Measurements of 2,3-diphosphoglyceric 
acid are used in the diagnosis and treatment of blood disorders that 
affect the delivery of oxygen by erythrocytes to tissues and in 
monitoring the quality of stored blood.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 
FR 38787, July 25, 2001]



Sec. 862.1260  Estradiol test system.

    (a) Identification. An estradiol test system is a device intended to 
measure estradiol, an estrogenic steroid, in plasma. Estradiol 
measurements are used in the diagnosis and treatment of various hormonal 
sexual disorders and in assessing placental function in complicated 
pregnancy.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]

[[Page 246]]



Sec. 862.1265  Estriol test system.

    (a) Identification. An estriol test system is a device intended to 
measure estriol, an estrogenic steroid, in plasma, serum, and urine of 
pregnant females. Estriol measurements are used in the diagnosis and 
treatment of fetoplacental distress in certain cases of high-risk 
pregnancy.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1270  Estrogens (total, in pregnancy) test system.

    (a) Identification. As estrogens (total, in pregnancy) test system 
is a device intended to measure total estrogens in plasma, serum, and 
urine during pregnancy. The device primarily measures estrone plus 
estradiol. Measurements of total estrogens are used to aid in the 
diagnosis and treatment of fetoplacental distress in certain cases of 
high-risk pregnancy.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1275  Estrogens (total, nonpregnancy) test system.

    (a) Identification. As estrogens (total, nonpregnancy) test system 
is a device intended to measure the level of estrogens (total estrone, 
estradiol, and estriol) in plasma, serum, and urine of males and 
nonpregnant females. Measurement of estrogens (total, nonpregnancy) is 
used in the diagnosis and treatment of numerous disorders, including 
infertility, amenorrhea (absence of menses) differentiation of primary 
and secondary ovarian malfunction, estrogen secreting testicular and 
ovarian tumors, and precocious puberty in females.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1280  Estrone test system.

    (a) Identification. An estrone test system is a device intended to 
measure estrone, an estrogenic steroid, in plasma. Estrone measurements 
are used in the diagnosis and treatment of numerous disorders, including 
infertility, amenorrhea, differentiation of primary and secondary 
ovarian malfunction, estrogen secreting testicular and ovarian tumors, 
and precocious puberty in females.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1285  Etiocholanolone test system.

    (a) Identification. An etiocholanolone test system is a device 
intended to measure etiocholanolone in serum and urine. Etiocholanolone 
is a metabolic product of the hormone testosterone and is excreted in 
the urine. Etiocholanolone measurements are used in the diagnosis and 
treatment of disorders of the testes and ovaries.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1290  Fatty acids test system.

    (a) Identification. A fatty acids test system is a device intended 
to measure fatty acids in plasma and serum. Measurements of fatty acids 
are used in the diagnosis and treatment of various disorders of lipid 
metabolism.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 
FR 38787, July 25, 2001]

[[Page 247]]



Sec. 862.1295  Folic acid test system.

    (a) Identification. A folic acid test system is a device intended to 
measure the vitamin folic acid in plasma and serum. Folic acid 
measurements are used in the diagnosis and treatment of megaloblastic 
anemia, which is characterized by the presence of megaloblasts (an 
abnormal red blood cell series) in the bone marrow.
    (b) Classification. Class II.

[52 FR 16122, May 1, 1987; 53 FR 11645, Apr. 8, 1988]



Sec. 862.1300  Follicle-stimulating hormone test system.

    (a) Identification. A follicle-stimulating hormone test system is a 
device intended to measure follicle-stimulating hormone (FSH) in plasma, 
serum, and urine. FSH measurements are used in the diagnosis and 
treatment of pituitary gland and gonadal disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1305  Formiminoglutamic acid (FIGLU) test system.

    (a) Identification. A formiminoglutamic acid (FIGLU) test system is 
a device intended to measure formiminolutamic acid in urine. FIGLU 
measurements obtained by this device are used in the diagnosis of 
anemias, such as pernicious anemia and congenital hemolytic anemia.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 
FR 38787, July 25, 2001]



Sec. 862.1310  Galactose test system.

    (a) Identification. A galactose test system is a device intended to 
measure galactose in blood and urine. Galactose measurements are used in 
the diagnosis and treatment of the hereditary disease galactosemia (a 
disorder of galactose metabolism) in infants.
    (b) Classification. Class I.



Sec. 862.1315  Galactose-1-phosphate uridyl transferase test system.

    (a) Identification. A galactose-1-phosphate uridyl transferase test 
system is a device intended to measure the activity of the enzyme 
galactose-1-phosphate uridyl transferase in erythrocytes (red blood 
cells). Measurements of galactose-1-phosphate uridyl transferase are 
used in the diagnosis and treatment of the hereditary disease 
galactosemia (disorder of galactose metabolism) in infants.
    (b) Classification. Class II.



Sec. 862.1320  Gastric acidity test system.

    (a) Identification. A gastric acidity test system is a device 
intended to measure the acidity of gastric fluid. Measurements of 
gastric acidity are used in the diagnosis and treatment of patients with 
peptic ulcer, Zollinger-Ellison syndrome (peptic ulcer due to gastrin-
secreting tumor of the pancreas), and related gastric disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 
FR 38787, July 25, 2001]



Sec. 862.1325  Gastrin test system.

    (a) Identification. A gastrin test system is a device intended to 
measure the hormone gastrin in plasma and serum. Measurements of gastrin 
are used in the diagnosis and treatment of patients with ulcers, 
pernicious anemia, and the Zollinger-Ellison syndrome (peptic ulcer due 
to a gastrin-secreting tumor of the pancreas).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]

[[Page 248]]



Sec. 862.1330  Globulin test system.

    (a) Identification. A globulin test system is a device intended to 
measure globulins (proteins) in plasma and serum. Measurements of 
globulin are used in the diagnosis and treatment of patients with 
numerous illnesses including severe liver and renal disease, multiple 
myeloma, and other disorders of blood globulins.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1335  Glucagon test system.

    (a) Identification. A glucagon test system is a device intended to 
measure the pancreatic hormone glucagon in plasma and serum. Glucagon 
measurements are used in the diagnosis and treatment of patients with 
various disorders of carbohydrate metabolism, including diabetes 
mellitus, hypoglycemia, and hyperglycemia.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1340  Urinary glucose (nonquantitative) test system.

    (a) Identification. A urinary glucose (nonquantitative) test system 
is a device intended to measure glucosuria (glucose in urine). Urinary 
glucose (nonquantitative) measurements are used in the diagnosis and 
treatment of carbohydrate metabolism disorders including diabetes 
mellitus, hypoglycemia, and hyperglycemia.
    (b) Classification. Class II.



Sec. 862.1345  Glucose test system.

    (a) Identification. A glucose test system is a device intended to 
measure glucose quantitatively in blood and other body fluids. Glucose 
measurements are used in the diagnosis and treatment of carbohydrate 
metabolism disorders including diabetes mellitus, neonatal hypoglycemia, 
and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
    (b) Classification. Class II (special controls). The device, when it 
is solely intended for use as a drink to test glucose tolerance, is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019; 85 
FR 18445, Apr. 2, 2020]



Sec. 862.1350  Continuous glucose monitor secondary alarm system.

    (a) Identification. A continuous glucose monitor (CGM) secondary 
alarm system is identified as a device intended to be used as a 
secondary alarm for a CGM to enable immediate awareness for potential 
clinical intervention to help assure patient safety.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 862.9. The 
special controls for this device are:
    (1) Devices being marketed must include appropriate measures to 
protect against unauthorized access to data and unauthorized 
modification of data.
    (2) The labeling must prominently and conspicuously display a 
warning that states ``Dosing decisions should not be made based on this 
device. The user should follow instructions on the continuous glucose 
monitoring system.''
    (3) The labeling for the device must include a statement that reads 
``This device is not intended to replace self-monitoring practices as 
advised by a physician.''

[82 FR 13550, Mar. 14, 2017, as amended at 84 FR 71796, Dec. 30, 2019; 
86 FR 20283, Apr. 19, 2021]



Sec. 862.1355  Integrated continuous glucose monitoring system.

    (a) Identification. An integrated continuous glucose monitoring 
system (iCGM) is intended to automatically measure glucose in bodily 
fluids continuously or frequently for a specified period of time. iCGM 
systems are designed to reliably and securely transmit glucose 
measurement data to digitally connected devices, including

[[Page 249]]

automated insulin dosing systems, and are intended to be used alone or 
in conjunction with these digitally connected medical devices for the 
purpose of managing a disease or condition related to glycemic control.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Design verification and validation must include the following:
    (i) Robust clinical data demonstrating the accuracy of the device in 
the intended use population.
    (ii) The clinical data must include a comparison between iCGM values 
and blood glucose values in specimens collected in parallel that are 
measured on an FDA-accepted laboratory-based glucose measurement method 
that is precise and accurate, and that is traceable to a higher order 
(e.g., an internationally recognized reference material and/or method).
    (iii) The clinical data must be obtained from a clinical study 
designed to fully represent the performance of the device throughout the 
intended use population and throughout the measuring range of the 
device.
    (iv) Clinical study results must demonstrate consistent analytical 
and clinical performance throughout the sensor wear period.
    (v) Clinical study results in the adult population must meet the 
following performance requirements:
    (A) For all iCGM measurements less than 70 milligrams/deciliter (mg/
dL), the percentage of iCGM measurements within 15 
mg/dL of the corresponding blood glucose value must be calculated, and 
the lower one-sided 95 percent confidence bound must exceed 85 percent.
    (B) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the 
percentage of iCGM measurements within 15 percent 
of the corresponding blood glucose value must be calculated, and the 
lower one-sided 95 percent confidence bound must exceed 70 percent.
    (C) For all iCGM measurements greater than 180 mg/dL, the percentage 
of iCGM measurements within 15 percent of the 
corresponding blood glucose value must be calculated, and the lower one-
sided 95 percent confidence bound must exceed 80 percent.
    (D) For all iCGM measurements less than 70 mg/dL, the percentage of 
iCGM measurements within 40 mg/dL of the 
corresponding blood glucose value must be calculated, and the lower one-
sided 95 percent confidence bound must exceed 98 percent.
    (E) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the 
percentage of iCGM measurements within 40 percent 
of the corresponding blood glucose value must be calculated, and the 
lower one-sided 95 percent confidence bound must exceed 99 percent.
    (F) For all iCGM measurements greater than180 mg/dL, the percentage 
of iCGM measurements within 40 percent of the 
corresponding blood glucose value must be calculated, and the lower one-
sided 95 percent confidence bound must exceed 99 percent.
    (G) Throughout the device measuring range, the percentage of iCGM 
measurements within 20 percent of the 
corresponding blood glucose value must be calculated, and the lower one-
sided 95 percent confidence bound must exceed 87 percent.
    (H) When iCGM values are less than 70 mg/dL, no corresponding blood 
glucose value shall read above 180 mg/dL.
    (I) When iCGM values are greater than 180 mg/dL, no corresponding 
blood glucose value shall read less than 70 mg/dL.
    (J) There shall be no more than 1 percent of iCGM measurements that 
indicate a positive glucose rate of change greater than 1 mg/dL per 
minute (/min) when the corresponding true negative glucose rate of 
change is less than -2 mg/dL/min as determined by the corresponding 
blood glucose measurements.
    (K) There shall be no more than 1 percent of iCGM measurements that 
indicate a negative glucose rate of change less than -1 mg/dL/min when 
the corresponding true positive glucose rate of change is greater than 2 
mg/dL/min as determined by the corresponding blood glucose measurements.
    (vi) Data demonstrating similar accuracy and rate of change 
performance of the iCGM in the pediatric population as compared to that 
in the adult population, or alternatively a clinical and/

[[Page 250]]

or technical justification for why pediatric data are not needed, must 
be provided and determined by FDA to be acceptable and appropriate.
    (vii) Data must demonstrate that throughout the claimed sensor life, 
the device does not allow clinically significant gaps in sensor data 
availability that would prevent any digitally connected devices from 
achieving their intended use.
    (2) Design verification and validation must include a detailed 
strategy to ensure secure and reliable means of iCGM data transmission 
to provide real-time glucose readings at clinically meaningful time 
intervals to devices intended to receive the iCGM glucose data.
    (3) Design verification and validation must include adequate 
controls established during manufacturing and at product release to 
ensure the released product meets the performance specifications as 
defined in paragraphs (b)(1) and (b)(2) of this section.
    (4) The device must demonstrate clinically acceptable performance in 
the presence of clinically relevant levels of potential interfering 
substances that are reasonably present in the intended use population, 
including but not limited to endogenous substances and metabolites, 
foods, dietary supplements, and medications.
    (5) The device must include appropriate measures to ensure that 
disposable sensors cannot be used beyond its claimed sensor wear period.
    (6) Design verification and validation must include results obtained 
through a usability study that demonstrates that the intended user can 
use the device safely and obtain the expected glucose measurement 
accuracy.
    (7) The labeling required under Sec. 809.10(b) of this chapter must 
include a separate description of the following sensor performance data 
observed in the clinical study performed in conformance with paragraph 
(b)(1) of this section for each intended use population, in addition to 
separate sensor performance data for each different iCGM insertion or 
use sites (e.g., abdomen, arm, buttock):
    (i) A description of the accuracy in the following blood glucose 
concentration ranges: less than 54 mg/dL, 54 mg/dL to less than 70 mg/
dL, 70 to 180 mg/dL, greater than 180 to 250 mg/dL, and greater than 250 
mg/dL.
    (ii) A description of the accuracy of positive and negative rate of 
change data.
    (iii) A description of the frequency and duration of gaps in sensor 
data.
    (iv) A description of the true, false, missed, and correct alert 
rates and a description of the available glucose concentration alert 
settings, if applicable.
    (v) A description of the observed duration of iCGM life for the 
device.

[87 FR 9238, Feb. 18, 2022]



Sec. 862.1356  Interoperable automated glycemic controller.

    (a) Identification. An interoperable automated glycemic controller 
is a device intended to automatically calculate drug doses based on 
inputs such as glucose and other relevant physiological parameters, and 
to command the delivery of such drug doses from a connected infusion 
pump. Interoperable automated glycemic controllers are designed to 
reliably and securely communicate with digitally connected devices to 
allow drug delivery commands to be sent, received, executed, and 
confirmed. Interoperable automated glycemic controllers are intended to 
be used in conjunction with digitally connected devices for the purpose 
of maintaining glycemic control.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Design verification and validation must include:
    (i) An appropriate, as determined by FDA, clinical implementation 
strategy, including data demonstrating appropriate, as determined by 
FDA, clinical performance of the device for its intended use, including 
all of its indications for use.
    (A) The clinical data must be representative of the performance of 
the device in the intended use population and in clinically relevant use 
scenarios and sufficient to demonstrate appropriate, as determined by 
FDA, clinical performance of the device for its intended use, including 
all of its indications for use.
    (B) For devices indicated for use with multiple therapeutic agents 
for the

[[Page 251]]

same therapeutic effect (e.g., more than one type of insulin), data 
demonstrating performance with each product or, alternatively, an 
appropriate, as determined by FDA, clinical justification for why such 
data are not needed.
    (C) When determined to be necessary by FDA, the strategy must 
include postmarket data collection to confirm safe real-world use and 
monitor for rare adverse events.
    (ii) Results obtained through a human factors study that 
demonstrates that an intended user can safely use the device for its 
intended use.
    (iii) A detailed and appropriate, as determined by FDA, strategy to 
ensure secure and reliable means of data transmission with other 
intended connected devices.
    (iv) Specifications that are appropriate, as determined by FDA, for 
connected devices that shall be eligible to provide input to (e.g., 
specification of glucose sensor performance) or accept commands from 
(e.g., specifications for drug infusion pump performance) the 
controller, and a detailed strategy for ensuring that connected devices 
meet these specifications.
    (v) Specifications for devices responsible for hosting the 
controller, and a detailed and appropriate, as determined by FDA, 
strategy for ensuring that the specifications are met by the hosting 
devices.
    (vi) Documentation demonstrating that appropriate, as determined by 
FDA, measures are in place (e.g., validated device design features) to 
ensure that safe therapy is maintained when communication with digitally 
connected devices is interrupted, lost, or re-established after an 
interruption. Validation testing results must demonstrate that critical 
events that occur during a loss of communications (e.g., commands, 
device malfunctions, occlusions, etc.) are handled and logged 
appropriately during and after the interruption to maintain patient 
safety.
    (vii) A detailed plan and procedure for assigning postmarket 
responsibilities including adverse event reporting, complaint handling, 
and investigations with the manufacturers of devices that are digitally 
connected to the controller.
    (2) Design verification and validation documentation must include 
appropriate design inputs and design outputs that are essential for the 
proper functioning of the device that have been documented and include 
the following:
    (i) Risk control measures to address device system hazards;
    (ii) Design decisions related to how the risk control measures 
impact essential performance; and
    (iii) A traceability analysis demonstrating that all hazards are 
adequately controlled and that all controls have been validated in the 
final device design.
    (3) The device shall include appropriate, as determined by FDA, and 
validated interface specifications for digitally connected devices. 
These interface specifications shall, at a minimum, provide for the 
following:
    (i) Secure authentication (pairing) to connected devices;
    (ii) Secure, accurate, and reliable means of data transmission 
between the controller and connected devices;
    (iii) Sharing of necessary state information between the controller 
and any connected devices (e.g., battery level, reservoir level, sensor 
use life, pump status, error conditions);
    (iv) Ensuring that the controller continues to operate safely when 
data is received in a manner outside the bounds of the parameters 
specified;
    (v) A detailed process and procedures for sharing the controller's 
interface specification with connected devices and for validating the 
correct implementation of that protocol; and
    (vi) A mechanism for updating the controller software, including any 
software that is required for operation of the controller in a manner 
that ensures its safety and performance.
    (4) The device design must ensure that a record of critical events 
is stored and accessible for an adequate period to allow for auditing of 
communications between digitally connected devices, and to facilitate 
the sharing of pertinent information with the responsible parties for 
those connected devices. Critical events to be stored by the controller 
must, at a minimum, include:

[[Page 252]]

    (i) Commands issued by the controller, and associated confirmations 
the controller receives from digitally connected devices;
    (ii) Malfunctions of the controller and malfunctions reported to the 
controller by digitally connected devices (e.g., infusion pump 
occlusion, glucose sensor shut down);
    (iii) Alarms and alerts and associated acknowledgements from the 
controller as well as those reported to the controller by digitally 
connected devices; and
    (iv) Connectivity events (e.g., establishment or loss of 
communications).
    (5) The device must only receive glucose input from devices cleared 
under Sec. 862.1355 (integrated continuous glucose monitoring system), 
unless FDA determines an alternate type of glucose input device is 
designed appropriately to allow the controller to meet the special 
controls contained within this section.
    (6) The device must only command drug delivery from devices cleared 
under Sec. 880.5730 of this chapter (alternate controller enabled 
infusion pump), unless FDA determines an alternate type of drug infusion 
pump device is designed appropriately to allow the controller to meet 
the special controls contained within this section.
    (7) An appropriate, as determined by FDA, training plan must be 
established for users and healthcare providers to assure the safety and 
performance of the device when used. This may include, but not be 
limited to, training on device contraindications, situations in which 
the device should not be used, notable differences in device 
functionality or features compared to similar alternative therapies, and 
information to help prescribers identify suitable candidate patients, as 
applicable.
    (8) The labeling required under Sec. 809.10(b) of this chapter must 
include:
    (i) A contraindication for use in pediatric populations except to 
the extent clinical performance data or other available information 
demonstrates that it can be safely used in pediatric populations in 
whole or in part.
    (ii) A prominent statement identifying any populations for which use 
of this device has been determined to be unsafe.
    (iii) A prominent statement identifying by name the therapeutic 
agents that are compatible with the controller, including their identity 
and concentration, as appropriate.
    (iv) The identity of those digitally connected devices with which 
the controller can be used, including descriptions of the specific 
system configurations that can be used, per the detailed strategy 
submitted under paragraph (b)(1)(iii) of this section.
    (v) A comprehensive description of representative clinical 
performance in the hands of the intended user, including information 
specific to use in the pediatric use population, as appropriate.
    (vi) A comprehensive description of safety of the device, including, 
for example, the incidence of severe hypoglycemia, diabetic 
ketoacidosis, and other relevant adverse events observed in a study 
conducted to satisfy paragraph (b)(1)(i) of this section.
    (vii) For wireless connection enabled devices, a description of the 
wireless quality of service required for proper use of the device.
    (viii) For any controller with hardware components intended for 
multiple patient reuse, instructions for safely reprocessing the 
hardware components between uses.

[87 FR 14172, Mar. 14, 2022]



Sec. 862.1358  Insulin therapy adjustment device.

    (a) Identification. An insulin therapy adjustment device is a device 
intended to incorporate biological inputs, including glucose measurement 
data from a continuous glucose monitor, to recommend insulin therapy 
adjustments as an aid in optimizing insulin therapy regimens for 
patients with diabetes mellitus.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Design verification and validation must include the following:
    (i) A complete description of the required data inputs, including 
timeframe over which data inputs must be collected and number of data 
points required for accurate recommendations;

[[Page 253]]

    (ii) A complete description of the types of device outputs and 
insulin therapy adjustment recommendations, including how the 
recommendations are generated;
    (iii) Robust data demonstrating the clinical validity of the device 
outputs and insulin therapy recommendations;
    (iv) A robust assessment of all input data specifications, including 
accuracy requirements for continuous glucose monitors and other devices 
generating data inputs, to ensure accurate and reliable therapy 
adjustment recommendations. This assessment must include adequate 
clinical justification for each specification;
    (v) A detailed strategy to ensure secure and reliable means of data 
transmission to and from the device, including data integrity checks, 
accuracy checks, reliability checks, and security measures;
    (vi) Robust data demonstrating that users can understand and 
appropriately interpret recommendations generated by the device; and
    (vii) An appropriate mitigation strategy to minimize the occurrence 
of dosing recommendation errors, and to mitigate the risk to patients of 
any residual dosing recommendation errors to a clinically acceptable 
level.
    (2) The device must not be intended for use in implementing 
automated insulin dosing.
    (3) Your 21 CFR 809.10(b) labeling must include:
    (i) The identification of specific insulin formulations that have 
been demonstrated to be compatible with use of the device;
    (ii) A detailed description of the specifications of compatible 
devices that provide acceptable input data (e.g., continuous glucose 
monitors, insulin pumps) used to provide accurate and reliable therapy 
adjustment recommendations;
    (iii) A detailed description of all types of required data (inputs) 
and dosing recommendations (outputs) that are provided by the device; 
and
    (iv) A description of device limitations, and instructions to 
prevent possible disruption of accurate therapy adjustment 
recommendations (e.g., time zone changes due to travel).

[83 FR 54874, Nov. 1, 2018]



Sec. 862.1360  Gamma-glutamyl transpeptidase and isoenzymes test system.

    (a) Identification. A gamma-glutamyl transpeptidase and isoenzymes 
test system is a device intended to measure the activity of the enzyme 
gamma-glutamyl transpeptidase (GGTP) in plasma and serum. Gamma-glutamyl 
transpeptidase and isoenzymes measurements are used in the diagnosis and 
treatment of liver diseases such as alcoholic cirrhosis and primary and 
secondary liver tumors.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1365  Glutathione test system.

    (a) Identification. A glutathione test system is a device intended 
to measure glutathione (the tripeptide of glycine, cysteine, and 
glutamic acid) in erythrocytes (red blood cells). Glutathione 
measurements are used in the diagnosis and treatment of certain drug-
induced hemolytic (erythrocyte destroying) anemias due to an inherited 
enzyme deficiency.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 
FR 38787, July 25, 2001]



Sec. 862.1370  Human growth hormone test system.

    (a) Identification. A human growth hormone test system is a device 
intended to measure the levels of human growth hormone in plasma. Human 
growth hormone measurements are used in the diagnosis and treatment of 
disorders involving the anterior lobe of the pituitary gland.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 254]]

subpart E of part 807 of this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1373  Hemoglobin A1c test system.

    (a) Identification. A hemoglobin A1c test system is a device used to 
measure the percentage concentration of hemoglobin A1c in blood. 
Measurement of hemoglobin A1c is used as an aid in the diagnosis of 
diabetes mellitus and as an aid in the identification of patients at 
risk for developing diabetes mellitus.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The device must have initial and annual standardization 
verification by a certifying glycohemoglobin standardization 
organization deemed acceptable by FDA.
    (2) The premarket notification submission must include performance 
testing to evaluate precision, accuracy, linearity, and interference, 
including the following:
    (i) Performance testing of device precision must, at a minimum, use 
blood samples with concentrations near 5.0 percent, 6.5 percent, 8.0 
percent, and 12 percent hemoglobin A1c. This testing must evaluate 
precision over a minimum of 20 days using at least three lots of the 
device and three instruments, as applicable.
    (ii) Performance testing of device accuracy must include a minimum 
of 120 blood samples that span the measuring interval of the device and 
compare results of the new device to results of a standardized test 
method. Results must demonstrate little or no bias versus the 
standardized method.
    (iii) Total error of the new device must be evaluated using single 
measurements by the new device compared to results of the standardized 
test method, and this evaluation must demonstrate a total error less 
than or equal to 6 percent.
    (iv) Performance testing must demonstrate that there is little to no 
interference from common hemoglobin variants, including Hemoglobin C, 
Hemoglobin D, Hemoglobin E, Hemoglobin A2, and Hemoglobin S.
    (3) When assay interference from Hemoglobin F or interference with 
other hemoglobin variants with low frequency in the population is 
observed, a warning statement must be placed in a black box and must 
appear in all labeling material for these devices describing the 
interference and any affected populations.

[79 FR 50551, Aug. 25, 2014]



Sec. 862.1375  Histidine test system.

    (a) Identification. A histidine test system is a device intended to 
measure free histidine (an amino acid) in plasma and urine. Histidine 
measurements are used in the diagnosis and treatment of hereditary 
histidinemia characterized by excess histidine in the blood and urine 
often resulting in mental retardation and disordered speech development.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1377  Urinary homocystine (nonquantitative) test system.

    (a) Identification. A urinary homocystine (nonquantitative) test 
system is a device intended to identify homocystine (an analogue of the 
amino acid cystine) in urine. The identification of urinary homocystine 
is used in the diagnosis and treatment of homocystinuria (homosystine in 
urine), a heritable metabolic disorder which may cause mental 
retardation.
    (b) Classification. Class II.



Sec. 862.1380  Hydroxybutyric dehydrogenase test system.

    (a) Identification. A hydroxybutyric dehydrogenase test system is a 
device intended to measure the activity of the enzyme alpha-
hydroxybutric dehydrogenase (HBD) in plasma or serum. HBD measurements 
are used in the diagnosis and treatment of myocardial infarction, renal 
damage (such as rejection of transplants), certain hematological 
diseases (such as acute leukemias and megaloblastic anemias) and, to a 
lesser degree, liver disease.
    (b) Classification. Class I (general controls). The device is exempt 
from the

[[Page 255]]

premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 
FR 38787, July 25, 2001]



Sec. 862.1385  17-Hydroxycorticosteroids (17-ketogenic steroids) 
test system.

    (a) Identification. A 17-hydroxycorticosteroids (17-ketogenic 
steroids) test system is a device intended to measure corticosteroids 
that possess a dihydroxyacetone
[GRAPHIC] [TIFF OMITTED] TR01FE93.028


moiety on the steroid nucleus in urine. Corticosteroids with this 
chemical configuration include cortisol, cortisone 11-desoxycortisol, 
desoxycorticosterone, and their tetrahydroderivatives. This group of 
hormones is synthesized by the adrenal gland. Measurements of 17-
hydroxycorticosteroids (17-ketogenic steroids) are used in the diagnosis 
and treatment of various diseases of the adrenal or pituitary glands and 
gonadal disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987; 52 FR 29468, Aug. 7, 1987, as amended at 65 
FR 2306, Jan. 14, 2000]



Sec. 862.1390  5-Hydroxyindole acetic acid/serotonin test system.

    (a) Identification. A 5-hydroxyindole acetic acid/serotonin test 
system is a device intended to measure 5-hydroxyindole acetic acid/
serotonin in urine. Measurements of 5-hydroxyindole acetic acid/
serotonin are used in the diagnosis and treatment of carcinoid tumors of 
endocrine tissue.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1395  17-Hydroxyprogesterone test system.

    (a) Identification. A 17-hydroxyprogesterone test system is a device 
intended to measure 17-hydroxyprogesterone (a steroid) in plasma and 
serum. Measurements of 17-hydroxyprogesterone are used in the diagnosis 
and treatment of various disorders of the adrenal glands or the ovaries.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1400  Hydroxyproline test system.

    (a) Identification. A hydroxyproline test system is a device 
intended to measure the amino acid hydroxyproline in urine. 
Hydroxyproline measurements are used in the diagnosis and treatment of 
various collagen (connective tissue) diseases, bone disease such as 
Paget's disease, and endocrine disorders such as hyperparathyroidism and 
hyperthyroidism.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]



Sec. 862.1405  Immunoreactive insulin test system.

    (a) Identification. An immunoreactive insulin test system is a 
device intended to measure immunoreactive insulin in serum and plasma. 
Immunoreactive insulin measurements are used in the diagnosis and 
treatment of various carbohydrate metabolism disorders, including 
diabetes mellitus, and hypoglycemia.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]

[[Page 256]]



Sec. 862.1410  Iron (non-heme) test system.

    (a) Identification. An iron (non-heme) test system is a device 
intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) 
measurements are used in the diagnosis and treatment of diseases such as 
iron deficiency anemia, hemochromatosis (a disease associated with 
widespread deposit in the tissues of two iron-containing pigments, 
hemosiderin and hemofuscin, and characterized by pigmentation of the 
skin), and chronic renal disease.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019]



Sec. 862.1415  Iron-binding capacity test system.

    (a) Identification. An iron-binding capacity test system is a device 
intended to measure iron-binding capacity in serum. Iron-binding 
capacity measurements are used in the diagnosis and treatment of anemia.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019]



Sec. 862.1420  Isocitric dehydrogenase test system.

    (a) Identification. An isocitric dehydrogenase test system is a 
device intended to measure the activity of the enzyme isocitric 
dehydrogenase in serum and plasma. Isocitric dehydrogenase measurements 
are used in the diagnosis and treatment of liver disease such as viral 
hepatitis, cirrhosis, or acute inflammation of the biliary tract; 
pulmonary disease such as pulmonary infarction (local arrest or sudden 
insufficiency of the blood supply to the lungs), and diseases associated 
with pregnancy.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 
FR 38788, July 25, 2001]



Sec. 862.1430  17-Ketosteroids test system.

    (a) Identification. A 17-ketosteroids test system is a device 
intended to measure 17-ketosteroids in urine. Measurements of 17-
ketosteroids are used in the diagnosis and treatment of disorders of the 
adrenal cortex and gonads and of other endocrine disorders, including 
hypertension, diabetes, and hypothyroidism.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1435  Ketones (nonquantitative) test system.

    (a) Identification. A ketones (nonquantitative) test system is a 
device intended to identify ketones in urine and other body fluids. 
Identification of ketones is used in the diagnosis and treatment of 
acidosis (a condition characterized by abnormally high acidity of body 
fluids) or ketosis (a condition characterized by increased production of 
ketone bodies such as acetone) and for monitoring patients on ketogenic 
diets and patients with diabetes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1440  Lactate dehydrogenase test system.

    (a) Identification. A lactate dehydrogenase test system is a device 
intended to measure the activity of the enzyme lactate dehydrogenase in 
serum. Lactate dehydrogenase measurements are used in the diagnosis and 
treatment of liver diseases such as acute viral hepatitis, cirrhosis, 
and metastatic carcinoma of the liver, cardiac diseases

[[Page 257]]

such as myocardial infarction, and tumors of the lung or kidneys.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 63 FR 59225, Nov. 3, 1998]



Sec. 862.1445  Lactate dehydrogenase isoenzymes test system.

    (a) Identification. A lactate dehydrogenase isoenzymes test system 
is a device intended to measure the activity of lactate dehydrogenase 
isoenzymes (a group of enzymes with similar biological activity) in 
serum. Measurements of lactate dehydrogenase isoenzymes are used in the 
diagnosis and treatment of liver diseases, such as viral hepatitis, and 
myocardial infarction.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019]



Sec. 862.1450  Lactic acid test system.

    (a) Identification. A lactic acid test system is a device intended 
to measure lactic acid in whole blood and plasma. Lactic acid 
measurements that evaluate the acid-base status are used in the 
diagnosis and treatment of lactic acidosis (abnormally high acidity of 
the blood).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1455  Lecithin/sphingomyelin ratio in amniotic fluid test system.

    (a) Identification. A lecithin/sphingomyelin ratio in amniotic fluid 
test system is a device intended to measure the lecithin/sphingomyelin 
ratio in amniotic fluid. Lecithin and sphingomyelin are phospholipids 
(fats or fat-like substances containing phosphorus). Measurements of the 
lecithin/sphingomyelin ratio in amniotic fluid are used in evaluating 
fetal maturity.
    (b) Classification. Class II.



Sec. 862.1460  Leucine aminopeptidase test system.

    (a) Identification. A leucine aminopeptidase test system is a device 
intended to measure the activity of the enzyme leucine amino-peptidase 
in serum, plasma, and urine. Leucine aminopeptidase measurements are 
used in the diagnosis and treatment of liver diseases such as viral 
hepatitis and obstructive jaundice.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1465  Lipase test system.

    (a) Identification. A lipase test system is a device intended to 
measure the activity of the enzymes lipase in serum. Lipase measurements 
are used in diagnosis and treatment of diseases of the pancreas such as 
acute pancreatitis and obstruction of the pancreatic duct.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1470  Lipid (total) test system.

    (a) Identification. A lipid (total) test system is a device intended 
to measure total lipids (fats or fat-like substances) in serum and 
plasma. Lipid (total) measurements are used in the diagnosis and 
treatment of various diseases involving lipid metabolism and 
atherosclerosis.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 
FR 38788, July 25, 2001]

[[Page 258]]



Sec. 862.1475  Lipoprotein test system.

    (a) Identification. A lipoprotein test system is a device intended 
to measure lipoprotein in serum and plasma. Lipoprotein measurements are 
used in the diagnosis and treatment of lipid disorders (such as diabetes 
mellitus), atherosclerosis, and various liver and renal diseases.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1485  Luteinizing hormone test system.

    (a) Identification. A luteinizing hormone test system is a device 
intended to measure luteinizing hormone in serum and urine. Luteinizing 
hormone measurements are used in the diagnosis and treatment of gonadal 
dysfunction.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1490  Lysozyme (muramidase) test system.

    (a) Identification. A lysozyme (muramidase) test system is a device 
intended to measure the activity of the bacteriolytic enzyme lysozyme 
(muramidase) in serum, plasma, leukocytes, and urine. Lysozyme 
measurements are used in the diagnosis and treatment of monocytic 
leukemia and kidney disease.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 
FR 38788, July 25, 2001]



Sec. 862.1495  Magnesium test system.

    (a) Identification. A magnesium test system is a device intended to 
measure magnesium levels in serum and plasma. Magnesium measurements are 
used in the diagnosis and treatment of hypomagnesemia (abnormally low 
plasma levels of magnesium) and hypermagnesemia (abnormally high plasma 
levels of magnesium).
    (b) Classification. Class I.



Sec. 862.1500  Malic dehydrogenase test system.

    (a) Identification. A malic dehydrogenase test system is a device 
that is intended to measure the activity of the enzyme malic 
dehydrogenase in serum and plasma. Malic dehydrogenase measurements are 
used in the diagnosis and treatment of muscle and liver diseases, 
myocardial infarctions, cancer, and blood disorders such as myelogenous 
(produced in the bone marrow) leukemia.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1505  Mucopolysaccharides (nonquantitative) test system.

    (a) Identification. A mucopolysaccharides (nonquantitative) test 
system is a device intended to measure the levels of mucopolysaccharides 
in urine. Mucopolysaccharide measurements in urine are used in the 
diagnosis and treatment of various inheritable disorders that affect 
bone and connective tissues, such as Hurler's, Hunter's, Sanfilippo's, 
Scheie's Morquio's and Maroteaux-Lamy syndromes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1509  Methylmalonic acid (nonquantitative) test system.

    (a) Identification. A methylmalonic acid (nonquantitative) test 
system is a device intended to identify methylmalonic acid in urine. The 
identification of methylmalonic acid in urine is used in the diagnosis 
and

[[Page 259]]

treatment of methylmalonic aciduria, a heritable metabolic disorder 
which, if untreated, may cause mental retardation.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019]



Sec. 862.1510  Nitrite (nonquantitative) test system.

    (a) Identification. A nitrite (nonquantitative) test system is a 
device intended to identify nitrite in urine. Nitrite identification is 
used in the diagnosis and treatment of uninary tract infection of 
bacterial origin.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1515  Nitrogen (amino-nitrogen) test system.

    (a) Identification. A nitrogen (amino-nitrogen) test system is a 
device intended to measure amino acid nitrogen levels in serum, plasma, 
and urine. Nitrogen (amino-nitrogen) measurements are used in the 
diagnosis and treatment of certain forms of severe liver disease and 
renal disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 
FR 38788, July 25, 2001]



Sec. 862.1520  5'-Nucleotidase test system.

    (a) Identification. A 5'-nucleotidase test system is a device 
intended to measure the activity of the enzyme 5'-nucleotidase in serum 
and plasma. Measurements of 5'-nucleotidase are used in the diagnosis 
and treatment of liver diseases and in the differentiations between 
liver and bone diseases in the presence of elevated serum alkaline 
phosphatase activity.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1530  Plasma oncometry test system.

    (a) Identification. A plasma oncometry test system is a device 
intended to measure plasma oncotic pressure. Plasma oncotic pressure is 
that portion of the total fluid pressure contributed by proteins and 
other molecules too large to pass through a specified membrane. 
Measurements of plasma oncotic pressure are used in the diagnosis and 
treatment of dehydration and circulatory disorders related to low serum 
protein levels and increased capillary permeability, such as edema and 
shock.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1535  Ornithine carbamyl transferase test system.

    (a) Identification. An ornithine carbamyl transferase test system is 
a device intended to measure the activity of the enzyme ornithine 
carbamyl transferase (OCT) in serum. Ornithine carbamyl transferase 
measurements are used in the diagnosis and treatment of liver diseases, 
such as infectious hepatitis, acute cholecystitis (inflammation of the 
gall bladder), cirrhosis, and liver metastases.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1540  Osmolality test system.

    (a) Identification. An osmolality test system is a device intended 
to measure ionic and nonionic solute concentration in body fluids, such 
as serum and

[[Page 260]]

urine. Osmolality measurement is used as an adjunct to other tests in 
the evaluation of a variety of diseases, including kidney diseases 
(e.g., chronic progressive renal failure), diabetes insipidus, other 
endocrine and metabolic disorders, and fluid imbalances.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1542  Oxalate test system.

    (a) Identification. An oxalate test system is a device intended to 
measure the concentration of oxalate in urine. Measurements of oxalate 
are used to aid in the diagnosis or treatment of urinary stones or 
certain other metabolic disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1545  Parathyroid hormone test system.

    (a) Identification. A parathyroid hormone test system is a device 
intended to measure the levels of parathyroid hormone in serum and 
plasma. Measurements of parathyroid hormone levels are used in the 
differential diagnosis of hypercalcemia (abnormally high levels of 
calcium in the blood) and hypocalcemia (abnormally low levels of calcium 
in the blood) resulting from disorders of calcium metabolism.
    (b) Classification. Class II.



Sec. 862.1550  Urinary pH (nonquantitative) test system.

    (a) Identification. A urinary pH (nonquantitative) test system is a 
device intended to estimate the pH of urine. Estimations of pH are used 
to evaluate the acidity or alkalinity of urine as it relates to numerous 
renal and metabolic disorders and in the monitoring of patients with 
certain diets.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1555  Phenylalanine test system.

    (a) Identification. A phenylalanine test system is a device intended 
to measure free phenylalanine (an amino acid) in serum, plasma, and 
urine. Measurements of phenylalanine are used in the diagnosis and 
treatment of congenital phenylketonuria which, if untreated, may cause 
mental retardation.
    (b) Classification. Class II.



Sec. 862.1560  Urinary phenylketones (nonquantitative) test system.

    (a) Identification. A urinary phenylketones (nonquantitative) test 
system is a device intended to identify phenylketones (such as 
phenylpyruvic acid) in urine. The identification of urinary 
phenylketones is used in the diagnosis and treatment of congenital 
phenylketonuria which, if untreated, may cause mental retardation.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1565  6-Phosphogluconate dehydrogenase test system.

    (a) Identification. A 6-phosphogluconate dehydrogenase test system 
is a device intended to measure the activity of the enzyme 6-
phosphogluconate dehydrogenase (6 PGD) in serum and erythrocytes. 
Measurements of 6-phosphogluconate dehydrogenase are used in the 
diagnosis and treatment of certain liver diseases (such as hepatitis) 
and anemias.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 
FR 38788, July 25, 2001]

[[Page 261]]



Sec. 862.1570  Phosphohexose isomerase test system.

    (a) Identification. A phosphohexose isomerase test system is a 
device intended to measure the activity of the enzyme phosphohexose 
isomerase in serum. Measurements of phosphohexose isomerase are used in 
the diagnosis and treatment of muscle diseases such as muscular 
dystrophy, liver diseases such as hepatitis or cirrhosis, and metastatic 
carcinoma.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1575  Phospholipid test system.

    (a) Identification. A phospholipid test system is a device intended 
to measure phospholipids in serum and plasma. Measurements of 
phospholipids are used in the diagnosis and treatment of disorders 
involving lipid (fat) metabolism.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 
FR 38788, July 25, 2001]



Sec. 862.1580  Phosphorus (inorganic) test system.

    (a) Identification. A phosphorus (inorganic) test system is a device 
intended to measure inorganic phosphorus in serum, plasma, and urine. 
Measurements of phosphorus (inorganic) are used in the diagnosis and 
treatment of various disorders, including parathyroid gland and kidney 
diseases, and vitamin D imbalance.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019]



Sec. 862.1585  Human placental lactogen test system.

    (a) Identification. A human placental lactogen test system is a 
device intended to measure the hormone human placental lactogen (HPL), 
(also known as human chorionic somatomammotrophin (HCS)), in maternal 
serum and maternal plasma. Measurements of human placental lactogen are 
used in the diagnosis and clinical management of high-risk pregnancies 
involving fetal distress associated with placental insufficiency. 
Measurements of HPL are also used in pregnancies complicated by 
hypertension, proteinuria, edema, post-maturity, placental 
insufficiency, or possible miscarriage.
    (b) Classification. Class II.



Sec. 862.1590  Porphobilinogen test system.

    (a) Identification. A porphobilinogen test system is a device 
intended to measure porphobilinogen (one of the derivatives of 
hemoglobin which can make the urine a red color) in urine. Measurements 
obtained by this device are used in the diagnosis and treatment of 
porphyrias (primarily inherited diseases associated with disturbed 
porphyrine metabolism), lead poisoning, and other diseases characterized 
by alterations in the heme pathway.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]



Sec. 862.1595  Porphyrins test system.

    (a) Identification. A porphyrins test system is a device intended to 
measure porphyrins (compounds formed during the biosynthesis of heme, a 
constituent of hemoglobin, and related compounds) in urine and feces. 
Measurements obtained by this device are used in the diagnosis and 
treatment of lead poisoning, porphyrias (primarily inherited diseases 
associated with disturbed porphyrin metabolism), and other diseases 
characterized by alterations in the heme pathway.

[[Page 262]]

    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1600  Potassium test system.

    (a) Identification. A potassium test system is a device intended to 
measure potassium in serum, plasma, and urine. Measurements obtained by 
this device are used to monitor electrolyte balance in the diagnosis and 
treatment of diseases conditions characterized by low or high blood 
potassium levels.
    (b) Classification. Class II.



Sec. 862.1605  Pregnanediol test system.

    (a) Identification. A pregnanediol test system is a device intended 
to measure pregnanediol (a major urinary metabolic product of 
progesterone) in urine. Measurements obtained by this device are used in 
the diagnosis and treatment of disorders of the ovaries or placenta.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1610  Pregnanetriol test system.

    (a) Identification. A pregnanetriol test system is a device intended 
to measure pregnanetriol (a precursor in the biosynthesis of the adrenal 
hormone cortisol) in urine. Measurements obtained by this device are 
used in the diagnosis and treatment of congenital adrenal hyperplasia 
(congenital enlargement of the adrenal gland).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1615  Pregnenolone test system.

    (a) Identification. A pregnenolone test system is a device intended 
to measure pregnenolone (a precursor in the biosynthesis of the adrenal 
hormone cortisol and adrenal androgen) in serum and plasma. Measurements 
obtained by this device are used in the diagnosis and treatment of 
diseases of the adrenal cortex or the gonads.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1620  Progesterone test system.

    (a) Identification. A progesterone test system is a device intended 
to measure progesterone (a female hormone) in serum and plasma. 
Measurements obtained by this device are used in the diagnosis and 
treatment of disorders of the ovaries or placenta.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1622  Prognostic test for assessment of liver related disease
progression.

    (a) Identification. A prognostic test for assessment of liver 
related disease progression is intended to measure one or more analytes 
obtained from human samples as an aid in assessing progression of liver 
related disease. This device is not intended for diagnosis of any 
disease, for monitoring the effect of any therapeutic product, for 
assessing progression to hepatocellular carcinoma, or for assessing 
disease progression in individuals with viral hepatitis. It is also not 
intended for the detection of viruses, viral antigens, or antibodies to 
viruses.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Design verification and validation must include clinical 
validation data providing:
    (i) Information demonstrating clinical performance in a population 
of patients with liver disease for the different risk categories (e.g., 
at lower risk, at higher risk) for progression of

[[Page 263]]

their disease using well characterized clinical specimens representing 
the intended use population collected from multiple intended clinical 
sites, or an alternative study design determined to be appropriate by 
FDA.
    (ii) Information demonstrating that the outcomes measured and the 
length of followup are clinically relevant for the progression of the 
specified liver disease.
    (iii) Information demonstrating that the clinical criteria for 
determining whether the target disease is present and that the exclusion 
and inclusion criteria for subjects who have the target disease are 
appropriate.
    (iv) Information demonstrating test performance of the complete test 
system, including any sample collection and processing steps.
    (v) Information, provided or referenced, generated in samples from 
non-diseased individuals, that demonstrate the upper and lower reference 
intervals for the output provided by the device.
    (2) The labeling required under 21 CFR 809.10(b) must include:
    (i) A warning statement that test results are not intended to 
diagnose disease or for monitoring the effect of any therapeutic 
product.
    (ii) A warning statement that test results are intended to be used 
in conjunction with other clinical and diagnostic findings, consistent 
with professional standards of practice, including information obtained 
by alternative methods, and clinical evaluation, as appropriate.
    (iii) A warning statement that describes any limitations on the 
clinical interpretation(s) of the test results.
    (iv) Detailed information on device performance, including any 
limitations to the data generated in the clinical study(ies) and 
information on device performance in relevant subgroups (e.g., severity 
of liver disease at the beginning of the observation period) observed in 
the clinical study(ies).
    (v) Information on the analytical performance of the device, 
including demonstration of reproducibility across multiple sites and 
multiple reagent lots, or an alternative reproducibility study design 
determined to be appropriate by FDA.

[88 FR 2519, Jan. 17, 2023]



Sec. 862.1625  Prolactin (lactogen) test system.

    (a) Identification. A prolactin (lactogen) test system is a device 
intended to measure the anterior pituitary polypeptide hormone prolactin 
in serum and plasma. Measurements obtained by this device are used in 
the diagnosis and treatment of disorders of the anterior pituitary gland 
or of the hypothalamus portion of the brain.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1630  Protein (fractionation) test system.

    (a) Identification. A protein (fractionation) test system is a 
device intended to measure protein fractions in blood, urine, 
cerebrospinal fluid, and other body fluids. Protein fractionations are 
used as an aid in recognizing abnormal proteins in body fluids and 
genetic variants of proteins produced in diseases with tissue 
destruction.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1635  Total protein test system.

    (a) Identification. A total protein test system is a device intended 
to measure total protein(s) in serum or plasma. Measurements obtained by 
this device are used in the diagnosis and treatment of a variety of 
diseases involving the liver, kidney, or bone marrow as well as other 
metabolic or nutritional disorders.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures

[[Page 264]]

in subpart E of part 807 of this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 63 FR 59225, Nov. 3, 1998]



Sec. 862.1640  Protein-bound iodine test system.

    (a) Identification. A protein-bound iodine test system is a device 
intended to measure protein-bound iodine in serum. Measurements of 
protein-bound iodine obtained by this device are used in the diagnosis 
and treatment of thyroid disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 
FR 38788, July 25, 2001]



Sec. 862.1645  Urinary protein or albumin (nonquantitative) test system.

    (a) Identification. A urinary protein or albumin (nonquantitative) 
test system is a device intended to identify proteins or albumin in 
urine. Identification of urinary protein or albumin (nonquantitative) is 
used in the diagnosis and treatment of disease conditions such as renal 
or heart diseases or thyroid disorders, which are characterized by 
proteinuria or albuminuria.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1650  Pyruvate kinase test system.

    (a) Identification. A pyruvate kinase test system is a device 
intended to measure the activity of the enzyme pyruvate kinase in 
erythrocytes (red blood cells). Measurements obtained by this device are 
used in the diagnosis and treatment of various inherited anemias due to 
pyruvate kinase deficiency or of acute leukemias.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1655  Pyruvic acid test system.

    (a) Identification. A pyruvic acid test system is a device intended 
to measure pyruvic acid (an intermediate compound in the metabolism of 
carbohydrate) in plasma. Measurements obtained by this device are used 
in the evaluation of electrolyte metabolism and in the diagnosis and 
treatment of acid-base and electrolyte disturbances or anoxia (the 
reduction of oxygen in body tissues).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1660  Quality control material (assayed and unassayed).

    (a) Identification. A quality control material (assayed and 
unassayed) for clinical chemistry is a device intended for medical 
purposes for use in a test system to estimate test precision and to 
detect systematic analytical deviations that may arise from reagent or 
analytical instrument variation. A quality control material (assayed and 
unassayed) may be used for proficiency testing in interlaboratory 
surveys. This generic type of device includes controls (assayed and 
unassayed) for blood gases, electrolytes, enzymes, multianalytes (all 
kinds), single (specified) analytes, or urinalysis controls.
    (b) Classification. Class I (general controls). Except when intended 
for use in donor screening tests, quality control materials (assayed and 
unassayed) are exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000, 84 
FR 71796, Dec. 30, 2019]

[[Page 265]]



Sec. 862.1665  Sodium test system.

    (a) Identification. A sodium test system is a device intended to 
measure sodium in serum, plasma, and urine. Measurements obtained by 
this device are used in the diagnosis and treatment of aldosteronism 
(excessive secretion of the hormone aldosterone), diabetes insipidus 
(chronic excretion of large amounts of dilute urine, accompanied by 
extreme thirst), adrenal hypertension, Addison's disease (caused by 
destruction of the adrenal glands), dehydration, inappropriate 
antidiuretic hormone secretion, or other diseases involving electrolyte 
imbalance.
    (b) Classification. Class II.



Sec. 862.1670  Sorbitol dehydrogenase test system.

    (a) Identification. A sorbitol dehydrogenase test system is a device 
intended to measure the activity of the enzyme sorbitol dehydrogenase in 
serum. Measurements obtained by this device are used in the diagnosis 
and treatment of liver disorders such as cirrhosis or acute hepatitis.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 
FR 38788, July 25, 2001]



Sec. 862.1675  Blood specimen collection device.

    (a) Identification. A blood specimen collection device is a device 
intended for medical purposes to collect and to handle blood specimens 
and to separate serum from nonserum (cellular) components prior to 
further testing. This generic type device may include blood collection 
tubes, vials, systems, serum separators, blood collection trays, or 
vacuum sample tubes.
    (b) Classification. Class II.



Sec. 862.1678  Tacrolimus test system.

    (a) Identification. A tacrolimus test system is a device intended to 
quantitatively determine tacrolimus concentrations as an aid in the 
management of transplant patients receiving therapy with this drug. This 
generic type of device includes immunoassays and chromatographic assays 
for tacrolimus.
    (b) Classification. Class II (special controls). The special control 
is ``Class II Special Controls Guidance Document: Cyclosporine and 
Tacrolimus Assays; Guidance for Industry and FDA.'' See Sec. 862.1(d) 
for the availability of this guidance document.

[67 FR 58329, Sept. 16, 2002]



Sec. 862.1680  Testosterone test system.

    (a) Identification. A testosterone test system is a device intended 
to measure testosterone (a male sex hormone) in serum, plasma, and 
urine. Measurement of testosterone are used in the diagnosis and 
treatment of disorders involving the male sex hormones (androgens), 
including primary and secondary hypogonadism, delayed or precocious 
puberty, impotence in males and, in females hirsutism (excessive hair) 
and virilization (masculinization) due to tumors, polycystic ovaries, 
and adrenogenital syndromes.
    (b) Classification. Class I.

[52 FR 16122, May 1, 1987; 53 FR 11645, Apr. 8, 1988]



Sec. 862.1685  Thyroxine-binding globulin test system.

    (a) Identification. A thyroxine-binding globulin test system is a 
device intended to measure thyroxine (thyroid)-binding globulin (TBG), a 
plasma protein which binds thyroxine, in serum and plasma. Measurements 
obtained by this device are used in the diagnosis and treatment of 
thyroid diseases.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019]



Sec. 862.1690  Thyroid stimulating hormone test system.

    (a) Identification. A thyroid stimulating hormone test system is a 
device intended to measure thyroid stimulating hormone, also known as 
thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements 
of thyroid stimulating hormone produced

[[Page 266]]

by the anterior pituitary are used in the diagnosis of thyroid or 
pituitary disorders.
    (b) Classification. Class II.



Sec. 862.1695  Free thyroxine test system.

    (a) Identification. A free thyroxine test system is a device 
intended to measure free (not protein bound) thyroxine (thyroid hormone) 
in serum or plasma. Levels of free thyroxine in plasma are thought to 
reflect the amount of thyroxine hormone available to the cells and may 
therefore determine the clinical metabolic status of thyroxine. 
Measurements obtained by this device are used in the diagnosis and 
treatment of thyroid diseases.
    (b) Classification. Class II.



Sec. 862.1700  Total thyroxine test system.

    (a) Identification. A total thyroxine test system is a device 
intended to measure total (free and protein bound) thyroxine (thyroid 
hormone) in serum and plasma. Measurements obtained by this device are 
used in the diagnosis and treatment of thyroid diseases.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019]



Sec. 862.1705  Triglyceride test system.

    (a) Identification. A triglyceride test system is a device intended 
to measure triglyceride (neutral fat) in serum and plasma. Measurements 
obtained by this device are used in the diagnosis and treatment of 
patients with diabetes mellitus, nephrosis, liver obstruction, other 
diseases involving lipid metabolism, or various endocrine disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1710  Total triiodothyronine test system.

    (a) Identification. A total triiodothyronine test system is a device 
intended to measure the hormone triiodothyronine in serum and plasma. 
Measurements obtained by this device are used in the diagnosis and 
treatment of thyroid diseases such as hyperthyroidism.
    (b) Classification. Class II. This device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 62286, Oct. 18, 2000]



Sec. 862.1715  Triiodothyronine uptake test system.

    (a) Identification. A triiodothyronine uptake test system is a 
device intended to measure the total amount of binding sites available 
for binding thyroid hormone on the thyroxine-binding proteins, thyroid-
binding globulin, thyroxine-binding prealbumin, and albumin of serum and 
plasma. The device provides an indirect measurement of thyrkoxine levels 
in serum and plasma. Measurements of triiodothyronine uptake are used in 
the diagnosis and treatment of thyroid disorders.
    (b) Classification. Class II. The device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 64 FR 1124, Jan. 8, 1999]



Sec. 862.1720  Triose phosphate isomerase test system.

    (a) Identification. A triose phosphate isomerase test system is a 
device intended to measure the activity of the enzyme triose phosphate 
isomerase in erythrocytes (red blood cells). Triose phosphate isomerase 
is an enzyme important in glycolysis (the energy-yielding conversion of 
glucose to lactic acid in various tissues). Measurements obtained by 
this device are used in the diagnosis and treatment of congenital triose 
phosphate isomerase enzyme deficiency, which causes a type of hemolytic 
anemia.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 267]]

subpart E of part 807 subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 
FR 38788, July 25, 2001]



Sec. 862.1725  Trypsin test system.

    (a) Identification. A trypsin test system is a device intended to 
measure the activity of trypsin (a pancreatic enzyme important in 
digestion for the breakdown of proteins) in blood and other body fluids 
and in feces. Measurements obtained by this device are used in the 
diagnosis and treatment of pancreatic disease.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1730  Free tyrosine test system.

    (a) Identification. A free tyrosine test system is a device intended 
to measure free tyrosine (an amono acid) in serum and urine. 
Measurements obtained by this device are used in the diagnosis and 
treatment of diseases such as congenital tyrosinemia (a disease that can 
cause liver/kidney disorders) and as an adjunct to the measurement of 
phenylalanine in detecting congenital phenylketonuria (a disease that 
can cause brain damage).
    (b) Classification. Class I.



Sec. 862.1770  Urea nitrogen test system.

    (a) Identification. A urea nitrogen test system is a device intended 
to measure urea nitrogen (an end-product of nitrogen metabolism) in 
whole blood, serum, plasma, and urine. Measurements obtained by this 
device are used in the diagnosis and treatment of certain renal and 
metabolic diseases.
    (b) Classification. Class II.



Sec. 862.1775  Uric acid test system.

    (a) Identification. A uric acid test system is a device intended to 
measure uric acid in serum, plasma, and urine. Measurements obtained by 
this device are used in the diagnosis and treatment of numerous renal 
and metabolic disorders, including renal failure, gout, leukemia, 
psoriasis, starvation or other wasting conditions, and of patients 
receiving cytotoxic drugs.
    (b) Classification. Class I (general controls). The device, when it 
is solely intended for use as an acid reduction of ferric ion test, a 
phosphotungstate reduction test, a gasometric uricase test, an 
ultraviolet uricase test, or an oxygen rate uricase test, is exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019; 85 
FR 18445, Apr. 2, 2020]



Sec. 862.1780  Urinary calculi (stones) test system.

    (a) Identification. A urinary calculi (stones) test system is a 
device intended for the analysis of urinary calculi. Analysis of urinary 
calculi is used in the diagnosis and treatment of calculi of the urinary 
tract.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1785  Urinary urobilinogen (nonquantitative) test system.

    (a) Identification. A urinary urobilinogen (nonquantitative) test 
system is a device intended to detect and estimate urobilinogen (a bile 
pigment degradation product of red cell hemoglobin) in urine. 
Estimations obtained by this device are used in the diagnosis and 
treatment of liver diseases and hemolytic (red cells) disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1790  Uroporphyrin test system.

    (a) Identification. A uroporphyrin test system is a device intended 
to measure uroporphyrin in urine. Measurements obtained by this device 
are used in the diagnosis and treatment of porphyrias

[[Page 268]]

(primarily inherited diseases associated with disturbed porphyrin 
metabolism), lead poisoning, and other diseases characterized by 
alterations in the heme pathway.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1795  Vanilmandelic acid test system.

    (a) Identification. A vanilmandelic acid test system is a device 
intended to measure vanilmandelic acid in urine. Measurements of 
vanilmandelic acid obtained by this device are used in the diagnosis and 
treatment of neuroblastoma, pheochromocytoma, and certain hypertensive 
conditions.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1805  Vitamin A test system.

    (a) Identification. A vitamin A test system is a device intended to 
measure vitamin A in serum or plasma. Measurements obtained by this 
device are used in the diagnosis and treatment of vitamin A deficiency 
conditions, including night blindness, or skin, eye, or intestinal 
disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1810  Vitamin B12 test system.

    (a) Identification. A vitamin B12 test system is a device 
intended to measure vitamin B12 in serum, plasma, and urine. 
Measurements obtained by this device are used in the diagnosis and 
treatment of anemias of gastrointestinal malabsorption.
    (b) Classification. Class II.



Sec. 862.1815  Vitamin E test system.

    (a) Identification. A vitamin E test system is a device intended to 
measure vitamin E (tocopherol) in serum. Measurements obtained by this 
device are used in the diagnosis and treatment of infants with vitamin E 
deficiency syndrome.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 
subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 
FR 38788, July 25, 2001]



Sec. 862.1820  Xylose test system.

    (a) Identification. A xylose test system is a device intended to 
measure xylose (a sugar) in serum, plasma, and urine. Measurements 
obtained by this device are used in the diagnosis and treatment of 
gastrointestinal malabsorption syndrome (a group of disorders in which 
there is subnormal absorption of dietary constituents and thus excessive 
loss from the body of the nonabsorbed substances).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.1825  Vitamin D test system.

    (a) Identification. A vitamin D test system is a device intended for 
use in clinical laboratories for the quantitative determination of 25-
hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin 
D in serum or plasma to be used in the assessment of vitamin D 
sufficiency.
    (b) Classification. Class II (special controls). Vitamin D test 
systems must comply with the following special controls:
    (1) Labeling in conformance with 21 CFR 809.10 and
    (2) Compliance with existing standards of the National Committee on 
Clinical Laboratory Standards.

[63 FR 40366, July 29, 1998]

[[Page 269]]



Sec. 862.1840  Total 25-hydroxyvitamin D mass spectrometry test system.

    (a) Identification. A total 25-hydroxyvitamin D mass spectrometry 
test system is a device intended for use in clinical laboratories for 
the quantitative determination of total 25-hydroxyvitamin D (25-OH-D) in 
serum or plasma to be used in the assessment of vitamin D sufficiency.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in part 807, subpart 
E, of this chapter subject to the limitations in Sec. 862.9. The device 
must comply with the following special controls:
    (1) The device must have initial and annual standardization 
verification by a certifying vitamin D standardization organization 
deemed acceptable by FDA.
    (2) The 21 CFR 809.10(b) compliant labeling must include detailed 
descriptions of performance testing conducted to evaluate precision, 
accuracy, linearity, interference, including the following:
    (i) Performance testing of device precision must, at a minimum, use 
intended sample type with Vitamin D concentrations at medically relevant 
decision points. At least one sample in the precision studies must be an 
unmodified patient sample. This testing must evaluate repeatability and 
reproducibility using a protocol from an FDA-recognized standard.
    (ii) Performance testing of device accuracy must include a minimum 
of 115 serum or plasma samples that span the measuring interval of the 
device and compare results of the new device to results of a reference 
method or a legally marketed standardized mass spectrometry based 
vitamin D assay. The results must be described in the 21 CFR 
809.10(b)(12) compliant labeling of the device.
    (iii) Interference from vitamin D analogs and metabolites including 
vitamin D2, vitamin D3, 1-hydroxyvitamin D2, 1-hydroxyvitamin D3, 3-Epi-
25-Hydroxyvitamin D2, 3-Epi-25-Hydroxyvitamin D3, 1,25-Dihydroxyvitamin 
D2, 1,25-Dihydroxyvitamin D3, 3-Epi-1,25-Dihydroxyvitamin D2, and 3-Epi-
1,25-Dihydroxyvitamin D3, 25, 26-Dihydroxyvitamin-D3, 24 (R), 25-
dihydroxyvitamin-D3, 23 (R), 25-dihydroxyvitamin-D3 must be described in 
the 21 CFR 809.10(b)(7) compliant labeling of the device.
    (3) The 21 CFR 809.10(b) compliant labeling must be supported by a 
reference range study representative of the performance of the device. 
The study must be conducted using samples collected from apparently 
healthy male and female adults at least 21 years of age and older from 
at least 3 distinct climatic regions within the United States in 
different weather seasons. The ethnic, racial, and gender background of 
this study population must be representative of the U.S. population 
demographics.
    (4) The results of the device as provided in the 21 CFR 809.10(b) 
compliant labeling and any test report generated must be reported as 
only total 25-hydroxyvitamin D.

[82 FR 51559, Nov. 7, 2017, as amended at 83 FR 25914, June 5, 2018]



                Subpart C_Clinical Laboratory Instruments



Sec. 862.2050  General purpose laboratory equipment labeled
or promoted for a specific medical use.

    (a) Identification. General purpose laboratory equipment labeled or 
promoted for a specific medical use is a device that is intended to 
prepare or examine specimens from the human body and that is labeled or 
promoted for a specific medical use.
    (b) Classification. Class I (general controls). The device is 
identified in paragraph (a) of this section and is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 862.9. The device is also 
exempt from the current good manufacturing practice requirements of the 
quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 16122, May 1, 1987, as amended at 66 FR 38788, July 25, 2001]

[[Page 270]]



Sec. 862.2100  Calculator/data processing module for clinical use.

    (a) Identification. A calculator/data processing module for clinical 
use is an electronic device intended to process laboratory data.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 
FR 38788, July 25, 2001; 86 FR 20283, Apr. 19, 2021]



Sec. 862.2120  Continuous glucose monitor data management system.

    (a) Identification. A continuous glucose monitor data management 
system is an electronic device intended to acquire, process, and 
correlate retrospective data from a continuous glucose monitoring 
device. This device is intended to be used by patients or their 
healthcare providers when determining therapeutic strategies. A 
continuous glucose monitor data management system is not a drug dose 
calculator and does not provide treatment recommendations.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 862.9.

[84 FR 57817, Oct. 29, 2019]



Sec. 862.2140  Centrifugal chemistry analyzer for clinical use.

    (a) Identification. A centrifugal chemistry analyzer for clinical 
use is an automatic device intended to centrifugally mix a sample and a 
reagent and spectrophotometrically measure concentrations of the sample 
constituents. This device is intended for use in conjunction with 
certain materials to measure a variety of analytes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.2150  Continuous flow sequential multiple chemistry 
analyzer for clinical use.

    (a) Identification. A continuous flow sequential multiple chemistry 
analyzer for clinical use is a modular analytical instrument intended to 
simultaneously perform multiple chemical procedures using the principles 
of automated continuous flow systems. This device is intended for use in 
conjunction with certain materials to measure a variety of analytes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]



Sec. 862.2160  Discrete photometric chemistry analyzer for clinical use.

    (a) Identification. A discrete photometric chemistry analyzer for 
clinical use is a device intended to duplicate manual analytical 
procedures by performing automatically various steps such as pipetting, 
preparing filtrates, heating, and measuring color intensity. This device 
is intended for use in conjunction with certain materials to measure a 
variety of analytes. Different models of the device incorporate various 
instrumentation such as micro analysis apparatus, double beam, single, 
or dual channel photometers, and bichromatic 2-wavelength photometers. 
Some models of the device may include reagent-containing components that 
may also serve as reaction units.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2170  Micro chemistry analyzer for clinical use.

    (a) Identification. A micro chemistry analyzer for clinical use is a 
device intended to duplicate manual analytical procedures by performing 
automatically various steps such as pipetting,

[[Page 271]]

preparing filtrates, heating, and measuring color intensity. The 
distinguishing characteristic of the device is that it requires only 
micro volume samples obtainable from pediatric patients. This device is 
intended for use in conjunction with certain materials to measure a 
variety of analytes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2230  Chromatographic separation material for clinical use.

    (a) Identification. A chromatographic separation material for 
clinical use is a device accessory (e.g., ion exchange absorbents, ion 
exchagne resins, and ion papers) intended for use in ion exchange 
chromatography, a procedure in which a compound is separated from a 
solution.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 61 FR 1119, Jan. 16, 1996; 66 
FR 38788, July 25, 2001]



Sec. 862.2250  Gas liquid chromatography system for clinical use.

    (a) Identification. A gas liquid chromatography system for clinical 
use is a device intended to separate one or more drugs or compounds from 
a mixture. Each of the constituents in a vaporized mixture of compounds 
is separated according to its vapor pressure. The device may include 
accessories such as columns, gases, column supports, and liquid coating.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2260  High pressure liquid chromatography system for clinical use.

    (a) Identification. A high pressure liquid chromatography system for 
clinical use is a device intended to separate one or more drugs or 
compounds from a solution by processing the mixture of compounds 
(solutes) through a column packed with materials of uniform size 
(stationary phase) under the influence of a high pressure liquid (mobile 
phase). Separation of the solutes occurs either by absorption, sieving, 
partition, or selective affinity.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2265  High throughput genomic sequence analyzer for clinical use.

    (a) Identification. A high throughput genomic sequence analyzer for 
clinical use is an analytical instrument system intended to generate, 
measure and sort signals in order to analyze nucleic acid sequences in a 
clinical sample. The device may include a signal reader unit; reagent 
handling, dedicated instrument control, and other hardware components; 
raw data storage mechanisms; data acquisition software; and software to 
process detected signals.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 862.9. The 
special controls for this device are:
    (1) The labeling for the instrument system must reference legally 
marketed pre-analytical and analytical reagents to be used with the 
instrument system and include or reference legally marketed analytical 
software that includes sequence alignment and variant calling functions, 
to be used with the instrument system.
    (2) The labeling for the instrument system must include a 
description of the following information:
    (i) The specimen type(s) validated as an appropriate source of 
nucleic acid for this instrument.

[[Page 272]]

    (ii) The type(s) of nucleic acids (e.g., germline DNA, tumor DNA) 
validated with this instrument.
    (iii) The type(s) of sequence variations (e.g. single nucleotide 
variants, insertions, deletions) validated with this instrument.
    (iv) The type(s) of sequencing (e.g., targeted sequencing) validated 
with this instrument.
    (v) The appropriate read depth for the sensitivity claimed and 
validation information supporting those claims.
    (vi) The nucleic acid extraction method(s) validated for use with 
the instrument system.
    (vii) Limitations must specify the types of sequence variations that 
the instrument cannot detect with the claimed accuracy and precision 
(e.g., insertions or deletions larger than a certain size, 
translocations).
    (viii) Performance characteristics of the instrument system must 
include:
    (A) Reproducibility data generated using multiple instruments and 
multiple operators, and at multiple sites. Samples tested must include 
all claimed specimen types, nucleic acid types, sequence variation 
types, and types of sequencing. Variants queried shall be located in 
varying sequence context (e.g., different chromosomes, GC-rich regions). 
Device results shall be compared to reference sequence data with high 
confidence.
    (B) Accuracy data for all claimed specimen types and nucleic acid 
types generated by testing a panel of well characterized samples to 
query all claimed sequence variation types, types of sequencing, and 
sequences located in varying sequence context (e.g., different 
chromosomes, GC-rich regions). The well-characterized sample panel shall 
include samples from at least two sources that have highly confident 
sequence based on well-validated sequencing methods. At least one 
reference source shall have sequence generated independently of the 
manufacturer with respect to technology and analysis. Percent agreement 
and percent disagreement with the reference sequences must be described 
for all regions queried by the instrument.
    (C) If applicable, data describing endogenous or exogenous 
substances that may interfere with the instrument system.
    (D) If applicable, data demonstrating the ability of the system to 
consistently generate an accurate result for a given sample across 
different indexing primer combinations.
    (ix) The upper and lower limit of input nucleic acid that will 
achieve the claimed accuracy and reproducibility. Data supporting such 
claims must also be summarized.

[82 FR 13552, Mar. 14, 2017, as amended at 84 FR 71797, Dec. 30, 2019]



Sec. 862.2270  Thin-layer chromatography system for clinical use.

    (a) Identification. A thin-layer chromatography (TLC) system for 
clinical use is a device intended to separate one or more drugs or 
compounds from a mixture. The mixture of compounds is absorbed onto a 
stationary phase or thin layer of inert material (e.g., cellulose, 
alumina, etc.) and eluted off by a moving solvent (moving phase) until 
equilibrium occurs between the two phases.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9. Particular components of TLC 
systems, i.e., the thin-layer chromatography apparatus, TLC atomizer, 
TLC developing tanks, and TLC ultraviolet light, are exempt from the 
current good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180 of this chapter, with respect to general requirements concerning 
records, and Sec. 820.198 of this chapter, with respect to complaint 
files.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2300  Colorimeter, photometer, or spectrophotometer for clinical use.

    (a) Identification. A colorimeter, a photometer, or a 
spectrophotometer for clinical use is an instrument intended to measure 
radiant energy emitted, transmitted, absorbed, or reflected under 
controlled conditions. The device may include a monochromator to produce 
light of a specific wavelength.

[[Page 273]]

    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2310  Clinical sample concentrator.

    (a) Identification. A clinical sample concentrator is a device 
intended to concentrate (by dialysis, evaporation, etc.) serum, urine, 
cerebrospinal fluid, and other body fluids before the fluids are 
analyzed.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 60 FR 38899, July 28, 1995; 66 
FR 38788, July 25, 2001]



Sec. 862.2320  Beta or gamma counter for clinical use.

    (a) Identification. A beta or gamma counter for clinical use is a 
device intended to detect and count beta or gamma radiation emitted by 
clinical samples. Clinical samples are prepared by addition of a 
radioactive reagent to the sample. These measurements are useful in the 
diagnosis and treatment of various disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995; 66 
FR 38788, July 25, 2001]



Sec. 862.2400  Densitometer/scanner (integrating, reflectance, TLC,
or radiochromatogram) for clinical use.

    (a) Identification. A densitometer/scanner (integrating, 
reflectance, thin-layer chromatography, or radiochromatogram) for 
clinical use is device intended to measure the concentration of a 
substance on the surface of a film or other support media by either a 
photocell measurement of the light transmission through a given area of 
the medium or, in the case of the radiochromatogram scanner, by 
measurement of the distribution of a specific radio-active element on a 
radiochromatogram.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2485  Electrophoresis apparatus for clinical use.

    (a) Identification. An electrophoresis apparatus for clinical use is 
a device intended to separate molecules or particles, including plasma 
proteins, lipoproteins, enzymes, and hemoglobulins on the basis of their 
net charge in specified buffered media. This device is used in 
conjunction with certain materials to measure a variety of analytes as 
an aid in the diagnosis and treatment of certain disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995; 66 
FR 38788, July 25, 2001]



Sec. 862.2500  Enzyme analyzer for clinical use.

    (a) Identification. An enzyme analyzer for clinical use is a device 
intended to measure enzymes in plasma or serum by nonkinetic or kinetic 
measurement of enzyme-catalyzed reactions. This device is used in 
conjunction with certain materials to measure a variety of enzymes as an 
aid in the diagnosis and treatment of certain enzyme-related disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2540  Flame emission photometer for clinical use.

    (a) Identification. A flame emission photometer for clinical use is 
a device

[[Page 274]]

intended to measure the concentration of sodium, potassium, lithium, and 
other metal ions in body fluids. Abnormal variations in the 
concentration of these substances in the body are indicative of certain 
disorders (e.g., electrolyte imbalance and heavy metal intoxication) and 
are, therefore, useful in diagnosis and treatment of those disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2560  Fluorometer for clinical use.

    (a) Identification. A fluorometer for clinical use is a device 
intended to measure by fluorescence certain analytes. Fluorescence is 
the property of certain substances of radiating, when illuminated, a 
light of a different wavelength. This device is used in conjunction with 
certain materials to measure a variety of analytes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2570  Instrumentation for clinical multiplex test systems.

    (a) Identification. Instrumentation for clinical multiplex test 
systems is a device intended to measure and sort multiple signals 
generated by an assay from a clinical sample. This instrumentation is 
used with a specific assay to measure multiple similar analytes that 
establish a single indicator to aid in diagnosis. Such instrumentation 
may be compatible with more than one specific assay. The device includes 
a signal reader unit, and may also integrate reagent handling, 
hybridization, washing, dedicated instrument control, and other hardware 
components, as well as raw data storage mechanisms, data acquisition 
software, and software to process detected signals.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 862.9. The 
special control is FDA's guidance document entitled ``Class II Special 
Controls Guidance Document: Instrumentation for Clinical Multiplex Test 
Systems.'' See Sec. 862.1(d) for the availability of this guidance 
document.

[70 FR 11868, Mar. 10, 2005, as amended at 84 FR 71797, Dec. 30, 2019]



Sec. 862.2680  Microtitrator for clinical use.

    (a) Identification. A microtitrator for clinical use is a device 
intended for use in micronanalysis to measure the concentration of a 
substance by reacting it with a measure ``micro'' volume of a known 
standardized solution.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2700  Nephelometer for clinical use.

    (a) Identification. A nephelometer for clinical use is a device 
intended to estimate the concentration of particles in a suspension by 
measuring their light scattering properties (the deflection of light 
rays by opaque particles in their path). The device is used in 
conjunction with certain materials to measure the concentration of a 
variety of analytes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2720  Plasma oncometer for clinical use.

    (a) Identification. A plasma oncometer for clinical use is a device 
intended to measure plasma oncotic pressure, which is that portion of 
the total plasma osmotic pressure contributed by protein and other 
molecules too large to pass through a specified semipermeable membrane. 
Because

[[Page 275]]

variations in plasma oncotic pressure are indications of certain 
disorders, measurements of the variations are useful in the diagnosis 
and treatment of these disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995; 66 
FR 38788, July 25, 2001]



Sec. 862.2730  Osmometer for clinical use.

    (a) Identification. An osmometer for clinical use is a device 
intended to measure the osmotic pressure of body fluids. Osmotic 
pressure is the pressure required to prevent the passage of a solution 
with a lesser solute concentration into a solution with greater solute 
concentration when the two solutions are separated by a semipermeable 
membrane. The concentration of a solution affects its osmotic pressure, 
freezing point, and other physiochemical properties. Osmometers 
determine osmotic pressure by methods such as the measurement of the 
freezing point. Measurements obtained by this device are used in the 
diagnosis and treatment of body fluid disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2750  Pipetting and diluting system for clinical use.

    (a) Identification. A pipetting and diluting system for clinical use 
is a device intended to provide an accurately measured volume of liquid 
at a specified temperature for use in certain test procedures. This 
generic type of device system includes serial, manual, automated, and 
semi-automated dilutors, pipettors, dispensers, and pipetting stations.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2800  Refractometer for clinical use.

    (a) Identification. A refractometer for clinical use is a device 
intended to determine the amount of solute in a solution by measuring 
the index of refraction (the ratio of the velocity of light in a vacuum 
to the velocity of light in the solution). The index of refraction is 
used to measure the concentration of certain analytes (solutes), such a 
plasma total proteins and urinary total solids. Measurements obtained by 
this device are used in the diagnosis and treatment of certain 
conditions.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995; 66 
FR 38788, July 25, 2001]



Sec. 862.2850  Atomic absorption spectrophotometer for clinical use.

    (a) Identification. An atomic absorption spectrophotometer for 
clinical use is a device intended to identify and measure elements and 
metals (e.g., lead and mercury) in human specimens. The metal elements 
are identified according to the wavelength and intensity of the light 
that is absorbed when the specimen is converted to the atomic vapor 
phase. Measurements obtained by this device are used in the diagnosis 
and treatment of certain conditions.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2860  Mass spectrometer for clinical use.

    (a) Identification. A mass spectrometer for clinical use is a device 
intended to identify inorganic or organic compounds (e.g., lead, 
mercury, and drugs) in human specimens by ionizing

[[Page 276]]

the compound under investigation and separating the resulting ions by 
means of an electrical and magnetic field according to their mass.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2900  Automated urinalysis system.

    (a) Identification. An automated urinalysis system is a device 
intended to measure certain of the physical properties and chemical 
constituents of urine by procedures that duplicate manual urinalysis 
systems. This device is used in conjunction with certain materials to 
measure a variety of urinary analytes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]



Sec. 862.2920  Plasma viscometer for clinical use.

    (a) Identification. A plasma viscometer for clinical use is a device 
intended to measure the viscosity of plasma by determining the time 
period required for the plasma to flow a measured distance through a 
calibrated glass tube. Measurements obtained by this device are used to 
monitor changes in the amount of solids present in plasma in various 
disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995; 66 
FR 38788, July 25, 2001]



               Subpart D_Clinical Toxicology Test Systems



Sec. 862.3030  Acetaminophen test system.

    (a) Identification. An acetaminophen test system is a device 
intended to measure acetaminophen, an analgestic and fever reducing 
drug, in serum. Measurements obtained by this device are used in the 
diagnosis and treatment of acetaminophen overdose.
    (b) Classification. Class II.



Sec. 862.3035  Amikacin test system.

    (a) Identification. An amikacin test system is a device intended to 
measure amikacin, an aminoglycoside antibiotic drug, in serum and 
plasma. Measurements obtained by this device are used in the diagnosis 
and treatment of amikacin overdose and in monitoring levels of amikacin 
to ensure appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3040  Alcohol test system.

    (a) Identification. An alcohol test system is a device intented to 
measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human 
body fluids (e.g., serum, whole blood, and urine). Measurements obtained 
by this device are used in the diagnosis and treatment of alcohol 
intoxication and poisoning.
    (b) Classification. Class II.



Sec. 862.3050  Breath-alcohol test system.

    (a) Identification. A breath-alcohol test system is a device intened 
to measure alcohol in the human breath. Measurements obtained by this 
device are used in the diagnosis of alcohol intoxication.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019]



Sec. 862.3080  Breath nitric oxide test system.

    (a) Identification. A breath nitric oxide test system is a device 
intended to measure fractional nitric oxide in human breath. Measurement 
of changes in fractional nitric oxide concentration in expired breath 
aids in evaluating an asthma patient's response to anti-inflammatory 
therapy, as an adjunct to established clinical and laboratory 
assessments of asthma.

[[Page 277]]

A breath nitric oxide test system combines chemiluminescence detection 
of nitric oxide with a pneumotachograph, display, and dedicated 
software.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance entitled ``Class II Special Controls Guidance 
Document: Breath Nitric Oxide Test System.'' See Sec. 862.1(d) for the 
availability of this guidance document.

[68 FR 40127, July 7, 2003]



Sec. 862.3100  Amphetamine test system.

    (a) Identification. An amphetamine test system is a device intended 
to measure amphetamine, a central nervous system stimulating drug, in 
plasma and urine. Measurements obtained by this device are used in the 
diagnosis and treatment of amphetamine use or overdose and in monitoring 
levels of amphetamine to ensure appropriate therapy.
    (b) Classification. Class II (special controls). An amphetamine test 
system is not exempt if it is intended for any use other than employment 
or insurance testing or is intended for Federal drug testing programs. 
The device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec. 862.9, provided the test system is intended for employment and 
insurance testing and includes a statement in the labeling that the 
device is intended solely for use in employment and insurance testing, 
and does not include devices intended for Federal drug testing programs 
(e.g., programs run by the Substance Abuse and Mental Health Services 
Administration (SAMHSA), the Department of Transportation (DOT), and the 
U.S. military).

[52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019]



Sec. 862.3110  Antimony test system.

    (a) Identification. An antimony test system is a device intended to 
measure antimony, a heavy metal, in urine, blood, vomitus, and stomach 
contents. Measurements obtained by this device are used in the diagnosis 
and treatment of antimony poisoning.
    (b) Classification. Class I.



Sec. 862.3120  Arsenic test system.

    (a) Identification. An arsenic test system is a device intended to 
measure arsenic, a poisonous heavy metal, in urine, vomitus, stomach 
contents, nails, hair, and blood. Measurements obtained by this device 
are used in the diagnosis and treatment of arsenic poisoning.
    (b) Classification. Class I.



Sec. 862.3150  Barbiturate test system.

    (a) Identification. A barbiturate test system is a device intended 
to measure barbiturates, a class of hypnotic and sedative drugs, in 
serum, urine, and gastric contents. Measurements obtained by this device 
are used in the diagnosis and treatment of barbiturate use or overdose 
and in monitoring levels of barbiturate to ensure appropriate therapy.
    (b) Classification. Class II (special controls). A barbiturate test 
system is not exempt if it is intended for any use other than employment 
or insurance testing or is intended for Federal drug testing programs. 
The device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec. 862.9, provided the test system is intended for employment and 
insurance testing and includes a statement in the labeling that the 
device is intended solely for use in employment and insurance testing, 
and does not include devices intended for Federal drug testing programs 
(e.g., programs run by the Substance Abuse and Mental Health Services 
Administration (SAMHSA), the Department of Transportation (DOT), and the 
U.S. military).

[52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019]



Sec. 862.3170  Benzodiazepine test system.

    (a) Identification. A benzodiazepine test system is a device 
intended to measure any of the benzodiazepine compounds, sedative and 
hypnotic drugs, in blood, plasma, and urine. The benzodiazepine 
compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, 
flurazepam, and nitrazepam. Measurements obtained by this device are 
used in the diagnosis and treatment of benzodiazepine use or

[[Page 278]]

overdose and in monitoring levels of benzodiazepines to ensure 
appropriate therapy.
    (b) Classification. Class II (special controls). A benzodiazepine 
test system is not exempt if it is intended for any use other than 
employment or insurance testing or is intended for Federal drug testing 
programs. The device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec. 862.9, provided the test system is intended for 
employment and insurance testing and includes a statement in the 
labeling that the device is intended solely for use in employment and 
insurance testing, and does not include devices intended for Federal 
drug testing programs (e.g., programs run by the Substance Abuse and 
Mental Health Services Administration (SAMHSA), the Department of 
Transportation (DOT), and the U.S. military).

[52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019]



Sec. 862.3200  Clinical toxicology calibrator.

    (a) Identification. A clinical toxicology calibrator is a device 
intended for medical purposes for use in a test system to establish 
points of reference that are used in the determination of values in the 
measurement of substances in human specimens. A clinical toxicology 
calibrator can be a mixture of drugs or a specific material for a 
particular drug (e.g., ethanol, lidocaine, etc.). (See also Sec. 862.2 
in this part.)
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019]



Sec. 862.3220  Carbon monoxide test system.

    (a) Identification. A carbon monoxide test system is a device 
intended to measure carbon monoxide or carboxyhemoglobin (carbon 
monoxide bound to the hemoglobin in the blood) in blood. Measurements 
obtained by this device are used in the diagnosis and treatment of or 
confirmation of carbon monoxide poisoning.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019]



Sec. 862.3240  Cholinesterase test system.

    (a) Identification. A cholinesterase test system is a device 
intended to measure cholinesterase (an enzyme that catalyzes the 
hydrolysis of acetylcholine to choline) in human specimens. There are 
two principal types of cholinesterase in human tissues. True 
cholinesterase is present at nerve endings and in erythrocytes (red 
blood cells) but is not present in plasma. Pseudo cholinesterase is 
present in plasma and liver but is not present in erythrocytes. 
Measurements obtained by this device are used in the diagnosis and 
treatment of cholinesterase inhibition disorders (e.g., insecticide 
poisoning and succinylcholine poisoning).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019]



Sec. 862.3250  Cocaine and cocaine metabolite test system.

    (a) Identification. A cocaine and cocaine metabolite test system is 
a device intended to measure cocaine and a cocaine metabolite 
(benzoylecgonine) in serum, plasma, and urine. Measurements obtained by 
this device are used in the diagnosis and treatment of cocaine use or 
overdose.
    (b) Classification. Class II (special controls). A cocaine and 
cocaine metabolite test system is not exempt if it is intended for any 
use other than employment or insurance testing or is intended for 
Federal drug testing programs. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 862.9, provided the test system is intended 
for employment and insurance testing

[[Page 279]]

and includes a statement in the labeling that the device is intended 
solely for use in employment and insurance testing, and does not include 
devices intended for Federal drug testing programs (e.g., programs run 
by the Substance Abuse and Mental Health Services Administration 
(SAMHSA), the Department of Transportation (DOT), and the U.S. 
military).

[52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019]



Sec. 862.3270  Codeine test system.

    (a) Identification. A codeine test system is a device intended to 
measure codeine (a narcotic pain-relieving drug) in serum and urine. 
Measurements obtained by this device are used in the diagnosis and 
treatment of codeine use or overdose and in monitoring levels of codeine 
to ensure appropriate therapy.
    (b) Classification. Class II (special controls). A codeine test 
system is not exempt if it is intended for any use other than employment 
or insurance testing or is intended for Federal drug testing programs. 
The device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec. 862.9, provided the test system is intended for employment and 
insurance testing and includes a statement in the labeling that the 
device is intended solely for use in employment and insurance testing, 
and does not include devices intended for Federal drug testing programs 
(e.g., programs run by the Substance Abuse and Mental Health Services 
Administration (SAMHSA), the Department of Transportation (DOT), and the 
U.S. military).

[52 FR 16122, May 1, 1987, as amended at 84 FR 71798, Dec. 30, 2019]



Sec. 862.3280  Clinical toxicology control material.

    (a) Identification. A clinical toxicology control material is a 
device intended to provide an estimation of the precision of a device 
test system and to detect and monitor systematic deviations from 
accuracy resulting from reagent or instrument defects. This generic type 
of device includes various single, and multi-analyte control materials.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000, 84 
FR 71798, Dec. 30, 2019]



Sec. 862.3300  Digitoxin test system.

    (a) Identification. A digitoxin test system is a device intended to 
measure digitoxin, a cardiovascular drug, in serum and plasma. 
Measurements obtained by this device are used in the diagnosis and 
treatment of digitoxin overdose and in monitoring levels of digitoxin to 
ensure appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3320  Digoxin test system.

    (a) Identification. A digoxin test system is a device intended to 
measure digoxin, a cardiovascular drug, in serum and plasma. 
Measurements obtained by this device are used in the diagnosis and 
treatment of digoxin overdose and in monitoring levels of digoxin to 
ensure appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3350  Diphenylhydantoin test system.

    (a) Identification. A diphenylhydantoin test system is a device 
intended to measure diphenylhydantoin, an antiepileptic drug, in human 
specimens. Measurements obtained by this device are used in the 
diagnosis and treatment of diphenylhydantoin overdose and in monitoring 
levels of diphenylhydantoin to ensure appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3360  Drug metabolizing enzyme genotyping system.

    (a) Identification. A drug metabolizing enzyme genotyping system is 
a device intended for use in testing deoxyribonucleic acid (DNA) 
extracted from clinical samples to identify the presence or absence of 
human genotypic markers encoding a drug metabolizing enzyme. This device 
is used as an aid in determining treatment choice and individualizing 
treatment

[[Page 280]]

dose for therapeutics that are metabolized primarily by the specific 
enzyme about which the system provides genotypic information.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance document entitled ``Class II Special Controls Guidance 
Document: Drug Metabolizing Enzyme Genotyping Test System.'' See Sec. 
862.1(d) for the availability of this guidance document.

[70 FR 11867, Mar. 10, 2005]



Sec. 862.3380  Ethosuximide test system.

    (a) Identification. An ethosuximide test system is a device intended 
to measure ethosuximide, an antiepileptic drug, in human specimens. 
Measurements obtained by this device are used in the diagnosis and 
treatment of ethosuximide overdose and in monitoring levels of 
ethosuximide to ensure appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3450  Gentamicin test system.

    (a) Identification. A gentamicin test system is a device intended to 
measure gentamicin, an antibiotic drug, in human specimens. Measurements 
obtained by this device are used in the diagnosis and treatment of 
gentamicin overdose and in monitoring levels of gentamicin to ensure 
appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3520  Kanamycin test system.

    (a) Identification. A kanamycin test system is a device intended to 
measure kanamycin, an antibiotic drug, in plasma and serum. Measurements 
obtained by this device are used in the diagnosis and treatment of 
kanamycin overdose and in monitoring levels of kanamycin to ensure 
appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3550  Lead test system.

    (a) Identification. A lead test system is a device intended to 
measure lead, a heavy metal, in blood and urine. Measurements obtained 
by this device are used in the diagnosis and treatment of lead 
poisoning.
    (b) Classification. Class II.



Sec. 862.3555  Lidocaine test system.

    (a) Identification. A lidocaine test system is a device intended to 
measure lidocaine, an antiarrythmic and anticonvulsant drug, in serum 
and plasma. Measurements obtained by this device are used in the 
diagnosis and treatment of lidocaine overdose or in monitoring levels of 
lidocaine to ensure appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3560  Lithium test system.

    (a) Identification. A lithium test system is a device intended to 
measure lithium (from the drug lithium carbonate) in serum or plasma. 
Measurements of lithium are used to assure that the proper drug dosage 
is administered in the treatment of patients with mental disturbances, 
such as manic-depressive illness (bipolar disorder).
    (b) Classification. Class II.



Sec. 862.3580  Lysergic acid diethylamide (LSD) test system.

    (a) Identification. A lysergic acid diethylamide (LSD) test system 
is a device intended to measure lysergic acid diethylamide, a 
hallucinogenic drug, in serum, urine, and gastric contents. Measurements 
obtained by this device are used in the diagnosis and treatment of LSD 
use or overdose.
    (b) Classification. Class II (special controls). A lysergic acid 
diethylamide (LSD) test system is not exempt if it is intended for any 
use other than employment or insurance testing or is intended for 
Federal drug testing programs. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 862.9, provided the test system is intended 
for employment and insurance testing and includes a statement in the 
labeling that the device is intended solely for use in employment and 
insurance testing, and does not include devices intended for Federal 
drug testing programs (e.g., programs run by the Substance Abuse and 
Mental Health Services Administration (SAMHSA), the Department of 
Transportation (DOT), and the U.S. military).

[52 FR 16122, May 1, 1987, as amended at 84 FR 71798, Dec. 30, 2019]

[[Page 281]]



Sec. 862.3590  Meprobamate test system.

    (a) Identification. A meprobamate test system is a device intended 
to measure meprobamate in human specimens. Measurements obtained by this 
device are used to detect the presence of meprobamate to diagnose the 
use or overdose of meprobamate or structurally-related drug compounds 
(e.g., prodrugs).
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Design verification and validation must include:
    (i) Robust data demonstrating the accuracy of the device when used 
in the intended specimen matrix. The accuracy data must include a 
comparison between the meprobamate test system results and meprobamate 
results that are measured on an FDA-accepted measurement method that is 
specific and accurate (e.g., gas or liquid chromatography combined with 
tandem mass spectrometry).
    (ii) Robust analytical data demonstrating the performance 
characteristics of the device, including, but not limited to, 
specificity, cross-reactivity to relevant endogenous and exogenous 
substances, and the reproducibility of analyte detection around the 
cutoff(s).
    (2) The intended use of the device must not include an indication 
for use in monitoring therapeutic drug concentrations or informing 
dosing adjustment decisions.
    (3) Your 21 CFR 809.10 labeling must include the following:
    (i) If indicated for use as a screening test to identify preliminary 
results for further confirmation, the intended use must state ``This 
assay provides only a preliminary analytical result. A more specific 
alternative chemical confirmatory method (e.g., gas or liquid 
chromatography and mass spectrometry) must be used to obtain a confirmed 
analytical result. Clinical consideration and professional judgment must 
be exercised with any drug of abuse test, particularly when the 
preliminary test result is positive.''
    (ii) A limiting statement that reads as follows: ``This test should 
not be used to monitor therapeutic drug concentrations or to inform 
dosing adjustment decisions.''

[83 FR 54876, Nov. 1, 2018]



Sec. 862.3600  Mercury test system.

    (a) Identification. A mercury test system is a device intended to 
measure mercury, a heavy metal, in human specimens. Measurements 
obtained by this device are used in the diagnosis and treatment of 
mercury poisoning.
    (b) Classification. Class I.



Sec. 862.3610  Methamphetamine test system.

    (a) Identification. A methamphetamine test system is a device 
intended to measure methamphetamine, a central nervous system 
stimulating drug, in serum, plasma, and urine. Measurements obtained by 
this device are used in the diagnosis and treatment of methamphetamine 
use or overdose.
    (b) Classification. Class II (special controls). A methamphetamine 
test system is not exempt if it is intended for any use other than 
employment or insurance testing or is intended for Federal drug testing 
programs. The device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec. 862.9, provided the test system is intended for 
employment and insurance testing and includes a statement in the 
labeling that the device is intended solely for use in employment and 
insurance testing, and does not include devices intended for Federal 
drug testing programs (e.g., programs run by the Substance Abuse and 
Mental Health Services Administration (SAMHSA), the Department of 
Transportation (DOT), and the U.S. military).

[52 FR 16122, May 1, 1987, as amended at 84 FR 71798, Dec. 30, 2019]



Sec. 862.3620  Methadone test system.

    (a) Identification. A methadone test system is a device intended to 
measure methadone, an addictive narcotic pain-relieving drug, in serum 
and urine. Measurements obtained by this device are used in the 
diagnosis and treatment of methadone use or overdose and

[[Page 282]]

to determine compliance with regulations in methadone maintenance 
treatment.
    (b) Classification. Class II (special controls). A methadone test 
system is not exempt if it is intended for any use other than employment 
or insurance testing or is intended for Federal drug testing programs. 
The device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec. 862.9, provided the test system is intended for employment and 
insurance testing and includes a statement in the labeling that the 
device is intended solely for use in employment and insurance testing, 
and does not include devices intended for Federal drug testing programs 
(e.g., programs run by the Substance Abuse and Mental Health Services 
Administration (SAMHSA), the Department of Transportation (DOT), and the 
U.S. military).

[52 FR 16122, May 1, 1987, as amended at 84 FR 71798, Dec. 30, 2019]



Sec. 862.3630  Methaqualone test system.

    (a) Identification. A methaqualone test system is a device intended 
to measure methaqualone, a hypnotic and sedative drug, in urine. 
Measurements obtained by this device are used in the diagnosis and 
treatment of methaqualone use or overdose.
    (b) Classification. Class II (special controls). A methaqualone test 
system is not exempt if it is intended for any use other than employment 
or insurance testing or is intended for Federal drug testing programs. 
The device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec. 862.9, provided the test system is intended for employment and 
insurance testing and includes a statement in the labeling that the 
device is intended solely for use in employment and insurance testing, 
and does not include devices intended for Federal drug testing programs 
(e.g., programs run by the Substance Abuse and Mental Health Services 
Administration (SAMHSA), the Department of Transportation (DOT), and the 
U.S. military).

[52 FR 16122, May 1, 1987, as amended at 84 FR 71798, Dec. 30, 2019]



Sec. 862.3640  Morphine test system.

    (a) Identification. A morphine test system is a device intended to 
measure morphine, an addictive narcotic pain-relieving drug, and its 
analogs in serum, urine, and gastric contents. Measurements obtained by 
this device are used in the diagnosis and treatment of morphine use or 
overdose and in monitoring levels of morphine and its analogs to ensure 
appropriate therapy.
    (b) Classification. Class II (special controls). A morphine test 
system is not exempt if it is intended for any use other than employment 
or insurance testing or is intended for Federal drug testing programs. 
The device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec. 862.9, provided the test system is intended for employment and 
insurance testing and includes a statement in the labeling that the 
device is intended solely for use in employment and insurance testing, 
and does not include devices intended for Federal drug testing programs 
(e.g., programs run by the Substance Abuse and Mental Health Services 
Administration (SAMHSA), the Department of Transportation (DOT), and the 
U.S. military).

[52 FR 16122, May 1, 1987, as amended at 84 FR 71798, Dec. 30, 2019]



Sec. 862.3645  Neuroleptic drugs radioreceptor assay test system.

    (a) Identification. A neuroleptic drugs radioceptor assay test 
system is a device intended to measure in serum or plasma the dopamine 
receptor blocking activity of neuroleptic drugs and their active 
metabolites. A neuroleptic drug has anti-psychotic action affecting 
principally psychomotor activity, is generally without hypnotic effects, 
and is a tranquilizer. Measurements obtained by this device are used to 
aid in determining whether a patient is taking the prescribed dosage 
level of such drugs.
    (b) Classification. Class II.

[[Page 283]]



Sec. 862.3650  Opiate test system.

    (a) Identification. An opiate test system is a device intended to 
measure any of the addictive narcotic pain-relieving opiate drugs in 
blood, serum, urine, gastric contents, and saliva. An opiate is any 
natural or synthetic drug that has morphine-like pharmocological 
actions. The opiates include drugs such as morphine, morphine 
glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements 
obtained by this device are used in the diagnosis and treatment of 
opiate use or overdose and in monitoring the levels of opiate 
administration to ensure appropriate therapy.
    (b) Classification. Class II (special controls). An opiate test 
system is not exempt if it is intended for any use other than employment 
or insurance testing or is intended for Federal drug testing programs. 
The device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec. 862.9, provided the test system is intended for employment and 
insurance testing and includes a statement in the labeling that the 
device is intended solely for use in employment and insurance testing, 
and does not include devices intended for Federal drug testing programs 
(e.g., programs run by the Substance Abuse and Mental Health Services 
Administration (SAMHSA), the Department of Transportation (DOT), and the 
U.S. military).

[52 FR 16122, May 1, 1987, as amended at 84 FR 71798, Dec. 30, 2019]



Sec. 862.3652  Organophosphate test system.

    (a) Identification. An organophosphate test system is a device 
intended to measure organophosphate metabolites quantitatively in human 
urine from individuals who have signs and symptoms consistent with 
cholinesterase poisoning. The data obtained by this device is intended 
to aid in the confirmation and investigation of organophosphate 
exposure.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The distribution of these devices is limited to laboratories 
with experienced personnel who are trained to measure and evaluate 
organophosphate exposure and guide public health response.
    (2) Analytical testing must demonstrate the device has appropriate 
performance characteristics, including adequate precision and accuracy 
across the measuring range and near medical decision points.

[82 FR 48415, Oct. 18, 2017]



Sec. 862.3660  Phenobarbital test system.

    (a) Identification. A phenobarbitol test system is a device intended 
to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, 
in human specimens. Measurements obtained by this device are used in the 
diagnosis and treatment of phenobarbital use or overdose and in 
monitoring levels of phenobarbital to ensure appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3670  Phenothiazine test system.

    (a) Identification. A phenothiazine test system is a device intended 
to measure any of the drugs of the phenothiazine class in human 
specimens. Measurements obtained by this device are used in the 
diagnosis and treatment of phenothiazine use or overdose.
    (b) Classification. Class II.



Sec. 862.3680  Primidone test system.

    (a) Identification. A primidone test system is a device intended to 
measure primidone, an antiepileptic drug, in human specimens. 
Measurements obtained by this device are used in the diagnosis and 
treatment of primidone overdose and in monitoring levels of primidone to 
ensure appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3700  Propoxyphene test system.

    (a) Identification. A propoxyphene test system is a device intended 
to measure propoxyphene, a pain-relieving drug, in serum, plasma, and 
urine. Measurements obtained by this device are used in the diagnosis 
and treatment of propoxyphene use or overdose or in monitoring levels of

[[Page 284]]

propoxyphene to ensure appropriate therapy.
    (b) Classification. Class II (special controls). A propoxyphene test 
system is not exempt if it is intended for any use other than employment 
or insurance testing or is intended for Federal drug testing programs. 
The device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec. 862.9, provided the test system is intended for employment and 
insurance testing and includes a statement in the labeling that the 
device is intended solely for use in employment and insurance testing, 
and does not include devices intended for Federal drug testing programs 
(e.g., programs run by the Substance Abuse and Mental Health Services 
Administration (SAMHSA), the Department of Transportation (DOT), and the 
U.S. military).

[52 FR 16122, May 1, 1987, as amended at 84 FR 71798, Dec. 30, 2019]



Sec. 862.3750  Quinine test system.

    (a) Identification. A quinine test system is a device intended to 
measure quinine, a fever-reducing and pain-relieving drug intended in 
the treatment of malaria, in serum and urine. Measurements obtained by 
this device are used in the diagnosis and treatment of quinine overdose 
and malaria.
    (b) Classification. Class I.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21450, June 8, 1988; 65 
FR 2310, Jan. 14, 2000]



Sec. 862.3800  Reagents for molecular diagnostic instrument test systems.

    (a) Identification. Reagents for molecular diagnostic test systems 
are reagents other than analyte specific reagents used as part of 
molecular diagnostic test systems, such as polymerases, nucleotides and 
nucleotide mixes, master mixes in which individual reagents are 
optimized to be used together, and labeled nucleic acid molecules.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedure in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 862.9.

[82 FR 61163, Dec. 27, 2017]



Sec. 862.3830  Salicylate test system.

    (a) Identification. A salicylate test system is a device intended to 
measure salicylates, a class of analgesic, antipyretic and anti-
inflammatory drugs that includes aspirin, in human specimens. 
Measurements obtained by this device are used in diagnosis and treatment 
of salicylate overdose and in monitoring salicylate levels to ensure 
appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3840  Sirolimus test system.

    (a) Identification. A sirolimus test system is a device intended to 
quantitatively determine sirolimus concentrations in whole blood. 
Measurements are used as an aid in management of transplant patients 
receiving therapy with sirolimus.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance document entitled ``Class II Special Controls Guidance 
Document: Sirolimus Test Systems.'' See Sec. 862.1(d) for the 
availability of this guidance document.

[69 FR 58259, Sept. 30, 2004]



Sec. 862.3850  Sulfonamide test system.

    (a) Identification. A sulfonamide test system is a device intended 
to measure sulfonamides, any of the antibacterial drugs derived from 
sulfanilamide, in human specimens. Measurements obtained by this device 
are used in the diagnosis and treatment of sulfonamide overdose and in 
monitoring sulfonamide levels to ensure appropriate therapy.
    (b) Classification. Class I.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21450, June 8, 1988; 65 
FR 2310, Jan. 14, 2000]



Sec. 862.3870  Cannabinoid test system.

    (a) Identification. A cannabinoid test system is a device intended 
to measure any of the cannabinoids, hallucinogenic compounds endogenous 
to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds 
include delta-9-tetrahydrocannabinol,

[[Page 285]]

cannabidiol, cannabinol, and cannabichromene. Measurements obtained by 
this device are used in the diagnosis and treatment of cannabinoid use 
or abuse and in monitoring levels of cannabinoids during clinical 
investigational use.
    (b) Classification. Class II (special controls). A cannabinoid test 
system is not exempt if it is intended for any use other than employment 
or insurance testing or is intended for Federal drug testing programs. 
The device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec. 862.9, provided the test system is intended for employment and 
insurance testing and includes a statement in the labeling that the 
device is intended solely for use in employment and insurance testing, 
and does not include devices intended for Federal drug testing programs 
(e.g., programs run by the Substance Abuse and Mental Health Services 
Administration (SAMHSA), the Department of Transportation (DOT), and the 
U.S. military).

[52 FR 16122, May 1, 1987, as amended at 84 FR 71799, Dec. 30, 2019]



Sec. 862.3880  Theophylline test system.

    (a) Identification. A theophylline test system is a device intended 
to measure theophylline (a drug used for stimulation of the muscles in 
the cardiovascular, respiratory, and central nervous systems) in serum 
and plasma. Measurements obtained by this device are used in the 
diagnosis and treatment of theophylline overdose or in monitoring levels 
of theophylline to ensure appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3900  Tobramycin test system.

    (a) Identification. A tobramycin test system is a device intended to 
measure tobramycin, an aminoglycoside antibiotic drug, in plasma and 
serum. Measurements obtained by this device are used in the diagnosis 
and treatment of tobramycin overdose and in monitoring levels of 
tobramycin to ensure appropriate therapy.
    (b) Classification. Class II.



Sec. 862.3910  Tricyclic antidepressant drugs test system.

    (a) Identification. A tricyclic antidepressant drugs test system is 
a device intended to measure any of the tricyclic antidepressant drugs 
in serum. The tricyclic antidepressant drugs include imipramine, 
desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. 
Measurements obtained by this device are used in the diagnosis and 
treatment of chronic depression to ensure appropriate therapy.
    (b) Classification. Class II (special controls). A tricyclic 
antidepressant drugs test system is not exempt if it is intended for any 
use other than employment or insurance testing or is intended for 
Federal drug testing programs. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 862.9, provided the test system is intended 
for employment and insurance testing and includes a statement in the 
labeling that the device is intended solely for use in employment and 
insurance testing, and does not include devices intended for Federal 
drug testing programs (e.g., programs run by the Substance Abuse and 
Mental Health Services Administration (SAMHSA), the Department of 
Transportation (DOT), and the U.S. military).

[52 FR 16122, May 1, 1987, as amended at 84 FR 71799, Dec. 30, 2019]



Sec. 862.3950  Vancomycin test system.

    (a) Identification. A vancomycin test system is a device intended to 
measure vancomycin, an antibiotic drug, in serum. Measurements obtained 
by this device are used in the diagnosis and treatment of vancomycin 
overdose and in monitoring the level of vancomycin to ensure appropriate 
therapy.
    (b) Classification. Class II.



PART 864_HEMATOLOGY AND PATHOLOGY DEVICES--Table of Contents



                      Subpart A_General Provisions

Sec.
864.1 Scope.
864.3 Effective dates of requirement for premarket approval.

[[Page 286]]

864.9 Limitations of exemptions from section 510(k) of the Federal Food, 
          Drug, and Cosmetic Act (the act).

                       Subpart B_Biological Stains

864.1850 Dye and chemical solution stains.
864.1860 Immunohistochemistry reagents and kits.
864.1865 Cervical intraepithelial neoplasia (CIN) test system.
864.1866 Lynch syndrome test systems.
864.1870 Early growth response 1 (EGR1) gene fluorescence in-situ 
          hybridization (FISH) test system for specimen 
          characterization.

               Subpart C_Cell and Tissue Culture Products

864.2220 Synthetic cell and tissue culture media and components.
864.2240 Cell and tissue culture supplies and equipment.
864.2260 Chromosome culture kit.
864.2280 Cultured animal and human cells.
864.2360 Mycoplasma detection media and components.
864.2800 Animal and human sera.
864.2875 Balanced salt solutions or formulations.

           Subpart D_Pathology Instrumentation and Accessories

864.3010 Tissue processing equipment.
864.3250 Specimen transport and storage container.
864.3260 OTC test sample collection systems for drugs of abuse testing.
864.3300 Cytocentrifuge.
864.3400 Device for sealing microsections.
864.3600 Microscopes and accessories.
864.3700 Whole slide imaging system.
864.3750 Software algorithm device to assist users in digital pathology.
864.3800 Automated slide stainer.
864.3875 Automated tissue processor.

                 Subpart E_Specimen Preparation Reagents

864.4010 General purpose reagent.
864.4020 Analyte specific reagents.
864.4400 Enzyme preparations.

        Subpart F_Automated and Semi-Automated Hematology Devices

864.5200 Automated cell counter.
864.5220 Automated differential cell counter.
864.5240 Automated blood cell diluting apparatus.
864.5260 Automated cell-locating device.
864.5300 Red cell indices device.
864.5350 Microsedimentation centrifuge.
864.5400 Coagulation instrument.
864.5425 Multipurpose system for in vitro coagulation studies.
864.5600 Automated hematocrit instrument.
864.5620 Automated hemoglobin system.
864.5680 Automated heparin analyzer.
864.5700 Automated platelet aggregation system.
864.5800 Automated sedimentation rate device.
864.5850 Automated slide spinner.
864.5950 Blood volume measuring device.

                   Subpart G_Manual Hematology Devices

864.6100 Bleeding time device.
864.6150 Capillary blood collection tube.
864.6160 Manual blood cell counting device.
864.6400 Hematocrit measuring device.
864.6550 Occult blood test.
864.6600 Osmotic fragility test.
864.6650 Platelet adhesion test.
864.6675 Platelet aggregometer.
864.6700 Erythrocyte sedimentation rate test.

                 Subpart H_Hematology Kits and Packages

864.7010 Flow cytometric test system for hematopoietic neoplasms.
864.7040 Adenosine triphosphate release assay.
864.7060 Antithrombin III assay.
864.7100 Red blood cell enzyme assay.
864.7140 Activated whole blood clotting time tests.
864.7250 Erythropoietin assay.
864.7275 Euglobulin lysis time tests.
864.7280 Factor V Leiden DNA mutation detection systems.
864.7290 Factor deficiency test.
864.7300 Fibrin monomer paracoagulation test.
864.7320 Fibrinogen/fibrin degradation products assay.
864.7340 Fibrinogen determination system.
864.7360 Erythrocytic glucose-6-phosphate dehydrogenase assay.
864.7375 Glutathione reductase assay.
864.7400 Hemoglobin A2 assay.
864.7415 Abnormal hemoglobin assay.
864.7425 Carboxyhemoglobin assay.
864.7440 Electrophoretic hemoglobin analysis system.
864.7455 Fetal hemoglobin assay.
864.7470 Glycosylated hemoglobin assay.
864.7490 Sulfhemoglobin assay.
864.7500 Whole blood hemoglobin assays.
864.7525 Heparin assay.
864.7660 Leukocyte alkaline phosphatase test.
864.7675 Leukocyte peroxidase test.
864.7695 Platelet factor 4 radioimmunoassay.
864.7720 Prothrombin consumption test.
864.7735 Prothrombin-proconvertin test and thrombotest.

[[Page 287]]

864.7750 Prothrombin time test.
864.7825 Sickle cell test.
864.7875 Thrombin time test.
864.7900 Thromboplastin generation test.
864.7925 Partial thromboplastin time tests.

                      Subpart I_Hematology Reagents

864.8100 Bothrops atrox reagent.
864.8150 Calibrator for cell indices.
864.8165 Calibrator for hemoglobin or hematocrit measurement.
864.8175 Calibrator for platelet counting.
864.8185 Calibrator for red cell and white cell counting.
864.8200 Blood cell diluent.
864.8500 Lymphocyte separation medium.
864.8540 Red cell lysing reagent.
864.8625 Hematology quality control mixture.
864.8950 Russell viper venom reagent.

  Subpart J_Products Used In Establishments That Manufacture Blood and 
                             Blood Products

864.9050 Blood bank supplies.
864.9100 Empty container for the collection and processing of blood and 
          blood components.
864.9125 Vacuum-assisted blood collection system.
864.9145 Processing system for frozen blood.
864.9160 Blood group substances of nonhuman origin for in vitro 
          diagnostic use.
864.9165 Blood establishment computer software and accessories.
864.9175 Automated blood grouping and antibody test system.
864.9185 Blood grouping view box.
864.9195 Blood mixing devices and blood weighing devices.
864.9205 Blood and plasma warming device.
864.9225 Cell-freezing apparatus and reagents for in vitro diagnostic 
          use.
864.9245 Automated blood cell separator.
864.9275 Blood bank centrifuge for in vitro diagnostic use.
864.9285 Automated cell-washing centrifuge for immuno-hematology.
864.9300 Automated Coombs test systems.
864.9320 Copper sulfate solution for specific gravity determinations.
864.9400 Stabilized enzyme solution.
864.9550 Lectins and protectins.
864.9575 Environmental chamber for storage of platelet concentrate.
864.9600 Potentiating media for in vitro diagnostic use.
864.9650 Quality control kit for blood banking reagents.
864.9700 Blood storage refrigerator and blood storage freezer.
864.9750 Heat-sealing device.
864.9875 Transfer set.

Subpart K_Products Used In Establishments That Manufacture Human Cells, 
        Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

864.9900 Cord blood processing system and storage container.

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    Editorial Note: Nomenclature changes to part 864 appear at 73 FR 
35341, June 23, 2008.



                      Subpart A_General Provisions



Sec. 864.1  Scope.

    (a) This part sets forth the classification of hematology and 
pathology devices intended for human use that are in commercial 
distribution.
    (b) The identification of a device in a regulation in this part is 
not a precise description of every device that is, or will be, subject 
to the regulation. A manufacturer who submits a premarket notification 
submission for a device under part 807 may not show merely that the 
device is accurately described by the section title and identification 
provisions of a regulation in this part, but shall state why the device 
is substantially equivalent to other devices, as required by Sec. 
807.87.
    (c) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.
    (d) Guidance documents referenced in this part are available on the 
Internet at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/default.htm.

[52 FR 17732, May 11, 1987, as amended at 69 FR 12273, Mar. 16, 2004; 78 
FR 18233, Mar. 26, 2013; 79 FR 50552, Aug. 25, 2014]



Sec. 864.3  Effective dates of requirement for premarket approval.

    A device included in this part that is classified into class III 
(premarket approval) shall not be commercially distributed after the 
date shown in the regulation classifying the device unless the 
manufacturer has an approval under section 515 of the act (unless an 
exemption has been granted under section 520(g)(2) of the act). An 
approval under section 515 of the act consists of

[[Page 288]]

FDA's issuance of an order approving an application for premarket 
approval (PMA) for the device or declaring completed a product 
development protocol (PDP) for the device.
    (a) Before FDA requires that a device commercially distributed 
before the enactment date of the amendments, or a device that has been 
found substantially equivalent to such a device, has an approval under 
section 515 of the act FDA must promulgate a regulation under section 
515(b) of the act requiring such approval, except as provided in 
paragraph (b) of this section. Such a regulation under section 515(b) of 
the act shall not be effective during the grace period ending on the 
90th day after its promulgation or on the last day of the 30th full 
calendar month after the regulation that classifies the device into 
class III is effective, whichever is later. See section 501(f)(2)(B) of 
the act. Accordingly, unless an effective date of the requirement for 
premarket approval is shown in the regulation for a device classified 
into class III in this part, the device may be commercially distributed 
without FDA's issuance of an order approving a PMA or declaring 
completed a PDP for the device. If FDA promulgates a regulation under 
section 515(b) of the act requiring premarket approval for a device, 
section 501(f)(1)(A) of the act applies to the device.
    (b) Any new, not substantially equivalent, device introduced into 
commercial distribution on or after May 28, 1976, including a device 
formerly marketed that has been substantially altered, is classified by 
statute (section 513(f) of the act) into class III without any grace 
period and FDA must have issued an order approving a PMA or declaring 
completed a PDP for the device before the device is commercially 
distributed unless it is reclassified. If FDA knows that a device being 
commercially distributed may be a ``new'' device as defined in this 
section because of any new intended use or other reasons, FDA may codify 
the statutory classification of the device into class III for such new 
use. Accordingly, the regulation for such a class III device states that 
as of the enactment date of the amendments, May 28, 1976, the device 
must have an approval under section 515 of the act before commercial 
distribution.

[52 FR 17732, May 11, 1987]



Sec. 864.9  Limitations of exemptions from section 510(k) of 
the Federal Food, Drug, and Cosmetic Act (the act).

    The exemption from the requirement of premarket notification 
(section 510(k) of the act) for a generic type of class I or II device 
is only to the extent that the device has existing or reasonably 
foreseeable characteristics of commercially distributed devices within 
that generic type or, in the case of in vitro diagnostic devices, only 
to the extent that misdiagnosis as a result of using the device would 
not be associated with high morbidity or mortality. Accordingly, 
manufacturers of any commercially distributed class I or II device for 
which FDA has granted an exemption from the requirement of premarket 
notification must still submit a premarket notification to FDA before 
introducing or delivering for introduction into interstate commerce for 
commercial distribution the device when:
    (a) The device is intended for a use different from the intended use 
of a legally marketed device in that generic type of device; e.g., the 
device is intended for a different medical purpose, or the device is 
intended for lay use where the former intended use was by health care 
professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro diagnostic 
device detects or identifies infectious agents by using deoxyribonucleic 
acid (DNA) probe or nucleic acid hybridization technology rather than 
culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of neoplastic 
diseases with the exception of immunohistochemical devices;

[[Page 289]]

    (2) For use in screening or diagnosis of familial or acquired 
genetic disorders, including inborn errors of metabolism;
    (3) For measuring an analyte that serves as a surrogate marker for 
screening, diagnosis, or monitoring life-threatening diseases such as 
acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, 
tuberculosis, or myocardial infarction or to monitor therapy;
    (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) or IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is intended 
for use in matrices other than serum or plasma;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).

[65 FR 2310, Jan. 14, 2000]



                       Subpart B_Biological Stains



Sec. 864.1850  Dye and chemical solution stains.

    (a) Identification. Dye and chemical solution stains for medical 
purposes are mixtures of synthetic or natural dyes or nondye chemicals 
in solutions used in staining cells and tissues for diagnostic 
histopathology, cytopathology, or hematology.
    (b) Classification. Class I (general controls). These devices are 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9. These 
devices are also exempt from the current good manufacturing practice 
requirements of the quality system regulation in part 820 of this 
chapter, with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.

[45 FR 60583, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 
66 FR 38789, July 25, 2001]



Sec. 864.1860  Immunohistochemistry reagents and kits.

    (a) Identification. Immunohistochemistry test systems (IHC's) are in 
vitro diagnostic devices consisting of polyclonal or monoclonal 
antibodies labeled with directions for use and performance claims, which 
may be packaged with ancillary reagents in kits. Their intended use is 
to identify, by immunological techniques, antigens in tissues or 
cytologic specimens. Similar devices intended for use with flow 
cytometry devices are not considered IHC's.
    (b) Classification of immunohistochemistry devices. (1) Class I 
(general controls). Except as described in paragraphs (b)(2) and (b)(3) 
of this section, these devices are exempt from the premarket 
notification requirements in part 807, subpart E of this chapter. This 
exemption applies to IHC's that provide the pathologist with adjunctive 
diagnostic information that may be incorporated into the pathologist's 
report, but that is not ordinarily reported to the clinician as an 
independent finding. These IHC's are used after the primary diagnosis of 
tumor (neoplasm) has been made by conventional histopathology using 
nonimmunologic histochemical stains, such as hematoxylin and eosin. 
Examples of class I IHC's are differentiation markers that are used as 
adjunctive tests to subclassify tumors, such as keratin.
    (2) Class II (special control, guidance document: ``FDA Guidance for 
Submission of Immunohistochemistry Applications to the FDA,'' Center for 
Devices and Radiologic Health, 1998). These IHC's are intended for the 
detection and/or measurement of certain target analytes in order to 
provide prognostic or predictive data that are not directly confirmed by 
routine histopathologic internal and external control specimens. These 
IHC's provide the pathologist with information that is ordinarily 
reported as independent diagnostic information to the ordering 
clinician, and the claims associated with these data are widely accepted 
and supported by valid scientific evidence. Examples of class II IHC's 
are those intended for semiquantitative

[[Page 290]]

measurement of an analyte, such as hormone receptors in breast cancer.
    (3) Class III (premarket approval). IHC's intended for any use not 
described in paragraphs (b)(1) or (b)(2) of this section.
    (c) Date of PMA or notice of completion of a PDP is required. As of 
May 28, 1976, an approval under section 515 of the Federal Food, Drug, 
and Cosmetic Act is required for any device described in paragraph 
(b)(3) of this section before this device may be commercially 
distributed. See Sec. 864.3.

[63 FR 30142, June 3, 1998]



Sec. 864.1865  Cervical intraepithelial neoplasia (CIN) test system.

    (a) Identification. A cervical intraepithelial neoplasia (CIN) test 
system is a device used to detect a biomarker associated with CIN in 
human tissues. The device is indicated as an adjunct test and not to be 
used as a stand-alone device. The test results must be interpreted in 
the context of the patient's clinical history including, but not limited 
to, prior and current cervical biopsy results, Papanicolaou (Pap) test 
results, human papillomavirus (HPV) test results, and morphology on 
hematoxylin and eosin (H&E) stained sections. This device is not 
intended to detect the presence of HPV.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Premarket notification submissions must include the following 
information:
    (i) The indications for use must specify the biomarker that is 
intended to be identified and its adjunct use (e.g., adjunct to 
examination of H&E stained slides) to improve consistency in the 
diagnosis of CIN.
    (ii) Summary of professional society recommendations, as applicable.
    (iii) A detailed device description including:
    (A) A detailed description of all test components, including all 
provided reagents and required, but not provided, ancillary reagents.
    (B) A detailed description of instrumentation and equipment, 
including illustrations or photographs of non-standard equipment or 
manuals.
    (C) If applicable, detailed documentation of the device software, 
including, but not limited to, stand-alone software applications and 
hardware-based devices that incorporate software.
    (D) A detailed description of appropriate positive and negative 
controls that are recommended or provided.
    (E) Detailed specifications for sample collection, processing, and 
storage.
    (F) A detailed description of methodology and assay procedure.
    (G) A description of the assay cutoff (the medical decision point 
between positive and negative) or other relevant criteria that 
distinguishes positive and negative results, including the rationale for 
the chosen cutoff or other relevant criteria and results supporting 
validation of the cutoff.
    (H) Detailed specification of the criteria for test results 
interpretation and reporting.
    (iv) Detailed information demonstrating the performance 
characteristics of the device, including:
    (A) Analytical specificity studies such as, but not limited to, 
antibody characterization (e.g., Western Blot, peptide inhibition 
analysis), studies conducted on panels of normal tissues and neoplastic 
tissues, interference by endogenous and exogenous substances as well as 
cross-reactivity, as applicable.
    (B) Device analytical sensitivity data generated by testing an 
adequate number of samples from individuals with the target condition 
including limit of blank, limit of detection, and limit of 
quantification, as applicable.
    (C) Device precision/reproducibility data to evaluate within-run, 
between-run, between-day, between-lot, between-site, between-reader, 
within-reader and total precision, as applicable, using a panel of 
samples covering the device measuring range and/or the relevant disease 
categories (e.g. No CIN, CIN1, CIN2, CIN3, cervical cancer) and testing 
in replicates across multiple, nonconsecutive days.
    (D) Device robustness/guardbanding studies to assess the tolerance 
ranges for various critical test and specimen parameters.
    (E) Device stability data, including real-time stability and 
shipping stability under various storage times,

[[Page 291]]

temperatures, and freeze-thaw conditions.
    (F) Data from a clinical study demonstrating clinical validity using 
well-characterized prospectively or retrospectively obtained clinical 
specimens, as appropriate, representative of the intended use 
population. The study must evaluate the consistency of the diagnosis of 
CIN, for example, by comparing the levels of agreements of diagnoses 
rendered by community pathologists to those rendered by a panel of 
expert pathologists. Agreement for each CIN diagnostic category (e.g., 
No CIN, CIN1, CIN2, CIN3, cancer) and for alternate diagnostic 
categories (e.g., No CIN, low grade squamous intraepithelial lesion 
(LSIL)-histology, high grade squamous intraepithelial lesion (HSIL)-
histology, cancer) between reference diagnosis by expert pathologist and 
community pathologist must be evaluated, as applicable. In addition, 
agreements for CIN binary categories as =CIN2 (i.e., CIN2 or 
CIN3 or cancer) and <=CIN1 (i.e., No CIN or CIN1) between reference 
diagnosis by expert pathologist with H&E staining and community 
pathologist with H&E staining and agreements for alternate CIN binary 
categories as =HSIL-histology (i.e., HSIL-histology or 
cancer) and <=LSIL-histology (i.e., No CIN or LSIL-histology) between 
reference diagnosis by an expert pathologist with H&E + [biomarker 
specified in paragraph (b)(1)(i) of this section] and a community 
pathologist with H&E + [biomarker specified in paragraph (b)(1)(i) of 
this section] must be evaluated and compared, as applicable.
    (G) The staining performance of the device as determined by the 
community pathologists during review of the study slides must be 
evaluated. The staining performance criteria assessed must include 
overall staining acceptability, background staining acceptability, and 
morphology acceptability, as applicable.
    (H) Appropriate training requirements for users, including 
interpretation manual, as applicable.
    (I) Identification of risk mitigation elements used by the device, 
including a description of all additional procedures, methods, and 
practices incorporated into the instructions for use that mitigate risks 
associated with testing.
    (2) The device's 21 CFR 809.10(b) compliant labeling must include a 
detailed description of the protocol, including the information 
described in paragraph (b)(1)(ii) of this section, as applicable, and a 
detailed description of the performance studies performed and the 
summary of the results, including those that relate to paragraph 
(b)(1)(ii) of this section, as applicable.

[83 FR 234, Jan. 3, 2018]



Sec. 864.1866  Lynch syndrome test systems.

    (a) Identification. Lynch syndrome test systems are in vitro 
diagnostic tests for use with tumor tissue to identify previously 
diagnosed cancer patients at risk for having Lynch syndrome.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Premarket notification submissions must include the following 
information, as appropriate:
    (i) A detailed description of all test components, including all 
provided reagents, and required but not provided, ancillary reagents.
    (ii) A detailed description of instrumentation and equipment, 
including illustrations or photographs of non-standard equipment or 
manuals.
    (iii) Detailed documentation of the device software, including, but 
not limited to, standalone software applications and hardware-based 
devices that incorporate software.
    (iv) A detailed description of quality controls including 
appropriate positive and negative controls that are recommended or 
provided.
    (v) Detailed specifications for sample collection, processing, and 
storage.
    (vi) A detailed description of methodology and assay procedure.
    (vii) A description of the assay cut-off (i.e., the medical decision 
point between positive and negative results) or other relevant criteria 
that distinguishes positive and negative results, or ordinal classes of 
marker expression, including the rationale for the chosen cut-off or 
other relevant criteria and results supporting validation of the cut-
off.

[[Page 292]]

    (viii) Detailed specification of the criteria for test result 
interpretation and reporting.
    (ix) Detailed information demonstrating the performance 
characteristics of the device, including:
    (A) Data from an appropriate study demonstrating clinical accuracy 
using well-characterized clinical specimens representative of the 
intended use population (i.e., concordance to Deoxyribonucleic Acid 
(DNA) sequencing results of the Lynch syndrome associated genes or 
method comparison to the predicate device using samples with known 
alterations in genes representative of Lynch syndrome). Pre-specified 
acceptance criteria must be provided and followed.
    (B) Appropriate device reproducibility data investigating all 
sources of variance (e.g., for distributed tests, data generated using a 
minimum of three sites, of which at least two sites must be external 
sites). Each site must perform testing over a minimum of 5 
nonconsecutive days evaluating a sample panel that spans the claimed 
measuring range, and includes the clinical threshold. Pre-specified 
acceptance criteria must be provided and followed.
    (C) Data demonstrating reader reproducibility, both within-reader 
and between-reader, assessed by three readers over 3 nonconsecutive days 
at each site, including a 2 week washout period between reads, as 
appropriate.
    (D) Device precision data using clinical samples spanning the 
measuring range and controls to evaluate the within-lot, between-lot, 
within-run, between run, and total variation.
    (E) Analytical specificity studies including as appropriate, western 
blots, peptide inhibition, testing in normal tissues and neoplastic 
tissues, interference by endogenous and exogenous substances, and cross-
reactivity and cross contamination testing.
    (F) Device analytical sensitivity data generated by testing an 
adequate number of samples from individuals with the target condition 
such that prevalence of the biomarker in the target population is 
established.
    (G) Device stability data, including real-time stability and in-use 
stability, and stability evaluating various storage times, temperatures, 
and freeze-thaw conditions, as appropriate.
    (H) The staining performance criteria assessed must include overall 
staining acceptability, background staining acceptability, and 
morphology acceptability, as appropriate.
    (I) Appropriate training requirements for users, including 
interpretation manual, as applicable.
    (J) Identification of risk mitigation elements used by the device, 
including a description of all additional procedures, methods, and 
practices incorporated into the instructions for use that mitigate risks 
associated with testing.
    (2) The device's Sec. 809.10(b) of this chapter compliant labeling 
must include a detailed description of the protocol, including the 
information described in paragraphs (b)(1)(i) through (viii) of this 
section, as appropriate, and a detailed description of the performance 
studies performed and the summary of the results, including those that 
relate to paragraph (b)(1)(ix) of this section, as appropriate.

[83 FR 8357, Feb. 27, 2018]



Sec. 864.1870  Early growth response 1 (EGR1) gene fluorescence
in-situ hybridization (FISH) test system for specimen
characterization.

    (a) Identification. An early growth response 1 (EGR1) gene 
fluorescence in-situ hybridization (FISH) test system for specimen 
characterization is a device intended to detect the EGR1 probe target on 
chromosome 5q in bone marrow specimens from patients with acute myeloid 
leukemia (AML) or myelodysplastic syndrome (MDS). The assay results are 
intended to be interpreted only by a qualified pathologist or 
cytogeneticist. These devices do not include automated systems that 
directly report results without review and interpretation by a qualified 
pathologist or cytogeneticist. These devices also do not include any 
device intended for use to select patient therapy, predict patient 
response to therapy, or to screen for disease as well as any device with 
a claim for a particular diagnosis, prognosis, monitoring, or risk 
assessment.

[[Page 293]]

    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Premarket notification submissions must also include the 
following information:
    (i) A detailed description of all probes included in the kit;
    (ii) Purpose of each probe;
    (iii) Probe molecular specificity;
    (iv) Probe specificity;
    (v) Probe limits;
    (vi) Probe sensitivity;
    (vii) Specification of required ancillary reagents, instrumentation, 
and equipment;
    (viii) Specification of the specimen collection, processing, storage 
and slide preparation methods;
    (ix) Specification of the assay procedure;
    (x) Specification of control elements that are incorporated into the 
recommended testing procedures;
    (xi) Specification of risk mitigation elements: Description of all 
additional procedures, methods, and practices incorporated into the 
directions for use that mitigate risks associated with testing;
    (xii) Specification of the criteria for test result interpretation 
and reporting;
    (xiii) Device analytical sensitivity data;
    (xiv) Device analytical specificity data;
    (xv) Device reference limit data;
    (xvi) Device precision/reproducibility data;
    (xvii) Device stability data to include:
    (A) Real-time stability,
    (B) Freeze-thaw stability,
    (C) Transport and temperature stability,
    (D) Post-hybridization signal stability,
    (E) Photostability of probe, and
    (xviii) Documentation that demonstrates the clinical validity of the 
device. The documentation must include data from clinical studies, a 
minimum of two peer-reviewed published literature references using the 
specific device seeking marketing clearance, or both. Documentation for 
the clinical studies and peer-reviewed published literature references 
cited must include the following elements:
    (A) Documentation that the sponsor's probe was used in the 
literature reference,
    (B) Number and type of specimens,
    (C) Target population studied,
    (D) Upper reference limit, and
    (E) Range of positive probe results.
    (2) Your Sec. 809.10(b)(12) of this chapter compliant labeling must 
include a statement summarizing the data identified in paragraphs 
(b)(1)(xiii) through (xviii) of this section and a description of the 
studies supporting the information, including the pre-specified 
acceptance criteria for these performance studies, justification for the 
pre-specified acceptance criteria, and whether the pre-specified 
acceptance criteria were met.
    (3) Your Sec. 809.10 of this chapter compliant labeling must 
include:
    (i) A warning that reads ``The assay results are intended to be 
interpreted only by a qualified pathologist or cytogeneticist.''
    (ii) A warning that reads ``This device is not for high-risk uses 
such as selecting therapy, predicting therapeutic response or disease 
screening.''
    (iii) A warning that reads ``The use of this device for diagnosis, 
monitoring or risk assessment has not been established.''

[79 FR 52196, Sept. 3, 2014]



               Subpart C_Cell And Tissue Culture Products



Sec. 864.2220  Synthetic cell and tissue culture media and components.

    (a) Identification. Synthetic cell and tissue culture media and 
components are substances that are composed entirely of defined 
components (e.g., amino acids, vitamins, inorganic salts) that are 
essential for the survival and development of cell lines of humans and 
other animals. This does not include tissue culture media for human ex 
vivo tissue and cell culture processing applications as described in 
Sec. 876.5885 of this chapter.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 294]]

subpart E of part 807 of this chapter subject to the limitations in 
Sec. 864.9.

[45 FR 60583, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 
66 FR 27024, May 16, 2001; 66 FR 38789, July 25, 2001]



Sec. 864.2240  Cell and tissue culture supplies and equipment.

    (a) Identification. Cell and tissue culture supplies and equipment 
are devices that are used to examine, propagate, nourish, or grow cells 
and tissue cultures. These include such articles as slide culture 
chambers, perfusion and roller apparatus, cell culture suspension 
systems, and tissue culture flasks, disks, tubes, and roller bottles.
    (b) Classification. Class I (general controls). These devices are 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9. If the 
devices are not labeled or otherwise represented as sterile, they are 
exempt from the current good manufacturing practice requirements of the 
quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[45 FR 60584, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 
66 FR 38789, July 25, 2001]



Sec. 864.2260  Chromosome culture kit.

    (a) Identification. A chromosome culture kit is a device containing 
the necessary ingredients (e.g., Minimum Essential Media (MEM) of 
McCoy's 5A culture media, phytohemagglutinin, fetal calf serum, 
antibiotics, and heparin) used to culture tissues for diagnosis of 
congenital chromosome abnormalities.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 864.9.

[45 FR 60585, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 
66 FR 38789, July 25, 2001]



Sec. 864.2280  Cultured animal and human cells.

    (a) Identification. Cultured animal and human cells are in vitro 
cultivated cell lines from the tissue of humans or other animals which 
are used in various diagnostic procedures, particularly diagnostic 
virology and cytogenetic studies.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 864.9.

[45 FR 60585, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]



Sec. 864.2360  Mycoplasma detection media and components.

    (a) Identification. Mycoplasma detection media and components are 
used to detect and isolate mycoplasma pleuropneumonia-like organisms 
(PPLO), a common microbial contaminant in cell cultures.
    (b) Classification. Class I (general controls). These devices are 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60586, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 
66 FR 38789, July 25, 2001]



Sec. 864.2800  Animal and human sera.

    (a) Identification. Animal and human sera are biological products, 
obtained from the blood of humans or other animals, that provide the 
necessary growth-promoting nutrients in a cell culture system.
    (b) Classification. Class I (general controls). These devices are 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60586, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 
66 FR 38789, July 25, 2001]



Sec. 864.2875  Balanced salt solutions or formulations.

    (a) Identification. A balanced salt solution or formulation is a 
defined mixture of salts and glucose in a simple medium. This device is 
included as a necessary component of most cell culture systems. This 
media component controls for pH, osmotic pressure, energy source, and 
inorganic ions.
    (b) Classification. Class I (general controls). These devices are 
exempt from

[[Page 295]]

the premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 864.9.

[45 FR 60586, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 
66 FR 38789, July 25, 2001]



           Subpart D_Pathology Instrumentation and Accessories



Sec. 864.3010  Tissue processing equipment.

    (a) Identification. Tissue processing equipment consists of devices 
used to prepare human tissue specimens for diagnostic histological 
examination by processing specimens through the various stages of 
decalcifying, infiltrating, sectioning, and mounting on microscope 
slides.
    (b) Classification. Class I (general controls). These devices are 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9. The 
devices are also exempt from the current good manufacturing practice 
requirements of the quality system regulation in part 820 of this 
chapter, with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.

[45 FR 60587, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 
66 FR 38789, July 25, 2001]



Sec. 864.3250  Specimen transport and storage container.

    (a) Identification. A specimen transport and storage container, 
which may be empty or prefilled, is a device intended to contain 
biological specimens, body waste, or body exudate during storage and 
transport in order that the matter contained therein can be destroyed or 
used effectively for diagnostic examination. If prefilled, the device 
contains a fixative solution or other general purpose reagent to 
preserve the condition of a biological specimen added to the container. 
This section does not apply to specimen transport and storage containers 
that are intended for use as part of an over-the-counter test sample 
collection system for drugs of abuse testing.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 864.9. If the device is not labeled or 
otherwise represented as sterile, it is exempt from the current good 
manufacturing practice requirements of the quality system regulation in 
part 820 of this chapter, with the exception of Sec. 820.180 of this 
chapter, with respect to general requirements concerning records, and 
Sec. 820.198 of this chapter, with respect to complaint files.

[54 FR 47206, Nov. 13, 1989, as amended at 65 FR 2310, Jan. 14, 2000; 65 
FR 18234, Apr. 7, 2000]



Sec. 864.3260  OTC test sample collection systems for drugs of abuse testing.

    (a) Identification. An over-the-counter (OTC) test sample collection 
system for drugs of abuse testing is a device intended to: Collect 
biological specimens (such as hair, urine, sweat, or saliva), outside of 
a medical setting and not on order of a health care professional (e.g., 
in the home, insurance, sports, or workplace setting); maintain the 
integrity of such specimens during storage and transport in order that 
the matter contained therein can be tested in a laboratory for the 
presence of drugs of abuse or their metabolites; and provide access to 
test results and counseling. This section does not apply to collection, 
transport, or laboratory testing of biological specimens for the 
presence of drugs of abuse or their metabolites that is performed to 
develop evidence for law enforcement purposes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification requirements in part 807, subpart E of 
this chapter subject to the limitations in Sec. 864.9 if it is sold, 
distributed, and used in accordance with the restrictions set forth in 
Sec. 809.40 of this chapter. If the device is not labeled or otherwise 
represented as sterile, it is exempt from the current good manufacturing 
practice requirements of the quality system regulation in part 820 of 
this chapter, with the exception of Sec. 820.198 of this chapter with 
respect to complaint files.

[65 FR 18234, Apr. 7, 2000]

[[Page 296]]



Sec. 864.3300  Cytocentrifuge.

    (a) Identification. A cytocentrifuge is a centrifuge used to 
concentrate cells from biological cell suspensions (e.g., cerebrospinal 
fluid) and to deposit these cells on a glass microscope slide for 
cytological examination.
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60588, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 
66 FR 38789, July 25, 2001]



Sec. 864.3400  Device for sealing microsections.

    (a) Identification. A device for sealing microsections is an 
automated instrument used to seal stained cells and microsections for 
histological and cytological examination.
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60589, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 
66 FR 38789, July 25, 2001]



Sec. 864.3600  Microscopes and accessories.

    (a) Identification. Microscopes and accessories are optical 
instruments used to enlarge images of specimens, preparations, and 
cultures for medical purposes. Variations of microscopes and accessories 
(through a change in the light source) used for medical purposes include 
the following:
    (1) Phase contrast microscopes, which permit visualization of 
unstained preparations by altering the phase relationship of light that 
passes around the object and through the object.
    (2) Fluorescense microscopes, which permit examination of specimens 
stained with fluorochromes that fluoresce under ultraviolet light.
    (3) Inverted stage microscopes, which permit examination of tissue 
cultures or other biological specimens contained in bottles or tubes 
with the light source mounted above the specimen.
    (b) Classification. Class I (general controls). These devices are 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9. If the 
device is not labeled or otherwise represented as sterile, it is exempt 
from the current good manufacturing practice requirements of the quality 
system regulation in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.

[45 FR 60590, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 
66 FR 38789, July 25, 2001]



Sec. 864.3700  Whole slide imaging system.

    (a) Identification. The whole slide imaging system is an automated 
digital slide creation, viewing, and management system intended as an 
aid to the pathologist to review and interpret digital images of 
surgical pathology slides. The system generates digital images that 
would otherwise be appropriate for manual visualization by conventional 
light microscopy.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Premarket notification submissions must include the following 
information:
    (i) The indications for use must specify the tissue specimen that is 
intended to be used with the whole slide imaging system and the 
components of the system.
    (ii) A detailed description of the device and bench testing results 
at the component level, including for the following, as appropriate:
    (A) Slide feeder;
    (B) Light source;
    (C) Imaging optics;
    (D) Mechanical scanner movement;
    (E) Digital imaging sensor;
    (F) Image processing software;
    (G) Image composition techniques;
    (H) Image file formats;
    (I) Image review manipulation software;
    (J) Computer environment; and
    (K) Display system.
    (iii) Detailed bench testing and results at the system level, 
including for the following, as appropriate:

[[Page 297]]

    (A) Color reproducibility;
    (B) Spatial resolution;
    (C) Focusing test;
    (D) Whole slide tissue coverage;
    (E) Stitching error; and
    (F) Turnaround time.
    (iv) Detailed information demonstrating the performance 
characteristics of the device, including, as appropriate:
    (A) Precision to evaluate intra-system and inter-system precision 
using a comprehensive set of clinical specimens with defined, clinically 
relevant histologic features from various organ systems and diseases. 
Multiple whole slide imaging systems, multiple sites, and multiple 
readers must be included.
    (B) Reproducibility data to evaluate inter-site variability using a 
comprehensive set of clinical specimens with defined, clinically 
relevant histologic features from various organ systems and diseases. 
Multiple whole slide imaging systems, multiple sites, and multiple 
readers must be included.
    (C) Data from a clinical study to demonstrate that viewing, 
reviewing, and diagnosing digital images of surgical pathology slides 
prepared from tissue slides using the whole slide imaging system is non-
inferior to using an optical microscope. The study should evaluate the 
difference in major discordance rates between manual digital (MD) and 
manual optical (MO) modalities when compared to the reference (e.g., 
main sign-out diagnosis).
    (D) A detailed human factor engineering process must be used to 
evaluate the whole slide imaging system user interface(s).
    (2) Labeling compliant with 21 CFR 809.10(b) must include the 
following:
    (i) The intended use statement must include the information 
described in paragraph (b)(1)(i) of this section, as applicable, and a 
statement that reads, ``It is the responsibility of a qualified 
pathologist to employ appropriate procedures and safeguards to assure 
the validity of the interpretation of images obtained using this 
device.''
    (ii) A description of the technical studies and the summary of 
results, including those that relate to paragraphs (b)(1)(ii) and (iii) 
of this section, as appropriate.
    (iii) A description of the performance studies and the summary of 
results, including those that relate to paragraph (b)(1)(iv) of this 
section, as appropriate.
    (iv) A limiting statement that specifies that pathologists should 
exercise professional judgment in each clinical situation and examine 
the glass slides by conventional microscopy if there is doubt about the 
ability to accurately render an interpretation using this device alone.

[83 FR 22, Jan. 2, 2018]



Sec. 864.3750  Software algorithm device to assist users in digital pathology.

    (a) Identification. A software algorithm device to assist users in 
digital pathology is an in vitro diagnostic device intended to evaluate 
acquired scanned pathology whole slide images. The device uses software 
algorithms to provide information to the user about presence, location, 
and characteristics of areas of the image with clinical implications. 
Information from this device is intended to assist the user in 
determining a pathology diagnosis.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The intended use on the device's label and labeling required 
under Sec. 809.10 of this chapter must include:
    (i) Specimen type;
    (ii) Information on the device input(s) (e.g., scanned whole slide 
images (WSI), etc.);
    (iii) Information on the device output(s) (e.g., format of the 
information provided by the device to the user that can be used to 
evaluate the WSI, etc.);
    (iv) Intended users;
    (v) Necessary input/output devices (e.g., WSI scanners, viewing 
software, etc.);
    (vi) A limiting statement that addresses use of the device as an 
adjunct; and
    (vii) A limiting statement that users should use the device in 
conjunction with complete standard of care evaluation of the WSI.
    (2) The labeling required under Sec. 809.10(b) of this chapter must 
include:
    (i) A detailed description of the device, including the following:
    (A) Detailed descriptions of the software device, including the 
detection/

[[Page 298]]

analysis algorithm, software design architecture, interaction with 
input/output devices, and necessary third-party software;
    (B) Detailed descriptions of the intended user(s) and recommended 
training for safe use of the device; and
    (C) Clear instructions about how to resolve device-related issues 
(e.g., cybersecurity or device malfunction issues).
    (ii) A detailed summary of the performance testing, including test 
methods, dataset characteristics, results, and a summary of sub-analyses 
on case distributions stratified by relevant confounders, such as 
anatomical characteristics, patient demographics, medical history, user 
experience, and scanning equipment, as applicable.
    (iii) Limiting statements that indicate:
    (A) A description of situations in which the device may fail or may 
not operate at its expected performance level (e.g., poor image quality 
or for certain subpopulations), including any limitations in the dataset 
used to train, test, and tune the algorithm during device development;
    (B) The data acquired using the device should only be interpreted by 
the types of users indicated in the intended use statement; and
    (C) Qualified users should employ appropriate procedures and 
safeguards (e.g., quality control measures, etc.) to assure the validity 
of the interpretation of images obtained using this device.
    (3) Design verification and validation must include:
    (i) A detailed description of the device software, including its 
algorithm and its development, that includes a description of any 
datasets used to train, tune, or test the software algorithm. This 
detailed description of the device software must include:
    (A) A detailed description of the technical performance assessment 
study protocols (e.g., regions of interest (ROI) localization study) and 
results used to assess the device output(s) (e.g., image overlays, image 
heatmaps, etc.);
    (B) The training dataset must include cases representing different 
pre-analytical variables representative of the conditions likely to be 
encountered when used as intended (e.g., fixation type and time, 
histology slide processing techniques, challenging diagnostic cases, 
multiple sites, patient demographics, etc.);
    (C) The number of WSI in an independent validation dataset must be 
appropriate to demonstrate device accuracy in detecting and localizing 
ROIs on scanned WSI, and must include subsets clinically relevant to the 
intended use of the device;
    (D) Emergency recovery/backup functions, which must be included in 
the device design;
    (E) System level architecture diagram with a matrix to depict the 
communication endpoints, communication protocols, and security 
protections for the device and its supportive systems, including any 
products or services that are included in the communication pathway; and
    (F) A risk management plan, including a justification of how the 
cybersecurity vulnerabilities of third-party software and services are 
reduced by the device's risk management mitigations in order to address 
cybersecurity risks associated with key device functionality (such as 
loss of image, altered metadata, corrupted image data, degraded image 
quality, etc.). The risk management plan must also include how the 
device will be maintained on its intended platform (e.g. a general 
purpose computing platform, virtual machine, middleware, cloud-based 
computing services, medical device hardware, etc.), which includes how 
the software integrity will be maintained, how the software will be 
authenticated on the platform, how any reliance on the platform will be 
managed in order to facilitate implementation of cybersecurity controls 
(such as user authentication, communication encryption and 
authentication, etc.), and how the device will be protected when the 
underlying platform is not updated, such that the specific risks of the 
device are addressed (such as loss of image, altered metadata, corrupted 
image data, degraded image quality, etc.).
    (ii) Data demonstrating acceptable, as determined by FDA, analytical 
device performance, by conducting analytical studies. For each 
analytical

[[Page 299]]

study, relevant details must be documented (e.g., the origin of the 
study slides and images, reader/annotator qualifications, method of 
annotation, location of the study site(s), challenging diagnoses, etc.). 
The analytical studies must include:
    (A) Bench testing or technical testing to assess device output, such 
as localization of ROIs within a pre-specified threshold. Samples must 
be representative of the entire spectrum of challenging cases likely to 
be encountered when the device is used as intended; and
    (B) Data from a precision study that demonstrates device performance 
when used with multiple input devices (e.g., WSI scanners) to assess 
total variability across operators, within-scanner, between-scanner and 
between-site, using clinical specimens with defined, clinically 
relevant, and challenging characteristics likely to be encountered when 
the device is used as intended. Samples must be representative of the 
entire spectrum of challenging cases likely to be encountered when the 
device is used as intended. Precision, including performance of the 
device and reproducibility, must be assessed by agreement between 
replicates.
    (iii) Data demonstrating acceptable, as determined by FDA, clinical 
validation must be demonstrated by conducting studies with clinical 
specimens. For each clinical study, relevant details must be documented 
(e.g., the origin of the study slides and images, reader/annotator 
qualifications, method of annotation, location of the study site(s) (on-
site/remote), challenging diagnoses, etc.). The studies must include:
    (A) A study demonstrating the performance by the intended users with 
and without the software device (e.g., unassisted and device-assisted 
reading of scanned WSI of pathology slides). The study dataset must 
contain sufficient numbers of cases from relevant cohorts that are 
representative of the scope of patients likely to be encountered given 
the intended use of the device (e.g., subsets defined by clinically 
relevant confounders, challenging diagnoses, subsets with potential 
biopsy appearance modifiers, concomitant diseases, and subsets defined 
by image scanning characteristics, etc.) such that the performance 
estimates and confidence intervals for these individual subsets can be 
characterized. The performance assessment must be based on appropriate 
diagnostic accuracy measures (e.g., sensitivity, specificity, predictive 
value, diagnostic likelihood ratio, etc.).
    (B) [Reserved]

[88 FR 7009, Feb. 2, 2023]



Sec. 864.3800  Automated slide stainer.

    (a) Identification. An automated slide stainer is a device used to 
stain histology, cytology, and hematology slides for diagnosis.
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60591, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 
66 FR 38789, July 25, 2001]



Sec. 864.3875  Automated tissue processor.

    (a) Identification. An automated tissue processor is an automated 
system used to process tissue specimens for examination through 
fixation, dehydration, and infiltration.
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60591, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 
66 FR 38789, July 25, 2001]



                 Subpart E_Specimen Preparation Reagents



Sec. 864.4010  General purpose reagent.

    (a) A general purpose reagent is a chemical reagent that has general 
laboratory application, that is used to collect, prepare, and examine 
specimens from the human body for diagnostic purposes, and that is not 
labeled or otherwise intended for a specific diagnostic application. It 
may be either an individual substance, or multiple substances 
reformulated, which, when combined with or used in conjunction

[[Page 300]]

with an appropriate analyte specific reagent (ASR) and other general 
purpose reagents, is part of a diagnostic test procedure or system 
constituting a finished in vitro diagnostic (IVD) test. General purpose 
reagents are appropriate for combining with one or more than one ASR in 
producing such systems and include labware or disposable constituents of 
tests; but they do not include laboratory machinery, automated or 
powered systems. General purpose reagents include cytological 
preservatives, decalcifying reagents, fixative and adhesives, tissue 
processing reagents, isotonic solutions and pH buffers. Reagents used in 
tests for more than one individual chemical substance or ligand are 
general purpose reagents (e.g., Thermus aquaticus (TAQ) polymerase, 
substrates for enzyme immunoassay (EIA)).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 864.9. If the device is 
not labeled or otherwise represented as sterile, it is exempt from the 
current good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180, with respect to general requirements concerning records, and 
Sec. 820.198, with respect to complaint files.

[45 FR 60592, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 
62 FR 62260, Nov. 21, 1997; 66 FR 38789, July 25, 2001]



Sec. 864.4020  Analyte specific reagents.

    (a) Identification. Analyte specific reagents (ASR's) are 
antibodies, both polyclonal and monoclonal, specific receptor proteins, 
ligands, nucleic acid sequences, and similar reagents which, through 
specific binding or chemical reaction with substances in a specimen, are 
intended for use in a diagnostic application for identification and 
quantification of an individual chemical substance or ligand in 
biological specimens. ASR's that otherwise fall within this definition 
are not within the scope of subpart E of this part when they are sold 
to:
    (1) In vitro diagnostic manufacturers; or
    (2) Organizations that use the reagents to make tests for purposes 
other than providing diagnostic information to patients and 
practitioners, e.g., forensic, academic, research, and other nonclinical 
laboratories.
    (b) Classification. (1) Class I (general controls). Except as 
described in paragraphs (b)(2) and (b)(3) of this section, these devices 
are exempt from the premarket notification requirements in part 807, 
subpart E of this chapter.
    (2) Class II (special controls/guidance documents), when the analyte 
is used in blood banking tests that have been classified as class II 
devices (e.g., certain cytomegalovirus serological and treponema 
pallidum nontreponemal test reagents). Guidance Documents:

    1. ``Specifications for Immunological Testing for Infectious 
Disease; Approved Guideline,'' NCCLS Document I/LA18-A, December 1994.
    2. ``Assessment of the Clinical Accuracy of Laboratory Tests Using 
Receiver Operating Characteristic (ROC) Plots; Tentative Guideline,'' 
NCCLS Document KGP10-T, December 1993.
    3. ``Review Criteria for Assessment of In Vitro Diagnostic Devices 
for Direct Detection of Mycobacterium spp,'' FDA, July 6, 1993, and its 
``Attachment 1,'' February 28, 1994.
    4. ``Draft Review Criteria for Nucleic Acid Amplification-Based In 
Vitro Diagnostic Devices for Direct Detection of Infectious 
Microorganisms,'' FDA, July 6, 1993.
    5. The Center for Biologics Evaluation and Research, FDA, ``Points 
to Consider in the Manufacture and Clinical Evaluation of In Vitro Tests 
to Detect Antibodies to the Human Immunodeficiency Virus, Type I'' (54 
FR 48943, November 28, 1989).

    (3) Class III (premarket approval), when:
    (i) The analyte is intended as a component in a test intended for 
use in the diagnosis of a contagious condition that is highly likely to 
result in a fatal outcome and prompt, accurate diagnosis offers the 
opportunity to mitigate the public health impact of the condition (e.g., 
human immunodeficiency virus (HIV/AIDS)or tuberculosis (TB)); or
    (ii) The analyte is intended as a component in a test intended for 
use in donor screening for conditions for which FDA has recommended or 
required testing in order to safeguard the blood supply or establish the 
safe use

[[Page 301]]

of blood and blood products (e.g., tests for hepatitis or tests for 
identifying blood groups).
    (c) Date of 510(k), or date of PMA or notice of completion of a 
product development protocol is required. (1) Preamendments ASR's; No 
effective date has been established for the requirement for premarket 
approval for the device described in paragraph (b)(3) of this section. 
See Sec. 864.3.
    (2) For postamendments ASR's; November 23, 1998.
    (d) Restrictions. Restrictions on the sale, distribution and use of 
ASR's are set forth in Sec. 809.30 of this chapter.

[62 FR 62260, Nov. 21, 1997]



Sec. 864.4400  Enzyme preparations.

    (a) Identification. Enzyme preparations are products that are used 
in the histopathology laboratory for the following purposes:
    (1) To disaggregate tissues and cells already in established 
cultures for preparation into subsequent cultures (e.g., trypsin);
    (2) To disaggregate fluid specimens for cytological examination 
(e.g., papain for gastric lavage or trypsin for sputum liquefaction);
    (3) To aid in the selective staining of tissue specimens (e.g., 
diastase for glycogen determination).
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60592, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 
66 FR 38789, July 25, 2001]



        Subpart F_Automated and Semi-Automated Hematology Devices



Sec. 864.5200  Automated cell counter.

    (a) Identification. An automated cell counter is a fully-automated 
or semi-automated device used to count red blood cells, white blood 
cells, or blood platelets using a sample of the patient's peripheral 
blood (blood circulating in one of the body's extremities, such as the 
arm). These devices may also measure hemoglobin or hematocrit and may 
also calculate or measure one or more of the red cell indices (the 
erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or 
the mean corpuscular hemoglobin concentration). These devices may use 
either an electronic particle counting method or an optical counting 
method.
    (b) Classification. Class II (performance standards).

[45 FR 60593, Sept. 12, 1980]



Sec. 864.5220  Automated differential cell counter.

    (a) Identification. An automated differential cell counter is a 
device used to identify one or more of the formed elements of the blood. 
The device may also have the capability to flag, count, or classify 
immature or abnormal hematopoietic cells of the blood, bone marrow, or 
other body fluids. These devices may combine an electronic particle 
counting method, optical method, or a flow cytometric method utilizing 
monoclonal CD (cluster designation) markers. The device includes 
accessory CD markers.
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA document entitled ``Class II Special Controls 
Guidance Document: Premarket Notifications for Automated Differential 
Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for 
Industry and FDA.''

[67 FR 1607, Jan. 14, 2002]



Sec. 864.5240  Automated blood cell diluting apparatus.

    (a) Identification. An automated blood cell diluting apparatus is a 
fully automated or semi-automated device used to make appropriate 
dilutions of a blood sample for further testing.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 864.9.

[45 FR 60596, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]



Sec. 864.5260  Automated cell-locating device.

    (a) Identification. An automated cell-locating device is a device 
used to locate blood cells on a peripheral blood smear, allowing the 
operator to identify and classify each cell according to

[[Page 302]]

type. (Peripheral blood is blood circulating in one of the body's 
extremities, such as the arm.)
    (b) Classification. Class II (performance standards).

[45 FR 60597, Sept. 12, 1980]



Sec. 864.5300  Red cell indices device.

    (a) Identification. A red cell indices device, usually part of a 
larger system, calculates or directly measures the erythrocyte mean 
corpuscular volume (MCV), the mean corpuscular hemoglobin (MCH), and the 
mean corpuscular hemoglobin concentration (MCHC). The red cell indices 
are used for the differential diagnosis of anemias.
    (b) Classification. Class II (performance standards).

[45 FR 60597, Sept. 12, 1980]



Sec. 864.5350  Microsedimentation centrifuge.

    (a) Identification. A microsedimentation centrifuge is a device used 
to sediment red cells for the microsedimentation rate test.
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60598, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 
66 FR 38789, July 25, 2001]



Sec. 864.5400  Coagulation instrument.

    (a) Identification. A coagulation instrument is an automated or 
semiautomated device used to determine the onset of clot formation for 
in vitro coagulation studies.
    (b) Classification. Class II (special controls). A fibrometer or 
coagulation timer intended for use with a coagulation instrument is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60598, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]



Sec. 864.5425  Multipurpose system for in vitro coagulation studies.

    (a) Identification. A multipurpose system for in vitro coagulation 
studies is a device consisting of one automated or semiautomated 
instrument and its associated reagents and controls. The system is used 
to perform a series of coagulation studies and coagulation factor 
assays.
    (b) Classification. Class II (special controls). A control intended 
for use with a multipurpose system for in vitro coagulation studies is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60599, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]



Sec. 864.5600  Automated hematocrit instrument.

    (a) Identification. An automated hematocrit instrument is a fully 
automated or semi-automated device which may or may not be part of a 
larger system. This device measures the packed red cell volume of a 
blood sample to distinguish normal from abnormal states, such as anemia 
and erythrocytosis (an increase in the number of red cells).
    (b) Classification. Class II (performance standards).

[45 FR 60600, Sept. 12, 1980]



Sec. 864.5620  Automated hemoglobin system.

    (a) Identification. An automated hemoglobin system is a fully 
automated or semi-automated device which may or may not be part of a 
larger system. The generic type of device consists of the reagents, 
calibrators, controls, and instrumentation used to determine the 
hemoglobin content of human blood.
    (b) Classification. Class II (performance standards).

[45 FR 60601, Sept. 12, 1980]



Sec. 864.5680  Automated heparin analyzer.

    (a) Identification. An automated heparin analyzer is a device used 
to determine the heparin level in a blood sample by mixing the sample 
with protamine (a heparin-neutralizing substance) and determining 
photometrically the onset of air-activated clotting. The analyzer also 
determines the amount of protamine necessary to neutralize the heparin 
in the patient's circulation.

[[Page 303]]

    (b) Classification. Class II (special controls).

[45 FR 60601, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987; 
58 FR 51571, Oct. 4, 1993]



Sec. 864.5700  Automated platelet aggregation system.

    (a) Identification. An automated platelet aggregation system is a 
device used to determine changes in platelet shape and platelet 
aggregation following the addition of an aggregating reagent to a 
platelet-rich plasma.
    (b) Classification. Class II (performance standards).

[45 FR 60602, Sept. 12, 1980]



Sec. 864.5800  Automated sedimentation rate device.

    (a) Identification. An automated sedimentation rate device is an 
instrument that measures automatically the erythrocyte sedimentation 
rate in whole blood. Because an increased sedimentation rate indicates 
tissue damage or inflammation, the erythrocyte sedimentation rate device 
is useful in monitoring treatment of a disease.
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60602, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 
66 FR 38790, July 25, 2001]



Sec. 864.5850  Automated slide spinner.

    (a) Identification. An automated slide spinner is a device that 
prepares automatically a blood film on a microscope slide using a small 
amount of peripheral blood (blood circulating in one of the body's 
extremities, such as the arm).
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60603, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 
66 FR 38790, July 25, 2001]



Sec. 864.5950  Blood volume measuring device.

    (a) Identification. A blood volume measuring device is a manual, 
semiautomated, or automated system that is used to calculate the red 
cell mass, plasma volume, and total blood volume.
    (b) Classification. Class II (performance standards).

[45 FR 60603, Sept. 12, 1980]



                   Subpart G_Manual Hematology Devices



Sec. 864.6100  Bleeding time device.

    (a) Identification. A bleeding time device is a device, usually 
employing two spring-loaded blades, that produces two small incisions in 
the patient's skin. The length of time required for the bleeding to stop 
is a measure of the effectiveness of the coagulation system, primarily 
the platelets.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.

[45 FR 60604, Sept. 12, 1980, as amended at 63 FR 59225, Nov. 3, 1998]



Sec. 864.6150  Capillary blood collection tube.

    (a) Identification. A capillary blood collection tube is a plain or 
heparinized glass tube of very small diameter used to collect blood by 
capillary action.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 864.9.

[45 FR 60604, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 
65 FR 2310, Jan. 14, 2000]



Sec. 864.6160  Manual blood cell counting device.

    (a) Identification. A manual blood cell counting device is a device 
used to count red blood cells, white blood cells, or blood platelets.
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in

[[Page 304]]

subpart E of part 807 of this chapter subject to the limitations in 
Sec. 864.9.

[45 FR 60605, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 
66 FR 38790, July 25, 2001]



Sec. 864.6400  Hematocrit measuring device.

    (a) Identification. A hematocrit measuring device is a system 
consisting of instruments, tubes, racks, and a sealer and a holder. The 
device is used to measure the packed red cell volume in blood to 
determine whether the patient's total red cell volume is normal or 
abnormal. Abnormal states include anemia (an abnormally low total red 
cell volume) and erythrocytosis (an abnormally high total red cell 
mass). The packed red cell volume is produced by centrifuging a given 
volume of blood.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.

[45 FR 60606, Sept. 12, 1980, as amended at 63 FR 59225, Nov. 3, 1998]



Sec. 864.6550  Occult blood test.

    (a) Identification. An occult blood test is a device used to detect 
occult blood in urine or feces. (Occult blood is blood present in such 
small quantities that it can be detected only by chemical tests of 
suspected material, or by microscopic or spectroscopic examination.)
    (b) Classification. Class II (special controls). A control intended 
for use with an occult blood test is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 864.9.

[45 FR 60606, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]



Sec. 864.6600  Osmotic fragility test.

    (a) Identification. An osmotic fragility test is a device used to 
determine the resistance of red blood cells to hemolysis (destruction) 
in varying concentrations of hypotonic saline solutions.
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60607, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 
66 FR 38790, July 25, 2001]



Sec. 864.6650  Platelet adhesion test.

    (a) Identification. A platelet adhesion test is a device used to 
determine in vitro platelet function.
    (b) Classification. Class II (performance standards).

[45 FR 60608, Sept. 12, 1980]



Sec. 864.6675  Platelet aggregometer.

    (a) Identification. A platelet aggregometer is a device, used to 
determine changes in platelet shape and platelet aggregation following 
the addition of an aggregating reagent to a platelet rich plasma.
    (b) Classification. Class II (performance standards).

[45 FR 60608, Sept. 12, 1980]



Sec. 864.6700  Erythrocyte sedimentation rate test.

    (a) Identification. An erythrocyte sedimentation rate test is a 
device that measures the length of time required for the red cells in a 
blood sample to fall a specified distance or a device that measures the 
degree of sedimentation taking place in a given length of time. An 
increased rate indicates tissue damage or inflammation.
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60608, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 
66 FR 38790, July 25, 2001]



                 Subpart H_Hematology Kits and Packages



Sec. 864.7010  Flow cytometric test system for hematopoietic neoplasms.

    (a) Identification. A flow cytometric test for hematopoietic 
neoplasms is a device that consists of reagents for immunophenotyping of 
human cells in relation to the level of expression, antigen density, and 
distribution of

[[Page 305]]

specific cellular markers. These reagents are used as an aid in the 
differential diagnosis or monitoring of hematologically abnormal 
patients having or suspected of having hematopoietic neoplasms. The 
results should be interpreted by a pathologist or equivalent 
professional in conjunction with other clinical and laboratory findings.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Premarket notification submissions must include the following 
information:
    (i) The indications for use must indicate the clinical hematopoietic 
neoplasms for which the assay was designed and validated, for example, 
chronic leukemia or lymphoma.
    (ii) A detailed device description including the following:
    (A) A detailed description of all test components, all required 
reagents, and all instrumentation and equipment, including illustrations 
or photographs of nonstandard equipment or methods.
    (B) Detailed documentation of the device software including, but not 
limited to, standalone software applications and hardware-based devices 
that incorporate software.
    (C) A detailed description of methodology and assay procedure.
    (D) A description of appropriate internal and external quality 
control materials that are recommended or provided. The description must 
identify those control elements that are incorporated into the testing 
procedure, if applicable.
    (E) Detailed specifications for sample collection, processing, and 
storage.
    (F) Detailed specification of the criteria for test results 
interpretation and reporting including pre-established templates.
    (G) If applicable, based on the output of the results, a description 
of the specific number of events to collect, result outputs, and 
analytical sensitivity of the assay that will be reported.
    (iii) Information that demonstrates the performance characteristics 
of the test, including:
    (A) Device performance data from either a method comparison study 
comparing the specific lymphocyte cell markers to a predicate device or 
data collected through a clinical study demonstrating clinical validity 
using well-characterized clinical specimens. Samples must be 
representative of the intended use population of the device including 
hematologic neoplasms and the specific sample types for which the test 
is indicated for use.
    (B) If applicable, device performance data from a clinical study 
demonstrating clinical validity for parameters not established in a 
predicate device of this generic type using well-characterized 
prospectively obtained clinical specimens including all hematologic 
neoplasms and the specific sample types for which the device is 
indicated for use.
    (C) Device precision data using clinical samples to evaluate the 
within-lot, between-lot, within-run, between run, site-to-site and total 
variation using a minimum of three sites, of which at least two sites 
must be external sites. Results shall be reported as the standard 
deviation and percentage coefficient of variation for each level tested.
    (D) Reproducibility data generated using a minimum of three lots of 
reagents to evaluate mean fluorescence intensity and variability of the 
recovery of the different markers and/or cell populations.
    (E) Data from specimen and reagent carryover testing performed using 
well-established methods (e.g., CLSI H26-A2).
    (F) Specimen and prepared sample stability data established for each 
specimen matrix in the anticoagulant combinations and storage/use 
conditions that will be indicated.
    (G) A study testing anticoagulant equivalency in all claimed 
specimen type/anticoagulant combinations using clinical specimens that 
are representative of the intended use population of the device.
    (H) Analytic sensitivity data using a dilution panel created from 
clinical samples.
    (I) Analytical specificity data, including interference and cross-
contamination.
    (J) Device stability data, including real-time stability of reagents 
under various storage times and temperatures.

[[Page 306]]

    (K) For devices that include polyclonal antibodies, Fluorescence 
Minus One (FMO) studies to evaluate non-specific binding for all 
polyclonal antibodies. Each FMO tube is compared to reagent reference to 
demonstrate that no additional population appears when one marker is 
absent. Pre-specified acceptance criteria must be provided and followed.
    (L) For devices indicated for use as a semi-quantitative test, 
linearity data using a dilution panel created from clinical samples.
    (M) For devices indicated for use as a semi-quantitative test, 
clinically relevant analytical sensitivity data, including limit of 
blank, limit of detection, and limit of quantification.
    (iv) Identification of risk mitigation elements used by the device, 
including a detailed description of all additional procedures, methods, 
and practices incorporated into the instructions for use that mitigate 
risks associated with testing the device.
    (2) The 21 CFR 809.10 compliant labeling must include the following:
    (i) The intended use statement in the 21 CFR 809.10(a)(2) and (b)(2) 
compliant labeling must include a statement that the results should be 
interpreted by a pathologist or equivalent professional in conjunction 
with other clinical and laboratory findings. The intended use statement 
must also include information on what the device detects and measures, 
whether the device is qualitative, semi-quantitative, and/or 
quantitative, the clinical indications for which the device is to be 
used, and the specific population(s) for which the device is intended.
    (ii) A detailed description of the performance studies conducted to 
comply with paragraph (b)(1)(iii) of this section and a summary of the 
results.
    (3) As part of the risk management activities performed under 21 CFR 
820.30 design controls, product labeling and instruction manuals must 
include clear examples of all expected phenotypic patterns and gating 
strategies using well-defined clinical samples representative of both 
abnormal and normal cellular populations. These samples must be selected 
based upon the indications described in paragraph (b)(1)(i) of this 
section.

[82 FR 61165, Dec. 27, 2017]



Sec. 864.7040  Adenosine triphosphate release assay.

    (a) Identification. An adenosine triphosphate release assay is a 
device that measures the release of adenosine triphosphate (ATP) from 
platelets following aggregation. This measurement is made on platelet-
rich plasma using a photometer and a luminescent firefly extract. 
Simultaneous measurements of platelet aggregation and ATP release are 
used to evaluate platelet function disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 864.9.

[45 FR 60609, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]



Sec. 864.7060  Antithrombin III assay.

    (a) Identification. An antithrombin III assay is a device that is 
used to determine the plasma level of antithrombin III (a substance 
which acts with the anticoagulant heparin to prevent coagulation). This 
determination is used to monitor the administration of heparin in the 
treatment of thrombosis. The determination may also be used in the 
diagnosis of thrombophilia (a congenital deficiency of antithrombin 
III).
    (b) Classification. Class II (performance standards).

[45 FR 60609, Sept. 12, 1980]



Sec. 864.7100  Red blood cell enzyme assay.

    (a) Identification. Red blood cell enzyme assay is a device used to 
measure the activity in red blood cells of clinically important 
enzymatic reactions and their products, such as pyruvate kinase or 2,3-
diphosphoglycerate. A red blood cell enzyme assay is used to determine 
the enzyme defects responsible for a patient's hereditary hemolytic 
anemia.
    (b) Classification. Class II (performance standards).

[45 FR 60610, Sept. 12, 1980]

[[Page 307]]



Sec. 864.7140  Activated whole blood clotting time tests.

    (a) Identification. An activated whole blood clotting time tests is 
a device, used to monitor heparin therapy for the treatment of venous 
thrombosis or pulmonary embolism by measuring the coagulation time of 
whole blood.
    (b) Classification. Class II (performance standards).

[45 FR 60611, Sept. 12, 1980]



Sec. 864.7250  Erythropoietin assay.

    (a) Identification. A erythropoietin assay is a device that measures 
the concentration of erythropoietin (an enzyme that regulates the 
production of red blood cells) in serum or urine. This assay provides 
diagnostic information for the evaluation of erythrocytosis (increased 
total red cell mass) and anemia.
    (b) Classification. Class II. The special control for this device is 
FDA's ``Document for Special Controls for Erythropoietin Assay Premarket 
Notification (510(k)s).''

[45 FR 60612, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987; 
65 FR 17144, Mar. 31, 2000]



Sec. 864.7275  Euglobulin lysis time tests.

    (a) Identification. A euglobulin lysis time test is a device that 
measures the length of time required for the lysis (dissolution) of a 
clot formed from fibrinogen in the euglobulin fraction (that fraction of 
the plasma responsible for the formation of plasmin, a clot lysing 
enzyme). This test evaluates natural fibrinolysis (destruction of a 
blood clot after bleeding has been arrested). The test also will detect 
accelerated fibrinolysis.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60612, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]



Sec. 864.7280  Factor V Leiden DNA mutation detection systems.

    (a) Identification. Factor V Leiden deoxyribonucleic acid (DNA) 
mutation detection systems are devices that consist of different 
reagents and instruments which include polymerase chain reaction (PCR) 
primers, hybridization matrices, thermal cyclers, imagers, and software 
packages. The detection of the Factor V Leiden mutation aids in the 
diagnosis of patients with suspected thrombophilia.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance entitled ``Class II Special Controls Guidance 
Document: Factor V Leiden DNA Mutation Detection Systems.'' (See Sec. 
864.1(d) for the availability of this guidance document.)

[69 FR 12273, Mar. 16, 2004]



Sec. 864.7290  Factor deficiency test.

    (a) Identification. A factor deficiency test is a device used to 
diagnose specific coagulation defects, to monitor certain types of 
therapy, to detect coagulation inhibitors, and to detect a carrier state 
(a person carrying both a recessive gene for a coagulation factor 
deficiency such as hemophilia and the corresponding normal gene).
    (b) Classification. Class II (performance standards).

[45 FR 60613, Sept. 12, 1980]



Sec. 864.7300  Fibrin monomer paracoagulation test.

    (a) Identification. A fibrin monomer paracoagulation test is a 
device used to detect fibrin monomer in the diagnosis of disseminated 
intravascular coagulation (nonlocalized clotting within a blood vessel) 
or in the differential diagnosis between disseminated intravascular 
coagulation and primary fibrinolysis (dissolution of the fibrin in a 
blood clot).
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9. The 
special control for this device is FDA's ``In Vitro Diagnostic Fibrin 
Monomer Paracoagulation Test.'' See Sec. 864.1(d) for information on 
obtaining this document.

[45 FR 60614, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987; 
65 FR 17144, Mar. 31, 2000, 84 FR 71799, Dec. 30, 2019]

[[Page 308]]



Sec. 864.7320  Fibrinogen/fibrin degradation products assay.

    (a) Identification. A fibrinogen/fibrin degradation products assay 
is a device used to detect and measure fibrinogen degradation products 
and fibrin degradation products (protein fragments produced by the 
enzymatic action of plasmin on fibrinogen and fibrin) as an aid in 
detecting the presence and degree of intravascular coagulation and 
fibrinolysis (the dissolution of the fibrin in a blood clot) and in 
monitoring therapy for disseminated intravascular coagulation 
(nonlocalized clotting in the blood vessels).
    (b) Classification. Class II (performance standards).

[45 FR 60615, Sept. 12, 1980]



Sec. 864.7340  Fibrinogen determination system.

    (a) Identification. A fibrinogen determination system is a device 
that consists of the instruments, reagents, standards, and controls used 
to determine the fibrinogen levels in disseminated intravascular 
coagulation (nonlocalized clotting within the blood vessels) and primary 
fibrinolysis (the dissolution of fibrin in a blood clot).
    (b) Classification. Class II (special controls). A control or 
fibrinogen standard intended for use with a fibrinogen determination 
system is exempt from the premarket notification procedures in subpart E 
of part 807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60615, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]



Sec. 864.7360  Erythrocytic glucose-6-phosphate dehydrogenase assay.

    (a) Identification. An erythrocytic glucose-6-phosphate 
dehydrogenase assay is a device used to measure the activity of the 
enzyme glucose-6-phosphate dehydrogenase or of glucose-6-phosphate 
dehydrogenase isoenzymes. The results of this assay are used in the 
diagnosis and treatment of nonspherocytic congenital hemolytic anemia or 
drug-induced hemolytic anemia associated with a glucose-6-phosphate 
dehydrogenase deficiency. This generic device includes assays based on 
fluorescence, electrophoresis, methemoglobin reduction, catalase 
inhibition, and ultraviolet kinetics.
    (b) Classification. Class II (performance standards).

[45 FR 60616, Sept. 12, 1980]



Sec. 864.7375  Glutathione reductase assay.

    (a) Identification. A glutathione reductase assay is a device used 
to determine the activity of the enzyme glutathione reductase in serum, 
plasma, or erythrocytes by such techniques as fluorescence and 
photometry. The results of this assay are used in the diagnosis of liver 
disease, glutathione reductase deficiency, or riboflavin deficiency.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60616, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]



Sec. 864.7400  Hemoglobin A2 assay.

    (a) Identification. A hemoglobin A2 assay is a device 
used to determine the hemoglobin A2 content of human blood. 
The measurement of hemoglobin A2 is used in the diagnosis of 
the thalassemias (hereditary hemolytic anemias characterized by 
decreased synthesis of one or more types of hemoglobin polypeptide 
chains).
    (b) Classification. Class II (performance standards).

[45 FR 60617, Sept. 12, 1980]



Sec. 864.7415  Abnormal hemoglobin assay.

    (a) Identification. An abnormal hemoglobin assay is a device 
consisting of the reagents, apparatus, instrumentation, and controls 
necessary to isolate and identify abnormal genetically determined 
hemoglobin types.
    (b) Classification. Class II (special controls). A control intended 
for use with an abnormal hemoglobin assay is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 864.9.

[45 FR 60618, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]

[[Page 309]]



Sec. 864.7425  Carboxyhemoglobin assay.

    (a) Identification. A carboxyhemoglobin assay is a device used to 
determine the carboxyhemoglobin (the compound formed when hemoglobin is 
exposed to carbon monoxide) content of human blood as an aid in the 
diagnosis of carbon monoxide poisoning. This measurement may be made 
using methods such as spectroscopy, colorimetry, spectrophotometry, and 
gasometry.
    (b) Classification. Class II (performance standards).

[45 FR 60619, Sept. 12, 1980]



Sec. 864.7440  Electrophoretic hemoglobin analysis system.

    (a) Identification. An electrophoretic hemoglobin analysis system is 
a device that electrophoretically separates and identifies normal and 
abnormal hemoglobin types as an aid in the diagnosis of anemia or 
erythrocytosis (increased total red cell mass) due to a hemoglobin 
abnormality.
    (b) Classification. Class II (performance standards).

[45 FR 60620, Sept. 12, 1980]



Sec. 864.7455  Fetal hemoglobin assay.

    (a) Identification. A fetal hemoglobin assay is a device that is 
used to determine the presence and distribution of fetal hemoglobin 
(hemoglobin F) in red cells or to measure the amount of fetal hemoglobin 
present. The assay may be used to detect fetal red cells in the maternal 
circulation or to detect the elevated levels of fetal hemoglobin 
exhibited in cases of hemoglobin abnormalities such as thalassemia (a 
hereditary hemolytic anemia characterized by a decreased synthesis of 
one or more types of hemoglobin polypeptide chains). The hemoglobin 
determination may be made by methods such as electrophoresis, alkali 
denaturation, column chromatography, or radial immunodiffusion.
    (b) Classification. Class II (special controls). A fetal hemoglobin 
stain intended for use with a fetal hemoglobin assay is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 864.9.

[45 FR 60620, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]



Sec. 864.7470  Glycosylated hemoglobin assay.

    (a) Identification. A glycosylated hemoglobin assay is a device used 
to measure the glycosylated hemoglobins (A1a, A1b, 
and A1c) in a patient's blood by a column chromatographic 
procedure. Measurement of glycosylated hemoglobin is used to assess the 
level of control of a patient's diabetes and to determine the proper 
insulin dosage for a patient. Elevated levels of glycosylated hemoglobin 
indicate uncontrolled diabetes in a patient.
    (b) Classification. Class II (performance standards).

[45 FR 60621, Sept. 12, 1980]



Sec. 864.7490  Sulfhemoglobin assay.

    (a) Identification. A sulfhemoglobin assay is a device consisting of 
the reagents, calibrators, controls, and instrumentation used to 
determine the sulfhemoglobin (a compound of sulfur and hemoglobin) 
content of human blood as an aid in the diagnosis of sulfhemoglobinemia 
(presence of sulfhemoglobin in the blood due to drug administration or 
exposure to a poison). This measurement may be made using methods such 
as spectroscopy, colorimetry, spectrophotometry, or gasometry.
    (b) Classification. Class II (performance standards).

[45 FR 60621, Sept. 12, 1980]



Sec. 864.7500  Whole blood hemoglobin assays.

    (a) Identification. A whole blood hemoglobin assay is a device 
consisting or reagents, calibrators, controls, or photometric or 
spectrophotometric instrumentation used to measure the hemoglobin 
content of whole blood for the detection of anemia. This generic device 
category does not include automated hemoglobin systems.
    (b) Classification. Class II (special controls). An acid hematin 
intended for use with whole blood hemoglobin assays is exempt from the 
premarket notification procedures in subpart E of

[[Page 310]]

part 807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60622, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]



Sec. 864.7525  Heparin assay.

    (a) Identification. A heparin assay is a device used to determine 
the level of the anticoagulant heparin in the patient's circulation. 
These assays are quantitative clotting time procedures using the effect 
of heparin on activated coagulation factor X (Stuart factor) or 
procedures based on the neutralization of heparin by protamine sulfate 
(a protein that neutralizes heparin).
    (b) Classification. Class II (performance standards).

[45 FR 60623, Sept. 12, 1980]



Sec. 864.7660  Leukocyte alkaline phosphatase test.

    (a) Identification. A leukocyte alkaline phosphatase test is a 
device used to identify the enzyme leukocyte alkaline phosphatase in 
neutrophilic granulocytes (granular leukocytes stainable by neutral 
dyes). The cytochemical identification of alkaline phosphatase depends 
on the formation of blue granules in cells containing alkaline 
phosphatase. The results of this test are used to differentiate chronic 
granulocytic leukemia (a malignant disease characterized by excessive 
overgrowth of granulocytes in the bone marrow) and reactions that 
resemble true leukemia, such as those occuring in severe infections and 
polycythemia (increased total red cell mass).
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60623, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 
66 FR 38790, July 25, 2001]



Sec. 864.7675  Leukocyte peroxidase test.

    (a) Identification. A leukocyte peroxidase test is a device used to 
distinguish certain myeloid cells derived from the bone marrow, i.e., 
neutrophils, eosinophils, and monocytes, from lymphoid cells of the 
lymphatic system and erythroid cells of the red blood cell series on the 
basis of their peroxidase activity as evidenced by staining. The results 
of this test are used in the differential diagnosis of the leukemias.
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60624, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 
66 FR 38790, July 25, 2001]



Sec. 864.7695  Platelet factor 4 radioimmunoassay.

    (a) Identification. A platelet factor 4 radioimmunoassay is a device 
used to measure the level of platelet factor 4, a protein released 
during platelet activation by radioimmunoassay. This device measures 
platelet activiation, which may indicate a coagulation disorder, such as 
myocardial infarction or coronary artery disease.
    (b) Classification. Class II (performance standards).

[45 FR 60625, Sept. 12, 1980; 46 FR 14890, Mar. 3, 1981]



Sec. 864.7720  Prothrombin consumption test.

    (a) Identification. A prothrombin consumption tests is a device that 
measures the patient's capacity to generate thromboplastin in the 
coagulation process. The test also is an indirect indicator of 
qualitative or quantitative platelet abnormalities. It is a screening 
test for thrombocytopenia (decreased number of blood platelets) and 
hemophilia A and B.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60625, Sept. 12, 1980, as amended at 84 FR 71800, Dec. 30, 2019]



Sec. 864.7735  Prothrombin-proconvertin test and thrombotest.

    (a) Identification. The prothrombin-proconvertin test and 
thrombotest are devices used in the regulation of coumarin therapy 
(administration of a

[[Page 311]]

coumarin anticoagulant such as sodium warfarin in the treatment of 
venous thrombosis and pulmonary embolism) and as a diagnostic test in 
conjunction with, or in place of, the Quick prothrombin time test to 
detect coagulation disorders.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60626, Sept. 12, 1980, as amended at 84 FR 71800, Dec. 30, 2019]



Sec. 864.7750  Prothrombin time test.

    (a) Identification. A prothrombin time test is a device used as a 
general screening procedure for the detection of possible clotting 
factor deficiencies in the extrinsic coagulation pathway, which involves 
the reaction between coagulation factors III and VII, and to monitor 
patients receiving coumarin therapy (the administration of one of the 
coumarin anticoagulants in the treatment of venous thrombosis or 
pulmonary embolism).
    (b) Classification. Class II (performance standards).

[45 FR 60626, Sept. 12, 1980]



Sec. 864.7825  Sickle cell test.

    (a) Identification. A sickle cell test is a device used to determine 
the sickle cell hemoglobin content of human blood to detect sickle cell 
trait or sickle cell diseases.
    (b) Classification. Class II (performance standards).

[45 FR 60627, Sept. 12, 1980]



Sec. 864.7875  Thrombin time test.

    (a) Identification. A thrombin time test is a device used to measure 
fibrinogen concentration and detect fibrin or fibrinogen split products 
for the evaluation of bleeding disorders.
    (b) Classification. Class II (performance standards).

[45 FR 60628, Sept. 12, 1980]



Sec. 864.7900  Thromboplastin generation test.

    (a) Identification. A thromboplastin generation test is a device 
used to detect and identify coagulation factor deficiencies and 
coagulation inhibitors.
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60628, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 
66 FR 38790, July 25, 2001]



Sec. 864.7925  Partial thromboplastin time tests.

    (a) Identification. A partial thromboplastin time test is a device 
used for primary screening for coagulation abnormalities, for evaluation 
of the effect of therapy on procoagulant disorders, and as an assay for 
coagulation factor deficiencies of the intrinsic coagulation pathway.
    (b) Classification. Class II (performance standards).

[45 FR 60629, Sept. 12, 1980]



                      Subpart I_Hematology Reagents



Sec. 864.8100  Bothrops atrox reagent.

    (a) Identification. A Bothrops atrox reagent is a device made from 
snake venom and used to determine blood fibrinogen levels to aid in the 
evaluation of disseminated intravascular coagulation (nonlocalized 
clotting in the blood vessels) in patients receiving heparin therapy 
(the administration of the anticoagulant heparin in the treatment of 
thrombosis) or as an aid in the classification of dysfibrinogenemia 
(presence in the plasma of functionally defective fibrinogen).
    (b) Classification. Class II (performance standards).

[45 FR 60629, Sept. 12, 1980]



Sec. 864.8150  Calibrator for cell indices.

    (a) Identification. A calibrator for cell indices is a device that 
approximates whole blood or certain blood cells and that is used to set 
an instrument intended to measure mean cell volume (MCV), mean 
corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin 
concentration (MCHC), or other cell indices. It is a suspension of 
particles or cells whose size, shape, concentration, and other 
characteristics

[[Page 312]]

have been precisely and accurately determined.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60631, Sept. 12, 1980, as amended at 84 FR 71800, Dec. 30, 2019]



Sec. 864.8165  Calibrator for hemoglobin or hematocrit measurement.

    (a) Identification. A calibrator for hemoglobin or hematocrit 
measurement is a device that approximates whole blood, red blood cells, 
or a hemoglobin derivative and that is used to set instruments intended 
to measure hemoglobin, the hematocrit, or both. It is a material whose 
characteristics have been precisely and accurately determined.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60632, Sept. 12, 1980, as amended at 84 FR 71800, Dec. 30, 2019]



Sec. 864.8175  Calibrator for platelet counting.

    (a) Identification. A calibrator for platelet counting is a device 
that resembles platelets in plasma or whole blood and that is used to 
set a platelet counting instrument. It is a suspension of particles or 
cells whose size, shape concentration, and other characteristics have 
been precisely and accurately determined.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60633, Sept. 12, 1980, as amended at 84 FR 71800, Dec. 30, 2019]



Sec. 864.8185  Calibrator for red cell and white cell counting.

    (a) Identification. A calibrator for red cell and white cell 
counting is a device that resembles red or white blood cells and that is 
used to set instruments intended to count red cells, white cells, or 
both. It is a suspension of particles or cells whose size, shape, 
concentration, and other characteristics have been precisely and 
accurately determined.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60634, Sept. 12, 1980, as amended at 84 FR 71800, Dec. 30, 2019]



Sec. 864.8200  Blood cell diluent.

    (a) Identification. A blood cell diluent is a device used to dilute 
blood for further testing, such as blood cell counting.
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60635, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 
66 FR 38790, July 25, 2001]



Sec. 864.8500  Lymphocyte separation medium.

    (a) Identification. A lymphocyte separation medium is a device used 
to isolate lymphocytes from whole blood.
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60636, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 
66 FR 38790, July 25, 2001]



Sec. 864.8540  Red cell lysing reagent.

    (a) Identification. A red cell lysing reagent is a device used to 
lyse (destroy) red blood cells for hemoglobin determinations or aid in 
the counting of white blood cells.
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60636, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 
66 FR 38790, July 25, 2001]



Sec. 864.8625  Hematology quality control mixture.

    (a) Identification. A hematology quality control mixture is a device 
used to

[[Page 313]]

ascertain the accuracy and precision of manual, semiautomated, and 
automated determinations of cell parameters such as white cell count 
(WBC), red cell count (RBC), platelet count (PLT), hemoglobin, 
hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular 
hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).
    (b) Classification. Class II (special controls). Except when 
intended for use in blood components, the device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 864.9.

[45 FR 60637, Sept. 12, 1980, as amended at 84 FR 71800, Dec. 30, 2019]



Sec. 864.8950  Russell viper venom reagent.

    (a) Identification. Russell viper venom reagent is a device used to 
determine the cause of an increase in the prothrombin time.
    (b) Classification. Class I (general controls).

[45 FR 60637, Sept. 12, 1980]



  Subpart J_Products Used In Establishments That Manufacture Blood and 
                             Blood Products



Sec. 864.9050  Blood bank supplies.

    (a) Identification. Blood bank supplies are general purpose devices 
intended for in vitro use in blood banking. This generic type of device 
includes products such as blood bank pipettes, blood grouping slides, 
blood typing tubes, blood typing racks, and cold packs for antisera 
reagents. The device does not include articles that are licensed by the 
Center for Biologics Evaluation and Research of the Food and Drug 
Administration.
    (b) Classification. Class I (general controls).

[45 FR 60638, Sept. 12, 1980, as amended at 53 FR 11253, Apr. 6, 1988]



Sec. 864.9100  Empty container for the collection and processing
of blood and blood components.

    (a) Identification. An empty container for the collection and 
processing of blood and blood components is a device intended for 
medical purposes that is an empty plastic bag or plastic or glass bottle 
used to collect, store, or transfer blood and blood components for 
further processing.
    (b) Classification. Class II (performance standards).

[45 FR 60638, Sept. 12, 1980]



Sec. 864.9125  Vacuum-assisted blood collection system.

    (a) Identification. A vacuum-assisted blood collection system is a 
device intended for medical purposes that uses a vacuum to draw blood 
for subsequent reinfusion.
    (b) Classification. Class I (general controls). The manual device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.

[45 FR 60639, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]



Sec. 864.9145  Processing system for frozen blood.

    (a) Identification. A processing system for frozen blood is a device 
used to glycerolize red blood cells prior to freezing to minimize 
hemolysis (disruption of the red cell membrane accompanied by the 
release of hemoglobin) due to freezing and thawing of red blood cells 
and to deglycerolize and wash thawed cells for subsequent reinfusion.
    (b) Classification. Class II (performance standards).

[45 FR 60639, Sept. 12, 1980]



Sec. 864.9160  Blood group substances of nonhuman origin for in
vitro diagnostic use.

    (a) Identification. Blood group substances of nonhuman origin for in 
vitro diagnostic use are materials, such as blood group specific 
substances prepared from nonhuman sources (e.g., pigs, cows, and horses) 
used to detect, identify, or neutralize antibodies to various human 
blood group antigens. This generic type of device does not include 
materials that are licensed by the Center for Biologics Evaluation and 
Research of the Food and Drug Administration.

[[Page 314]]

    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.

[45 FR 60640, Sept. 12, 1980, as amended at 53 FR 11253, Apr. 6, 1988; 
63 FR 59225, Nov. 3, 1998]



Sec. 864.9165  Blood establishment computer software and accessories.

    (a) Identification. Blood establishment computer software (BECS) is 
a device used in the manufacture of blood and blood components to assist 
in the prevention of disease in humans by identifying ineligible donors, 
by preventing the release of unsuitable blood and blood components for 
transfusion or for further manufacturing into products for human 
treatment or diagnosis, by performing compatibility testing between 
donor and recipient, or by performing positive identification of 
patients and blood components at the point of transfusion to prevent 
transfusion reactions. This generic type of device may include a BECS 
accessory, a device intended for use with BECS to augment the 
performance of the BECS or to expand or modify its indications for use.
    (b) Classification. Class II (special controls). The special 
controls for these devices are:
    (1) Software performance and functional requirements including 
detailed design specifications (e.g., algorithms or control 
characteristics, alarms, device limitations, and safety requirements).
    (2) Verification and validation testing and hazard analysis must be 
performed.
    (3) Labeling must include:
    (i) Software limitations;
    (ii) Unresolved anomalies, annotated with an explanation of the 
impact on safety or effectiveness;
    (iii) Revision history; and
    (iv) Hardware and peripheral specifications.
    (4) Traceability matrix must be performed.
    (5) Performance testing to ensure the safety and effectiveness of 
the system must be performed, including when adding new functional 
requirements (e.g., electrical safety, electromagnetic compatibility, or 
wireless coexistence).

[83 FR 23217, June 18, 2018]



Sec. 864.9175  Automated blood grouping and antibody test system.

    (a) Identification. An automated blood grouping and antibody test 
system is a device used to group erythrocytes (red blood cells) and to 
detect antibodies to blood group antigens.
    (b) Classification. Class II (performance standards).

[45 FR 60641, Sept. 12, 1980]



Sec. 864.9185  Blood grouping view box.

    (a) Identification. A blood grouping view box is a device with a 
glass or plastic viewing surface, which may be illuminated and heated, 
that is used to view cell reactions in antigen-antibody testing.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 864.9.

[45 FR 60641, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]



Sec. 864.9195  Blood mixing devices and blood weighing devices.

    (a) Identification. A blood mixing device is a device intended for 
medical purposes that is used to mix blood or blood components by 
agitation. A blood weighing device is a device intended for medical 
purposes that is used to weigh blood or blood components as they are 
collected.
    (b) Classification. Class I (general controls). The manual device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.

[45 FR 60642, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]



Sec. 864.9205  Blood and plasma warming device.

    (a) Nonelectromagnetic blood or plasma warming device--(1) 
Identification. A nonelectromagnetic blood and plasma warming device is 
a device that warms blood or plasma, by means other than electromagnetic 
radiation, prior to administration.

[[Page 315]]

    (2) Classification. Class II (performance standards).
    (b) Electromagnetic blood and plasma warming device--(1) 
Identification. An electromagnetic blood and plasma warming device is a 
device that employs electromagnetic radiation (radiowaves or microwaves) 
to warm a bag or bottle of blood or plasma prior to administration.
    (2) Classfication. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval for the device described in paragraph (b)(1). See Sec. 864.3.

[45 FR 60642, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987]



Sec. 864.9225  Cell-freezing apparatus and reagents for in vitro 
diagnostic use.

    (a) Identification. Cell-freezing apparatus and reagents for in 
vitro diagnostic use are devices used to freeze human red blood cells 
for in vitro diagnostic use.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 864.9.

[45 FR 60643, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]



Sec. 864.9245  Automated blood cell separator.

    (a) Identification. An automated blood cell separator is a device 
that uses a centrifugal or filtration separation principle to 
automatically withdraw whole blood from a donor, separate the whole 
blood into blood components, collect one or more of the blood 
components, and return to the donor the remainder of the whole blood and 
blood components. The automated blood cell separator device is intended 
for routine collection of blood and blood components for transfusion or 
further manufacturing use.
    (b) Classification. Class II (special controls). The special control 
for this device is a guidance for industry and FDA staff entitled 
``Class II Special Controls Guidance Document: Automated Blood Cell 
Separator Device Operating by Centrifugal or Filtration Separation 
Principle.''

[72 FR 67644, Nov. 30, 2007]



Sec. 864.9275  Blood bank centrifuge for in vitro diagnostic use.

    (a) Identification. A blood bank centrifuge for in vitro diagnostic 
use is a device used only to separate blood cells for further diagnostic 
testing.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 864.9.

[45 FR 60645, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]



Sec. 864.9285  Automated cell-washing centrifuge for immuno-hematology.

    (a) Identification. An automated cell-washing centrifuge for immuno-
hematology is a device used to separate and prepare cells and sera for 
further in vitro diagnostic testing.
    (b) Classification. Class II (performance standards).

[45 FR 60646, Sept. 12, 1980]



Sec. 864.9300  Automated Coombs test systems.

    (a) Identification. An automated Coombs test system is a device used 
to detect and identify antibodies in patient sera or antibodies bound to 
red cells. The Coombs test is used for the diagnosis of hemolytic 
disease of the newborn, and autoimmune hemolytic anemia. The test is 
also used in crossmatching and in investigating transfusion reactions 
and drug-induced red cell sensitization.
    (b) Classification. Class II (performance standards).

[45 FR 60646, Sept. 12, 1980]



Sec. 864.9320  Copper sulfate solution for specific gravity 
determinations.

    (a) Identification. A copper sulfate solution for specific gravity 
determinations is a device used to determine whether the hemoglobin 
content of a potential donor's blood meets the required level (12.5 
grams per 100 milliliters of blood for women and 13.5 grams per 100 
milliliters of blood for men).

[[Page 316]]

    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 864.9.

[45 FR 60647, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]



Sec. 864.9400  Stabilized enzyme solution.

    (a) Identification. A stabilized enzyme solution is a reagent 
intended for medical purposes that is used to enhance the reactivity of 
red blood cells with certain antibodies, including antibodies that are 
not detectable by other techniques. These enzyme solutions include 
papain, bromelin, ficin, and trypsin.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60647, Sept. 12, 1980, as amended at 84 FR 71800, Dec. 30, 2019]



Sec. 864.9550  Lectins and protectins.

    (a) Identification. Lectins and protectins are proteins derived from 
plants and lower animals that cause cell agglutination in the presence 
of certain antigens. These substances are used to detect blood group 
antigens for in vitro diagnostic purposes.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.

[45 FR 60648, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998]



Sec. 864.9575  Environmental chamber for storage of platelet concentrate.

    (a) Identification. An environmental chamber for storage of platelet 
concentrate is a device used to hold platelet-rich plasma within a 
preselected temperature range.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.

[45 FR 60648, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998]



Sec. 864.9600  Potentiating media for in vitro diagnostic use.

    (a) Identification. Potentiating media for in vitro diagnostic use 
are media, such as bovine albumin, that are used to suspend red cells 
and to enhance cell reactions for antigen-antibody testing.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.

[45 FR 60649, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998]



Sec. 864.9650  Quality control kit for blood banking reagents.

    (a) Identification. A quality control kit for blood banking reagents 
is a device that consists of sera, cells, buffers, and antibodies used 
to determine the specificity, potency, and reactivity of the cells and 
reagents used for blood banking.
    (b) Classification. Class II (performance standards).

[45 FR 60649, Sept. 12, 1980]



Sec. 864.9700  Blood storage refrigerator and blood storage freezer.

    (a) Identification. A blood storage refrigerator and a blood storage 
freezer are devices intended for medical purposes that are used to 
preserve blood and blood products by storing them at cold or freezing 
temperatures.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.

[45 FR 60650, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998]



Sec. 864.9750  Heat-sealing device.

    (a) Identification. A heat-sealing device is a device intended for 
medical purposes that uses heat to seal plastic bags containing blood or 
blood components.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 864.9.

[45 FR 60650, Sept. 12, 1980, as amended at 65 FR 2311, Jan. 14, 2000]

[[Page 317]]



Sec. 864.9875  Transfer set.

    (a) Identification. A transfer set is a device intended for medical 
purposes that consists of a piece of tubing with suitable adaptors used 
to transfer blood or plasma from one container to another.
    (b) Classification. Class II (performance standards).

[45 FR 60651, Sept. 12, 1980]



Subpart K_Products Used In Establishments That Manufacture Human Cells, 
        Tissues, and Cellular and Tissue-Based Products (HCT/Ps)



Sec. 864.9900  Cord blood processing system and storage container.

    (a) Identification. A cord blood processing system and storage 
container is a device intended for use in the processing and the storage 
of cord blood. This device is a functionally closed processing system 
that includes containers, other soft goods, and a centrifugation system 
for cord blood concentration, and a final container for the 
cryopreservation and the storage of a cord blood product.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's guidance document entitled ``Class II Special 
Controls Guidance Document: Cord Blood Processing System and Storage 
Container.'' For the availability of this guidance document, see Sec. 
864.1(d).

[72 FR 4638, Feb. 1, 2007]



PART 866_IMMUNOLOGY AND MICROBIOLOGY DEVICES--Table of Contents



                      Subpart A_General Provisions

Sec.
866.1 Scope.
866.3 Effective dates of requirement for premarket approval.
866.9 Limitations of exemptions from section 510(k) of the Federal Food, 
          Drug, and Cosmetic Act (the act).

                      Subpart B_Diagnostic Devices

866.1620 Antimicrobial susceptibility test disc.
866.1640 Antimicrobial susceptibility test powder.
866.1645 Fully automated short-term incubation cycle antimicrobial 
          susceptibility system.
866.1655 System for detection of microorganisms and antimicrobial 
          resistance using reporter expression.
866.1700 Culture medium for antimicrobial susceptibility tests.

                     Subpart C_Microbiology Devices

866.2050 Staphylococcal typing bacteriophage.
866.2120 Anaerobic chamber.
866.2160 Coagulase plasma.
866.2170 Automated colony counter.
866.2180 Manual colony counter.
866.2190 Automated image assessment system for microbial colonies on 
          solid culture media.
866.2300 Multipurpose culture medium.
866.2320 Differential culture medium.
866.2330 Enriched culture medium.
866.2350 Microbiological assay culture medium.
866.2360 Selective culture medium.
866.2390 Transport culture medium.
866.2410 Culture medium for pathogenic Neisseria spp.
866.2420 Oxidase screening test for gonorrhea.
866.2440 Automated medium dispensing and stacking device.
866.2450 Supplement for culture media.
866.2480 Quality control kit for culture media.
866.2500 Microtiter diluting and dispensing device.
866.2540 Microbiological incubator.
866.2560 Microbial growth monitor.
866.2580 Gas-generating device.
866.2600 Wood's fluorescent lamp.
866.2660 Microorganism differentiation and identification device.
866.2680 Streptococcus spp. nucleic acid-based assay.
866.2850 Automated zone reader.
866.2900 Microbiological specimen collection and transport device.

                     Subpart D_Serological Reagents

866.3010 Acinetobacter calcoaceticus serological reagents.
866.3020 Adenovirus serological reagents.
866.3035 Arizona spp. serological reagents.
866.3040 Aspergillus spp. serological reagents.
866.3045 In vitro diagnostic device for Bacillus spp. detection.
866.3050 Beta-glucan serological assays.
866.3060 Blastomyces dermatitidis serological reagents.
866.3065 Bordetella spp. serological reagents.
866.3085 Brucella spp. serological reagents.
866.3110 Campylobacter fetus serological reagents.
866.3120 Chlamydia serological reagents.

[[Page 318]]

866.3125 Citrobacter spp. serological reagents.
866.3130 Clostridium difficile toxin gene amplification assay.
866.3135 Coccidioides immitis serological reagents.
866.3140 Corynebacterium spp. serological reagents.
866.3145 Coxsackievirus serological reagents.
866.3165 Cryptococcus neoformans serological reagents.
866.3169 Hepatitis C virus antibody tests.
866.3170 Nucleic acid-based hepatitis C virus ribonucleic acid tests.
866.3175 Cytomegalovirus serological reagents.
866.3200 Echinococcus spp. serological reagents.
866.3205 Echovirus serological reagents.
866.3210 Endotoxin assay.
866.3215 Device to detect and measure non-microbial analyte(s) in human 
          clinical specimens to aid in assessment of patients with 
          suspected sepsis.
866.3220 Entamoeba histolytica serological reagents.
866.3225 Enterovirus nucleic acid assay.
866.3235 Epstein-Barr virus serological reagents.
866.3240 Equine encephalomyelitis virus serological reagents.
866.3250 Erysipelothrix rhusiopathiae serological reagents.
866.3255 Escherichia coli serological reagents.
866.3270 Flavobacterium spp. serological reagents.
866.3280 Francisella tularensis serological reagents.
866.3290 Gonococcal antibody test (GAT).
866.3300 Haemophilus spp. serological reagents.
866.3305 Herpes simplex virus serological assays.
866.3309 Herpes virus nucleic acid-based cutaneous and mucocutaneous 
          lesion panel.
866.3310 Hepatitis A virus (HAV) serological assays.
866.3320 Histoplasma capsulatum serological reagents.
866.3328 Influenza virus antigen detection test system.
866.3330 Influenza virus serological reagents.
866.3332 Reagents for detection of specific novel influenza A viruses.
866.3336 John Cunningham Virus serological reagents.
866.3340 Klebsiella spp. serological reagents.
866.3350 Leptospira spp. serological reagents.
866.3355 Listeria spp. serological reagents.
866.3360 Lymphocytic choriomeningitis virus serological reagents.
866.3361 Mass spectrometer system for clinical use for the 
          identification of microorganisms.
866.3365 Multiplex nucleic acid assay for identification of 
          microorganisms and resistance markers from positive blood 
          cultures.
866.3370 Mycobacterium tuberculosis immunofluorescent reagents.
866.3372 Nucleic acid-based in vitro diagnostic devices for the 
          detection of Mycobacterium tuberculosis complex in respiratory 
          specimens.
866.3373 Nucleic acid-based in vitro diagnostic devices for the 
          detection of Mycobacterium tuberculosis complex (MTB-complex) 
          and the genetic mutations associated with MTB-complex 
          antibiotic resistance in respiratory specimens.
866.3375 Mycoplasma spp. serological reagents.
866.3380 Mumps virus serological reagents.
866.3390 Neisseria spp. direct serological test reagents.
866.3395 Norovirus serological reagents.
866.3400 Parainfluenza virus serological reagents.
866.3402 Plasmodium species antigen detection assays.
866.3405 Poliovirus serological reagents.
866.3410 Proteus spp. (Weil-Felix) serological reagents.
866.3415 Pseudomonas spp. serological reagents.
866.3460 Rabiesvirus immunofluorescent reagents.
866.3470 Reovirus serological reagents.
866.3480 Respiratory syncytial virus serological reagents.
866.3490 Rhinovirus serological reagents.
866.3500 Rickettsia serological reagents.
866.3510 Rubella virus serological reagents.
866.3520 Rubeola (measles) virus serological reagents.
866.3550 Salmonella spp. serological reagents.
866.3600 Schistosoma spp. serological reagents.
866.3630 Serratia spp. serological reagents.
866.3660 Shigella spp. serological reagents.
866.3680 Sporothrix schenckii serological reagents.
866.3700 Staphylococcus aureus serological reagents.
866.3720 Streptococcus spp. exoenzyme reagents.
866.3740 Streptococcus spp. serological reagents.
866.3780 Toxoplasma gondii serological reagents.
866.3820 Treponema pallidum nontreponemal test reagents.
866.3830 Treponema pallidum treponemal test reagents.
866.3850 Trichinella spiralis serological reagents.
866.3860 Trichomonas vaginalis nucleic acid assay.
866.3870 Trypanosoma spp. serological reagents.
866.3900 Varicella-zoster virus serological reagents.

[[Page 319]]

866.3920 Assayed quality control material for clinical microbiology 
          assays.
866.3930 Vibrio cholerae serological reagents.
866.3940 West Nile virus serological reagents.
866.3945 Dengue virus serological reagents.
866.3946 Dengue virus nucleic acid amplification test reagents.
866.3950 In vitro human immunodeficiency virus (HIV) drug resistance 
          genotype assay.
866.3955 Human immunodeficiency virus (HIV) drug resistance genotyping 
          assay using next generation sequencing technology.
866.3956 Human immunodeficiency virus (HIV) serological diagnostic and/
          or supplemental test.
866.3957 Human immunodeficiency virus (HIV) nucleic acid (NAT) 
          diagnostic and/or supplemental test.
866.3958 Human immunodeficiency virus (HIV) viral load monitoring test.
866.3960 Nucleic acid-based device for the amplification, detection, and 
          identification of microbial pathogens directly from whole 
          blood specimens.
866.3970 Device to detect and identify microbial pathogen nucleic acids 
          in cerebrospinal fluid.
866.3980 Respiratory viral panel multiplex nucleic acid assay.
866.3985 Device to detect and identify microorganisms and associated 
          resistance marker nucleic acids directly in respiratory 
          specimens.
866.3990 Gastrointestinal microorganism multiplex nucleic acid-based 
          assay.

         Subpart E_Immunology Laboratory Equipment and Reagents

866.4070 RNA Preanalytical Systems.
866.4100 Complement reagent.
866.4500 Immunoelectrophoresis equipment.
866.4520 Immunofluorometer equipment.
866.4540 Immunonephelometer equipment.
866.4600 Ouchterlony agar plate.
866.4700 Automated fluorescence in situ hybridization (FISH) enumeration 
          systems.
866.4750 Automated indirect immunofluorescence microscope and software-
          assisted system.
866.4800 Radial immunodiffusion plate.
866.4830 Rocket immunoelectrophoresis equipment.
866.4900 Support gel.

                  Subpart F_Immunological Test Systems

866.5040 Albumin immunological test system.
866.5060 Prealbumin immunological test system.
866.5065 Human allotypic marker immuno logical test system.
866.5080 Alpha-1-antichymotrypsin immuno logical test system.
866.5090 Antimitochondrial antibody immuno logical test system.
866.5100 Antinuclear antibody immuno logical test system.
866.5110 Antiparietal antibody immuno logical test system.
866.5120 Antismooth muscle antibody immunological test system.
866.5130 Alpha-1-antitrypsin immunological test system.
866.5150 Bence-Jones proteins immunological test system.
866.5160 Beta-globulin immunological test system.
866.5170 Breast milk immunological test system.
866.5180 Fecal calprotectin immunological test system.
866.5200 Carbonic anhydrase B and C immunological test system.
866.5210 Ceruloplasmin immunological test system.
866.5220 Cohn fraction II immunological test system.
866.5230 Colostrum immunological test system.
866.5240 Complement components immuno logical test system.
866.5250 Complement C1 inhibitor (inact ivator) immunological 
          test system.
866.5260 Complement C3b inactivator immunological test 
          system.
866.5270 C-reactive protein immunological test system.
866.5320 Properidin factor B immunological test system.
866.5330 Factor XIII, A, S, immunological test system.
866.5340 Ferritin immunological test system.
866.5350 Fibrinopeptide A immunological test system.
866.5360 Cohn fraction IV immunological test system.
866.5370 Cohn fraction V immunological test system.
866.5380 Free secretory component immuno logical test system.
866.5400 Alpha-globulin immunological test system.
866.5420 Alpha-1-glycoproteins immuno logical test system.
866.5425 Alpha-2-glycoproteins immuno logical test system.
866.5430 Beta-2-glycoprotein I immuno logical test system.
866.5440 Beta-2-glycoprotein III immuno logical test system.
866.5460 Haptoglobin immunological test system.
866.5470 Hemoglobin immunological test system.
866.5490 Hemopexin immunological test system.

[[Page 320]]

866.5500 Hypersensitivity pneumonitis immunological test system.
866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
866.5520 Immunoglobulin G (Fab fragment specific) immunological test 
          system.
866.5530 Immunoglobulin G (Fc fragment specific) immunological test 
          system.
866.5540 Immunoglobulin G (Fd fragment specific) immunological test 
          system.
866.5550 Immunoglobulin (light chain specific) immunological test 
          system.
866.5560 Lactic dehydrogenase immuno logical test system.
866.5570 Lactoferrin immunological test system.
866.5580 Alpha-1-lipoprotein immunological test system.
866.5590 Lipoprotein X immunological test system.
866.5600 Low-density lipoprotein immuno logical test system.
866.5620 Alpha-2-macroglobulin immuno logical test system.
866.5630 Beta-2-microglobulin immuno logical test system.
866.5640 Infectious mononucleosis immuno logical test system.
866.5660 Multiple autoantibodies immuno logical test system.
866.5665 Aquaporin-4 autoantibody immunological test system.
866.5670 Zinc transporter 8 autoantibody immunological test system.
866.5680 Myoglobin immunological test system.
866.5700 Whole human plasma or serum immunological test system.
866.5715 Plasminogen immunological test system.
866.5735 Prothrombin immunological test system.
866.5750 Radioallergosorbent (RAST) immuno logical test system.
866.5760 Tryptase test system.
866.5765 Retinol-binding protein immuno logical test system.
866.5775 Rheumatoid factor immunological test system.
866.5785 Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) 
          test systems.
866.5800 Seminal fluid (sperm) immuno logical test system.
866.5820 Systemic lupus erythematosus immuno logical test system.
866.5830 Brain trauma assessment test.
866.5860 Total spinal fluid immunological test system.
866.5870 Thyroid autoantibody immuno logical test system.
866.5880 Transferrin immunological test system.
866.5890 Inter-alpha trypsin inhibitor immunological test system.
866.5900 Cystic fibrosis transmembrane conductance regulator (CFTR) gene 
          mutation detection system.
866.5910 Quality control material for cystic fibrosis nucleic acid 
          assays.
866.5930 Newborn screening test for severe combined immunodeficiency 
          disorder (SCID).
866.5940 Autosomal recessive carrier screening gene mutation detection 
          system.
866.5950 Genetic health risk assessment system.
866.5960 Human leukocyte antigen typing companion diagnostic test.

      Subpart G_Tumor Associated Antigen Immunological Test Systems

866.6010 Tumor associated antigen immunological test system.
866.6020 Immunomagnetic circulating cancer cell selection and 
          enumeration system.
866.6030 AFP-L3% immunological test system.
866.6040 Gene expression profiling test system for breast cancer 
          prognosis.
866.6050 Ovarian adnexal mass assessment score test system.
866.6060 BCR-ABL quantitation test.
866.6080 Next generation sequencing based tumor profiling test.

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    Source: 47 FR 50823, Nov. 9, 1982, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 866 appear at 73 FR 
35341, June 23, 2008.



                      Subpart A_General Provisions



Sec. 866.1  Scope.

    (a) This part sets forth the classification of immunology and 
microbiology devices intended for human use that are in commercial 
distribution.
    (b) The indentification of a device in a regulation in this part is 
not a precise description of every device that is, or will be, subject 
to the regulation. A manufacturer who submits a premarket notification 
submission for a device under part 807 may not show merely that the 
device is accurately described by the section title and identification 
provisions of a regulation in this part, but shall state why the device 
is substantially equivalent to other devices, as required by Sec. 
807.87.
    (c) To avoid duplicative listings, an immunology and microbiology 
device that has two or more types of uses (e.g., used both as a 
diagnostic device and as a microbiology device) is listed only in one 
subpart.

[[Page 321]]

    (d) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.
    (e) Guidance documents referenced in this part are available on the 
Internet at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/default.htm.

[52 FR 17733, May 11, 1987, as amended at 68 FR 5827, Feb. 5, 2003; 79 
FR 50552, Aug. 25, 2014]



Sec. 866.3  Effective dates of requirement for premarket approval.

    A device included in this part that is classified into class III 
(Premarket approval) shall not be commercially distributed after the 
date shown in the regulation classifying the device unless the 
manufacturer has an approval under section 515 of the act (unless an 
exemption has been granted under section 520(g)(2) of the act). An 
approval under section 515 of the act consists of FDA's issuance of an 
order approving an application for premarket approval (PMA) for the 
device or declaring completed a product development protocol (PDP) for 
the device.
    (a) Before FDA requires that a device commercially distributed 
before the enactment date of the amendments, or a device that has been 
found substantially equivalent to such a device, has an approval under 
section 515 of the act FDA must promulgate a regulation under section 
515(b) of the act requiring such approval, except as provided in 
paragraphs (b) and (c) of this section. Such a regulation under section 
515(b) of the act shall not be effective during the grace period ending 
on the 90th day after its promulgation or on the last day of the 30th 
full calendar month after the regulation that classifies the device into 
class III is effective, whichever is later. See section 501(f)(2)(B) of 
the act. Accordingly, unless an effective date of the requirement for 
premarket approval is shown in the regulation for a device classified 
into class III in this part, the device may be commercially distributed 
without FDA's issuance of an order approving a PMA or declaring 
completed a PDP for the device. If FDA promulgates a regulation under 
section 515(b) of the act requiring premarket approval for a device, 
section 501(f)(1)(A) of the act applies to the device.
    (b) Any new, not substantially equivalent, device introduced into 
commercial distribution on or after May 28, 1976, including a device 
formerly marketed that has been substantially altered, is classified by 
statute (section 513(f) of the act) into class III without any grace 
period and FDA must have issued an order approving a PMA or declaring 
completed a PDP for the device before the device is commercially 
distributed unless it is reclassified. If FDA knows that a device being 
commercially distributed may be a ``new'' device as defined in this 
section because of any new intended use or other reasons, FDA may codify 
the statutory classification of the device into class III for such new 
use. Accordingly, the regulation for such a class III device states that 
as of the enactment date of the amendments, May 28, 1976, the device 
must have an approval under section 515 of the act before commercial 
distribution.
    (c) A device identified in a regulation in this part that is 
classified into class III and that is subject to the transitional 
provisions of section 520(l) of the act is automatically classified by 
statute into class III and must have an approval under section 515 of 
the act before being commercially distributed. Accordingly, the 
regulation for such a class III transitional device states that as of 
the enactment date of the amendments, May 28, 1976, the device must have 
an approval under section 515 of the act before commercial distribution.

[52 FR 17733, May 11, 1987; 52 FR 22577, June 12, 1987]



Sec. 866.9  Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

    The exemption from the requirement of premarket notification 
(section 510(k) of the act) for a generic type of class I or II device 
is only to the extent that the device has existing or reasonably 
foreseeable characteristics of commercially distributed devices within 
that generic type or, in the case of in vitro diagnostic devices, only 
to the extent that misdiagnosis as a result of using the device would 
not be associated with high morbidity or mortality.

[[Page 322]]

Accordingly, manufacturers of any commercially distributed class I or II 
device for which FDA has granted an exemption from the requirement of 
premarket notification must still submit a premarket notification to FDA 
before introducing or delivering for introduction into interstate 
commerce for commercial distribution the device when:
    (a) The device is intended for a use different from the intended use 
of a legally marketed device in that generic type of device; e.g., the 
device is intended for a different medical purpose, or the device is 
intended for lay use where the former intended use was by health care 
professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro diagnostic 
device detects or identifies infectious agents by using deoxyribonucleic 
acid (DNA) probe or nucleic acid hybridization technology rather than 
culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of neoplastic 
diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial or acquired 
genetic disorders, including inborn errors of metabolism;
    (3) For measuring an analyte that serves as a surrogate marker for 
screening, diagnosis, or monitoring life-threatening diseases such as 
acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, 
tuberculosis, or myocardial infarction or to monitor therapy;
    (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) or IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is intended 
for use in matrices other than serum or plasma;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).

[65 FR 2311, Jan. 14, 2000]



                      Subpart B_Diagnostic Devices



Sec. 866.1620  Antimicrobial susceptibility test disc.

    (a) Identification. An antimicrobial susceptibility test disc is a 
device that consists of antimicrobic-impregnated paper discs used to 
measure by a disc-agar diffusion technique or a disc-broth elution 
technique the in vitro susceptibility of most clinically important 
bacterial pathogens to antimicrobial agents. In the disc-agar diffusion 
technique, bacterial susceptibility is ascertained by directly measuring 
the magnitude of a zone of bacterial inhibition around the disc on an 
agar surface. The disc-broth elution technique is associated with an 
automated rapid susceptibility test system and employs a fluid medium in 
which susceptibility is ascertained by photometrically measuring changes 
in bacterial growth resulting when antimicrobial material is eluted from 
the disc into the fluid medium. Test results are used to determine the 
antimicrobial agent of choice in the treatment of bacterial diseases.
    (b) Classification. Class II (performance standards).



Sec. 866.1640  Antimicrobial susceptibility test powder.

    (a) Identification. An antimicrobial susceptibility test powder is a 
device that consists of an antimicrobial drug powder packaged in vials 
in specified amounts and intended for use in clinical laboratories for 
determining in vitro susceptibility of bacterial pathogens to these 
therapeutic agents. Test results are used to determine the antimicrobial 
agent of choice in the treatment of bacterial diseases.
    (b) Classification. Class II (performance standards).

[[Page 323]]



Sec. 866.1645  Fully automated short-term incubation cycle antimicrobial 
susceptibility system.

    (a) Identification. A fully automated short-term incubation cycle 
antimicrobial susceptibility system is a device that incorporates 
concentrations of antimicrobial agents into a system for the purpose of 
determining in vitro susceptibility of bacterial pathogens isolated from 
clinical specimens. Test results obtained from short-term (less than 16 
hours) incubation are used to determine the antimicrobial agent of 
choice to treat bacterial diseases.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's guidance document entitled ``Class II Special 
Controls Guidance Document: Antimicrobial Susceptibility Test (AST) 
Systems; Guidance for Industry and FDA.''

[68 FR 5827, Feb. 5, 2003]



Sec. 866.1655  System for detection of microorganisms and antimicrobial
resistance using reporter expression.

    (a) Identification. A system for detection of microorganisms and 
antimicrobial resistance using reporter expression is an in vitro 
diagnostic device intended for the detection and identification of live 
microorganisms and the detection of associated antimicrobial drug 
susceptibility or resistance in specimens from patients at risk of 
colonization or suspected of infection.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The intended use for the device in the labeling required under 
Sec. 809.10 of this chapter must include a detailed description of the 
targets the device detects, the type of results provided to the user, 
the clinical indications appropriate for test use, and the specific 
population(s) for which the device is intended.
    (2) Any device used for specimen collection and transport must be 
FDA-cleared, approved, or -classified as 510(k) exempt (standalone or as 
part of a test system) for the collection of the specimen types claimed 
by this device and for the maintenance of viability of the targeted 
microorganisms; alternatively, the specimen collection device must be 
cleared in a premarket submission as a part of this device.
    (3) The labeling required under Sec. 809.10(b) of this chapter must 
include:
    (i) A detailed description of the device, including reagents, 
instruments, ancillary materials, applicable specimen collection and 
transport device(s) and control elements, and a detailed explanation of 
the methodology, including all pre-analytical methods for handling and 
processing of specimens and controls to maintain organism viability;
    (ii) Detailed descriptions of the test procedure, including the 
preparation and maintenance of quality controls and the interpretation 
of test results;
    (iii) Detailed discussion of the performance characteristics of the 
device for all claimed organisms and specimen types based on analytical 
studies, including evaluation of analytical sensitivity, inclusivity, 
cross-reactivity, potentially interfering substances and microorganisms, 
contamination, specimen stability, precision, and reproducibility;
    (iv) Detailed discussion of the performance characteristics of the 
device observed in a clinical study performed on a population that is 
consistent with the intended use population in comparison to the results 
obtained by a reference or comparator method determined to be acceptable 
by FDA, for microbial detection, identification, and antimicrobial 
susceptibility testing; and
    (v) A limiting statement indicating that a negative test result does 
not preclude colonization or infection with organisms that do not 
express detectable levels of the reporter that is identified by the 
device.
    (4) Design verification and validation must include:
    (i) A detailed description of the device, including an explanation 
of the technology, hardware, software, and consumables, as well as an 
explanation of the result algorithms and method(s) of data processing 
from signal acquisition to result assignment;
    (ii) A detailed description of the impact of any software, including 
software applications and hardware-based devices that incorporate 
software, on the device's functions;

[[Page 324]]

    (iii) Detailed documentation of the analytical and clinical studies 
required in paragraphs (b)(3)(iii) and (iv) of this section, including 
the study protocols containing descriptions of the test methods, 
prescribed methods of data analysis and acceptance criteria, final study 
reports, and data line listings;
    (iv) Detailed documentation of quality control procedures, including 
an explanation of how quality control materials were selected, the 
recommended frequency of testing, methods of control preparation, 
acceptance criteria for performance and the results from quality control 
testing performed during the analytical and clinical studies required 
under paragraphs (b)(3)(iii) and (iv) of this section;
    (v) Detailed documentation of studies performed to establish onboard 
and in-use reagent stability, including the test method(s), data 
analysis plans, acceptance criteria, final study reports, and data line 
listings;
    (vi) Detailed documentation of studies to establish reagent shelf-
life for the assay kit and each applicable specimen collection and 
transport device, including study protocols containing descriptions of 
the test method(s), data analysis plans, and acceptance criteria; and
    (vii) Documentation of an appropriate end user device training 
program that will be offered as part of efforts to assure appropriate 
conduct of the assay and to mitigate the risk associated with false 
results, including failure to use the device correctly or correctly 
interpret results.

[87 FR 6417, Feb. 4, 2022]



Sec. 866.1700  Culture medium for antimicrobial susceptibility tests.

    (a) Identification. A culture medium for antimicrobial 
susceptibility tests is a device intended for medical purposes that 
consists of any medium capable of supporting the growth of many of the 
bacterial pathogens that are subject to antimicrobial susceptibility 
tests. The medium should be free of components known to be antagonistic 
to the common agents for which susceptibility tests are performed in the 
treatment of disease.
    (b) Classification. Class II (performance standards).



                     Subpart C_Microbiology Devices



Sec. 866.2050  Staphylococcal typing bacteriophage.

    (a) Identification. A staphylococcal typing bacteriophage is a 
device consisting of a bacterial virus intended for medical purposes to 
identify pathogenic staphylococcal bacteria through use of the 
bacteria's susceptibility to destruction by the virus. Test results are 
used principally for the collection of epidemiological information.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25045, June 12, 1989; 66 
FR 38790, July 25, 2001]



Sec. 866.2120  Anaerobic chamber.

    (a) Identification. An anaerobic chamber is a device intended for 
medical purposes to maintain an anaerobic (oxygen free) environment. It 
is used to isolate and cultivate anaerobic microorganisms.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9. The device is 
also exempt from the good manufacturing practice requirements of the 
quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[47 FR 50823, Nov. 9, 1982, as amended at 66 FR 38790, July 25, 2001]



Sec. 866.2160  Coagulase plasma.

    (a) Identification. Coagulase plasma is a device that consists of 
freeze-dried animal or human plasma that is intended for medical 
purposes to perform coagulase tests primarily on staphylococcal 
bacteria. When reconstituted, the fluid plasma is clotted by the action 
of the enzyme coagulase which is produced by pathogenic staphylococci. 
Test results are used primarily as an aid in the diagnosis of disease 
caused by pathogenic bacteria belonging to

[[Page 325]]

the genus Staphylococcus and provide epidemiological information on 
disease caused by these microorganisms.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 
FR 38790, July 25, 2001]



Sec. 866.2170  Automated colony counter.

    (a) Identification. An automated colony counter is a mechanical 
device intended for medical purposes to determine the number of 
bacterial colonies present on a bacteriological culture medium contained 
in a petri plate. The number of colonies counted is used in the 
diagnosis of disease as a measure of the degree of bacterial infection.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25045, June 12, 1989; 66 
FR 38790, July 25, 2001]



Sec. 866.2180  Manual colony counter.

    (a) Identification. A manual colony counter is a device intended for 
medical purposes that consists of a printed grid system superimposed on 
an illuminated screen. Petri plates containing bacterial colonies to be 
counted are placed on the screen for better viewing and ease of 
counting. The number of colonies counted is used in the diagnosis of 
disease as a measure of the degree of bacterial infection.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9. The device is 
also exempt from the good manufacturing practice requirements of the 
quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[47 FR 50823, Nov. 9, 1982, as amended at 66 FR 38790, July 25, 2001]



Sec. 866.2190  Automated image assessment system for microbial 
colonies on solid culture media.

    (a) Identification. An automated image assessment system for 
microbial colonies on solid culture media is a system that is intended 
to assess the presence or absence of microbial colonies on solid 
microbiological culture medium, and to interpret their number, and 
phenotypic and morphologic characteristics through analysis of two 
dimensional digital images as an aid in diagnosis of infectious disease.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Premarket notification submissions must include a detailed 
description of the device, including the technology employed, components 
and software modules, as well as a detailed explanation of the result 
algorithms and any expert rules that are used to assess colony 
characteristics and enumerate colonies from image capture through end 
result.
    (2) Premarket notification submissions must include detailed 
documentation of the analytical studies performed to characterize device 
performance to support the intended use, as appropriate.
    (3) Premarket notification submissions must include detailed 
documentation from clinical studies performed on a population that is 
consistent with the intended use population.
    (i) The clinical studies must establish the device performance based 
on comparison to results obtained by an acceptable reference method, as 
appropriate.
    (ii) The clinical study documentation must include the study 
protocol with a predefined statistical analysis plan and the final 
report documenting support for the Indications for Use and the results 
of the statistical analysis, as appropriate.
    (4) Premarket notification submissions must include detailed 
documentation for device software, including but not limited to software 
applications and hardware based components that incorporate software, 
and any decision-making thresholds used to generate results for the 
device. If a part of

[[Page 326]]

a Total Laboratory Automation System, the premarket notification 
submission must include detailed documentation addressing the instrument 
and software system integration.
    (5) Premarket notification submissions must include detailed 
documentation of appropriate instructions for use regarding the intended 
user's device quality control procedures for the instrument system and 
components, as appropriate.
    (6) The 21 CFR 809.10 compliant device labeling must include:
    (i) Detailed user instructions to mitigate the risk of failure to 
operate the instrument correctly.
    (ii) A detailed explanation of the interpretation of results and 
limitations regarding the need for review of culture plates by a 
qualified microbiologist, as appropriate.
    (iii) A summary of performance data obtained from the analytical 
studies used to support device performance, as appropriate.
    (iv) A summary of performance data obtained from clinical studies 
performed on a population that is consistent with the intended use 
population, as appropriate.
    (7) Under 21 CFR 820.30 compliant design control, device 
manufacturers must, as appropriate:
    (i) Conduct human factors/usability validation testing with the 
final version of the labeling and related materials to adequately 
mitigate the risk of failure to operate the instrument correctly.
    (ii) Document a device training program that will be offered to the 
end user to adequately mitigate the risk of failure to operate the 
instrument correctly.

[82 FR 47969, Oct. 16, 2017]



Sec. 866.2300  Multipurpose culture medium.

    (a) Identification. A multipurpose culture medium is a device that 
consists primarily of liquid or solid biological materials intended for 
medical purposes for the cultivation and identification of several types 
of pathogenic microorganisms without the need of additional nutritional 
supplements. Test results aid in the diagnosis of disease and also 
provide epidemiological information on diseases caused by these 
microorganisms.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 
FR 38790, July 25, 2001]



Sec. 866.2320  Differential culture medium.

    (a) Identification. A differential culture medium is a device that 
consists primarily of liquid biological materials intended for medical 
purposes to cultivate and identify different types of pathogenic 
microorganisms. The identification of these microorganisms is 
accomplished by the addition of a specific biochemical component(s) to 
the medium. Microorganisms are identified by a visible change (e.g., a 
color change) in a specific biochemical component(s) which indicates 
that specific metabolic reactions have occurred. Test results aid in the 
diagnosis of disease and also provide epidemiological information on 
diseases caused by these microorganisms.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 
FR 38790, July 25, 2001]



Sec. 866.2330  Enriched culture medium.

    (a) Identification. An enriched culture medium is a device that 
consists primarily of liquid or solid biological materials intended for 
medical purposes to cultivate and identify fastidious microorganisms 
(those having complex nutritional requirements). The device consists of 
a relatively simple basal medium enriched by the addition of such 
nutritional components as blood, blood serum, vitamins, and extracts of 
plant or animal tissues. The device is used in the diagnosis of disease 
caused by pathogenic microorganisms and also provides epidemiological 
information on these diseases.
    (b) Classification. Class I (general controls). The device is exempt 
from the

[[Page 327]]

premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 
FR 38791, July 25, 2001]



Sec. 866.2350  Microbiological assay culture medium.

    (a) Identification. A microbiological assay culture medium is a 
device that consists primarily of liquid or solid biological materials 
intended for medical purposes to cultivate selected test microorganisms 
in order to measure by microbiological procedures the concentration in a 
patient's serum of certain substances, such as amino acids, 
antimicrobial agents, and vitamins. The concentration of these 
substances is measured by their ability to promote or inhibit the growth 
of the test organism in the innoculated medium. Test results aid in the 
diagnosis of disease resulting from either deficient or excessive 
amounts of these substances in a patient's serum. Tests results may also 
be used to monitor the effects of the administration of certain 
antimicrobial drugs.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 
FR 38791, July 25, 2001]



Sec. 866.2360  Selective culture medium.

    (a) Identification. A selective culture medium is a device that 
consists primarily of liquid or solid biological materials intended for 
medical purposes to cultivate and identify certain pathogenic 
microorganisms. The device contains one or more components that suppress 
the growth of certain microorganisms while either promoting or not 
affecting the growth of other microorganisms. The device aids in the 
diagnosis of disease caused by pathogenic microorganisms and also 
provides epidemiological information on these diseases.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 
FR 38791, July 25, 2001]



Sec. 866.2390  Transport culture medium.

    (a) Identification. A transport culture medium is a device that 
consists of a semisolid, usually non-nutrient, medium that maintains the 
viability of suspected pathogens contained in patient specimens while in 
transit from the specimen collection area to the laboratory. The device 
aids in the diagnosis of disease caused by pathogenic microorganisms and 
also provides epidemiological information on these diseases.
    (b) Classification. Class I (general controls).



Sec. 866.2410  Culture medium for pathogenic Neisseria spp.

    (a) Identification. A culture medium for pathogenic Neisseria spp. 
is a device that consists primarily of liquid or solid biological 
materials used to cultivate and identify pathogenic Neisseria spp. The 
identification aids in the diagnosis of disease caused by bacteria 
belonging to the genus Neisseria, such as epidemic cerebrospinal 
meningitis, other meningococcal disease, and gonorrhea, and also 
provides epidemiological information on these microorganisms.
    (b) Classification. Class II (performance standards).



Sec. 866.2420  Oxidase screening test for gonorrhea.

    (a) Identification. An oxidase screening test for gonorrhea is an in 
vitro device that consists of the articles intended to identify by 
chemical reaction, cytochrome oxidase, an oxidizing enzyme that is 
associated with certain bacteria including Neisseria gonorrhoeae. A 
sample of a male's urethral discharge is obtained on a swab which is 
placed into a wetting agent containing an ingredient that will react 
with cytochrome oxidase. When cytochrome oxidase is present, the swab 
turns a dark purple color within 3 minutes. Because it is unlikely that 
cytochrome oxidase-positive organisms other than Neisseria

[[Page 328]]

gonorrhoeae are present in the urethral discharge of males, the 
identification of cytochrome oxidase with this device indicates 
presumptive infection of the patient with the causative agent of 
gonorrhea.
    (b) Classification. Class III (premarket approval) (transitional 
device).
    (c) Date PMA or notice of completion of a PDP is required. As of May 
28, 1976, an approval under section 515 of the act is required before 
this device may be commercially distributed. See Sec. 866.3.

[47 FR 50823, Nov. 9, 1982, as amended at 52 FR 17734, May 11, 1987]



Sec. 866.2440  Automated medium dispensing and stacking device.

    (a) Identification. An automated medium dispensing and stacking 
device is a device intended for medical purposes to dispense a 
microbiological culture medium into petri dishes and then mechanically 
stack the petri dishes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9. The device is 
also exempt from the good manufacturing practice requirements of the 
quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[47 FR 50823, Nov. 9, 1982, as amended at 66 FR 38791, July 25, 2001]



Sec. 866.2450  Supplement for culture media.

    (a) Identification. A supplement for culture media is a device, such 
as a vitamin or sugar mixture, that is added to a solid or liquid basal 
culture medium to produce a desired formulation and that is intended for 
medical purposes to enhance the growth of fastidious microorganisms 
(those having complex nutritional requirements). This device aids in the 
diagnosis of diseases caused by pathogenic microorganisms.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 
FR 38791, July 25, 2001]



Sec. 866.2480  Quality control kit for culture media.

    (a) Identification. A quality control kit for culture media is a 
device that consists of paper discs (or other suitable materials), each 
impregnated with a specified, freeze-dried, viable microorganism, 
intended for medical purposes to determine if a given culture medium is 
able to support the growth of that microorganism. The device aids in the 
diagnosis of disease caused by pathogenic microorganisms and also 
provides epidemiological information on these diseases.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 
FR 38791, July 25, 2001]



Sec. 866.2500  Microtiter diluting and dispensing device.

    (a) Identification. A microtiter diluting and dispensing device is a 
mechanical device intended for medical purposes to dispense or serially 
dilute very small quantities of biological or chemical reagents for use 
in various diagnostic procedures.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 
FR 38791, July 25, 2001]



Sec. 866.2540  Microbiological incubator.

    (a) Identification. A microbiological incubator is a device with 
various chambers or water-filled compartments in which controlled 
environmental conditions, particularly temperature, are maintained. It 
is intended for medical purposes to cultivate microorganisms and aid in 
the diagnosis of disease.

[[Page 329]]

    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9. The device is 
also exempt from the good manufacturing practice requirements of the 
quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[47 FR 50823, Nov. 9, 1982, as amended at 66 FR 38791, July 25, 2001]



Sec. 866.2560  Microbial growth monitor.

    (a) Identification. A microbial growth monitor is a device intended 
for medical purposes that measures the concentration of bacteria 
suspended in a liquid medium by measuring changes in light scattering 
properties, optical density, electrical impedance, or by making direct 
bacterial counts. The device aids in the diagnosis of disease caused by 
pathogenic microorganisms.
    (b) Classification. Class I. With the exception of automated blood 
culturing system devices that are used in testing for bacteria, fungi, 
and other microorganisms in blood and other normally sterile body 
fluids, this device is exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 60 FR 38482, July 27, 1995]



Sec. 866.2580  Gas-generating device.

    (a) Identification. A gas-generating device is a device intended for 
medical purposes that produces predetermined amounts of selected gases 
to be used in a closed chamber in order to establish suitable 
atmospheric conditions for cultivation of microorganisms with special 
atmospheric requirements. The device aids in the diagnosis of disease.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 
FR 38791, July 25, 2001]



Sec. 866.2600  Wood's fluorescent lamp.

    (a) Identification. A Wood's fluorescent lamp is a device intended 
for medical purposes to detect fluorescent materials (e.g., fluorescein 
pigment produced by certain microorganisms) as an aid in the 
identification of these microorganisms. The device aids in the diagnosis 
of disease.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9. The device is 
also exempt from the good manufacturing practice requirements of the 
quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[47 FR 50823, Nov. 9, 1982, as amended at 66 FR 38791, July 25, 2001]



Sec. 866.2660  Microorganism differentiation and identification device.

    (a) Identification. A microorganism differentiation and 
identification device is a device intended for medical purposes that 
consists of one or more components, such as differential culture media, 
biochemical reagents, and paper discs or paper strips impregnated with 
test reagents, that are usually contained in individual compartments and 
used to differentiate and identify selected microorganisms. The device 
aids in the diagnosis of disease.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]



Sec. 866.2680  Streptococcus spp. nucleic acid-based assay.

    (a) Identification. A Streptococcus spp. nucleic acid-based assay is 
a qualitative in vitro diagnostic device intended to simultaneously 
detect and identify various Streptococcus spp. nucleic acids extracted 
directly from clinical specimens. The device detects specific nucleic 
acid sequences for organism identification. The identification

[[Page 330]]

aids in the diagnosis of diseases caused by bacteria belonging to the 
genus Streptococcus and provides epidemiological information on these 
diseases. Pathogenic streptococci are associated with infections, such 
as sore throat, impetigo (an infection characterized by small pustules 
on the skin), urinary tract infections, rheumatic fever, and kidney 
disease.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Premarket notification submissions must include detailed device 
description documentation, including the device components, ancillary 
reagents required but not provided, and a detailed explanation of the 
methodology including primer/probe sequence, design, and rationale for 
sequence selection.
    (2) Premarket notification submissions must include detailed 
documentation from the following analytical and clinical performance 
studies: Analytical sensitivity (Limit of Detection), reactivity, 
inclusivity, precision, reproducibility, interference, cross reactivity, 
carry-over, and cross contamination.
    (3) Premarket notification submissions must include detailed 
documentation from a clinical study. The study, performed on a study 
population consistent with the intended use population, must compare the 
device performance to results obtained from well-accepted reference 
methods.
    (4) Premarket notification submissions must include detailed 
documentation for device software, including, but not limited to, 
software applications and hardware-based devices that incorporate 
software.
    (5) Premarket notification submissions must include database 
implementation methodology, construction parameters, and quality 
assurance protocols, as appropriate.
    (6) The device labeling must include limitations regarding the need 
for culture confirmation of negative specimens, as appropriate.
    (7) A detailed explanation of the interpretation of results and 
acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) 
compliant labeling.
    (8) Premarket notification submissions must include details on an 
end user device training program that will be offered while marketing 
the device, as appropriate.

[82 FR 50074, Oct. 30, 2017]



Sec. 866.2850  Automated zone reader.

    (a) Identification. An automated zone reader is a mechanical device 
intended for medical purposes to measure zone diameters of microbial 
growth inhibition (or exhibition), such as those observed on the surface 
of certain culture media used in disc-agar diffusion antimicrobial 
susceptibility tests. The device aids in decisionmaking respecting the 
treatment of disease.
    (b) Classification. Class I (general controls).



Sec. 866.2900  Microbiological specimen collection and transport device.

    (a) Identification. A microbiological specimen collection and 
transport device is a specimen collecting chamber intended for medical 
purposes to preserve the viability or integrity of microorganisms in 
specimens during storage of specimens after their collection and during 
their transport from the collecting area to the laboratory. The device 
may be labeled or otherwise represented as sterile. The device aids in 
the diagnosis of disease caused by pathogenic microorganisms.
    (b) Classification. Class I (general controls). The device, when 
solely intended for use in the collection of concentrated parasites from 
specimens and transport, is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 84 FR 71800, Dec. 30, 2019; 85 
FR 18445, Apr. 2, 2020]



                     Subpart D_Serological Reagents



Sec. 866.3010  Acinetobacter calcoaceticus serological reagents.

    (a) Identification. Acinetobacter calcoaceticus serological reagents 
are devices that consist of Acinetobacter calcoaceticus antigens and 
antisera used to identify this bacterium from cultured isolates derived 
from clinical

[[Page 331]]

specimens. The identification aids in the diagnosis of disease caused by 
the bacterium Acinetobacter calcoaceticus and provides epidemiological 
information on disease caused by this microorganism. This organism 
becomes pathogenic in patients with burns or with immunologic 
deficiency, and infection can result in sepsis (blood poisoning).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 
FR 38791, July 25, 2001]



Sec. 866.3020  Adenovirus serological reagents.

    (a) Identification. Adenovirus serological reagents are devices that 
consist of antigens and antisera used in serological tests to identify 
antibodies to adenovirus in serum. Additionally, some of these reagents 
consist of adenovirus antisera conjugated with a fluorescent dye and are 
used to identify adenoviruses directly from clinical specimens. The 
identification aids in the diagnosis of disease caused by adenoviruses 
and provides epidemiological information on these diseases. Adenovirus 
infections may cause pharyngitis (inflammation of the throat), acute 
respiratory diseases, and certain external diseases of the eye (e.g., 
conjunctivitis).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 
FR 38791, July 25, 2001]



Sec. 866.3035  Arizona spp. serological reagents.

    (a) Identification. Arizona spp. serological reagents are devices 
that consist of antisera and antigens used to identify Arizona spp. in 
cultured isolates derived from clinical specimens. The identification 
aids in the diagnosis of disease caused by bacteria belonging to the 
genus Arizona and provides epidemiological information on diseases 
caused by these microorganisms. Arizona spp. can cause gastroenteritis 
(food poisoning) and sepsis (blood poisoning).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 
FR 38791, July 25, 2001]



Sec. 866.3040  Aspergillus spp. serological reagents.

    (a) Identification. Aspergillus spp. serological reagents are 
devices that consist of antigens and antisera used in various 
serological tests to identify antibodies to Aspergillus spp. in serum. 
The identification aids in the diagnosis of aspergillosis caused by 
fungi belonging to the genus Aspergillus. Aspergillosis is a disease 
marked by inflammatory granulomatous (tumor-like) lessions in the skin, 
ear, eyeball cavity, nasal sinuses, lungs, and occasionally the bones.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]



Sec. 866.3045  In vitro diagnostic device for Bacillus spp. detection.

    (a) Identification. An in vitro diagnostic device for Bacillus 
species (spp.) detection is a prescription device used to detect and 
differentiate among Bacillus spp. and presumptively identify B. 
anthracis and other Bacillus spp. from cultured isolates or clinical 
specimens as an aid in the diagnosis of anthrax and other diseases 
caused by Bacillus spp. This device may consist of Bacillus spp. 
antisera conjugated with a fluorescent dye (immunofluorescent reagents) 
used to presumptively identify bacillus-like organisms in clinical 
specimens; bacteriophage used for differentiating B. anthracis from 
other Bacillus spp. based on susceptibility to lysis by the phage; or 
antigens used to identify antibodies to B. anthracis (anti-toxin and 
anti-capsular) in

[[Page 332]]

serum. Bacillus infections include anthrax (cutaneous, inhalational, or 
gastrointestinal) caused by B. anthracis, and gastrointestinal disease 
and non-gastrointestinal infections caused by B. cereus.
    (b) Classification. Class II (special controls). The special 
controls are set forth in FDA's special controls guideline document 
entitled ``In Vitro Diagnostic Devices for Bacillus spp. Detection; 
Class II Special Controls Guideline for Industry and Food and Drug 
Administration Staff.'' For availability of the guideline document, see 
Sec. 866.1(e).
    (c) Restriction on Distribution. The distribution of these devices 
is limited to laboratories that follow public health guidelines that 
address appropriate biosafety conditions, interpretation of test 
results, and coordination of findings with public health authorities.
    (d) Restriction on Use. The use of this device is restricted to 
prescription use and must comply with the following:
    (1) The device must be in the possession of:
    (i)(A) A person, or his agents or employees, regularly and lawfully 
engaged in the manufacture, transportation, storage, or wholesale or 
retail distribution of such device; or
    (B) A practitioner, such as a physician, licensed by law to use or 
order the use of such device; and
    (ii) The device must be sold only to or on the prescription or other 
order of such practitioner for use in the course of his professional 
practice.
    (2) The label of the device shall bear the statement ``Caution: 
Federal law restricts this device to sale by or on the order of a 
____'', the blank to be filled with the word ``physician'' or with the 
descriptive designation of any other practitioner licensed by the law of 
the State in which he practices to use or order the use of the device.
    (3) Any labeling, as defined in section 201(m) of the Federal Food, 
Drug, and Cosmetic Act, whether or not it is on or within a package from 
which the device is to be dispensed, distributed by, or on behalf of the 
manufacturer, packer, or distributor of the device, that furnishes or 
purports to furnish information for use of the device contains adequate 
information for such use, including indications, effects, routes, 
methods, and frequency and duration of administration and any relevant 
hazards, contraindications, side effects, and precautions, under which 
practitioners licensed by law to employ the device can use the device 
safely and for the purposes for which it is intended, including all 
purposes for which it is advertised or represented. This information 
will not be required on so-called reminder-piece labeling which calls 
attention to the name of the device but does not include indications or 
other use information.
    (4) All labeling, except labels and cartons, bearing information for 
use of the device also bears the date of the issuance or the date of the 
latest revision of such labeling.

[84 FR 12088, Apr. 1, 2019]



Sec. 866.3050  Beta-glucan serological assays.

    (a) Identification. Beta-glucan serological assays are devices that 
consist of antigens or proteases used in serological assays. The device 
is intended for use for the presumptive diagnosis of fungal infection. 
The assay is indicated for use in patients with symptoms of, or medical 
conditions predisposing the patient to invasive fungal infection. The 
device can be used as an aid in the diagnosis of deep seated mycoses and 
fungemias.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance document entitled ``Class II Special Controls Guidance 
Document: Serological Assays for the Detection of Beta-Glucan.'' See 
Sec. 866.1(e) for the availability of this guidance document.

[69 FR 56936, Sept. 23, 2004]



Sec. 866.3060  Blastomyces dermatitidis serological reagents.

    (a) Identification. Blastomyces dermatitidis serological reagents 
are devices that consist of antigens and antisera used in serological 
tests to identify antibodies to Blastomyces determatitidis in serum. The 
identification aids in the diagnosis of blastomycosis caused by the 
fungus Blastomyces dermatitidis. Blastomycosis is a chronic 
granulomatous (tumor-like) disease, which may be limited to

[[Page 333]]

the skin or lung or may be widely disseminated in the body resulting in 
lesions of the bones, liver, spleen, and kidneys.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59226, Nov. 3, 1998]



Sec. 866.3065  Bordetella spp. serological reagents.

    (a) Identification. Bordetella spp. serological reagents are devices 
that consist of antigens and antisera, including antisera conjugated 
with a fluorescent dye, used in serological tests to identify Bordetella 
spp. from cultured isolates or directly from clinical specimens. The 
identification aids in the diagnosis of diseases caused by bacteria 
belonging to the genus Bordetella and provides epidemiological 
information on these diseases. Bordetella spp. cause whooping cough 
(Bordetella pertussis) and other similiarly contagious and acute 
respiratory infections characterized by pneumonitis (inflammation of the 
lungs).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 
FR 38791, July 25, 2001]



Sec. 866.3085  Brucella spp. serological reagents.

    (a) Identification. Brucella spp. serological reagents are devices 
that consist of antigens and antisera used for serological 
identification of Brucella spp. from cultured isolates derived from 
clinical specimens or to identify antibodies to Brucella spp. in serum. 
Additionally, some of these reagents consist of antisera conjugated with 
a fluorescent dye (immunofluorescent reagents) used to identify Brucella 
spp. directly from clinical specimens or cultured isolates derived from 
clinical specimens. The identification aids in the diagnosis of 
brucellosis (e.g., undulant fever, Malta fever) caused by bacteria 
belonging to the genus Brucella and provides epidemiological information 
on diseases caused by these microorganisms.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59226, Nov. 3, 1998]



Sec. 866.3110  Campylobacter fetus serological reagents.

    (a) Identification. Campylobacter fetus serological reagents are 
devices that consist of antisera conjugated with a fluorescent dye used 
to identify Campylobacter fetus from clinical specimens or cultured 
isolates derived from clinical specimens. The identification aids in the 
diagnosis of diseases caused by this bacterium and provides 
epidemiological information on these diseases. Campylobacter fetus is a 
frequent cause of abortion in sheep and cattle and is sometimes 
responsible for endocarditis (inflammation of certain membranes of the 
heart) and enteritis (inflammation of the intestines) in humans.
    (b) Classification. Class I (general controls).



Sec. 866.3120  Chlamydia serological reagents.

    (a) Identification. Chlamydia serological reagents are devices that 
consist of antigens and antisera used in serological tests to identify 
antibodies to chlamydia in serum. Additionally, some of these reagents 
consist of chlamydia antisera conjugated with a fluorescent dye used to 
identify chlamydia directly from clinical specimens or cultured isolates 
derived from clinical specimens. The identification aids in the 
diagnosis of disease caused by bacteria belonging to the genus Chlamydia 
and provides epidemiological information on these diseases. Chlamydia 
are the causative agents of psittacosis (a form of pneumonia), 
lymphogranuloma venereum (a venereal disease), and trachoma (a chronic 
disease of the eye and eyelid).
    (b) Classification. Class I (general controls).

[[Page 334]]



Sec. 866.3125  Citrobacter spp. serological reagents.

    (a) Identification. Citrobacter spp. serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify Citrobacter spp. from cultured isolates derived from 
clinical specimens. The identification aids in the diagnosis of disease 
caused by bacteria belonging to the genus Citrobacter and provides 
epidemiological information on diseases caused by these microorganisms. 
Citrobacter spp. have occasionally been associated with urinary tract 
infections.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 
FR 38791, July 25, 2001]



Sec. 866.3130  Clostridium difficile toxin gene amplification assay.

    (a) Identification. A Clostridium difficile toxin gene amplification 
assay is a device that consists of reagents for the amplification and 
detection of target sequences in Clostridium difficile toxin genes in 
fecal specimens from patients suspected of having Clostridium difficile 
infection (CDI). The detection of clostridial toxin genes, in 
conjunction with other laboratory tests, aids in the clinical laboratory 
diagnosis of CDI caused by Clostridium difficile.
    (b) Classification. Class II (special controls). The special 
controls are set forth in FDA's guideline document entitled: ``Class II 
Special Controls Guideline: Toxin Gene Amplification Assays for the 
Detection of Clostridium difficile; Guideline for Industry and Food and 
Drug Administration Staff.'' See Sec. 866.1(e) for information on 
obtaining this document.

[80 FR 51939, Aug. 27, 2015]



Sec. 866.3135  Coccidioides immitis serological reagents.

    (a) Identification. Coccidioides immitis serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Coccidioides immitis in serum. The 
identification aids in the diagnosis of coccidioidomycosis caused by a 
fungus belonging to the genus Coccidioides and provides epidemiological 
information on diseases caused by this microorganism. An infection with 
Coccidioides immitis produces symptoms varying in severity from those 
accompanying the common cold to those of influenza.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59226, Nov. 3, 1998]



Sec. 866.3140  Corynebacterium spp. serological reagents.

    (a) Identification. Corynebacterium spp. serological reagents are 
devices that consist of antisera conjugated with a fluorescent dye used 
to identify Corynebacterium spp. from clinical specimens. The 
identification aids in the diagnosis of disease caused by bacteria 
belonging to the genus Corynebacterium and provides epidemiological 
information on diseases caused by these microorganisms. The principal 
human pathogen of this genus, Corynebacterium diphtheriae, causes 
diphtheria. However, many other types of corynebacteria form part of the 
normal flora of the human respiratory tract, other mucus membranes, and 
skin, and are either nonpathogenic or have an uncertain role.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]



Sec. 866.3145  Coxsackievirus serological reagents.

    (a) Identification. Coxsackievirus serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify antibodies to coxsackievirus in serum. Additionally, some of 
these reagents consist of coxsackievirus antisera conjugated with a 
fluorescent dye that are used to identify coxsackievirus from clinical 
specimens or from tissue culture isolates derived from clinical 
specimens.

[[Page 335]]

The identification aids in the diagnosis of coxsackievirus infections 
and provides epidemiological information on diseases caused by these 
viruses. Coxsackieviruses produce a variety of infections, including 
common colds, meningitis (inflammation of brain and spinal cord 
membranes), herpangina (brief fever accompanied by ulcerated lesions of 
the throat), and myopericarditis (inflammation of heart tissue).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]



Sec. 866.3165  Cryptococcus neoformans serological reagents.

    (a) Identification. Cryptococcus neoformans serological reagents are 
devices that consist of antigens used in serological tests to identify 
antibodies to Cryptococcus neoformans in serum. Additionally, some of 
these reagents consist of antisera conjugated with a fluorescent dye 
(immunofluorescent reagents) and are used to identify Cryptococcus 
neoformans directly from clinical specimens or from cultured isolates 
derived from clinical specimens. The identification aids in the 
diagnosis of cryptococcosis and provides epidemiological information on 
this type of disease. Cryptococcosis infections are found most often as 
chronic meningitis (inflammation of brain membranes) and, if not 
treated, are usually fatal.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59226, Nov. 3, 1998]



Sec. 866.3169  Hepatitis C virus antibody tests.

    (a) Identification. A hepatitis C virus (HCV) antibody test is 
identified as an in vitro diagnostic device intended for use with human 
serum, plasma, or other matrices as a prescription device that aids in 
the diagnosis of HCV infection in persons with signs and symptoms of 
hepatitis and in persons at risk for hepatitis C infection. The test is 
not intended for screening blood, plasma, cell, or tissue donors.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The labeling required under Sec. 809.10(b) of this chapter must 
include:
    (i) A prominent statement that the test is not intended for the 
screening of blood, plasma, and cell or tissue donors.
    (ii) Limitations, which must be updated to reflect current clinical 
practice and disease presentation and management. The limitations must 
include, but are not limited to, statements that indicate:
    (A) When appropriate, the performance characteristics of the test 
have not been established in populations of immunocompromised or 
immunosuppressed patients or, other special populations where test 
performance may be affected.
    (B) The detection of HCV antibodies indicates a present or past 
infection with hepatitis C virus, but does not differentiate between 
acute, chronic, or resolved infection.
    (C) The specimen types for which the device has been cleared, and 
that use of the test with specimen types other than those specifically 
cleared for this device may result in inaccurate test results.
    (D) Test results are to be interpreted by qualified licensed 
healthcare professionals in conjunction with the individual's clinical 
presentation, history, and other laboratory results.
    (E) A non-reactive test result may occur early during acute 
infection, prior to development of a host antibody response to 
infection, or when analyte levels are below the limit of detection of 
the test.
    (iii) A detailed explanation of the principles of operation and 
procedures for performing the test.
    (2) Design verification and validation must include the following:
    (i) A detailed device description, including all parts that make up 
the device, ancillary reagents required but not provided, an explanation 
of the device methodology, and design of the

[[Page 336]]

antigen(s) and capture antibody(ies) sequences, rationale for the 
selected epitope(s), degree of amino acid sequence conservation of the 
target, and the design and nature of all primary, secondary, and 
subsequent standards used for calibration.
    (ii) Documentation and characterization (e.g., supplier, 
determination of identity, and stability) of all critical reagents 
(including description of the antigen(s) and capture antibody(ies)), and 
protocols for maintaining product integrity throughout its labeled shelf 
life.
    (iii) Risk analysis and management strategies, such as Failure Modes 
Effects Analysis and/or Hazard Analysis and Critical Control Points 
summaries and their impact on test performance.
    (iv) Final release criteria to be used for manufactured test lots 
with appropriate evidence that lots released at the extremes of the 
specifications will meet the claimed analytical and clinical performance 
characteristics as well as the stability claims.
    (v) Stability studies for reagents must include documentation of an 
assessment of real-time stability for multiple reagent lots using the 
indicated specimen types and must use acceptance criteria that ensure 
that analytical and clinical performance characteristics are met when 
stability is assigned based on the extremes of the acceptance range.
    (vi) All stability protocols, including acceptance criteria.
    (vii) Final release test results for each lot used in clinical 
studies.
    (viii) Multisite reproducibility study that includes the testing of 
three independent production lots.
    (ix) Analytical performance studies and results for determining the 
limit of blank (LoB), limit of detection (LoD), cutoff, precision 
(reproducibility) including lot-to-lot and/or instrument-to-instrument 
precision, interference, cross reactivity, carryover, hook effect, 
seroconversion panel testing, matrix equivalency, specimen stability, 
reagent stability, and cross-genotype antibody detection sensitivity, 
when appropriate.
    (x) Analytical sensitivity of the test is the same or better than 
that of other cleared or approved tests.
    (xi) Detailed documentation of clinical performance testing from a 
multisite clinical study. Performance must be analyzed relative to an 
FDA cleared or approved HCV antibody test, or a comparator that FDA has 
determined is appropriate. This study must be conducted using 
appropriate patient samples, with an acceptable number of HCV positive 
and negative samples in applicable risk categories. Additional relevant 
patient groups must be validated as appropriate. The samples may be a 
combination of fresh and repository samples, sourced from geographically 
diverse areas. The study designs, including number of samples tested, 
must be sufficient to meet the following criteria:
    (A) Clinical sensitivity of the test must have a lower bound of the 
95 percent confidence interval of greater than or equal to 95 percent.
    (B) Clinical specificity of the test must have a lower bound of the 
95 percent confidence interval of greater than or equal to 96 percent.
    (3) For any HCV antibody test intended for Point of Care (PoC) use, 
the following special controls, in addition to those listed in 
paragraphs (b)(1) and (2) of this section, apply:
    (i) Clinical studies must be conducted at PoC sites.
    (ii) Additional labeling must include a brief summary of the 
instructions for use that are appropriate for use in a PoC environment.

[86 FR 66176, Nov. 22, 2021]



Sec. 866.3170  Nucleic acid-based hepatitis C virus ribonucleic acid tests.

    (a) Identification. A nucleic acid-based hepatitis C virus (HCV) 
ribonucleic acid (RNA) test is identified as an in vitro diagnostic 
device intended for prescription use as an aid in the diagnosis of HCV 
infection in specified populations, and/or as an aid in the management 
of HCV-infected patients including guiding the selection of genotype-
specific treatment in individuals with chronic HCV infection. The test 
is intended for use with human serum or plasma. The test is not intended 
for use as a donor screening test for the presence of HCV antibodies in 
blood, blood products, or tissue donors.

[[Page 337]]

    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) For all nucleic acid-based HCV RNA tests, the labeling required 
under Sec. 809.10(b) of this chapter must include:
    (i) A prominent statement that the test is not intended for use as a 
donor screening test for the presence of HCV RNA from human cells, 
tissues, and cellular and tissue-based products.
    (ii) A detailed explanation of the principles of operation and 
procedures for performing the assay.
    (iii) A detailed explanation of the interpretation of results.
    (iv) Limitations, which must be updated to reflect current clinical 
practice and disease presentation and management. These limitations must 
include, but are not limited to, statements that indicate:
    (A) The specimen types for which the device has been cleared and 
that use of this test kit with specimen types other than those 
specifically cleared for this device may result in inaccurate test 
results.
    (B) When applicable, that assay performance characteristics have not 
been established in populations of immunocompromised or immunosuppressed 
patients or, other populations where test performance may be affected.
    (C) Test results are to be interpreted by qualified licensed 
healthcare professionals in conjunction with the individual's clinical 
presentation, history, and other laboratory results.
    (2) For all nucleic acid-based HCV RNA tests, the design 
verification and validation must include:
    (i) Detailed device description, including the device components, 
ancillary reagents required but not provided, and an explanation of the 
device methodology. Additional information appropriate to the technology 
must be included such as design of primers and probes, rationale for the 
selected gene targets, specifications for amplicon size, and degree of 
nucleic acid sequence conservation.
    (ii) For devices with assay calibrators, the design and nature of 
all primary, secondary, and subsequent quantitation standards used for 
calibration as well as their traceability to a standardized reference 
material that FDA has determined is appropriate (e.g., a recognized 
consensus standard). In addition, analytical testing must be performed 
following the release of a new lot of the standard material that was 
used for device clearance or approval, or when there is a transition to 
a new calibration standard.
    (iii) Documentation and characterization (e.g., determination of the 
identity, supplier, purity, and stability) of all critical reagents 
(including nucleic acid sequences for primers and probes) and protocols 
for maintaining product integrity.
    (iv) Detailed documentation of analytical performance studies 
conducted as appropriate to the technology, specimen types tested, and 
intended use of the device, including, but not limited to, limit of 
detection (LoD), upper and lower limits of quantitation (ULoQ and LLoQ, 
respectively), linearity, precision, endogenous and exogenous 
interferences, cross reactivity, carryover, matrix equivalency, and 
sample and reagent stability. Samples selected for use in analytical 
studies or used to prepare samples for use in analytical studies must be 
from subjects with clinically relevant circulating genotypes in the 
United States. Cross-reactivity studies must include samples from HCV 
RNA negative subjects with other causes of liver disease, including 
autoimmune hepatitis, alcoholic liver disease, chronic hepatitis B 
virus, primary biliary cirrhosis, and nonalcoholic steatohepatitis, when 
applicable. The effect of each claimed nucleic-acid isolation and 
purification procedure on detection must be evaluated.
    (v) Risk analysis and management strategies, such as Failure Modes 
Effects Analysis and/or Hazard Analysis and Critical Control Points 
summaries and their impact on test performance.
    (vi) Final release criteria to be used for manufactured test lots 
with appropriate evidence that lots released at the extremes of the 
specifications will meet the claimed analytical and clinical performance 
characteristics as well as the stability claims.
    (vii) Multisite reproducibility study that includes the testing of 
three independent production lots.

[[Page 338]]

    (viii) All stability protocols, including acceptance criteria.
    (ix) Final release test results for each lot used in clinical 
studies.
    (x) Analytical sensitivity and specificity of the test must be the 
same or better than that of other cleared or approved tests.
    (xi) Lot-to-lot precision studies, as appropriate.
    (3) For devices intended for the qualitative detection of HCV RNA, 
in addition to the special controls listed in paragraphs (b)(1) and (2) 
of this section, the design verification and validation must include 
detailed documentation of performance from a multisite clinical study. 
Performance must be analyzed relative to an FDA cleared or approved 
qualitative HCV RNA test, or a comparator that FDA has determined is 
appropriate. This study must be conducted using appropriate patient 
samples, with appropriate numbers of HCV positive and negative samples 
in applicable risk categories. Additional genotypes must be validated 
using appropriate numbers and types of samples. The samples may be a 
combination of fresh and repository samples, sourced from within and 
outside the United States, as appropriate. The study designs, including 
number of samples tested, must be sufficient to meet the following 
criteria:
    (i) Clinical sensitivity of the test must have a lower bound of the 
95 percent confidence interval of greater than or equal to 95 percent.
    (ii) Clinical specificity of the test must have a lower bound of the 
95 percent confidence interval of greater than or equal to 96 percent.
    (4) For devices intended for the quantitative detection of HCV RNA, 
the following special controls, in addition to those listed in 
paragraphs (b)(1) and (2) of this section, apply:
    (i) Labeling required under Sec. 809.10(b) of this chapter must 
include a prominent statement that the test is not intended as a 
diagnostic test to confirm the presence of active HCV infection, when 
applicable.
    (ii) Design verification and validation must include the following:
    (A) Detailed documentation of the following analytical performance 
studies conducted as appropriate to the technology, specimen types 
tested, and intended use of the device, including but not limited to: 
LoD, ULoQ and LLoQ. LoD, LLoQ, and linearity studies must demonstrate 
acceptable device performance with all HCV genotypes detected by the 
device.
    (B) Detailed documentation of clinical performance testing from 
either:
    (1) A multisite clinical study with an appropriate number of 
clinical samples from chronically HCV infected patients in which the 
results are compared to an FDA-cleared or approved quantitative HCV RNA 
test, or a comparator that FDA has determined is appropriate. This study 
must include a sufficient number of HCV positive samples containing an 
analyte concentration near the LLoQ to describe performance at this 
level. Clinical samples must cover the full range of the device output 
and must be consistent with the distribution of these genotypes in the 
U.S. population. Clinical samples may be supplemented with diluted 
clinical samples for those viral load concentrations that are not 
sufficiently covered by natural clinical specimens, or
    (2) A clinical study with prospectively collected samples 
demonstrating clinical validity of the device.
    (C) Detailed documentation of a qualitative analysis near the lower 
end of the measuring range demonstrating acceptable performance when 
used as an aid in diagnosis.
    (5) For devices intended for HCV RNA genotyping, in addition to the 
special controls listed in paragraphs (b)(1) and (2) of this section, 
design verification and validation must include the following:
    (i) Detailed documentation of an analytical performance study 
demonstrating the LoD for all HCV genotypes detected by the device.
    (ii) Detailed documentation, including results, of a multisite 
clinical study that assesses genotyping accuracy (i.e., the proportion 
of interpretable results that match with the reference method result) 
and the genotyping rate (i.e., the proportion of results that were 
interpretable).
    (6) For any nucleic acid-based HCV RNA test intended for Point of 
Care (PoC) use, the following special controls, in addition to those 
listed in

[[Page 339]]

paragraphs (b)(1) and (2) of this section, apply:
    (i) Clinical studies must be conducted at PoC sites.
    (ii) Additional labeling must include a brief summary of the 
instructions for use that are appropriate for use in a PoC environment.

[86 FR 66172, Nov. 22, 2021]



Sec. 866.3175  Cytomegalovirus serological reagents.

    (a) Identification. Cytomegalovirus serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify antibodies to cytomegalovirus in serum. The identification aids 
in the diagnosis of diseases caused by cytomegaloviruses (principally 
cytomegalic inclusion disease) and provides epidemiological information 
on these diseases. Cytomegalic inclusion disease is a generalized 
infection of infants and is caused by intrauterine or early postnatal 
infection with the virus. The disease may cause severe congenital 
abnormalities, such as microcephaly (abnormal smallness of the head), 
motor disability, and mental retardation. Cytomegalovirus infection has 
also been associated with acquired hemolytic anemia, acute and chronic 
hepatitis, and an infectious mononucleosis-like syndrome.
    (b) Classification. Class II (performance standards).



Sec. 866.3200  Echinococcus spp. serological reagents.

    (a) Identification. Echinococcus spp. serological reagents are 
devices that consist of Echinococcus spp. antigens and antisera used in 
serological tests to identify antibodies to Echinococcus spp. in serum. 
The identification aids in the diagnosis of echinococcosis, caused by 
parasitic tapeworms belonging to the genus Echinococcus and provides 
epidemiological information on this disease. Echinococcosis is 
characterized by the development of cysts in the liver, lung, kidneys, 
and other organs formed by the larva of the infecting organisms.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]



Sec. 866.3205  Echovirus serological reagents.

    (a) Identification. Echovirus serological reagents are devices that 
consist of antigens and antisera used in serological tests to identify 
antibodies to echovirus in serum. Additionally, some of these reagents 
consist of echovirus antisera conjugated with a fluorescent dye used to 
identify echoviruses from clinical specimens or from tissue culture 
isolates derived from clinical specimens. The identification aids in the 
diagnosis of echovirus infections and provides epidemiological 
information on diseases caused by these viruses. Echoviruses cause 
illnesses such as meningitis (inflammation of the brain and spinal cord 
membranes), febrile illnesses (accompanied by fever) with or without 
rash, and the common cold.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 
FR 38791, July 25, 2001]



Sec. 866.3210  Endotoxin assay.

    (a) Identification. An endotoxin assay is a device that uses 
serological techniques in whole blood. The device is intended for use in 
conjunction with other laboratory findings and clinical assessment of 
the patient to aid in the risk assessment of critically ill patients for 
progression to severe sepsis.
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA guidance entitled ``Class II Special Controls 
Guidance Document: Endotoxin Assay.'' See Sec. 866.1(e) for the 
availability of this guidance document.

[68 FR 62008, Oct. 31, 2003. Redesignated at 70 FR 53069, Sept. 7, 2005]

[[Page 340]]



Sec. 866.3215  Device to detect and measure non-microbial analyte(s)
in human clinical specimens to aid in assessment of patients with 
suspected sepsis.

    (a) Identification. A device to detect and measure non-microbial 
analyte(s) in human clinical specimens to aid in assessment of patients 
with suspected sepsis is identified as an in vitro device intended for 
the detection and qualitative and/or quantitative measurement of one or 
more non-microbial analytes in human clinical specimens to aid in the 
assessment of patients with suspected sepsis when used in conjunction 
with clinical signs and symptoms and other clinical and laboratory 
findings.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Premarket notification submissions must include the device's 
detailed Indications for Use statement describing what the device 
detects and measures, the results provided to the user, whether the 
measure is qualitative and/or quantitative, the clinical indications for 
which the test is to be used, and the specific population(s) for which 
the device use is intended.
    (2) Premarket notification submissions must include detailed 
documentation of the device description, including (as applicable), all 
device components, software, ancillary reagents required but not 
provided, explanation of the device principle and methodology, and for 
molecular devices include detailed documentation of the primer/probe 
sequence, design, and rationale for sequence selection.
    (3) Premarket notification submissions must include detailed 
documentation of applicable analytical studies, such as, analytical 
sensitivity (Limit of Detection, Limit of Blank, and Limit of 
Quantitation), precision, reproducibility, analytical measuring range, 
interference, cross-reactivity, and specimen stability.
    (4) Premarket notification submissions must include detailed 
documentation of a prospective clinical study or, if appropriate, 
results from an equivalent sample set. This detailed documentation must 
include the following information:
    (i) Results must demonstrate adequate device performance relative to 
a well-accepted comparator.
    (ii) Clinical sample results must demonstrate consistency of device 
output throughout the device measuring range likely to be encountered in 
the Intended Use population.
    (iii) Clinical study documentation must include the original study 
protocol (including predefined statistical analysis plan), study report 
documenting support for the Indications for Use(s), and results of all 
statistical analyses.
    (5) Premarket notification submissions must include evaluation of 
the level of the non-microbial analyte in asymptomatic patients with 
demographic characteristics (e.g., age, racial, ethnic, and gender 
distribution) similar to the Intended Use population.
    (6) As part of the risk management activities performed under 21 CFR 
820.30 design controls, you must document an appropriate end user device 
training program that will be offered as part of your efforts to 
mitigate the risk of failure to correctly operate the instrument.
    (7) A detailed explanation of the interpretation of results and 
acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) 
compliant labeling, and a detailed explanation of the interpretation of 
the limitations of the samples (e.g., collected on day of diagnosis) 
must be included in the device's 21 CFR 809.10(b)(10) compliant 
labeling.

[82 FR 49099, Oct. 24, 2017]



Sec. 866.3220  Entamoeba histolytica serological reagents.

    (a) Identification. Entamoeba histolytica serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Entamoeba histolytica in serum. Additionally, 
some of these reagents consist of antisera conjugated with a fluorescent 
dye (immunofluorescent reagents) used to identify Entamoeba histolytica 
directly from clinical specimens. The identification aids in the 
diagnosis of amebiasis caused by the microscopic protozoan parasite 
Entamoeba histolytica and provides epidemiological information

[[Page 341]]

on diseases caused by this parasite. The parasite may invade the skin, 
liver, intestines, lungs, and diaphragm, causing disease conditions such 
as indolent ulcers, an amebic hepatitis, amebic dysentery, and pulmonary 
lesions.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982; 47 FR 56846, Dec. 21, 1982, as amended at 63 
FR 59226, Nov. 3, 1998]



Sec. 866.3225  Enterovirus nucleic acid assay.

    (a) Identification. An enterovirus nucleic acid assay is a device 
that consists of primers, probes, enzymes, and controls for the 
amplification and detection of enterovirus ribonucleic acid (RNA) in 
cerebrospinal fluid (CSF) from individuals who have signs and symptoms 
consistent with meningitis or meningoencephalitis. The detection of 
enterovirus RNA, in conjunction with other laboratory tests, aids in the 
clinical laboratory diagnosis of viral meningitis caused by enterovirus.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance document entitled ``Class II Special Controls Guidance 
Document: Nucleic Acid Amplification Assay for the Detection of 
Enterovirus RNA.'' See Sec. 866.1(e) for the availability of this 
guidance document.

[74 FR 8, Jan. 2, 2009]



Sec. 866.3235  Epstein-Barr virus serological reagents.

    (a) Identification. Epstein-Barr virus serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Epstein-Barr virus in serum. The 
identification aids in the diagnosis of Epstein-Barr virus infections 
and provides epidemiological information on diseases caused by these 
viruses. Epstein-Barr viruses are thought to cause infectious 
mononucleosis and have been associated with Burkitt's lymphoma (a tumor 
of the jaw in African children and young adults) and postnasal carcinoma 
(cancer).
    (b) Classification. Class I (general controls).



Sec. 866.3240  Equine encephalomyelitis virus serological reagents.

    (a) Identification. Equine encephalomyelitis virus serological 
reagents are devices that consist of antigens and antisera used in 
serological tests to identify antobodies to equine encephalomyelitis 
virus in serum. The identification aids in the diagnosis of diseases 
caused by equine encephalomyelitis viruses and provides epidemiological 
information on these viruses. Equine encephalomyelitis viruses are 
transmitted to humans by the bite of insects, such as mosquitos and 
ticks, and may cause encephalitis (inflammation of the brain), rash, 
acute arthritis, or hepatitis.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]



Sec. 866.3250  Erysipelothrix rhusiopathiae serological reagents.

    (a) Identification. Erysipelothrix rhusiopathiae serological 
reagents are devices that consist of antigens and antisera used in 
serological tests to identify Erysipelothrix rhusiopathiae from cultured 
isolates derived from clinical specimens. The identification aids in the 
diagnosis of disease caused by this bacterium belonging to the genus 
Erysipelothrix. This organism is responsible for a variety of 
inflammations of the skin following skin abrasions from contact with 
fish, shellfish, or poultry.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 
FR 38791, July 25, 2001]

[[Page 342]]



Sec. 866.3255  Escherichia coli serological reagents.

    (a) Identification. Escherichia coli serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify Escherichia coli from cultured isolates derived from 
clinical specimens. Additionally, some of these reagents consist of 
Escherichia coli antisera conjugated with a fluorescent dye used to 
identify Escherichia coli directly from clinical specimens or cultured 
isolates derived from clinical specimens. The identification aids in the 
diagnosis of diseases caused by this bacterium belonging to the genus 
Escherichia, and provides epidemiological information on diseases caused 
by this microorganism. Although Escherichia coli constitutes the greater 
part of the microorganisms found in the intestinal tract in humans and 
is usually nonpathogenic, those strains which are pathogenic may cause 
urinary tract infections or epidemic diarrheal disease, especially in 
children.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 
FR 38791, July 25, 2001]



Sec. 866.3270  Flavobacterium spp. serological reagents.

    (a) Identification. Flavobacterium spp. serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify Flavobacteriuim spp. from cultured isolates derived from 
clinical specimens. The identification aids in the diagnosis of disease 
caused by bacteria belonging to the genus Flavobacterium and provides 
epidemiological information on diseases caused by these microorganisms. 
Most members of this genus are found in soil and water and, under 
certain conditions, may become pathogenic to humans. Flavobacterium 
meningosepticum is highly virulent for the newborn, in whom it may cause 
epidemics of septicemia (blood poisoning) and meningitis (inflammation 
of the membranes of the brain) and is usually attributable to 
contaminated hospital equipment.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 
FR 38792, July 25, 2001]



Sec. 866.3280  Francisella tularensis serological reagents.

    (a) Identification. Francisella tularensis serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Francisella tularensis in serum or to identify 
Francisella tularensis in cultured isolates derived from clinical 
specimens. Additionally, some of these reagents consist of antisera 
conjugated with a fluorescent dye (immunofluorescent reagents) used to 
identify Francisella tularensis directly from clinical specimens. The 
identification aids in the diagnosis of tularemia caused by Francisella 
tularensis and provides epidemiological information on this disease. 
Tularemia is a desease principally of rodents, but may be transmitted to 
humans through handling of infected animals, animal products, or by the 
bites of fleas and ticks. The disease takes on several forms depending 
upon the site of infection, such as skin lesions, lymph node 
enlargements, or pulmonary infection.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59226, Nov. 3, 1998]



Sec. 866.3290  Gonococcal antibody test (GAT).

    (a) Identification. A gonococcal antibody test (GAT) is an in vitro 
device that consists of the reagents intended to identify by 
immunochemical techniques, such as latex agglutination, indirect 
fluorescent antibody, or radioimmunoassay, antibodies to Neisseria 
gonorrhoeae in sera of asymptomatic females at low risk of infection. 
Identification of antibodies with this device may indicate past or 
present infection of the patient with Neisseria gonorrhoeae.

[[Page 343]]

    (b) Classification. Class III (premarket approval) (transitional 
device).
    (c) Date PMA or notice of completion of a PDP is required. As of May 
28, 1976, an approval under section 515 of the act is required before 
this device may be commercially distributed. See Sec. 866.3.

[47 FR 50823, Nov. 9, 1982, as amended at 52 FR 17734, May 11, 1987]



Sec. 866.3300  Haemophilus spp. serological reagents.

    (a) Identification. Haemophilus spp. serological reagents are 
devices that consist of antigens and antisera, including antisera 
conjugated with a fluorescent dye, that are used in serological tests to 
identify Haemophilus spp. directly from clinical specimens or tissue 
culture isolates derived from clinical specimens. The identification 
aids in the diagnosis of diseases caused by bacteria belonging to the 
genus Haemophilus and provides epidemiological information on diseases 
cause by these microorganisms. Diseases most often caused by Haemophilus 
spp. include pneumonia, pharyngitis, sinusitis, vaginitis, chancroid 
venereal disease, and a contagious form of conjunctivitis (inflammation 
of eyelid membranes).
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59226, Nov. 3, 1998]



Sec. 866.3305  Herpes simplex virus serological assays.

    (a) Identification. Herpes simplex virus serological assays are 
devices that consist of antigens and antisera used in various 
serological tests to identify antibodies to herpes simplex virus in 
serum. Additionally, some of the assays consist of herpes simplex virus 
antisera conjugated with a fluorescent dye (immunofluorescent assays) 
used to identify herpes simplex virus directly from clinical specimens 
or tissue culture isolates derived from clinical specimens. The 
identification aids in the diagnosis of diseases caused by herpes 
simplex viruses and provides epidemiological information on these 
diseases. Herpes simplex viral infections range from common and mild 
lesions of the skin and mucous membranes to a severe form of 
encephalitis (inflammation of the brain). Neonatal herpes virus 
infections range from a mild infection to a severe generalized disease 
with a fatal outcome.
    (b) Classification. Class II (special controls). The device is 
classified as class II (special controls). The special control for the 
device is FDA's revised guidance document entitled ``Class II Special 
Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 
Serological Assays.'' For availability of the guidance revised document, 
see Sec. 866.1(e).

[72 FR 15830, Apr. 3, 2007, as amended at 74 FR 42775, Aug. 25, 2009; 76 
FR 48717, Aug. 9, 2011]



Sec. 866.3309  Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel.

    (a) Identification. A herpes virus nucleic acid-based cutaneous and 
mucocutaneous lesion panel is a qualitative in vitro diagnostic device 
intended for the simultaneous detection and differentiation of different 
herpes viruses in cutaneous and mucocutaneous lesion samples from 
symptomatic patients suspected of Herpetic infections. Negative results 
do not preclude infection and should not be used as the sole basis for 
treatment or other patient management decisions. The assay is not 
intended for use in cerebrospinal fluid samples.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Premarket notification submissions must include detailed 
documentation for the device description, including the device 
components, ancillary reagents required but not provided, and a detailed 
explanation of the methodology including primer design and selection.
    (2) Premarket notification submissions must include detailed 
documentation from the following analytical and clinical performance 
studies: Analytical sensitivity (Limit of Detection), reactivity, 
inclusivity, precision, reproducibility, interference, cross reactivity, 
carry-over, and cross contamination.

[[Page 344]]

    (3) Premarket notification submissions must include detailed 
documentation of a clinical study using lesion samples in which Herpes 
Simplex Virus 1, Herpes Simplex Virus 2, or Varicella Zoster Virus DNA 
detection was requested. The study must compare the device performance 
to an appropriate well established reference method.
    (4) A detailed explanation of the interpretation of results and 
acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) 
compliant labeling.
    (5) The device labeling must include a limitation statement that 
reads: ``The device is not intended for use with cerebrospinal fluid or 
to aid in the diagnosis of HSV or VZV infections of the central nervous 
system (CNS).''
    (6) Premarket notification submissions must include quality 
assurance protocols and a detailed documentation for device software, 
including, but not limited to, standalone software applications and 
hardware-based devices that incorporate software.
    (7) The risk management activities performed as part of the 
manufacturer's 21 CFR 820.30 design controls must document an 
appropriate end user device training program that will be offered as 
part of efforts to mitigate the risk of failure to correctly operate the 
instrument.

[83 FR 52314, Oct. 17, 2018]



Sec. 866.3310  Hepatitis A virus (HAV) serological assays.

    (a) Identification. HAV serological assays are devices that consist 
of antigens and antisera for the detection of hepatitis A virus-specific 
IgM, IgG, or total antibodies (IgM and IgG), in human serum or plasma. 
These devices are used for testing specimens from individuals who have 
signs and symptoms consistent with acute hepatitis to determine if an 
individual has been previously infected with HAV, or as an aid to 
identify HAV-susceptible individuals. The detection of these antibodies 
aids in the clinical laboratory diagnosis of an acute or past infection 
by HAV in conjunction with other clinical laboratory findings. These 
devices are not intended for screening blood or solid or soft tissue 
donors.
    (b) Classification. Class II (special controls). The special control 
is ``Guidance for Industry and FDA Staff: Class II Special Controls 
Guidance Document: Hepatitis A Virus Serological Assays.'' See Sec. 
866.1(e) for the availability of this guidance document.

[71 FR 6679, Feb. 9, 2006]



Sec. 866.3320  Histoplasma capsulatum serological reagents.

    (a) Identification. Histoplasma capsulatum serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Histoplasma capsulatum in serum. Additionally, 
some of these reagents consist of Histoplasma capsulatum antisera 
conjugated with a fluorescent dye (immunofluorescent reagents) used to 
identify Histoplasma capsulatum from clinical specimens or cultured 
isolates derived from clinical specimens. The identification aids in the 
diagnosis of histoplasmosis caused by this fungus belonging to the genus 
Histoplasma and provides epidemiological information on the diseases 
caused by this fungus. Histoplasmosis usually is a mild and often 
asymptomatic respiratory infection, but in a small number of infected 
individuals the lesions may spread to practically all tissues and 
organs.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59227, Nov. 3, 1998]



Sec. 866.3328  Influenza virus antigen detection test system.

    (a) Identification. An influenza virus antigen detection test system 
is a device intended for the qualitative detection of influenza viral 
antigens directly from clinical specimens in patients with signs and 
symptoms of respiratory infection. The test aids in the diagnosis of 
influenza infection and provides epidemiological information on 
influenza. Due to the propensity of the virus to mutate, new strains 
emerge over time which may potentially affect the performance of these 
devices. Because influenza is highly

[[Page 345]]

contagious and may lead to an acute respiratory tract infection causing 
severe illness and even death, the accuracy of these devices has serious 
public health implications.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The device's sensitivity and specificity performance 
characteristics or positive percent agreement and negative percent 
agreement, for each specimen type claimed in the intended use of the 
device, must meet one of the following two minimum clinical performance 
criteria:
    (i) For devices evaluated as compared to an FDA-cleared nucleic acid 
based-test or other currently appropriate and FDA accepted comparator 
method other than correctly performed viral culture method:
    (A) The positive percent agreement estimate for the device when 
testing for influenza A and influenza B must be at the point estimate of 
at least 80 percent with a lower bound of the 95 percent confidence 
interval that is greater than or equal to 70 percent.
    (B) The negative percent agreement estimate for the device when 
testing for influenza A and influenza B must be at the point estimate of 
at least 95 percent with a lower bound of the 95 percent confidence 
interval that is greater than or equal to 90 percent.
    (ii) For devices evaluated as compared to correctly performed viral 
culture method as the comparator method:
    (A) The sensitivity estimate for the device when testing for 
influenza A must be at the point estimate of at least 90 percent with a 
lower bound of the 95 percent confidence interval that is greater than 
or equal to 80 percent. The sensitivity estimate for the device when 
testing for influenza B must be at the point estimate of at least 80 
percent with a lower bound of the 95 percent confidence interval that is 
greater than or equal to 70 percent.
    (B) The specificity estimate for the device when testing for 
influenza A and influenza B must be at the point estimate of at least 95 
percent with a lower bound of the 95 percent confidence interval that is 
greater than or equal to 90 percent.
    (2) When performing testing to demonstrate the device meets the 
requirements in paragraph (b)(1) of this section, a currently 
appropriate and FDA accepted comparator method must be used to establish 
assay performance in clinical studies.
    (3) Annual analytical reactivity testing of the device must be 
performed with contemporary influenza strains. This annual analytical 
reactivity testing must meet the following criteria:
    (i) The appropriate strains to be tested will be identified by FDA 
in consultation with the Centers for Disease Control and Prevention 
(CDC) and sourced from CDC or an FDA-designated source. If the annual 
strains are not available from CDC, FDA will identify an alternative 
source for obtaining the requisite strains.
    (ii) The testing must be conducted according to a standardized 
protocol considered and determined by FDA to be acceptable and 
appropriate.
    (iii) By July 31 of each calendar year, the results of the last 3 
years of annual analytical reactivity testing must be included as part 
of the device's labeling. If a device has not been on the market long 
enough for 3 years of annual analytical reactivity testing to have been 
conducted since the device received marketing authorization from FDA, 
then the results of every annual analytical reactivity testing since the 
device received marketing authorization from FDA must be included. The 
results must be presented as part of the device's labeling in a tabular 
format, which includes the detailed information for each virus tested as 
described in the certificate of authentication, either by:
    (A) Placing the results directly in the device's Sec. 809.10(b) of 
this chapter compliant labeling that physically accompanies the device 
in a separate section of the labeling where the analytical reactivity 
testing data can be found; or
    (B) In the device's label or in other labeling that physically 
accompanies the device, prominently providing a hyperlink to the 
manufacturer's public Web site where the analytical reactivity testing 
data can be found. The manufacturer's home page, as well as the primary 
part of the manufacturer's Web site that discusses the device,

[[Page 346]]

must provide a prominently placed hyperlink to the Web page containing 
this information and must allow unrestricted viewing access.
    (4) If one of the actions listed at section 564(b)(1)(A)-(D) of the 
Federal Food, Drug, and Cosmetic Act occurs with respect to an influenza 
viral strain, or if the Secretary of Health and Human Services (HHS) 
determines, under section 319(a) of the Public Health Service Act, that 
a disease or disorder presents a public health emergency, or that a 
public health emergency otherwise exists, with respect to an influenza 
viral strain:
    (i) Within 30 days from the date that FDA notifies manufacturers 
that characterized viral samples are available for test evaluation, the 
manufacturer must have testing performed on the device with those viral 
samples in accordance with a standardized protocol considered and 
determined by FDA to be acceptable and appropriate. The procedure and 
location of testing may depend on the nature of the emerging virus.
    (ii) Within 60 days from the date that FDA notifies manufacturers 
that characterized viral samples are available for test evaluation and 
continuing until 3 years from that date, the results of the influenza 
emergency analytical reactivity testing, including the detailed 
information for the virus tested as described in the certificate of 
authentication, must be included as part of the device's labeling in a 
tabular format, either by:
    (A) Placing the results directly in the device's Sec. 809.10(b) of 
this chapter compliant labeling that physically accompanies the device 
in a separate section of the labeling where analytical reactivity 
testing data can be found, but separate from the annual analytical 
reactivity testing results; or
    (B) In a section of the device's label or in other labeling that 
physically accompanies the device, prominently providing a hyperlink to 
the manufacturer's public Web site where the analytical reactivity 
testing data can be found. The manufacturer's home page, as well as the 
primary part of the manufacturer's Web site that discusses the device, 
must provide a prominently placed hyperlink to the Web page containing 
this information and must allow unrestricted viewing access.

[82 FR 3618, Jan. 12, 2017]



Sec. 866.3330  Influenza virus serological reagents.

    (a) Identification. Influenza virus serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify antibodies to influenza in serum. The identification aids in 
the diagnosis of influenza (flu) and provides epidemiological 
information on influenza. Influenza is an acute respiratory tract 
disease, which is often epidemic.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 
FR 38792, July 25, 2001]



Sec. 866.3332  Reagents for detection of specific novel influenza A viruses.

    (a) Identification. Reagents for detection of specific novel 
influenza A viruses are devices that are intended for use in a nucleic 
acid amplification test to directly detect specific virus RNA in human 
respiratory specimens or viral cultures. Detection of specific virus RNA 
aids in the diagnosis of influenza caused by specific novel influenza A 
viruses in patients with clinical risk of infection with these viruses, 
and also aids in the presumptive laboratory identification of specific 
novel influenza A viruses to provide epidemiological information on 
influenza. These reagents include primers, probes, and specific 
influenza A virus controls.
    (b) Classification. Class II (special controls). The special 
controls are:
    (1) FDA's guidance document entitled ``Class II Special Controls 
Guidance Document: Reagents for Detection of Specific Novel Influenza A 
Viruses.'' See Sec. 866.1(e) for information on obtaining this 
document.
    (2) The distribution of these devices is limited to laboratories 
with experienced personnel who have training in standardized molecular 
testing procedures and expertise in viral diagnosis,

[[Page 347]]

and appropriate biosafety equipment and containment.

[71 FR 14379, Mar. 22, 2006]



Sec. 866.3336  John Cunningham Virus serological reagents.

    (a) Identification. John Cunningham Virus serological reagents are 
devices that consist of antigens and antisera used in serological assays 
to identify antibodies to John Cunningham Virus in serum and plasma. The 
identification aids in the risk stratification for the development of 
progressive multifocal leukoencephalopathy in multiple sclerosis and 
Crohn's disease patients undergoing natalizumab therapy. These devices 
are for adjunctive use, in the context of other clinical risk factors 
for the development of progressive multifocal leukoencephalopathy.
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA guideline document entitled ``Class II 
Special Controls Guideline: John Cunningham Virus Serological 
Reagents.'' For availability of the guideline document, see Sec. 
866.1(e).

[79 FR 3740, Jan. 23, 2014]



Sec. 866.3340  Klebsiella spp. serological reagents.

    (a) Identification. Klebsiella spp. serological reagents are devices 
that consist of antigens and antisera, including antisera conjugated 
with a fluorescent dye (immunofluorescent reagents), that are used in 
serological tests to identify Klebsiella spp. from cultured isolates 
derived from clinical specimens. The identification aids in the 
diagnosis of diseases caused by bacteria belonging to the genus 
Klebsiella and provides epidemiological information on these diseases. 
These organisms can cause serious urinary tract and pulmonary 
infections, particularly in hospitalized patients.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 
FR 38792, July 25, 2001]



Sec. 866.3350  Leptospira spp. serological reagents.

    (a) Identification. Leptospira spp. serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify antibodies to Leptospira spp. in serum or identify Leptospira 
spp. from cultured isolates derived from clinical specimens. 
Additionally, some of these antisera are conjugated with a fluorescent 
dye (immunofluorescent reagents) and used to identify Leptospira spp. 
directly from clinical specimens. The identification aids in the 
diagnosis of leptospirosis caused by bacteria belonging to the genus 
Leptospira and provides epidemiological information on this disease. 
Leptospira infections range from mild fever-producing illnesses to 
severe liver and kidney involvement producing hemorrhage and dysfunction 
of these organs.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59227, Nov. 3, 1998]



Sec. 866.3355  Listeria spp. serological reagents.

    (a) Identification. Listeria spp. serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify Listeria spp. from cultured isolates derived from clinical 
specimens. Additionally, some of these reagents consist of Listeria spp. 
antisera conjugated with a fluorescent dye (immunofluorescent reagents) 
used to identify Listeria spp. directly from clinical specimens. The 
identification aids in the diagnosis of listeriosis, a disease caused by 
bacteria belonging to the genus Listeria, and provides epidemiological 
information on diseases caused by these microorganisms. Listeria 
monocytogenes, the most common human pathogen of this genus, causes 
meningitis (inflammation of the brain membranes) and meningoencephalitis 
(inflammation of the brain and brain membranes) and is often fatal if 
untreated. A second form of human listeriosis is an intrauterine 
infection in pregnant women that results in a

[[Page 348]]

high mortality rate for infants before or after birth.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]



Sec. 866.3360  Lymphocytic choriomeningitis virus serological reagents.

    (a) Identification. Lymphocytic choriomeningitis virus serological 
reagents are devices that consist of antigens and antisera used in 
serological tests to identify antibodies to lymphocytic choriomeningitis 
virus in serum. The identification aids in the diagnosis of lymphocytic 
choriomeningitis virus infections and provides epidemiological 
information on diseases caused by these viruses. Lymphocytic 
choriomeningitis viruses usually cause a mild cerebral meningitis 
(inflammation of membranes that envelop the brain) and occasionally a 
mild pneumonia, but in rare instances may produce severe and even fatal 
illnesses due to complications from cerebral meningitis and pneumonia.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]



Sec. 866.3361  Mass spectrometer system for clinical use
for the identification of microorganisms.

    (a) Identification. A mass spectrometer system for clinical use for 
the identification of microorganisms is a qualitative in vitro 
diagnostic device intended for the identification of microorganisms 
cultured from human specimens. The device is comprised of an ionization 
source, a mass analyzer, and a spectral database. The device is 
indicated for use in conjunction with other clinical and laboratory 
findings to aid in the diagnosis of bacterial and fungal infections.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Premarket notification submissions must include detailed 
documentation for device software, including, but not limited to, 
standalone software applications and hardware-based devices that 
incorporate software.
    (2) Premarket notification submissions must include database 
implementation methodology, construction parameters, and quality 
assurance protocols.
    (3) A detailed explanation of the interpretation of results and 
acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) 
compliant labeling.
    (4) As part of the risk management activities performed as part of 
your 21 CFR 820.30 design controls, you must document an appropriate end 
user device training program that will be offered as part of your 
efforts to mitigate the risk of failure to correctly operate the 
instrument.
    (5) Premarket notification submissions must include details on the 
appropriate end user device training program that will be offered while 
marketing the device.

[82 FR 49101, Oct. 24, 2017]



Sec. 866.3365  Multiplex nucleic acid assay for identification
of microorganisms and resistance markers from positive blood
cultures.

    (a) Identification. A multiplex nucleic acid assay for 
identification of microorganisms and resistance markers from positive 
blood cultures is a qualitative in vitro device intended to 
simultaneously detect and identify microorganism nucleic acids from 
blood cultures that test positive by Gram stain or other microbiological 
stains. The device detects specific nucleic acid sequences for 
microorganism identification as well as for antimicrobial resistance. 
This device aids in the diagnosis of bloodstream infections when used in 
conjunction with other clinical and laboratory findings. However, the 
device does not replace traditional methods for culture and 
susceptibility testing.
    (b) Classification. Class II (special controls). The special control 
for this

[[Page 349]]

device is FDA's guideline document entitled ``Class II Special Controls 
Guideline: Multiplex Nucleic Acid Assay for Identification of 
Microorganisms and Resistance Markers from Positive Blood Cultures.'' 
For availability of the guideline document, see Sec. 866.1(e).

[80 FR 30154, May 27, 2015]



Sec. 866.3370  Mycobacterium tuberculosis immunofluorescent reagents.

    (a) Identification. Mycobacterium tuberculosis immunofluorescent 
reagents are devices that consist of antisera conjugated with a 
fluorescent dye used to identify Mycobacterium tuberculosis directly 
from clinical specimens. The identification aids in the diagnosis of 
tuberculosis and provides epidemiological information on this disease. 
Mycobacterium tuberculosis is the common causative organism in human 
tuberculosis, a chronic infectious disease characterized by formation of 
tubercles (small rounded nodules) and tissue necrosis (destruction), 
usually occurring in the lung.
    (b) Classification. Class I (general controls).



Sec. 866.3372  Nucleic acid-based in vitro diagnostic devices 
for the detection of Mycobacterium tuberculosis complex in 
respiratory specimens.

    (a) Identification. Nucleic acid-based in vitro diagnostic devices 
for the detection of Mycobacterium tuberculosis complex in respiratory 
specimens are qualitative nucleic acid-based in vitro diagnostic devices 
intended to detect Mycobacterium tuberculosis complex nucleic acids 
extracted from human respiratory specimens. These devices are non-
multiplexed and intended to be used as an aid in the diagnosis of 
pulmonary tuberculosis when used in conjunction with clinical and other 
laboratory findings. These devices do not include devices intended to 
detect the presence of organism mutations associated with drug 
resistance. Respiratory specimens may include sputum (induced or 
expectorated), bronchial specimens (e.g., bronchoalveolar lavage or 
bronchial aspirate), or tracheal aspirates.
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA document entitled ``Class II Special Controls 
Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the 
Detection of Mycobacterium tuberculosis Complex in Respiratory 
Specimens.'' For availability of the guideline document, see Sec. 
866.1(e).

[79 FR 31027, May 30, 2014]



Sec. 866.3373  Nucleic acid-based in vitro diagnostic devices
for the detection of Mycobacterium tuberculosis complex (MTB-complex)
and the genetic mutations associated with MTB-complex antibiotic
resistance in respiratory specimens
    (a) Identification. Nucleic acid-based in vitro diagnostic devices 
for the detection of Mycobacterium tuberculosis complex (MTB-complex) 
and the genetic mutations associated with MTB-complex antibiotic 
resistance in respiratory specimens are qualitative nucleic acid-based 
devices that detect the presence of MTB-complex-associated nucleic acid 
sequences in respiratory samples. These devices are intended to aid in 
the diagnosis of pulmonary tuberculosis and the selection of an initial 
treatment regimen when used in conjunction with clinical findings and 
other laboratory results. These devices do not provide confirmation of 
antibiotic susceptibility since other mechanisms of resistance may exist 
that may be associated with a lack of clinical response to treatment 
other than those detected by the device.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The FDA document entitled ``Class II Special Controls Guideline: 
Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of 
Mycobacterium tuberculosis Complex and Genetic Mutations Associated with 
Antibiotic Resistance in Respiratory Specimens,'' which addresses the 
mitigation of risks specific to the detection of MTB-complex. For 
availability of the document, see Sec. 866.1(e).
    (2) The following items, which address the mitigation of risks 
specific to the detection of the genetic mutations associated with 
antibiotic resistance of MTB-complex:

[[Page 350]]

    (i) The device must include an external positive assay control as 
appropriate. Acceptable positive assay controls include MTB-complex 
isolates containing one or more antibiotic-resistance associated target 
sequences detected by the device.
    (ii) The device must include internal controls as appropriate. An 
acceptable internal control may include human nucleic acid co-extracted 
with MTB-complex containing nucleic acid sequences associated with 
antibiotic resistance and primers amplifying human housekeeping genes 
(e.g., RNaseP, [beta]-actin).
    (iii) The device's intended use must include a description of the 
scope of antibiotic resistance targeted by the assay, i.e., the specific 
drugs and/or drug classes.
    (iv) The specific performance characteristics section of the 
device's labeling must include information regarding the specificity of 
the assay oligonucleotides for detecting mutations associated with 
antibiotic resistance of MTB-complex, and any information indicating the 
potential for non-specific binding (e.g., BLAST search).
    (v) In demonstrating device performance you must perform:
    (A) Pre-analytical studies that evaluate:
    (1) Frozen samples. If there is use of any frozen samples in the 
device performance studies, or if there is a device claim for the use of 
frozen samples for testing, the effect of freezing samples prior to 
testing and the effect of multiple freeze/thaw cycles on both antibiotic 
susceptible and antibiotic resistant strains of MTB-complex.
    (2) Nucleic acid extraction methods. Extraction methods must 
parallel those used in devices for the detection of MTB-complex nucleic 
acid and confirm that the detection of the genetic mutations associated 
with antibiotic resistance is not affected.
    (B) Analytical studies that analyze:
    (1) Limit of Detection. Limit of Detection must be determined in the 
most challenging matrix (e.g., sputum) claimed for use with the device. 
The Limit of Detection must be determined using both antibiotic 
susceptible and antibiotic resistant strains of MTB-complex. The 
antibiotic resistant strains must be those with well characterized 
genetic mutations associated with antibiotic resistance.
    (2) Analytical Reactivity (Inclusivity). Testing must be conducted 
to evaluate the ability of the device to detect genetic mutations 
associated with antibiotic resistance in a diversity of MTB-complex 
strains. Isolates used in testing must be well characterized. Isolate 
strain characterization must be determined using standardized reference 
methods recognized by a reputable scientific body and appropriate to the 
strain lineage.
    (3) Within-Laboratory (Repeatability) Precision Testing. Within-
laboratory precision studies, if appropriate, must include at least one 
antibiotic resistant and one antibiotic susceptible strain of MTB-
complex.
    (4) Between Laboratory Reproducibility Testing. The protocol for the 
reproducibility study may vary slightly depending on the assay format; 
however, the panel must include at least one antibiotic resistant and 
one antibiotic susceptible strain of MTB-complex.
    (C) Clinical Studies. Clinical performance of the device must be 
established by conducting prospective clinical studies that include 
subjects with culture confirmed active tuberculosis. Studies must 
attempt to enroll subjects at risk for antibiotic-resistant MTB-complex; 
however, it may be necessary to include supplemental antibiotic 
resistant retrospective and contrived samples. Clinical studies must 
compare device results to both phenotypic drug susceptibility testing 
and genotypic reference methods. The genotypic reference method must be 
a polymerase chain reaction based method that uses primers different 
from those in the experimental device and confirmed by bidirectional 
sequencing.

[79 FR 63036, Oct. 22, 2014]



Sec. 866.3375  Mycoplasma spp. serological reagents.

    (a) Identification. Mycoplasma spp. serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify antibodies to Mycoplasma spp. in serum. Additionally, some of 
these reagents consist of Mycoplasma spp. antisera conjugated

[[Page 351]]

with a fluorescent dye (immunofluorescent reagents) used to identify 
Mycoplasma spp. directly from clinical specimens. The identification 
aids in the diagnosis of disease caused by bacteria belonging to the 
genus Mycoplasma and provides epidemiological information on diseases 
caused by these microorganisms. Mycoplasma spp. are associated with 
inflammatory conditions of the urinary and respiratory tracts, the 
genitals, and the mouth. The effects in humans of infection with 
Mycoplasma pneumoniae range from inapparent infection to mild or severe 
upper respiratory disease, ear infection, and bronchial pneumonia.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]



Sec. 866.3380  Mumps virus serological reagents.

    (a) Identification. Mumps virus serological reagents consist of 
antigens and antisera used in serological tests to identify antibodies 
to mumps virus in serum. Additionally, some of these reagents consist of 
antisera conjugated with a fluorescent dye (immunofluorescent reagents) 
used in serological tests to identify mumps viruses from tissue culture 
isolates derived from clinical specimens. The identification aids in the 
diagnosis of mumps and provides epidemiological information on mumps. 
Mumps is an acute contagious disease, particularly in children, 
characterized by an enlargement of one or both of the parotid glands 
(glands situated near the ear), although other organs may also be 
involved.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]



Sec. 866.3390  Neisseria spp. direct serological test reagents.

    (a) Identification. Neisseria spp. direct serological test reagents 
are devices that consist of antigens and antisera used in serological 
tests to identify Neisseria spp. from cultured isolates. Additionally, 
some of these reagents consist of Neisseria spp. antisera conjugated 
with a fluorescent dye (immunofluorescent reagents) which may be used to 
detect the presence of Neisseria spp. directly from clinical specimens. 
The identification aids in the diagnosis of disease caused by bacteria 
belonging to the genus Neisseria, such as epidemic cerebrospinal 
meningitis, meningococcal disease, and gonorrhea, and also provides 
epidemiological information on diseases caused by these microorganisms. 
The device does not include products for the detection of gonorrhea in 
humans by indirect methods, such as detection of antibodies or of 
oxidase produced by gonococcal organisms.
    (b) Classification. Class II (performance standards).



Sec. 866.3395  Norovirus serological reagents.

    (a) Identification. Norovirus serological reagents are devices that 
consist of antigens and antisera used in serological tests to detect the 
presence of norovirus antigens in fecal samples. These devices aid in 
the diagnosis of norovirus infection in the setting of an individual 
patient with symptoms of acute gastroenteritis when the individual 
patient is epidemiologically linked to other patients with symptoms of 
acute gastroenteritis and/or aid in the identification of norovirus as 
the etiology of an outbreak of acute gastroenteritis in the setting of 
epidemiologically linked patients with symptoms of acute 
gastroenteritis.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9. The 
special control is FDA's guidance document entitled ``Class II Special 
Controls Guidance Document: Norovirus Serological Reagents.'' See Sec. 
866.1(e) for the availability of this guidance document.

[76 FR 14274, Mar. 9, 2012, as amended at 84 FR 71800, Dec. 30, 2019]

[[Page 352]]



Sec. 866.3400  Parainfluenza virus serological reagents.

    (a) Identification. Parainfluenza virus serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to parainfluenza virus in serum. The 
identification aids in the diagnosis of parainfluenza virus infections 
and provides epidemiological information on diseases caused by these 
viruses. Parainfluenza viruses cause a variety of respiratory illnesses 
ranging from the common cold to pneumonia.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 
FR 38792, July 25, 2001]



Sec. 866.3402  Plasmodium species antigen detection assays.

    (a) Identification. A Plasmodium species antigen detection assay is 
a device that employs antibodies for the detection of specific malaria 
parasite antigens, including histidine-rich protein-2 (HRP2) specific 
antigens, and pan malarial antigens in human whole blood. These devices 
are used for testing specimens from individuals who have signs and 
symptoms consistent with malaria infection. The detection of these 
antigens aids in the clinical laboratory diagnosis of malaria caused by 
the four malaria species capable of infecting humans: Plasmodium 
falciparum, Plasmodium vivax, Plasmodium ovale, and Plasmodium malariae, 
and aids in the differential diagnosis of Plasmodium falciparum 
infections from other less virulent Plasmodium species. The device is 
intended for use in conjunction with other clinical laboratory findings.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance document entitled ``Class II Special Controls Guidance 
Document: Plasmodium species Antigen Detection Assays.'' See Sec. 
866.1(e) for the availability of this guidance document.

[73 FR 29054, May 20, 2008]



Sec. 866.3405  Poliovirus serological reagents.

    (a) Identification. Poliovirus serological reagents are devices that 
consist of antigens and antisera used in serological tests to identify 
antibodies to poliovirus in serum. Additionally, some of these reagents 
consist of poliovirus antisera conjugated with a fluorescent dye 
(immunofluorescent reagents) used to identify polioviruses from clinical 
specimens or from tissue culture isolates derived from clinical 
specimens. The identification aids in the diagnosis of poliomyelitis 
(polio) and provides epidemiological information on this disease. 
Poliomyelitis is an acute infectious disease which in its serious form 
affects the central nervous system resulting in atrophy (wasting away) 
of groups of muscles, ending in contraction and permanent deformity.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.3410  Proteus spp. (Weil-Felix) serological reagents.

    (a) Identification. Proteus spp. (Weil-Felix) serological reagents 
are devices that consist of antigens and antisera, including antisera 
conjugated with a fluorescent dye (immunofluorescent reagents), derived 
from the bacterium Proteus vulgaris used in agglutination tests (a 
specific type of antigen-antibody reaction) for the detection of 
antibodies to rickettsia (virus-like bacteria) in serum. Test results 
aid in the diagnosis of diseases caused by bacteria belonging to the 
genus Rickettsiae and provide epidemiological information on these 
diseases. Rickettsia are generally transmitted by arthropods (e.g., 
ticks and mosquitoes) and produce infections in humans characterized by 
rash and fever (e.g., typhus fever, spotted fever, Q fever, and trench 
fever).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 353]]

subpart E of part 807 of this chapter subject to the limitations in 
Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 
FR 38792, July 25, 2001]



Sec. 866.3415  Pseudomonas spp. serological reagents.

    (a) Identification. Pseudomonas spp. serological reagents are 
devices that consist of antigens and antisera, including antisera 
conjugated with a fluorescent dye (immunofluorescent reagents), used to 
identify Pseudomonas spp. from clinical specimens or from cultured 
isolates derived from clinical specimens. The identification aids in the 
diagnosis of disease caused by bacteria belonging to the genus 
Pseudomonas. Pseudomonas aeruginosa is a major cause of hospital-
acquired infections, and has been associated with urinary tract 
infections, eye infections, burn and wound infections, blood poisoning, 
abscesses, and meningitis (inflammation of brain membranes). Pseudomonas 
pseudomallei causes melioidosis, a chronic pneumonia.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59227, Nov. 3, 1998]



Sec. 866.3460  Rabiesvirus immuno fluorescent reagents.

    (a) Identification. Rabiesvirus immunofluorescent reagents are 
devices that consist of rabiesvirus antisera conjugated with a 
fluorescent dye used to identify rabiesvirus in specimens taken from 
suspected rabid animals. The identification aids in the diagnosis of 
rabies in patients exposed by animal bites and provides epidemiological 
information on rabies. Rabies is an acute infectious disease of the 
central nervous system which, if undiagnosed, may be fatal. The disease 
is commonly transmitted to humans by a bite from a rabid animal.
    (b) Classification. Class II (performance standards).



Sec. 866.3470  Reovirus serological reagents.

    (a) Identification. Reovirus serological reagents are devices that 
consist of antigens and antisera used in serological tests to identify 
antibodies to reovirus in serum. The identification aids in the 
diagnosis of reovirus infections and provides epidemiological 
information on diseases caused by these viruses. Reoviruses are thought 
to cause only mild respiratory and gastrointestinal illnesses.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 
FR 38792, July 25, 2001]



Sec. 866.3480  Respiratory syncytial virus serological reagents.

    (a) Identification. Respiratory syncytial virus serological reagents 
are devices that consist of antigens and antisera used in serological 
tests to identify antibodies to respiratory syncytial virus in serum. 
Additionally, some of these reagents consist of respiratory syncytial 
virus antisera conjugated with a fluorescent dye (immunofluorescent 
reagents) and used to identify respiratory syncytial viruses from 
clinical specimens or from tissue culture isolates derived from clinical 
specimens. The identification aids in the diagnosis of respiratory 
syncytial virus infections and provides epidemiological information on 
diseases caused by these viruses. Respiratory syncytial viruses cause a 
number of respiratory tract infections, including the common cold, 
pharyngitis, and infantile bronchopneumonia.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]

[[Page 354]]



Sec. 866.3490  Rhinovirus serological reagents.

    (a) Identification. Rhinovirus serological reagents are devices that 
consist of antigens and antisera used in serological tests to identify 
antibodies to rhinovirus in serum. The identification aids in the 
diagnosis of rhinovirus infections and provides epidemiological 
information on diseases caused by these viruses. Rhinoviruses cause 
common colds.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 
FR 38792, July 25, 2001]



Sec. 866.3500  Rickettsia serological reagents.

    (a) Identification. Rickettsia serological reagents are devices that 
consist of antigens and antisera used in serological tests to identify 
antibodies to rickettsia in serum. Additionally, some of these reagents 
consist of rickettsial antisera conjugated with a fluorescent dye 
(immunofluorescent reagents) used to identify rickettsia directly from 
clinical specimens. The identification aids in the diagnosis of diseases 
caused by virus-like bacteria belonging to the genus Rickettsiae and 
provides epidemiological information on these diseases. Rickettsia are 
generally transmitted by arthropods (e.g., ticks and mosquitoes) and 
produce infections in humans characterized by rash and fever (e.g., 
typhus fever, spotted fever, Q fever, and trench fever).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.3510  Rubella virus serological reagents.

    (a) Identification. Rubella virus serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify antibodies to rubella virus in serum. The identification aids 
in the diagnosis of rubella (German measles) or confirmation of a 
person's immune status from past infections or immunizations and 
provides epidemiological information on German measles. Newborns 
infected in the uterus with rubella virus may be born with multiple 
congenital defects (rubella syndrome).
    (b) Classification. Class II. The special controls for this device 
are:
    (1) National Committee for Clinical Laboratory Standards':
    (i) 1/LA6 ``Detection and Quantitation of Rubella IgG Antibody: 
Evaluation and Performance Criteria for Multiple Component Test 
Products, Speciment Handling, and Use of the Test Products in the 
Clinical Laboratory, October 1997,''
    (ii) 1/LA18 ``Specifications for Immunological Testing for 
Infectious Diseases, December 1994,''
    (iii) D13 ``Agglutination Characteristics, Methodology, Limitations, 
and Clinical Validation, October 1993,''
    (iv) EP5 ``Evaluation of Precision Performance of Clinical Chemistry 
Devices, February 1999,'' and
    (v) EP10 ``Preliminary Evaluation of the Linearity of Quantitive 
Clinical Laboratory Methods, May 1998,''
    (2) Centers for Disease Control's:
    (i) Low Titer Rubella Standard,
    (ii) Reference Panel of Well Characterized Rubella Sera, and
    (3) World Health Organization's International Rubella Standard.

[47 FR 50823, Nov. 9, 1982, as amended at 52 FR 17734, May 11, 1987; 65 
FR 17144, Mar. 31, 2000]



Sec. 866.3520  Rubeola (measles) virus serological reagents.

    (a) Identification. Rubeola (measles) virus serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to rubeola virus in serum. The identification 
aids in the diagnosis of measles and provides epidemiological 
information on the disease. Measles is an acute, highly infectious 
disease of the respiratory and reticuloendothelial tissues, particularly 
in children, characterized by a confluent and blotchy rash.
    (b) Classification. Class I (general controls). The device is exempt 
from the

[[Page 355]]

premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 
FR 38792, July 25, 2001]



Sec. 866.3550  Salmonella spp. serological reagents.

    (a) Identification. Salmonella spp. serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify Salmonella spp. from cultured isolates derived from clinical 
specimens. Additionally, some of these reagents consist of antisera 
conjugated with a fluorescent dye (immunofluorescent reagents) used to 
identify Salmonella spp. directly from clinical specimens or cultured 
isolates derived from clinical specimens. The identification aids in the 
diagnosis of salmonellosis caused by bacteria belonging to the genus 
Salmonella and provides epidemiological information on this disease. 
Salmonellosis is characterized by high grade fever (``enteric fever''), 
severe diarrhea, and cramps.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59227, Nov. 3, 1998]



Sec. 866.3600  Schistosoma spp. serological reagents.

    (a) Identification. Schistosoma spp. serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Schistosoma spp. in serum. The identification 
aids in the diagnosis of schistosomiasis caused by parasitic flatworms 
of the genus Schistosoma. Schistosomiasis is characterized by a variety 
of acute and chronic infections. Acute infection is marked by fever, 
allergic symptoms, and diarrhea. Chronic effects are usually severe and 
are caused by fibrous degeneration of tissue around deposited eggs of 
the parasite in the liver, lungs, and central nervous system. 
Schistosomes can also cause schistosome dermatitis (e.g., swimmer's 
itch), a skin disease marked by intense itching.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.3630  Serratia spp. serological reagents.

    (a) Identification. Serratia spp. serological reagents are devices 
that consist of antigens and antisera used in serological tests to 
identify Serratia spp. from cultured isolates. The identification aids 
in the diagnosis of disease caused by bacteria belonging to the genus 
Serratia and provides epidemiological information on these diseases. 
Serratia spp. are occasionally associated with gastroenteritis (food 
poisoning) and wound infections.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 
FR 38792, July 25, 2001]



Sec. 866.3660  Shigella spp. serological reagents.

    (a) Identification. Shigella spp. serological reagents are devices 
that consist of antigens and antisera, including antisera conjugated 
with a fluorescent dye (immunofluorescent reagents), used in serological 
tests to identify Shigella spp. from cultured isolates. The 
identification aids in the diagnosis of shigellosis caused by bacteria 
belonging to the genus Shigella and provides epidemiological information 
on this disease. Shigellosis is characterized by abdominal pain, cramps, 
diarrhea, and fever.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59227, Nov. 3, 1998]

[[Page 356]]



Sec. 866.3680  Sporothrix schenckii serological reagents.

    (a) Identification. Sporothrix schenckii serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Sporothrix schenckii in serum. The 
identification aids in the diagnosis of sporothrichosis caused by a 
fungus belonging to the genus Sporothrix and provides epidemiological 
information on this disease. Sporothrichosis is a chronic tumorlike 
infection primarily of the skin.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.3700  Staphylococcus aureus serological reagents.

    (a) Identification. Staphylococcus aureus serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify enterotoxin (toxin affecting the intestine) producing 
staphylococci from cultured isolates. The identification aids in the 
diagnosis of disease caused by this bacterium belonging to the genus 
Staphylococcus and provides epidemiological information on these 
diseases. Certain strains of Staphylococcus aureus produce an 
enterotoxin while growing in meat, dairy, or bakery products. After 
ingestion, this enterotoxin is absorbed in the gut and causes 
destruction of the intestinal lining (gastroenteritis).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 
FR 38792, July 25, 2001]



Sec. 866.3720  Streptococcus spp. exo enzyme reagents.

    (a) Identification. Streptococcus spp. exoenzyme reagents are 
devices used to identify antibodies to Streptococcus spp. exoenzyme in 
serum. The identification aids in the diagnosis of disease caused by 
bacteria belonging to the genus Streptococcus and provides 
epidemiological information on these diseases. Pathogenic streptococci 
are associated with infections, such as sore throat, impetigo (an 
infection characterized by small pustules on the skin), urinary tract 
infections, rheumatic fever, and kidney disease.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 
FR 38792, July 25, 2001]



Sec. 866.3740  Streptococcus spp. serological reagents.

    (a) Identification. Streptococcus spp. serological reagents are 
devices that consist of antigens and antisera (excluding streptococcal 
exoenzyme reagents made from enzymes secreted by streptococci) used in 
serological tests to identify Streptococcus spp. from cultured isolates 
derived from clinical specimens. The identification aids in the 
diagnosis of diseases caused by bacteria belonging to the genus 
Streptococcus and provides epidemiological information on these 
diseases. Pathogenic streptococci are associated with infections, such 
as sore throat, impetigo (an infection characterized by small pustules 
on the skin), urinary tract infections, rheumatic fever, and kidney 
disease.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.3780  Toxoplasma gondii serological reagents.

    (a) Identification. Toxoplasma gondii serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Toxoplasma gondii in serum. Additionally, some 
of these reagents consist of antisera conjugated with a fluorescent dye 
(immunofluorescent reagents) used to identify Toxoplasma gondii from 
clinical specimens. The identification

[[Page 357]]

aids in the diagnosis of toxoplasmosis caused by the parasitic protozoan 
Toxoplasma gondii and provides epidemiological information on this 
disease. Congenital toxoplasmosis is characterized by lesions of the 
central nervous system, which if undetected and untreated may lead to 
brain defects, blindness, and death of an unborn fetus. The disease is 
characterized in children by inflammation of the brain and spinal cord.
    (b) Classification. Class II (performance standards).



Sec. 866.3820  Treponema pallidum non treponemal test reagents.

    (a) Identification. Treponema pallidum nontreponemal test reagents 
are devices that consist of antigens derived from nontreponemal sources 
(sources not directly associated with treponemal organisms) and control 
sera (standardized sera with which test results are compared) used in 
serological tests to identify reagin, an antibody-like agent, which is 
produced from the reaction of treponema microorganisms with body 
tissues. The identification aids in the diagnosis of syphilis caused by 
microorganisms belonging to the genus Treponema and provides 
epidemiological information on syphilis.
    (b) Classification. Class II (performance standards).



Sec. 866.3830  Treponema pallidum tre ponemal test reagents.

    (a) Identification. Treponema pallidum treponemal test reagents are 
devices that consist of the antigens, antisera and all control reagents 
(standardized reagents with which test results are compared) which are 
derived from treponemal sources and that are used in the fluorescent 
treponemal antibody absorption test (FTA-ABS), the Treponema pallidum 
immobilization test (T.P.I.), and other treponemal tests used to 
identify antibodies to Treponema pallidum directly from infecting 
treponemal organisms in serum. The identification aids in the diagnosis 
of syphilis caused by bacteria belonging to the genus Treponema and 
provides epidemiological information on syphilis.
    (b) Classification. Class II (performance standards).



Sec. 866.3850  Trichinella spiralis serological reagents.

    (a) Identification. Trichinella spiralis serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Trichinella spiralis in serum. The 
identification aids in the diagnosis of trichinosis caused by parasitic 
roundworms belonging to the genus Trichinella and provides 
epidemiological information on trichinosis. Trichinosis is caused by 
ingestion of undercooked, infested meat, especially pork, and 
characterized by fever, muscle weakness, and diarrhea.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.3860  Trichomonas vaginalis nucleic acid assay.

    (a) Identification. A Trichomonas vaginalis nucleic acid assay is a 
device that consists of primers, probes, enzymes, and controls for the 
amplification and detection of trichomonas nucleic acids in endocervical 
swabs, vaginal swabs, and female urine specimens, from women symptomatic 
for vaginitis, cervicitis, or urethritis and/or to aid in the diagnosis 
of trichomoniasis in asymptomatic women. The detection of trichomonas 
nucleic acids, in conjunction with other laboratory tests, aids in the 
clinical laboratory diagnosis of trichomoniasis caused by Trichomonas 
vaginalis.
    (b) Classification. Class II (special controls). The special 
controls are set forth in FDA's guideline document entitled: ``Class II 
Special Controls Guideline: Nucleic Acid Amplification Assays for the 
Detection of Trichomonas vaginalis; Guideline for Industry and Food and 
Drug Administration Staff.'' See Sec. 866.1(e) for information on 
obtaining this document.

[80 FR 46192, Aug. 4, 2015]

[[Page 358]]



Sec. 866.3870  Trypanosoma spp. serological reagents.

    (a) Identification. Trypanosoma spp. serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Trypanosoma spp. in serum. The identification 
aids in the diagnosis of trypanosomiasis, a disease caused by parasitic 
protozoans belonging to the genus Trypanosoma. Trypanosomiasis in adults 
is a chronic disease characterized by fever, chills, headache, and 
vomiting. Central nervous system involvement produces typical sleeping 
sickness syndrome: physical exhaustion, inability to eat, tissue 
wasting, and eventual death. Chagas disease, an acute form of 
trypanosomiasis in children, most seriously affects the central nervous 
system and heart muscle.
    (b) Classification. Class I (general controls).



Sec. 866.3900  Varicella-zoster virus serological reagents.

    (a) Identification. Varicella-zoster virus serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to varicella-zoster in serum. The identification 
aids in the diagnosis of diseases caused by varicella-zoster viruses and 
provides epidemiological information on these diseases. Varicella 
(chicken pox) is a mild, highly infectious disease, chiefly of children. 
Zoster (shingles) is the recurrent form of the disease, occurring in 
adults who were previously infected with varicella-zoster viruses. 
Zoster is the response (characterized by a rash) of the partially immune 
host to a reactivation of varicella viruses present in latent form in 
the patient's body.
    (b) Classification. Class II (performance standards).



Sec. 866.3920  Assayed quality control material for clinical
microbiology assays.

    (a) Identification. An assayed quality control material for clinical 
microbiology assays is a device indicated for use in a test system to 
estimate test precision or to detect systematic analytical deviations 
that may arise from reagent or analytical instrument variation. This 
type of device consists of single or multiple microbiological analytes 
intended for use with either qualitative or quantitative assays.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Premarket notification submissions must include detailed device 
description documentation and information concerning the composition of 
the quality control material, including, as appropriate:
    (i) Analyte concentration;
    (ii) Expected values;
    (iii) Analyte source;
    (iv) Base matrix;
    (v) Added components;
    (vi) Safety and handling information; and
    (vii) Detailed instructions for use.
    (2) Premarket notification submissions must include detailed 
documentation, including line data as well as detailed study protocols 
and a statistical analysis plan used to establish performance, 
including:
    (i) Description of the process for value assignment and validation.
    (ii) Description of the protocol(s) used to establish stability.
    (iii) Line data establishing precision/reproducibility.
    (iv) Where applicable, assessment of matrix effects and any 
significant differences between the quality control material and typical 
patient samples in terms of conditions known to cause analytical error 
or affect assay performance.
    (v) Where applicable, identify or define traceability or 
relationship to a domestic or international standard reference material 
and/or method.
    (vi) Where applicable, detailed documentation related to studies for 
surrogate controls.
    (3) Premarket notification submissions must include an adequate 
mitigation (e.g., real-time stability program) to the risk of false 
results due to potential modifications to the assays specified in the 
device's 21 CFR 809.10 compliant labeling.
    (4) Your 21 CFR 809.10 compliant labeling must include the 
following:
    (i) The intended use of your 21 CFR 809.10(a)(2) and (b)(2) 
compliant labeling must include the following:

[[Page 359]]

    (A) Assayed control material analyte(s);
    (B) Whether the material is intended for quantitative or qualitative 
assays;
    (C) Stating if the material is a surrogate control; and
    (D) The system(s), instrument(s), or test(s) for which the quality 
control material is intended.
    (ii) The intended use in your 21 CFR 809.10(a)(2) and (b)(2) 
compliant labeling must include the following statement: ``This product 
is not intended to replace manufacturer controls provided with the 
device.''
    (iii) A limiting statement that reads ``Quality control materials 
should be used in accordance with local, state, federal regulations, and 
accreditation requirements.''

[82 FR 34850, July 27, 2017]



Sec. 866.3930  Vibrio cholerae serological reagents.

    (a) Identification. Vibrio cholerae serological reagents are devices 
that are used in the agglutination (an antigen-antibody clumping 
reaction) test to identify Vibrio cholerae from cultured isolates 
derived from clinical specimens. The identification aids in the 
diagnosis of cholera caused by the bacterium Vibrio cholerae and 
provides epidemiological information on cholera. Cholera is an acute 
infectious disease characterized by severe diarrhea with extreme fluid 
and electrolyte (salts) depletion, and by vomiting, muscle cramps, and 
prostration. If untreated, the severe dehydration may lead to shock, 
renal failure, cardiovascular collapse, and death.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59227, Nov. 3, 1998]



Sec. 866.3940  West Nile virus serological reagents.

    (a) Identification. West Nile virus serological reagents are devices 
that consist of antigens and antisera for the detection of anti-West 
Nile virus IgM antibodies, in human serum, from individuals who have 
signs and symptoms consistent with viral meningitis/encephalitis. The 
detection aids in the clinical laboratory diagnosis of viral meningitis/
encephalitis caused by West Nile virus.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance entitled ``Class II Special Controls Guidance 
Document: Serological Reagents for the Laboratory Diagnosis of West Nile 
Virus.'' See Sec. 866.1(e) for the availability of this guidance 
document.

[68 FR 61745, Oct. 30, 2003]



Sec. 866.3945  Dengue virus serological reagents.

    (a) Identification. Dengue virus serological reagents are devices 
that consist of antigens and antibodies for the detection of dengue 
virus and dengue antibodies in individuals who have signs and symptoms 
of dengue fever or dengue hemorrhagic fever. The detection aids in the 
clinical laboratory diagnosis of dengue fever or dengue hemorrhagic 
fever caused by dengue virus.
    (b) Classification. Class II (special controls). The special control 
is FDA's guideline entitled ``Class II Special Controls Guideline: 
Dengue Virus Serological Reagents.'' For availability of the guideline 
document, see Sec. 866.1(e).

[79 FR 31023, May 30, 2014]



Sec. 866.3946  Dengue virus nucleic acid amplification test reagents.

    (a) Identification. Dengue virus nucleic acid amplification test 
reagents are devices that consist of primers, probes, enzymes, and 
controls for the amplification and detection of dengue virus serotypes 
1, 2, 3, or 4 from viral ribonucleic acid (RNA) in human serum and 
plasma from individuals who have signs and symptoms consistent with 
dengue (mild or severe). The identification of dengue virus serotypes 1, 
2, 3, or 4 in human serum and plasma (sodium citrate) collected from 
human patients with dengue provides epidemiologic information for 
surveillance of circulating dengue viruses.
    (b) Classification. Class II (special controls). The special control 
is FDA's guideline entitled ``Class II Special

[[Page 360]]

Controls Guideline: Dengue Virus Nucleic Acid Amplification Test 
Reagents.'' For availability of the guideline document, see Sec. 
866.1(e).

[79 FR 53609, Sept. 10, 2014]



Sec. 866.3950  In vitro human immunodeficiency virus (HIV) drug
resistance genotype assay.

    (a) Identification. The in vitro HIV drug resistance genotype assay 
is a device that consists of nucleic acid reagent primers and probes 
together with software for predicting drug resistance/susceptibility 
based on results obtained with these primers and probes. It is intended 
for use in detecting HIV genomic mutations that confer resistance to 
specific antiretroviral drugs, as an aid in monitoring and treating HIV 
infection.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's guidance document entitled ``Class II Special 
Controls Guidance Document: In Vitro HIV Drug Resistance Genotype 
Assay.'' See Sec. 866.1(e) for the availability of this guidance 
document.

[72 FR 44382, Aug. 8, 2007]



Sec. 866.3955  Human immunodeficiency virus (HIV) drug resistance
genotyping assay using next generation sequencing technology.

    (a) Identification. The HIV drug resistance genotyping assay using 
next generation sequencing (NGS) technology is a prescription in vitro 
diagnostic device intended for use in detecting HIV genomic mutations 
that confer resistance to specific antiretroviral drugs. The device is 
intended to be used as an aid in monitoring and treating HIV infection.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The intended use of the device must:
    (i) Specify the analyte (RNA or DNA), the genes in which mutations 
are detected, the clinical indications appropriate for test use, the 
sample type, and the specific population(s) for which the device in 
intended.
    (ii) State that the device in not intended for use as an aid in the 
diagnosis of infection with HIV or to confirm the presence of HIV 
infection, or for screening donors of blood, plasma, or human cells, 
tissues, and cellular and tissue-based products.
    (2) The labeling must include:
    (i) A detailed device description, including but not limited to, all 
procedures from collection of the patient sample to reporting the final 
result, all device components, the control elements incorporated into 
the test procedure, instrument requirements, and reagents required for 
use but not provided as part of the device.
    (ii) Performance characteristics from analytical studies and all 
intended specimen types.
    (iii) A list of specific mutations detected.
    (iv) The name and version of the standardized database used for 
sequence comparison and results derivation.
    (v) A detailed explanation of the interpretation of test results, 
including acceptance criteria for evaluating the validity of a test run.
    (vi) A limitation statement that the device is intended to be used 
in conjunction with clinical history and other laboratory findings. 
Results of this test are intended to be interpreted by a physician or 
equivalent.
    (vii) A limitation statement that lack of detection of drug 
resistance mutations does not preclude the possibility of genetic 
mutation.
    (viii) A limitation statement indicating the relevant genetic 
mutations that are included in the standardized database of HIV genomic 
sequences used for comparison and results derivation but that are not 
detected by the test.
    (ix) A limitation statement that detection of a genomic drug 
resistance mutation may not correlate with phenotypic gene expression.
    (x) A limitation statement that the test does not detect all genetic 
mutations associated with antiviral drugs.
    (xi) A limitation statement listing the HIV types for which the test 
is not intended, if any.
    (3) Device verification and validation must include:
    (i) Design of primer sequences and rationale for sequence selection.

[[Page 361]]

    (ii) Computational path from collected raw data to reported result.
    (iii) Detailed documentation of analytical studies including, but 
not limited to, characterization of the cutoff, analytical sensitivity, 
inclusivity, reproducibility, interference, cross reactivity, instrument 
and method carryover/cross contamination, sample stability, and handling 
for all genomic mutations claimed in the intended use.
    (iv) Precision studies that include all genomic mutations claimed in 
the intended use.
    (v) Detailed documentation of a multisite clinical study evaluating 
the sensitivity and specificity of the device. Clinical study subjects 
must represent the intended use population and device results for all 
targets claimed in the intended use must be compared to Sanger 
sequencing or other methods found acceptable by FDA. Drug resistance-
associated mutations at or above the 20 percent frequency level must 
detect the mutations in greater than 90 percent of at least 10 
replicates, for each of drug class evaluated.
    (vi) Documentation that variant calling is performed at a level of 
coverage that supports positive detection of all genomic mutations 
claimed in the intended use.
    (vii) Detailed documentation of limit of detection (LoD) studies in 
which device performance is evaluated by testing a minimum of 100 HIV-
positive clinical samples including samples with analyte concentrations 
near the clinical decision points and near the LoD.
    (A) The LoD for the device must be determined using a minimum of 10 
HIV-1 group M genotypes if applicable. A detection rate at 1 x LoD 
greater than or equal to 95 percent must be demonstrated for mutations 
with a frequency greater than 20 percent.
    (B) The LoD of genetic mutations at frequency levels less than 20 
percent must be established.
    (viii) A predefined HIV genotyping bioinformatics analysis pipeline 
(BAP). The BAP must adequately describe the bioinformatic analysis of 
the sequencing data, including but not limited to read alignment, 
variant calling, assembly, genotyping, quality control, and final result 
reporting.
    (ix) A clear description of the selection and use of the 
standardized database that is used for sequence comparison and results 
derivation.
    (4) Premarket notification submissions must include the information 
in paragraphs (b)(3)(i) through (ix) of this section.

[85 FR 7217, Feb. 7, 2020]



Sec. 866.3956  Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test.

    (a) Identification. Human immunodeficiency virus (HIV) serological 
diagnostic and supplemental tests are prescription devices for the 
qualitative detection of HIV antigen(s) and/or detection of antibodies 
against HIV in human body fluids or tissues. The tests are intended for 
use as an aid in the diagnosis of infection with HIV and are for 
professional use only. The test results are intended to be interpreted 
in conjunction with other relevant clinical and laboratory findings. 
These tests are not intended to be used for monitoring patient status, 
or for screening donors of blood or blood products, or human cells, 
tissues, and cellular and tissue-based products (HCT/Ps).
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) For all HIV serological diagnostic and supplemental tests
    (i) The labeling must include:
    (A) An intended use that states that the device is not intended for 
use for screening donors of blood or blood products or HCT/Ps.
    (B) A detailed explanation of the principles of operation and 
procedures used for performing the assay.
    (C) A detailed explanation of the interpretation of results and 
recommended actions to take based on results.
    (D) Limitations, which must be updated to reflect current clinical 
practice and disease presentation and management. The limitations must 
include, but are not limited to, statements that indicate:
    (1) The matrices with which the device has been cleared, and that 
use of this test kit with specimen types other than those specifically 
cleared for this

[[Page 362]]

device may result in inaccurate test results.
    (2) The test is not intended to be used to monitor individuals who 
are undergoing treatment for HIV infection.
    (3) A specimen with a reactive result should be investigated further 
following current guidelines.
    (4) All test results should be interpreted in conjunction with the 
individual's clinical presentation, history, and other laboratory 
results.
    (5) A test result that is nonreactive does not exclude the 
possibility of exposure to or infection with HIV. Nonreactive results in 
this assay may be due to analyte levels that are below the limit of 
detection of this assay.
    (ii) Device verification and validation must include:
    (A) Detailed device description, including the device components, 
ancillary reagents required but not provided, and an explanation of the 
methodology. Additional information appropriate to the technology must 
be included, such as the amino acid sequence of antigen(s) and design of 
capture antibodies.
    (B) For devices with assay calibrators, the design of all primary, 
secondary, and subsequent quantitation standards used for calibration as 
well as their traceability to a reference material. In addition, 
analytical testing must be performed following the release of a new lot 
of the standard material that was used for device clearance, or when 
there is a transition to a new calibration standard.
    (C) Detailed documentation of analytical performance studies 
conducted as appropriate to the technology, specimen types tested, and 
intended use of the device, including, but not limited to, limit of 
blank, limit of detection, cutoff determination, precision, endogenous 
and exogenous interferences, cross reactivity, carryover, quality 
control, matrix equivalency, and sample and reagent stability. Samples 
selected for use in analytical studies or used to prepare samples for 
use in analytical studies must be from subjects with clinically relevant 
circulating genotypes in the United States.
    (D) Multisite reproducibility study that includes the testing of 
three independent production lots.
    (E) Analytical sensitivity of the test must be the same as or better 
than that of other cleared or approved tests. Samples tested must 
include appropriate numbers and types of samples, including real 
clinical samples near the lower limit of detection. Analytical 
specificity of the test must be the same as or better than that of other 
cleared or approved tests. Samples must include appropriate numbers and 
types of samples from patients with different underlying illnesses or 
infections and from patients with potential endogenous interfering 
substances.
    (F) Detailed documentation of performance from a multisite clinical 
study. Performance must be analyzed relative to an FDA-cleared or 
approved comparator. This study must be conducted using patient samples, 
with an appropriate number of HIV positive and HIV negative samples in 
applicable risk categories. Additional subgroups or types must be 
validated using appropriate numbers and types of samples. The samples 
may be a combination of fresh and repository samples, sourced from 
within and outside the United States, as appropriate. The study designs, 
including number of samples tested, must be sufficient to meet the 
following criteria:
    (1) Clinical sensitivity of the test must have a lower bound of the 
95 percent confidence interval of greater than or equal to 99 percent.
    (2) Clinical specificity of the test must have a lower bound of the 
95 percent confidence interval of greater than or equal to 99 percent.
    (G) Strategies for detection of new strains, types, subtypes, 
genotypes, and genetic mutations as they emerge.
    (H) Risk analysis and management strategies, such as Failure Modes 
Effects Analysis and/or Hazard Analysis and Critical Control Points 
summaries and their impact on test performance.
    (I) Final release criteria to be used for manufactured test lots 
with appropriate evidence that lots released at the extremes of the 
specifications will meet the claimed analytical and clinical performance 
characteristics as well as the stability claims.
    (J) All stability protocols, including acceptance criteria.

[[Page 363]]

    (K) Appropriate and acceptable procedure(s) for evaluating customer 
complaints and other device information that determines when to submit a 
medical device report.
    (L) Premarket notification submissions must include the information 
contained in paragraph (b)(1)(ii)(A) through (K) of this section.
    (iii) Manufacturers must submit a log of all complaints. The log 
must include the following information regarding each complaint if 
available: The type of event (e.g., false negative/false nonreactive or 
false positive/false reactive), lot, date, population, and whether or 
not the complaint was reported under part 803 of this chapter (Medical 
Device Reporting). The log must be submitted annually on the anniversary 
of clearance for 5 years following clearance of a traditional premarket 
notification.
    (2) If the test is intended for Point of Care (PoC) use, the 
following special controls, in addition to those listed in paragraph 
(b)(1) of this section apply:
    (i) The PoC labeling must include a statement that the test is 
intended for PoC use.
    (ii) The PoC labeling must include the following information near 
the statement of the intended use:
    (A) That the test is for distribution to clinical laboratories that 
have an adequate quality assurance program, including planned systematic 
activities that provide adequate confidence that requirements for 
quality will be met and where there is assurance that operators will 
receive and use the instructional materials.
    (B) That the test is for use only by an agent of a clinical 
laboratory.
    (C) Instructions for individuals to receive the ``Subject 
Information Notice'' prior to specimen collection and appropriate 
information when test results are provided.
    (iii) PoC labeling must include instructions to follow current 
guidelines for informing the individual of the test result and its 
interpretation.
    (iv) The instructions in the labeling must state that reactive 
results are considered preliminary and should be confirmed following 
current guidelines.
    (v) Device verification and validation for PoC use must include:
    (A) Detailed documentation of performance from a multisite clinical 
study conducted at appropriate PoC sites. Performance must be analyzed 
relative to an FDA cleared or approved comparator. This study must be 
conducted using patient samples, with appropriate numbers of HIV 
positive and HIV negative samples in applicable risk categories. 
Additional subgroup or type claims must be validated using appropriate 
numbers and types of samples. The samples may be a combination of fresh 
and repository samples, sourced from within and outside the United 
States, as appropriate. If the test is intended solely for PoC use, the 
test must meet only the performance criteria in paragraphs 
(b)(2)(v)(A)(1) and (2) of this section and not the criteria in 
paragraph (b)(1)(ii)(F) of this section:
    (1) Clinical sensitivity of the test must have a lower bound of the 
95 percent confidence interval of greater than or equal to 98 percent.
    (2) Clinical specificity of the test must have a lower bound of the 
95 percent confidence interval of greater than or equal to 98 percent.
    (B) Premarket notification submissions must include the information 
contained in paragraph (b)(2)(v)(A) of this section.
    (3) If the test is intended for supplemental use in addition to use 
as an aid in initial diagnosis, the following special controls, in 
addition to those listed in paragraphs (b)(1) and (2) of this section, 
as appropriate, apply:
    (i) The labeling must include a statement that the test is intended 
for use as an additional test to confirm the presence of HIV antibodies 
or antigens in specimens found to be repeatedly reactive by a diagnostic 
screening test.
    (ii) Device validation and verification for supplemental use must 
include a clinical study, including samples that were initially reactive 
and repeatedly reactive on a diagnostic test but were negative or 
indeterminate on a different confirmatory test. Premarket notification 
submissions must include this information.
    (4) If the test is intended solely as a supplemental test, the 
following special controls, in addition to those listed in paragraphs 
(b)(1) and (2) of this

[[Page 364]]

section, except those in paragraphs (b)(1)(ii)(F) and (b)(2)(v)(A) of 
this section, as appropriate, apply:
    (i) The labeling must include a statement that the test is intended 
for use as an additional test to confirm the presence of HIV antibodies 
or antigens in specimens found to be repeatedly reactive by a diagnostic 
screening test.
    (ii) The labeling must clearly state that the test is not for use 
for initial diagnosis or is not intended as a first-line test.
    (iii) Device validation and verification must include a clinical 
study including samples that were initially reactive and repeatedly 
reactive on a diagnostic test but were negative or indeterminate on a 
confirmatory test. Premarket notification submissions must include this 
information.
    (5) If the test is intended to differentiate different HIV types, 
the following special controls, in addition to those listed in 
paragraphs (b)(1) through (4) of this section, as appropriate, apply:
    (i) The labeling must include the statement that the test is 
intended for the confirmation of initial results from a diagnostic test 
and differentiation of different HIV types.
    (ii) The results interpretation in the labeling must include 
instructions for the user on how to interpret the results, including un-
typeable and co-infection results.
    (iii) Device validation and verification must include evaluation of 
analytical and clinical sensitivity and specificity for each of the HIV 
types, strains, and subtypes of HIV intended to be differentiated. 
Premarket notification submissions must include this information.

[87 FR 29665, May 16, 2022]



Sec. 866.3957  Human immunodeficiency virus (HIV) nucleic acid (NAT)
diagnostic and/or supplemental test.

    (a) Identification. Human immunodeficiency virus (HIV) nucleic acid 
(NAT) diagnostic and supplemental tests are prescription devices for the 
qualitative detection of HIV nucleic acid in human body fluids or 
tissues. The tests are intended for use as an aid in the diagnosis of 
infection with HIV and are for professional use only. The test results 
are intended to be interpreted in conjunction with other relevant 
clinical and laboratory findings. These tests are not intended to be 
used for monitoring patient status, or for screening donors of blood or 
blood products, or human cells, tissues, or cellular or tissue-based 
products (HCT/Ps).
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) For all HIV NAT diagnostic and/or supplemental tests
    (i) The labeling must include:
    (A) An intended use that states that the device is not intended for 
use for screening donors of blood or blood products, or HCT/Ps.
    (B) A detailed explanation of the principles of operation and 
procedures used for performing the assay.
    (C) A detailed explanation of the interpretation of results and 
recommended actions to take based on results.
    (D) Limitations, which must be updated to reflect current clinical 
practice and disease presentation and management. The limitations must 
include, but are not limited to, statements that indicate:
    (1) The matrices with which the device has been cleared, and that 
use of this test kit with specimen types other than those specifically 
cleared for this device may result in inaccurate test results.
    (2) The test is not intended to be used to monitor individuals who 
are undergoing treatment for HIV infection.
    (3) A specimen with a reactive result should be investigated further 
following current guidelines.
    (4) All test results should be interpreted in conjunction with the 
individual's clinical presentation, history, and other laboratory 
results.
    (5) A test result that is nonreactive does not exclude the 
possibility of exposure to or infection with HIV. Nonreactive results in 
this assay may be due to analyte levels that are below the limit of 
detection of this assay.
    (ii) Device verification and validation must include:

[[Page 365]]

    (A) Detailed device description, including the device components, 
ancillary reagents required but not provided, and an explanation of the 
methodology. Additional information appropriate to the technology must 
be included, such as design of primers and probes.
    (B) For devices with assay calibrators, the design and nature of all 
primary, secondary, and subsequent quantitation standards used for 
calibration as well as their traceability to a reference material. In 
addition, analytical testing must be performed following the release of 
a new lot of the standard material that was used for device clearance, 
or when there is a transition to a new calibration standard.
    (C) Detailed documentation of analytical performance studies 
conducted as appropriate to the technology, specimen types tested, and 
intended use of the device, including, but not limited to, limit of 
blank, limit of detection, cutoff determination, precision, endogenous 
and exogenous interferences, cross reactivity, carryover, quality 
control, matrix equivalency, and sample and reagent stability. Samples 
selected for use in analytical studies or used to prepare samples for 
use in analytical studies must be from subjects with clinically relevant 
circulating genotypes in the United States. The effect of each claimed 
nucleic-acid isolation and purification procedure on detection must be 
evaluated.
    (D) Multisite reproducibility study that includes the testing of 
three independent production lots.
    (E) Analytical sensitivity of the test must be the same as or better 
than that of other cleared or approved tests. Samples tested must 
include appropriate numbers and types of samples, including real 
clinical samples near the lower limit of detection. Analytical 
specificity of the test must be as the same as or better than that of 
other cleared or approved tests. Samples must include appropriate 
numbers and types of samples from patients with different underlying 
illnesses or infections and from patients with potential endogenous 
interfering substances.
    (F) Detailed documentation of performance from a multisite clinical 
study. Performance must be analyzed relative to an FDA cleared or 
approved comparator. This study must be conducted using appropriate 
patient samples, with appropriate numbers of HIV positive and negative 
samples in applicable risk categories. Additional subtype, strain, or 
types must be validated using appropriate numbers and types of samples. 
The samples may be a combination of fresh and repository samples, 
sourced from within and outside the United States, as appropriate. The 
study designs, including number of samples tested, must be sufficient to 
meet the following criteria:
    (1) Clinical sensitivity of the test must have a lower bound of the 
95 percent confidence interval of greater than or equal to 99 percent.
    (2) Clinical specificity of the test must have a lower bound of the 
95 percent confidence interval of greater than or equal to 99 percent.
    (G) Strategies for detection of new strains, types, subtypes, 
genotypes, and genetic mutations as they emerge.
    (H) Risk analysis and management strategies, such as Failure Modes 
Effects Analysis and/or Hazard Analysis and Critical Control Points 
summaries and their impact on test performance.
    (I) Final release criteria to be used for manufactured test lots 
with appropriate evidence that lots released at the extremes of the 
specifications will meet the claimed analytical and clinical performance 
characteristics as well as the stability claims.
    (J) All stability protocols, including acceptance criteria.
    (K) Appropriate and acceptable procedure(s) for evaluating customer 
complaints and other device information that determine when to submit a 
medical device report.
    (L) Premarket notification submissions must include the information 
contained in paragraph (b)(1)(ii)(A) through (K) of this section.
    (iii) Manufacturers must submit a log of all complaints. The log 
must include the following information regarding each complaint, if 
available: The type of event (e.g., false negative/false nonreactive or 
false positive/false reactive), lot, date, population, and whether or 
not the complaint was reported under part 803 of this chapter (Medical 
Device Reporting). The log must be

[[Page 366]]

submitted annually on the anniversary of clearance for 5 years following 
clearance of a traditional premarket notification.
    (2) If the test is intended for Point of Care (PoC) use, the 
following special controls, in addition to those listed in paragraph 
(b)(1) of this section, apply:
    (i) The PoC labeling must include a statement that the test is 
intended for PoC use.
    (ii) The PoC labeling must include the following information near 
the statement of the intended use:
    (A) That the test is for distribution to clinical laboratories that 
have an adequate quality assurance program, including planned systematic 
activities that provide adequate confidence that requirements for 
quality will be met and where there is assurance that operators will 
receive and use the instructional materials.
    (B) That the test is for use only by an agent of a clinical 
laboratory.
    (C) Instructions for individuals to receive the ``Subject 
Information Notice'' prior to specimen collection and appropriate 
information when test results are provided.
    (iii) PoC labeling must include instructions to follow current 
guidelines for informing the individual of the test result and its 
interpretation.
    (iv) The instructions in the labeling must state that reactive 
results are considered preliminary and should be confirmed following 
current guidelines.
    (v) Device verification and validation for PoC use must include:
    (A) Detailed documentation from a well-conducted multisite clinical 
study conducted at appropriate PoC sites. Performance must be analyzed 
relative to an FDA cleared or approved comparator. This study must be 
conducted using patient samples, with appropriate numbers of HIV 
positive and HIV negative samples in applicable risk categories. 
Additional subgroup or type claims must be validated using appropriate 
numbers and types of samples. The samples may be a combination of fresh 
and repository samples, sourced from within and outside the United 
States, as appropriate. If the test is intended solely for PoC use, the 
test must meet only the performance criteria in paragraphs 
(b)(2)(v)(A)(1) and (2) of this section and not the criteria in 
paragraph (b)(1)(ii)(F) of this section:
    (1) Clinical sensitivity of the test must have a lower bound of the 
95 percent confidence interval of greater than or equal to 98 percent.
    (2) Clinical specificity of the test must have a lower bound of the 
95 percent confidence interval of greater than or equal to 98 percent.
    (B) Premarket notification submissions must include the information 
contained in paragraph (b)(2)(v)(A) of this section.
    (3) If the test is intended for supplemental use in addition to use 
as an aid in initial diagnosis, the following special controls, in 
addition to those listed in paragraphs (b)(1) and (2) of this section, 
as appropriate, apply:
    (i) The labeling must include a statement that the test is intended 
for use as an additional test to confirm the presence of HIV viral 
nucleic acid in specimens found to be repeatedly reactive by a 
diagnostic screening test.
    (ii) Device validation and verification for supplemental use must 
include a clinical study, including samples that were initially reactive 
and repeatedly reactive on a diagnostic test but were negative or 
indeterminate on a confirmatory test. Premarket notification submissions 
must include this information.
    (4) If the test is intended solely as a supplemental test, the 
following special controls, in addition to those listed in paragraphs 
(b)(1) and (2) of this section, except those in paragraphs (b)(1)(ii)(F) 
and (b)(2)(v)(A) of this section, as appropriate, apply:
    (i) The labeling must include a statement that the test is intended 
for use as an additional test to confirm the presence of HIV viral 
nucleic acid in specimens found to be repeatedly reactive by a 
diagnostic screening test.
    (ii) The labeling must clearly state that the test is not for use 
for initial diagnosis or is not intended as a first-line test.
    (iii) Device validation and verification must include a clinical 
study including samples that were initially reactive and repeatedly 
reactive on a diagnostic test but were negative or indeterminate on a 
confirmatory

[[Page 367]]

test. Premarket notification submissions must include this information.
    (5) If the test is intended to differentiate different HIV types, 
the following special controls, in addition to those listed in 
paragraphs (b)(1) through (4) of this section, as appropriate, apply:
    (i) The labeling must include the statement that the test is 
intended for the confirmation of initial results and differentiation of 
different HIV types.
    (ii) The results interpretation in the labeling must include 
instructions for the user on how to interpret the results, including un-
typeable and co-infection results.
    (iii) Device validation and verification must include evaluation of 
analytical and clinical sensitivity and specificity for each of the 
types, strains, and subtypes of HIV intended to be differentiated. 
Premarket notification submissions must include this information.

[87 FR 29667, May 16, 2022]



Sec. 866.3958  Human immunodeficiency virus (HIV) viral load monitoring test.

    (a) Identification. A human immunodeficiency virus (HIV) viral load 
monitoring test is an in vitro diagnostic prescription device for the 
quantitation of the amount of HIV ribonucleic acid (RNA) in human body 
fluids. The test is intended for use in the clinical management of 
individuals living with HIV and is for professional use only. The test 
results are intended to be interpreted in conjunction with other 
relevant clinical and laboratory findings. The test is not intended to 
be used as an aid in diagnosis or for screening donors of blood or blood 
products or human cells, tissues, or cellular and tissue-based products 
(HCT/Ps).
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The labeling must include:
    (i) An intended use that states that the device is not intended for 
use as an aid in diagnosis or for use in screening donors of blood or 
blood products, or HCT/Ps.
    (ii) A detailed explanation of the principles of operation and 
procedures used for assay performance.
    (iii) A detailed explanation of the interpretation of results and 
that recommended actions should be based on current clinical guidelines.
    (iv) Limitations, which must be updated to reflect current clinical 
practice and patient management. The limitations must include, but are 
not limited to, statements that indicate:
    (A) The matrices and sample types with which the device has been 
cleared and that use of this test with specimen types other than those 
specifically cleared for this device may cause inaccurate test results.
    (B) Mutations in highly conserved regions may affect binding of 
primers and/or probes resulting in the under-quantitation of virus or 
failure to detect the presence of virus.
    (C) All test results should be interpreted in conjunction with the 
individual's clinical presentation, history, and other laboratory 
results.
    (2) Device verification and validation must include:
    (i) Detailed device description, including the device components, 
ancillary reagents required but not provided, and an explanation of the 
device methodology. Additional information appropriate to the technology 
must be included, such as detailed information on the design of primers 
and probes.
    (ii) For devices with assay calibrators, the design and nature of 
all primary, secondary, and subsequent quantitation standards used for 
calibration as well as their traceability to a reference material. In 
addition, analytical testing must be performed following the release of 
a new lot of the standard material that was used for device clearance, 
or when there is a transition to a new calibration standard.
    (iii) Detailed documentation of analytical performance studies 
conducted as appropriate to the technology, specimen types tested, and 
intended use of the device, including but not limited to, limit of 
blank, limit of detection, limit of quantitation, cutoff determination, 
precision, linearity, endogenous and exogenous interferences, cross-
reactivity, carry-over, quality control, matrix equivalency, sample and 
reagent stability. Samples selected for use in analytical studies or 
used to prepare samples for use in analytical

[[Page 368]]

studies must be from subjects with clinically relevant genotypes 
circulating in the United States.
    (iv) Multisite reproducibility study that includes the testing of 
three independent production lots.
    (v) Analytical sensitivity of the device must demonstrate acceptable 
performance at current clinically relevant medical decision points. 
Samples tested to demonstrate analytical sensitivity must include 
appropriate numbers and types of samples, including real clinical 
samples near the lower limit of quantitation and any clinically relevant 
medical decision points. Analytical specificity of the device must 
demonstrate acceptable performance. Samples tested to demonstrate 
analytical specificity must include appropriate numbers and types of 
samples from patients with different underlying illnesses and infection 
and from patients with potential interfering substances.
    (vi) Detailed documentation of performance from a multisite clinical 
study or a multisite analytical method comparison study.
    (A) For devices evaluated in a multisite clinical study, the study 
must use specimens from individuals living with HIV being monitored for 
changes in viral load, and the test results must be compared to the 
clinical status of the patients.
    (B) For tests evaluated in a multisite analytical method comparison 
study, the performance of the test must be compared to an FDA-cleared or 
approved comparator. The multisite method comparison study must include 
appropriate numbers and types of samples with analyte concentrations 
across the measuring range of the assay, representing clinically 
relevant genotypes. The multisite method comparison study design, 
including number of samples tested, must be sufficient to meet the 
following criteria:
    (1) Agreement between the two tests across the measuring range of 
the assays must have an r2 of greater than or equal to 0.95.
    (2) The bias between the test and comparator assay, as determined by 
difference plots, must be less than or equal to 0.5 log copies/mL.
    (vii) Detailed documentation of a single-site analytical method 
comparison study between the device and an FDA-cleared or approved 
comparator if a multisite clinical study is performed under 
paragraph(b)(2)(vi) of this section. The analytical method comparison 
study must use appropriate numbers and types of samples with analyte 
concentrations across the measuring range of the assay, representing 
clinically relevant genotypes. The results must meet the criteria in 
paragraphs (b)(2)(vi)(B)(1) and (2) of this section.
    (viii) Strategies for detection of new strains, types, subtypes, 
genotypes, and genetic mutations as they emerge.
    (ix) Risk analysis and management strategies, such as Failure Modes 
Effects Analysis and/or Hazard Analysis and Critical Control Points 
summaries and their impact on test performance.
    (x) Final release criteria to be used for manufactured device lots 
with an appropriate justification that lots released at the extremes of 
the specifications will meet the claimed analytical and clinical 
performance characteristics as well as the stability claims.
    (xi) All stability protocols, including acceptance criteria.
    (xii) Appropriate and acceptable procedure(s) for addressing 
complaints and other device information that determines when to submit a 
medical device report.
    (xiii) Premarket notification submissions must include the 
information contained in paragraphs (b)(2)(i) through (xii) of this 
section.

[87 FR 66548, Nov. 4, 2022]



Sec. 866.3960  Nucleic acid-based device for the amplification,
detection, and identification of microbial pathogens directly from
whole blood specimens.

    (a) Identification. A nucleic acid-based device for the 
amplification, detection, and identification of microbial pathogens 
directly from whole blood specimens is a qualitative in vitro device 
intended for the amplification, detection, and identification of 
microbial-associated nucleic acid sequences from patients with suspected 
bloodstream infections. This device is intended to aid in the diagnosis 
of bloodstream infection when used in conjunction with

[[Page 369]]

clinical signs and symptoms and other laboratory findings.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Premarket notification submissions must include detailed device 
description documentation, including the device components, ancillary 
reagents required but not provided, and a detailed explanation of the 
methodology, including primer/probe sequence, design, and rationale for 
sequence selection.
    (2) Premarket notification submissions must include detailed 
documentation from the following analytical and clinical performance 
studies: Analytical sensitivity (limit of detection), reactivity, 
inclusivity, precision, reproducibility, interference, cross reactivity, 
carryover, and cross contamination.
    (3) Premarket notification submissions must include detailed 
documentation from a clinical study. The study, performed on a study 
population consistent with the intended use population, must compare the 
device performance to results obtained from well-accepted reference 
methods.
    (4) Premarket notification submissions must include detailed 
documentation for device software, including, but not limited to, 
software applications and hardware-based devices that incorporate 
software.
    (5) The device labeling must include limitations regarding the need 
for culture confirmation of negative specimens, as appropriate.
    (6) A detailed explanation of the interpretation of results and 
acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) 
compliant labeling.
    (7) Premarket notification submissions must include details on an 
end user device training program that will be offered while marketing 
the device, as appropriate.
    (8) As part of the risk management activities performed as part of 
your 21 CFR 820.30 design controls, you must document an appropriate end 
user device training program that will be offered as part of your 
efforts to mitigate the risk of failure to correctly operate the 
instrument.

[82 FR 47967, Oct. 16, 2017]



Sec. 866.3970  Device to detect and identify microbial pathogen 
nucleic acids in cerebrospinal fluid.

    (a) Identification. A device to detect and identify microbial 
pathogen nucleic acids in cerebrospinal fluid is a qualitative in vitro 
device intended for the detection and identification of microbial-
associated nucleic acid sequences from patients suspected of meningitis 
or encephalitis. A device to detect and identify microbial pathogen 
nucleic acids in cerebrospinal fluid is intended to aid in the diagnosis 
of meningitis or encephalitis when used in conjunction with clinical 
signs and symptoms and other clinical and laboratory findings.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Premarket notification submissions must include detailed device 
description documentation, including the device components, ancillary 
reagents required but not provided, and a detailed explanation of the 
methodology, including primer/probe sequence, design, and rationale for 
sequence selection.
    (2) Premarket notification submissions must include detailed 
documentation from the following analytical studies: Analytical 
sensitivity (limit of detection), inclusivity, reproducibility, 
interference, cross reactivity, and specimen stability.
    (3) Premarket notification submissions must include detailed 
documentation from a clinical study. The study, performed on a study 
population consistent with the intended use population, must compare the 
device performance to results obtained from well-accepted comparator 
methods.
    (4) Premarket notification submissions must include detailed 
documentation for device software, including, but not limited to, 
software applications and hardware-based devices that incorporate 
software.
    (5) The Intended Use statement in the device labeling must include a 
statement that the device is intended

[[Page 370]]

to be used in conjunction with standard of care culture.
    (6) A detailed explanation of the interpretation of results and 
acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) 
compliant labeling.
    (7) The device labeling must include a limitation stating that the 
negative results do not preclude the possibility of central nervous 
system infection.
    (8) The device labeling must include a limitation stating that 
device results are not intended to be used as the sole basis for 
diagnosis, treatment, or other patient management decisions.
    (9) The device labeling must include a limitation stating that 
positive results do not mean that the organism detected is infectious or 
is the causative agent for clinical symptoms.
    (10) As part of the risk management activities performed as part of 
your 21 CFR 820.30 design controls, you must document an appropriate end 
user device training program that will be offered as part of your 
efforts to mitigate the risk of failure to correctly operate the 
instrument.

[82 FR 48763, Oct. 20, 2017]



Sec. 866.3980  Respiratory viral panel multiplex nucleic acid assay.

    (a) Identification. A respiratory viral panel multiplex nucleic acid 
assay is a qualitative in vitro diagnostic device intended to 
simultaneously detect and identify multiple viral nucleic acids 
extracted from human respiratory specimens or viral culture. The 
detection and identification of a specific viral nucleic acid from 
individuals exhibiting signs and symptoms of respiratory infection aids 
in the diagnosis of respiratory viral infection when used in conjunction 
with other clinical and laboratory findings. The device is intended for 
detection and identification of a combination of the following viruses:
    (1) Influenza A and Influenza B;
    (2) Influenza A subtype H1 and Influenza A subtype H3;
    (3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial 
Virus subtype B;
    (4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus;
    (5) Human Metapneumovirus;
    (6) Rhinovirus; and
    (7) Adenovirus.
    (b) Classification. Class II (special controls). The special 
controls are:
    (1) FDA's guidance document entitled ``Class II Special Controls 
Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid 
Assay;''
    (2) For a device that detects and identifies Human Metapneumovirus, 
FDA's guidance document entitled ``Class II Special Controls Guidance 
Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid 
Assays;'' and
    (3) For a device that detects and differentiates Influenza A subtype 
H1 and subtype H3, FDA's guidance document entitled ``Class II Special 
Controls Guidance Document: Testing for Detection and Differentiation of 
Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.'' See 
Sec. 866.1(e) for the availability of these guidance documents.

[74 FR 52138, Oct. 9, 2009]



Sec. 866.3985  Device to detect and identify microorganisms and
associated resistance marker nucleic acids directly in 
respiratory specimens.

    (a) Identification. A device to detect and identify microorganisms 
and associated resistance marker nucleic acids directly from respiratory 
specimens is an in vitro diagnostic device intended for the detection 
and identification of microorganisms and associated resistance markers 
in respiratory specimens collected from patients with signs or symptoms 
of respiratory infection. The device is intended to aid in the diagnosis 
of respiratory infection in conjunction with clinical signs and symptoms 
and other laboratory findings. These devices do not provide confirmation 
of antibiotic susceptibility since mechanisms of resistance may exist 
other than those detected by the device.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The intended use for the 21 CFR 809.10 labeling must include a 
detailed description of what the device detects, the type of results 
provided to the user, the clinical indications appropriate for

[[Page 371]]

test use, and the specific population(s) for which the device is 
intended.
    (2) The 21 CFR 809.10(b) labeling must include:
    (i) A detailed device description, including all device components, 
control elements incorporated into the test procedure, instrument 
requirements, ancillary reagents required but not provided, and a 
detailed explanation of the methodology, including all pre-analytical 
methods for processing of specimens.
    (ii) Performance characteristics from analytical studies, including, 
but not limited to, limit of detection, inclusivity, reproducibility, 
cross reactivity, interfering substances, competitive inhibition, 
carryover/cross contamination, specimen stability, and linearity, as 
applicable.
    (iii) A limiting statement that the device is intended to be used in 
conjunction with clinical history, signs and symptoms, and results of 
other diagnostic tests, including culture and antimicrobial 
susceptibility testing.
    (iv) A detailed explanation of the interpretation of test results 
for clinical specimens and acceptance criteria for any quality control 
testing.
    (v) A limiting statement that negative results for microorganisms do 
not preclude the possibility of infection, and should not be used as the 
sole basis for diagnosis, treatment, or other patient management 
decisions.
    (vi) If applicable, a limiting statement that detected 
microorganisms may not be the cause of lower respiratory tract infection 
and may be indicative of colonizing or normal respiratory flora.
    (vii) If applicable, a limiting statement that detection of 
resistance markers cannot be definitively linked to specific 
microorganisms and that the source of a detected resistance marker may 
be an organism not detected by the assay, including colonizing flora.
    (viii) If applicable, a limiting statement that detection of 
antibiotic resistance markers may not correlate with phenotypic gene 
expression.
    (3) The 21 CFR 809.10(b) labeling and any test report generated by 
the device must include a limiting statement that negative results for 
resistance markers do not indicate susceptibility of detected 
microorganisms.
    (4) Design verification and validation must include:
    (i) Performance characteristics from clinical studies that include 
prospective (sequential) samples and, if appropriate, additional 
characterized samples. The study must be performed on a study population 
consistent with the intended use population and compare the device 
performance to results obtained from an FDA accepted reference method 
and/or FDA accepted comparator method, as appropriate. Results from the 
clinical studies must include the clinical study protocol (including 
predefined statistical analysis plan, if applicable), clinical study 
report, and results of all statistical analyses.
    (ii) A detailed device description including the following:
    (A) Thorough description of the assay methodology including, but not 
limited to, primer/probe sequences, primer/probe design, and rationale 
for target sequence selection, as applicable.
    (B) Algorithm used to generate a final result from raw data (e.g., 
how raw signals are converted into a reported result).
    (iii) A detailed description of device software, including, but not 
limited to, validation activities and outcomes.
    (iv) As part of the risk management activities, an appropriate end 
user device training program must be offered as an effort to mitigate 
the risk of failure from user error.

[84 FR 9228, Mar. 14, 2019]



Sec. 866.3990  Gastrointestinal microorganism multiplex nucleic
acid-based assay.

    (a) Identification. A gastrointestinal microorganism multiplex 
nucleic acid-based assay is a qualitative in vitro diagnostic device 
intended to simultaneously detect and identify multiple gastrointestinal 
microbial nucleic acids extracted from human stool specimens. The device 
detects specific nucleic acid sequences for organism identification as 
well as for determining the presence of toxin genes. The detection and 
identification of a specific gastrointestinal microbial nucleic acid 
from individuals exhibiting

[[Page 372]]

signs and symptoms of gastrointestinal infection aids in the diagnosis 
of gastrointestinal infection when used in conjunction with clinical 
evaluation and other laboratory findings. A gastrointestinal 
microorganism multiplex nucleic acid-based assay also aids in the 
detection and identification of acute gastroenteritis in the context of 
outbreaks.
    (b) Classification. Class II (special controls). The special 
controls are set forth in FDA's guideline document entitled: ``Class II 
Special Controls Guideline: Gastrointestinal Microorganism Multiplex 
Nucleic Acid-Based Assays for Detection and Identification of 
Microorganisms and Toxin Genes from Human Stool Specimens.'' For 
availability of the guideline document, see Sec. 866.1(e).

[80 FR 67314, Nov. 2, 2015]



         Subpart E_Immunology Laboratory Equipment and Reagents



Sec. 866.4070  RNA Preanalytical Systems.

    (a) Identification. RNA Preanalytical Systems are devices intended 
to collect, store, and transport patient specimens, and stabilize 
intracellular RNA from the specimens, for subsequent isolation and 
purification of the intracellular RNA for RT-PCR used in in vitro 
molecular diagnostic testing.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance document entitled ``Class II Special Controls Guidance 
Document: RNA Preanalytical Systems (RNA Collection, Stabilization and 
Purification System for RT-PCR Used in Molecular Diagnostic Testing).'' 
See Sec. 866.1(e) for the availability of this guidance document.

[70 FR 49863, Aug. 25, 2005]



Sec. 866.4100  Complement reagent.

    (a) Identification. A complement reagent is a device that consists 
of complement, a naturally occurring serum protein from any warm-blooded 
animal such as guinea pigs, that may be included as a component part of 
serological test kits used in the diagnosis of disease.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 2001, as amended at 66 FR 38792, July 25, 2001]



Sec. 866.4500  Immunoelectrophoresis equipment.

    (a) Identification. Immunoelectrophoresis equipment for clinical use 
with its electrical power supply is a device used for separating protein 
molecules. Immunoelectrophoresis is a procedure in which a complex 
protein mixture is placed in an agar gel and the various proteins are 
separated on the basis of their relative mobilities under the influence 
of an electric current. The separated proteins are then permitted to 
diffuse through the agar toward a multispecific antiserum, allowing 
precipitation and visualization of the separate complexes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 
FR 38792, July 25, 2001]



Sec. 866.4520  Immunofluorometer equipment.

    (a) Identification. Immunofluorometer equipment for clinical use 
with its electrical power supply is a device used to measure the 
fluorescence of fluorochrome-labeled antigen-antibody complexes. The 
concentration of these complexes may be measured by means of reflected 
light. A beam of light is passed through a solution in which a 
fluorochrome has been selectively attached to serum protein antibody 
molecules in suspension. The amount of light emitted by the fluorochrome 
label is detected by a photodetector, which converts light energy into 
electrical energy. The amount of electrical energy registers on a 
readout system such as a digital voltmeter or a recording chart. This 
electrical readout is called the fluorescence value and is used to 
measure the concentration of antigen-antibody complexes.

[[Page 373]]

    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 
FR 38792, July 25, 2001]



Sec. 866.4540  Immunonephelometer equipment.

    (a) Identification. Immunonephelometer equipment for clinical use 
with its electrical power supply is a device that measures light 
scattering from antigen-antibody complexes. The concentration of these 
complexes may be measured by means of reflected light. A beam of light 
passed through a solution is scattered by the particles in suspension. 
The amount of light is detected by a photodetector, which converts light 
energy into electrical energy. The amount of electrical energy registers 
on a readout system such as a digital voltmeter or a recording chart. 
This electrical readout is called the light-scattering value and is used 
to measure the concentration of antigen-antibody complexes. This generic 
type of device includes devices with various kinds of light sources, 
such as laser equipment.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 
FR 38792, July 25, 2001]



Sec. 866.4600  Ouchterlony agar plate.

    (a) Identification. An ouchterlony agar plate for clinical use is a 
device containing an agar gel used to examine antigen-antibody 
reactions. In immunodiffusion, antibodies and antigens migrate toward 
each other through gel which originally contained neither of these 
reagents. As the reagents come in contact with each other, they combine 
to form a precipitate that is trapped in the gel matrix and is 
immobilized.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 
FR 38792, July 25, 2001]



Sec. 866.4700  Automated fluorescence in situ hybridization (FISH) 
enumeration systems.

    (a) Identification. An automated FISH enumeration system is a device 
that consists of an automated scanning microscope, image analysis 
system, and customized software applications for FISH assays. This 
device is intended for in vitro diagnostic use with FISH assays as an 
aid in the detection, counting and classification of cells based on 
recognition of cellular color, size, and shape, and in the detection and 
enumeration of FISH signals in interphase nuclei of formalin-fixed, 
paraffin-embedded human tissue specimens.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance document entitled ``Class II Special Controls Guidance 
Document: Automated Fluorescence in situ Hybridization (FISH) 
Enumeration Systems.'' See Sec. 866.1(e) for the availability of this 
guidance document.

[70 FR 14534, Mar. 23, 2005]



Sec. 866.4750  Automated indirect immunofluorescence microscope 
and software-assisted system.

    (a) Identification. An automated indirect immunofluorescence 
microscope and software assisted system is a device that acquires, 
analyzes, stores, and displays digital images of indirect 
immunofluorescent slides. It is intended to be used as an aid in the 
determination of antibody status in clinical samples. The device may 
include a fluorescence microscope with light source, a motorized 
microscope stage, dedicated instrument controls, a camera, a computer, a 
sample processor, or other hardware components. The device may use 
fluorescent signal acquisition and processing software, data storage and 
transferring mechanisms, or assay specific algorithms to suggest 
results. A trained operator must confirm results generated with the 
device.

[[Page 374]]

    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The labeling for the device must reference legally marketed 
assays intended for use with the device.
    (2) Premarket notification submissions must include the following 
information:
    (i) A detailed description of the device that includes:
    (A) A detailed description of instrumentation and equipment, and 
illustrations or photographs of non-standard equipment or methods, if 
applicable;
    (B) Detailed documentation of the software, including, but not 
limited to, stand-alone software applications and hardware-based devices 
that incorporate software, if applicable;
    (C) A detailed description of appropriate internal and external 
quality controls that are recommended or provided. The description must 
identify those control elements that are incorporated into the 
recommended testing procedures;
    (D) Detailed description and specifications for sample preparation, 
processing, and storage, if applicable;
    (E) Methodology and protocols for detecting fluorescence and 
visualizing results; and
    (F) Detailed specification of the criteria for test results 
interpretation and reporting.
    (ii) Data demonstrating the performance characteristics of the 
device, which must include:
    (A) A comparison study of the results obtained with the conventional 
manual method (i.e., reference standard), the device, and the reading of 
the digital image without aid of the software, using the same set of 
patient samples for each. The study must use a legally marketed assay 
intended for use with the device. Patient samples must be from the 
assay-specific intended use population and differential diagnosis 
population. Samples must also cover the assay measuring range, if 
applicable;
    (B) Device clinical performance established by comparing device 
results at multiple U.S. sites to the clinical diagnostic standard used 
in the United States, using patient samples from the assay-specific 
intended use population and the differential diagnosis population. For 
all samples, the diagnostic clinical criteria and the demographic 
information must be collected and provided. Clinical validation must be 
based on the determination of clinical sensitivity and clinical 
specificity using the test results (e.g., antibody status based on 
fluorescence to include pattern and titer, if applicable) compared to 
the clinical diagnosis of the subject from whom the clinical sample was 
obtained. The data must be summarized in tabular format comparing the 
result generated by automated, manual, and digital only interpretation 
to the disease status;
    (C) Device precision/reproducibility data generated from within-run, 
between-run, between-day, between-lot, between-operator, between-
instruments, between-site, and total precision for multiple 
nonconsecutive days (as applicable) using multiple operators, multiple 
instruments and at multiple sites. A well-characterized panel of patient 
samples or pools from the associated assay specific intended use 
population must be used;
    (D) Device linearity data generated from patient samples covering 
the assay measuring range, if applicable;
    (E) Device analytical sensitivity data, including limit of blank, 
limit of detection, and limit of quantitation, if applicable;
    (F) Device assay specific cutoff, if applicable;
    (G) Device analytical specificity data, including interference by 
endogenous and exogenous substances, if applicable;
    (H) Device instrument carryover data, if applicable;
    (I) Device stability data including real-time stability under 
various storage times and temperatures, if applicable; and
    (J) Information on traceability to a reference material and 
description of value assignment of calibrators and controls, if 
applicable.
    (iii) Identification of risk mitigation elements used by the device, 
including description of all additional procedures, methods, and 
practices, incorporated into the directions for use that mitigate risks 
associated with testing.

[[Page 375]]

    (3) Your 21 CFR 809.10 compliant labeling must include:
    (i) A warning statement that reads ``The device is for use by a 
trained operator in a clinical laboratory setting'';
    (ii) A warning statement that reads ``All software-aided results 
must be confirmed by the trained operator'';
    (iii) A warning statement that reads ``This device is only for use 
with reagents that are indicated for use with the device''; and
    (iv) A description of the protocol and performance studies performed 
in accordance with paragraph (b)(2)(ii) of this section and a summary of 
the results, if applicable.

[82 FR 52648, Nov. 14, 2017, as amended at 86 FR 20283, Apr. 19, 2021]



Sec. 866.4800  Radial immunodiffusion plate.

    (a) Identification. A radial immunodiffusion plate for clinical use 
is a device that consists of a plastic plate to which agar gel 
containing antiserum is added. In radial immunodiffusion, antigens 
migrate through gel which originally contains specific antibodies. As 
the reagents come in contact with each other, they combine to form a 
precipitate that is trapped in the gel matrix and immobilized.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 66 FR 38792, July 25, 2001]



Sec. 866.4830  Rocket immunoelectro phoresis equipment.

    (a) Identification. Rocket immunoelectrophoresis equipment for 
clinical use is a device used to perform a specific test on proteins by 
using a procedure called rocket immunoelectrophoresis. In this 
procedure, an electric current causes the protein in solution to migrate 
through agar gel containing specific antisera. The protein precipitates 
with the antisera in a rocket-shaped pattern, giving the name to the 
device. The height of the peak (or the area under the peak) is 
proportional to the concentration of the protein.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 
FR 38792, July 25, 2001]



Sec. 866.4900  Support gel.

    (a) Identification. A support gel for clinical use is a device that 
consists of an agar or agarose preparation that is used while measuring 
various kinds of, or parts of, protein molecules by various 
immunochemical techniques, such as immunoelectrophoresis, 
immunodiffusion, or chromatography.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 
FR 38792, July 25, 2001]



                  Subpart F_Immunological Test Systems



Sec. 866.5040  Albumin immunological test system.

    (a) Identification. An albumin immunological test system is a device 
that consists of the reagents used to measure by immunochemical 
techniques the albumin (a plasma protein) in serum and other body 
fluids. Measurement of albumin aids in the diagnosis of kidney and 
intestinal diseases.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59227, Nov. 3, 1998]



Sec. 866.5060  Prealbumin immunological test system.

    (a) Identification. A prealbumin immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the prealbumin (a plasma protein) in serum and other body 
fluids. Measurement of prealbumin levels in

[[Page 376]]

serum may aid in the assessment of the patient's nutritional status.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.5065  Human allotypic marker immunological test system.

    (a) Identification. A human allotypic marker immunological test 
system is a device that consists of the reagents used to identify by 
immunochemical techniques the inherited human protein allotypic markers 
(such as nGm, nA2 m, and Km allotypes) in serum and other 
body fluids. The identification may be used while studying population 
genetics.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.5080  Alpha-1-antichymotrypsin immunological test system.

    (a) Identification. An alpha-1-antichymotrypsin immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques alpha-1-antichymotrypsin (a protein) in serum, 
other body fluids, and tissues. Alpha-1-antichymotrypsin helps protect 
tissues against proteolytic (protein-splitting) enzymes released during 
infection.
    (b) Classification. Class II (performance standards).



Sec. 866.5090  Antimitochondrial antibody immunological test system.

    (a) Identification. An antimitochondrial antibody immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques the antimitochondrial antibodies in human 
serum. The measurements aid in the diagnosis of diseases that produce a 
spectrum of autoantibodies (antibodies produced against the body's own 
tissue), such as primary biliary cirrhosis (degeneration of liver 
tissue) and chronic active hepatitis (inflammation of the liver).
    (b) Classification. Class II (performance standards).



Sec. 866.5100  Antinuclear antibody immunological test system.

    (a) Identification. An antinuclear antibody immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques the autoimmune antibodies in serum, other body 
fluids, and tissues that react with cellular nuclear constituents 
(molecules present in the nucleus of a cell, such as ribonucleic acid, 
deoxyribonucleic acid, or nuclear proteins). The measurements aid in the 
diagnosis of systemic lupus erythematosus (a multisystem autoimmune 
disease in which antibodies attack the victim's own tissues), hepatitis 
(a liver disease), rheumatoid arthritis, Sj[ouml]gren's syndrome 
(arthritis with inflammation of the eye, eyelid, and salivary glands), 
and systemic sclerosis (chronic hardening and shrinking of many body 
tissues).
    (b) Classification. Class II (performance standards).



Sec. 866.5110  Antiparietal antibody immunological test system.

    (a) Identification. An antiparietal antibody immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques the specific antibody for gastric parietal 
cells in serum and other body fluids. Gastric parietal cells are those 
cells located in the stomach that produce a protein that enables vitamin 
B12 to be absorbed by the body. The measurements aid in the 
diagnosis of vitamin B12 deficiency (or pernicious anemia), 
atrophic gastritis (inflammation of the stomach), and autoimmune 
connective tissue diseases (diseases resulting when the body produces 
antibodies against its own tissues).
    (b) Classification. Class II (performance standards).



Sec. 866.5120  Antismooth muscle antibody immunological test system.

    (a) Identification. An antismooth muscle antibody immunological test 
system is a device that consists of the reagents used to measure by

[[Page 377]]

immunochemical techniques the antismooth muscle antibodies (antibodies 
to nonstriated, involuntary muscle) in serum. The measurements aid in 
the diagnosis of chronic hepatitis (inflammation of the liver) and 
autoimmune connective tissue diseases (diseases resulting from 
antibodies produced against the body's own tissues).
    (b) Classification Class II (performance standards).



Sec. 866.5130  Alpha-1-antitrypsin immunological test system.

    (a) Identification. An alpha-1-antitrypsin immunological test system 
is a device that consists of the reagents used to measure by 
immunochemical techniques the alpha-1-antitrypsin (a plasma protein) in 
serum, other body fluids, and tissues. The measurements aid in the 
diagnosis of several conditions including juvenile and adult cirrhosis 
of the liver. In addition, alpha-1-antitrypsin deficiency has been 
associated with pulmonary emphysema.
    (b) Classification. Class II (performance standards).



Sec. 866.5150  Bence-Jones proteins immunological test system.

    (a) Identification. A Bence-Jones proteins immunological test system 
is a device that consists of the reagents used to measure by 
immunochemical techniques the Bence-Jones proteins in urine and plasma. 
Immunoglobulin molecules normally consist of pairs of polypeptide chains 
(subunits) of unequal size (light chains and heavy chains) bound 
together by several disulfide bridges. In some cancerous conditions, 
there is a proliferation of one plasma cell (antibody-producing cell) 
with excess production of light chains of one specific kind (monoclonal 
light chains). These free homogeneous light chains not associated with 
an immunoglobulin molecule can be found in urine and plasma, and have 
been called Bence-Jones proteins. Measurement of Bence-Jones proteins 
and determination that they are monoclonal aid in the diagnosis of 
multiple myeloma (malignant proliferation of plasma cells), 
Waldenstrom's macroglobulinemia (increased production of large 
immunoglobulins by spleen and bone marrow cells), leukemia (cancer of 
the blood-forming organs), and lymphoma (cancer of the lymphoid tissue).
    (b) Classification. Class II (performance standards).



Sec. 866.5160  Beta-globulin immunolog ical test system.

    (a) Identification. A beta-globulin immunological test system is a 
device that consists of reagents used to measure by immunochemical 
techniques beta globulins (serum protein) in serum and other body 
fluids. Beta-globulin proteins include beta-lipoprotein, transferrin, 
glycoproteins, and complement, and are rarely associated with specific 
pathologic disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.5170  Breast milk immunological test system.

    (a) Identification. A breast milk immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the breast milk proteins.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 59 FR 63007, Dec. 7, 1994; 66 
FR 38793, July 25, 2001]



Sec. 866.5180  Fecal calprotectin immunological test system.

    (a) Identification. A fecal calprotectin immunological test system 
is an in vitro diagnostic device that consists of reagents used to 
quantitatively measure, by immunochemical techniques, fecal calprotectin 
in human stool specimens. The device is intended forin vitro diagnostic 
use as an aid in the diagnosis of inflammatory bowel diseases (IBD), 
specifically Crohn's disease and ulcerative colitis, and as an aid in 
differentiation of IBD from irritable bowel syndrome.
    (b) Classification. Class II (special controls). The special control 
for these

[[Page 378]]

devices is FDA's guidance document entitled ``Class II Special Controls 
Guidance Document: Fecal Calprotectin Immunological Test Systems.'' For 
the availability of this guidance document, see Sec. 866.1(e).

[71 FR 42598, July 27, 2006]



Sec. 866.5200  Carbonic anhydrase B and C immunological test system.

    (a) Identification. A carbonic anhydrase B and C immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques specific carbonic anhydrase protein molecules 
in serum and other body fluids. Measurements of carbonic anhydrase B and 
C aid in the diagnosis of abnormal hemoglobin metabolism.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.5210  Ceruloplasmin immunolog ical test system.

    (a) Identification. A ceruloplasmin immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the ceruloplasmin (copper-transporting serum protein) in 
serum, other body fluids, or tissues. Measurements of ceruloplasmin aid 
in the diagnosis of copper metabolism disorders.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 84 FR 71800, Dec. 30, 2019]



Sec. 866.5220  Cohn fraction II immunolog ical test system.

    (a) Identification. A Cohn fraction II immunological test system is 
a device that consists of the reagents that contain or are used to 
measure that fraction of plasma containing protein gamma globulins, 
predominantly of the IgG class. The device may be used as a 
coprecipitant in radioimmunoassay methods, as raw material for the 
purification of IgG subclasses, and to reduce nonspecific adsorption of 
plasma proteins in immunoassay techniques. Measurement of these proteins 
aids in the diagnosis of any disease concerned with abnormal levels of 
IgG gamma globulins such as agammaglobulinemia or multiple myeloma.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 59 FR 63007, Dec. 7, 1994; 66 
FR 38793, July 25, 2001]



Sec. 866.5230  Colostrum immunological test system.

    (a) Identification. A colostrum immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the specific proteins in colostrum. Colostrum is a substance 
excreted by the mammary glands during pregnancy and until production of 
breast milk begins 1 to 5 days after childbirth.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 59 FR 63007, Dec. 7, 1994; 66 
FR 38793, July 25, 2001]



Sec. 866.5240  Complement components immunological test system.

    (a) Identification. A complement components immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques complement components C1q, 
C1r, C1s, C2, C3, 
C4, C5, C6, C7, 
C8, and C9, in serum, other body fluids, and 
tissues. Complement is a group of serum proteins which destroy 
infectious agents. Measurements of these proteins aids in the diagnosis 
of immunologic disorders, especially those associated with deficiencies 
of complement components.
    (b) Classification. Class II (performance standards).

[47 FR 50823, Nov. 9, 1982, as amended at 53 FR 11253, Apr. 6, 1988]

[[Page 379]]



Sec. 866.5250  Complement C1 inhibitor (inactivator) immunological test system.

    (a) Identification. A complement C1 inhibitor 
(inactivator) immunological test system is a device that consists of the 
reagents used to measure by immunochemical techniques the complement 
C1 inhibitor (a plasma protein) in serum. Complement 
C1 inhibitor occurs normally in plasma and blocks the action 
of the C1 component of complement (a group of serum proteins 
which destroy infectious agents). Measurement of complement 
C1 inhibitor aids in the diagnosis of hereditary 
angioneurotic edema (increased blood vessel permeability causing 
swelling of tissues) and a rare form of angioedema associated with 
lymphoma (lymph node cancer).
    (b) Classification. Class II (performance standards).



Sec. 866.5260  Complement C3b inactivator immunological test system.

    (a) Identification. A complement C3b inactivator 
immunological test system is a device that consists of the reagents used 
to measure by immunochemical techniques the complement C3b 
inactivator (a plasma protein) in serum. Complement is a group of serum 
proteins that destroy infectious agents. Measurement of complement 
C3b inactivator aids in the diagnosis of inherited antibody 
dysfunction.
    (b) Classification. Class II (performance standards).



Sec. 866.5270  C-reactive protein immuno logical test system.

    (a) Identification. A C-reactive protein immunological test system 
is a device that consists of the reagents used to measure by 
immunochemical techniques the C-reactive protein in serum and other body 
fluids. Measurement of C-reactive protein aids in evaluation of the 
amount of injury to body tissues.
    (b) Classification. Class II (performance standards).



Sec. 866.5320  Properdin factor B immuno logical test system.

    (a) Identification. A properdin factor B immunological test system 
is a device that consists of the reagents used to measure by 
immunochemical techniques properdin factor B in serum and other body 
fluids. The deposition of properdin factor B in body tissues or a 
corresponding depression in the amount of properdin factor B in serum 
and other body fluids is evidence of the involvement of the alternative 
to the classical pathway of activation of complement (a group of plasma 
proteins which cause the destruction of cells which are foreign to the 
body). Measurement of properdin factor B aids in the diagnosis of 
several kidney diseases, e.g., chronic glomerulonephritis (inflammation 
of the glomeruli of the kidney), lupus nephritis (kidney disease 
associated with a multisystem autoimmune disease, systemic lupus 
erythematosus), as well as several skin diseases, e.g., dermititis 
herpetiformis (presence of vesicles on the skin that burn and itch), and 
pemphigus vulgaris (large vesicles on the skin). Other diseases in which 
the alternate pathway of complement activation has been implicated 
include rheumatoid arthritis, sickle cell anemia, and gram-negative 
bacteremia.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59227, Nov. 3, 1998]



Sec. 866.5330  Factor XIII, A, S, immuno logical test system.

    (a) Identification. A factor XIII, A, S, immunological test system 
is a device that consists of the reagents used to measure by 
immunochemical techniques the factor XIII (a bloodclotting factor), in 
platelets (A) or serum (S). Measurements of factor XIII, A, S, aid in 
the diagnosis and treatment of certain bleeding disorders resulting from 
a deficiency of this factor.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9. This exemption does not apply to 
factor deficiency tests classified under Sec. 864.7290 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]

[[Page 380]]



Sec. 866.5340  Ferritin immunological test system.

    (a) Identification. A ferritin immunological test system is a device 
that consists of the reagents used to measure by immunochemical 
techniques the ferritin (an iron-storing protein) in serum and other 
body fluids. Measurements of ferritin aid in the diagnosis of diseases 
affecting iron metabolism, such as hemochromatosis (iron overload) and 
iron deficiency amemia.
    (b) Classification. Class II (performance standards).



Sec. 866.5350  Fibrinopeptide A immuno logical test system.

    (a) Identification. A fibrinopeptide A immunological test system is 
a device that consists of the reagents used to measure by immunochemical 
techniques the fibrinopeptide A (a blood-clotting factor) in plasma and 
other body fluids. Measurement of fibrinopeptide A may aid in the 
diagnosis and treatment of certain blood-clotting disorders.
    (b) Classification. Class II (performance standards).



Sec. 866.5360  Cohn fraction IV immuno logical test system.

    (a) Identification. A Cohn fraction IV immunological test system is 
a device that consists of or measures that fraction of plasma proteins, 
predominantly alpha- and beta- globulins, used as a raw material for the 
production of pure alpha- or beta- globulins. Measurement of specific 
alpha- or beta- globulins aids in the diagnosis of many diseases, such 
as Wilson's disease (an inherited disease affecting the liver and 
brain), Tangier's disease (absence of alpha-1-lipoprotein), 
malnutrition, iron deficiency anemia, red blood cell disorders, and 
kidney disease.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982; 47 FR 56846, Dec. 21, 1982, as amended at 59 
FR 63007, Dec. 7, 1994; 66 FR 38793, July 25, 2001]



Sec. 866.5370  Cohn fraction V immuno logical test system.

    (a) Identification. A Cohn fraction V immunological test system is a 
device that consists of or measures that fraction of plasma containing 
predominantly albumin (a plasma protein). This test aids in the 
diagnosis of diseases where albumin levels may be depressed, e.g., 
nephrosis (disease of the kidney), proteinuria (protein in the urine), 
gastroenteropathy (disease of the stomach and small intestine), 
rheumatoid arthritis, and viral hepatitis.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 59 FR 63007, Dec. 7, 1994; 66 
FR 38793, July 25, 2001]



Sec. 866.5380  Free secretory component immuno logical test system.

    (a) Identification. A free secretory component immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques free secretory component (normally a portion 
of the secretory IgA antibody molecule) in body fluids. Measurement of 
free secretory component (protein molecules) aids in the diagnosis or 
repetitive lung infections and other hypogammaglobulinemic conditions 
(low antibody levels).
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59227, Nov. 3, 1998]



Sec. 866.5400  Alpha-globulin immuno logical test system.

    (a) Identification. An alpha-globulin immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the alpha-globulin (a serum protein) in serum and other body 
fluids. Measurement of alpha-globulin may aid in the diagnosis of 
inflammatory lesions, infections, severe burns, and a variety of other 
conditions.

[[Page 381]]

    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.5420  Alpha-1-glycoproteins immunological test system.

    (a) Identification. An alpha-1-glycoproteins immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques alpha-1-glycoproteins (a group of plasma 
proteins found in the alpha-1 group when subjected to electrophoresis) 
in serum and other body fluids. Measurement of specific alpha-1-
glycoproteins may aid in the diagnosis of collagen (connective tissue) 
disorders, tuberculosis, infections, extensive malignancy, and diabetes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.5425  Alpha-2-glycoproteins immunological test system.

    (a) Identification. An alpha-2-glycoproteins immunolgical test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques the alpha-2-glycoproteins (a group of plasma 
proteins found in the alpha-2 group when subjected to electrophoresis) 
in serum and other body fluids. Measurement of alpha-2-glycoproteins 
aids in the diagnosis of some cancers and genetically inherited 
deficiencies of these plasma proteins.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.5430  Beta-2-glycoprotein I immunological test system.

    (a) Identification. A beta-2-glycoprotein I immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques the beta-2-glycoprotein I (a serum protein) in 
serum and other body fluids. Measurement of beta-2-glycoprotein I aids 
in the diagnosis of an inherited deficiency of this serum protein.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.5440  Beta-2-glycoprotein III immunological test system.

    (a) Identification. A beta-2-glycoprotein III immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques the beta-2-glycoprotein III (a serum protein) 
in serum and other body fluids. Measurement of beta-2-glycoprotein III 
aids in the diagnosis of an inherited deficiency of this serum protein 
and a variety of other conditions.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.5460  Haptoglobin immunological test system.

    (a) Identification. A haptoglobin immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the haptoglobin (a protein that binds hemoglobin, the oxygen-
carrying pigment in red blood cells) in serum. Measurement of 
haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in 
which the red blood cells rupture and release hemoglobin) related to the 
formation of hemoglobin-haptoglobin complexes and certain kidney 
diseases.

[[Page 382]]

    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59227, Nov. 3, 1998]



Sec. 866.5470  Hemoglobin immunological test system.

    (a) Indentification. A hemoglobin immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the different types of free hemoglobin (the oxygen-carrying 
pigment in red blood cells) in blood, urine, plasma, or other body 
fluids. Measurements of free hemoglobin aid in the diagnosis of various 
hematologic disorders, such as sickle cell anemia, Fanconi's anemia (a 
rare inherited disease), aplastic anemia (bone marrow does not produce 
enough blood cells), and leukemia (cancer of the blood-forming organs).
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 84 FR 71800, Dec. 30, 2019]



Sec. 866.5490  Hemopexin immunological test system.

    (a) Indentification. A hemopexin immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the hemopexin (a serum protein that binds heme, a component 
of hemoglobin) in serum. Measurement of hemopexin aids in the diagnosis 
of various hematologic disorders, such as hemolytic anemia (anemia due 
to shortened in vivo survival of mature red blood cells and inability of 
the bone marrow to compensate for their decreased life span) and sickle 
cell anemia.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59227, Nov. 3, 1998]



Sec. 866.5500  Hypersensitivity pneumonitis immunological test system.

    (a) Identification. A hypersensitivity pneumonitis immunological 
test system is a device that consists of the reagents used to measure by 
immunochemical techniques the immunoglobulin antibodies in serum which 
react specifically with organic dust derived from fungal or animal 
protein sources. When these antibodies react with such dusts in the 
lung, immune complexes precipitate and trigger an inflammatory reaction 
(hypersensitivity pneumonitis). Measurement of these immunoglobulin G 
antibodies aids in the diagnosis of hypersensitivity pneumonitis and 
other allergic respiratory disorders.
    (b) Classification. Class II (performance standards).



Sec. 866.5510  Immunoglobulins A, G, M, D, and E immunological 
test system.

    (a) Identification. An immunoglobulins A, G, M, D, and E 
immunological test system is a device that consists of the reagents used 
to measure by immunochemical techniques the immunoglobulins A, G, M, D, 
an E (serum antibodies) in serum. Measurement of these immunoglobulins 
aids in the diagnosis of abnormal protein metabolism and the body's lack 
of ability to resist infectious agents.
    (b) Classification. Class II (performance standards).



Sec. 866.5520  Immunoglobulin G (Fab fragment specific)
immunological test system.

    (a) Identification. An immunoglobulin G (Fab fragment specific) 
immunological test system is a device that consists of the reagents used 
to measure by immunochemical techniques the Fab antigen-binding fragment 
resulting from breakdown of immunoglobulin G antibodies in urine, serum, 
and other body fluids. Measurement of Fab fragments of immunoglobulin G 
aids in the diagnosis of lymphoproliferative disorders, such as multiple 
myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia 
(increased immunoglobulin production by the spleen and bone marrow 
cells), and

[[Page 383]]

lymphoma (tumor of the lymphoid tissues).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 
FR 38793, July 25, 2001]



Sec. 866.5530  Immunoglobulin G (Fc fragment specific)
immunological test system.

    (a) Identification. An immunoglobulin G (Fc fragment specific) 
immunological test system is a device that consists of the reagents used 
to measure by immunochemical techniques the Fc (carbohydrate containing) 
fragment of immunoglobulin G (resulting from breakdown of immunoglobulin 
G antibodies) in urine, serum, and other body fluids. Measurement of 
immunoglobulin G Fc fragments aids in the diagnosis of plasma cell 
antibody-forming abnormalities, e.g., gamma heavy chain disease.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 
FR 38793, July 25, 2001]



Sec. 866.5540  Immunoglobulin G (Fd fragment specific) 
immunological test system.

    (a) Identification. An immunoglobulin G (Fd fragment specific) 
immunological test system is a device that consists of the reagents used 
to measure by immunochemical techniques the amino terminal (antigen-
binding) end (Fd fragment) of the heavy chain (a subunit) of the 
immunoglobulin antibody molecule in serum. Measurement of immunoglobulin 
G Fd fragments aids in the diagnosis of plasma antibody-forming cell 
abnormalities.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 59 FR 63007, Dec. 7, 1994; 66 
FR 38793, July 25, 2001]



Sec. 866.5550  Immunoglobulin (light chain specific) immunological
test system.

    (a) Identification. An immunoglobulin (light chain specific) 
immunological test system is a device that consists of the reagents used 
to measure by immunochemical techniques both kappa and lambda types of 
light chain portions of immunoglobulin molecules in serum, other body 
fluids, and tissues. In some disease states, an excess of light chains 
are produced by the antibody-forming cells. These free light chains, 
unassociated with gamma globulin molecules, can be found in a patient's 
body fluids and tissues. Measurement of the various amounts of the 
different types of light chains aids in the diagnosis of multiple 
myeloma (cancer of antibody-forming cells), lymphocytic neoplasms 
(cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased 
production of large immunoglobulins), and connective tissue diseases 
such as rheumatoid arthritis or systemic lupus erythematosus.
    (b) Classification. Class II (performance standards).



Sec. 866.5560  Lactic dehydrogenase immunological test system.

    (a) Identification. A lactic dehydrogenase immunological test system 
is a device that consists of the reagents used to measure by 
immunochemical techniques the activity of the lactic dehydrogenase 
enzyme in serum. Increased levels of lactic dehydrogenase are found in a 
variety of conditions, including megaloblastic anemia (decrease in the 
number of mature red blood cells), myocardial infarction (heart 
disease), and some forms of leukemia (cancer of the blood-forming 
organs). However, the diagnostic usefulness of this device is limited 
because of the many conditions known to cause increased lactic 
dehydrogenase levels.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 384]]

subpart E of part 807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.5570  Lactoferrin immunological test system.

    (a) Identification. A lactoferrin immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the lactoferrin (an iron-binding protein with the ability to 
inhibit the growth of bacteria) in serum, breast milk, other body 
fluids, and tissues. Measurement of lactoferrin may aid in the diagnosis 
of an inherited deficiency of this protein.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]



Sec. 866.5580  Alpha-1-lipoprotein immuno logical test system.

    (a) Identification. An alpha-1-lipoprotein immunological test system 
is a device that consists of the reagents used to measure by 
immunochemical techniques the alpha-1-lipoprotein (high-density 
lipoprotein) in serum and plasma. Measurement of alpha-1-lipoprotein may 
aid in the diagnosis of Tangier disease (a hereditary disorder of fat 
metabolism).
    (b) Classification. Class II (performance standards).



Sec. 866.5590  Lipoprotein X immunolog ical test system.

    (a) Identification. A lipoprotein X immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques lipoprotein X (a high-density lipoprotein) in serum and other 
body fluids. Measurement of lipoprotein X aids in the diagnosis of 
obstructive liver disease.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2313, Jan. 14, 2000]



Sec. 866.5600  Low-density lipoprotein immunological test system.

    (a) Identification. A low-density lipoprotein immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques the low-density lipoprotein in serum and other 
body fluids. Measurement of low-density lipoprotein in serum may aid in 
the diagnosis of disorders of lipid (fat) metabolism and help to 
identify young persons at risk from cardiovascular diseases.
    (b) Classification. Class II (performance standards).



Sec. 866.5620  Alpha-2-macroglobulin immunological test system.

    (a) Identification. An alpha-2-macroglobulin immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques the alpha-2-macroglobulin (a serum protein) in 
plasma. Measurement of alpha-2-macroglobulin may aid in the diagnosis of 
blood-clotting or clot lysis disorders.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 84 FR 71800, Dec. 30, 2019]



Sec. 866.5630  Beta-2-microglobulin immunological test system.

    (a) Identification. A beta-2-microglobulin immunological test system 
is a device that consists of the reagents used to measure by 
immunochemical techniques beta-2-microglobulin (a protein molecule) in 
serum, urine, and other body fluids. Measurement of beta-2-microglobulin 
aids in the diagnosis of active rheumatoid arthritis and kidney disease.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures

[[Page 385]]

in subpart E of part 807 of this chapter subject to the limitations in 
Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 84 FR 71800, Dec. 30, 2019]



Sec. 866.5640  Infectious mononucleosis immunological test system.

    (a) Identification. An infectious mononucleosis immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques heterophile antibodies frequently associated 
with infectious mononucleosis in serum, plasma, and other body fluids. 
Measurements of these antibodies aid in the diagnosis of infectious 
mononucleosis.
    (b) Classification. Class II (performance standards).

[47 FR 50823, Nov. 9, 1982; 47 FR 56846, Dec. 21, 1982]



Sec. 866.5660  Multiple autoantibodies immunological test system.

    (a) Identification. A multiple autoantibodies immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques the autoantibodies (antibodies produced 
against the body's own tissues) in serum and other body fluids. 
Measurement of multiple autoantibodies aids in the diagnosis of 
autoimmune disorders (disease produced when the body's own tissues are 
injured by autoantibodies).
    (b) Classification. Class II (performance standards).



Sec. 866.5665  Aquaporin-4 autoantibody immunological test system.

    (a) Identification. An Aquaporin-4 autoantibody immunological test 
system is a device that consists of reagents used to measure by 
immunochemical techniques autoantibodies in human serum samples that 
react with Aquaporin-4 (AQP4Ab). The measurements aid in the diagnosis 
of neuromyelitis optica (NMO) and neuromyelitis optica spectrum 
disorders (NMOSD) in conjunction with other clinical, laboratory, and 
radiological (e.g., magnetic resonance imaging) findings.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Premarket notification submissions must include the following 
information:
    (i) A detailed device description including:
    (A) A detailed description of all components including all required 
ancillary reagents in the test;
    (B) If applicable, a detailed description of instrumentation and 
equipment, including illustrations or photographs of non-standard 
equipment or manuals;
    (C) If applicable, detailed documentation of the device software, 
including, but not limited to, standalone software applications and 
hardware-based devices that incorporate software;
    (D) A detailed description of appropriate internal and external 
quality controls that are recommended or provided. The description must 
identify those control elements that are incorporated into the specified 
testing procedures;
    (E) Detailed specifications for sample collection, processing, and 
storage;
    (F) A detailed description of methodology and assay procedure;
    (G) A description of how the assay cutoff (the medical decision 
point between positive and negative) was established and validated as 
well as supporting data; and
    (H) Detailed specification of the criteria for test results 
interpretation and reporting.
    (ii) Detailed information demonstrating the performance 
characteristics of the device, including:
    (A) Device precision/reproducibility data generated from within-run, 
between-run, between-day, between-lot, between-site, and total precision 
for multiple nonconsecutive days, as applicable. A well characterized 
panel of patient samples or pools from the indicated population that 
covers the device measuring range must be used.
    (B) Device linearity data generated from samples covering the device 
measuring range, if applicable.
    (C) Information on traceability to a reference material and 
description of value assignment of calibrators and controls, if 
applicable.
    (D) Device analytical sensitivity data, including limit of blank, 
limit of

[[Page 386]]

detection, and limit of quantitation, if applicable.
    (E) Device analytical specificity data, including interference by 
endogenous and exogenous substances, as well as cross-reactivity with 
samples derived from patients with other autoimmune diseases or 
conditions.
    (F) Device instrument carryover data, when applicable.
    (G) Device stability data, including real-time stability under 
various storage times and temperatures.
    (H) Specimen stability data, including stability under various 
storage times, temperatures, freeze-thaw, and transport conditions, 
where appropriate.
    (I) Method comparison data generated by comparison of the results 
obtained with the device to those obtained with a legally marketed 
predicate device with similar indications of use. A well-characterized 
panel of patient samples from the indicated population covering the 
device measuring range must be used.
    (J) Specimen matrix comparison data, if more than one specimen type 
or anticoagulant can be tested with the device. Samples used for 
comparison must be from well-characterized patient samples covering the 
device measuring range.
    (K) Clinical performance must be established by comparing data 
generated by testing samples from the indicated population and the 
differential diagnosis or non-target disease groups with the device to 
the clinical diagnostic standard.
    (1) The diagnosis of NMO and NMOSD must be based on clinical 
findings, laboratory tests (e.g., serological tests), and radiological 
tests (e.g., magnetic resonance imaging).
    (2) The differential diagnosis or non-target disease group must 
include the applicable diseases or conditions, including but not be 
limited to the following: Multiple sclerosis, stroke, Lyme disease, 
shingles, syphilis, human immunodeficiency virus, hepatitis B, 
tuberculosis, Srgen's syndrome, systemic lupus erythematous, systemic 
vasculitis, sarcoidosis, Graves' disease, Hashimoto's disease, Type I 
diabetes, rheumatoid arthritis, Addison's disease, and myasthenia 
gravis.
    (3) Diagnosis of diseases or conditions for the differential or non-
target disease groups must be based on established diagnostic criteria 
and clinical evaluation.
    (4) For all samples, the diagnostic clinical criteria and the 
demographic information must be collected and provided.
    (5) The clinical validation results must demonstrate clinical 
sensitivity and clinical specificity for the test values based on the 
presence or absence of NMO and NMOSD.
    (6) The data must be summarized in tabular format comparing the 
interpretation of results to the disease status.
    (L) Expected/reference values generated by testing an adequate 
number of samples from apparently healthy normal individuals.
    (iii) Identification of risk mitigation elements used by the device, 
including description of all additional procedures, methods, and 
practices incorporated into the directions for use that mitigate risks 
associated with testing.
    (2) The device's 21 CFR 809.10(b) compliant labeling must include 
warnings relevant to the device including:
    (i) A warning statement that reads ``The device is for use by 
laboratory professionals in a clinical laboratory setting''; and
    (ii) A warning statement that reads ``The device is not to be used 
as a stand-alone device but as an adjunct to other clinical information. 
A diagnosis of Neuromyelitis Optica (NMO) and Neuromyelitis Optica 
Spectrum Disorders (NMOSD) should not be made on a single test result. 
The clinical symptoms, results from physical examination, laboratory 
tests (e.g., serological tests), and radiological tests (e.g. Magnetic 
Resonance Imaging), when appropriate, should always be taken into 
account when considering the diagnosis of NMO and NMOSD.''
    (3) The device's 21 CFR 809.10(b) compliant labeling must include a 
detailed description of the protocol and performance studies performed 
in accordance with paragraph (b)(1)(ii) of this section and a summary of 
the results.

[82 FR 50076, Oct. 30, 2017]

[[Page 387]]



Sec. 866.5670  Zinc transporter 8 autoantibody immunological test system.

    (a) Identification. A zinc transporter 8 autoantibody immunological 
test system is a device that consists of reagents used to measure, by 
immunochemical techniques, the autoantibodies in human serum samples 
that react with Zinc Transporter 8 (ZnT8). The measurements aid in the 
diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes) in 
conjunction with other clinical and laboratory findings.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Premarket notification submissions must include the following 
information:
    (i) A detailed description of the device that includes:
    (A) A detailed description of all components in the test system, 
including a description of the assay components in the kit and all 
required ancillary reagents;
    (B) A detailed description of instrumentation and equipment, and 
illustrations or photographs of non-standard equipment or methods if 
applicable;
    (C) Detailed documentation of the device software, including, but 
not limited to, standalone software applications and hardware-based 
devices that incorporate software where applicable;
    (D) A detailed description of appropriate internal and external 
quality controls that are recommended or provided. The description must 
identify those control elements that are incorporated into the 
recommended testing procedures;
    (E) Detailed specifications for sample collection, processing, and 
storage;
    (F) A detailed description of methodology and assay procedure; and
    (G) Detailed specification of the criteria for test results 
interpretation and reporting.
    (ii) Information that demonstrates the performance characteristics 
of the device, including:
    (A) Device precision/reproducibility data generated from within-run, 
between-run, between-day, between-lot, between-operator, between-
instruments, between-site, and total precision for multiple 
nonconsecutive days as applicable. A well characterized panel of patient 
samples or pools from the intended use population that covers the device 
measuring range must be used;
    (B) Device linearity data generated from patient samples covering 
the assay measuring range if applicable;
    (C) Information on traceability to a reference material and 
description of value assignment of calibrators and controls if 
applicable;
    (D) Device analytical sensitivity data, including limit of blank, 
limit of detection and limit of quantitation if applicable;
    (E) Device analytical specificity data, including interference by 
endogenous and exogenous substances, as well as cross-reactivity with 
samples derived from patients with other autoimmune diseases or 
conditions;
    (F) Device instrument carryover data when applicable;
    (G) Device stability data including real-time stability under 
various storage times and temperatures;
    (H) Specimen stability data, including stability under various 
storage times, temperatures, freeze-thaw, and transport conditions where 
appropriate;
    (I) Method comparison data generated by comparison of the results 
obtained with the device to those obtained with a legally marketed 
predicate device with similar indication of use. Patient samples from 
the intended use population covering the device measuring range must be 
used;
    (J) Specimen matrix comparison data if more than one specimen type 
or anticoagulant can be tested with the device. Samples used for 
comparison must be from patient samples covering the device measuring 
range;
    (K) A description of how the assay cut-off (the medical decision 
point between positive and negative) was established and validated as 
well as supporting data;
    (L) Clinical performance must be established by comparing data 
generated by testing samples from the intended use population and the 
differential diagnosis groups with the device to the clinical diagnostic 
standard. The diagnosis of Type 1 diabetes mellitus must

[[Page 388]]

be based on clinical history, physical examination, and laboratory 
tests, such as one or more pancreatic or insulin autoantibody test. 
Because the intended use population for Type 1 diabetes mellitus 
includes subjects less than 18 years old, samples from representative 
numbers of these subjects must be included. Representative numbers of 
samples from all age strata must also be included. The differential 
diagnosis groups must include, but not be limited to the following: Type 
2 diabetes mellitus; metabolic syndrome; latent autoimmune diabetes in 
adults; other autoimmune diseases such as celiac disease (without a 
concomitant diagnosis of Type 1 diabetes mellitus), systemic lupus 
erythematosus, rheumatoid arthritis, and Hashimoto's thyroiditis; 
infection; renal disease; and testicular cancer. Diseases for the 
differential groups must be based on established diagnostic criteria and 
clinical evaluation. For all samples, the diagnostic clinical criteria 
and the demographic information must be collected and provided. The 
clinical validation results must demonstrate clinical sensitivity and 
clinical specificity for the test values based on the presence or 
absence of Type 1 diabetes mellitus. The data must be summarized in 
tabular format comparing the interpretation of results to the disease 
status; and
    (M) Expected/reference values generated by testing an adequate 
number of samples from apparently healthy normal individuals.
    (iii) Identification of risk mitigation elements used by the device, 
including description of all additional procedures, methods, and 
practices incorporated into the directions for use that mitigate risks 
associated with testing.
    (2) Your 21 CFR 809.10(a) compliant label and 21 CFR 809.10(b) 
compliant labeling must include warnings relevant to the assay 
including:
    (i) A warning statement that reads, ``The device is for use by 
laboratory professionals in a clinical laboratory setting'';
    (ii) A warning statement that reads, ``The test is not a stand-alone 
test but an adjunct to other clinical information. A diagnosis of Type 1 
diabetes mellitus should not be made on a single test result. The 
clinical symptoms, results on physical examination, and laboratory tests 
(e.g., serological tests), when appropriate, should always be taken into 
account when considering the diagnosis of Type 1 diabetes mellitus and 
Type 2 diabetes mellitus'';
    (iii) A warning statement that reads, ``Absence of Zinc T8 
autoantibody does not rule out a diagnosis of Type 1 diabetes 
mellitus''; and
    (iv) A warning statement that reads, ``The assay has not been 
demonstrated to be effective for monitoring the stage of disease or its 
response to treatment.''
    (3) Your 21 CFR 809.10(b) compliant labeling must include a 
description of the protocol and performance studies performed in 
accordance with paragraph (b)(1)(ii) of this section and a summary of 
the results.

[82 FR 49103, Oct. 20, 2017]



Sec. 866.5680  Myoglobin immunological test system.

    (a) Identification. A myoglobin immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the myoglobin (an oxygen storage protein found in muscle) in 
serum and other body fluids. Measurement of myoglobin aids in the rapid 
diagnosis of heart or renal disease.
    (b) Classification. Class II (performance standards).



Sec. 866.5700  Whole human plasma or serum immunological test system.

    (a) Identification. A whole human plasma or serum immunological test 
system is a device that consists of reagents used to measure by 
immunochemical techniques the proteins in plasma or serum. Measurements 
of proteins in plasma or serum aid in the diagnosis of any disease 
concerned with abnormal levels of plasma or serum proteins, e.g., 
agammaglobulinemia, allergies, multiple myeloma, rheumatoid vasculitis, 
or hereditary angioneurotic edema.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 389]]

subpart E of part 807 of this chapter subject to the limitations in 
Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 59 FR 63007, Dec. 7, 1994; 66 
FR 38793, July 25, 2001]



Sec. 866.5715  Plasminogen immunological test system.

    (a) Identification. A plasminogen immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the plasminogen (an inactive substance from which plasmin, a 
blood-clotting factor, is formed) in serum, other body fluids, and 
tissues. Measurement of plasminogen levels may aid in the diagnosis of 
fibrinolytic (blood-clotting) disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2313, Jan. 14, 2000]



Sec. 866.5735  Prothrombin immunological test system.

    (a) Identification. A prothrombin immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the prothrombin (clotting factor II) in serum. Measurements 
of the amount of antigenically competent (ability to react with protein 
antibodies) prothrombin aid in the diagnosis of blood-clotting 
disorders.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9. This exemption does not apply to 
multipurpose systems for in vitro coagulation studies classified under 
Sec. 864.5425 of this chapter or prothrombin time tests classified 
under Sec. 864.7750 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2313, Jan. 14, 2000]



Sec. 866.5750  Radioallergosorbent (RAST) immunological test system.

    (a) Identification. A radioallergosorbent immunological test system 
is a device that consists of the reagents used to measure by 
immunochemical techniques the allergen antibodies (antibodies which 
cause an allergic reaction) specific for a given allergen. Measurement 
of specific allergen antibodies may aid in the diagnosis of asthma, 
allergies, and other pulmonary disorders.
    (b) Classification. Class II (special controls). The device, when 
intended to detect any of the allergens included in Table 1 in this 
paragraph, is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec. 866.9.

       Table 1--Class II Exempt Allergens Under Sec. 866.5750--
          Radioallergosorbent (RAST) Immunological Test Systems
------------------------------------------------------------------------
                                                            Source
          Allergen code            Allergen product   (taxonomical name)
------------------------------------------------------------------------
                              Grass Pollens
------------------------------------------------------------------------
g1..............................  Sweet vernal grass  Anthoxanthum
                                                       odoratum.
g3..............................  Cocksfoot grass,    Dactylis
                                   Orchard grass.      glomerata.
g4..............................  Meadow fescue.....  Festuca elatior.
g5..............................  Rye-grass           Lolium perenne.
                                   (perennial rye
                                   grass).
g7..............................  Common reed         Phragmites
                                   (common reed        communis.
                                   grass).
g8..............................  Meadow grass,       Poa pratensis.
                                   Kentucky blue
                                   (June grass).
g9..............................  Redtop, Bentgrass.  Agrostis
                                                       stolonifera,
                                                       Agrostis gigantea
                                                       (Agrostis alba).
g11.............................  Brome grass.......  Bromus inermis.
g12.............................  Cultivated rye      Secale cereale.
                                   (cultivated rye
                                   grass).
g13.............................  Velvet grass......  Holcus lanatus.
g14.............................  Cultivated oat      Avena sativa.
                                   (cultivated oat
                                   grass).
g15.............................  Cultivated wheat    Triticum aestivum
                                   (cultivated wheat   (Triticum spp.).
                                   grass).
g16.............................  Meadow foxtail      Alopecurus
                                   (meadow foxtail     pratensis.
                                   grass).
g17.............................  Bahia grass.......  Paspalum notatum.
g24.............................  Wheat grass,        Agropyron smithii
                                   Western.            (Elymus smithii).
g30.............................  Bluegrass, annual.  Poa annua.
g70.............................  Wild rye grass....  Elymus triticoides
                                                       Elymus
                                                       condensatus.
g71.............................  Canary grass......  Phalaris
                                                       arundinacea.

[[Page 390]]

 
g201............................  Barley, cultivated  Hordeum vulgare.
g202............................  Maize, corn         Zea mays.
                                   (cultivated corn).
g203............................  Salt grass........  Distichlis
                                                       spicata.
g204............................  False oat-grass...  Arrhenatherum
                                                       elatius.
g216............................  Cyn d 1...........  Cynodon dactylon.
g701............................  Phl p 1.0102, Phl   Phleum pratense.
                                   p 5.0101.
g702............................  Phl p 7.0101......  Phleum pratense.
g703............................  Phl p 12.0101.....  Phleum pratense.
------------------------------------------------------------------------
                              Weed Pollens
------------------------------------------------------------------------
w2..............................  Western ragweed...  Ambrosia
                                                       psilostachya.
w4..............................  False ragweed.....  Ambrosia
                                                       acanthicarpa
                                                       (Franseria
                                                       acanthicarpa).
w5..............................  Wormwood..........  Artemisia
                                                       absinthium
                                                       Artemisia annua.
w6..............................  Mugwort...........  Artemisia
                                                       vulgaris.
w7..............................  Marguerite, ox-eye  Chrysanthemum
                                   daisy.              leucanthemum.
w8..............................  Dandelion.........  Taraxacum vulgare,
                                                       Taraxacum
                                                       officinale.
w9..............................  Plantain            Plantago
                                   (English),          lanceolata.
                                   Ribwort.
w10.............................  Goosefoot, lamb's   Chenopodium album.
                                   quarters.
w11.............................  Saltwort            Salsola kali
                                   (prickly),          (Salsola
                                   Russian thistle.    pestifer).
w12.............................  Goldenrod.........  Solidago virgaurea
                                                       (Solidago spp.).
w13.............................  Cocklebur, common.  Xanthium commune.
w14.............................  Common pigweed      Amaranthus
                                   (rough pigweed).    retroflexus.
w15.............................  Scale, Lenscale...  Atriplex
                                                       lentiformis.
w16.............................  Rough marsh elder.  Iva ciliate, Iva
                                                       annua.
w17.............................  Firebush (Kochia).  Kochia scoparia.
w18.............................  Sheep sorrel......  Rumex acetosella.
w19.............................  Wall pellitory....  Parietaria
                                                       officinalis.
w20.............................  Nettle (Common      Urtica dioica.
                                   stinging nettle).
w21.............................  Wall pellitory....  Parietaria
                                                       judaica.
w22.............................  Japanese hop        Humulus japonicas
                                   (careless weed).    (Humulus
                                                       scandens).
w23.............................  Yellow dock,        Rumex crispus.
                                   Yellow dockweed.
w24.............................  Spiny pigweed.....  Amaranthus
                                                       spinosus.
w27.............................  Carnation.........  Dianthus spp.
w28.............................  Rose..............  Rosa rugosa.
w33.............................  Clover............  Trifolium
                                                       pratense.
w35.............................  Mexican tea.......  Chenopodium
                                                       ambrosioides.
w36.............................  Rabbit bush.......  Ambrosia deltoidea
                                                       (Franseria
                                                       deltoides).
w37.............................  Salt bush, annual.  Atriplex wrightii.
w39.............................  Water hemp,         Amaranthus rudis
                                   Western.            (Acnida
                                                       tamariscina).
w41.............................  Burrobrush........  Hymenoclea
                                                       salsola.
w42.............................  Poverty weed......  Baccharis
                                                       neglecta.
w43.............................  Common sagebrush..  Artemisia
                                                       tridentata.
w45.............................  Alfalfa...........  Medicago sativa.
w46.............................  Dog fennel........  Eupatorium
                                                       capillifolium.
w53.............................  Geranium..........  Geranium spp.
w67.............................  Groundsel bush....  Baccharis
                                                       halimifolia.
w69.............................  Iodine bush.......  Allenrolfea
                                                       occidentalis.
w70.............................  Ragweed, slender..  Ambrosia
                                                       confertiflora.
w75.............................  Wing scale          Atriplex
                                   (wingscale).        canescens.
w82.............................  Careless weed.....  Amaranthus
                                                       palmeri,
                                                       Amaranthus
                                                       hybridus.
w90.............................  Japanese hop......  Humulus japonicas
                                                       (Humulus
                                                       scandens).
w203............................  Rape (rape pollen)  Brassica napus.
w204............................  Sunflower.........  Helianthus annuus.
w206............................  Camomile..........  Matricaria
                                                       chamomilla.
w207............................  Lupin.............  Lupinus spp.
w210............................  Sugar-beet........  Beta vulgaris.
w211............................  Par j 2.0101......  Parietaria
                                                       judaica.
w231............................  Art v 1...........  Artemisia vulgaris
                                                       (Mugwort).
w232............................  Sal k 1...........  Salsola kali.
w233............................  Art v 3...........  Artemisa vulgaris
                                                       (LTP, Mugwort).
w234............................  Pla l 1...........  Plantago
                                                       lanceolata.
w235............................  Che a 1.0101......  Chenopodium album.
w236............................  Mer a 1.0101......  Mercurialis annua.
a753............................  Art v 1...........  Artemisia vulgaris
                                                       (Mugwort weed).
------------------------------------------------------------------------
                              Tree Pollens
------------------------------------------------------------------------
t1..............................  Box-elder (Maple).  Acer negundo, Acer
                                                       saccharum.
t2..............................  Gray alder,         Alnus incana.
                                   speckled alder
                                   (alder).

[[Page 391]]

 
t4..............................  Hazel, hazelnut...  Corylus avellana,
                                                       Corylus
                                                       americana.
t5..............................  American beech      Fagus grandifolia
                                   (beech).            (Fagus
                                                       americana).
t6..............................  Mountain juniper,   Juniperus ashei
                                   Mountain cedar.     (Juniperus
                                                       sabinoides).
t8..............................  Elm...............  Ulmus americana.
t9..............................  Olive.............  Olea europaea.
t10.............................  Walnut............  Juglans
                                                       californica,
                                                       Juglans nigra.
t11.............................  Maple leaf          Platanus
                                   sycamore, London    acerifolia.
                                   plane, Plane tree.
t61.............................  Sycamore..........  Platanus
                                                       occidentalis.
t12.............................  Willow............  Salix caprea,
                                                       Salix nigra.
t14.............................  Cottonwood          Populus deltoides.
                                   (Eastern
                                   Cottonwood/Black
                                   Cottonwood).
t15.............................  White ash.........  Fraxinus
                                                       americana.
t16.............................  White pine........  Pinus strobus.
t18.............................  Eucalyptus, gum-    Eucalyptus
                                   tree.               globulus
                                                       (Eucalyptus
                                                       spp.).
t19/t26.........................  Acacia............  Acacia longifolia
                                                       (Acacia spp.).
t20.............................  Mesquite..........  Prosopis
                                                       glandulosa/
                                                       Prosopis
                                                       juliflora.
t21.............................  Melaleuca, cajeput  Melaleuca
                                   tree.               quinquenervia
                                                       (Melaleuca
                                                       leucadendron).
t22.............................  Pecan, hickory....  Carya
                                                       illinoinensis
                                                       (Carya pecan).
t23.............................  Italian/            Cupressus
                                   Mediterranean/      sempervirens.
                                   funeral cypress.
t24.............................  Japanese cypress..  Chamaecyparis
                                                       obtusa
                                                       (Chamaecyparis
                                                       spp.).
t25.............................  Ash...............  Fraxinus
                                                       excelsior.
t27.............................  Maple, red........  Acer rubrum.
t29.............................  Acacia............  Acacia spp.
t30.............................  Birch, white......  Betula
                                                       populifolia.
t32.............................  Willow, black.....  Salix nigra.
t33.............................  Ash, Arizona......  Fraxinus velutina.
t35.............................  Cedar, salt.......  Tamarix gallica.
t37.............................  Bald cypress        Taxodium
                                   (white bald         distichum.
                                   cypress).
t38.............................  Elm, Chinese/       Ulmus pumila.
                                   Siberian.
t40.............................  Hazelnut tree.....  Corylus americana.
t41.............................  White hickory.....  Carya alba (Carya
                                                       tomentosa).
t42.............................  Oak, red..........  Quercus rubra.
t43.............................  Loblolly pine.....  Pinus taeda.
t44.............................  Hackberry.........  Celtis
                                                       occidentalis.
t45.............................  Cedar elm.........  Ulmus crassifolia.
t47.............................  Juniper, one seed.  Juniperus
                                                       monosperma.
t48.............................  Pine, lodgepole...  Pinus contorta.
t49.............................  Pine, ponderosa...  Pinus ponderosa.
t50.............................  Beech, European...  Fagus sylvatica.
t51.............................  Tree of Heaven....  Ailanthus
                                                       altissima.
t52.............................  Western white pine  Pinus monticola.
t54.............................  Russian olive.....  Elaeagnus
                                                       angustifolia.
t55.............................  Scotch broom......  Cytisus scoparius.
t56.............................  Bayberry..........  Myrica cerifera.
t57.............................  Red cedar.........  Juniperus
                                                       virginiana.
t60.............................  Western juniper...  Juniperus
                                                       occidentalis.
t61.............................  Sycamore..........  Platanus
                                                       occidentalis.
t70.............................  Mulberry (white     Morus alba.
                                   mulberry).
t71.............................  Red mulberry......  Morus rubra.
t72.............................  Queen palm........  Arecastrum
                                                       romanzoffiamon.
t73.............................  Australian pine...  Casuarina
                                                       equisetifolia.
t77.............................  Oak mix (red,       Quercus spp.
                                   white, black).
t80.............................  Japanese cypress..  Chamaecyparis
                                                       obtusa.
t81.............................  Japanese alder....  Alnus japonica.
t83.............................  Mango tree........  Mangifera indica.
t90.............................  Walnut, black.....  Juglans nigra.
t96.............................  Poplar, white       Populus alba.
                                   (poplar).
t103/t218.......................  Virginia live oak   Quercus
                                   (live oak).         virginiana.
t105............................  Pepper tree.......  Schinus molle.
t110............................  Orange tree.......  Citrus sinensis.
t201............................  Spruce, Norway      Picea abies (Picea
                                   spruce.             excelsa).
t202............................  Alder, smooth.....  Alnus incana spp.
                                                       Rugosa (Alnus
                                                       rugosa).
t203............................  Horse chestnut....  Aesculus
                                                       hippocastanum.
t205............................  Elder.............  Sambucus nigra.
t206............................  Chestnut..........  Castanea sativa.
t207............................  Douglas fir.......  Pseudotsuga
                                                       menziesii
                                                       (Pseudotsuga
                                                       taxifolia).
t208............................  Linden............  Tilia cordata.
t209............................  Horn beam.........  Carpinus betulus.
t210............................  Privet............  Ligustrum vulgare.
t211............................  Sweet gum.........  Liquidambar
                                                       styraciflua.
t212............................  Cedar.............  Libocedrus
                                                       decurrens.

[[Page 392]]

 
t213............................  Pine..............  Pinus radiata.
t214............................  Date palm.........  Phoenix
                                                       canariensis.
t215............................  Lilac.............  Syringa vulgaris.
t217............................  Pepper tree.......  Schinus molle.
t217............................  Red alder.........  Alnus rubra.
t218............................  Virginia live oak.  Quercus
                                                       virginiana.
t218............................  Bayberry (bayberry/ Myrica gale.
                                   sweet gale).
t219............................  Palo verde........  Cercidium
                                                       floridum.
t219............................  Red cedar.........  Juniperus
                                                       virginiana.
t220............................  Bet v 4...........  Betula verrucosa
                                                       (Birch).
t221............................  Bet v 2.0101, Bet   Betula verrucosa
                                   v 4.                (Birch).
t222............................  Cypress (Arizona    Cupressus
                                   cypress).           arizonica.
t223............................  Oil palm..........  Elaeis guineensis.
t224............................  Ole e 1...........  Olea europaea.
t225............................  Bet v 6...........  Betula verrucosa
                                                       (Birch).
t226............................  Cup a 1...........  Cupressus
                                                       arizonica.
t227............................  Ole e 7...........  Olea Europaea.
t228............................  Aspen, quaking....  Populus
                                                       tremuloides.
t229............................  Eastern hemlock...  Tsuga canadensis.
t230............................  Redwood (sequoia).  Sequoia
                                                       sempervirens.
t232............................  Pussy willow......  Salix discolor.
t240............................  Ole e 9.0101......  Olea Europaea.
t241............................  Pla a 1.0101......  Platanus
                                                       acerifolia.
t242............................  Pla a 2...........  Platanus
                                                       acerifolia.
t243............................  Pla a 3.0101......  Platanus
                                                       acerifolia.
t244............................  Cor a 1.0103......  Corylus avellana.
t245............................  Aln g 1.0101......  Alnus glutinosa.
t246............................  Cry j 1...........  Cryptomeria
                                                       japonica.
t280............................  Locust tree.......  Robinia
                                                       pseudoacacia.
t401............................  Brazilian           Schinus
                                   peppertree.         terebinthifolius.
t402............................  Mastic tree.......  Pistacia
                                                       lentiscus.
t404............................  Tree of heaven....  Ailanthus
                                                       altissima.
t406............................  Date palm.........  Phoenix
                                                       dactylifera.
a482............................  Ole e 1...........  Olea europaea
                                                       (Olive Oil).
------------------------------------------------------------------------
                                  Mites
------------------------------------------------------------------------
d207............................  Blo t 5.0101......  Blomia tropicalis.
d208............................  Lep d 2.0101......  Lepidoglyphus
                                                       destructor.
------------------------------------------------------------------------
                      Microorganisms, Molds, Yeast
------------------------------------------------------------------------
m1..............................  Penicillium         Penicillium
                                   chrysogenum         chrysogenum
                                   (Penicillium        (Penicillium
                                   notatum).           notatum).
m2..............................  Cladosporium        Cladosporium
                                   herbarum            herbarum
                                   (Hormodendrum).     (Hormodendrum).
m3..............................  Aspergillus         Aspergillus
                                   fumigatus.          fumigatus.
m4..............................  Mucor racemosus...  Mucor racemosus.
m5..............................  Candida albicans..  Candida albicans.
m7..............................  Botrytis cinerea..  Botrytis cinerea.
m8..............................  Drechslera halodes  Drechslera halodes
                                   (Setomelanomma      (Setomelanomma
                                   rostrata,           rostrata,
                                   Helminthosporium    Helminthosporium
                                   halodes,            halodes.
                                   Helminthosporium
                                   interseminatum).
m9..............................  Fusarium            Fusarium
                                   moniliforme         moniliforme
                                   (Fusarium           (Fusarium
                                   proliferatum).      proliferatum).
m10.............................  Stemphylium         Stemphylium
                                   botryosum.          herbarum
                                                       (Stemphylium
                                                       botryosum).
m11.............................  Rhizopus nigricans  Rhizopus
                                                       nigricans.
m12.............................  Aureobasidium       Aureobasidium
                                   pullulans.          pullulans.
m13.............................  Phoma betae.......  Phoma betae.
m14.............................  Epicoccum           Epicoccum
                                   purpurascens.       purpurascens
                                                       (Epicoccum
                                                       nigrum).
m15.............................  Trichoderma viride  Trichoderma
                                                       viride.
m16.............................  Curvularia lunata.  Curvularia lunata,
                                                       Curvularia
                                                       specifera
                                                       (K923044).
m17.............................  Cladosporium        Cladosporium
                                   fulvum.             fulvum.
m18.............................  Fusarium culmorum.  Fusarium culmorum.
m19.............................  Aspergillus         Aspergillus
                                   versicolor.         versicolor.
m20.............................  Mucor mucedo......  Mucor mucedo.
m21.............................  Aspergillus         Aspergillus
                                   clavatus.           clavatus.
m22.............................  Micropolyspora      Saccharopolyspora
                                   faeni.              rectivirgula
                                                       (Micropolyspora
                                                       faeni).
m23.............................  Thermoactinomyces   Thermoactinomyces
                                   vulgaris.           vulgaris.
m24.............................  Stachybotrys atra.  Stachybotrys
                                                       chartarum
                                                       (Stachybotrys
                                                       atra).
m24.............................  Paecilomyces spp..  Paecilomyces spp.
m25.............................  Aspergillus         Aspergillus
                                   versicolor.         versicolor.

[[Page 393]]

 
m25.............................  Penicillium         Penicillium
                                   brevicompactum.     brevicompactum.
m26.............................  Cladosporium        Cladosporium
                                   cladosporioides.    cladosporioides.
m26.............................  Penicillium         Penicillium
                                   citrinum.           citrinum.
m27.............................  Penicillium spp...  Penicillium spp.
m29.............................  Aspergillus repens  Aspergillus
                                                       repens.
m30.............................  Penicillium         Penicillium
                                   roqueforti.         roqueforti.
m32.............................  Cladosporium        Cladosporium
                                   cladosporioides.    cladosporioides.
m34.............................  Serpula lacrymans.  Serpula lacrymans.
m36.............................  Aspergillus         Aspergillus
                                   terreus.            terreus.
m37.............................  Trichophyton        Trichophyton
                                   mentagrophytes.     mentagrophytes.
m40.............................  Aspergillus         Aspergillus
                                   amstelodami.        amstelodami.
m43.............................  Saccharomyces       Saccharomyces
                                   Carlsberg.          carlsbergensis.
m44.............................  Saccharomyces       Saccharomyces
                                   cerevisiae.         cerevisiae.
m45.............................  Hormodendrum        Hormodendrum
                                   hordei.             hordei.
m46.............................  Bipolaris           Bipolaris
                                   spicifera.          spicifera.
m47.............................  Aspergillus         Aspergillus
                                   nidulans.           nidulans.
m48.............................  Aspergillus oryzae  Aspergillus
                                                       oryzae.
m49.............................  Fusarium oxysporum  Fusarium
                                                       oxysporum.
m50.............................  Micropolyspora      Saccharopolyspora
                                   faeni.              rectivirgula
                                                       (Micropolyspora
                                                       faeni).
m51.............................  Thermoactinomyces   Thermoactinomyces
                                   vulgaris.           vulgaris.
m53.............................  Microspora canis..  Microsporum canis
                                                       (Microspora
                                                       canis).
m54.............................  Aspergillus flavus  Aspergillus
                                                       flavus.
m63.............................  Helminthosporium    Helminthosporium
                                   intersemin.         intersemin.
m66.............................  Mucor plumbeus....  Mucor plumbeus.
m67.............................  Mycogone..........  Mycogone
                                                       perniciosa.
m68.............................  Nigrospora oryzae.  Nigrospora oryzae.
m69.............................  Rhodotorula.......  Rhodotorula rubra
                                                       (Rhodotorula
                                                       mucilaginosa).
m70.............................  Malassezia furfur   Malassezia furfur
                                   (Pityrosporum       (Pityrosporum
                                   orbiculare).        orbiculare).
m71.............................  Spondylocladium...  Spondylocladium
                                                       spp.
m72.............................  Epidermophyton....  Epidermophyton
                                                       floccosum.
m73.............................  Epicoccum nigrum..  Epicoccum
                                                       purpurascens
                                                       (Epicoccum
                                                       nigrum).
m80.............................  Staphylococcal      Staphylococcus
                                   enterotoxin A       aureus.
                                   (Sta a SEA).
m80.............................  Helminthosporium    Helminthosporium
                                   spp.                spp.
m81.............................  Staphylococcal      Staphylococcus
                                   enterotoxin B       aureus.
                                   (Sta a SEB).
m88.............................  Stemphylium solani  Stemphylium
                                                       solani.
m93.............................  Gliocladium         Gliocladium
                                   fimbriatum.         fimbriatum.
m94.............................  Phycomyces          Phycomyces
                                   blakesleeanus.      blakesleeanus.
m201............................  Tilletia tritici    Tilletia tritici
                                   (Ustilago nuda,     (Ustilago nuda,
                                   Ustilago tritici)   Ustilago
                                   (Barley smut).      tritici).
m202............................  Acremonium          Acremonium
                                   kiliense            kiliense
                                   (Cephalosporium     (Cephalosporium
                                   acremonium).        acremonium).
m203............................  Trichosporon        Trichosporon
                                   pullulans.          pullulans.
m204............................  Ulocladium          Ulocladium
                                   chartarum.          chartarum.
m205............................  Trichophyton        Trichophyton
                                   rubrum.             rubrum.
m207............................  Aspergillus niger.  Aspergillus niger.
m208............................  Chaetomium          Chaetomium
                                   globosum.           globosum.
m209............................  Penicillium         Penicillium
                                   frequentans.        glabrum
                                                       (Penicillium
                                                       frequentans).
m209............................  Stachybotrys        Stachybotrys
                                   chartarum.          chartarum
                                                       (Stachybotrys
                                                       atra).
m210............................  Trichophyton        Trichophyton
                                   mentagrophytes      mentagrophytes
                                   var. goetzii.       var. goetzii.
m211............................  Trichophyton        Trichophyton
                                   mentagrophytes      mentagrophytes
                                   var.                var.
                                   interdigitale.      interdigitale.
m211............................  Oat smut..........  Ustilago avenae.
m212............................  Micropolyspora      Saccharopolyspora
                                   faeni.              rectivirgula
                                                       (Micropolyspora
                                                       faeni).
m212............................  Geotrichum          Geotrichum
                                   candidum.           candidum.
m213............................  Bermuda grass smut  Ustilago
                                                       cynodontis.
m214............................  Johnson grass smut  Sphacelotheca
                                                       cruenta.
m215............................  Corn smut.........  Ustilago maydis.
m218............................  Asp f 1.0101......  Aspergillus
                                                       fumigatus.
a3050...........................  Asp r 1...........  Aspergillus
                                                       restrictus.
m219............................  Asp f 2...........  Aspergillus
                                                       fumigatus.
m220............................  Asp f 3.0101......  Aspergillus
                                                       fumigatus.
m221............................  Asp f 4...........  Aspergillus
                                                       fumigatus.
m222............................  Asp f 6.0101......  Aspergillus
                                                       fumigatus.
m223............................  Staphylococcal      Staphylococcus
                                   enterotoxin C       aureus.
                                   (Sta a SEC).
m224............................  Staphylococcal      Staphylococcus
                                   enterotoxin D       aureus.
                                   (Sta a SED).
m226............................  Staphylococcal      Staphylococcus
                                   enterotoxin TSST    aureus.
                                   (Sta a TSST).
m227............................  Malassezia spp.     Malassezia spp.
                                   (Pityrosporum       (Pityrosporum
                                   spp.).              spp.).
m228............................  Aspergillus
                                   flavus..
m229............................  Alt a 1.0101......  Alternaria
                                                       alternata
                                                       (Alternaria
                                                       tenuis).
m230............................  Alt a 6.0101......  Alternaria
                                                       alternata
                                                       (Alternaria
                                                       tenuis).

[[Page 394]]

 
m231............................  Cla h 8.0101......  Cladosporium
                                                       herbarum
                                                       (Hormodendrum).
m300............................  Eurotium spp......  Eurotium spp.
m304............................  Aspergillus oryzae  Aspergillus
                                                       oryzae.
m305............................  Penicillium         Penicillium
                                   brevicompactum.     brevicompactum.
m309............................  Aspergillus         Aspergillus
                                   terreus.            terreus.
m310............................  Aspergillus         Aspergillus
                                   nidulans.           nidulans.
m311............................  Aspergillus flavus  Aspergillus
                                                       flavus.
m312............................  Aspergillus         Aspergillus
                                   clavatus.           clavatus.
------------------------------------------------------------------------
                           Epidermal & Animal
------------------------------------------------------------------------
e6..............................  Guinea pig          Cavia porcellus.
                                   epithelium.
e7..............................  Pigeon droppings..  Columba palumbus,
                                                       Columba livia.
e25.............................  Chicken serum.....  Gallus domesticus
                                                       (Gallus gallus
                                                       domesticus;
                                                       Gallus spp.).
e26.............................  Parrot serum......  Psittacoidea spp.
e62.............................  Camel.............  Camelus
                                                       dromedaries.
e70.............................  Goose feathers....  Anser anser.
e71.............................  Mouse epithelium..  Mus musculus (Mus
                                                       spp.).
e73.............................  Rat epithelium....  Rattus norvegicus.
e74.............................  Rat urine proteins  Rattus norvegicus,
                                                       Rattus rattus.
e75.............................  Rat serum proteins  Rattus norvegicus,
                                                       Rattus rattus.
e76.............................  Mouse serum         Mus musculus (Mus
                                   proteins.           spp.).
e77.............................  Budgerigar          Melopsittacus
                                   droppings.          undulatus.
e78.............................  Budgerigar          Melopsittacus
                                   feathers.           undulatus.
e79.............................  Budgerigar serum    Melopsittacus
                                   proteins.           undulatus.
e80.............................  Goat epithelium...  Capra hircus.
e81.............................  Sheep epithelium..  Ovis aries (Ovis
                                                       spp.).
e82.............................  Rabbit epithelium.  Oryctolagus
                                                       cuniculus
                                                       (Oryctolagus
                                                       spp.).
e83.............................  Swine epithelium..  Sus scrofa (Sus
                                                       scrofa
                                                       domesticus; Sus
                                                       spp.).
e84.............................  Hamster epithelium  Cricetus cricetus,
                                                       Mesocricetus
                                                       auratus, and
                                                       Phodopus
                                                       sungorus.
e85.............................  Chicken feathers..  Gallus domesticus
                                                       (Gallus gallus
                                                       domesticus;
                                                       Gallus spp.).
e86.............................  Duck feathers.....  Anas
                                                       platyrhynchos.
e87.............................  Rat epithelium,     Rattus norvegicus
                                   serum proteins,     Rattus rattus.
                                   and urine
                                   proteins.
e88.............................  Mouse epithelium,   Mus musculus (Mus
                                   serum proteins,     spp.).
                                   and urine
                                   proteins (mouse).
e89.............................  Turkey feathers...  Meleagris
                                                       gallopavo.
e90.............................  Budgerigar serum    Melopsittacus
                                   proteins,           undulatus.
                                   feathers, and
                                   droppings.
e91.............................  Pigeon serum        Streptopelia
                                   proteins,           roseogrisea,
                                   feathers, and       Psittacidae spp.
                                   droppings.
e92.............................  Parrot serum        Ara spp.
                                   proteins,
                                   feathers, and
                                   droppings.
e93.............................  Pigeon serum        Streptopelia
                                   proteins.           roseogrisea.
e94.............................  Fel d 1.0101......  Felis domesticus.
a345............................  Fel d 1...........  Felis domesticus.
e98.............................  Parrot droppings..  Psittacoidea spp.
e101............................  Can f 1.0101......  Canis familiaris
                                                       (Canis
                                                       domesticus).
a174............................  Can f 1...........  Canis familiaris
                                                       (Canis
                                                       domesticus).
e102............................  Can f 2.0101......  Canis familiaris
                                                       (Canis
                                                       domesticus).
e196............................  Parakeet feathers.  Nymphicus
                                                       hollandicus.
e197............................  Parakeet droppings  Nymphicus
                                                       hollandicus.
e198............................  Parakeet serum....  Nymphicus
                                                       hollandicus.
e199............................  Canary bird serum.  Serinus canarius.
e200............................  Canary bird         Serinus canarius.
                                   droppings.
e201............................  Canary bird         Serinus canarius.
                                   feathers (Canary
                                   feathers).
e202............................  Reindeer            Rangifer tarandus.
                                   epithelium.
e203............................  Mink epithelium...  Mustela spp.
e204............................  Bos d 6...........  Bos domesticus
                                                       (Bos taurus; Bos
                                                       spp.).
e205............................  Horse, serum        Equus caballus
                                   proteins.           (Equus spp.).
e206............................  Rabbit, serum       Oryctolagus
                                   proteins.           cuniculus
                                                       (Oryctolagus
                                                       spp.).
e208............................  Chinchilla          Chinchilla
                                   epithelium.         laniger.
e209............................  Gerbil epithelium.  Meriones
                                                       unguiculatus.
e210............................  Fox epithelium....  Vulpes vulpes.
e211............................  Rabbit, urine       Oryctolagus
                                   proteins.           cuniculus
                                                       (Oryctolagus
                                                       spp.).
e212............................  Swine, urine        Sus scrofa (Sus
                                   proteins.           scrofa
                                                       domesticus; Sus
                                                       spp.).
e213............................  Parrot feathers...  Ara spp.
e214............................  Finch feathers....  Lonchura
                                                       domestica.
e215............................  Pigeon feathers...  Streptopelia
                                                       roseogrisea
                                                       (Streptopelia
                                                       spp.), Columbia
                                                       spp.
e216............................  Deer epithelium...  Dama dama.

[[Page 395]]

 
e217............................  Ferret epithelium.  Mustela putorius.
e218............................  Chicken droppings.  Gallus domesticus
                                                       (Gallus gallus
                                                       domesticus;
                                                       Gallus spp.).
e219............................  Chicken, serum      Gallus domesticus
                                   proteins.           (Gallus gallus
                                                       domesticus;
                                                       Gallus spp.).
e220............................  Fel d 2, Cat serum  Felis domesticus.
                                   albumin.
e221............................  Can f 3...........  Canis familiaris
                                                       (Canis
                                                       domesticus) (Dog
                                                       serum albumin).
e222............................  Swine serum         Sus scrofa (Sus
                                   albumin (Sus s      scrofa
                                   PSA).               domesticus; Sus
                                                       spp.).
e225............................  Lovebird feathers.  Psittacoidea
                                                       agapomis.
e226............................  Can f 5.0101......  Canis familiaris.
e227............................  Equ c 1.0101......  Equus caballus.
e228............................  Fel d 4.0101......  Felis domesticus.
e230............................  Equ c 3...........  Equus caballus.
e231............................  Mus m 1...........  Mus musculus.
------------------------------------------------------------------------
                                  Food
------------------------------------------------------------------------
f9..............................  Rice..............  Oryza sativa.
f12.............................  Pea (green pea)...  Pisum sativum.
f15.............................  White bean........  Phaseolus
                                                       vulgaris.
f19.............................  Cayenne pepper....  Capsicum
                                                       frutescens
                                                       (Capsicum annum).
f21.............................  Sugar cane........  Saccharum
                                                       officinarum.
f22.............................  Raspberry.........  Rubus idaeus.
f26.............................  Pork..............  Sus scrofa (Sus
                                                       scrofa
                                                       domesticus; Sus
                                                       spp.).
f29.............................  Watermelon........  Citrullus lanatus
                                                       (Citrullus
                                                       vulgaris).
f31.............................  Carrot............  Daucus carota.
f32.............................  Oyster mushroom...  Pleurotus
                                                       ostreatus.
f33.............................  Orange............  Citrus sinensis.
f35.............................  Potato............  Solanum tuberosum.
f43.............................  Mother's milk.....  Homo sapiens.
f44.............................  Strawberry........  Fragaria vesca
                                                       (Fragaria spp.).
f45.............................  Yeast, baker's....  Saccharomyces
                                                       cerevisiae.
f46.............................  Pepper, Red.......  Capsicum annuum.
f47.............................  Garlic............  Allium sativum.
f48.............................  Onion.............  Allium cepa.
f49.............................  Apple.............  Malus x domestica
                                                       (Malus spp.).
f51.............................  Bamboo shoot......  Phyllostachys
                                                       pubescens.
f52.............................  Cacao/chocolate...  Theobroma cacao.
f54.............................  Sweet potato......  Ipomoea batatas.
f55.............................  Common millet.....  Panicum miliaceum.
f56.............................  Foxtail millet....  Setaria italica.
f57.............................  Japanese millet...  Echinochloa crus-
                                                       galli.
f58.............................  Pacific squid.....  Todarodes
                                                       pacificus.
f59.............................  Octopus...........  Octopus vulgaris
                                                       (Octopus spp.).
f63.............................  Kefir.............  NA.
f67.............................  Parmesan cheese...  NA.
f81.............................  Cheese, cheddar     NA.
                                   type.
f82.............................  Cheese, mold type.  NA.
f83.............................  Chicken...........  Gallus domesticus
                                                       (Gallus gallus
                                                       domesticus;
                                                       Gallus spp.).
f86.............................  Parsley...........  Petroselinum
                                                       crispum.
f87.............................  Melon.............  Cucumis melo
                                                       Cucumis melo +
                                                       Citrullus
                                                       lanatus.
f88.............................  Mutton (lamb).....  Ovis aries (Ovis
                                                       spp.).
f90.............................  Malt..............  Hordeum vulgare.
f92.............................  Banana............  Musa spp.
f93.............................  Cacao.............  Theobroma cacao.
f94.............................  Pear..............  Pyrus communis
                                                       (Pyrus spp.).
f97.............................  Yam...............  Dioscorea spp.
                                                       Dioscorea
                                                       opposita.
f97.............................  Chamomile tea.....  Matricaria
                                                       chamomilla.
f98.............................  Gliadin...........  Triticum aestivum
                                                       (Triticum spp.).
f102............................  Cantaloupe........  Cucumis melo var.
                                                       cantalupensis.
f105............................  Chocolate.........  Theobroma cacao.
f109............................  Cottonseed........  Gossypium
                                                       hirsutum.
f110............................  Giant radish......  Raphanus sativus.
f118............................  Zucchini..........  Cucurbita pepo.
f119............................  Radish............  Raphanus sativus.
f120............................  Venison...........  Capreolus
                                                       capeolus.
f121............................  Pinto bean........  Phaseolus
                                                       vulgaris.
f122............................  Cheese, American..  NA.

[[Page 396]]

 
f127............................  Black-eyed pea....  Vigna unguiculata.
f131............................  Black Olive.......  Olea europaea.
f136............................  Red beet..........  Beta vulgaris var.
                                                       conditiva.
f139............................  Goat's Cheese.....  Capra aegagrus.
f140............................  Bran..............  NA.
f141............................  Corn (vegetables).  Zea mays.
f152............................  Green bell pepper.  Capsicum annuum.
f155............................  Brewer's yeast....  Saccharomyces
                                                       carlsbergensis.
f157............................  Duck..............  Anas domesticus.
f158............................  Goose.............  Anser anser.
f160............................  Camembert cheese..  NA.
f162............................  Nectarine.........  Prunus persica
                                                       var. nucipersica.
f163............................  Kohlrabi..........  Brassica oleracea
                                                       var. gongylodes.
f65.............................  Perch.............
f166............................  Leek..............  Allium porrum.
f170............................  Cheese              NA.
                                   (Switzerland)
                                   (Swiss cheese).
f174............................  Fig...............  Ficus carica.
f177............................  Cranberry.........  Vaccinium
                                                       macrocarpon.
f179............................  Raisin............  Vitis spp.
f182............................  Lima bean.........  Phaseolus lunatus.
f198............................  Flaxseed (bruised   Linum
                                   grain).             usitatissimum.
f199............................  Untreated native    Bos domesticus
                                   milk.               (Bos taurus; Bos
                                                       spp.).
f208............................  Lemon.............  Citrus limon.
f209............................  Grapefruit........  Citrus paradisi.
f210............................  Pineapple.........  Ananas comosus.
f211............................  Blackberry........  Rubus fruticosus.
f212............................  Mushroom            Agaricus hortensis
                                   (champignon).       (Agaricus spp.).
f213............................  Rabbit............  Oryctolagus
                                                       cuniculus
                                                       (Oryctolagus
                                                       spp.).
f214............................  Spinach...........  Spinacia oleracea.
f215............................  Lettuce...........  Lactuca sativa.
f216............................  Cabbage...........  Brassica oleracea
                                                       var. capitata.
f217............................  Brussels sprouts..  Brassica oleracea
                                                       var. gem.
f218............................  Paprika, sweet      Capsicum annuum.
                                   pepper.
f219............................  Fennel seed.......  Foeniculum
                                                       vulgare.
f219............................  Sage..............  Salvia
                                                       officinalis.
f220............................  Cinnamon..........  Cinnamomum spp.
f221............................  Coffee............  Coffea spp.
f222............................  Tea...............  Camellia sinensis.
f223............................  Green olive.......  Olea europaea.
f225............................  Summer squash,      Cucurbita pepo.
                                   pumpkin.
f225............................  Pumpkin...........  Cucurbita maxima.
f226............................  Pumpkin seed......  Cucurbita pepo.
f227............................  Sugar-beet seed...  Beta vulgaris.
f229............................  Safflower Seed....  Carthamus
                                                       tinctorius.
f231............................  Milk, boiled......  Bos domesticus
                                                       (Bos taurus; Bos
                                                       spp.).
f234............................  Vanilla...........  Vanilla
                                                       planifolia.
f237............................  Apricot...........  Prunus armeniaca.
f241............................  Gouda cheese......  NA.
f242............................  Cherry............  Prunus avium.
f244............................  Cucumber..........  Cucumis sativus.
f246............................  Guar, guar gum....  Cyamopsis
                                                       tetragonoloba.
f247............................  Honey.............  NA.
f248............................  Rosemary..........  Rosmarinus
                                                       officinalis.
f254............................  Plaice............  Pleuronectes
                                                       platessa.
f255............................  Plum..............  Prunus domestica,
                                                       Prunus americana.
f258............................  Squid.............  Loligo spp.
f259............................  Grape.............  Vitis vinifera
                                                       (Vitis spp.).
f260............................  Broccoli..........  Brassica oleracea
                                                       var. italica
                                                       (Brassica
                                                       oleracea var.
                                                       cultivar).
f261............................  Asparagus.........  Asparagus
                                                       officinalis.
f262............................  Aubergine,          Solanum melongena.
                                   eggplant.
f263............................  Green pepper......  Piper nigrum,
                                                       Capsicum annuum.
f264............................  Eel...............  Anguilla anguilla.
f265............................  Caraway...........  Carum carvi.
f265............................  Cumin.............  Cuminum cyminum.
f266............................  Mace..............  Myristica
                                                       fragrans.
f267............................  Cardamon..........  Elettaria
                                                       cardamomum.
f268............................  Clove.............  Syzygium
                                                       aromaticum.
f269............................  Basil.............  Ocimum basilicum.
f270............................  Ginger............  Zingiber
                                                       officinale.

[[Page 397]]

 
f271............................  Anise.............  Pimpinella anisum.
f272............................  Tarragon..........  Artemisia
                                                       dracunculus.
f273............................  Thyme.............  Thymus vulgaris.
f274............................  Marjoram..........  Origanum majorana.
f275............................  Lovage............  Levisticum
                                                       officinale.
f276............................  Fennel, fresh.....  Foeniculum
                                                       vulgare.
f277............................  Dill..............  Anethum
                                                       graveolens.
f278............................  Bay leaf..........  Laurus nobilis.
f279............................  Chili pepper......  Capsicum
                                                       frutescens.
f280............................  Black pepper......  Piper nigrum.
f281............................  Curry (Santa        NA.
                                   Maria).
f282............................  Nutmeg............  Myristica
                                                       fragrans.
f283............................  Oregano...........  Origanum vulgare.
f284............................  Turkey meat.......  Meleagris
                                                       gallopavo.
f285............................  Elk/moose meat....  Alces spp.
f286............................  Mare's milk.......  Equus caballus
                                                       (Equus spp.).
f287............................  Red kidney bean...  Phaseolus
                                                       vulgaris.
f288............................  Blueberry.........  Vaccinium
                                                       myrtillus
                                                       (Vaccinium spp.).
f289............................  Date..............  Phoenix
                                                       dactylifera.
f291............................  Cauliflower.......  Brassica oleracea
                                                       var. botrytis.
f292............................  Guava.............  Psidium guajava.
f293............................  Papaya............  Carica papaya.
f294............................  Passion fruit,      Passiflora edulis
                                   Maracuja.           (Passiflora
                                                       spp.).
f295............................  Carambola.........  Averrhoa
                                                       carambola.
f296............................  Carob.............  Ceratonia siliqua.
f297............................  Gum Arabic........  Acacia senegal
                                                       (Acacia spp.).
f298............................  Tragacanth........  Astragalus spp.
f299............................  Sweet chestnut      Castanea sativa.
                                   (chestnut).
f300............................  Pinto bean........  Phaseolus spp.
f301............................  Persimmon (kaki     Diospyros kaki.
                                   fruit, sharon).
f302............................  Mandarin            Citrus reticulata.
                                   (tangerine,
                                   clementine,
                                   satsumas).
f305............................  Fenugreek.........  Trigonella foenum-
                                                       graecum.
f306............................  Lime..............  Citrus
                                                       aurantifolia.
f307............................  Hake..............  Merluccius
                                                       merluccius.
f308............................  Sardine (pilchard)  Sardina
                                                       pilchardus.
f310............................  Blue vetch........  Lathyrus sativus.
f311............................  Megrim............  Lepidorhombus
                                                       whiffiagonis.
f315............................  Green bean........  Phaseolus
                                                       vulgaris.
f316............................  Rape seed.........  Brassica napus.
f317............................  Coriander.........  Coriandrum
                                                       sativum.
f318............................  Jack fruit........  Artocarpus
                                                       heterophyllus.
f319............................  Beetroot..........  Beta vulgaris.
f320............................  Crayfish..........  Astacus astacus.
f321............................  Horse meat........  Equus caballus
                                                       (Equus spp.).
f322............................  Red currant.......  Ribes sylvestre.
f324............................  Hop (fruit cone)..  Humulus lupulus.
f325............................  Saffron...........  Colchicum
                                                       autumnale.
f328............................  Fig...............  Ficus carica.
f329............................  Watermelon........  Citrullus lanatus.
f330............................  Rose hip..........  Rosa spp.
f331............................  Saffron...........  Crocus sativus.
f332............................  Mint..............  Mentha piperita.
f333............................  Linseed...........  Linum
                                                       usitatissimum.
f336............................  Jujube............  Ziziphus jujuba.
f336............................  Wine vinegar......  Vitis vinifera
                                                       (Vitis spp.).
f337............................  Sole..............  Solea solea.
f337............................  English sole......  Parophrys vetulus.
f338............................  Wine, white.......  Vitis vinifera
                                                       (Vitis spp.).
f339............................  Allspice..........  Pimenta dioica.
f339............................  Wine, red.........  Vitis vinifera
                                                       (Vitis spp.).
f341............................  Cranberry.........  Vaccinium
                                                       oxycoccus,
                                                       Vaccinium
                                                       macrocarpon.
f342............................  Olive (black,       Olea europaea.
                                   fresh).
f343............................  Raspberry.........  Rubus idaeus.
f344............................  Sage..............  Salvia
                                                       officinalis.
f346............................  Chives............  Allium
                                                       schoenoprasum.
f347............................  Quinoa............  Chenopodium
                                                       quinoa.
f348............................  Litchi............  Litchi chinensis.
f349............................  Chum salmon roe...  Oncorhynchus keta.
f358............................  Artichoke.........  Cynara scolymus.
f360............................  Yogurt............  NA.

[[Page 398]]

 
f368............................  Black bass........  Micropterus
                                                       dolomieu
                                                       (Micropterus
                                                       dolomieui).
f374............................  Karaya gum........  Sterculia urens.
f375............................  Horseradish.......  Armoracia
                                                       rusticana.
f377............................  Maple syrup.......  NA.
f379............................  Okra..............  Abelmoschus
                                                       esculentus.
f382............................  Beet, sugar.......  Beta vulgaris var.
                                                       altissima.
f401............................  Loquat............  Eriobotrya
                                                       japonica.
f402............................  Fig...............  Ficus carica.
f403............................  Brewer's yeast....  Saccharomyces
                                                       cerevisiae.
f405............................  Mint..............  Mentha spp.
f406............................  Arugula...........  Eruca vesicaria.
------------------------------------------------------------------------
                               House Dust
------------------------------------------------------------------------
h1..............................  Greer Labs., Inc..  NA.
h2..............................  Hollister-Stier     NA.
                                   Labs.
h6..............................  Japan.............  NA.
------------------------------------------------------------------------
                            Venoms & Insects
------------------------------------------------------------------------
i7..............................  Midge.............  Chironomus
                                                       yoshimatsui.
i8..............................  Moth..............  Bombyx mori,
                                                       Heterocera spp.
i47.............................  Water flea........  Daphnia spp.
i49.............................  Deer fly..........  Chrysops spp.
i51.............................  Black ant.........  Camponotus
                                                       pennsylvanicus.
i54.............................  Flea mix (dog/      Ctenocephalides
                                   cat), common flea.  spp.
i71.............................  Mosquito..........  Aedes communis,
                                                       Aedes spp. and
                                                       Culex spp.
i72.............................  Green nimitti.....  Cladotanytarsus
                                                       lewisi.
i73.............................  Blood worm........  Chironomus thummi,
                                                       Chironomusri
                                                       parius,
                                                       Chironomus spp.
i75.............................  European hornet...  Vespa crabro.
i76.............................  Berlin beetle.....  Trogoderma
                                                       angustum.
i77.............................  European paper      Polistes
                                   wasp.               dominulus.
i78.............................  Fly...............  Musca domestica.
i80.............................  Bumblebee.........  Bombus
                                                       pennsylvanicus.
i201............................  Horse bot fly.....  Gasterophilus
                                                       intestinalis.
i202............................  Grain weevil......  Sitophilus
                                                       granarius.
i203............................  Mediterranean       Ephestia
                                   flour moth.         kuehniella
                                                       (Anagasta
                                                       kuehniella).
i204............................  Horse fly.........  Tabanus spp.
i205............................  Bumblebee.........  Bombus terrestris.
i208............................  Api m 1.0101......  Apis mellifera.
a45.............................  Api m 1...........  Apis mellifera.
i209............................  Ves v 5.0101......  Vespula vulgaris.
a670............................  Ves v 5...........  Vespula vulgaris.
i210............................  Pol d 5.0101......  Polistes
                                                       dominulus.
i211............................  Ves v 1.0101......  Vespula vulgaris.
i213............................  Api m 4...........  Apis mellifera.
i214............................  Api m 2...........  Apis mellifera.
i215............................  Api m 3...........  Apis mellifera.
i216............................  Api m 5...........  Apis mellifera.
i217............................  Api m 10..........  Apis mellifera.
i220............................  Bla g 1.0101......  Blattella
                                                       germanica.
i221............................  Bla g 2.0101......  Blattella
                                                       germanica.
i222............................  Bla g 5.0101......  Blattella
                                                       germanica.
i223............................  Bla g 7...........  Blattella
                                                       germanica.
a46.............................  Api m 2...........  Apis mellifera.
------------------------------------------------------------------------
                              Miscellaneous
------------------------------------------------------------------------
o1..............................  Cotton, crude       Gossypium spp.
                                   fibers.
o3..............................  Cotton (treated)..  Gossypium spp.
o70.............................  Seminal fluid.....  Homo sapiens.
o71.............................  Staphylococcus      Staphylococcus
                                   aureus.             aureus.
o72.............................  Pichia pastoris     Pichia pastoris.
                                   crude extract
                                   customer specific.
o72.............................  Sperm-sediment....  Homo sapiens.
o73.............................  Pichia pastoris     Pichia pastoris.
                                   crude extr.
                                   vector customer
                                   specific.
o74.............................  Pichia pastoris     Pichia pastoris.
                                   with vector
                                   customer specific.
o201............................  Tobacco leaf,       Nicotiana tabacum.
                                   tobacco dust.
o202............................  Artemia salina,     Artemia salina.
                                   fish feed.
o203............................  Tetramin, fish      NA.
                                   feed.

[[Page 399]]

 
o207............................  Daphnia, fish feed  Daphnia spp.
o211............................  Mealworm..........  Tenebrio molitor.
o212............................  Streptavidin......  Streptomyces
                                                       avidini.
o213............................  MBP (maltose        Escherichia coli.
                                   binding protein).
o214............................  CCD; MUXF3 from     Ananas comosus.
                                   bromelain.
o72.............................  Enterotoxin A (Sta  Staphylococcus
                                   a SEA).             aureus.
o73.............................  Enterotoxin B (Sta  Staphylococcus
                                   a SEB).             aureus.
------------------------------------------------------------------------
                                Parasites
------------------------------------------------------------------------
p1..............................  Ascaris...........  Ascaris suum.
p2..............................  Echinococcus......  Echinococcus
                                                       granulosus.
p3..............................  Schistosoma.......  Schistosoma
                                                       mansoni.
p4..............................  Anisakis (Herring   Anisakis simplex
                                   Worm).              (Anisakis spp.).
p5..............................  Toxocara canis....  Toxocara canis.
p10.............................  Ani s 3.0101......  Anisakis simplex
                                                       (Anisakis spp.).
p11.............................  Ani s 1...........  Anisakis simplex
                                                       (Anisakis spp.).
------------------------------------------------------------------------
                              Occupational
------------------------------------------------------------------------
k4..............................  Threshing dust....  NA.
k5..............................  Flax..............  NA.
k7..............................  Hay Dust..........  NA.
k8..............................  Hop (hops)........  Humulus lupulus.
k12.............................  Grain mill dust...  NA.
k14.............................  Kapok.............  NA.
k20.............................  Sheep's wool        Ovis aries (Ovis
                                   (treated) (wool).   spp.).
k21.............................  Sheep's wool        Ovis aries (Ovis
                                   (Untreated).        spp.).
k23.............................  Straw Dust........  NA.
k33.............................  Oak...............  NA.
k70.............................  Green coffee bean.  Coffea spp.
k71.............................  Castor bean.......  Ricinus communis.
k72.............................  Ispaghula.........  Plantago psyllium/
                                                       Plantago ovata.
k73.............................  Silk waste........  NA.
k74.............................  Silk..............  Bombyx mori.
k75.............................  Isocyanate TDI      NA.
                                   (Toluene
                                   diisocyanate).
k76.............................  Isocyanate MDI      NA.
                                   (Diphenylmethane
                                   diisocyanate).
k77.............................  Isocyanate HDI      NA.
                                   (Hexamethylen
                                   diisocyanate).
k78.............................  Ethylene oxide....  NA.
k79.............................  Phthalic anhydride  NA.
k80.............................  Formaldehyde/       NA.
                                   Formalin.
k81.............................  Ficus.............  Ficus benjamina
                                                       (Ficus spp.).
k83.............................  Cotton seed.......  Gossypium
                                                       hirsutum.
k84.............................  Sunflower seed....  Helianthus annuus.
k85.............................  Chloramin T.......  NA.
k86.............................  Trimellitic         NA.
                                   anhydride, TMA.
k87.............................  Asp o 21, alpha-    Aspergillus
                                   amylase.            oryzae.
k89.............................  Orris root........  Iris florentina.
k99.............................  HSA (Human Serum    Homo sapiens.
                                   Albumin) (Hom s
                                   HSA).
k201............................  Car p 1, Papain...  Carica papaya.
k202............................  Ana c 2, Bromelain  Ananas comosus.
k204............................  Maxatase..........  Bacillus
                                                       licheniformis.
k205............................  Alcalase..........  Bacillus spp.
k206............................  Savinase, Protease  Bacillus spp.
                                   1 (Bac l
                                   Subtilisin).
k208............................  Gal d 4, Lysozyme.  Gallus domesticus
                                                       (Gallus gallus
                                                       domesticus;
                                                       Gallus spp.).
k209............................  Hexahydrophtalic    NA.
                                   anhydrid.
k210............................  Maleic anhydride..  NA.
k211............................  Methyltetrahydroph  NA.
                                   talic anhydrid.
k212............................  Abachi wood dust..  Triplochiton
                                                       scleroxylon.
k213............................  Pepsin (Sus s       Sus scrofa (Sus
                                   Pepsin).            scrofa
                                                       domesticus; Sus
                                                       spp.).
k213............................  TCPA..............  NA.
k214............................  Bougainvillea.....  Bougainvillea spp.
k225............................  Horse radish        Armoracia
                                   peroxidase (Arm r   rusticana.
                                   HRP).
k226............................  Ascorbate oxidase   Cucurbita pepo.
                                   (Cuc p ascorbate
                                   oxidase).
k301............................  Flour dust........  Triticum spp.
k501............................  Savinase customer   Proprietary
                                   specific.           knowledge of
                                                       customer.
k502............................  Lipolase customer   Proprietary
                                   specific.           knowledge of
                                                       customer.
k503............................  Termamyl customer   Proprietary
                                   specific.           knowledge of
                                                       customer.
k504............................  Clazinase customer  Proprietary
                                   specific.           knowledge of
                                                       customer.
------------------------------------------------------------------------


[[Page 400]]


[47 FR 50823, Nov. 9, 1982, as amended at 84 FR 71800, Dec. 30, 2019]



Sec. 866.5760  Tryptase test system.

    (a) Identification. A tryptase test system is a device that aids in 
the diagnosis of systemic mastocytosis. It is intended for in vitro 
diagnostic use as an aid in the clinical diagnosis of patients with a 
suspicion of systemic mastocytosis in conjunction with other clinical 
and laboratory findings.
    (b) Classification. Class II (special controls). The special control 
is FDA's guideline entitled ``Class II Special Controls Guideline: 
Tryptase Test System as an Aid in the Diagnosis of Systemic 
Mastocytosis.'' For availability of the document, see Sec. 866.1(e).

[79 FR 56010, Sept. 18, 2014]



Sec. 866.5765  Retinol-binding protein immunological test system.

    (a) Identification. A retinol-binding protein immunological test 
system is a device that consists of the reagents used to measure by 
immunochemical techniques the retinol-binding protein that binds and 
transports vitamin A in serum and urine. Measurement of this protein may 
aid in the diagnosis of kidney disease and in monitoring patients with 
kidney transplants.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2313, Jan. 14, 2000]



Sec. 866.5775  Rheumatoid factor immuno logical test system.

    (a) Identification. A rheumatoid factor immunological test system is 
a device that consists of the reagents used to measure by immunochemical 
techniques the rheumatoid factor (antibodies to immunoglobulins) in 
serum, other body fluids, and tissues. Measurement of rheumatoid factor 
may aid in the diagnosis of rheumatoid arthritis.
    (b) Classification. Class II (performance standards).



Sec. 866.5785  Anti-Saccharomyces cerevisiae (S. cerevisiae)
antibody (ASCA) test systems.

    (a) Identification. The Anti-Saccharomyces cerevisiae (S. 
cerevisiae) antibody (ASCA) test system is an in vitro diagnostic device 
that consists of the reagents used to measure, by immunochemical 
techniques, antibodies to S. cerevisiae (baker's or brewer's yeast) in 
human serum or plasma. Detection of S. cerevisiae antibodies may aid in 
the diagnosis of Crohn's disease.
    (b) Classification. Class II (special controls). The special control 
is FDA's ``Guidance for Industry and FDA Reviewers: Class II Special 
Control Guidance Document for Anti-Saccharomyces cerevisiae (S. 
cerevisiae) Antibody (ASCA) Premarket Notifications.''

[65 FR 70307, Nov. 22, 2000]



Sec. 866.5800  Seminal fluid (sperm) immunological test system.

    (a) Identification. A seminal fluid (sperm) immunological test 
system is a device that consists of the reagents used for legal purposes 
to identify and differentiate animal and human semen. The test results 
may be used as court evidence in alleged instances of rape and other 
sex-related crimes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[54 FR 25047, June 12, 1989, as amended at 66 FR 38793, July 25, 2001]



Sec. 866.5820  Systemic lupus erythema tosus immunological test system.

    (a) Identification. A systemic lupus erythematosus (SLE) 
immunological test system is a device that consists of the reagents used 
to measure by immunochemical techniques the autoimmune antibodies in 
serum and other body fluids that react with cellular nuclear double-
stranded deoxyribonucleic acid (DNA) or other nuclear constituents that 
are specifically diagnostic of SLE. Measurement of nuclear double-

[[Page 401]]

stranded DNA antibodies aids in the diagnosis of SLE (a multisystem 
autoimmune disease in which tissues are attacked by the person's own 
antibodies).
    (b) Classification. Class II (performance standards).



Sec. 866.5830  Brain trauma assessment test.

    (a) Identification. A brain trauma assessment test is a device that 
consists of reagents used to detect and measure brain injury biomarkers 
in human specimens. The measurements aid in the evaluation of patients 
with suspected mild traumatic brain injury in conjunction with other 
clinical information to assist in determining the need for head imaging 
per current standard of care.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The 21 CFR 809.10(b) compliant labeling must include detailed 
descriptions of and results from performance testing conducted to 
evaluate precision, accuracy, linearity, analytical sensitivity, 
interference, and cross-reactivity. This information must include the 
following:
    (i) Performance testing of device precision must, at minimum, use 
one unmodified clinical specimen from the intended use population with 
concentration of the brain injury biomarker(s) near the medical decision 
point. Contrived specimens that have been generated from pooling of 
multiple samples or spiking of purified analyte to cover the measuring 
range may be used, but the contrived samples must be prepared to mimic 
clinical specimens as closely as possible. This testing must evaluate 
repeatability and reproducibility using a protocol from an FDA-
recognized standard.
    (ii) Device performance data must be demonstrated through a clinical 
study and must include the following:
    (A) Data demonstrating clinical validity including the clinical 
sensitivity and specificity, and positive and negative predictive value 
of the test in the intended use population of patients with suspected 
mild traumatic brain injury (i.e., Glasgow Coma Score (GCS) of 13-15), 
or equivalent standard of care for determination of severity of 
traumatic brain injury (TBI).
    (B) Study must be performed using the operators and in settings that 
are representative of the types of operators and settings for which the 
device is intended to be used.
    (C) All eligible subjects must meet the well-defined study inclusion 
and exclusion criteria that define the intended use population. The 
prevalence of diseased or injured subjects in the study population must 
reflect the prevalence of the device's intended use population, or 
alternatively, statistical measures must be used to account for any bias 
due to enrichment of subpopulations of the intended use population.
    (D) All eligible subjects must have undergone a head computerized 
tomography (CT) scan or other appropriate clinical diagnostic standard 
used to determine the presence of an intracranial lesion as part of 
standard of care and must also be evaluated by the subject device. All 
clinical diagnostic standards used in the clinical study must follow 
standard clinical practice in the United States.
    (E) Relevant demographic variables and baseline characteristics 
including medical history and neurological history. In addition, head 
injury characteristics, neurological assessments, and physical evidence 
of trauma must be provided for each subject. This information includes 
but is not limited to the following: Time since head injury, time from 
head injury to CT scan, time from head injury to blood draw, GCS score 
or equivalent, experience of loss of consciousness, presence of 
confusion, episodes of vomiting, post-traumatic amnesia characteristics, 
presence of post-traumatic seizures, drug or alcohol intoxication, 
mechanism of injury, acute intracranial lesion type, neurosurgical 
lesion, and cranial fracture.
    (F) Each CT scan or other imaging result must be independently 
evaluated in a blinded manner by at least two board-certified 
radiologists to determine whether it is positive or negative as defined 
by the presence or absence of acute intracranial lesions. This 
independent review must be conducted

[[Page 402]]

without access to test results of the device. Prior to conducting the 
review, the criteria and procedures to be followed for scoring the 
images must be established, including the mechanism for determining 
consensus.
    (G) All the clinical samples must be tested with the subject device 
blinded to the TBI status and the neurological-lesion-status of the 
subject.
    (H) Details on how missing values in data are handled must be 
provided.
    (I) For banked clinical samples, details on storage conditions and 
storage period must be provided. In addition, a specimen stability study 
must be conducted for the duration of storage to demonstrate integrity 
of archived clinical samples. The samples evaluated in the assay test 
development must not be used to establish the clinical validity of the 
assays.
    (iii) Performance testing of device analytical specificity must 
include the most commonly reported concomitant medications present in 
specimens from the intended use population. Additionally, potential 
cross-reacting endogenous analytes must be evaluated at the highest 
concentration reported in specimens from the intended use population.
    (iv) Expected/reference values generated by testing a statistically 
appropriate number of samples from apparently healthy normal 
individuals.
    (2) The 21 CFR 809.10(a) and (b) compliant labeling must include the 
following limitations:
    (i) A limiting statement that this device is not intended to be used 
a stand-alone device but as an adjunct to other clinical information to 
aid in the evaluation of patients who are being considered for standard 
of care neuroimaging.
    (ii) A limiting statement that reads ``A negative result is 
generally associated with the absence of acute intracranial lesions. An 
appropriate neuroimaging method is required for diagnosis of acute 
intracranial lesions.''
    (iii) As applicable, a limiting statement that reads ``This device 
is for use by laboratory professionals in a clinical laboratory 
setting.''

[83 FR 27701, June 14, 2018]



Sec. 866.5860  Total spinal fluid immuno logical test system.

    (a) Identification. A total spinal fluid immunological test system 
is a device that consists of the reagents used to measure by 
immunochemical techniques the total protein in cerebrospinal fluid. 
Measurement of spinal fluid proteins may aid in the diagnosis of 
multiple sclerosis and other diseases of the nervous system.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 
FR 38793, July 25, 2001]



Sec. 866.5870  Thyroid autoantibody immunological test system.

    (a) Identification. A thyroid autoantibody immunological test system 
is a device that consists of the reagents used to measure by 
immunochemical techniques the thyroid autoantibodies (antibodies 
produced against the body's own tissues). Measurement of thyroid 
autoantibodies may aid in the diagnosis of certain thyroid disorders, 
such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic 
goiter (enlargement of thyroid gland), Grave's disease (enlargement of 
the thyroid gland with protrusion of the eyeballs), and cancer of the 
thyroid.
    (b) Classification. Class II (performance standards).



Sec. 866.5880  Transferrin immunological test system.

    (a) Identification. A transferrin immunological test system is a 
device that consists of the reagents used to measure by immunochemical 
techniques the transferrin (an iron-binding and transporting serum 
protein) in serum, plasma, and other body fluids. Measurement of 
transferrin levels aids in the diagnosis of malnutrition, acute 
inflammation, infection, and red blood cell disorders, such as iron 
deficiency anemia.
    (b) Classification. Class II (performance standards).

[[Page 403]]



Sec. 866.5890  Inter-alpha trypsin inhibitor immunological test system.

    (a) Identification. An inter-alpha trypsin inhibitor immunological 
test system is a device that consists of the reagents used to measure by 
immunochemical techniques the inter-alpha trypsin inhibitor (a protein) 
in serum and other body fluids. Measurement of inter-alpha trypsin 
inhibitor may aid in the diagnosis of acute bacterial infection and 
inflammation.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 53 FR 11253, Apr. 6, 1988; 65 
FR 2313, Jan. 14, 2000]



Sec. 866.5900  Cystic fibrosis transmembrane conductance regulator 
(CFTR) gene mutation detection system.

    (a) Identification. The CFTR gene mutation detection system is a 
device used to simultaneously detect and identify a panel of mutations 
and variants in the CFTR gene. It is intended as an aid in confirmatory 
diagnostic testing of individuals with suspected cystic fibrosis (CF), 
carrier identification, and newborn screening. This device is not 
intended for stand-alone diagnostic purposes, prenatal diagnostic, pre-
implantation, or population screening.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance document entitled ``Class II Special Controls Guidance 
Document: CFTR Gene Mutation Detection System.'' See Sec. 866.1(e) for 
the availability of this guidance document.

[70 FR 61738, Oct. 26, 2005]



Sec. 866.5910  Quality control material for cystic fibrosis nucleic
acid assays.

    (a) Identification. Quality control material for cystic fibrosis 
nucleic acid assays. A quality control material for cystic fibrosis 
nucleic acid assays is a device intended to help monitor reliability of 
a test system by detecting analytical deviations such as those that may 
arise from reagent or instrument variation in genetic testing. This type 
of device includes recombinant, synthetic, and cell line-based DNA 
controls.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9. The 
special control is FDA's guidance document entitled ``Class II Special 
Controls Guidance Document: Quality Control Material for Cystic Fibrosis 
Nucleic Acid Assays.'' See Sec. 866.1(e) for the availability of this 
guidance document.

[72 FR 1176, Jan. 10, 2007, as amended at 84 FR 71811, Dec. 30, 2019]



Sec. 866.5930  Newborn screening test for severe combined
immunodeficiency disorder (SCID).

    (a) Identification. A newborn screening test for SCID is a 
prescription device intended to measure T-cell receptor excision circle 
(TREC) DNA obtained from dried blood spot specimens on filter paper 
using a polymerase chain reaction based test as an aid in screening 
newborns for SCID. Presumptive positive results must be followed up by 
diagnostic confirmatory testing. This test is not intended for use as a 
diagnostic test, or for screening of SCID-like syndromes, such as 
DiGeorge syndrome or Omenn syndrome. It is also not intended to screen 
for less acute SCID syndromes, such as leaky SCID or variant SCID.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Premarket notification submissions must include the following 
information:
    (i) The intended use must indicate:
    (A) The test is not intended for diagnostic use, or for screening of 
SCID-like syndromes, such as DiGeorge syndrome or Omenn syndrome; and
    (B) The test is not intended to screen for less acute SCID 
syndromes, such as leaky SCID or variant SCID.
    (ii) A detailed description of all components in the test that 
includes:
    (A) A detailed description of the test components, all required 
reagents, instrumentation and equipment, including illustrations or 
photographs of nonstandard equipment or methods;

[[Page 404]]

    (B) Detailed documentation of the device software including, but not 
limited to, standalone software applications and hardware-based devices 
that incorporate software;
    (C) Specifications for the filter paper, which must be appropriately 
labeled for in vitro diagnostic use, to be used in specimen collection 
and how it will be used in specimen collection validation. These 
specifications must include: descriptive characteristics of the filter 
paper, instructions on how a lab should choose the appropriate filter 
paper, chemical properties of the filter paper, interference concerns 
associated with the chemicals in the filter paper, absorption properties 
of the filter paper, punch size, absorption capacity, testing for 
homogeneity of punches, diameter of the circle for the dried blood spot 
aliquot, absorption time, physical composition, and number and size of 
punches to be tested;
    (D) Methodology and protocols for detection of T-cell receptor 
excision circles and methods for determination of results. The cutoff 
must be selected before conducting clinical and analytical studies;
    (E) A description of the result outputs along with sample reports. 
Sample reports must include the scale used in reporting of results 
(e.g., TREC copies/[micro]L) and the range of values that will be 
reported out; and
    (F) A description of appropriate internal and external controls that 
are recommended or provided. The description must identify those control 
elements that are incorporated into the testing procedure.
    (iii) Information that demonstrates the performance characteristics 
of the test, including:
    (A) Data that demonstrates the clinical validity of the device, 
using well characterized prospectively or retrospectively obtained 
clinical specimens representative of the intended use population. A 
minimum of 10 to 15 confirmed positive specimens must be obtained from 
more than 1 site, including relevant annotation, and, at 1 year or 
beyond, a SCID diagnosis by flow cytometry or clinically meaningful 
information regarding the status of the subject must be obtained. 
Additional specimens should have been obtained that are characterized by 
other disorders that can be found by screening specimens that have low 
or absent TREC (e.g., other T-cell lymphopenic disorders) to supplement 
the range of results. The clinical validation study must have a pre-
specified clinical decision point (i.e., cutoff to distinguish positive 
and negative results). Results must be summarized in tabular format 
comparing interpretation of results to the reference method. Point 
estimates together with two-sided 95 percent confidence intervals must 
be provided for the positive percent agreement, negative percent 
agreement, and overall percent agreement. Data must include the retest 
rate, the false positive rate before retest, the final false positive 
rate, and the false negative rate;
    (B) Device reproducibility data generated, using a minimum of three 
sites of which at least two must be external sites, with two operators 
at each site. Each site must conduct a minimum of five runs per operator 
over five nonconsecutive days evaluating a minimum of six different 
relevant TREC concentrations that span and are well distributed over the 
measuring range and include the clinical cutoff. Specimens must include 
cord blood and cord blood diluted with ABO matched adult blood 
specimens. Identical specimens from the same sample panel must be tested 
at each site. Each specimen must be run in triplicate and include 
controls run in triplicate. Results must be reported as the standard 
deviation and percentage coefficient of variation for each level tested. 
Results must also be displayed as a dichotomous variable around the 
cutoff. Total variation must be partitioned into the sum of within-lab 
and between-lab variations with pre-specified acceptance criteria and 95 
percent confidence intervals for all data. Pre-specified acceptance 
criteria must be provided and followed;
    (C) Device precision data using clinical samples to evaluate the 
within-lot, between-lot, within-run, between run, and total variation. A 
range of TREC levels of the specimen must include samples within the 
measuring range, samples above and below the measuring range, as well as 
with samples very near above and below the cutoff value. At least three 
replicates of each

[[Page 405]]

specimen must be tested with controls and calibrator(s) according to the 
device instructions for use. The precision study must use well 
characterized samples using different lots, instruments, and operators. 
Results must be summarized in tabular format. Pre-specified acceptance 
criteria must be provided and followed;
    (D) Linearity of the test must be demonstrated using a dilution 
panel from clinical samples. The range of dilution samples must include 
samples within the measuring range, samples above and below the 
measuring range, as well as with samples very near above and below the 
cutoff value. Results of the regression analysis must be summarized in 
tabular format and fitted into a linear regression model with the 
individual measurement results against the dilution factors. Pre-
specified acceptance criteria must be provided and followed;
    (E) Device analytic sensitivity data, including limit of blank, 
limit of detection, and limit of quantification;
    (F) Device specificity data, including interference, carryover, 
cross-contamination, and in silico analysis of potential off-target 
genomic sequences;
    (G) Device stability data, including real-time stability of samples 
under various storage times, temperatures, and freeze-thaw conditions. A 
separate shipping stability study must be performed;
    (H) Lot-to-lot reproducibility study of each filter paper that will 
be validated with the test. The lot-to-lot study must include a minimum 
of three lots of each blood spot card that will be validated with the 
test and be conducted over five nonconsecutive days. The sample panel 
must consist of specimens with a range of TREC levels and include 
samples within the measuring range, samples above and below the 
measuring range, and samples very near above and below the cutoff value. 
Multiple punches must be obtained from each card for demonstration of 
homogeneity of the analyte across the dried blood spot. Comparability of 
the test performance for each filter paper must be demonstrated. 
Stability and storage of TREC DNA on each blood spot card must be 
demonstrated. Results of the lot-to-lot study must be summarized 
providing the mean, standard deviation, and percentage coefficient of 
variation in a tabular format. Data must be calculated for within-run, 
between-run, within-lot, and between-lot. Data demonstrating the 
concordance between results across different filter papers must be 
provided. Study acceptance criteria must be provided and followed; and
    (I) If applicable, a thermocycler reproducibility study must be 
performed using thermocyclers from three independent thermocyler 
manufacturers. The sample panel must consist of specimens with a range 
of TREC levels and must include samples within the measuring range, 
samples above and below the measuring range, and samples very near above 
and below the cutoff value. The study must be done using three filter 
paper lots and conducted over five nonconsecutive days. Results of the 
thermocycler reproducibility study must be summarized providing the 
mean, standard deviation, and percentage coefficient of variance in a 
tabular format. Data must be calculated for the within-run, between-run, 
within-lot, between-lot, and between thermocycler manufacturer study 
results. Study acceptance criteria must be provided and followed.
    (iv) Identification of risk mitigation elements used by your device, 
including a description of all additional procedures, methods, and 
practices incorporated into the directions for use that mitigate risks 
associated with testing.
    (2) Your Sec. 809.10 compliant labeling must include:
    (i) A warning statement that reads ``This test is not intended for 
diagnostic use, preimplantation or prenatal testing, or for screening of 
SCID-like syndromes, such as DiGeorge syndrome or Omenn syndrome. It is 
also not intended to screen for less acute SCID syndromes, such as leaky 
SCID or variant SCID.'';
    (ii) A warning statement that reads ``Test results are intended to 
be used in conjunction with other clinical and diagnostic findings, 
consistent with professional standards of practice, including 
confirmation by alternative methods and clinical evaluation, as 
appropriate.'';

[[Page 406]]

    (iii) A description of the performance studies listed in paragraph 
(b)(1)(iii) and a summary of the results; and
    (iv) A description of the filter paper specifications required for 
the test.

[82 FR 50079, Oct. 30, 2017]



Sec. 866.5940  Autosomal recessive carrier screening gene mutation
detection system.

    (a) Identification. Autosomal recessive carrier screening gene 
mutation detection system is a qualitative in vitro molecular diagnostic 
system used for genotyping of clinically relevant variants in genomic 
DNA isolated from human specimens intended for prescription use or over-
the-counter use. The device is intended for autosomal recessive disease 
carrier screening in adults of reproductive age. The device is not 
intended for copy number variation, cytogenetic, or biochemical testing.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 866.9, except 
Sec. 866.9(c)(2). Autosomal recessive carrier screening gene mutation 
detection system must comply with the following special controls:
    (1) If the device is offered over-the-counter, the device 
manufacturer must provide information to a potential purchaser or actual 
test report recipient about how to obtain access to a board-certified 
clinical molecular geneticist or equivalent to assist in pre- and post-
test counseling.
    (2) The device must use a collection device that is FDA cleared, 
approved, or classified as 510(k) exempt, with an indication for in 
vitro diagnostic use in DNA testing.
    (3) The device's labeling must include a prominent hyperlink to the 
manufacturer's public Web site where the manufacturer shall make the 
information identified in this section publicly available. The 
manufacturer's home page, as well as the primary part of the 
manufacturer's Web site that discusses the device, must provide a 
prominently placed hyperlink to the Web page containing this information 
and must allow unrestricted viewing access. If the device can be 
purchased from the Web site or testing using the device can be ordered 
from the Web site, the same information must be found on the Web page 
for ordering the device or provided in a prominently placed and publicly 
accessible hyperlink on the Web page for ordering the device. Any 
changes to the device that could significantly affect safety or 
effectiveness would require new data or information in support of such 
changes, which would also have to be posted on the manufacturer's Web 
site. The information must include:
    (i) A detailed device description including:
    (A) Gene (or list of the genes if more than one) and variants the 
test detects (using standardized nomenclature, Human Genome Organization 
(HUGO) nomenclature, and coordinates).
    (B) Scientifically established clinical validity of each variant 
detected and reported by the test, which must be well-established in 
peer-reviewed journal articles, authoritative summaries of the 
literature such as Genetics Home Reference (http://ghr.nlm.nih.gov/), 
GeneReviews (http://www.ncbi.nlm.nih.gov/books/NBK1116/), or similar 
summaries of valid scientific evidence, and/or professional society 
recommendations, including:
    (1) Genotype-phenotype information for the reported mutations.
    (2) Relevant American College of Medical Genetics (ACMG) or American 
Congress of Obstetricians and Gynecologists (ACOG) guideline 
recommending testing of the specific gene(s) and variants the test 
detects and recommended populations, if available. If not available, a 
statement stating that professional guidelines currently do not 
recommend testing for this specific gene(s) and variants.
    (3) Table of expected prevalence of carrier status in major ethnic 
and racial populations and the general population.
    (C) The specimen type (e.g., saliva, whole blood), matrix, and 
volume.
    (D) Assay steps and technology used.
    (E) Specification of required ancillary reagents, instrumentation, 
and equipment.
    (F) Specification of the specimen collection, processing, storage, 
and preparation methods.

[[Page 407]]

    (G) Specification of risk mitigation elements and description of all 
additional procedures, methods, and practices incorporated into the 
directions for use that mitigate risks associated with testing.
    (H) Information pertaining to the probability of test failure (e.g., 
failed quality control) based on data from clinical samples, description 
of scenarios in which a test can fail (i.e., low sample volume, low DNA 
concentration, etc.), how customers will be notified, and followup 
actions to be taken.
    (I) Specification of the criteria for test result interpretation and 
reporting.
    (ii) Information that demonstrates the performance characteristics 
of the device, including:
    (A) Accuracy (method comparison) of study results for each claimed 
specimen type.
    (1) Accuracy of the device shall be evaluated with fresh clinical 
specimens collected and processed in a manner consistent with the 
device's instructions for use. If this is impractical, fresh clinical 
samples may be substituted or supplemented with archived clinical 
samples. Archived samples shall have been collected previously in 
accordance with the device's instructions for use, stored appropriately, 
and randomly selected. In some instances, use of contrived samples or 
human cell line samples may also be appropriate; the contrived or human 
cell line samples shall mimic clinical specimens as much as is feasible 
and provide an unbiased evaluation of the device's accuracy.
    (2) Accuracy must be evaluated as compared to bidirectional 
sequencing or other methods identified as appropriate by FDA. 
Performance criteria for both the comparator method and device must be 
predefined and appropriate to the test's intended use. Detailed 
appropriate study protocols must be provided.
    (3) Information provided shall include the number and type of 
specimens, broken down by clinically relevant variants, that were 
compared to bidirectional sequencing or other methods identified as 
appropriate by FDA. The accuracy, defined as positive percent agreement 
(PPA) and negative percent agreement (NPA), must be measured; accuracy 
point estimates must be greater than 99 percent (both per reported 
variant and overall) and uncertainty of the point estimate must be 
presented using the 95 percent confidence interval. Clinical specimens 
must include both homozygous wild type and heterozygous genotypes. The 
number of clinical specimens for each variant reported that must be 
included in the accuracy study must be based on the variant prevalence. 
Common variants (greater than 0.1 percent allele frequency in ethnically 
relevant population) must have at least 20 unique heterozygous clinical 
specimens tested. Rare variants (less than or equal to 0.1 percent 
allele frequency in ethnically relevant population) shall have at least 
three unique mutant heterozygous specimens tested. Any no calls (i.e., 
absence of a result) or invalid calls (e.g., failed quality control) in 
the study must be included in accuracy study results and reported 
separately. Variants that have a point estimate for PPA or NPA of less 
than 99 percent (incorrect test results as compared to bidirectional 
sequencing or other methods identified as appropriate by FDA) must not 
be incorporated into test claims and reports. Accuracy measures 
generated from clinical specimens versus contrived samples or cell lines 
must be presented separately. Results must be summarized and presented 
in tabular format, by sample and by genotype. Point estimate of PPA 
should be calculated as the number of positive results divided by the 
number of specimens known to harbor variants (mutations) without ``no 
calls'' or invalid calls. The point estimate of NPA should be calculated 
as the number of negative results divided by the number of wild type 
specimens tested without ``no calls'' or invalid calls, for each variant 
that is being reported. Point estimates should be calculated along with 
95 percent two-sided confidence intervals.
    (4) Information shall be reported on the clinical positive 
predictive value (PPV) and negative predictive value (NPV) for carrier 
status (and where possible, for each variant) in each population. 
Specifically, to calculate PPV and NPV, estimate test coverage (TC)

[[Page 408]]

and the percent of persons with variant(s) included in the device among 
all carriers: PPV = (PPA * TC * [pi])/(PPA * TC * [pi] + (1 - NPA) * (1 
- [pi])) and NPV = (NPA * (1 - [pi]))/(NPA *(1 - [pi]) + (1 - PPA*TC) * 
[pi]) where PPA and NPA described either in paragraph 
(b)(3)(ii)(A)(4)(i) or in paragraph (b)(3)(ii)(A)(4)(ii) of this section 
and [pi] is prevalence of carriers in the population (pre-test risk to 
be a carrier for the disease).
    (i) For the point estimates of PPA and NPA less than 100 percent, 
use the calculated estimates in the PPV and NPV calculations.
    (ii) Point estimates of 100 percent may have high uncertainty. If 
these variants are measured using highly multiplexed technology, 
calculate the random error rate for the overall device and incorporate 
that rate in the estimation of the PPA and NPA as calculated previously. 
Then use these calculated estimates in the PPV and NPV calculations. 
This type of accuracy study is helpful in determining that there is no 
systematic error in such devices.
    (B) Precision (reproducibility): Precision data must be generated 
using multiple instruments and multiple operators, on multiple non-
consecutive days, and using multiple reagent lots. The sample panel must 
include specimens with claimed sample type (e.g. saliva samples) 
representing different genotypes (i.e., wild type, heterozygous). 
Performance criteria must be predefined. A detailed study protocol must 
be created in advance of the study and then followed. The ``failed 
quality control'' rate must be indicated. It must be clearly documented 
whether results were generated from clinical specimens, contrived 
samples, or cell lines. The study results shall state, in a tabular 
format, the variants tested in the study and the number of replicates 
for each variant, and what testing conditions were studied (i.e., number 
of runs, days, instruments, reagent lots, operators, specimens/type, 
etc). The study must include all nucleic acid extraction steps from the 
claimed specimen type or matrix, unless a separate extraction study for 
the claimed sample type is performed. If the device is to be used at 
more than one laboratory, different laboratories must be included in the 
precision study (and reproducibility must be evaluated). The percentage 
of ``no calls'' or invalid calls, if any, in the study must be provided 
as a part of the precision (reproducibility) study results.
    (C) Analytical specificity data: Data must be generated evaluating 
the effect on test performance of potential endogenous and exogenous 
interfering substances relevant to the specimen type, evaluation of 
cross-reactivity of known cross-reactive alleles and pseudogenes, and 
assessment of cross-contamination.
    (D) Analytical sensitivity data: Data must be generated 
demonstrating the minimum amount of DNA that will enable the test to 
perform accurately in 95 percent of runs.
    (E) Device stability data: The manufacturer must establish upper and 
lower limits of input nucleic acid and sample stability that will 
achieve the claimed accuracy and reproducibility. Data supporting such 
claims must be described.
    (F) Specimen type and matrix comparison data: Specimen type and 
matrix comparison data must be generated if more than one specimen type 
or anticoagulant can be tested with the device, including failure rates 
for the different specimen types.
    (iii) If the device is offered over-the-counter, including cases in 
which the test results are provided direct-to-consumer, the manufacturer 
must conduct a study that assesses user comprehension of the device's 
labeling and test process and provide a concise summary of the results 
of the study. The following items must be included in the user study:
    (A) The test manufacturer must perform pre- and post-test user 
comprehension studies to assess user ability to understand the possible 
results of a carrier test and their clinical meaning. The comprehension 
test questions must directly evaluate the material being presented to 
the user in the test reports.
    (B) The test manufacturer must provide a carrier testing education 
module to potential and actual test report recipients. The module must 
define

[[Page 409]]

terms that are used in the test reports and explain the significance of 
carrier status.
    (C) The user study must meet the following criteria:
    (1) The study participants must be comprised of a statistically 
justified and demographically diverse population (determined using 
methods such as quota-based sampling) that is representative of the 
intended user population. Furthermore, the users must be comprised of a 
diverse range of age and educational levels that have no prior 
experience with the test or its manufacturer. These factors shall be 
well-defined in the inclusion and exclusion criteria.
    (2) All sources of bias (e.g., non-responders) must be predefined 
and accounted for in the study results with regard to both responders 
and non-responders.
    (3) The testing must follow a format where users have limited time 
to complete the studies (such as an onsite survey format and a one-time 
visit with a cap on the maximum amount of time that a participant has to 
complete the tests).
    (4) Users must be randomly assigned to study arms. Test reports 
given to users must: Define the condition being tested and related 
symptoms; explain the intended use and limitations of the test; explain 
the relevant ethnicities regarding the variant tested; explain carrier 
status and relevance to the user's ethnicity; and provide links to 
additional information pertaining to situations where the user is 
concerned about their test results or would like followup information as 
indicated in test labeling. The study shall assess participants' ability 
to understand the following comprehension concepts: The test's 
limitations, purpose, and results.
    (5) Study participants must be untrained, naive to the test subject 
of the study, and be provided only the materials that will be available 
to them when the test is marketed.
    (6) The user comprehension study must meet the predefined primary 
endpoint criteria, including a minimum of a 90 percent or greater 
overall comprehension rate (i.e. selection of the correct answer) for 
each comprehension concept to demonstrate that the education module and 
test reports are adequate for over-the-counter use.
    (D) A summary of the user comprehension study must be provided and 
include the following:
    (1) Results regarding reports that are provided for each gene/
variant/ethnicity tested.
    (2) Statistical methods used to analyze all data sets.
    (3) Completion rate, non-responder rate, and reasons for non-
response/data exclusion, as well as a summary table of comprehension 
rates regarding comprehension concepts (purpose of test, test results, 
test limitations, ethnicity relevance for the test results, etc.) for 
each study report.
    (4) Your 21 CFR 809.10 compliant labeling and any test report 
generated must include the following warning and limitation statements, 
as applicable:
    (i) A warning that reads ``The test is intended only for autosomal 
recessive carrier screening in adults of reproductive age.''
    (ii) A statement accurately disclosing the genetic coverage of the 
test in lay terms, including, as applicable, information on variants not 
queried by the test, and the proportion of incident disease that is not 
related to the gene(s) tested. For example, where applicable, the 
statement would have to include a warning that the test does not or may 
not detect all genetic variants related to the genetic disease, and that 
the absence of a variant tested does not rule out the presence of other 
genetic variants that may be disease-related. Or, where applicable, the 
statement would have to include a warning that the basis for the disease 
for which the genetic carrier status is being tested is unknown or 
believed to be non-heritable in a substantial number of people who have 
the disease, and that a negative test result cannot rule out the 
possibility that any offspring may be affected with the disease. The 
statement would have to include any other warnings needed to accurately 
convey to consumers the degree to which the test is informative for 
carrier status.
    (iii) For prescription use tests, the following warnings that read:

[[Page 410]]

    (A) ``The results of this test are intended to be interpreted by a 
board-certified clinical molecular geneticist or equivalent and should 
be used in conjunction with other available laboratory and clinical 
information.''
    (B) ``This device is not intended for disease diagnosis, prenatal 
testing of fetuses, risk assessment, prognosis or pre-symptomatic 
testing, susceptibility testing, or newborn screening.''
    (iv) For over-the-counter tests, a statement that reads ``This test 
is not intended to diagnose a disease, or tell you anything about your 
risk for developing a disease in the future. On its own, this test is 
also not intended to tell you anything about the health of your fetus, 
or your newborn child's risk of developing a particular disease later on 
in life.''
    (v) For over-the-counter tests, the following warnings that read:
    (A) ``This test is not a substitute for visits to a healthcare 
provider. It is recommended that you consult with a healthcare provider 
if you have any questions or concerns about your results.''
    (B) ``The test does not diagnose any health conditions. Results 
should be used along with other clinical information for any medical 
purposes.''
    (C) ``The laboratory may not be able to process your sample. The 
probability that the laboratory cannot process your saliva sample can be 
up to [actual probability percentage].''
    (D) ``Your ethnicity may affect how your genetic health results are 
interpreted.''
    (vi) For a positive result in an over-the-counter test when the 
positive predictive value for a specific population is less than 50 
percent and more than 5 percent, a warning that reads ``The positive 
result you obtained may falsely identify you as a carrier. Consider 
genetic counseling and followup testing.''
    (vii) For a positive result in an over-the-counter test when the 
positive predictive value for a specific population is less than 5 
percent, a warning that reads ``The positive result you obtained is very 
likely to be incorrect due to the rarity of this variant. Consider 
genetic counseling and followup testing.''
    (5) The testing done to comply with paragraph (b)(3) of this section 
must show the device meets or exceeds each of the following performance 
specifications:
    (i) The accuracy must be shown to be equal to or greater than 99 
percent for both PPA and NPA. Variants that have a point estimate for 
PPA or NPA of less than 99 percent (incorrect test results as compared 
to bidirectional sequencing or other methods identified as appropriate 
by FDA) must not be incorporated into test claims and reports.
    (ii) Precision (reproducibility) performance must meet or exceed 99 
percent for both positive and negative results.
    (iii) The user comprehension study must obtain values of 90 percent 
or greater user comprehension for each comprehension concept.
    (6) The distribution of this device, excluding the collection device 
described in paragraph (b)(2) of this section, shall be limited to the 
manufacturer, the manufacturer's subsidiaries, and laboratories 
regulated under the Clinical Laboratory Improvement Amendments.

[80 FR 65630, Oct. 27, 2015, as amended at 82 FR 51570, Nov. 7, 2017]



Sec. 866.5950  Genetic health risk assessment system.

    (a) Identification. A genetic health risk assessment system is a 
qualitative in vitro molecular diagnostic system used for detecting 
variants in genomic deoxyribonucleic acid (DNA) isolated from human 
specimens that will provide information to users about their genetic 
risk of developing a disease to inform lifestyle choices and/or 
conversations with a health care professional. This assessment system is 
for over-the-counter use. This device does not determine the person's 
overall risk of developing a disease.
    (b) Classification. Class II (special controls). The genetic health 
risk assessment system device, when it has previously received a first-
time FDA marketing authorization (e.g., 510(k) clearance) for the 
genetic health risk assessment system (a ``one-time FDA

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reviewed genetic health risk assessment system''), is exempt from the 
premarket notification procedures in part 807, subpart E, of this 
chapter subject to the limitations in Sec. 866.9. The device must 
comply with the following special controls:
    (1) The 21 CFR 809.10 compliant labeling and any prepurchase page 
and test report generated, unless otherwise specified, must include:
    (i) A section addressed to users with the following information:
    (A) The limiting statement explaining that this test provides 
genetic risk information based on assessment of specific genetic 
variants but does not report on a user's entire genetic profile. This 
test [does not/may not, as appropriate] detect all genetic variants 
related to a given disease, and the absence of a variant tested does not 
rule out the presence of other genetic variants that may be related to 
the disease.
    (B) The limiting statement explaining that other companies offering 
a genetic risk test may be detecting different genetic variants for the 
same disease, so the user may get different results using a test from a 
different company.
    (C) The limiting statement explaining that other factors such as 
environmental and lifestyle risk factors may affect the risk of 
developing a given disease.
    (D) The limiting statement explaining that some people may feel 
anxious about getting genetic test health results. This is normal. If 
the potential user feels very anxious, such user should speak to his or 
her doctor or other health care professional prior to collection of a 
sample for testing. This test is not a substitute for visits to a doctor 
or other health care professional. Users should consult with their 
doctor or other health care professional if they have any questions or 
concerns about the results of their test or their current state of 
health.
    (E) Information about how to obtain access to a genetic counselor, 
board-certified clinical molecular geneticist, or equivalent health care 
professional about the results of a user's test.
    (F) The limiting statement explaining that this test is not intended 
to diagnose a disease, tell you anything about your current state of 
health, or be used to make medical decisions, including whether or not 
you should take a medication or how much of a medication you should 
take.
    (G) A limiting statement explaining that the laboratory may not be 
able to process a sample, and a description of the next steps to be 
taken by the manufacturer and/or the customer, as applicable.
    (ii) A section in your 21 CFR 809.10 labeling and any test report 
generated that is for health care professionals who may receive the test 
results from their patients with the following information:
    (A) The limiting statement explaining that this test is not intended 
to diagnose a disease, determine medical treatment, or tell the user 
anything about their current state of health.
    (B) The limiting statement explaining that this test is intended to 
provide users with their genetic information to inform lifestyle 
decisions and conversations with their doctor or other health care 
professional.
    (C) The limiting statement explaining that any diagnostic or 
treatment decisions should be based on testing and/or other information 
that you determine to be appropriate for your patient.
    (2) The genetic test must use a sample collection device that is 
FDA-cleared, -approved, or -classified as 510(k) exempt, with an 
indication for in vitro diagnostic use in over-the-counter DNA testing.
    (3) The device's labeling must include a hyperlink to the 
manufacturer's public Web site where the manufacturer shall make the 
information identified in paragraph (b)(3) of this section publicly 
available. The manufacturer's home page, as well as the primary part of 
the manufacturer's Web site that discusses the device, must provide a 
hyperlink to the Web page containing this information and must allow 
unrestricted viewing access. If the device can be purchased from the Web 
site or testing using the device can be ordered from the Web site, the 
same information must be found on the Web page for ordering the device 
or provided in a publicly accessible hyperlink on the

[[Page 412]]

Web page for ordering the device. Any changes to the device that could 
significantly affect safety or effectiveness would require new data or 
information in support of such changes, which would also have to be 
posted on the manufacturer's Web site. The information must include:
    (i) An index of the material being provided to meet the requirements 
in paragraph (b)(3) of this section and its location.
    (ii) A section that highlights summary information that allows the 
user to understand how the test works and how to interpret the results 
of the test. This section must, at a minimum, be written in plain 
language understandable to a lay user and include:
    (A) Consistent explanations of the risk of disease associated with 
all variants included in the test. If there are different categories of 
risk, the manufacturer must provide literature references that support 
the different risk categories. If there will be multiple test reports 
and multiple variants, the risk categories must be defined similarly 
among them. For example, ``increased risk'' must be defined similarly 
between different test reports and different variant combinations.
    (B) Clear context for the user to understand the context in which 
the cited clinical performance data support the risk reported. This 
includes, but is not limited to, any risks that are influenced by 
ethnicity, age, gender, environment, and lifestyle choices.
    (C) Materials that explain the main concepts and terminology used in 
the test that include:
    (1) Definitions: Scientific terms that are used in the test reports.
    (2) Prepurchase page: This page must contain information that 
informs the user about what information the test will provide. This 
includes, but is not limited to, variant information, the condition or 
disease associated with the variant(s), professional guideline 
recommendations for general genetic risk testing, the limitations 
associated with the test (e.g., test does not detect all variants 
related to the disease) and any precautionary information about the test 
the user should be aware of before purchase. When the test reports the 
risk of a life-threatening or irreversibly debilitating disease or 
condition for which there are few or no options to prevent, treat, or 
cure the disease, a user opt-in section must be provided. This opt-in 
page must be provided for each disease that falls into this category and 
must provide specific information relevant to each test result. The opt-
in page must include:
    (i) An option to accept or decline to receive this specific test 
result;
    (ii) Specification of the risk involved if the user is found to have 
the specific genetic test result;
    (iii) Professional guidelines that recommend when genetic testing 
for the associated target condition is or is not recommended; and
    (iv) A recommendation to speak with a health care professional, 
genetic counselor, or equivalent professional before getting the results 
of the test.
    (3) Frequently asked questions (FAQ) page: This page must provide 
information that is specific for each variant/disease pair that is 
reported. Information provided in this section must be scientifically 
valid and supported by corresponding publications. The FAQ page must 
explain the health condition/disease being tested, the purpose of the 
test, the information the test will and will not provide, the relevance 
of race and ethnicity to the test results, information about the 
population to which the variants in the test is most applicable, the 
meaning of the result(s), other risk factors that contribute to disease, 
appropriate followup procedures, how the results of the test may affect 
the user's family, including children, and links to resources that 
provide additional information.
    (iii) A technical information section containing the following 
information:
    (A) Gene(s) and variant(s) the test detects using standardized 
nomenclature, Human Genome Organization nomenclature and coordinates as 
well as Single Nucleotide Polymorphism Database (dbSNP) reference SNP 
numbers (rs).
    (B) Scientifically established disease-risk association of each 
variant detected and reported by the test. This risk association 
information must include:
    (1) Genotype-phenotype information for the reported variants.

[[Page 413]]

    (2) Table of expected frequency and risks of developing the disease 
in relevant ethnic populations and the general population.
    (3) A statement about the current professional guidelines for 
testing these specific gene(s) and variant(s).
    (i) If professional guidelines are available, provide the 
recommendations in the professional guideline for the gene, variant, and 
disease, for when genetic testing should or should not be performed, and 
cautionary information that should be communicated when a particular 
gene and variant is detected.
    (ii) If professional guidelines are not available, provide a 
statement that the professional guidelines are not available for these 
specific gene(s) and variant(s).
    (C) The specimen type (e.g., saliva, capillary whole blood).
    (D) Assay steps and technology used.
    (E) Specification of required ancillary reagents, instrumentation, 
and equipment.
    (F) Specification of the specimen collection, processing, storage, 
and preparation methods.
    (G) Specification of risk mitigation elements and description of all 
additional procedures, methods, and practices incorporated into the 
directions for use that mitigate risks associated with testing.
    (H) Information pertaining to the probability of test failure (i.e., 
percentage of tests that failed quality control) based on data from 
clinical samples, a description of scenarios in which a test can fail 
(i.e., low sample volume, low DNA concentration, etc.), how users will 
be notified of a test failure, and the nature of followup actions on a 
failed test to be taken by the user and the manufacturer.
    (I) Specification of the criteria for test result interpretation and 
reporting.
    (J) Information that demonstrates the performance characteristics of 
the test, including:
    (1) Accuracy of study results for each claimed specimen type.
    (i) Accuracy of the test shall be evaluated with fresh clinical 
specimens collected and processed in a manner consistent with the test's 
instructions for use. If this is impractical, fresh clinical samples may 
be substituted or supplemented with archived clinical samples. Archived 
samples shall have been collected previously in accordance with the 
instructions for use, stored appropriately, and randomly selected. In 
some limited circumstances, use of contrived samples or human cell line 
samples may also be appropriate and used as an acceptable alternative. 
The contrived or human cell line samples shall mimic clinical specimens 
as much as is feasible and provide an unbiased evaluation of the device 
accuracy.
    (ii) Accuracy must be evaluated by comparison to bidirectional 
Sanger sequencing or other methods identified as appropriate by FDA. 
Performance criteria for both the comparator method and the device must 
be predefined and appropriate to the device's intended use. Detailed 
study protocols must be provided.
    (iii) Test specimens must include all genotypes that will be 
included in the tests and reports. The number of samples tested in the 
accuracy study for each variant reported must be based on the variant 
frequency using either the minimum numbers of samples identified in this 
paragraph or, when determined appropriate and identified by FDA, a 
minimum number of samples determined using an alternative method. When 
appropriate, the same samples may be used in testing to demonstrate the 
accuracy of testing for multiple genotypes by generating sequence 
information at multiple relevant genetic locations. At least 20 unique 
samples representing the wild-type genotype must be tested. To test 
samples that are heterozygous for the reported variant(s), common 
variants (0.1 percent variant frequency in the relevant 
population) must be tested with at least 20 unique samples. Rare 
variants (<=0.1 percent variant frequency in the relevant population) 
must be tested with at least three unique samples. To test samples that 
are homozygous for the reported variant(s), variants with =2 
percent variant frequency in a relevant population must be tested with 
at least 20 unique samples. Variants with a frequency in the relevant 
population <2 percent and =0.5 percent must be tested with at 
least 10 unique samples. Variants with

[[Page 414]]

a frequency in the relevant population <0.5 percent must be tested with 
at least three unique samples. If variants with a frequency of <0.5 
percent are not found within the relevant population and homozygous 
samples are not tested, then the test results for this homozygous rare 
variant must not be reported to the user.
    (iv) Information about the accuracy study shall include the number 
and type of samples that were compared to bidirectional Sanger 
sequencing or other methods identified as appropriate by FDA. This 
information must either be reported in tabular format and arranged by 
clinically relevant variants or reported using another method identified 
as appropriate by FDA. As an example, for samples with different 
genotypes DD, Dd, and dd, the following table represents data from the 
accuracy study presented in tabular format:
[GRAPHIC] [TIFF OMITTED] TR07NO17.001

    (v) The accuracy represents the degrees of agreement between the 
device results and the comparator results. The accuracy must be 
evaluated by measuring different percent agreements (PA) of device 
results with the comparator results and percent of `no calls' or 
`invalid calls.' Calculate the rate of `no calls' and `invalid calls' 
for each comparator output as %Inv(DD) = A4/NDD, 
%Inv(Dd) = B4/NDd, %Inv(dd) = C4/
Ndd. If `no calls' or `invalid calls' are required to be 
retested according to the device instructions for use, the percent

[[Page 415]]

of final `no calls' or `invalid calls' must be provided. In the table 
presenting the results of the accuracy study, use only the final results 
(i.e., after retesting the initial `no calls' or `invalid calls', if 
required according to the instructions for use). Samples that resulted 
in a `no call' or `invalid call' after retesting must not be included in 
the final calculations of agreement. If the percentages of `no calls' or 
`invalid calls' for each comparator output are similar, combine these 
estimates as (A4 + B4 + C4)/
(NDD + NDd + Ndd) and provide a 95 
percent two-sided confidence interval. The percent of final `no calls' 
or `invalid calls' must be clinically acceptable.
    (vi) Point estimates of percent agreement for each genotype must be 
calculated as the number of correct calls for that genotype divided by 
the number of samples known to contain that genotype excluding `no 
calls' or `invalid calls'. The calculations must be performed as 
follows:
[GRAPHIC] [TIFF OMITTED] TR07NO17.002

    (vii) For percent agreements for DD, Dd and dd (PA(DD[bond]DD), 
PA(Dd[bond]Dd) and PA(dd[bond]dd)) as described in paragraph 
(b)(3)(iii)(J)(1)(vi) of this section, the 95 percent two-sided 
confidence intervals must be provided. The accuracy point estimates for 
percent agreements for DD, Dd and dd must be =99 percent per 
reported variant and overall. Any variants that have a point estimate 
for either PA(DD[bond]DD), PA(Dd[bond]Dd), or PA(dd[bond]dd) of <99 
percent compared to bidirectional sequencing or other methods identified 
as appropriate by FDA must not be incorporated into test claims and 
reports. Accuracy results generated from clinical specimens versus 
contrived samples or cell lines must be presented separately. Results 
must be summarized and presented in tabular format by sample type and by 
genotype or must be reported using another method identified as 
appropriate by FDA (see paragraph (b)(3)(iii)(J)(1)(iv) of this 
section).
    (viii) Information must be reported on the Technical Positive 
Predictive Value (TPPV) related to the analytical (technical) 
performance of the device for genotypes in each relevant subpopulation 
(e.g., ethnicity, gender, age, geographical location, etc.). TPPV is the 
percentage of individuals with the genotype truly present among 
individuals whose test reports indicate that this genotype is present. 
The TPPV depends on the accuracy measures of percent agreements and on 
the frequency of the genotypes in the subpopulation being studied. The 
f(DD) is the frequency of DD and f(Dd) is the frequency of Dd in the 
subpopulation being studied; TPPV must be calculated as described in 
paragraphs (b)(3)(iii)(J)(1)(ix) through (xi) of this section.
    (ix) For variants where the point estimates of PA(DD[bond]DD), 
PA(Dd[bond]Dd) and PA(dd[bond]dd) are less than 100 percent, use these 
point estimates in TPPV calculations.

[[Page 416]]

    (x) Point estimates of 100 percent in the accuracy study may have 
high uncertainty about performance of the test in the population. If 
these variants are measured using highly multiplexed technology, 
calculate the random error rate for the overall device. The accuracy 
study described in paragraph (b)(3)(iii)(J) of this section in those 
cases is more to determine that there is no systematic error in such 
devices. In those cases, incorporate that rate in the estimation of the 
percent agreements as calculated in paragraph (b)(3)(iii)(J)(1)(vi) of 
this section and include it in TPPV calculations.
    (xi) The TPPV for subpopulations with genotype frequencies of f(dd), 
f(Dd) and f(DD) = 1-f(dd)-f(Dd) in the subpopulation is calculated as:
[GRAPHIC] [TIFF OMITTED] TR07NO17.003

    (2) Precision and reproducibility data must be provided using 
multiple instruments and multiple operators, on multiple non-consecutive 
days, and using multiple reagent lots. The sample panel must either 
include specimens from the claimed sample type (e.g., saliva) 
representing all genotypes for each variant (e.g., wild type, 
heterozygous, and homozygous) or, if an alternative panel composition of 
specimens is identified by FDA as appropriate, a panel composed of those 
specimens FDA identified as appropriate. A detailed study protocol must 
be created in advance of the study and must include predetermined 
acceptance criteria for performance results. The percentage of samples 
that failed quality control must be indicated (i.e., the total number of 
sample replicates for which a sequence variant cannot be called (no 
calls) or that fail sequencing quality control criteria divided by the 
total number of replicates tested). It must be clearly documented 
whether results were generated from clinical specimens, contrived 
samples, or cell lines. The study results shall report the variants 
tested in the study and the number of replicates for each variant, and 
what conditions were tested (i.e., number of runs, days, instruments, 
reagent lots, operators, specimens/type, etc.). Results must be 
evaluated and presented in tabular format and stratified by study 
parameter (e.g., by site, instrument(s), reagent lot, operator, and 
sample variant). The study must include all extraction steps from the 
claimed specimen type or matrix, unless a separate extraction 
reproducibility study for the claimed sample type is performed. If the 
device is to be used at more than one laboratory, different laboratories 
must be included in the reproducibility study and reproducibility across 
sites must be evaluated. Any no calls or invalid calls in the study must 
be listed as a part of the precision and reproducibility study results.
    (3) Analytical specificity data: Data must be provided that 
evaluates the effect of potential endogenous and exogenous interferents 
on test performance,

[[Page 417]]

including specimen extraction and variant detection. Interferents tested 
must include those reasonably likely to be potentially relevant to the 
sample type used for the device.
    (4) Interfering variant data: Nucleotide mutations that can 
interfere with the technology must be cited and evaluated. Data must be 
provided to demonstrate the effect of the interfering variant(s) on the 
performance of the correct calls. Alternatively, for each suspected 
interfering mutation for which data is not provided demonstrating the 
effect of the interfering variant, the manufacturer must identify the 
suspected interfering variants in the labeling and indicate that the 
impact that the interfering variants may have on the assay's performance 
has not been studied by providing a statement that reads ``It is 
possible that the presence of [insert clearly identifying information 
for the suspected interfering variant] in a sample may interfere with 
the performance of this test. However, its effect on the performance of 
this test has not been studied.''
    (5) Analytical sensitivity data: Data must be provided demonstrating 
the minimum amount of DNA that will enable the test to perform correctly 
in 95 percent of runs.
    (6) Reagent stability: The manufacturer must evaluate reagent 
stability using wild-type, heterozygous, and homozygous samples. Reagent 
stability data must demonstrate that the reagents maintain the claimed 
accuracy and reproducibility. Data supporting such claims must be 
provided.
    (7) Specimen type and matrix comparison data: Specimen type and 
matrix comparison data must be generated if more than one specimen type 
can be tested with this device, including failure rates for the 
different specimens.
    (K) Clinical performance summary.
    (1) Information to support the clinical performance of each variant 
reported by the test must be provided.
    (2) Manufacturers must organize information by the specific variant 
combination as appropriate (e.g., wild type, heterozygous, homozygous, 
compound heterozygous, hemizygous genotypes). For each variant 
combination, information must be provided in the clinical performance 
section to support clinical performance for the risk category (e.g., not 
at risk, increased risk). For each variant combination, a summary of key 
results must be provided in tabular format or using another method 
identified as appropriate by FDA to include the appropriate information 
regarding variant type, data source, definition of the target condition 
(e.g., disease), clinical criteria for determining whether the target 
disease is present or absent, description of subjects with the target 
disease present and target disease absent (exclusion or inclusion 
criteria), and technical method for genotyping. When available, 
information on the effect of the variant on risk must be provided as the 
risk of a disease (lifetime risk or lifetime incidences) for an 
individual compared with the general population risk.
    (i) If odds ratios are available, using information about the 
genotype distribution either among individuals with the target disease 
absent, or in the general population, or information about the risk 
variant frequency and odds ratios, the likelihood ratios for the 
corresponding device results along with 95 percent confidence intervals 
must be calculated. Using information about pretest risk ([pi]), an 
estimate of likelihood ratio (LR), and a relationship between post-test 
risk R as R/(1-R) = LR[middot][pi]/(1-[pi]), the post-test risk R must 
be calculated.
    (ii) When available, likelihood ratios (LR) for different test 
results must be presented in a tabular format along with references to 
the source data or using another method identified as appropriate by FDA 
as stated in paragraph (b)(3)(iii)(K)(2) of this section. When these 
values are not directly available in published literature, likelihood 
ratios can be separately calculated along with the 95 percent confidence 
interval with references to the source data. Note that a minimum 
requirement for the presence of the variant's effect on the risk is that 
a corresponding LR is statistically higher than 1 (a lower bound of 95 
percent two-sided confidence interval is larger than 1). It means that 
the post-test risk is statistically higher than the pretest risk (an 
observed value of the

[[Page 418]]

difference between the post-test and pretest risks).
    (L) Materials that explain the main concepts and terminology used in 
the test that includes, but is not limited to:
    (1) Definitions: Scientific terms that are used in the test reports.
    (2) Prepurchase page: This page must contain information that 
informs the user about what the test will provide. This includes, but is 
not limited to, variant information, the condition or disease associated 
with the variant(s), professional guideline recommendations for general 
genetic risk testing, the limitations associated with the test (e.g., 
test does not detect all variants related to the disease) and any 
precautionary information about the test the user should be aware of 
before purchase. When the test reports the risk of a life-threatening or 
irreversibly debilitating disease or condition for which there are few 
or no options to prevent, treat, or cure the disease, a user opt-in 
section must be provided. This opt-in page must be provided for each 
disease that falls into this category and must provide specific 
information relevant to each test result. The opt-in page must include:
    (i) An option to accept or decline to receive this specific test 
result;
    (ii) Specification of the risk involved if the user is found to have 
the specific genetic test result;
    (iii) Professional guidelines that recommend when genetic testing 
for the associated target condition is or is not recommended; and
    (iv) A recommendation to speak with a health care professional, 
genetic counselor, or equivalent professional before getting the results 
of the test.
    (3) Frequently asked questions (FAQ) page: This page must provide 
information that is specific for each variant/disease pair that is 
reported. Information provided in this section must be scientifically 
valid and supported by corresponding publications. The FAQ page must 
explain the health condition/disease being tested, the purpose of the 
test, the information the test will and will not provide, the relevance 
of race and ethnicity on the test results, information about the 
population to which the variants in the test is most applicable, the 
meaning of the result(s), other risks factors that contribute to 
disease, appropriate followup procedures, how the results of the test 
may affect the user's family, including children, and links to resources 
that provide additional information.
    (M) User comprehension study: Information on a study that assesses 
comprehension of the test process and results by potential users of the 
test must be provided.
    (1) The test manufacturer must provide a genetic risk education 
module to na[iuml]ve user comprehension study participants prior to 
their participation in the user comprehension study. The module must 
define terms that are used in the test reports and explain the 
significance of genetic risk reports.
    (2) The test manufacturer must perform pre- and post-test user 
comprehension studies. The comprehension test questions must include 
directly evaluating a representative sample of the material being 
presented to the user as described in paragraph (b)(3)(ii) of this 
section.
    (3) The manufacturer must provide a justification from a physician 
and/or genetic counselor that identifies the appropriate general and 
variant-specific concepts contained within the material being tested in 
the user comprehension study to ensure that all relevant concepts are 
incorporated in the study.
    (4) The user study must meet the following criteria:
    (i) The study participants must comprise a statistically sufficient 
sample size and demographically diverse population (determined using 
methods such as quota-based sampling) that is representative of the 
intended user population. Furthermore, the study participants must 
comprise a diverse range of age and educational levels and have no prior 
experience with the test or its manufacturer. These factors shall be 
well defined in the inclusion and exclusion criteria.
    (ii) All sources of bias must be predefined and accounted for in the 
study results with regard to both responders and non-responders.

[[Page 419]]

    (iii) The testing must follow a format where users have limited time 
to complete the studies (such as an onsite survey format and a one-time 
visit with a cap on the maximum amount of time that a participant has to 
complete the tests).
    (iv) Users must be randomly assigned to study arms. Test reports in 
the user comprehension study given to users must define the target 
condition being tested and related symptoms, explain the intended use 
and limitations of the test, explain the relevant ethnicities in regard 
to the variant tested, explain genetic health risks and relevance to the 
user's ethnicity, and assess participants' ability to understand the 
following comprehension concepts: The test's limitations, purpose, 
appropriate action, test results, and other factors that may have an 
impact on the test results.
    (v) Study participants must be untrained, be na[iuml]ve to the test 
subject of the study, and be provided the labeling prior to the start of 
the user comprehension study.
    (vi) The user comprehension study must meet the predefined primary 
endpoint criteria, including a minimum of a 90 percent or greater 
overall comprehension rate (i.e., selection of the correct answer) for 
each comprehension concept. Other acceptance criteria may be acceptable 
depending on the concept being tested. Meeting or exceeding this overall 
comprehension rate demonstrates that the materials presented to the user 
are adequate for over-the-counter use.
    (vii) The analysis of the user comprehension results must include 
results regarding reports that are provided for each gene/variant/
ethnicity tested, statistical methods used to analyze all data sets, and 
completion rate, non-responder rate, and reasons for nonresponse/data 
exclusion. A summary table of comprehension rates regarding 
comprehension concepts (e.g., purpose of test, test results, test 
limitations, ethnicity relevance for the test results, etc.) for each 
study report must be included.
    (4) The intended use of the device must not include the following 
indications for use:
    (i) Prenatal testing;
    (ii) Determining predisposition for cancer where the result of the 
test may lead to prophylactic screening, confirmatory procedures, or 
treatments that may incur morbidity or mortality to the patient;
    (iii) Assessing the presence of genetic variants that impact the 
metabolism, exposure, response, risk of adverse events, dosing, or 
mechanisms of prescription or over-the-counter medications; or
    (iv) Assessing the presence of deterministic autosomal dominant 
variants.

[82 FR 51561, Nov. 7, 2017, as amended at 83 FR 25914, June 5, 2018]



Sec. 866.5960  Human leukocyte antigen typing companion diagnostic test.

    (a) Identification. A human leukocyte antigen (HLA) typing companion 
diagnostic (CDx) test is a prescription genotyping or phenotyping in 
vitro diagnostic product intended for use as an aid in identifying 
patients who have specific HLA allele(s) or express specific HLA 
antigen(s) and may benefit from treatment with a corresponding 
therapeutic product or are likely to be at increased risk for serious 
adverse reactions as a result of treatment with a corresponding 
therapeutic product.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The intended use of the device must specify the target HLA 
allele(s) or antigen(s), the patient population(s), and the 
corresponding therapeutic product(s).
    (2) Design verification and validation must include:
    (i) Detailed documentation of an analytical accuracy study that uses 
well-characterized samples including clinical samples from intended use 
population(s) focusing on the target allele(s) needed for patient 
selection;
    (ii) Detailed documentation of precision studies (repeatability, 
reproducibility) that evaluate possible sources of variation that may 
affect test results;
    (iii) Detailed documentation of a study determining range of input 
sample concentrations that meet performance specifications;
    (iv) Detailed description of the ambiguity resolution method, if 
applicable;

[[Page 420]]

    (v) For a sequencing-based assay, documentation of coverage and 
predefined coverage threshold of target genomic regions, pertinent 
variant types, and sequence contexts;
    (vi) For multiplex assays, documentation of a risk assessment and 
design specifications that are in place to prevent incorrect reactivity 
assignment;
    (vii) Description of a plan on how to ensure the performance of the 
device does not change when new HLA alleles are identified, and/or when 
reactivity assignments are changed; and
    (viii) Detailed description of device software including standalone 
software, or software and bioinformatics analysis pipeline, if 
applicable, incorporated in the instruments, and documentation of 
software including the level of concern and associated risks, software 
requirement specifications, software design specifications (e.g., 
algorithms, alarms and device limitations), hazard analysis, 
traceability matrix, verification and validation testing, unresolved 
anomalies, hardware requirements, and effective cybersecurity 
management.
    (3) Clinical validity data (which may include summary reports from 
clinical trials, comparison studies using clinical samples, or through 
an alternative approach determined to be appropriate by FDA), 
demonstrating the following, as applicable:
    (i) Which patients identified by the HLA CDx test are most likely to 
benefit from the corresponding therapeutic product; and
    (ii) Which patients identified by the HLA CDx test are likely to be 
at increased risk for serious adverse reactions as a result of treatment 
with the corresponding therapeutic product.
    (4) If the HLA test used in the clinical trials is different from 
the HLA CDx test in the premarket notification submission, the 
submission must include results of a bridging study, or an alternative 
approach determined to be appropriate by FDA.

[87 FR 79252, Dec. 27, 2022]



      Subpart G_Tumor Associated Antigen immunological Test Systems



Sec. 866.6010  Tumor-associated antigen immunological test system.

    (a) Identification. A tumor-associated antigen immunological test 
system is a device that consists of reagents used to qualitatively or 
quantitatively measure, by immunochemical techniques, tumor-associated 
antigens in serum, plasma, urine, or other body fluids. This device is 
intended as an aid in monitoring patients for disease progress or 
response to therapy or for the detection of recurrent or residual 
disease.
    (b) Classification. Class II (special controls). Tumor markers must 
comply with the following special controls: (1) A guidance document 
entitled ``Guidance Document for the Submission of Tumor Associated 
Antigen Premarket Notifications (510(k)s) to FDA,'' and (2) voluntary 
assay performance standards issued by the National Committee on Clinical 
Laboratory Standards.

[62 FR 66005, Dec. 17, 1997]



Sec. 866.6020  Immunomagnetic circulating cancer cell selection 
and enumeration system.

    (a) Identification. An immunomagnetic circulating cancer cell 
selection and enumeration system is a device that consists of biological 
probes, fluorochromes, and other reagents; preservation and preparation 
devices; and a semiautomated analytical instrument to select and count 
circulating cancer cells in a prepared sample of whole blood. This 
device is intended for adjunctive use in monitoring or predicting cancer 
disease progression, response to therapy, and for the detection of 
recurrent disease.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's guidance document entitled ``Class II Special 
Controls Guidance Document: Immunomagnetic Circulating Cancer Cell 
Selection and Enumeration System.'' See Sec. 866.1(e) for availability 
of this guidance document.

[69 FR 26038, May 11, 2004]

[[Page 421]]



Sec. 866.6030  AFP-L3% immunological test system.

    (a) Identification. An AFP-L3% immunological test system is an in 
vitro device that consists of reagents and an automated instrument used 
to quantitatively measure, by immunochemical techniques, AFP and AFP-L3 
subfraction in human serum. The device is intended for in vitro 
diagnostic use as an aid in the risk assessment of patients with chronic 
liver disease for development of hepatocellular carcinoma, in 
conjunction with other laboratory findings, imaging studies, and 
clinical assessment.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance document entitled ``Class II Special Controls Guidance 
Document: AFP-L3% Immunological Test Systems.'' See Sec. 866.1(e) for 
the availability of this guidance document.

[70 FR 57749, Oct. 4, 2005]



Sec. 866.6040  Gene expression profiling test system for breast 
cancer prognosis.

    (a) Identification. A gene expression profiling test system for 
breast cancer prognosis is a device that measures the ribonucleic acid 
(RNA) expression level of multiple genes and combines this information 
to yield a signature (pattern or classifier or index) to aid in 
prognosis of previously diagnosed breast cancer.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance document entitled ``Class II Special Controls Guidance 
Document: Gene Expression Profiling Test System for Breast Cancer 
Prognosis.'' See Sec. 866.1(e) for the availability of this guidance 
document.

[72 FR 26291, May 9, 2007]



Sec. 866.6050  Ovarian adnexal mass assessment score test system.

    (a) Identification. An ovarian/adnexal mass assessment test system 
is a device that measures one or more proteins in serum or plasma. It 
yields a single result for the likelihood that an adnexal pelvic mass in 
a woman, for whom surgery is planned, is malignant. The test is for 
adjunctive use, in the context of a negative primary clinical and 
radiological evaluation, to augment the identification of patients whose 
gynecologic surgery requires oncology expertise and resources.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's guidance document entitled ``Class II Special 
Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test 
System.'' For the availability of this guidance document, see Sec. 
866.1(e).
    (c) Black box warning. Under section 520(e) of the Federal Food, 
Drug, and Cosmetic Act these devices are subject to the following 
restriction: A warning statement must be placed in a black box and must 
appear in all advertising, labeling, and promotional material for these 
devices. That warning statement must read:
[GRAPHIC] [TIFF OMITTED] TR30DE11.007


[[Page 422]]



[76 FR 16294, Mar. 23, 2011, as amended at 76 FR 82131, Dec. 30, 2011]



Sec. 866.6060  BCR-ABL quantitation test.

    (a) Identification. A BCR-ABL quantitation test is identified as a 
reverse transcription-quantitative polymerase chain reaction (RT-qPCR) 
test for the quantitation of BCR-ABL1 expressed on the International 
Scale (IS) and control transcripts in total RNA from whole blood of 
diagnosed t(9;22) positive chronic myeloid leukemia (CML) patients 
during monitoring of treatment with tyrosine kinase inhibitors. This 
test is not intended for the diagnosis of CML.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Premarket notification submissions must include the following 
information:
    (i) The indication for use must indicate the variant(s) for which 
the assay was designed and validated, for example BCR-ABL e13a2 and/or 
e14a2.
    (ii) A detailed description of all components in the test, including 
the following:
    (A) A detailed description of the test components, all required 
reagents, instrumentation and equipment, including illustrations or 
photographs of non-standard equipment or methods;
    (B) Detailed documentation of the device software including, but not 
limited to, standalone software applications and hardware-based devices 
that incorporate software;
    (C) Methodology and protocols for control procedures for the assay 
to allow reporting on the International Scale;
    (D) A description of the result outputs, analytical sensitivity of 
the assay, and the range of values that will be reported; and
    (E) A description of appropriate internal and external controls that 
are recommended or provided. The description must identify those control 
elements that are incorporated into the testing procedure.
    (iii) Information that demonstrates the performance characteristics 
of the test, including:
    (A) For indications for use based on a threshold established in a 
predicate device of this generic type, device performance data from 
either a method comparison study to the predicate device or through a 
clinical study demonstrating clinical validity using well-characterized 
prospectively or retrospectively obtained clinical specimens, as 
appropriate, representative of the intended use population;
    (B) For indications for use based on a threshold not established in 
a predicate device of this generic type, device performance data from a 
clinical study demonstrating clinical validity using well-characterized 
prospectively or retrospectively obtained clinical specimens, as 
appropriate, representative of the intended use population;
    (C) Device reproducibility data generated, using a minimum of three 
sites, of which at least two sites must be external sites, with two 
operators at each site. Each site must conduct a minimum of three runs 
per operator over non-consecutive days evaluating a minimum of five 
different BCR-ABL concentrations that span and are well distributed over 
the measuring range and include MR3 (0.1 percent IS). Results shall be 
reported as the standard deviation and percentage coefficient of 
variation for each level tested. Prespecified acceptance criteria must 
be provided and followed;
    (D) Device precision data using clinical samples to evaluate the 
within-lot, between-lot, within-run, between run, and total variation;
    (E) Device linearity data using a dilution panel created from 
clinical samples;
    (F) Device analytic sensitivity data, including limit of blank, 
limit of detection, and limit of quantification;
    (G) Device specificity data, including interference and cross-
contamination; and
    (H) Device stability data, including real-time stability of samples 
under various storage times, temperatures, and freeze-thaw conditions.
    (iv) Identification of risk mitigation elements used by your device, 
including a detailed description of all additional procedures, methods, 
and practices incorporated into the instructions for use that mitigate 
risks associated with testing using your device.

[[Page 423]]

    (2) Your 21 CFR 809.10 compliant labeling must include the 
following:
    (i) The intended use in your 21 CFR 809.10(a)(2) and (b)(2) 
complaint labeling must include an indication for use statement that 
reads ``This test is not intended for the diagnosis of CML''; and
    (ii) A detailed description of the performance studies conducted to 
comply with paragraph (b)(1)(iii) of this section and a summary of the 
results.
    (3) Your device output must include results on the International 
Scale (IS) and your assay must include multipoint calibration controls 
traceable to a relevant international reference panel (e.g., the World 
Health Organization International Genetic Reference Panel for 
quantitation of BCR-ABL mRNA).

[82 FR 50532, Nov. 1, 2017]



Sec. 866.6080  Next generation sequencing based tumor profiling test.

    (a) Identification. A next generation sequencing (NGS) based tumor 
profiling test is a qualitative in vitro diagnostic test intended for 
NGS analysis of tissue specimens from malignant solid neoplasms to 
detect somatic mutations in a broad panel of targeted genes to aid in 
the management of previously diagnosed cancer patients by qualified 
health care professionals.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Premarket notification submissions must include the following 
information:
    (i) A detailed description of all somatic mutations that are 
intended to be detected by the test and that are adequately supported in 
accordance with paragraph (b)(1)(v) of this section and reported in the 
test results in accordance with paragraph (b)(2)(iv) of this section, 
including:
    (A) A listing of mutations that are cancer mutations with evidence 
of clinical significance.
    (B) As appropriate, a listing of mutations that are cancer mutations 
with potential clinical significance.
    (ii) The indications for use must specify the following:
    (A) The test is indicated for previously diagnosed cancer patients.
    (B) The intended specimen type(s) and matrix (e.g., formalin-fixed, 
paraffin-embedded tumor tissue).
    (C) The mutation types (e.g., single nucleotide variant, insertion, 
deletion, copy number variation or gene rearrangement) for which 
validation data has been provided.
    (D) The name of the testing facility or facilities, as applicable.
    (iii) A detailed device description including the following:
    (A) A description of the test in terms of genomic coverage, as 
follows:
    (1) Tabulated summary of all mutations reported, grouped according 
to gene and target region within each gene, along with the specific cDNA 
and amino acid positions for each mutation.
    (2) A description of any within-gene targeted regions that cannot be 
reported and the data behind such conclusion.
    (B) Specifications for specimen requirements including any specimen 
collection devices and preservatives, specimen volume, minimum tumor 
content, specimen handling, DNA extraction, and criteria for DNA quality 
and quantity metrics that are prerequisite to performing the assay.
    (C) A detailed description of all test components, reagents, 
instrumentation, and software required. Detailed documentation of the 
device software including but not limited to, software applications and 
hardware-based devices that incorporate software.
    (D) A detailed description of the methodology and protocols for each 
step of the test, including description of the quality metrics, 
thresholds, and filters at each step of the test that are implemented 
for final result reporting and a description of the metrics for run-
failures, specimen-failures, invalids, as applicable.
    (E) A list of links provided by the device to the user or accessed 
by the device for internal or external information (e.g., decision rules 
or databases) supporting clinical significance of test results for the 
panel or its elements in accordance with paragraphs (b)(1)(v) and 
(b)(2)(vi) of this section.
    (F) A description of internal and external controls that are 
recommended or provided and control procedures.

[[Page 424]]

The description must identify those control elements that are 
incorporated into the testing procedure.
    (iv) Information demonstrating analytical validity of the device 
according to analytical performance characteristics, evaluated either 
specifically for each gene/mutation or, when clinically and practically 
justified, using a representative approach based on other mutations of 
the same type, including:
    (A) Data that adequately supports the intended specimen type (e.g., 
formalin-fixed, paraffin-embedded tumor tissue), specimen handling 
protocol, and nucleic acid purification for specific tumor types or for 
a pan-tumor claim.
    (B) A summary of the empirical evidence obtained to demonstrate how 
the analytical quality metrics and thresholds were optimized.
    (C) Device precision data using clinical samples to adequately 
evaluate intra-run, inter-run, and total variability. The samples must 
cover all mutation types tested (both positive and negative samples) and 
include samples near the limit of detection of the device. Precision 
must be assessed by agreement within replicates on the assay final 
result for each representative mutation, as applicable, and also 
supported by sequencing quality metrics for targeted regions across the 
panel.
    (D) Description of the protocols and/or data adequately 
demonstrating the interchangeability of reagent lots and multiplexing 
barcodes.
    (E) A description of the nucleic acid assay input concentration 
range and the evidence to adequately support the range.
    (F) A description of the data adequately supporting the limit of 
detection of the device.
    (G) A description of the data to adequately support device accuracy 
using clinical specimens representing the intended specimen type and 
range of tumor types, as applicable.
    (1) Clinical specimens tested to support device accuracy must 
adequately represent the list of cancer mutations with evidence of 
clinical significance to be detected by the device.
    (2) For mutations that are designated as cancer mutations with 
evidence of clinical significance and that are based on evidence 
established in the intended specimen type (e.g., tumor tissues) but for 
a different analyte type (e.g., protein, RNA) and/or a measurement 
(e.g., incorporating a score or copy number) and/or with an alternative 
technology (e.g., IHC, RT-qPCR, FISH), evidence of accuracy must include 
clinically adequate concordance between results for the mutation and the 
medically established biomarker test (e.g., evidence generated from an 
appropriately sized method comparison study using clinical specimens 
from the target population).
    (3) For qualitative DNA mutations not described in paragraph 
(b)(1)(iv)(G)(2) of this section, accuracy studies must include both 
mutation-positive and wild-type results.
    (H) Adequate device stability information.
    (v) Information that adequately supports the clinical significance 
of the panel must include:
    (A) Criteria established on what types and levels of evidence will 
clinically validate a mutation as a cancer mutation with evidence of 
clinical significance versus a cancer mutation with potential clinical 
significance.
    (B) For representative mutations of those designated as cancer 
mutations with evidence of clinical significance, a description of the 
clinical evidence associated with such mutations, such as clinical 
evidence presented in professional guidelines, as appropriate, with 
method comparison performance data as described in paragraph 
(b)(1)(iv)(G) of this section.
    (C) For all other mutations designated as cancer mutations with 
potential clinical significance, a description of the rationale for 
reporting.
    (2) The 21 CFR 809.10 compliant labeling and any product information 
and test report generated, must include the following, as applicable:
    (i) The intended use statement must specify the following:
    (A) The test is indicated for previously diagnosed cancer patients.
    (B) The intended specimen type(s) and matrix (e.g., formalin-fixed, 
paraffin-embedded tumor tissue).
    (C) The mutation types (e.g., single nucleotide variant, insertion, 
deletion,

[[Page 425]]

copy number variation or gene rearrangement) for which validation data 
has been provided.
    (D) The name of the testing facility or facilities, as applicable.
    (ii) A description of the device and summary of the results of the 
performance studies performed in accordance with paragraphs (b)(1)(iii), 
(b)(1)(iv), and (b)(1)(v) of this section.
    (iii) A description of applicable test limitations, including, for 
device specific mutations validated with method comparison data to a 
medically established test in the same intended specimen type, 
appropriate description of the level of evidence and/or the differences 
between next generation sequencing results and results from the 
medically established test (e.g., as described in professional 
guidelines).
    (iv) A listing of all somatic mutations that are intended to be 
detected by the device and that are reported in the test results under 
the following two categories or equivalent designations, as appropriate: 
``cancer mutations panel with evidence of clinical significance'' or 
``cancer mutations panel with potential clinical significance.''
    (v) For mutations reported under the category of ``cancer mutations 
panel with potential clinical significance,'' a limiting statement that 
states ``For the mutations listed in [cancer mutations panel with 
potential clinical significance or equivalent designation], the clinical 
significance has not been demonstrated [with adequate clinical evidence 
(e.g., by professional guidelines) in accordance with paragraph 
(b)(1)(v) of this section] or with this test.''
    (vi) For mutations under the category of ``cancer mutations panel 
with evidence of clinical significance,'' or equivalent designation, 
link(s) for physicians to access internal or external information 
concerning decision rules or conclusions about the level of evidence for 
clinical significance that is associated with the marker in accordance 
with paragraph (b)(1)(v) of this section.

[83 FR 28995, June 22, 2018]



PART 868_ANESTHESIOLOGY DEVICES--Table of Contents



                      Subpart A_General Provisions

Sec.
868.1 Scope.
868.3 Effective dates of requirement for premarket approval.
868.9 Limitations of exemptions from section 510(k) of the Federal Food, 
          Drug, and Cosmetic Act (the act).

                      Subpart B_Diagnostic Devices

868.1030 Manual algesimeter.
868.1040 Powered algesimeter.
868.1075 Argon gas analyzer.
868.1100 Arterial blood sampling kit.
868.1120 Indwelling blood oxyhemoglobin concentration analyzer.
868.1150 Indwelling blood carbon dioxide partial pressure 
          (PCO2) analyzer.
868.1170 Indwelling blood hydrogen ion concentration (pH) analyzer.
868.1200 Indwelling blood oxygen partial pressure (PO2) 
          analyzer.
868.1400 Carbon dioxide gas analyzer.
868.1430 Carbon monoxide gas analyzer.
868.1500 Enflurane gas analyzer.
868.1505 Ventilatory electrical impedance tomograph.
868.1575 Gas collection vessel.
868.1620 Halothane gas analyzer.
868.1640 Helium gas analyzer.
868.1670 Neon gas analyzer.
868.1690 Nitrogen gas analyzer.
868.1700 Nitrous oxide gas analyzer.
868.1720 Oxygen gas analyzer.
868.1730 Oxygen uptake computer.
868.1750 Pressure plethysmograph.
868.1760 Volume plethysmograph.
868.1780 Inspiratory airway pressure meter.
868.1800 Rhinoanemometer.
868.1840 Diagnostic spirometer.
868.1850 Monitoring spirometer.
868.1860 Peak-flow meter for spirometry.
868.1870 Gas volume calibrator.
868.1880 Pulmonary-function data calculator.
868.1890 Predictive pulmonary-function value calculator.
868.1900 Diagnostic pulmonary-function interpretation calculator.
868.1910 Esophageal stethoscope.
868.1920 Esophageal stethoscope with electrical conductors.
868.1930 Stethoscope head.
868.1965 Switching valve (ploss).
868.1975 Water vapor analyzer.

                      Subpart C_Monitoring Devices

868.2025 Ultrasonic air embolism monitor.
868.2300 Bourdon gauge flowmeter.
868.2320 Uncompensated thorpe tube flowmeter.

[[Page 426]]

868.2340 Compensated thorpe tube flowmeter.
868.2350 Gas calibration flowmeter.
868.2375 Breathing frequency monitor.
868.2377 Apnea monitor.
868.2380 Nitric oxide analyzer.
868.2385 Nitrogen dioxide analyzer.
868.2450 Lung water monitor.
868.2480 Cutaneous carbon dioxide (PcCO2) monitor.
868.2500 Cutaneous oxygen (PcO2) monitor.
868.2550 Pneumotachometer.
868.2600 Airway pressure monitor.
868.2610 Gas pressure gauge.
868.2620 Gas pressure calibrator.
868.2700 Pressure regulator.
868.2775 Electrical peripheral nerve stimulator.
868.2875 Differential pressure transducer.
868.2885 Gas flow transducer.
868.2900 Gas pressure transducer.

Subparts D-E [Reserved]

                      Subpart F_Therapeutic Devices

868.5090 Emergency airway needle.
868.5095 Retrograde intubation device.
868.5100 Nasopharyngeal airway.
868.5105 External negative pressure airway aid.
868.5110 Oropharyngeal airway.
868.5115 Device to relieve acute upper airway obstruction.
868.5120 Anesthesia conduction catheter.
868.5130 Anesthesia conduction filter.
868.5140 Anesthesia conduction kit.
868.5150 Anesthesia conduction needle.
868.5160 Gas machine for anesthesia or analgesia.
868.5165 Nitric oxide administration apparatus.
868.5170 Laryngotracheal topical anesthesia applicator.
868.5180 Rocking bed.
868.5220 Blow bottle.
868.5240 Anesthesia breathing circuit.
868.5250 Breathing circuit circulator.
868.5260 Breathing circuit bacterial filter.
868.5270 Breathing system heater.
868.5273 Positive airway pressure delivery system.
868.5280 Breathing tube support.
868.5300 Carbon dioxide absorbent.
868.5310 Carbon dioxide absorber.
868.5320 Reservoir bag.
868.5330 Breathing gas mixer.
868.5340 Nasal oxygen cannula.
868.5350 Nasal oxygen catheter.
868.5365 Posture chair for cardiac or pulmonary treatment.
868.5375 Heat and moisture condenser (artificial nose).
868.5400 Electroanesthesia apparatus.
868.5420 Ether hook.
868.5430 Gas-scavenging apparatus.
868.5440 Portable oxygen generator.
868.5450 Respiratory gas humidifier.
868.5454 High flow humidified oxygen delivery device.
868.5460 Therapeutic humidifier for home use.
868.5470 Hyperbaric chamber.
868.5480 Isocapnic ventilation device.
868.5530 Flexible laryngoscope.
868.5540 Rigid laryngoscope.
868.5550 Anesthetic gas mask.
868.5560 Gas mask head strap.
868.5570 Nonrebreathing mask.
868.5580 Oxygen mask.
868.5590 Scavenging mask.
868.5600 Venturi mask.
868.5620 Breathing mouthpiece.
868.5630 Nebulizer.
868.5640 Medicinal nonventilatory nebulizer (atomizer).
868.5650 Esophageal obturator.
868.5655 Portable liquid oxygen unit.
868.5665 Powered percussor.
868.5675 Rebreathing device.
868.5690 Incentive spirometer.
868.5700 Nonpowered oxygen tent.
868.5710 Electrically powered oxygen tent.
868.5720 Bronchial tube.
868.5730 Tracheal tube.
868.5740 Tracheal/bronchial differential ventilation tube.
868.5750 Inflatable tracheal tube cuff.
868.5760 Cuff spreader.
868.5770 Tracheal tube fixation device.
868.5780 Tube introduction forceps.
868.5790 Tracheal tube stylet.
868.5795 Tracheal tube cleaning brush.
868.5800 Tracheostomy tube and tube cuff.
868.5810 Airway connector.
868.5820 Dental protector.
868.5830 Autotransfusion apparatus.
868.5860 Pressure tubing and accessories.
868.5870 Nonrebreathing valve.
868.5880 Anesthetic vaporizer.
868.5895 Continuous ventilator.
868.5905 Noncontinuous ventilator (IPPB).
868.5915 Manual emergency ventilator.
868.5925 Powered emergency ventilator.
868.5935 External negative pressure ventilator.
868.5955 Intermittent mandatory ventilation attachment.
868.5965 Positive end expiratory pressure breathing attachment.
868.5975 Ventilator tubing.
868.5995 Tee drain (water trap).

                         Subpart G_Miscellaneous

868.6100 Anesthetic cabinet, table, or tray.
868.6175 Cardiopulmonary emergency cart.
868.6225 Nose clip.
868.6250 Portable air compressor.
868.6400 Calibration gas.
868.6700 Anesthesia stool.
868.6810 Tracheobronchial suction catheter.
868.6820 Patient position support.
868.6885 Medical gas yoke assembly.


[[Page 427]]


    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    Source: 47 FR 31142, July 16, 1982, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 868 appear at 73 FR 
35341, June 23, 2008.



                      Subpart A_General Provisions



Sec. 868.1  Scope.

    (a) This part sets forth the classification of anesthesiology 
devices intended for human use that are in commercial distribution.
    (b) The identification of a device in a regulation in this part is 
not a precise description of every device that is, or will be, subject 
to the regulation. A manufacturer who submits a premarket notification 
submission for a device under part 807 may not show merely that the 
device is accurately described by the section title and identification 
provisions of a regulation in this part, but shall state why the device 
is substantially equivalent to other devices, as required by Sec. 
807.87.
    (c) To avoid duplicative listings, an anesthesiology device that has 
two or more types of uses (e.g., used both as a diagnostic device and as 
a therapeutic device) is listed only in one subpart.
    (d) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.
    (e) Guidance documents referenced in this part are available on the 
Internet at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/default.htm.

[52 FR 17734, May 11, 1987, as amended at 67 FR 76681, Dec. 13, 2002; 78 
FR 18233, Mar. 26, 2013]



Sec. 868.3  Effective dates of requirement for premarket approval.

    A device included in this part that is classified into class III 
(premarket approval) shall not be commercially distributed after the 
date shown in the regulation classifying the device unless the 
manufacturer has an approval under section 515 of the act (unless an 
exemption has been granted under section 520(g)(2) of the act). An 
approval under section 515 of the act consists of FDA's issuance of an 
order approving an application for premarket approval (PMA) for the 
device or declaring completed a product development protocol (PDP) for 
the device.
    (a) Before FDA requires that a device commercially distributed 
before the enactment date of the amendments, or a device that has been 
found substantially equivalent to such a device, has an approval under 
section 515 of the act FDA must promulgate a regulation under section 
515(b) of the act requiring such approval, except as provided in 
paragraph (b) of this section. Such a regulation under section 515(b) of 
the act shall not be effective during the grace period ending on the 
90th day after its promulgation or on the last day of the 30th full 
calendar month after the regulation that classifies the device into 
class III is effective, whichever is later. See section 501(f)(2)(B) of 
the act. Accordingly, unless an effective date of the requirement for 
premarket approval is shown in the regulation for a device classified 
into class III in this part, the device may be commercially distributed 
without FDA's issuance of an order approving a PMA or declaring 
completed a PDP for the device. If FDA promulgates a regulation under 
section 515(b) of the act requiring premarket approval for a device, 
section 501(f)(1)(A) of the act applies to the device.
    (b) Any new, not substantially equivalent, device introduced into 
commercial distribution on or after May 28, 1976, including a device 
formerly marketed that has been substantially altered, is classified by 
statute (section 513(f) of the act) into class III without any grace 
period and FDA must have issued an order approving a PMA or declaring 
completed a PDP for the device before the device is commercially 
distributed unless it is reclassified. If FDA knows that a device being 
commercially distributed may be a ``new'' device as defined in this 
section because of any new intended use or other reasons, FDA may codify 
the statutory classification of the device into class III for such new 
use. Accordingly, the regulation for such a class III device states that 
as of the enactment date of

[[Page 428]]

the amendments, May 28, 1976, the device must have an approval under 
section 515 of the act before commercial distribution.

[52 FR 17734, May 11, 1987]



Sec. 868.9  Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    The exemption from the requirement of premarket notification 
(section 510(k) of the act) for a generic type of class I or II device 
is only to the extent that the device has existing or reasonably 
foreseeable characteristics of commercially distributed devices within 
that generic type or, in the case of in vitro diagnostic devices, only 
to the extent that misdiagnosis as a result of using the device would 
not be associated with high morbidity or mortality. Accordingly, 
manufacturers of any commercially distributed class I or II device for 
which FDA has granted an exemption from the requirement of premarket 
notification must still submit a premarket notification to FDA before 
introducing or delivering for introduction into interstate commerce for 
commercial distribution the device when:
    (a) The device is intended for a use different from the intended use 
of a legally marketed device in that generic type of device; e.g., the 
device is intended for a different medical purpose, or the device is 
intended for lay use where the former intended use was by health care 
professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro diagnostic 
device detects or identifies infectious agents by using deoxyribonucleic 
acid (DNA) probe or nucleic acid hybridization technology rather than 
culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of neoplastic 
diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial or acquired 
genetic disorders, including inborn errors of metabolism;
    (3) For measuring an analyte that serves as a surrogate marker for 
screening, diagnosis, or monitoring life-threatening diseases such as 
acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, 
tuberculosis, or myocardial infarction or to monitor therapy;
    (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) or IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is intended 
for use in matrices other than serum or plasma;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).

[65 FR 2313, Jan. 14, 2000]



                      Subpart B_Diagnostic Devices



Sec. 868.1030  Manual algesimeter.

    (a) Identification. A manual algesimeter is a mechanical device 
intended to determine a patient's sensitivity to pain after 
administration of an anesthetic agent, e.g., by pricking with a sharp 
point.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[54 FR 25048, June 12, 1989, as amended at 66 FR 38793, July 25, 2001]

[[Page 429]]



Sec. 868.1040  Powered algesimeter.

    (a) Identification. A powered algesimeter is a device using 
electrical stimulation intended to determine a patient's sensitivity to 
pain after administration of an anesthetic agent.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 84 FR 71811, Dec. 30, 2019]



Sec. 868.1075  Argon gas analyzer.

    (a) Identification. An argon gas analyzer is a device intended to 
measure the concentration of argon in a gas mixture to aid in 
determining the patient's ventilatory status. The device may use 
techniques such as mass spectrometry or thermal conductivity.
    (b) Classification. Class II (performance standards).



Sec. 868.1100  Arterial blood sampling kit.

    (a) Identification. An arterial blood sampling kit is a device, in 
kit form, used to obtain arterial blood samples from a patient for blood 
gas determinations. The kit may include a syringe, needle, cork, and 
heparin.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 
FR 38793, July 25, 2001]



Sec. 868.1120  Indwelling blood oxyhemoglobin concentration analyzer.

    (a) Identification. An indwelling blood oxyhemoglobin concentration 
analyzer is a photoelectric device used to measure, in vivo, the oxygen-
carrying capacity of hemoglobin in blood to aid in determining the 
patient's physiological status.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before September 21, 2004, for any indwelling 
blood oxyhemoglobin concentration analyzer that was in commercial 
distribution before May 28, 1976, or that has, on or before September 
21, 2004, been found to be substantially equivalent to an indwelling 
blood oxyhemoglobin concentration analyzer that was in commercial 
distribution before May 28, 1976. Any other indwelling blood 
oxyhemoglobin concentration analyzer shall have an approved PMA or 
declared completed PDP in effect before being placed in commercial 
distribution.

[47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 52 
FR 22577, June 12, 1987; 69 FR 34920, June 23, 2004]



Sec. 868.1150  Indwelling blood carbon dioxide partial pressure
(P2CO2) analyzer.

    (a) Identification. An indwelling blood carbon dioxide partial 
pressure PCO2 analyzer is a device that consists of a 
catheter-tip PCO2 transducer (e.g., PCO2 
electrode) and that is used to measure, in vivo, the partial pressure of 
carbon dioxide in blood to aid in determining the patient's circulatory, 
ventilatory, and metabolic status.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's ``Class II Special Controls Guidance Document: 
Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.''

[47 FR 31142, July 16, 1982; 47 FR 40410, Sept. 14, 1982, as amended at 
52 FR 17735, May 11, 1987; 66 FR 57368, Nov. 15, 2001]



Sec. 868.1170  Indwelling blood hydrogen ion concentration (pH) analyzer.

    (a) Identification. An indwelling blood hydrogen ion concentration 
(pH) analyzer is a device that consists of a catheter-tip pH electrode 
and that is used to measure, in vivo, the hydrogen ion concentration 
(pH) in blood to aid in determining the patient's acid-base balance.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's ``Class II Special Controls Guidance Document: 
Indwelling

[[Page 430]]

Blood Gas Analyzers; Final Guidance for Industry and FDA.''

[47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 66 
FR 57368, Nov. 15, 2001]



Sec. 868.1200  Indwelling blood oxygen partial pressure (PO2) analyzer.

    (a) Identification. An indwelling blood oxygen partial pressure 
(PO2) analyzer is a device that consists of a catheter-tip 
PO2 transducer (e.g., PO2 electrode) and that is 
used to measure, in vivo, the partial pressure of oxygen in blood to aid 
in determining the patient's circulatory, ventilatory, and metabolic 
status.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's ``Class II Special Controls Guidance Document: 
Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.''

[47 FR 31142, July 16, 1982; 47 FR 40410, Sept. 14, 1982, as amended at 
52 FR 17735, May 11, 1987; 66 FR 57368, Nov. 15, 2001]



Sec. 868.1400  Carbon dioxide gas analyzer.

    (a) Identification. A carbon dioxide gas analyzer is a device 
intended to measure the concentration of carbon dioxide in a gas mixture 
to aid in determining the patient's ventilatory, circulatory, and 
metabolic status. The device may use techniques such as chemical 
titration, absorption of infrared radiation, gas chromatography, or mass 
spectrometry.
    (b) Classification. Class II (performance standards).



Sec. 868.1430  Carbon monoxide gas analyzer.

    (a) Identification. A carbon monoxide gas analyzer is a device 
intended to measure the concentration of carbon monoxide in a gas 
mixture to aid in determining the patient's ventilatory status. The 
device may use techniques such as infrared absorption or gas 
chromatography.
    (b) Classification. Class II (performance standards).



Sec. 868.1500  Enflurane gas analyzer.

    (a) Identification. An enflurane gas analyzer is a device intended 
to measure the concentration of enflurane anesthetic in a gas mixture.
    (b) Classification. Class II (performance standards).



Sec. 868.1505  Ventilatory electrical impedance tomograph.

    (a) Identification. A ventilatory electrical impedance tomograph is 
a prescription non-invasive, non-radiological ventilatory device that 
provides an assessment of local impedance variation within a cross-
section of a patient's thorax.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use, 
including the following:
    (i) Characterization of device parameters, including signal-to-noise 
ratio, voltage accuracy, drift, reciprocity accuracy, amplitude 
response, position error, and ringing;
    (ii) Real time evaluation of local impedance variation;
    (iii) Plethysmogram accuracy testing; and
    (iv) Use life testing of reusable components.
    (3) Performance data must validate reprocessing instructions for any 
reusable components of the device.
    (4) Performance data must demonstrate the electrical, thermal, and 
mechanical safety and the electromagnetic compatibility of the device.
    (5) Software verification, validation, and hazard analysis must be 
performed.
    (6) Labeling must include the following:
    (i) Guidance for interpretation of the images generated;
    (ii) A warning that the device should be removed before use of a 
defibrillator, or defibrillator interaction information based on 
defibrillator performance testing with the device;
    (iii) A use life for any reusable components; and

[[Page 431]]

    (iv) Instructions for reprocessing any reusable components.

[84 FR 15098, Apr. 15, 2019]



Sec. 868.1575  Gas collection vessel.

    (a) Identification. A gas collection vessel is a container-like 
device intended to collect a patient's exhaled gases for subsequent 
analysis. It does not include a sampling pump.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 
FR 38793, July 25, 2001]



Sec. 868.1620  Halothane gas analyzer.

    (a) Identification. A halothane gas analyzer is a device intended to 
measure the concentration of halothane anesthetic in a gas mixture. The 
device may use techniques such as mass spectrometry or absorption of 
infrared or ultraviolet radiation.
    (b) Classification. Class II (performance standards).



Sec. 868.1640  Helium gas analyzer.

    (a) Identification. A helium gas analyzer is a device intended to 
measure the concentration of helium in a gas mixture during pulmonary 
function testing. The device may use techniques such as thermal 
conductivity, gas chromatography, or mass spectrometry.
    (b) Classification. Class II (performance standards).



Sec. 868.1670  Neon gas analyzer.

    (a) Identification. A neon gas analyzer is a device intended to 
measure the concentration of neon in a gas mixture exhaled by a patient. 
The device may use techniques such as mass spectrometry or thermal 
conductivity.
    (b) Classification. Class II (performance standards).



Sec. 868.1690  Nitrogen gas analyzer.

    (a) Identification. A nitrogen gas analyzer is a device intended to 
measure the concentration of nitrogen in respiratory gases to aid in 
determining a patient's ventilatory status. The device may use 
techniques such as gas chromatography or mass spectrometry.
    (b) Classification. Class II (performance standards).



Sec. 868.1700  Nitrous oxide gas analyzer.

    (a) Identification. A nitrous oxide gas analyzer is a device 
intended to measure the concentration of nitrous oxide anesthetic in a 
gas mixture. The device may use techniques such as infrared absorption 
or mass spectrometry.
    (b) Classification. Class II (performance standards).



Sec. 868.1720  Oxygen gas analyzer.

    (a) Identification. An oxygen gas analyzer is a device intended to 
measure the concentration of oxygen in respiratory gases by techniques 
such as mass spectrometry, polarography, thermal conductivity, or gas 
chromatography. This generic type of device also includes paramagnetic 
analyzers.
    (b) Classification. Class II (performance standards).



Sec. 868.1730  Oxygen uptake computer.

    (a) Identification. An oxygen uptake computer is a device intended 
to compute the amount of oxygen consumed by a patient and may include 
components for determining expired gas volume and composition.
    (b) Classification. Class II (performance standards).



Sec. 868.1750  Pressure plethysmograph.

    (a) Identification. A pressure plethysmograph is a device used to 
determine a patient's airway resistance and lung volumes by measuring 
pressure changes while the patient is in an airtight box.
    (b) Classification. Class II (performance standards).



Sec. 868.1760  Volume plethysmograph.

    (a) Identification. A volume plethysmograph is an airtight box, in 
which a patient sits, that is used to determine the patient's lung 
volume changes.
    (b) Classification. Class II (performance standards).

[[Page 432]]



Sec. 868.1780  Inspiratory airway pressure meter.

    (a) Identification. An inspiratory airway pressure meter is a device 
used to measure the amount of pressure produced in a patient's airway 
during maximal inspiration.
    (b) Classification. Class II (performance standards).



Sec. 868.1800  Rhinoanemometer.

    (a) Identification. A rhinoanemometer is a device used to quantify 
the amount of nasal congestion by measuring the airflow through, and 
differential pressure across, a patient's nasal passages.
    (b) Classification. Class II (performance standards).



Sec. 868.1840  Diagnostic spirometer.

    (a) Identification. A diagnostic spirometer is a device used in 
pulmonary function testing to measure the volume of gas moving in or out 
of a patient's lungs.
    (b) Classification. Class II (performance standards).



Sec. 868.1850  Monitoring spirometer.

    (a) Identification. A monitoring spirometer is a device used to 
measure continuously a patient's tidal volume (volume of gas inhaled by 
the patient during each respiration cycle) or minute volume (the tidal 
volume multiplied by the rate of respiration for 1 minute) for the 
evaluation of the patient's ventilatory status.
    (b) Classification. Class II (performance standards).



Sec. 868.1860  Peak-flow meter for spirometry.

    (a) Identification. A peak-flow meter for spirometry is a device 
used to measure a patient's maximum ventilatory flow rate.
    (b) Classification. Class II (performance standards).



Sec. 868.1870  Gas volume calibrator.

    (a) Identification. A gas volume calibrator is a device that is 
intended for medical purposes and that is used to calibrate the output 
of gas volume measurement instruments by delivering a known gas volume.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 
FR 38793, July 25, 2001]



Sec. 868.1880  Pulmonary-function data calculator.

    (a) Identification. A pulmonary-function data calculator is a device 
used to calculate pulmonary-function values based on actual physical 
data obtained during pulmonary-function testing.
    (b) Classification. Class II (performance standards).



Sec. 868.1890  Predictive pulmonary-function value calculator.

    (a) Identification. A predictive pulmonary-function value calculator 
is a device used to calculate normal pulmonary-function values based on 
empirical equations.
    (b) Classification. Class II (performance standards).



Sec. 868.1900  Diagnostic pulmonary-function interpretation calculator.

    (a) Identification. A diagnostic pulmonary-function interpretation 
calculator is a device that interprets pulmonary study data to determine 
clinical significance of pulmonary-function values.
    (b) Classification. Class II (performance standards).



Sec. 868.1910  Esophageal stethoscope.

    (a) Identification. An esophageal stethoscope is a nonpowered device 
that is inserted into a patient's esophagus to enable the user to listen 
to heart and breath sounds.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000]



Sec. 868.1920  Esophageal stethoscope with electrical conductors.

    (a) Identification. An esophageal stethoscope with electrical 
conductors is a device that is inserted into the esophagus to listen to 
a patient's heart and breath sounds and to monitor

[[Page 433]]

electrophysiological signals. The device may also incorporate a 
thermistor for temperature measurement.
    (b) Classification. Class II (performance standards).



Sec. 868.1930  Stethoscope head.

    (a) Identification. A stethoscope head is a weighted chest piece 
used during anesthesia to listen to a patient's heart, breath, and other 
physiological sounds.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 
66 FR 38793, July 25, 2001]



Sec. 868.1965  Switching valve (ploss).

    (a) Identification. A switching valve (ploss) is a three-way valve 
located between a stethoscope placed over the heart, a blood pressure 
cuff, and an earpiece. The valve allows the user to eliminate one sound 
channel and listen only to a patient's heart or korotkoff (blood 
pressure) sounds through the other channel.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 
66 FR 38793, July 25, 2001]



Sec. 868.1975  Water vapor analyzer.

    (a) Identification. A water vapor analyzer is a device intended to 
measure the concentration of water vapor in a patient's expired gases by 
using techniques such as mass spectrometry.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 
FR 38793, July 25, 2001]



                      Subpart C_Monitoring Devices



Sec. 868.2025  Ultrasonic air embolism monitor.

    (a) Identification. An ultrasonic air embolism monitor is a device 
used to detect air bubbles in a patient's blood stream. It may use 
Doppler or other ultrasonic principles.
    (b) Classification. Class II (performance standards).



Sec. 868.2300  Bourdon gauge flowmeter.

    (a) Identification. A bourdon gauge flowmeter is a device intended 
for medical purposes that is used in conjunction with respiratory 
equipment to sense gas pressure. The device is calibrated to indicate 
gas flow rate when the outflow is open to the atmosphere.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 
FR 38794, July 25, 2001]



Sec. 868.2320  Uncompensated thorpe tube flowmeter.

    (a) Identification. An uncompensated thorpe tube flowmeter is a 
device intended for medical purposes that is used to indicate and 
control gas flow rate accurately. The device includes a vertically 
mounted tube and is calibrated when the outlet of the flowmeter is open 
to the atmosphere.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 
FR 38794, July 25, 2001]

[[Page 434]]



Sec. 868.2340  Compensated thorpe tube flowmeter.

    (a) Identification. A compensated thorpe tube flowmeter is a device 
intended for medical purposes that is used to control and measure gas 
flow rate accurately. The device includes a vertically mounted tube, 
with the outlet of the flowmeter calibrated to a reference pressure.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 
FR 38794, July 25, 2001]



Sec. 868.2350  Gas calibration flowmeter.

    (a) Identification. A gas calibration flowmeter is a device intended 
for medical purposes that is used to calibrate flowmeters and accurately 
measure gas flow.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 
FR 38794, July 25, 2001]



Sec. 868.2375  Breathing frequency monitor.

    (a) Identification. A breathing (ventilatory) frequency monitor is a 
device intended to measure or monitor a patient's respiratory rate. The 
device may provide an audible or visible alarm when the respiratory 
rate, averaged over time, is outside operator settable alarm limits. 
This device does not include the apnea monitor classified in Sec. 
868.2377.
    (b) Classification. Class II (performance standards).

[47 FR 31142, July 16, 1982, as amended at 67 FR 46852, July 17, 2002]



Sec. 868.2377  Apnea monitor.

    (a) Identification. An apnea monitor is a complete system intended 
to alarm primarily upon the cessation of breathing timed from the last 
detected breath. The apnea monitor also includes indirect methods of 
apnea detection such as monitoring of heart rate and other physiological 
parameters linked to the presence or absence of adequate respiration.
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA guidance document entitled ``Class II Special 
Controls Guidance Document: Apnea Monitors; Guidance for Industry and 
FDA.''

[67 FR 46852, July 17, 2002]



Sec. 868.2380  Nitric oxide analyzer.

    (a) Identification. The nitric oxide analyzer is a device intended 
to measure the concentration of nitric oxide in respiratory gas mixtures 
during administration of nitric oxide.
    (b) Classification. Class II. The special control for this device is 
FDA's ``Guidance Document for Premarket Notification Submissions for 
Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and 
Nitrogen Dioxide Analyzer.''

[65 FR 14465, Mar. 3, 2000]



Sec. 868.2385  Nitrogen dioxide analyzer.

    (a) Identification. The nitrogen dioxide analyzer is a device 
intended to measure the concentration of nitrogen dioxide in respiratory 
gas mixtures during administration of nitric oxide.
    (b) Classification. Class II (special controls). The device, when it 
is a standalone nitrogen dioxide analyzer and not those that are 
components of nitric oxide delivery systems intended to monitor nitrogen 
dioxide levels during inhaled nitric oxide therapy, is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 868.9. The special control 
is FDA's ``Guidance Document for Premarket Notification Submissions for 
Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and 
Nitrogen Dioxide Analyzer.'' See Sec. 868.1(e) for the availability of 
this guidance document.

[65 FR 11465, Mar. 3, 2000, as amended at 84 FR 71811, Dec. 30, 2019]



Sec. 868.2450  Lung water monitor.

    (a) Identification. A lung water monitor is a device used to monitor 
the trend of fluid volume changes in a patient's lung by measuring 
changes in

[[Page 435]]

thoracic electrical impedance (resistance to alternating current) by 
means of electrodes placed on the patient's chest.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP for a device is required to be filed 
with the Food and Drug Administration on or before July 12, 2000, for 
any lung water monitor that was in commercial distribution before May 
28, 1976, or that has, on or before July 12, 2000, been found to be 
substantially equivalent to a lung water monitor that was in commercial 
distribution before May 28, 1976. Any other lung water monitor device 
shall have an approved PMA or declared completed PDP in effect before 
being placed in commercial distribution.

[47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 65 
FR 19834, Apr. 13, 2000]



Sec. 868.2480  Cutaneous carbon dioxide (PcCO2) monitor.

    (a) Identification. A cutaneous carbon dioxide (PcCO2) monitor is a 
noninvasive heated sensor and a pH-sensitive glass electrode placed on a 
patient's skin, which is intended to monitor relative changes in a 
hemodynamically stable patient's cutaneous carbon dioxide tension as an 
adjunct to arterial carbon dioxide tension measurement.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's ``Class II Special Controls Guidance Document: 
Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance 
for Industry and FDA.'' See Sec. 868.1(e) for the availability of this 
guidance document.

[54 FR 27160, June 28, 1989, as amended at 67 FR 76681, Dec. 13, 2002]



Sec. 868.2500  Cutaneous oxygen (PcO2) monitor.

    (a) Identification. A cutaneous oxygen (PcO2) monitor is a 
noninvasive, heated sensor (e.g., a Clark-type polargraphic electrode) 
placed on the patient's skin that is intended to monitor relative 
changes in the cutaneous oxygen tension.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 868.9. The 
special control is FDA's ``Class II Special Controls Guidance Document: 
Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance 
for Industry and FDA.'' See Sec. 868.1(e) for the availability of this 
guidance document.

[67 FR 76681, Dec. 13, 2002, as amended at 84 FR 71811, Dec. 30, 2019]



Sec. 868.2550  Pneumotachometer.

    (a) Identification. A pneumotachometer is a device intended for 
medical purposes that is used to determine gas flow by measuring the 
pressure differential across a known resistance. The device may use a 
set of capillaries or a metal screen for the resistive element.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 84 FR 71811, Dec. 30, 2019]



Sec. 868.2600  Airway pressure monitor.

    (a) Identification. An airway pressure monitor is a device used to 
measure the pressure in a patient's upper airway. The device may include 
a pressure gauge and an alarm.
    (b) Classification. Class II (performance standards).



Sec. 868.2610  Gas pressure gauge.

    (a) Identification. A gas pressure gauge (e.g., bourdon tube 
pressure gauge) is a device intended for medical purposes that is used 
to measure gas pressure in a medical gas delivery system.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 
FR 38794, July 25, 2001]

[[Page 436]]



Sec. 868.2620  Gas pressure calibrator.

    (a) Identification. A gas pressure calibrator is a device intended 
for medical purposes that is used to calibrate pressure-measuring 
instruments by generating a known gas pressure.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 
FR 38794, July 25, 2001]



Sec. 868.2700  Pressure regulator.

    (a) Identification. A pressure regulator is a device, often called a 
pressure-reducing valve, that is intended for medical purposes and that 
is used to convert a medical gas pressure from a high variable pressure 
to a lower, more constant working pressure. This device includes 
mechanical oxygen regulators.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 
FR 38794, July 25, 2001]



Sec. 868.2775  Electrical peripheral nerve stimulator.

    (a) Identification. An electrical peripheral nerve stimulator 
(neuromuscular blockade monitor) is a device used to apply an electrical 
current to a patient to test the level of pharmacological effect of 
anesthetic drugs and gases.
    (b) Classification. Class II (performance standards).



Sec. 868.2875  Differential pressure transducer.

    (a) Identification. A differential pressure transducer is a two-
chambered device intended for medical purposes that is often used during 
pulmonary function testing. It generates an electrical signal for 
subsequent display or processing that is proportional to the difference 
in gas pressures in the two chambers.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 
FR 38794, July 25, 2001]



Sec. 868.2885  Gas flow transducer.

    (a) Identification. A gas flow transducer is a device intended for 
medical purposes that is used to convert gas flow rate into an 
electrical signal for subsequent display or processing.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 
FR 38794, July 25, 2001]



Sec. 868.2900  Gas pressure transducer.

    (a) Identification. A gas pressure transducer is a device intended 
for medical purposes that is used to convert gas pressure into an 
electrical signal for subsequent display or processing.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996]

Subparts D-E [Reserved]



                      Subpart F_Therapeutic Devices



Sec. 868.5090  Emergency airway needle.

    (a) Identification. An emergency airway needle is a device intended 
to puncture a patient's cricothyroid membrane to provide an emergency 
airway during upper airway obstruction.
    (b) Classification. Class II (performance standards).



Sec. 868.5095  Retrograde intubation device.

    (a) Identification. A retrograde intubation device is a prescription 
device used to perform retrograde

[[Page 437]]

intubation via the cricothyroid membrane. The device may contain or be 
labeled for use with guidewires and intubating catheters, in addition to 
needles (Sec. 868.5090), syringe (Sec. 880.5860 of this chapter), and 
hemostats (Sec. 878.4800 of this chapter).
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use, 
including the following:
    (i) Wire guide tensile, flex, fracture, and corrosion testing;
    (ii) Catheter tensile strength testing at likely points of failure;
    (iii) Catheter kink radius testing;
    (iv) Compatibility of device components that interact, including 
compatibility in connection, disconnection, and ability to transfer 
fluids;
    (v) Dimensional validation;
    (vi) Accuracy testing of markings; and
    (vii) Validation of the maximum airway pressure.
    (2) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the identified shelf life.
    (3) The device must be demonstrated to be biocompatible.
    (4) Labeling must include:
    (i) Instructions for use; and
    (ii) Package labels that clearly identify the minimum compatible 
size of endotracheal tube.

[86 FR 73678, Dec. 28, 2021]



Sec. 868.5100  Nasopharyngeal airway.

    (a) Identification. A nasopharyngeal airway is a device used to aid 
breathing by means of a tube inserted into a patient's pharynx through 
the nose to provide a patent airway.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 
FR 38794, July 25, 2001]



Sec. 868.5105  External negative pressure airway aid.

    (a) Identification. An external negative pressure airway aid is a 
prescription device that applies negative pressure to a patient's neck 
to aid in providing a patent airway during procedures requiring 
anesthesia.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must document any adverse events 
observed during clinical use, including impaired blood flow, and 
demonstrate that the device performs as intended under anticipated 
conditions.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated patient positions, does 
not fail during use, and does not lose negative pressure capability. The 
following testing should be performed:
    (i) Ability of the device to maintain a seal during various patient 
positions;
    (ii) Device leakage testing to demonstrate the device maintains 
vacuum;
    (iii) Drop testing to ensure the device does not incur functional 
damage after dropping the device; and
    (iv) Functional testing after high and low storage temperature.
    (3) All patient contacting components must be demonstrated to be 
biocompatible.
    (4) Labeling must include:
    (i) A summary of clinical testing results, including any adverse 
events and evidence that effectiveness has been achieved.
    (ii) Technical specifications of the device, including collar sizes, 
maximum duration of use, operating temperature, and storage temperature 
range.
    (iii) Technical specifications of the vacuum source, including 
maximum vacuum level and operational vacuum level.
    (iv) Instructions for use that includes how to place the device, 
determination of size, verification of suction, reference to training 
materials, and information on troubleshooting the device if it does not 
attach properly.

[[Page 438]]

    (v) A warning to screen patients for carotid artery disease due to 
the probable risk of the device to dislodge arterial plaques in the 
carotid artery.
    (vi) A warning to exclude patients with anatomical abnormalities.
    (vii) A warning not to use the device during medical procedures 
involving medications that contain propofol.

[82 FR 60867, Dec. 26, 2017]



Sec. 868.5110  Oropharyngeal airway.

    (a) Identification. An oropharyngeal airway is a device inserted 
into a patient's pharynx through the mouth to provide a patent airway.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 
FR 38794, July 25, 2001]



Sec. 868.5115  Device to relieve acute upper airway obstruction.

    (a) Identification. The device is a raised, rounded pad that, in the 
event of choking on a foreign body, can be applied to the abdomen and 
pushed upward to generate expulsion pressure to remove the obstruction 
to relieve acute upper airway obstruction.
    (b) Classification. Class II (special controls) (``Class II Special 
Control Guidance Document for Acute Upper Airway Obstruction Devices''). 
The device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter, subject to Sec. 868.9.

[65 FR 39099, June 23, 2000; 65 FR 47669, Aug. 3, 2000]



Sec. 868.5120  Anesthesia conduction catheter.

    (a) Identification. An anesthesia conduction catheter is a flexible 
tubular device used to inject local anesthetics into a patient and to 
provide continuous regional anesthesia.
    (b) Classification. Class II (performance standards).



Sec. 868.5130  Anesthesia conduction filter.

    (a) Identification. An anesthesia conduction filter is a microporous 
filter used while administering to a patient injections of local 
anesthetics to minimize particulate (foreign material) contamination of 
the injected fluid.
    (b) Classification. Class II (performance standards).



Sec. 868.5140  Anesthesia conduction kit.

    (a) Identification. An anesthesia conduction kit is a device used to 
administer to a patient conduction, regional, or local anesthesia. The 
device may contain syringes, needles, and drugs.
    (b) Classification. Class II (performance standards).



Sec. 868.5150  Anesthesia conduction needle.

    (a) Identification. An anesthesia conduction needle is a device used 
to inject local anesthetics into a patient to provide regional 
anesthesia.
    (b) Classification. Class II (performance standards).



Sec. 868.5160  Gas machine for anesthesia or analgesia.

    (a) Gas machine for anesthesia--(1) Identification. A gas machine 
for anesthesia is a device used to administer to a patient, continuously 
or intermittently, a general inhalation anesthetic and to maintain a 
patient's ventilation. The device may include a gas flowmeter, 
vaporizer, ventilator, breathing circuit with bag, and emergency air 
supply.
    (2) Classification. Class II (performance standards).
    (b) Gas machine for analgesia--(1) Identification. A gas machine for 
analgesia is a device used to administer to a patient an analgesic 
agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 
70 percent nitrous oxide).
    (2) Classification. Class II (performance standards).



Sec. 868.5165  Nitric oxide administration apparatus.

    (a) Identification. The nitric oxide administration apparatus is a 
device used to add nitric oxide to gases that are to be breathed by a 
patient. The nitric

[[Page 439]]

oxide administration apparatus is to be used in conjunction with a 
ventilator or other breathing gas administration system.
    (b) Classification. Class II. The special control for this device is 
FDA's ``Guidance Document for Premarket Notification Submissions for 
Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and 
Nitrogen Dioxide Analyzer.''

[65 FR 11465, Mar. 3, 2000]



Sec. 868.5170  Laryngotracheal topical anesthesia applicator.

    (a) Identification. A laryngotracheal topical anesthesia applicator 
is a device used to apply topical anesthetics to a patient's 
laryngotracheal area.
    (b) Classification. Class II (performance standards).



Sec. 868.5180  Rocking bed.

    (a) Identification. A rocking bed is a device intended for temporary 
use to help patient ventilation (breathing) by repeatedly tilting the 
patient, thereby using the weight of the abdominal contents to move the 
diaphragm.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 84 FR 71811, Dec. 30, 2019]



Sec. 868.5220  Blow bottle.

    (a) Identification. A blow bottle is a device that is intended for 
medical purposes to induce a forced expiration from a patient. The 
patient blows into the device to move a column of water from one bottle 
to another.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9. If the device is 
not labeled or otherwise represented as sterile, it is exempt from the 
current good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180, with respect to general requirements concerning records, and 
Sec. 820.198, with respect to complaint files.

[47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 
66 FR 38794, July 25, 2001]



Sec. 868.5240  Anesthesia breathing circuit.

    (a) Identification. An anesthesia breathing circuit is a device that 
is intended to administer medical gases to a patient during anesthesia. 
It provides both an inhalation and exhalation route and may include a 
connector, adaptor, and Y-piece.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 
FR 38794, July 25, 2001]



Sec. 868.5250  Breathing circuit circulator.

    (a) Identification. A breathing circuit circulator is a turbine 
device that is attached to a closed breathing circuit and that is 
intended to circulate anesthetic gases continuously by maintaining the 
unidirectional valves in an open position and reducing mechanical dead 
space and resistance in the breathing circuit.
    (b) Classification. Class II (performance standards).



Sec. 868.5260  Breathing circuit bacterial filter.

    (a) Identification. A breathing circuit bacterial filter is a device 
that is intended to remove microbiological and particulate matter from 
the gases in the breathing circuit.
    (b) Classification. Class II (performance standards).



Sec. 868.5270  Breathing system heater.

    (a) Identification. A breathing system heater is a device that is 
intended to warm breathing gases before they enter a patient's airway. 
The device may include a temperature controller.
    (b) Classification. Class II (performance standards).

[[Page 440]]



Sec. 868.5273  Positive airway pressure delivery system.

    (a) Identification. A positive airway pressure delivery system is a 
prescription noninvasive ventilatory device that delivers expiratory 
positive airway pressure for patients suffering from obstructive sleep 
apnea. The system also provides positive airway pressure during 
incipient apnea. The system may include a dedicated flow generator and a 
patient interface.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use, 
including the following:
    (i) Waveform testing must simulate breathing conditions and evaluate 
pressure and airflow response over a range and combination of high and 
low breath rates and tidal volumes.
    (ii) Use life testing must demonstrate adequate device performance 
over the labeled use life of the device.
    (iii) Device integrity testing must demonstrate that the device can 
withstand typical forces expected during use.
    (iv) Carbon dioxide rebreathing testing must be performed.
    (v) System flow rate, maximum expiratory pressure, inhalation 
pressure, and intra-mask static pressure testing must be performed.
    (vi) Air bolus testing must demonstrate that the device can 
withstand worst-case scenario air pressures.
    (vii) Maximum limited pressure testing of the flow generator in 
single fault condition must be performed.
    (viii) Maximum output temperature testing of delivered gas, if 
humidified, must be performed.
    (3) Performance data must validate reprocessing instructions for any 
reusable components of the device.
    (4) Performance data must demonstrate the electrical, thermal, and 
mechanical safety and the electromagnetic compatibility of the device.
    (5) Software verification, validation, and hazard analysis must be 
performed.
    (6) Labeling must include the following:
    (i) Therapy pressure range;
    (ii) Use life and replacement schedule for all components;
    (iii) Cleaning instructions; and
    (iv) Instructions for assembly and connection of device components.

[83 FR 52966, Oct. 19, 2018]



Sec. 868.5280  Breathing tube support.

    (a) Identification. A breathing tube support is a device that is 
intended to support and anchor a patient's breathing tube(s).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 
66 FR 38794, July 25, 2001]



Sec. 868.5300  Carbon dioxide absorbent.

    (a) Identification. A carbon dioxide absorbent is a device intended 
for medical purposes that consists of an absorbent material (e.g., soda 
lime) that is intended to remove carbon dioxide from the gases in the 
breathing circuit.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 
FR 38794, July 25, 2001]



Sec. 868.5310  Carbon dioxide absorber.

    (a) Identification. A carbon dioxide absorber is a device that is 
intended for medical purposes and that is used in a breathing circuit as 
a container for carbon dioxide absorbent. It may include a canister and 
water drain.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 
FR 38794, July 25, 2001]

[[Page 441]]



Sec. 868.5320  Reservoir bag.

    (a) Identification. A reservoir bag is a device, usually made of 
conductive rubber, intended for use in a breathing circuit as a 
reservoir for breathing gas and to assist, control, or monitor a 
patient's ventilation.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 
FR 38794, July 25, 2001]



Sec. 868.5330  Breathing gas mixer.

    (a) Identification. A breathing gas mixer is a device intended for 
use in conjunction with a respiratory support apparatus to control the 
mixing of gases that are to be breathed by a patient.
    (b) Classification. Class II (performance standards).



Sec. 868.5340  Nasal oxygen cannula.

    (a) Identification. A nasal oxygen cannula is a two-pronged device 
used to administer oxygen to a patient through both nostrils.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 59 FR 63007, Dec. 7, 1994; 66 
FR 38794, July 25, 2001]



Sec. 868.5350  Nasal oxygen catheter.

    (a) Identification. A nasal oxygen catheter is a device intended to 
be inserted through a patient's nostril to administer oxygen.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 59 FR 63007, Dec. 7, 1994; 66 
FR 38794, July 25, 2001]



Sec. 868.5365  Posture chair for cardiac or pulmonary treatment.

    (a) Identification. A posture chair for cardiac or pulmonary 
treatment is a device intended to assist in the rehabilitation and 
mobilization of patients with chronic heart or lung disease.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 
66 FR 38794, July 25, 2001]



Sec. 868.5375  Heat and moisture condenser (artificial nose).

    (a) Identification. A heat and moisture condenser (artificial nose) 
is a device intended to be positioned over a tracheotomy (a surgically 
created opening in the throat) or tracheal tube (a tube inserted into 
the trachea) to warm and humidify gases breathed in by a patient.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 
FR 38795, July 25, 2001]



Sec. 868.5400  Electroanesthesia apparatus.

    (a) Identification. An electroanesthesia apparatus is a device used 
for the induction and maintenance of anesthesia during surgical 
procedures by means of an alternating or pulsed electric current that is 
passed through electrodes fixed to a patient's head.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before December 26, 1996 for any 
electroanesthesia apparatus that was in commercial distribution before 
May 28, 1976, or that has, on or before December 26, 1996 been found to 
be substantially equivalent to an electroanesthesia apparatus that was 
in commercial distribution before May 28, 1976. Any other 
electroanesthesia apparatus shall have an approved PMA or a declared 
completed PDP in effect

[[Page 442]]

before being placed in commercial distribution.

[47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 61 
FR 50706, Sept. 27, 1996]



Sec. 868.5420  Ether hook.

    (a) Identification. An ether hook is a device that fits inside a 
patient's mouth and that is intended to deliver vaporized ether.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9. If the device is 
not labeled or otherwise represented as sterile, it is exempt from the 
current good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180, with respect to general requirements concerning records, and 
Sec. 820.198, with respect to complaint files.

[47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 
66 FR 38795, July 25, 2001]



Sec. 868.5430  Gas-scavenging apparatus.

    (a) Identification. A gas-scavenging apparatus is a device intended 
to collect excess anesthetic, analgesic, or trace gases or vapors from a 
patient's breathing system, ventilator, or extracorporeal pump-
oxygenator, and to conduct these gases out of the area by means of an 
exhaust system.
    (b) Classification. Class II (performance standards).



Sec. 868.5440  Portable oxygen generator.

    (a) Identification. A portable oxygen generator is a device that is 
intended to release oxygen for respiratory therapy by means of either a 
chemical reaction or physical means (e.g., a molecular sieve).
    (b) Classification. Class II (performance standards).



Sec. 868.5450  Respiratory gas humidifier.

    (a) Identification. A respiratory gas humidifier is a device that is 
intended to add moisture to, and sometimes to warm, the breathing gases 
for administration to a patient. Cascade, gas, heated, and prefilled 
humidifiers are included in this generic type of device.
    (b) Classification. Class II (performance standards).



Sec. 868.5454  High flow humidified oxygen delivery device.

    (a) Identification. A high flow humidified oxygen delivery device is 
a prescription device that delivers high flow oxygen with humidification 
for patients who are suffering from respiratory distress and/or 
hypoxemia.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions for use, 
including the following:
    (i) Alarm testing must be performed;
    (ii) Continuous use thermal stability testing must be performed;
    (iii) Humidity output testing must be performed; and
    (iv) Blender performance testing must evaluate fraction of inspired 
oxygen (FiO2) blending accuracy.
    (3) Performance data must validate cleaning instructions for any 
reusable components of the device.
    (4) Electrical safety, thermal safety, mechanical safety, 
electromagnetic compatibility, and radiofrequency identification testing 
must be performed.
    (5) Software verification, validation, and hazard analysis must be 
performed.
    (6) Labeling must include:
    (i) A description of available FiO2 ranges for different 
flowrates and inlet gas pressures;
    (ii) Instructions for applicable flowrates for all intended 
populations;
    (iii) A warning that patients on high flow oxygen are acute and 
require appropriate monitoring, to include pulse oximetry;
    (iv) A warning regarding the risk of condensation at low set 
temperatures and certain flows; and
    (v) A description of all alarms and their functions.

[83 FR 54007, Oct. 26, 2018]

[[Page 443]]



Sec. 868.5460  Therapeutic humidifier for home use.

    (a) Identification. A therapeutic humidifier for home use is a 
device that adds water vapor to breathing gases and that is intended for 
respiratory therapy or other medical purposes. The vapor produced by the 
device pervades the area surrounding the patient, who breathes the vapor 
during normal respiration.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982; 47 FR 40410, Sept. 14, 1982, as amended at 
61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001]



Sec. 868.5470  Hyperbaric chamber.

    (a) Identification. A hyperbaric chamber is a device that is 
intended to increase the environmental oxygen pressure to promote the 
movement of oxygen from the environment to a patient's tissue by means 
of pressurization that is greater than atmospheric pressure. This device 
does not include topical oxygen chambers for extremities (Sec. 
878.5650).
    (b) Classification. Class II (performance standards).



Sec. 868.5480  Isocapnic ventilation device.

    (a) Identification. An isocapnic ventilation device is a 
prescription device used to administer a blend of carbon dioxide and 
oxygen gases to a patient to induce hyperventilation. This device may be 
labeled for use with breathing circuits made of reservoir bags (Sec. 
868.5320), oxygen cannulas (Sec. 868.5340), masks (Sec. 868.5550), 
valves (Sec. 868.5870), resuscitation bags (Sec. 868.5915), and/or 
tubing (Sec. 868.5925).
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Nonclinical performance testing data must demonstrate that the 
device performs as intended under anticipated conditions of use, 
including the following performance characteristics:
    (i) Gas concentration accuracy testing for the range of intended 
concentrations;
    (ii) Airway pressure delivery accuracy testing;
    (iii) Supplemental O2 flowrate accuracy testing;
    (iv) Alarm testing; and
    (v) Use life testing.
    (2) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (3) Labeling must include the following:
    (i) Instructions for use;
    (ii) A precaution that monitoring of capnography is necessary during 
treatment with non-spontaneously breathing patients; and
    (iii) Use life specification.

[86 FR 68397, Dec. 2, 2021]



Sec. 868.5530  Flexible laryngoscope.

    (a) Identification. A flexible laryngoscope is a fiberoptic device 
used to examine and visualize a patient's upper airway and aid placement 
of a tracheal tube.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 41107, Sept. 17, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 
66 FR 38795, July 25, 2001]



Sec. 868.5540  Rigid laryngoscope.

    (a) Identification. A rigid laryngoscope is a device used to examine 
and visualize a patient's upper airway and aid placement of a tracheal 
tube.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9

[47 FR 41107, Sept. 17, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 
66 FR 38795, July 25, 2001]



Sec. 868.5550  Anesthetic gas mask.

    (a) Identification. An anesthetic gas mask is a device, usually made 
of conductive rubber, that is positioned over a patient's nose or mouth 
to direct anesthetic gases to the upper airway.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 444]]

subpart E of part 807 of this chapter subject to the limitations in 
Sec. 868.9.

[47 FR 41107, Sept. 17, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 
66 FR 38795, July 25, 2001]



Sec. 868.5560  Gas mask head strap.

    (a) Identification. A gas mask head strap is a device used to hold 
an anesthetic gas mask in position on a patient's face.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 41107, Sept. 17, 1982, as amended at 54 FR 25048, June 12, 1989; 
66 FR 38795, July 25, 2001]



Sec. 868.5570  Nonrebreathing mask.

    (a) Identification. A nonrebreathing mask is a device fitting over a 
patient's face to administer oxygen. It utilizes one-way valves to 
prevent the patient from rebreathing previously exhaled gases.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 
FR 38795, July 25, 2001]



Sec. 868.5580  Oxygen mask.

    (a) Identification. An oxygen mask is a device placed over a 
patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 
FR 38795, July 25, 2001]



Sec. 868.5590  Scavenging mask.

    (a) Identification. A scavenging mask is a device positioned over a 
patient's nose to deliver anesthetic or analgesic gases to the upper 
airway and to remove excess and exhaled gas. It is usually used during 
dentistry.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 
FR 38795, July 25, 2001]



Sec. 868.5600  Venturi mask.

    (a) Identification. A venturi mask is a device containing an air-
oxygen mixing mechanism that dilutes 100 percent oxygen to a 
predetermined concentration and delivers the mixed gases to a patient.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 
FR 38795, July 25, 2001]



Sec. 868.5620  Breathing mouthpiece.

    (a) Identification. A breathing mouthpiece is a rigid device that is 
inserted into a patient's mouth and that connects with diagnostic or 
therapeutic respiratory devices.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000]



Sec. 868.5630  Nebulizer.

    (a) Identification. A nebulizer is a device intended to spray 
liquids in aerosol form into gases that are delivered directly to the 
patient for breathing. Heated, ultrasonic, gas, venturi, and refillable 
nebulizers are included in this generic type of device.
    (b) Classification. Class II (performance standards).



Sec. 868.5640  Medicinal nonventilatory nebulizer (atomizer).

    (a) Identification. A medicinal nonventilatory nebulizer (atomizer) 
is a device that is intended to spray liquid medication in aerosol form 
into the air that a patient will breathe.

[[Page 445]]

    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000]



Sec. 868.5650  Esophageal obturator.

    (a) Identification. An esophageal obturator is a device inserted 
through a patient's mouth to aid ventilation of the patient during 
emergency resuscitation by occluding (blocking) the esophagus, thereby 
permitting positive pressure ventilation through the trachea. The device 
consists of a closed-end semirigid esophageal tube that is attached to a 
face mask.
    (b) Classification. Class II (performance standards).



Sec. 868.5655  Portable liquid oxygen unit.

    (a) Identification. A portable liquid oxygen unit is a portable, 
thermally insulated container of liquid oxygen that is intended to 
supplement gases to be inhaled by a patient, is sometimes accompanied by 
tubing and an oxygen mask. An empty portable liquid oxygen unit is a 
device, while the oxygen contained therein is a drug.
    (b) Classification. Class II (performance standards).



Sec. 868.5665  Powered percussor.

    (a) Identification. A powered percussor is a device that is intended 
to transmit vibration through a patient's chest wall to aid in freeing 
mucus deposits in the lung in order to improve bronchial drainage and 
that may be powered by electricity or compressed gas.
    (b) Classification. Class II (performance standards).



Sec. 868.5675  Rebreathing device.

    (a) Identification. A rebreathing device is a device that enables a 
patient to rebreathe exhaled gases. It may be used in conjunction with 
pulmonary function testing or for increasing minute ventilation.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000]



Sec. 868.5690  Incentive spirometer.

    (a) Identification. An incentive spirometer is a device that 
indicates a patient's breathing volume or flow and that provides an 
incentive to the patient to improve his or her ventilation.
    (b) Classification. Class II (performance standards).



Sec. 868.5700  Nonpowered oxygen tent.

    (a) Identification. A nonpowered oxygen tent is a device that 
encloses a patient's head and upper body to contain oxygen delivered to 
the patient for breathing. This generic type of device includes infant 
oxygen hoods.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000]



Sec. 868.5710  Electrically powered oxygen tent.

    (a) Identification. An electrically powered oxygen tent is a device 
that encloses a patient's head and, by means of an electrically powered 
unit, administers breathing oxygen and controls the temperature and 
humidity of the breathing gases. This generic type device includes the 
pediatric aerosol tent.
    (b) Classification. Class II (performance standards).



Sec. 868.5720  Bronchial tube.

    (a) Identification. A bronchial tube is a device used to 
differentially intubate a patient's bronchus (one of the two main 
branches of the trachea leading directly to the lung) in order to 
isolate a portion of lung distal to the tube.
    (b) Classification. Class II (performance standards).



Sec. 868.5730  Tracheal tube.

    (a) Identification. A tracheal tube is a device inserted into a 
patient's trachea via the nose or mouth and used to maintain an open 
airway.

[[Page 446]]

    (b) Classification. Class II (performance standards).



Sec. 868.5740  Tracheal/bronchial differential ventilation tube.

    (a) Identification. A tracheal/bronchial differential ventilation 
tube is a device used to isolate the left or the right lung of a patient 
for anesthesia or pulmonary function testing.
    (b) Classification. Class II (performance standards).



Sec. 868.5750  Inflatable tracheal tube cuff.

    (a) Identification. An inflatable tracheal tube cuff is a device 
used to provide an airtight seal between a tracheal tube and a patient's 
trachea.
    (b) Classification. Class II (performance standards).



Sec. 868.5760  Cuff spreader.

    (a) Identification. A cuff spreader is a device used to install 
tracheal tube cuffs on tracheal or tracheostomy tubes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9. If the device is 
not labeled or otherwise represented as sterile, it is exempt from the 
current good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180, with respect to general requirements concerning records, and 
Sec. 820.198, with respect to complaint files.

[47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 
66 FR 38795, July 25, 2001]



Sec. 868.5770  Tracheal tube fixation device.

    (a) Identification. A tracheal tube fixation device is a device used 
to hold a tracheal tube in place, usually by means of straps or pinch 
rings.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 
FR 38795, July 25, 2001]



Sec. 868.5780  Tube introduction forceps.

    (a) Identification. Tube introduction forceps (e.g., Magill forceps) 
are a right-angled device used to grasp a tracheal tube and place it in 
a patient's trachea.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 
FR 38795, July 25, 2001]



Sec. 868.5790  Tracheal tube stylet.

    (a) Identification. A tracheal tube stylet is a device used 
temporarily to make rigid a flexible tracheal tube to aid its insertion 
into a patient.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 
FR 38795, July 25, 2001]



Sec. 868.5795  Tracheal tube cleaning brush.

    (a) Identification. A tracheal tube cleaning brush is a device 
consisting of a brush with plastic bristles intended to clean tracheal 
cannula devices after their removal from patients.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9. If the device is 
not labeled or otherwise represented as sterile, it is exempt from the 
current good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180, with respect to general requirements concerning records, and 
Sec. 820.198, with respect to complaint files.

[51 FR 40388, Nov. 6, 1986, as amended at 66 FR 38795, July 25, 2001]



Sec. 868.5800  Tracheostomy tube and tube cuff.

    (a) Identification. A tracheostomy tube and tube cuff is a device 
intended to be placed into a surgical opening of

[[Page 447]]

the trachea to facilitate ventilation to the lungs. The cuff may be a 
separate or integral part of the tracheostomy tube and is, when 
inflated, intended to establish a seal between the tracheal wall and the 
tracheostomy tube. The cuff is used to prevent the patient's aspiration 
of substances, such as blood or vomit, or to provide a means for 
positive-pressure ventilation of the patient. This device is made of 
either stainless steel or plastic.
    (b) Classification. Class II.

[51 FR 40389, Nov. 6, 1986]



Sec. 868.5810  Airway connector.

    (a) Identification. An airway connector is a device intended to 
connect a breathing gas source to a tracheal tube, tracheostomy tube, or 
mask.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 
FR 38795, July 25, 2001]



Sec. 868.5820  Dental protector.

    (a) Identification. A dental protector is a device intended to 
protect a patient's teeth during manipulative procedures within a 
patient's oral cavity.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 
FR 38795, July 25, 2001]



Sec. 868.5830  Autotransfusion apparatus.

    (a) Identification. An autotransfusion apparatus is a device used to 
collect and reinfuse the blood lost by a patient due to surgery or 
trauma.
    (b) Classification. Class II (performance standards).



Sec. 868.5860  Pressure tubing and accessories.

    (a) Identification. Pressure tubing and accessories are flexible or 
rigid devices intended to deliver pressurized medical gases.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 
FR 38796, July 25, 2001]



Sec. 868.5870  Nonrebreathing valve.

    (a) Identification. A nonrebreathing valve is a one-way valve that 
directs breathing gas flow to the patient and vents exhaled gases into 
the atmosphere.
    (b) Classification. Class II (performance standards).



Sec. 868.5880  Anesthetic vaporizer.

    (a) Identification. An anesthetic vaporizer is a device used to 
vaporize liquid anesthetic and deliver a controlled amount of the vapor 
to the patient.
    (b) Classification. Class II (performance standards).



Sec. 868.5895  Continuous ventilator.

    (a) Identification. A continuous ventilator (respirator) is a device 
intended to mechanically control or assist patient breathing by 
delivering a predetermined percentage of oxygen in the breathing gas. 
Adult, pediatric, and neonatal ventilators are included in this generic 
type of device.
    (b) Classification. Class II (performance standards).



Sec. 868.5905  Noncontinuous ventilator (IPPB).

    (a) Identification. A noncontinuous ventilator (intermittent 
positive pressure breathing-IPPB) is a device intended to deliver 
intermittently an aerosol to a patient's lungs or to assist a patient's 
breathing.
    (b) Classification. Class II (performance standards).



Sec. 868.5915  Manual emergency ventilator.

    (a) Identification. A manual emergency ventilator is a device, 
usually incorporating a bag and valve, intended to provide emergency 
respiratory support by means of a face mask or a tube inserted into a 
patient's airway.
    (b) Classification. Class II (performance standards).

[[Page 448]]



Sec. 868.5925  Powered emergency ventilator.

    (a) Identification. A powered emergency ventilator is a demand valve 
or inhalator intended to provide emergency respiratory support by means 
of a face mask or a tube inserted into a patient's airway.
    (b) Classification. Class II (performance standards).



Sec. 868.5935  External negative pressure ventilator.

    (a) Identification. An external negative pressure ventilator (e.g., 
iron lung, cuirass) is a device chamber that is intended to support a 
patient's ventilation by alternately applying and releasing external 
negative pressure over the diaphragm and upper trunk of the patient.
    (b) Classification. Class II (performance standards).



Sec. 868.5955  Intermittent mandatory ventilation attachment.

    (a) Identification. An intermittent mandatory ventilation (IMV) 
attachment is a device attached to a mechanical ventilator that allows 
spontaneous breathing by a patient while providing mechanical 
ventilation at a preset rate.
    (b) Classification. Class II (performance standards).



Sec. 868.5965  Positive end expiratory pressure breathing attachment.

    (a) Identification. A positive end expiratory pressure (PEEP) 
breathing attachment is a device attached to a ventilator that is used 
to elevate pressure in a patient's lungs above atmospheric pressure at 
the end of exhalation.
    (b) Classification. Class II (performance standards).



Sec. 868.5975  Ventilator tubing.

    (a) Identification. Ventilator tubing is a device intended for use 
as a conduit for gases between a ventilator and a patient during 
ventilation of the patient.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 
FR 38796, July 25, 2001]



Sec. 868.5995  Tee drain (water trap).

    (a) Identification. A tee drain (water trap) is a device intended to 
trap and drain water that collects in ventilator tubing during 
respiratory therapy, thereby preventing an increase in breathing 
resistance.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 
FR 38796, July 25, 2001]



                         Subpart G_Miscellaneous



Sec. 868.6100  Anesthetic cabinet, table, or tray.

    (a) Identification. An anesthetic cabinet, table, or tray is a 
device intended to store anesthetic equipment and drugs. The device is 
usually constructed to eliminate build-up of static electrical charges.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 
66 FR 38796, July 25, 2001]



Sec. 868.6175  Cardiopulmonary emergency cart.

    (a) Identification. A cardiopulmonary emergency cart is a device 
intended to store and transport resuscitation supplies for emergency 
treatment. The device does not include any equipment used in 
cardiopulmonary resuscitation.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation

[[Page 449]]

in part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.

[47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 
66 FR 38796, July 25, 2001]



Sec. 868.6225  Nose clip.

    (a) Identification. A nose clip is a device intended to close a 
patient's external nares (nostrils) during diagnostic or therapeutic 
procedures.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 
66 FR 38796, July 25, 2001]



Sec. 868.6250  Portable air compressor.

    (a) Identification. A portable air compressor is a device intended 
to provide compressed air for medical purposes, e.g., to drive 
ventilators and other respiratory devices.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 84 FR 71811, Dec. 30, 2019]



Sec. 868.6400  Calibration gas.

    (a) Identification. A calibration gas is a device consisting of a 
container of gas of known concentration intended to calibrate medical 
gas concentration measurement devices.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1121, Jan. 16, 1996; 66 
FR 38796, July 25, 2001]



Sec. 868.6700  Anesthesia stool.

    (a) Identification. An anesthesia stool is a device intended for use 
as a stool for the anesthesiologist in the operating room.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 54 FR 25049, June 12, 1989; 
66 FR 38796, July 25, 2001]



Sec. 868.6810  Tracheobronchial suction catheter.

    (a) Identification. A tracheobronchial suction catheter is a device 
used to aspirate liquids or semisolids from a patient's upper airway.
    (b) Classification. Class 1 (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 65 FR 2314, Jan. 14, 2000]



Sec. 868.6820  Patient position support.

    (a) Identification. A patient position support is a device intended 
to maintain the position of an anesthetized patient during surgery.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1121, Jan. 16, 1996; 66 
FR 38796, July 25, 2001]



Sec. 868.6885  Medical gas yoke assembly.

    (a) Identification. A medical gas yoke assembly is a device intended 
to connect medical gas cylinders to regulators or needle valves to 
supply gases for anesthesia or respiratory therapy. The device may 
include a particulate filter.
    (b) Classification. Class I (general controls). The device is exempt 
from the

[[Page 450]]

premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1121, Jan. 16, 1996; 66 
FR 38796, July 25, 2001]



PART 870_CARDIOVASCULAR DEVICES--Table of Contents



                      Subpart A_General Provisions

Sec.
870.1 Scope.
870.3 Effective dates of requirement for premarket approval.
870.9 Limitations of exemptions from section 510(k) of the Federal Food, 
          Drug, and Cosmetic Act (the act).

               Subpart B_Cardiovascular Diagnostic Devices

870.1025 Arrhythmia detector and alarm (including ST-segment measurement 
          and alarm).
870.1100 Blood pressure alarm.
870.1110 Blood pressure computer.
870.1120 Blood pressure cuff.
870.1130 Noninvasive blood pressure measurement system.
870.1140 Venous blood pressure manometer.
870.1200 Diagnostic intravascular catheter.
870.1210 Continuous flush catheter.
870.1220 Electrode recording catheter or electrode recording probe.
870.1230 Fiberoptic oximeter catheter.
870.1240 Flow-directed catheter.
870.1250 Percutaneous catheter.
870.1251 Temporary catheter for embolic protection during transcatheter 
          intracardiac procedures.
870.1252 Percutaneous catheter for creation of an arteriovenous fistula 
          for hemodialysis access.
870.1255 Balloon aortic valvuloplasty catheter.
870.1270 Intracavitary phonocatheter system.
870.1280 Steerable catheter.
870.1290 Steerable catheter control system.
870.1300 Catheter cannula.
870.1310 Vessel dilator for percutaneous catheterization.
870.1330 Catheter guide wire.
870.1340 Catheter introducer.
870.1342 Reverse central venous recanalization system.
870.1345 Intravascular bleed monitor.
870.1350 Catheter balloon repair kit.
870.1360 Trace microsphere.
870.1370 Catheter tip occluder.
870.1380 Catheter stylet.
870.1390 Trocar.
870.1405 Interventional cardiovascular implant simulation software 
          device.
870.1415 Coronary vascular physiologic simulation software device.
870.1420 Coronary artery disease risk indicator using acoustic heart 
          signals.
870.1425 Programmable diagnostic computer.
870.1435 Single-function, preprogrammed diagnostic computer.
870.1450 Densitometer.
870.1650 Angiographic injector and syringe.
870.1660 Indicator injector.
870.1670 Syringe actuator for an injector.
870.1750 External programmable pacemaker pulse generator.
870.1800 Withdrawal-infusion pump.
870.1875 Stethoscope.
870.1915 Thermodilution probe.

               Subpart C_Cardiovascular Monitoring Devices

870.2050 Biopotential amplifier and signal conditioner.
870.2060 Transducer signal amplifier and signal conditioner.
870.2100 Cardiovascular blood flowmeter.
870.2120 Extravascular blood flow probe.
870.2200 Adjunctive cardiovascular status indicator.
870.2210 Adjunctive predictive cardiovascular indicator.
870.2220 Adjunctive hemodynamic indicator with decision point.
870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
870.2310 Apex cardiograph (vibrocardiograph).
870.2320 Ballistocardiograph.
870.2330 Echocardiograph.
870.2340 Electrocardiograph.
870.2345 Electrocardiograph software for over-the-counter use.
870.2350 Electrocardiograph lead switching adaptor.
870.2360 Electrocardiograph electrode.
870.2370 Electrocardiograph surface electrode tester.
870.2390 Phonocardiograph.
870.2400 Vectorcardiograph.
870.2450 Medical cathode-ray tube display.
870.2600 Signal isolation system.
870.2620 Line isolation monitor.
870.2640 Portable leakage current alarm.
870.2675 Oscillometer.
870.2700 Oximeter.
870.2710 Ear oximeter.
870.2750 Impedance phlebograph.
870.2770 Impedance plethysmograph.
870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
870.2785 Software for optical camera-based measurement of pulse rate, 
          heart rate, breathing rate, and/or respiratory rate.
870.2786 Hardware and software for optical camera-based measurement of 
          pulse rate,

[[Page 451]]

          heart rate, breathing rate, and/or respiratory rate.
870.2790 Photoplethysmograph analysis software for over-the-counter use.
870.2800 Medical magnetic tape recorder.
870.2810 Paper chart recorder.
870.2840 Apex cardiographic transducer.
870.2850 Extravascular blood pressure transducer.
870.2855 Implantable Intra-aneurysm Pressure Measurement System.
870.2860 Heart sound transducer.
870.2870 Catheter tip pressure transducer.
870.2880 Ultrasonic transducer.
870.2890 Vessel occlusion transducer.
870.2900 Patient transducer and electrode cable (including connector).
870.2910 Radiofrequency physiological signal transmitter and receiver.
870.2920 Telephone electrocardiograph transmitter and receiver.

               Subpart D_Cardiovascular Prosthetic Devices

870.3250 Vascular clip.
870.3260 Vena cava clip.
870.3300 Vascular embolization device.
870.3375 Cardiovascular intravascular filter.
870.3450 Vascular graft prosthesis.
870.3460 Endovascular suturing system.
870.3470 Intracardiac patch or pledget made of polypropylene, 
          polyethylene terephthalate, or polytetrafluoroethylene.
870.3535 Intra-aortic balloon and control system.
870.3545 Ventricular bypass (assist) device.
870.3600 External pacemaker pulse generator.
870.3605 Pacing system analyzer.
870.3610 Implantable pacemaker pulse generator.
870.3620 Pacemaker lead adaptor.
870.3630 Pacemaker generator function analyzer.
870.3640 Indirect pacemaker generator function analyzer.
870.3650 Pacemaker polymeric mesh bag.
870.3670 Pacemaker charger.
870.3680 Cardiovascular permanent or temporary pacemaker electrode.
870.3690 Pacemaker test magnet.
870.3700 Pacemaker programmers.
870.3710 Pacemaker repair or replacement material.
870.3720 Pacemaker electrode function tester.
870.3730 Pacemaker service tools.
870.3800 Annuloplasty ring.
870.3850 Carotid sinus nerve stimulator.
870.3925 Replacement heart valve.
870.3935 Prosthetic heart valve holder.
870.3945 Prosthetic heart valve sizer.

                Subpart E_Cardiovascular Surgical Devices

870.4075 Endomyocardial biopsy device.
870.4100 Extracorporeal circuit and accessories for long-term 
          respiratory/cardiopulmonary failure.
870.4150 Extracorporeal system for carbon dioxide removal.
870.4200 Cardiopulmonary bypass accessory equipment.
870.4205 Cardiopulmonary bypass bubble detector.
870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
870.4220 Cardiopulmonary bypass heart-lung machine console.
870.4230 Cardiopulmonary bypass defoamer.
870.4240 Cardiopulmonary bypass heat exchanger.
870.4250 Cardiopulmonary bypass temperature controller.
870.4260 Cardiopulmonary bypass arterial line blood filter.
870.4270 Cardiopulmonary bypass cardiotomy suction line blood filter.
870.4280 Cardiopulmonary prebypass filter.
870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
870.4300 Cardiopulmonary bypass gas control unit.
870.4310 Cardiopulmonary bypass coronary pressure gauge.
870.4320 Cardiopulmonary bypass pulsatile flow generator.
870.4330 Cardiopulmonary bypass on-line blood gas monitor.
870.4340 Cardiopulmonary bypass level sensing monitor and/or control.
870.4350 Cardiopulmonary bypass oxygenator.
870.4360 Nonroller-type blood pump.
870.4370 Roller-type cardiopulmonary bypass blood pump.
870.4380 Cardiopulmonary bypass pump speed control.
870.4390 Cardiopulmonary bypass pump tubing.
870.4400 Cardiopulmonary bypass blood reservoir.
870.4410 Cardiopulmonary bypass in-line blood gas sensor.
870.4420 Cardiopulmonary bypass cardiotomy return sucker.
870.4430 Cardiopulmonary bypass intracardiac suction control.
870.4450 Vascular clamp.
870.4475 Surgical vessel dilator.
870.4500 Cardiovascular surgical instruments.
870.4510 Apical closure device.
870.4875 Intraluminal artery stripper.
870.4885 External vein stripper.

[[Page 452]]

              Subpart F_Cardiovascular Therapeutic Devices

870.5050 Patient care suction apparatus.
870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
870.5150 Embolectomy catheter.
870.5175 Septostomy catheter.
870.5200 External cardiac compressor.
870.5210 Cardiopulmonary resuscitation (CPR) aid.
870.5225 External counter-pulsating device.
870.5300 DC-defibrillator (including paddles).
870.5310 Automated external defibrillator system.
870.5325 Defibrillator tester.
870.5550 External transcutaneous cardiac pacemaker (noninvasive).
870.5700 Steerable cardiac ablation catheter remote control system.
870.5800 Compressible limb sleeve.
870.5900 Thermal regulating system.
870.5910 Esophageal thermal regulation device.
870.5925 Automatic rotating tourniquet.

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    Source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 870 appear at 73 FR 
35341, June 23, 2008.



                      Subpart A_General Provisions



Sec. 870.1  Scope.

    (a) This part sets forth the classification of cardiovascular 
devices intended for human use that are in commercial distribution.
    (b) The identification of a device in a regulation in this part is 
not a precise description of every device that is, or will be, subject 
to the regulation. A manufacturer who submits a premarket notification 
submission for a device under part 807 may not show merely that the 
device is accurately described by the section title and identification 
provisions of a regulation in this part, but shall state why the device 
is substantially equivalent to other devices, as required by Sec. 
807.87.
    (c) To avoid duplicative listings, a cardiovascular device that has 
two or more types of uses (e.g., used both as a diagnostic device and as 
a therapeutic device) is listed only in one subpart.
    (d) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.
    (e) Guidance documents referenced in this part are available on the 
Internet at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/default.htm..

[52 FR 17735, May 11, 1987, as amended at 68 FR 61344, Oct. 28, 2003; 78 
FR 18233, Mar. 26, 2013]



Sec. 870.3  Effective dates of requirement for premarket approval.

    A device included in this part that is classified into class III 
(premarket approval) shall not be commercially distributed after the 
date shown in the regulation classifying the device unless the 
manufacturer has an approval under section 515 of the act (unless an 
exemption has been granted under section 520(g)(2) of the act). An 
approval under section 515 of the act consists of FDA's issuance of an 
order approving an application for premarket approval (PMA) for the 
device or declaring completed a product development protocol (PDP) for 
the device.
    (a) Before FDA requires that a device commercially distributed 
before the enactment date of the amendments, or a device that has been 
found substantially equivalent to such a device, has an approval under 
section 515 of the act FDA must promulgate a regulation under section 
515(b) of the act requiring such approval, except as provided in 
paragraph (b) of this section. Such a regulation under section 515(b) of 
the act shall not be effective during the grace period ending on the 
90th day after its promulgation or on the last day of the 30th full 
calendar month after the regulation that classifies the device into 
class III is effective, whichever is later. See section 501(f)(2)(B) of 
the act. Accordingly, unless an effective date of the requirement for 
premarket approval is shown in the regulation for a device classified 
into class III in this part, the device may be commercially distributed 
without FDA's issuance of an order approving a PMA or declaring 
completed a PDP for the device. If FDA promulgates a regulation under 
section 515(b) of the act requiring premarket approval for a device, 
section 501(f)(1)(A) of the act applies to the device.

[[Page 453]]

    (b) Any new, not substantially equivalent, device introduced into 
commercial distribution on or after May 28, 1976, including a device 
formerly marketed that has been substantially altered, is classified by 
statute (section 513(f) of the act) into class III without any grace 
period and FDA must have issued an order approving a PMA or declaring 
completed a PDP for the device before the device is commercially 
distributed unless it is reclassified. If FDA knows that a device being 
commercially distributed may be a ``new'' device as defined in this 
section because of any new intended use or other reasons, FDA may codify 
the statutory classification of the device into class III for such new 
use. Accordingly, the regulation for such a class III device states that 
as of the enactment date of the amendments, May 28, 1976, the device 
must have an approval under section 515 of the act before commercial 
distribution.

[52 FR 17735, May 11, 1987]



Sec. 870.9  Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    The exemption from the requirement of premarket notification 
(section 510(k) of the act) for a generic type of class I or II device 
is only to the extent that the device has existing or reasonably 
foreseeable characteristics of commercially distributed devices within 
that generic type or, in the case of in vitro diagnostic devices, only 
to the extent that misdiagnosis as a result of using the device would 
not be associated with high morbidity or mortality. Accordingly, 
manufacturers of any commercially distributed class I or II device for 
which FDA has granted an exemption from the requirement of premarket 
notification must still submit a premarket notification to FDA before 
introducing or delivering for introduction into interstate commerce for 
commercial distribution the device when:
    (a) The device is intended for a use different from the intended use 
of a legally marketed device in that generic type of device; e.g., the 
device is intended for a different medical purpose, or the device is 
intended for lay use where the former intended use was by health care 
professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro diagnostic 
device detects or identifies infectious agents by using deoxyribonucleic 
acid (DNA) probe or nucleic acid hybridization technology rather than 
culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of neoplastic 
diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial or acquired 
genetic disorders, including inborn errors of metabolism;
    (3) For measuring an analyte that serves as a surrogate marker for 
screening, diagnosis, or monitoring life-threatening diseases such as 
acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, 
tuberculosis, or myocardial infarction or to monitor therapy;
    (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) or IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is intended 
for use in matrices other than serum or plasma;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).

[65 FR 2314, Jan. 14, 2000]

[[Page 454]]



               Subpart B_Cardiovascular Diagnostic Devices



Sec. 870.1025  Arrhythmia detector and alarm (including ST-segment measurement and alarm).

    (a) Identification. The arrhythmia detector and alarm device 
monitors an electrocardiogram and is designed to produce a visible or 
audible signal or alarm when atrial or ventricular arrhythmia, such as 
premature contraction or ventricular fibrillation, occurs.
    (b) Classification. Class II (special controls). The guidance 
document entitled ``Class II Special Controls Guidance Document: 
Arrhythmia Detector and Alarm'' will serve as the special control. See 
Sec. 870.1 for the availability of this guidance document.

[68 FR 61344, Oct. 28, 2003]



Sec. 870.1100  Blood pressure alarm.

    (a) Identification. A blood pressure alarm is a device that accepts 
the signal from a blood pressure transducer amplifier, processes the 
signal, and emits an alarm when the blood pressure falls outside a pre-
set upper or lower limit.
    (b) Classification. Class II (performance standards).



Sec. 870.1110  Blood pressure computer.

    (a) Identification. A blood pressure computer is a device that 
accepts the electrical signal from a blood pressure transducer amplifier 
and indicates the systolic, diastolic, or mean pressure based on the 
input signal.
    (b) Classification. Class II (performance standards).



Sec. 870.1120  Blood pressure cuff.

    (a) Identification. A blood pressure cuff is a device that has an 
inflatable bladder in an inelastic sleeve (cuff) with a mechanism for 
inflating and deflating the bladder. The cuff is used in conjunction 
with another device to determine a subject's blood pressure.
    (b) Classification. Class II (performance standards).



Sec. 870.1130  Noninvasive blood pressure measurement system.

    (a) Identification. A noninvasive blood pressure measurement system 
is a device that provides a signal from which systolic, diastolic, mean, 
or any combination of the three pressures can be derived through the use 
of tranducers placed on the surface of the body.
    (b) Classification. Class II (performance standards).



Sec. 870.1140  Venous blood pressure manometer.

    (a) Identification. A venous blood pressure manometer is a device 
attached to a venous catheter to indicate manometrically the central or 
peripheral venous pressure.
    (b) Classification. Class II (performance standards).



Sec. 870.1200  Diagnostic intravascular catheter.

    (a) Identification. An intravascular diagnostic catheter is a device 
used to record intracardiac pressures, to sample blood, and to introduce 
substances into the heart and vessels. Included in this generic device 
are right-heart catheters, left-heart catheters, and angiographic 
catheters, among others.
    (b) Classification. Class II (performance standards).



Sec. 870.1210  Continuous flush catheter.

    (a) Identification. A continuous flush catheter is an attachment to 
a catheter-transducer system that permits continuous intravascular 
flushing at a slow infusion rate for the purpose of eliminating 
clotting, back-leakage, and waveform damping.
    (b) Classification. Class II (performance standards).



Sec. 870.1220  Electrode recording catheter or electrode recording probe.

    (a) Identification. An electrode recording catheter or an electrode 
recording probe is a device used to detect an intracardiac 
electrocardiogram, or to detect cardiac output or left-to-right heart 
shunts. The device may be unipolar or multipolar for electrocardiogram 
detection, or may be a platinum-tipped catheter which senses the 
presence of a special indicator for cardiac output or left-to-right 
heart shunt determinations.
    (b) Classification. Class II (performance standards).

[[Page 455]]



Sec. 870.1230  Fiberoptic oximeter catheter.

    (a) Identification. A fiberoptic oximeter catheter is a device used 
to estimate the oxygen saturation of the blood. It consists of two 
fiberoptic bundles that conduct light at a desired wavelength through 
blood and detect the reflected and scattered light at the distal end of 
the catheter.
    (b) Classification. Class II (performance standards).



Sec. 870.1240  Flow-directed catheter.

    (a) Identification. A flow-directed catheter is a device that 
incorporates a gas-filled balloon to help direct the catheter to the 
desired position.
    (b) Classification. Class II (performance standards).



Sec. 870.1250  Percutaneous catheter.

    (a) Identification. A percutaneous catheter is a device that is 
introduced into a vein or artery through the skin using a dilator and a 
sheath (introducer) or guide wire.
    (b) Classification. Class II (performance standards).



Sec. 870.1251  Temporary catheter for embolic protection during transcatheter intracardiac procedures.

    (a) Identification. This device is a single use percutaneous 
catheter system that has (a) blood filter(s) at the distal end. This 
device is indicated for use while performing transcatheter intracardiac 
procedures. The device is used to filter blood in a manner that may 
prevent embolic material (thrombus/debris) from the transcatheter 
intracardiac procedure from traveling towards the cerebral circulation.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be tested:
    (i) Simulated-use testing in a clinically relevant bench anatomic 
model to assess the following:
    (A) Delivery, deployment, and retrieval, including quantifying 
deployment and retrieval forces, and procedural time; and
    (B) Device compatibility and lack of interference with the 
transcatheter intracardiac procedure and device.
    (ii) Tensile strengths of joints and components, tip flexibility, 
torque strength, torque response, and kink resistance.
    (iii) Flow characteristics.
    (A) The ability of the filter to not impede blood flow.
    (B) The amount of time the filter can be deployed in position and/or 
retrieved from its location without disrupting blood flow.
    (iv) Characterization and verification of all dimensions.
    (2) Animal testing must demonstrate that the device performs as 
intended under anticipated conditions of use. The following performance 
characteristics must be assessed:
    (i) Delivery, deployment, and retrieval, including quantifying 
procedural time.
    (ii) Device compatibility and lack of interference with the 
transcatheter intracardiac procedure and device.
    (iii) Flow characteristics.
    (A) The ability of the filter to not impede blood flow.
    (B) The amount of time the filter can be deployed in position and/or 
retrieved from its location without disrupting blood flow.
    (iv) Gross pathology and histopathology assessing vascular injury 
and downstream embolization.
    (3) All patient contacting components of the device must be 
demonstrated to be biocompatible.
    (4) Performance data must demonstrate the sterility of the device 
components intended to be provided sterile.
    (5) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the identified shelf life.
    (6) Labeling for the device must include:
    (i) Instructions for use;
    (ii) Compatible transcatheter intracardiac procedure devices;
    (iii) A detailed summary of the clinical testing conducted; and

[[Page 456]]

    (iv) A shelf life and storage conditions.
    (7) Clinical performance testing must demonstrate:
    (i) The ability to safely deliver, deploy, and remove the device;
    (ii) The ability of the device to filter embolic material while not 
impeding blood flow;
    (iii) Secure positioning and stability of the position throughout 
the transcatheter intracardiac procedure; and
    (iv) Evaluation of all adverse events including death, stroke, and 
vascular injury.

[83 FR 4140, Jan. 30, 2018]



Sec. 870.1252  Percutaneous catheter for creation of an arteriovenous
fistula for hemodialysis access.

    (a) Identification. This device is a single use percutaneous 
catheter system that creates an arteriovenous fistula in the arm of 
patients with chronic kidney disease who need hemodialysis.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must evaluate:
    (i) The ability to safely deliver, deploy, and remove the device;
    (ii) The ability of the device to create an arteriovenous fistula;
    (iii) The ability of the arteriovenous fistula to attain a blood 
flow rate and diameter suitable for hemodialysis;
    (iv) The ability of the fistula to be used for vascular access for 
hemodialysis;
    (v) The patency of the fistula; and
    (vi) The rates and types of all adverse events.
    (2) Animal testing must demonstrate that the device performs as 
intended under anticipated conditions of use. The following performance 
characteristics must be assessed:
    (i) Delivery, deployment, and retrieval of the device;
    (ii) Compatibility with other devices labeled for use with the 
device;
    (iii) Patency of the fistula;
    (iv) Characterization of blood flow at the time of the fistula 
creation procedure and at chronic followup; and
    (v) Gross pathology and histopathology assessing vascular injury and 
downstream embolization.
    (3) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be tested:
    (i) Simulated-use testing in a clinically relevant bench anatomic 
model to assess the delivery, deployment, activation, and retrieval of 
the device;
    (ii) Tensile strengths of joints and components;
    (iii) Accurate positioning and alignment of the device to achieve 
fistula creation; and
    (iv) Characterization and verification of all dimensions.
    (4) Electrical performance, electrical safety, and electromagnetic 
compatibility (EMC) testing must be performed for devices with 
electrical components.
    (5) Software verification, validation, and hazard analysis must be 
performed for devices that use software.
    (6) All patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (7) Performance data must demonstrate the sterility of the device 
components intended to be provided sterile.
    (8) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the identified shelf life.
    (9) Labeling for the device must include:
    (i) Instructions for use;
    (ii) Identification of system components and compatible devices;
    (iii) Expertise needed for the safe use of the device;
    (iv) A detailed summary of the clinical testing conducted and the 
patient population studied; and
    (v) A shelf life and storage conditions.

[87 FR 9241, Feb. 18, 2022]



Sec. 870.1255  Balloon aortic valvuloplasty catheter.

    (a) Identification. A balloon aortic valvuloplasty catheter is a 
catheter with a balloon at the distal end of the

[[Page 457]]

shaft, which is intended to treat stenosis in the aortic valve when the 
balloon is expanded.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The device must be demonstrated to be biocompatible.
    (2) Sterility and shelf life testing must demonstrate the sterility 
of patient-contacting components and the shelf life of these components.
    (3) Non-clinical performance evaluation must demonstrate that the 
device performs as intended under anticipated conditions of use, 
including device delivery, inflation, deflation, and removal.
    (4) In vivo evaluation of the device must demonstrate device 
performance, including the ability of the device to treat aortic 
stenosis.
    (5) Labeling must include a detailed summary of the device-related 
and procedure-related complications pertinent to the use of the device.

[82 FR 34852, July 27, 2017]



Sec. 870.1270  Intracavitary phonocatheter system.

    (a) Identification. An intracavitary phonocatheter system is a 
system that includes a catheter with an acoustic transducer and the 
associated device that processes the signal from the transducer; this 
device records bioacoustic phenomena from a transducer placed within the 
heart, blood vessels, or body cavities.
    (b) Classification. Class II (performance standards).



Sec. 870.1280  Steerable catheter.

    (a) Identification. A steerable catheter is a catheter used for 
diagnostic and monitoring purposes whose movements are directed by a 
steering control unit.
    (b) Classification. Class II (performance standards).



Sec. 870.1290  Steerable catheter control system.

    (a) Identification. A steerable catheter control system is a device 
that is connected to the proximal end of a steerable guide wire that 
controls the motion of the steerable catheter.
    (b) Classification. Class II (performance standards).



Sec. 870.1300  Catheter cannula.

    (a) Identification. A catheter cannula is a hollow tube which is 
inserted into a vessel or cavity; this device provides a rigid or 
semirigid structure which can be connected to a tube or connector.
    (b) Classification. Class II (performance standards).



Sec. 870.1310  Vessel dilator for percutaneous catheterization.

    (a) Identification. A vessel dilator for percutaneous 
catheterization is a device which is placed over the guide wire to 
enlarge the opening in the vessel, and which is then removed before 
sliding the catheter over the guide wire.
    (b) Classification. Class II (performance standards).



Sec. 870.1330  Catheter guide wire.

    (a) Identification. A catheter guide wire is a coiled wire that is 
designed to fit inside a percutaneous catheter for the purpose of 
directing the catheter through a blood vessel.
    (b) Classification. Class II (special controls). The device, when it 
is a torque device that is manually operated, non-patient contacting, 
and intended to manipulate non-cerebral vascular guide wires, is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71811, Dec. 30, 2019]



Sec. 870.1340  Catheter introducer.

    (a) Identification. A catheter introducer is a sheath used to 
facilitate placing a catheter through the skin into a vein or artery.
    (b) Classification. Class II (performance standards).



Sec. 870.1342  Reverse central venous recanalization system.

    (a) Identification. A reverse central venous recanalization system 
is a prescription device for obtaining central venous access to 
facilitate catheter insertion into the central venous system. Reverse 
recanalization involves the initiation of an access path from within the 
vein and then progressing to the

[[Page 458]]

skin for patients with upper body venous occlusions or other conditions 
that preclude central venous access by other methods.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must fulfill the following:
    (i) Demonstrate the ability to safely deliver, deploy, and remove 
the device; and
    (ii) Evaluate all adverse events including death, bleeding, damage 
to non-target tissue and organs, blood vessel perforation or rupture, 
and hematoma.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be tested:
    (i) Simulated-use testing in a clinically relevant bench anatomic 
model to assess the delivery, deployment, and retrieval of the system;
    (ii) Compatibility with other devices labeled for use with the 
device;
    (iii) Tensile strengths of joints and components;
    (iv) Kink resistance of system components;
    (v) Radiopacity of components used to monitor procedure under 
fluoroscopy;
    (vi) Characterization and verification of all dimensions; and
    (vii) Leakage of air or fluid.
    (3) All patient contacting components of the device must be 
demonstrated to be biocompatible.
    (4) Performance data must demonstrate the sterility of the device 
components intended to be provided sterile.
    (5) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the identified shelf life.
    (6) Labeling for the device must include:
    (i) Instructions for use, including a description of compatible 
devices;
    (ii) A detailed summary of the clinical testing conducted and;
    (iii) Shelf life and storage conditions.

[87 FR 26991, May 6, 2022]



Sec. 870.1345  Intravascular bleed monitor.

    (a) Identification. An intravascular bleed monitor is a probe, 
catheter, or catheter introducer that measures changes in bioimpedance 
and uses an algorithm to detect or monitor progression of potential 
internal bleeding complications.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) In vivo animal performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use and 
evaluate the following:
    (i) Device performance characteristics;
    (ii) Adverse effects, including gross necropsy and histopathology; 
and
    (iii) Device usability, including device preparation, device 
handling, and user interface.
    (2) Non-clinical performance testing data must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be tested:
    (i) Tensile testing of joints and materials;
    (ii) Mechanical integrity testing;
    (iii) Friction testing;
    (iv) Flush testing;
    (v) Air leakage and liquid leakage testing;
    (vi) Latching and unlatching testing;
    (vii) Kink and bend testing;
    (viii) Insertion force testing;
    (ix) Torque testing;
    (x) Corrosion testing; and
    (xi) Dimensional tolerance testing.
    (3) Performance data must support the sterility and pyrogenicity of 
the device components intended to be provided sterile.
    (4) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the identified shelf life.
    (5) The patient contacting components of the device must be 
demonstrated to be biocompatible.
    (6) Software verification, validation, and hazard analysis must be 
performed.

[[Page 459]]

    (7) Performance data must demonstrate electromagnetic compatibility 
(EMC), electrical safety, thermal safety, and mechanical safety.
    (8) Human factors performance evaluation must demonstrate that the 
user can correctly use the device, based solely on reading the 
directions for use.
    (9) Labeling must include:
    (i) Instructions for use;
    (ii) A shelf life and storage conditions;
    (iii) Compatible procedures;
    (iv) A sizing table; and
    (v) Quantification of blood detected.

[87 FR 34778, June 8, 2022]



Sec. 870.1350  Catheter balloon repair kit.

    (a) Identification. A catheter balloon repair kit is a device used 
to repair or replace the balloon of a balloon catheter. The kit contains 
the materials, such as glue and balloons, necessary to effect the repair 
or replacement.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before December 26, 1996 for any catheter 
balloon repair kit that was in commercial distribution before May 28, 
1976, or that has, on or before December 26, 1996 been found to be 
substantially equivalent to a catheter balloon repair kit that was in 
commercial distribution before May 28, 1976. Any other catheter balloon 
repair kit shall have an approved PMA or a declared completed PDP in 
effect before being placed in commercial distribution.

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 61 
FR 50706, Sept. 27, 1996]



Sec. 870.1360  Trace microsphere.

    (a) Identification. A trace microsphere is a radioactively tagged 
nonbiodegradable particle that is intended to be injected into an artery 
or vein and trapped in the capillary bed for the purpose of studying 
blood flow within or to an organ.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before December 26, 1996 for any trace 
microsphere that was in commercial distribution before May 28, 1976, or 
that has, on or before December 26, 1996 been found to be substantially 
equivalent to a trace microsphere that was in commercial distribution 
before May 28, 1976. Any other trace microsphere shall have an approved 
PMA or a declared completed PDP in effect before being placed in 
commercial distribution.

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 61 
FR 50706, Sept. 27, 1996]



Sec. 870.1370  Catheter tip occluder.

    (a) Identification. A catheter tip occluder is a device that is 
inserted into certain catheters to prevent flow through one or more 
orifices.
    (b) Classification. Class II (performance standards).



Sec. 870.1380  Catheter stylet.

    (a) Identification. A catheter stylet is a wire that is run through 
a catheter or cannula to render it stiff.
    (b) Classification. Class II (performance standards).



Sec. 870.1390  Trocar.

    (a) Identification. A trocar is a sharp-pointed instrument used with 
a cannula for piercing a vessel or chamber to facilitate insertion of 
the cannula.
    (b) Classification. Class II (special controls). Except for trocars 
that are reprocessed for multiple use, the device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71811, Dec. 30, 2019]



Sec. 870.1405  Interventional cardiovascular implant simulation
software device.

    (a) Identification. An interventional cardiovascular implant 
simulation software device is a prescription device that provides a 
computer simulation of an interventional cardiovascular implant device 
inside a patient's cardiovascular anatomy. It performs computational 
modeling to predict the

[[Page 460]]

interaction of the interventional cardiovascular implant device with the 
patient-specific anatomical environment.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Software verification, validation, and hazard analysis, with 
identification of appropriate mitigations, must be performed, including 
a full verification and validation of the software according to the 
predefined software specifications.
    (2) Computational modeling verification and validation activities 
must be performed to establish the predictive capability of the device 
for its indications for use.
    (3) Performance validation testing must be provided to demonstrate 
the accuracy and clinical relevance of the modeling methods for the 
intended implantation simulations, including the following:
    (i) Computational modeling results must be compared to clinical data 
supporting the indications for use to demonstrate accuracy and clinical 
meaningfulness of the simulations;
    (ii) Agreement between computational modeling results and clinical 
data must be assessed and demonstrated across the full intended 
operating range (e.g., full range of patient population, implant device 
sizes and patient anatomic morphologies). Any selection criteria or 
limitations of the samples must be described and justified;
    (iii) Endpoints (e.g., performance goals) and sample sizes 
established must be justified as to how they were determined and why 
they are clinically meaningful; and
    (iv) Validation must be performed and controls implemented to 
characterize and ensure consistency (i.e., repeatability and 
reproducibility) of modeling outputs:
    (A) Testing must be performed using multiple qualified operators and 
using the procedure that will be implemented under anticipated 
conditions of use; and
    (B) The factors (e.g., medical imaging dataset, operator) must be 
identified regarding which were held constant and which were varied 
during the evaluation, and a description must be provided for the 
computations and statistical analyses used to evaluate the data.
    (4) Human factors evaluation must be performed to evaluate the 
ability of the user interface and labeling to allow for intended users 
to correctly use the device and interpret the provided information.
    (5) Device labeling must be provided that describes the following:
    (i) Warnings that identify anatomy and image acquisition factors 
that may impact simulation results and provide cautionary guidance for 
interpretation of the provided simulation results;
    (ii) Device simulation inputs and outputs, and key assumptions made 
in the simulation and determination of simulated outputs; and
    (iii) The computational modeling performance of the device for 
presented simulation outputs, and the supporting evidence for this 
performance.

[87 FR 79803, Dec. 28, 2022]



Sec. 870.1415  Coronary vascular physiologic simulation software device.

    (a) Identification. A coronary vascular physiologic simulation 
software device is a prescription device that provides simulated 
functional assessment of blood flow in the coronary vascular system 
using data extracted from medical device imaging to solve algorithms and 
yield simulated metrics of physiologic information (e.g., blood flow, 
coronary flow reserve, fractional flow reserve, myocardial perfusion). A 
coronary vascular physiologic simulation software device is intended to 
generate results for use and review by a qualified clinician.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Adequate software verification and validation based on 
comprehensive hazard analysis, with identification of appropriate 
mitigations, must be performed, including:
    (i) Full characterization of the technical parameters of the 
software, including:
    (A) Any proprietary algorithm(s) used to model the vascular anatomy; 
and

[[Page 461]]

    (B) Adequate description of the expected impact of all applicable 
image acquisition hardware features and characteristics on performance 
and any associated minimum specifications;
    (ii) Adequate consideration of privacy and security issues in the 
system design; and
    (iii) Adequate mitigation of the impact of failure of any subsystem 
components (e.g., signal detection and analysis, data storage, system 
communications and cybersecurity) with respect to incorrect patient 
reports and operator failures.
    (2) Adequate non-clinical performance testing must be provided to 
demonstrate the validity of computational modeling methods for flow 
measurement; and
    (3) Clinical data supporting the proposed intended use must be 
provided, including the following:
    (i) Output measure(s) must be compared to a clinically acceptable 
method and must adequately represent the simulated measure(s) the device 
provides in an accurate and reproducible manner;
    (ii) Clinical utility of the device measurement accuracy must be 
demonstrated by comparison to that of other available diagnostic tests 
(e.g., from literature analysis);
    (iii) Statistical performance of the device within clinical risk 
strata (e.g., age, relevant comorbidities, disease stability) must be 
reported;
    (iv) The dataset must be adequately representative of the intended 
use population for the device (e.g., patients, range of vessel sizes, 
imaging device models). Any selection criteria or limitations of the 
samples must be fully described and justified;
    (v) Statistical methods must consider the predefined endpoints:
    (A) Estimates of probabilities of incorrect results must be provided 
for each endpoint,
    (B) Where multiple samples from the same patient are used, 
statistical analysis must not assume statistical independence without 
adequate justification, and
    (C) The report must provide appropriate confidence intervals for 
each performance metric;
    (vi) Sensitivity and specificity must be characterized across the 
range of available measurements;
    (vii) Agreement of the simulated measure(s) with clinically 
acceptable measure(s) must be assessed across the full range of 
measurements;
    (viii) Comparison of the measurement performance must be provided 
across the range of intended image acquisition hardware; and
    (ix) If the device uses a cutoff threshold or operates across a 
spectrum of disease, it must be established prior to validation, and it 
must be justified as to how it was determined and clinically validated;
    (4) Adequate validation must be performed and controls implemented 
to characterize and ensure consistency (i.e., repeatability and 
reproducibility) of measurement outputs:
    (i) Acceptable incoming image quality control measures and the 
resulting image rejection rate for the clinical data must be specified, 
and
    (ii) Data must be provided within the clinical validation study or 
using equivalent datasets demonstrating the consistency (i.e., 
repeatability and reproducibility) of the output that is representative 
of the range of data quality likely to be encountered in the intended 
use population and relevant use conditions in the intended use 
environment;
    (A) Testing must be performed using multiple operators meeting 
planned qualification criteria and using the procedure that will be 
implemented in the production use of the device, and
    (B) The factors (e.g., medical imaging dataset, operator) must be 
identified regarding which were held constant and which were varied 
during the evaluation, and a description must be provided for the 
computations and statistical analyses used to evaluate the data;
    (5) Human factors evaluation and validation must be provided to 
demonstrate adequate performance of the user interface to allow for 
users to accurately measure intended parameters, particularly where 
parameter settings that have impact on measurements require significant 
user intervention; and

[[Page 462]]

    (6) Device labeling must be provided that adequately describes the 
following:
    (i) The device's intended use, including the type of imaging data 
used, what the device measures and outputs to the user, whether the 
measure is qualitative or quantitative, the clinical indications for 
which it is to be used, and the specific population for which the device 
use is intended;
    (ii) Appropriate warnings specifying the intended patient 
population, identifying anatomy and image acquisition factors that may 
impact measurement results, and providing cautionary guidance for 
interpretation of the provided measurements;
    (iii) Key assumptions made in the calculation and determination of 
simulated measurements;
    (iv) The measurement performance of the device for all presented 
parameters, with appropriate confidence intervals, and the supporting 
evidence for this performance. Per-vessel clinical performance, 
including where applicable localized performance according to vessel and 
segment, must be included as well as a characterization of the 
measurement error across the expected range of measurement for key 
parameters based on the clinical data;
    (v) A detailed description of the patients studied in the clinical 
validation (e.g., age, gender, race or ethnicity, clinical stability, 
current treatment regimen) as well as procedural details of the clinical 
study (e.g., scanner representation, calcium scores, use of beta-
blockers or nitrates); and
    (vi) Where significant human interface is necessary for accurate 
analysis, adequately detailed description of the analysis procedure 
using the device and any data features that could affect accuracy of 
results.

[80 FR 63673, Oct. 21, 2015]



Sec. 870.1420  Coronary artery disease risk indicator using acoustic heart signals.

    (a) Identification. A coronary artery disease risk indicator using 
acoustic heart signals is a device that records heart sounds including 
murmurs and vibrations to calculate a patient-specific risk of presence 
of coronary artery disease, as an aid in cardiac analysis and diagnosis.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must fulfill the following:
    (i) Testing must include a discussion of the patient population and 
any statistical techniques used for analyzing the data; and
    (ii) Testing must be representative of the intended use population 
for the device. Any selection criteria or sample limitations must be 
fully described and justified.
    (2) Acoustic performance testing must evaluate microphone 
sensitivity, sound acquisition bandwidth, and amplitude accuracy. The 
acoustic sensor specifications and mechanism used to capture heart 
sounds must be described.
    (3) A scientific justification for the validity of the algorithm(s) 
must be provided. This justification must fulfill the following:
    (i) All inputs and outputs of the algorithm must be fully described;
    (ii) The procedure for segmenting, characterizing, and classifying 
the acoustic signal must be fully described; and
    (iii) This justification must include verification of the algorithm 
calculations and validation using an independent data set.
    (4) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (5) Software verification, validation, and hazard analysis must be 
performed.
    (6) Human factors/usability testing must demonstrate that the user 
can correctly use the device, including device placement, based solely 
on reading the directions for use.
    (7) Performance data must demonstrate the electromagnetic 
compatibility and electrical safety of the device.
    (8) Labeling must include the following:
    (i) A description of what the device measures and outputs to the 
user;
    (ii) Instructions for proper placement of the device;
    (iii) Instructions on care and cleaning of the device;

[[Page 463]]

    (iv) Warnings identifying sensor acquisition factors that may impact 
measurement results and instructions for mitigating these factors; and
    (v) The expected performance of the device for all intended use 
populations and environments.

[87 FR 32990, June 1, 2022]



Sec. 870.1425  Programmable diagnostic computer.

    (a) Identification. A programmable diagnostic computer is a device 
that can be programmed to compute various physiologic or blood flow 
parameters based on the output from one or more electrodes, transducers, 
or measuring devices; this device includes any associated commercially 
supplied programs.
    (b) Classification. Class II (performance standards).



Sec. 870.1435  Single-function, preprogrammed diagnostic computer.

    (a) Identification. A single-function, preprogrammed diagnostic 
computer is a hard-wired computer that calculates a specific 
physiological or blood-flow parameter based on information obtained from 
one or more electrodes, transducers, or measuring devices.
    (b) Classification. Class II (performance standards).



Sec. 870.1450  Densitometer.

    (a) Identification. A densitometer is a device used to measure the 
transmission of light through an indicator in a sample of blood.
    (b) Classification. Class II (performance standards).



Sec. 870.1650  Angiographic injector and syringe.

    (a) Identification. An angiographic injector and syringe is a device 
that consists of a syringe and a high-pressure injector which are used 
to inject contrast material into the heart, great vessels, and coronary 
arteries to study the heart and vessels by x-ray photography.
    (b) Classification. Class II (special controls). The device, when it 
is a non-patient contacting balloon inflation syringe intended only to 
inflate/deflate balloon catheters and monitor pressure within the 
balloon, is exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter subject to the limitations in Sec. 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71811, Dec. 30, 2019]



Sec. 870.1660  Indicator injector.

    (a) Identification. An indicator injector is an electrically or gas-
powered device designed to inject accurately an indicator solution into 
the blood stream. This device may be used in conjuction with a 
densitometer or thermodilution device to determine cardiac output.
    (b) Classification. Class II (performance standards).



Sec. 870.1670  Syringe actuator for an injector.

    (a) Identification. A syringe actuator for an injector is an 
electrical device that controls the timing of an injection by an 
angiographic or indicator injector and synchronizes the injection with 
the electrocardiograph signal.
    (b) Classification. Class II (performance standards).



Sec. 870.1750  External programmable pacemaker pulse generator.

    (a) Identification. An external programmable pacemaker pulse 
generators is a device that can be programmed to produce one or more 
pulses at preselected intervals; this device is used in 
electrophysiological studies.
    (b) Classification. Class II (performance standards).



Sec. 870.1800  Withdrawal-infusion pump.

    (a) Identification. A withdrawal-infusion pump is a device designed 
to inject accurately drugs into the bloodstream and to withdraw blood 
samples for use in determining cardiac output.
    (b) Classification. Class II (performance standards).



Sec. 870.1875  Stethoscope.

    (a) Manual stethoscope--(1) Identification. A manual stethoscope is 
a mechanical device used to project the sounds associated with the 
heart, arteries, and veins and other internal organs.

[[Page 464]]

    (2) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 870.9.
    (b) Electronic stethoscope--(1) Identification. An electronic 
stethoscope is an electrically amplified device used to project the 
sounds associated with the heart, arteries, and veins and other internal 
organs.
    (2) Classification. Class II (special controls). The device, when it 
is a lung sound monitor, is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec. 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 
FR 38796, July 25, 2001; 84 FR 71811, Dec. 30, 2019]



Sec. 870.1915  Thermodilution probe.

    (a) Identification. A thermodilution probe is a device that monitors 
cardiac output by use of thermodilution techniques; this device is 
commonly attached to a catheter that may have one or more probes.
    (b) Classification. Class II (performance standards).



               Subpart C_Cardiovascular Monitoring Devices



Sec. 870.2050  Biopotential amplifier and signal conditioner.

    (a) Identification. A biopotential amplifier and signal conditioner 
is a device used to amplify or condition an electrical signal of 
biologic origin.
    (b) Classification. Class II (performance standards).



Sec. 870.2060  Transducer signal amplifier and conditioner.

    (a) Identification. A transducer signal amplifier and conditioner is 
a device used to provide the excitation energy for the transducer and to 
amplify or condition the signal emitted by the transducer.
    (b) Classification. Class II (performance standards).



Sec. 870.2100  Cardiovascular blood flowmeter.

    (a) Identification. A cardiovascular blood flowmeter is a device 
that is connected to a flow transducer that energizes the transducer and 
processes and displays the blood flow signal.
    (b) Classification. Class II (performance standards).



Sec. 870.2120  Extravascular blood flow probe.

    (a) Identification. An extravascular blood flow probe is an 
extravascular ultrasonic or electromagnetic probe used in conjunction 
with a blood flowmeter to measure blood flow in a chamber or vessel.
    (b) Classification. Class II (performance standards).



Sec. 870.2200  Adjunctive cardiovascular status indicator.

    (a) Identification. The adjunctive cardiovascular status indicator 
is a prescription device based on sensor technology for the measurement 
of a physical parameter(s). This device is intended for adjunctive use 
with other physical vital sign parameters and patient information and is 
not intended to independently direct therapy.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Software description, verification, and validation based on 
comprehensive hazard analysis must be provided, including:
    (i) Full characterization of technical parameters of the software, 
including any proprietary algorithm(s);
    (ii) Description of the expected impact of all applicable sensor 
acquisition hardware characteristics on performance and any associated 
hardware specifications;
    (iii) Specification of acceptable incoming sensor data quality 
control measures; and
    (iv) Mitigation of impact of user error or failure of any subsystem 
components (signal detection and analysis, data display, and storage) on 
accuracy of patient reports.
    (2) Scientific justification for the validity of the status 
indicator algorithm(s) must be provided. Verification of algorithm 
calculations and validation testing of the algorithm using a data set 
separate from the training data must demonstrate the validity of 
modeling.

[[Page 465]]

    (3) Usability assessment must be provided to demonstrate that risk 
of misinterpretation of the status indicator is appropriately mitigated.
    (4) Clinical data must be provided in support of the intended use 
and include the following:
    (i) Output measure(s) must be compared to an acceptable reference 
method to demonstrate that the output measure(s) represent(s) the 
predictive measure(s) that the device provides in an accurate and 
reproducible manner;
    (ii) The data set must be representative of the intended use 
population for the device. Any selection criteria or limitations of the 
samples must be fully described and justified;
    (iii) Agreement of the measure(s) with the reference measure(s) must 
be assessed across the full measurement range; and
    (iv) Data must be provided within the clinical validation study or 
using equivalent datasets to demonstrate the consistency of the output 
and be representative of the range of data sources and data quality 
likely to be encountered in the intended use population and relevant use 
conditions in the intended use environment.
    (5) Labeling must include the following:
    (i) The type of sensor data used, including specification of 
compatible sensors for data acquisition;
    (ii) A description of what the device measures and outputs to the 
user;
    (iii) Warnings identifying sensor reading acquisition factors that 
may impact measurement results;
    (iv) Guidance for interpretation of the measurements, including 
warning(s) specifying adjunctive use of the measurements;
    (v) Key assumptions made in the calculation and determination of 
measurements;
    (vi) The measurement performance of the device for all presented 
parameters, with appropriate confidence intervals, and the supporting 
evidence for this performance; and
    (vii) A detailed description of the patients studied in the clinical 
validation (e.g., age, gender, race/ethnicity, clinical stability) as 
well as procedural details of the clinical study.

[82 FR 35067, July 28, 2017]



Sec. 870.2210  Adjunctive predictive cardiovascular indicator.

    (a) Identification. The adjunctive predictive cardiovascular 
indicator is a prescription device that uses software algorithms to 
analyze cardiovascular vital signs and predict future cardiovascular 
status or events. This device is intended for adjunctive use with other 
physical vital sign parameters and patient information and is not 
intended to independently direct therapy.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) A software description and the results of verification and 
validation testing based on a comprehensive hazard analysis and risk 
assessment must be provided, including:
    (i) A full characterization of the software technical parameters, 
including algorithms;
    (ii) A description of the expected impact of all applicable sensor 
acquisition hardware characteristics and associated hardware 
specifications;
    (iii) A description of sensor data quality control measures;
    (iv) A description of all mitigations for user error or failure of 
any subsystem components (including signal detection, signal analysis, 
data display, and storage) on output accuracy;
    (v) A description of the expected time to patient status or clinical 
event for all expected outputs, accounting for differences in patient 
condition and environment; and
    (vi) The sensitivity, specificity, positive predictive value, and 
negative predictive value in both percentage and number form.
    (2) A scientific justification for the validity of the predictive 
cardiovascular indicator algorithm(s) must be provided. This 
justification must include verification of the algorithm calculations 
and validation using an independent data set.
    (3) A human factors and usability engineering assessment must be 
provided that evaluates the risk of misinterpretation of device output.
    (4) A clinical data assessment must be provided. This assessment 
must fulfill the following:

[[Page 466]]

    (i) The assessment must include a summary of the clinical data used, 
including source, patient demographics, and any techniques used for 
annotating and separating the data.
    (ii) The clinical data must be representative of the intended use 
population for the device. Any selection criteria or sample limitations 
must be fully described and justified.
    (iii) The assessment must demonstrate output consistency using the 
expected range of data sources and data quality encountered in the 
intended use population and environment.
    (iv) The assessment must evaluate how the device output correlates 
with the predicted event or status.
    (5) Labeling must include:
    (i) A description of what the device measures and outputs to the 
user;
    (ii) Warnings identifying sensor acquisition factors that may impact 
measurement results;
    (iii) Guidance for interpretation of the measurements, including a 
statement that the output is adjunctive to other physical vital sign 
parameters and patient information;
    (iv) A specific time or a range of times before the predicted 
patient status or clinical event occurs, accounting for differences in 
patient condition and environment;
    (v) Key assumptions made during calculation of the output;
    (vi) The type(s) of sensor data used, including specification of 
compatible sensors for data acquisition;
    (vii) The expected performance of the device for all intended use 
populations and environments; and
    (viii) Relevant characteristics of the patients studied in the 
clinical validation (including age, gender, race or ethnicity, and 
patient condition) and a summary of validation results.

[87 FR 8191, Feb. 14, 2022]



Sec. 870.2220  Adjunctive hemodynamic indicator with decision point.

    (a) Identification. An adjunctive hemodynamic indicator with 
decision point is a device that identifies and monitors hemodynamic 
condition(s) of interest and provides notifications at a clinically 
meaningful decision point. This device is intended to be used 
adjunctively along with other monitoring and patient information.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Software description, verification, and validation based on 
comprehensive hazard analysis and risk assessment must be provided, 
including:
    (i) Full characterization of technical parameters of the software, 
including algorithm(s);
    (ii) Description of the expected impact of all applicable sensor 
acquisition hardware characteristics on performance and any associated 
hardware specifications;
    (iii) Specification of acceptable incoming sensor data quality 
control measures;
    (iv) Mitigation of impact of user error or failure of any subsystem 
components (signal detection and analysis, data display, and storage) on 
output accuracy; and
    (v) The sensitivity, specificity, positive predictive value, and 
negative predictive value in both percentage and number form for 
clinically meaningful pre-specified time windows consistent with the 
device output.
    (2) Scientific justification for the validity of the hemodynamic 
indicator algorithm(s) must be provided. Verification of algorithm 
calculations and validation testing of the algorithm must use an 
independent data set.
    (3) Usability assessment must be provided to demonstrate that risk 
of misinterpretation of the status indicator is appropriately mitigated.
    (4) Clinical data must support the intended use and include the 
following:
    (i) The assessment must include a summary of the clinical data used, 
including source, patient demographics, and any techniques used for 
annotating and separating the data;
    (ii) Output measure(s) must be compared to an acceptable reference 
method to demonstrate that the output represents the measure(s) that the 
device provides in an accurate and reproducible manner;
    (iii) The data set must be representative of the intended use 
population for the device. Any selection criteria or limitations of the 
samples must be fully described and justified;

[[Page 467]]

    (iv) Where continuous measurement variables are displayed, agreement 
of the output with the reference measure(s) must be assessed across the 
full measurement range; and
    (v) Data must be provided within the clinical validation study or 
using equivalent datasets to demonstrate the consistency of the output 
and be representative of the range of data sources and data quality 
likely to be encountered in the intended use population and relevant use 
conditions in the intended use environment.
    (5) Labeling must include the following:
    (i) The type of sensor data used, including specification of 
compatible sensors for data acquisition, and a clear description of what 
the device measures and outputs to the user;
    (ii) Warnings identifying factors that may impact output results;
    (iii) Guidance for interpretation of the outputs, including 
warning(s) specifying adjunctive use of the measurements;
    (iv) Key assumptions made in the calculation and determination of 
measurements; and
    (v) A summary of the clinical validation data, including details of 
the patient population studied (e.g., age, gender, race/ethnicity), 
clinical study protocols, and device performance with confidence 
intervals for all intended use populations.

[87 FR 79254, Dec. 27, 2022]



Sec. 870.2300  Cardiac monitor (including cardiotachometer and rate alarm).

    (a) Identification. A cardiac monitor (including cardiotachometer 
and rate alarm) is a device used to measure the heart rate from an 
analog signal produced by an electrocardiograph, vectorcardiograph, or 
blood pressure monitor. This device may sound an alarm when the heart 
rate falls outside preset upper and lower limits.
    (b) Classification. Class II (performance standards).



Sec. 870.2310  Apex cardiograph (vibrocardiograph).

    (a) Identification. An apex cardiograph (vibrocardiograph) is a 
device used to amplify or condition the signal from an apex 
cardiographic transducer and to produce a visual display of the motion 
of the heart; this device also provides any excitation energy required 
by the transducer.
    (b) Classification. Class II (performance standards).



Sec. 870.2320  Ballistocardiograph.

    (a) Identification. A ballistocardiograph is a device, including a 
supporting structure on which the patient is placed, that moves in 
response to blood ejection from the heart. The device often provides a 
visual display.
    (b) Classification. Class II (performance standards).



Sec. 870.2330  Echocardiograph.

    (a) Identification. An echocardiograph is a device that uses 
ultrasonic energy to create images of cardiovascular structures. It 
includes phased arrays and two-dimensional scanners.
    (b) Classification. Class II (performance standards).



Sec. 870.2340  Electrocardiograph.

    (a) Identification. An electrocardiograph is a device used to 
process the electrical signal transmitted through two or more 
electrocardiograph electrodes and to produce a visual display of the 
electrical signal produced by the heart.
    (b) Classification. Class II (performance standards).



Sec. 870.2345  Electrocardiograph software for over-the-counter use.

    (a) Identification. An electrocardiograph software device for over-
the-counter use creates, analyzes, and displays electrocardiograph data 
and can provide information for identifying cardiac arrhythmias. This 
device is not intended to provide a diagnosis.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing under anticipated conditions of use 
must demonstrate the following:
    (i) The ability to obtain an electrocardiograph of sufficient 
quality for display and analysis; and
    (ii) The performance characteristics of the detection algorithm as 
reported

[[Page 468]]

by sensitivity and either specificity or positive predictive value.
    (2) Software verification, validation, and hazard analysis must be 
performed. Documentation must include a characterization of the 
technical specifications of the software, including the detection 
algorithm and its inputs and outputs.
    (3) Non-clinical performance testing must validate detection 
algorithm performance using a previously adjudicated data set.
    (4) Human factors and usability testing must demonstrate the 
following:
    (i) The user can correctly use the device based solely on reading 
the device labeling; and
    (ii) The user can correctly interpret the device output and 
understand when to seek medical care.
    (5) Labeling must include:
    (i) Hardware platform and operating system requirements;
    (ii) Situations in which the device may not operate at an expected 
performance level;
    (iii) A summary of the clinical performance testing conducted with 
the device;
    (iv) A description of what the device measures and outputs to the 
user; and
    (v) Guidance on interpretation of any results.

[86 FR 2549, Jan. 18, 2022]



Sec. 870.2350  Electrocardiograph lead switching adaptor.

    (a) Identification. An electrocardiograph lead switching adaptor is 
a passive switching device to which electrocardiograph limb and chest 
leads may be attached. This device is used to connect various 
combinations of limb and chest leads to the output terminals in order to 
create standard lead combinations such as leads I, II, and III.
    (b) Classification. Class II (performance standards).



Sec. 870.2360  Electrocardiograph electrode.

    (a) Identification. An electrocardiograph electrode is the 
electrical conductor which is applied to the surface of the body to 
transmit the electrical signal at the body surface to a processor that 
produces an electrocardiogram or vectorcardiogram.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 870.9. The 
special control for this device is the FDA guidance document entitled 
``Class II Special Controls Guidance Document: Electrocardiograph 
Electrodes.'' See Sec. 870.1(e) for availability information of 
guidance documents.

[45 FR 7907, Feb. 5, 1980, as amended at 76 FR 43585, July 21, 2011]



Sec. 870.2370  Electrocardiograph surface electrode tester.

    (a) Identification. An electrocardiograph surface electrode tester 
is a device used to test the function and application of 
electrocardiograph electrodes.
    (b) Classification. Class II (performance standards).



Sec. 870.2390  Phonocardiograph.

    (a) Identification. A phonocardiograph is a device used to amplify 
or condition the signal from a heart sound transducer. This device 
furnishes the excitation energy for the transducer and provides a visual 
or audible display of the heart sounds.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 
FR 38796, July 25, 2001]



Sec. 870.2400  Vectorcardiograph.

    (a) Identification. A vectorcardiograph is a device used to process 
the electrical signal transmitted through electrocardiograph electrodes 
and to produce a visual display of the magnitude and direction of the 
electrical signal produced by the heart.
    (b) Classification. Class II (performance standards).



Sec. 870.2450  Medical cathode-ray tube display.

    (a) Identification. A medical cathode-ray tube display is a device 
designed primarily to display selected biological signals. This device 
often incorporates

[[Page 469]]

special display features unique to a specific biological signal.
    (b) Classification. Class II (performance standards).



Sec. 870.2600  Signal isolation system.

    (a) Identification. A signal isolation system is a device that 
electrically isolates the patient from equipment connected to the 
commercial power supply received from a utility company. This isolation 
may be accomplished, for example, by transformer coupling, acoustic 
coupling, or optical coupling.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 
FR 38796, July 25, 2001]



Sec. 870.2620  Line isolation monitor.

    (a) Identification. A line isolation monitor is a device used to 
monitor the electrical leakage current from a power supply electrically 
isolated from the commercial power supply received from a utility 
company.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 
FR 38796, July 25, 2001]



Sec. 870.2640  Portable leakage current alarm.

    (a) Identification. A portable leakage current alarm is a device 
used to measure the electrical leakage current between any two points of 
an electrical system and to sound an alarm if the current exceeds a 
certain threshold.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 
FR 38796, July 25, 2001]



Sec. 870.2675  Oscillometer.

    (a) Identification. An oscillometer is a device used to measure 
physiological oscillations of any kind, e.g., changes in the volume of 
arteries.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]



Sec. 870.2700  Oximeter.

    (a) Identification. An oximeter is a device used to transmit 
radiation at a known wavelength(s) through blood and to measure the 
blood oxygen saturation based on the amount of reflected or scattered 
radiation. It may be used alone or in conjunction with a fiberoptic 
oximeter catheter.
    (b) Classification. Class II (performance standards).



Sec. 870.2710  Ear oximeter.

    (a) Identification. An ear oximeter is an extravascular device used 
to transmit light at a known wavelength(s) through blood in the ear. The 
amount of reflected or scattered light as indicated by this device is 
used to measure the blood oxygen saturation.
    (b) Classification. Class II (performance standards).



Sec. 870.2750  Impedance phlebograph.

    (a) Identification. An impedance phlebograph is a device used to 
provide a visual display of the venous pulse or drainage by measuring 
electrical impedance changes in a region of the body.
    (b) Classification. Class II (performance standards).



Sec. 870.2770  Impedance plethysmograph.

    (a) Identification. An impedance plethysmograph is a device used to 
estimate peripheral blood flow by measuring electrical impedance changes 
in a region of the body such as the arms and legs.
    (b) Classification. Class II (special controls). The device, when it 
is a body composition analyzer which is not intended to diagnose or 
treat any medical condition, is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec. 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]

[[Page 470]]



Sec. 870.2780  Hydraulic, pneumatic, or photoelectric plethysmographs.

    (a) Identification. A hydraulic, pneumatic, or photoelectric 
plethysmograph is a device used to estimate blood flow in a region of 
the body using hydraulic, pneumatic, or photoelectric measurement 
techniques.
    (b) Classification. Class II (performance standards).



Sec. 870.2785  Software for optical camera-based measurement of pulse
rate, heart rate, breathing rate, and/or respiratory rate.

    (a) Identification. The device uses software algorithms to analyze 
video signal and estimate pulse rate, heart rate, breathing rate, and/or 
respiratory rate. This device is not intended to independently direct 
therapy.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) A software description and the results of verification and 
validation testing based on a comprehensive hazard analysis and risk 
assessment must include:
    (i) A full characterization of the software technical parameters, 
including algorithms;
    (ii) If required image acquisition hardware is not included with the 
device, full specifications of the hardware requirements and testing to 
demonstrate the specified hardware ensures adequate data for validated 
and accurate measurements;
    (iii) A description of the expected impact of all applicable sensor 
acquisition hardware characteristics and associated hardware 
specifications;
    (iv) A description of all mitigations for user error or failure of 
any subsystem components (including signal detection, signal analysis, 
data display, and storage) on output accuracy; and
    (v) Software documentation must include a cybersecurity 
vulnerability and management process to assure software functionality.
    (2) Clinical data must be provided. This assessment must fulfill the 
following:
    (i) The clinical data must be representative of the intended use 
population for the device. Any selection criteria or sample limitations 
must be fully described and justified.
    (ii) The assessment must demonstrate output consistency using the 
expected range of data sources and data quality encountered in the 
intended use population and environment.
    (iii) The assessment must compare device output with a clinically 
accurate patient-contacting relevant comparator device in an accurate 
and reproducible manner.
    (3) A human factors and usability engineering assessment must be 
provided that evaluates the risk of improper measurement.
    (4) Labeling must include:
    (i) A description of what the device measures and outputs to the 
user;
    (ii) Warnings identifying sensor acquisition factors or subject 
conditions or characteristics (garment types/textures, motion, etc.) 
that may impact measurement results;
    (iii) Guidance for interpretation of the measurements, including a 
statement that the output is adjunctive to other physical vital sign 
parameters and patient information;
    (iv) The expected performance of the device for all intended use 
populations and environments; and
    (v) Robust instructions to ensure correct system setup.

[88 CFR 6167, Jan. 31, 2023]



Sec. 870.2786  Hardware and software for optical camera-based
measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.

    (a) Identification. The device uses an optical sensor system and 
software algorithms to obtain and analyze video signal and estimate 
pulse rate, heart rate, breathing rate, and/or respiratory rates. This 
device is not intended to independently direct therapy.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) A software description and the results of verification and 
validation testing based on a comprehensive hazard analysis and risk 
assessment must include:
    (i) A full characterization of the software technical parameters, 
including algorithms;

[[Page 471]]

    (ii) A description of all mitigations for user error or failure of 
any subsystem components (including signal detection, signal analysis, 
data display, and storage) on output accuracy; and
    (iii) Software documentation must include a cybersecurity 
vulnerability and management process to assure software functionality.
    (2) Performance testing must demonstrate the safety of any 
illuminating optics.
    (3) Clinical data must be provided. This assessment must fulfill the 
following:
    (i) The clinical data must be representative of the intended use 
population for the device. Any selection criteria or sample limitations 
must be fully described and justified.
    (ii) The assessment must demonstrate output consistency using the 
expected range of data sources and data quality encountered in the 
intended use population and environment.
    (iii) The assessment must compare device output with a clinically 
accurate patient-contacting relevant comparator device in an accurate 
and reproducible manner.
    (4) A human factors and usability engineering assessment must be 
provided that evaluates the risk of improper measurement.
    (5) Labeling must include:
    (i) A description of what the device measures and outputs to the 
user;
    (ii) Warnings identifying sensor acquisition factors or subject 
conditions or characteristics (garment types/textures, motion, etc.) 
that may impact measurement results;
    (iii) Guidance for interpretation of the measurements, including a 
statement that the output is adjunctive to other physical vital sign 
parameters and patient information;
    (iv) The expected performance of the device for all intended use 
populations and environments; and
    (v) Robust instructions to ensure correct system setup.

[88 FR 976, Jan. 6, 2023]



Sec. 870.2790  Photoplethysmograph analysis software for over-the-counter use.

    (a) Identification. A photoplethysmograph analysis software device 
for over-the-counter use analyzes photoplethysmograph data and provides 
information for identifying irregular heart rhythms. This device is not 
intended to provide a diagnosis.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must demonstrate the performance 
characteristics of the detection algorithm under anticipated conditions 
of use.
    (2) Software verification, validation, and hazard analysis must be 
performed. Documentation must include a characterization of the 
technical specifications of the software, including the detection 
algorithm and its inputs and outputs.
    (3) Non-clinical performance testing must demonstrate the ability of 
the device to detect adequate photoplethysmograph signal quality.
    (4) Human factors and usability testing must demonstrate the 
following:
    (i) The user can correctly use the device based solely on reading 
the device labeling; and
    (ii) The user can correctly interpret the device output and 
understand when to seek medical care.
    (5) Labeling must include:
    (i) Hardware platform and operating system requirements;
    (ii) Situations in which the device may not operate at an expected 
performance level;
    (iii) A summary of the clinical performance testing conducted with 
the device;
    (iv) A description of what the device measures and outputs to the 
user; and
    (v) Guidance on interpretation of any results.

[87 FR 6419, Feb. 4, 2022]



Sec. 870.2800  Medical magnetic tape recorder.

    (a) Identification. A medical magnetic tape recorder is a device 
used to record and play back signals from, for example, physiological 
amplifiers, signal conditioners, or computers.

[[Page 472]]

    (b) Classification. Class II (performance standards).



Sec. 870.2810  Paper chart recorder.

    (a) Identification. A paper chart recorder is a device used to print 
on paper, and create a permanent record of the signal from, for example, 
a physiological amplifier, signal conditioner, or computer.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 
FR 38796, July 25, 2001]



Sec. 870.2840  Apex cardiographic transducer.

    (a) Identification. An apex cardiographic transducer is a device 
used to detect motion of the heart (acceleration, velocity, or 
displacement) by changes in the mechanical or electrical properties of 
the device.
    (b) Classification. Class II (performance standards).



Sec. 870.2850  Extravascular blood pressure transducer.

    (a) Identification. An extravascular blood pressure transducer is a 
device used to measure blood pressure by changes in the mechanical or 
electrical properties of the device. The proximal end of the transducer 
is connected to a pressure monitor that produces an analog or digital 
electrical signal related to the electrical or mechanical changes 
produced in the transducer.
    (b) Classification. Class II (performance standards).



Sec. 870.2855  Implantable Intra-aneurysm Pressure Measurement System.

    (a) Identification. Implantable intra-aneurysm pressure measurement 
system is a device used to measure the intra-sac pressure in a vascular 
aneurysm. The device consists of a pressure transducer that is implanted 
into the aneurysm and a monitor that reads the pressure from the 
transducer.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance document entitled ``Class II Special Controls Guidance 
Document: Implantable Intra-Aneurysm Pressure Measurement System.'' See 
Sec. 870.1 (e) for the availability of this guidance document.

[71 FR 7871, Feb. 15, 2006]



Sec. 870.2860  Heart sound transducer.

    (a) Identification. A heart sound transducer is an external 
transducer that exhibits a change in mechanical or electrical properties 
in relation to sounds produced by the heart. This device may be used in 
conjunction with a phonocardiograph to record heart sounds.
    (b) Classification. Class II (performance standards).



Sec. 870.2870  Catheter tip pressure transducer.

    (a) Identification. A catheter tip pressure transducer is a device 
incorporated into the distal end of a catheter. When placed in the 
bloodstream, its mechanical or electrical properties change in relation 
to changes in blood pressure. These changes are transmitted to accessory 
equipment for processing.
    (b) Classification. Class II (performance standards).



Sec. 870.2880  Ultrasonic transducer.

    (a) Identification. An ultrasonic transducer is a device applied to 
the skin to transmit and receive ultrasonic energy that is used in 
conjunction with an echocardiograph to provide imaging of cardiovascular 
structures. This device includes phased arrays and two-dimensional 
scanning transducers.
    (b) Classification. Class II (performance standards).



Sec. 870.2890  Vessel occlusion transducer.

    (a) Identification. A vessel occlusion transducer is a device used 
to provide an electrical signal corresponding to sounds produced in a 
partially occluded vessel. This device includes motion, sound, and 
ultrasonic transducers.
    (b) Classification. Class II (performance standards).



Sec. 870.2900  Patient transducer and electrode cable (including connector).

    (a) Identification. A patient transducer and electrode cable 
(including connector) is an electrical conductor

[[Page 473]]

used to transmit signals from, or power or excitation signals to, 
patient-connected electrodes or transducers.
    (b) Classification. Class II (performance standards).



Sec. 870.2910  Radiofrequency physiological signal transmitter and receiver.

    (a) Identification. A radiofrequency physiological signal 
transmitter and receiver is a device used to condition a physiological 
signal so that it can be transmitted via radiofrequency from one 
location to another, e.g., a central monitoring station. The received 
signal is reconditioned by the device into its original format so that 
it can be displayed.
    (b) Classification. Class II (performance standards).



Sec. 870.2920  Telephone electrocardiograph transmitter and receiver.

    (a) Identification. A telephone electrocardiograph transmitter and 
receiver is a device used to condition an electrocardiograph signal so 
that it can be transmitted via a telephone line to another location. 
This device also includes a receiver that reconditions the received 
signal into its original format so that it can be displayed. The device 
includes devices used to transmit and receive pacemaker signals.
    (b) Classification. Class II (performance standards).



               Subpart D_Cardiovascular Prosthetic Devices



Sec. 870.3250  Vascular clip.

    (a) Identification. A vascular clip is an implanted extravascular 
device designed to occlude, by compression, blood flow in small blood 
vessels other than intracranial vessels.
    (b) Classification. Class II (performance standards).



Sec. 870.3260  Vena cava clip.

    (a) Identification. A vena cava clip is an implanted extravascular 
device designed to occlude partially the vena cava for the purpose of 
inhibiting the flow of thromboemboli through that vessel.
    (b) Classification. Class II (performance standards).



Sec. 870.3300  Vascular embolization device.

    (a) Identification. A vascular embolization device is an 
intravascular implant intended to control hemorrhaging due to aneurysms, 
certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), 
and arteriovenous malformations. This does not include cyanoacrylates 
and other embolic agents, which act by polymerization or precipitation. 
Embolization devices used in neurovascular applications are also not 
included in this classification, see Sec. 882.5950 of this chapter.
    (b) Classification. Class II (special controls.) The special control 
for this device is the FDA guidance document entitled ``Class II Special 
Controls Guidance Document: Vascular and Neurovascular Embolization 
Devices.'' For availability of this guidance document, see Sec. 
870.1(e).

[69 FR 77899, Dec. 29, 2004]



Sec. 870.3375  Cardiovascular intravascular filter.

    (a) Identification. A cardiovascular intravascular filter is an 
implant that is placed in the inferior vena cava for the purpose of 
preventing pulmonary thromboemboli (blood clots generated in the lower 
limbs and broken loose into the blood stream) from flowing into the 
right side of the heart and the pulmonary circulation.
    (b) Classification. Class II. The special controls for this device 
are:
    (1) ``Use of International Standards Organization's ISO 10993 
`Biological Evaluation of Medical Devices Part I: Evaluation and 
Testing,' '' and
    (2) FDA's:
    (i) ``510(k) Sterility Review Guidance and Revision of 2/12/90 (K90-
1)'' and
    (ii) ``Guidance for Cardiovascular Intravascular Filter 510(k) 
Submissions.''

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 65 
FR 17144, Mar. 31, 2000]



Sec. 870.3450  Vascular graft prosthesis.

    (a) Identification. A vascular graft prosthesis is an implanted 
device intended to repair, replace, or bypass sections of native or 
artificial vessels, excluding coronary or cerebral

[[Page 474]]

vasculature, and to provide vascular access. It is commonly constructed 
of materials such as polyethylene terephthalate and 
polytetrafluoroethylene, and it may be coated with a biological coating, 
such as albumin or collagen, or a synthetic coating, such as silicone. 
The graft structure itself is not made of materials of animal origin, 
including human umbilical cords.
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA guidance document entitled ``Guidance 
Document for Vascular Prostheses 510(k) Submissions.''

[66 FR 18542, Apr. 10, 2001]



Sec. 870.3460  Endovascular Suturing System.

    (a) Identification. An endovascular suturing system is a medical 
device intended to provide fixation and sealing between an endovascular 
graft and the native artery. The system is comprised of the implant 
device and an endovascular delivery device used to implant the 
endovascular suture.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The device should be demonstrated to be biocompatible;
    (2) Sterility and shelf life testing should demonstrate the 
sterility of patient-contacting components and the shelf-life of these 
components;
    (3) Non-clinical and clinical performance testing should demonstrate 
substantial equivalence in safety and effectiveness, including 
durability, compatibility, migration resistance, corrosion resistance, 
and delivery and deployment;
    (4) Non-clinical testing should evaluate the compatibility of the 
device in an magnetic resonance (MR) environment;
    (5) Appropriate analysis and non-clinical testing should validate 
electromagnetic compatibility (EMC) and electrical safety;
    (6) The sale, distribution, and use of the device are restricted to 
prescription use in accordance with 21 CFR 801.109 of this chapter; and
    (7) Labeling must bear all information required for the safe and 
effective use of the device as outlined in Sec. 801.109(c) of this 
chapter, including a detailed summary of the non-clinical and clinical 
evaluations pertinent to use of the device.

[77 FR 8119, Feb. 14, 2012]



Sec. 870.3470  Intracardiac patch or pledget made of polypropylene,
polyethylene terephthalate, or polytetrafluoroethylene.

    (a) Identification. An intracardiac patch or pledget made of 
polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is 
a fabric device placed in the heart that is used to repair septal 
defects, for patch grafting, to repair tissue, and to buttress sutures.
    (b) Classification. Class II (performance standards).



Sec. 870.3535  Intra-aortic balloon and control system.

    (a) Identification. An intra-aortic balloon and control system is a 
prescription device that consists of an inflatable balloon, which is 
placed in the aorta to improve cardiovascular functioning during certain 
life-threatening emergencies, and a control system for regulating the 
inflation and deflation of the balloon. The control system, which 
monitors and is synchronized with the electrocardiogram, provides a 
means for setting the inflation and deflation of the balloon with the 
cardiac cycle.
    (b) Classification. (1) Class II (special controls) when the device 
is indicated for acute coronary syndrome, cardiac and non-cardiac 
surgery, or complications of heart failure. The special controls for 
this device are:
    (i) Appropriate analysis and non-clinical testing must be conducted 
to validate electromagnetic compatibility and electrical safety of the 
device;
    (ii) Software verification, validation, and hazard analysis must be 
performed;
    (iii) The device must be demonstrated to be biocompatible;
    (iv) Sterility and shelf-life testing must demonstrate the sterility 
of patient-contacting components and the shelf life of these components;
    (v) Non-clinical performance evaluation of the device must 
demonstrate mechanical integrity, durability, and reliability to support 
its intended purpose; and

[[Page 475]]

    (vi) Labeling must include a detailed summary of the device- and 
procedure-related complications pertinent to use of the device.
    (2) Class III (premarket approval) when the device is indicated for 
septic shock and pulsatile flow generation.
    (c) Date premarket approval application (PMA) or notice of 
completion of product development protocol (PDP) is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before March 31, 2014, for any intra-aortic 
balloon and control system indicated for septic shock or pulsatile flow 
generation that was in commercial distribution before May 28, 1976, or 
that has, on or before March 31, 2014, been found to be substantially 
equivalent to any intra-aortic balloon and control system indicated for 
septic shock or pulsatile flow generation that was in commercial 
distribution before May 28, 1976. Any other intra-aortic balloon and 
control system indicated for septic shock or pulsatile flow generation 
shall have an approved PMA or declared completed PDP in effect before 
being placed in commercial distribution.

[78 FR 79303, Dec. 31, 2013]



Sec. 870.3545  Ventricular bypass (assist) device.

    (a) Identification. A ventricular bypass (assist) device is a device 
that assists the left or right ventricle in maintaining circulatory 
blood flow. The device is either totally or partially implanted in the 
body.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before November 21, 2011, for any ventricular 
bypass (assist) device that was in commercial distribution before May 
28, 1976, or that has, on or before November 21, 2011, been found to be 
substantially equivalent to any ventricular bypass (assist) device that 
was in commercial distribution before May 28, 1976. Any other 
ventricular bypass (assist) device shall have an approved PMA or 
declared completed PDP in effect before being placed in commercial 
distribution.

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 76 
FR 50666, Aug. 16, 2011]



Sec. 870.3600  External pacemaker pulse generator.

    (a) Identification. An external pacemaker pulse generator (EPPG) is 
a prescription device that has a power supply and electronic circuits 
that produce a periodic electrical pulse to stimulate the heart. This 
device, which is used outside the body, is used as a temporary 
substitute for the heart's intrinsic pacing system until a permanent 
pacemaker can be implanted, or to control irregular heartbeats in 
patients following cardiac surgery or a myocardial infarction. The 
device may have adjustments for impulse strength, duration, R-wave 
sensitivity, and other pacing variables.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Appropriate analysis/testing must validate electromagnetic 
compatibility (EMC) within a hospital environment.
    (2) Electrical bench testing must demonstrate device safety during 
intended use. This must include testing with the specific power source 
(i.e., battery power, AC mains connections, or both).
    (3) Non-clinical performance testing data must demonstrate the 
performance characteristics of the device. Testing must include the 
following:
    (i) Testing must demonstrate the accuracy of monitoring functions, 
alarms, measurement features, therapeutic features, and all adjustable 
or programmable parameters as identified in labeling;
    (ii) Mechanical bench testing of material strength must demonstrate 
that the device and connection cables will withstand forces or 
conditions encountered during use;
    (iii) Simulated use analysis/testing must demonstrate adequate user 
interface for adjustable parameters, performance of alarms, display 
screens, interface with external devices (e.g. data storage, printing), 
and indicator(s) functionality under intended use conditions; and

[[Page 476]]

    (iv) Methods and instructions for cleaning the pulse generator and 
connection cables must be validated.
    (4) Appropriate software verification, validation, and hazard 
analysis must be performed.
    (5) Labeling must include the following:
    (i) The labeling must clearly state that these devices are intended 
for use in a hospital environment and under the supervision of a 
clinician trained in their use;
    (ii) Connector terminals should be clearly, unambiguously marked on 
the outside of the EPPG device. The markings should identify positive 
(+) and negative (-) polarities. Dual chamber devices should clearly 
identify atrial and ventricular terminals;
    (iii) The labeling must list all pacing modes available in the 
device;
    (iv) Labeling must include a detailed description of any special 
capabilities (e.g., overdrive pacing or automatic mode switching); and
    (v) Appropriate electromagnetic compatibility information must be 
included.

[81 FR 22529, Apr. 18, 2016]



Sec. 870.3605  Pacing system analyzer.

    (a) Identification. A pacing system analyzer (PSA) is a prescription 
device that combines the functionality of a pacemaker electrode function 
tester (Sec. 870.3720) and an external pacemaker pulse generator (EPPG) 
(Sec. 870.3600). It is connected to a pacemaker lead and uses a power 
supply and electronic circuits to supply an accurately calibrated, 
variable pacing pulse for measuring the patient's pacing threshold and 
intracardiac R-wave potential. A PSA may be a single, dual, or triple 
chamber system and can simultaneously deliver pacing therapy while 
testing one or more implanted pacing leads.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Appropriate analysis/testing must validate electromagnetic 
compatibility (EMC) within a hospital environment.
    (2) Electrical bench testing must demonstrate device safety during 
intended use. This must include testing with the specific power source 
(i.e., battery power, AC mains connections, or both).
    (3) Non-clinical performance testing data must demonstrate the 
performance characteristics of the device. Testing must include the 
following:
    (i) Testing must demonstrate the accuracy of monitoring functions, 
alarms, measurement features, therapeutic features, and all adjustable 
or programmable parameters as identified in labeling;
    (ii) Mechanical bench testing of material strength must demonstrate 
that the device and connection cables will withstand forces or 
conditions encountered during use;
    (iii) Simulated use analysis/testing must demonstrate adequate user 
interface for adjustable parameters, performance of alarms, display 
screens, interface with external devices (e.g. data storage, printing), 
and indicator(s) functionality under intended use conditions; and
    (iv) Methods and instructions for cleaning the pulse generator and 
connection cables must be validated.
    (4) Appropriate software verification, validation, and hazard 
analysis must be performed.
    (5) Labeling must include the following:
    (i) The labeling must clearly state that these devices are intended 
for use in a hospital environment and under the supervision of a 
clinician trained in their use;
    (ii) Connector terminals should be clearly, unambiguously marked on 
the outside of the PSA. The markings should identify positive (+) and 
negative (-) polarities. Dual chamber devices should clearly identify 
atrial and ventricular terminals. Triple chamber devices should clearly 
identify atrial, right ventricular, and left ventricular terminals;
    (iii) The labeling must list all pacing modes available in the 
device;
    (iv) Labeling must include a detailed description of any special 
capabilities (e.g., overdrive pacing or automatic mode switching);
    (v) Labeling must limit the use of external pacing to the implant 
procedure; and

[[Page 477]]

    (vi) Appropriate electromagnetic compatibility information must be 
included.

[81 FR 22350, Apr. 18, 2016]



Sec. 870.3610  Implantable pacemaker pulse generator.

    (a) Identification. An implantable pacemaker pulse generator is a 
device that has a power supply and electronic circuits that produce a 
periodic electrical pulse to stimulate the heart. This device is used as 
a substitute for the heart's intrinsic pacing system to correct both 
intermittent and continuous cardiac rhythm disorders. This device may 
include triggered, inhibited, and asynchronous modes and is implanted in 
the human body.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before September 20, 2012, for any implantable 
pacemaker pulse generator device that was in commercial distribution 
before May 28, 1976, or that has, on or before September 20, 2012, been 
found to be substantially equivalent to any implantable pacemaker pulse 
generator device that was in commercial distribution before May 28, 
1976. Any other implantable pacemaker pulse generator device shall have 
an approved PMA or declared completed PDP in effect before being placed 
in commercial distribution.

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 77 
FR 37576, June 22, 2012]



Sec. 870.3620  Pacemaker lead adaptor.

    (a) Identification. A pacemaker lead adaptor is a device used to 
adapt a pacemaker lead so that it can be connected to a pacemaker pulse 
generator produced by a different manufacturer.
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA guidance document entitled ``Guidance for the 
Submission of Research and Marketing Applications for Permanent 
Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions.''

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 66 
FR 18542, Apr. 10, 2001]



Sec. 870.3630  Pacemaker generator function analyzer.

    (a) Identification. A pacemaker generator function analyzer is a 
device that is connected to a pacemaker pulse generator to test any or 
all of the generator's parameters, including pulse duration, pulse 
amplitude, pulse rate, and sensing threshold.
    (b) Classification. Class II (performance standards).



Sec. 870.3640  Indirect pacemaker generator function analyzer.

    (a) Identification. An indirect pacemaker generator function 
analyzer is an electrically powered device that is used to determine 
pacemaker function or pacemaker battery function by periodically 
monitoring an implanted pacemaker's pulse rate and pulse width. The 
device is noninvasive, and it detects pacemaker pulse rate and width via 
external electrodes in contact with the patient's skin.
    (b) Classification. Class II (performance standards).



Sec. 870.3650  Pacemaker polymeric mesh bag.

    (a) Identification. A pacemaker polymeric mesh bag is an implanted 
device used to hold a pacemaker pulse generator. The bag is designed to 
create a stable implant environment for the pulse generator.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 
FR 38796, July 25, 2001]



Sec. 870.3670  Pacemaker charger.

    (a) Identification. A pacemaker charger is a device used 
transcutaneously to recharge the batteries of a rechargeable pacemaker.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 
FR 38796, July 25, 2001]

[[Page 478]]



Sec. 870.3680  Cardiovascular permanent or temporary pacemaker electrode.

    (a) Temporary pacemaker electrode--(1) Identification. A temporary 
pacemaker electrode is a device consisting of flexible insulated 
electrical conductors with one end connected to an external pacemaker 
pulse generator and the other end applied to the heart. The device is 
used to transmit a pacing electrical stimulus from the pulse generator 
to the heart and/or to transmit the electrical signal of the heart to 
the pulse generator.
    (2) Classification. Class II (performance standards).
    (b) Permanent pacemaker electrode--(1) Identification. A permanent 
pacemaker electrode is a device consisting of flexible insulated 
electrical conductors with one end connected to an implantable pacemaker 
pulse generator and the other end applied to the heart. The device is 
used to transmit a pacing electrical stimulus from the pulse generator 
to the heart and/or to transmit the electrical signal of the heart to 
the pulse generator.
    (2) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before October 4, 2012, for any permanent 
pacemaker electrode device that was in commercial distribution before 
May 28, 1976, or that has, on or before October 4, 2012, been found to 
be substantially equivalent to any permanent pacemaker electrode device 
that was in commercial distribution before May 28, 1976. Any other 
pacemaker repair or replacement material device shall have an approved 
PMA or declared completed PDP in effect before being placed in 
commercial distribution.

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 77 
FR 39927, July 6, 2012]



Sec. 870.3690  Pacemaker test magnet.

    (a) Identification. A pacemaker test magnet is a device used to test 
an inhibited or triggered type of pacemaker pulse generator and cause an 
inhibited or triggered generator to revert to asynchronous operation.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 
FR 38796, July 25, 2001]



Sec. 870.3700  Pacemaker programmers.

    (a) Identification. A pacemaker programmer is a device used to 
noninvasively change one or more of the electrical operating 
characteristics of a pacemaker.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before September 20, 2012, for any pacemaker 
programmer that was in commercial distribution before May 28, 1976, or 
that has, on or before September 20, 2012, been found to be 
substantially equivalent to any pacemaker programmer that was in 
commercial distribution before May 28, 1976. Any other pacemaker 
programmer shall have an approved PMA or declared completed PDP in 
effect before being placed in commercial distribution.

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 77 
FR 37573, June 22, 2012]



Sec. 870.3710  Pacemaker repair or replacement material.

    (a) Identification. A pacemaker repair or replacement material is an 
adhesive, a sealant, a screw, a crimp, or any other material used to 
repair a pacemaker lead or to reconnect a pacemaker lead to a pacemaker 
pulse generator.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before November 21, 2011, for any pacemaker 
repair or replacement material device that was in commercial 
distribution before May 28,

[[Page 479]]

1976, or that has, on or before November 21, 2011, been found to be 
substantially equivalent to any pacemaker repair or replacement material 
device that was in commercial distribution before May 28, 1976. Any 
other pacemaker repair or replacement material device shall have an 
approved PMA or declared completed PDP in effect before being placed in 
commercial distribution.

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 76 
FR 50666, Aug. 16, 2011]



Sec. 870.3720  Pacemaker electrode function tester.

    (a) Identification. A pacemaker electrode function tester is a 
device which is connected to an implanted pacemaker lead that supplies 
an accurately calibrated, variable pacing pulse for measuring the 
patient's pacing threshold and intracardiac R-wave potential.
    (b) Classification. Class II (performance standards).



Sec. 870.3730  Pacemaker service tools.

    (a) Identification. Pacemaker service tools are devices such as 
screwdrivers and Allen wrenches, used to repair a pacemaker lead or to 
reconnect a pacemaker lead to a pacemaker generator.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 54 FR 25049, June 12, 1989; 66 
FR 38797, July 25, 2001]



Sec. 870.3800  Annuloplasty ring.

    (a) Identification. An annuloplasty ring is a rigid or flexible ring 
implanted around the mitral or tricuspid heart valve for reconstructive 
treatment of valvular insufficiency.
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA guidance document entitled ``Guidance for 
Annuloplasty Rings 510(k) Submissions.''

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 66 
FR 18542, Apr. 10, 2001]



Sec. 870.3850  Carotid sinus nerve stimulator.

    (a) Identification. A carotid sinus nerve stimulator is an 
implantable device used to decrease arterial pressure by stimulating 
Hering's nerve at the carotid sinus.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any carotid 
sinus nerve stimulator that was in commercial distribution before May 
28, 1976, or that has, on or before December 26, 1996 been found to be 
substantially equivalent to a carotid sinus nerve stimulator that was in 
commercial distribution before May 28, 1976. Any other carotid sinus 
nerve stimulator shall have an approved PMA or a declared completed PDP 
in effect before being placed in commercial distribution.

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 61 
FR 50706, Sept. 27, 1996]



Sec. 870.3925  Replacement heart valve.

    (a) Identification. A replacement heart valve is a device intended 
to perform the function of any of the heart's natural valves. This 
device includes valves constructed of prosthetic materials, biologic 
valves (e.g., porcine valves), or valves constructed of a combination of 
prosthetic and biologic materials.
    (b) Classification. Class III (premarket approval).
    (c) Date premarket approval application (PMA) or notice of 
completion of a product development protocol (PDP) is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 9, 1987 for any 
replacement heart valve that was in commercial distribution before May 
28, 1976, or that has on or before December 9, 1987 been found to be 
substantially equivalent to a replacement heart valve that was in 
commercial distribution before May 28, 1976. Any other replacement heart 
valve shall have an approved PMA or a declared completed PDP in effect 
before being placed in commercial distribution.

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 18163, May 13, 1987; 52 
FR 23137, June 17, 1987]

[[Page 480]]



Sec. 870.3935  Prosthetic heart valve holder.

    (a) Identification. A prosthetic heart valve holder is a device used 
to hold a replacement heart valve while it is being sutured into place.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996]



Sec. 870.3945  Prosthetic heart valve sizer.

    (a) Identification. A prosthetic heart valve sizer is a device used 
to measure the size of the natural valve opening to determine the size 
of the appropriate replacement heart valve.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 
FR 38797, July 25, 2001]



                Subpart E_Cardiovascular Surgical Devices



Sec. 870.4075  Endomyocardial biopsy device.

    (a) Identification. An endomyocardial biopsy device is a device used 
in a catheterization procedure to remove samples of tissue from the 
inner wall of the heart.
    (b) Classification. Class II (performance standards).



Sec. 870.4100  Extracorporeal circuit and accessories for long-term
respiratory/cardiopulmonary failure.

    (a) Identification. An extracorporeal circuit and accessories for 
long-term respiratory/cardiopulmonary support (6 hours) is a 
system of devices and accessories that provides assisted extracorporeal 
circulation and physiologic gas exchange of the patient's blood in 
patients with acute respiratory failure or acute cardiopulmonary 
failure, where other available treatment options have failed, and 
continued clinical deterioration is expected or the risk of death is 
imminent. The main devices and accessories of the system include, but 
are not limited to, the console (hardware), software, and disposables, 
including, but not limited to, an oxygenator, blood pump, heat 
exchanger, cannulae, tubing, filters, and other accessories (e.g., 
monitors, detectors, sensors, connectors).
    (b) Classification--Class II (special controls). The special 
controls for this device are:
    (1) The technological characteristics of the device must ensure that 
the geometry and design parameters are consistent with the intended use, 
and that the devices and accessories in the circuit are compatible;
    (2) The devices and accessories in the circuit must be demonstrated 
to be biocompatible;
    (3) Sterility and shelf-life testing must demonstrate the sterility 
of any patient-contacting devices and accessories in the circuit and the 
shelf life of these devices and accessories;
    (4) Non-clinical performance evaluation of the devices and 
accessories in the circuit must demonstrate substantial equivalence of 
the performance characteristics on the bench, mechanical integrity, 
electromagnetic compatibility (where applicable), software, durability, 
and reliability;
    (5) In vivo evaluation of the devices and accessories in the circuit 
must demonstrate their performance over the intended duration of use, 
including a detailed summary of the clinical evaluation pertinent to the 
use of the devices and accessories to demonstrate their effectiveness if 
a specific indication (patient population and/or condition) is 
identified; and
    (6) Labeling must include a detailed summary of the non-clinical and 
in vivo evaluations pertinent to use of the devices and accessories in 
the circuit and adequate instructions with respect to anticoagulation, 
circuit setup, performance characteristics with respect to compatibility 
among different devices and accessories in the circuit, and maintenance 
during a procedure.

[81 FR 7451, Feb. 12, 2016]



Sec. 870.4150  Extracorporeal system for carbon dioxide removal.

    (a) Identification. An extracorporeal system for carbon dioxide 
removal is a system of devices and accessories that

[[Page 481]]

provides assisted extracorporeal carbon dioxide removal from the 
patient's blood in patients with acute respiratory failure, where other 
available treatment options have failed, and continued clinical 
deterioration is expected or the risk of death is imminent. The main 
devices and accessories of the system include, but are not limited to, 
the console (hardware), software, and disposables, including, but not 
limited to, a gas exchanger, blood pump, cannulae, tubing, filters, and 
other accessories (e.g., monitors, detectors, sensors, connectors).
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) In vivo evaluation, which may include animal testing and 
clinical data, of the devices and accessories in the circuit must 
demonstrate their performance over the intended duration of use, 
including a detailed summary of the in vivo evaluation pertinent to the 
use of the devices and accessories to demonstrate their effectiveness.
    (2) The technological characteristics of the device must ensure that 
the geometry and design parameters are consistent with the intended use, 
and that the devices and accessories in the circuit are compatible.
    (3) Non-clinical performance testing of the devices and accessories 
in the circuit must demonstrate that the device performs as intended 
under anticipated conditions of use. The following performance 
characteristics must be tested:
    (i) Mechanical integrity;
    (ii) Durability; and
    (iii) Reliability.
    (4) All patient contacting components of the device must be 
demonstrated to be biocompatible.
    (5) Performance testing must demonstrate the electrical safety and 
electromagnetic compatibility (EMC) of any electrical components.
    (6) Software validation, verification, and hazard analysis must be 
performed.
    (7) Performance testing must demonstrate the sterility of all 
patient-contacting components.
    (8) Performance testing must support the shelf life of the device by 
demonstrating continued sterility and device functionality over the 
identified shelf life.
    (9) Labeling must include the following:
    (i) A detailed summary of the non-clinical and in vivo evaluations 
pertinent to use of the device and accessories in the circuit;
    (ii) Adequate instructions with respect to circuit setup, 
performance characteristics with respect to compatibility among 
different devices and accessories in the circuit, and maintenance during 
a procedure; and
    (iii) A shelf life.

[87 FR 80039, Dec. 29, 2022]



Sec. 870.4200  Cardiopulmonary bypass accessory equipment.

    (a) Identification. Cardiopulmonary bypass accessory equipment is a 
device that has no contact with blood and that is used in the 
cardiopulmonary bypass circuit to support, adjoin, or connect 
components, or to aid in the setup of the extracorporeal line, e.g., an 
oxygenator mounting bracket or system-priming equipment.
    (b) Classification. (1) Class I. The device is classified as class I 
if it does not involve an electrical connection to the patient. The 
device is exempt from the premarket notification procedures in subpart E 
of part 807 of this chapter subject to Sec. 870.9.
    (2) Class II (special controls). The device is classified as class 
II if it involves an electrical connection to the patient. The special 
controls are as follows:
    (i) The performance standard under part 898 of this chapter, and
    (ii) The guidance document entitled ``Guidance on the Performance 
Standard for Electrode Lead Wires and Patient Cables.'' The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 870.9.

[65 FR 19319, Apr. 11, 2000]



Sec. 870.4205  Cardiopulmonary bypass bubble detector.

    (a) Identification. A cardiopulmonary bypass bubble detector is a 
device used to detect bubbles in the arterial return line of the 
cardiopulmonary bypass circuit.

[[Page 482]]

    (b) Classification. Class II (performance standards).



Sec. 870.4210  Cardiopulmonary bypass vascular catheter, cannula, or tubing.

    (a) Identification. A cardiopulmonary bypass vascular catheter, 
cannula, or tubing is a device used in cardiopulmonary surgery to 
cannulate the vessels, perfuse the coronary arteries, and to 
interconnect the catheters and cannulas with an oxygenator. The device 
includes accessory bypass equipment.
    (b) Classification. Class II (performance standards).



Sec. 870.4220  Cardiopulmonary bypass heart-lung machine console.

    (a) Identification. A cardiopulmonary bypass heart-lung machine 
console is a device that consists of a control panel and the electrical 
power and control circuitry for a heart-lung machine. The console is 
designed to interface with the basic units used in a gas exchange 
system, including the pumps, oxygenator, and heat exchanger.
    (b) Classification. Class II (performance standards).



Sec. 870.4230  Cardiopulmonary bypass defoamer.

    (a) Identification. A cardiopulmonary bypass defoamer is a device 
used in conjunction with an oxygenator during cardiopulmonary bypass 
surgery to remove gas bubbles from the blood.
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA guidance document entitled ``Guidance for 
Extracorporeal Blood Circuit Defoamer 510(k) Submissions.''

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 66 
FR 18542, Apr. 10, 2001]



Sec. 870.4240  Cardiopulmonary bypass heat exchanger.

    (a) Identification. A cardiopulmonary bypass heat exchanger is a 
device, consisting of a heat exchange system used in extracorporeal 
circulation to warm or cool the blood or perfusion fluid flowing through 
the device.
    (b) Classification. Class II (performance standards).



Sec. 870.4250  Cardiopulmonary bypass temperature controller.

    (a) Identification. A cardiopulmonary bypass temperature controller 
is a device used to control the temperature of the fluid entering and 
leaving a heat exchanger.
    (b) Classification. Class II (performance standards).



Sec. 870.4260  Cardiopulmonary bypass arterial line blood filter.

    (a) Identification. A cardiopulmonary bypass arterial line blood 
filter is a device used as part of a gas exchange (oxygenator) system to 
filter nonbiologic particles and emboli (blood clots or pieces of 
foreign material flowing in the bloodstream which will obstruct 
circulation by blocking a vessel) out of the blood. It is used in the 
arterial return line.
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA guidance document entitled ``Guidance for 
Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.''

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 66 
FR 18542, Apr. 10, 2001]



Sec. 870.4270  Cardiopulmonary bypass cardiotomy suction line blood filter.

    (a) Identification. A cardiopulmonary bypass cardiotomy suction line 
blood filter is a device used as part of a gas exchange (oxygenator) 
system to filter nonbiologic particles and emboli (a blood clot or a 
piece of foreign material flowing in the bloodstream which will obstruct 
circulation by blocking a vessel) out of the blood. This device is 
intended for use in the cardiotomy suction line.
    (b) Classification. Class II (performance standards).



Sec. 870.4280  Cardiopulmonary prebypass filter.

    (a) Identification. A cardiopulmonary prebypass filter is a device 
used during priming of the oxygenator circuit to remove particulates or 
other debris from the circuit prior to initiating bypass. The device is 
not used to filter blood.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures

[[Page 483]]

in subpart E of part 807 of this chapter subject to the limitations in 
Sec. 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]



Sec. 870.4290  Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

    (a) Identification. A cardiopulmonary bypass adaptor, stopcock, 
manifold, or fitting is a device used in cardiovascular diagnostic, 
surgical, and therapeutic applications to interconnect tubing, 
catheters, or other devices.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]



Sec. 870.4300  Cardiopulmonary bypass gas control unit.

    (a) Identification. A cardiopulmonary bypass gas control unit is a 
device used to control and measure the flow of gas into the oxygenator. 
The device is calibrated for a specific gas.
    (b) Classification. Class II (performance standards).



Sec. 870.4310  Cardiopulmonary bypass coronary pressure gauge.

    (a) Identification. A cardiopulmonary bypass coronary pressure gauge 
is a device used in cardiopulmonary bypass surgery to measure the 
pressure of the blood perfusing the coronary arteries.
    (b) Classification. Class II (performance standards).



Sec. 870.4320  Cardiopulmonary bypass pulsatile flow generator.

    (a) Identification. A cardiopulmonary bypass pulsatile flow 
generator is an electrically and pneumatically operated device used to 
create pulsatile blood flow. The device is placed in a cardiopulmonary 
bypass circuit downstream from the oxygenator.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before September 21, 2004, for any 
cardiopulmonary bypass pulsatile flow generator that was in commercial 
distribution before May 28, 1976, or that has, on or before September 
21, 2004, been found to be substantially equivalent to any 
cardiopulmonary bypass pulsatile flow generator that was in commercial 
distribution before May 28, 1976. Any other cardiopulmonary bypass 
pulsatile flow generator shall have an approved PMA or declared 
completed PDP in effect before being placed in commercial distribution.

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 69 
FR 34920, June 23, 2004]



Sec. 870.4330  Cardiopulmonary bypass on-line blood gas monitor.

    (a) Identification. A cardiopulmonary bypass on-line blood gas 
monitor is a device used in conjunction with a blood gas sensor to 
measure the level of gases in the blood.
    (b) Classification. Class II (performance standards).



Sec. 870.4340  Cardiopulmonary bypass level sensing monitor and/or control.

    (a) Identification. A cardiopulmonary bypass level sensing monitor 
and/or control is a device used to monitor and/or control the level of 
blood in the blood reservoir and to sound an alarm when the level falls 
below a predetermined value.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]



Sec. 870.4350  Cardiopulmonary bypass oxygenator.

    (a) Identification. A cardiopulmonary bypass oxygenator is a device 
used to exchange gases between blood and a gaseous environment to 
satisfy the gas exchange needs of a patient during open-heart surgery.
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA guidance document entitled ``Guidance for

[[Page 484]]

Cardiopulmonary Bypass Oxygenators 510(k) Submissions.''

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 66 
FR 18542, Apr. 10, 2001]



Sec. 870.4360  Nonroller-type blood pump.

    (a) Nonroller-type cardiopulmonary and circulatory bypass blood 
pump--(1) Identification. A nonroller-type cardiopulmonary and 
circulatory bypass blood pump is a prescription device that uses a 
method other than revolving rollers to pump the blood through an 
extracorporeal circuit for periods lasting less than 6 hours for the 
purpose of providing either:
    (i) Full or partial cardiopulmonary bypass (i.e., circuit includes 
an oxygenator) during open surgical procedures on the heart or great 
vessels; or
    (ii) Temporary circulatory bypass for diversion of flow around a 
planned disruption of the circulatory pathway necessary for open 
surgical procedures on the aorta or vena cava.
    (2) Classification--Class II (special controls). The special 
controls for this device are:
    (i) Non-clinical performance testing must perform as intended over 
the intended duration of use and demonstrate the following: Operating 
parameters, dynamic blood damage, heat generation, air entrapment, 
mechanical integrity, and durability/reliability;
    (ii) The patient-contacting components of the device must be 
demonstrated to be biocompatible;
    (iii) Sterility and shelf life testing must demonstrate the 
sterility of patient-contacting components and the shelf life of these 
components; and
    (iv) Labeling must include information regarding the duration of 
use, and a detailed summary of the device- and procedure-related 
complications pertinent to use of the device.
    (b) Nonroller-type temporary ventricular support blood pump--(1) 
Identification. A nonroller-type temporary ventricular support blood 
pump is a prescription device that uses any method resulting in blood 
propulsion to provide the temporary ventricular assistance required for 
support of the systemic and/or pulmonary circulations during periods 
when there is ongoing or anticipated hemodynamic instability due to 
immediately reversible alterations in ventricular myocardial function 
resulting from mechanical or physiologic causes. Duration of use would 
be less than 6 hours.
    (2) Classification. Class III (premarket approval).
    (c) Date premarket approval application (PMA) or notice of 
completion of product development protocol (PDP) is required. A PMA or 
notice of completion of a PDP is required to be filed with FDA on or 
before September 8, 2015, for any nonroller-type temporary ventricular 
support blood pump that was in commercial distribution before May 28, 
1976, or that has, on or before September 8, 2015, been found to be 
substantially equivalent to any nonroller-type temporary ventricular 
support blood pump that was in commercial distribution before May 28, 
1976. Any other nonroller-type temporary ventricular support blood pump 
shall have an approved PMA or declared completed PDP in effect before 
being placed in commercial distribution.

[80 FR 32311, June 8, 2015]



Sec. 870.4370  Roller-type cardiopulmonary bypass blood pump.

    (a) Identification. A roller-type cardiopulmonary bypass blood pump 
is a device that uses a revolving roller mechanism to pump the blood 
through the cardiopulmonary bypass circuit during bypass surgery.
    (b) Classification. Class II (performance standards).



Sec. 870.4380  Cardiopulmonary bypass pump speed control.

    (a) Identification. A cardiopulmonary bypass pump speed control is a 
device used that incorporates an electrical system or a mechanical 
system, or both, and is used to control the speed of blood pumps used in 
cardiopulmonary bypass surgery.
    (b) Classification. Class II (performance standards).



Sec. 870.4390  Cardiopulmonary bypass pump tubing.

    (a) Identification. A cardiopulmonary bypass pump tubing is 
polymeric tubing which is used in the blood pump

[[Page 485]]

head and which is cyclically compressed by the pump to cause the blood 
to flow through the cardiopulmonary bypass circuit.
    (b) Classification. Class II (performance standards).



Sec. 870.4400  Cardiopulmonary bypass blood reservoir.

    (a) Identification. A cardiopulmonary bypass blood reservoir is a 
device used in conjunction with short-term extracorporeal circulation 
devices to hold a reserve supply of blood in the bypass circulation.
    (b) Classification. Class II (special controls), except that a 
reservoir that contains a defoamer or filter is classified into the same 
class as the defoamer or filter. The device, when it is a 
cardiopulmonary bypass blood reservoir that does not contain defoamers 
or blood filters, is exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter subject to the limitations in 
Sec. 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]



Sec. 870.4410  Cardiopulmonary bypass in-line blood gas sensor.

    (a) Identification. A cardiopulmonary bypass in-line blood gas 
sensor is a transducer that measures the level of gases in the blood.
    (b) Classification. Class II (performance standards).



Sec. 870.4420  Cardiopulmonary bypass cardiotomy return sucker.

    (a) Identification. A cardiopulmonary bypass cardiotomy return 
sucker is a device that consists of tubing, a connector, and a probe or 
tip that is used to remove blood from the chest or heart during 
cardiopulmonary bypass surgery.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]



Sec. 870.4430  Cardiopulmonary bypass intracardiac suction control.

    (a) Identification. A cardiopulmonary bypass intracardiac suction 
control is a device which provides the vacuum and control for a 
cardiotomy return sucker.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]



Sec. 870.4450  Vascular clamp.

    (a) Identification. A vascular clamp is a surgical instrument used 
to occlude a blood vessel temporarily.
    (b) Classification. Class II (performance standards).



Sec. 870.4475  Surgical vessel dilator.

    (a) Identification. A surgical vessel dilator is a device used to 
enlarge or calibrate a vessel.
    (b) Classification. Class II (performance standards).



Sec. 870.4500  Cardiovascular surgical instruments.

    (a) Identification. Cardiovascular surgical instruments are surgical 
instruments that have special features for use in cardiovascular 
surgery. These devices include, e.g., forceps, retractors, and scissors.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 54 FR 25049, June 12, 1989; 66 
FR 38797, July 25, 2001]



Sec. 870.4510  Apical closure device.

    (a) Identification. An apical closure device is a prescription 
device consisting of a delivery system and implant component that is 
used for soft tissue approximation of cardiac apical tissue during 
transcatheter valve replacement procedures.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient contacting materials must be evaluated to be 
biocompatible.
    (2) Performance data must validate the sterility of the patient-
contacting components of the device.

[[Page 486]]

    (3) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the labeled shelf life.
    (4) Non-clinical performance testing data must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be tested:
    (i) Consistent and reliable implant deployment;
    (ii) Assessment of implant pull-out force; and
    (iii) Sheath size compatibility with implant.
    (5) In vivo evaluation of the device must demonstrate device 
performance, including device operation resulting in closure of the 
myocardial wound.
    (6) Labeling must include the following:
    (i) Detailed information explaining how the device operates;
    (ii) Sheath size that device can accommodate;
    (iii) Identification of the minimum myocardial wall thickness to 
ensure optimal device function; and
    (iv) A shelf life.

[81 FR 71371, Oct. 17, 2016]



Sec. 870.4875  Intraluminal artery stripper.

    (a) Identification. An intraluminal artery stripper is a device used 
to perform an endarterectomy (removal of plaque deposits from 
arterisclerotic arteries.)
    (b) Classification. Class II (performance standards).



Sec. 870.4885  External vein stripper.

    (a) Identification. An external vein stripper is an extravascular 
device used to remove a section of a vein.
    (b) Classification. Class II (performance standards).



              Subpart F_Cardiovascular Therapeutic Devices



Sec. 870.5050  Patient care suction apparatus.

    (a) Identification. A patient care suction apparatus is a device 
used with an intrathoracic catheter to withdraw fluid from the chest 
during the recovery period following surgery.
    (b) Classification. Class II (performance standards).



Sec. 870.5100  Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.

    (a) Standard PTCA Catheter--(1) Identification. A PTCA catheter is a 
device that operates on the principle of hydraulic pressurization 
applied through an inflatable balloon attached to the distal end. A PTCA 
balloon catheter has a single or double lumen shaft. The catheter 
features a balloon of appropriate compliance for the clinical 
application, constructed from a polymer. The balloon is designed to 
uniformly expand to a specified diameter and length at a specific 
pressure as labeled, with well characterized rates of inflation and 
deflation and a defined burst pressure. The device generally features a 
type of radiographic marker to facilitate fluoroscopic visualization of 
the balloon during use. A PTCA catheter is intended for balloon 
dilatation of a hemodynamically significant coronary artery or bypass 
graft stenosis in patients evidencing coronary ischemia for the purpose 
of improving myocardial perfusion. A PTCA catheter may also be intended 
for the treatment of acute myocardial infarction; treatment of in-stent 
restenosis (ISR) and/or post-deployment stent expansion.
    (2) Classification. Class II (special controls). The special control 
for this device is ``Class II Special Controls Guidance Document for 
Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) 
Catheters.'' See Sec. 870.1(e) for the availability of this guidance 
document.
    (b) Cutting/scoring PTCA Catheter--(1) Identification. A cutting/
scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring 
elements attached, which is used in those circumstances where a high 
pressure balloon resistant lesion is encountered. A cutting/scoring PTCA 
catheter is intended for the treatment of hemodynamically significant 
coronary artery stenosis for the purpose of improving myocardial 
perfusion. A cutting/scoring PTCA catheter may also be indicated for use 
in complex type C

[[Page 487]]

lesions or for the treatment of in-stent restenosis.
    (2) Classification. Class III (premarket approval). As of May 28, 
1976, an approval under section 515 of the act is required before this 
device may be commercially distributed. See Sec. 870.3.

[75 FR 54496, Sept. 8, 2010]



Sec. 870.5150  Embolectomy catheter.

    (a) Identification. An embolectomy catheter is a balloon-tipped 
catheter that is used to remove thromboemboli, i.e., blood clots which 
have migrated in blood vessels from one site in the vascular tree to 
another.
    (b) Classification. Class II (performance standards).



Sec. 870.5175  Septostomy catheter.

    (a) Identification. A septostomy catheter is a special balloon 
catheter that is used to create or enlarge the atrial septal defect 
found in the heart of certain infants.
    (b) Classification. Class II (performance standards).



Sec. 870.5200  External cardiac compressor.

    (a) Identification. An external cardiac compressor is an externally 
applied prescription device that is electrically, pneumatically, or 
manually powered and is used to compress the chest periodically in the 
region of the heart to provide blood flow during cardiac arrest. 
External cardiac compressor devices are used as an adjunct to manual 
cardiopulmonary resuscitation (CPR) when effective manual CPR is not 
possible (e.g., during patient transport or extended CPR when fatigue 
may prohibit the delivery of effective/consistent compressions to the 
victim, or when insufficient EMS personnel are available to provide 
effective CPR).
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Nonclinical performance testing under simulated physiological 
conditions must demonstrate the reliability of the delivery of specific 
compression depth and rate over the intended duration of use.
    (2) Labeling must include the following:
    (i) The clinical training necessary for the safe use of this device;
    (ii) Adjunctive use only indication prominently displayed on labels 
physically placed on the device and in any device manuals or other 
labeling;
    (iii) Information on the patient population for which the device has 
been demonstrated to be effective (including patient size and/or age 
limitations, e.g., adult, pediatric and/or infant); and
    (iv) Information on the time necessary to deploy the device as 
demonstrated in the performance testing.
    (3) For devices that incorporate electrical components, appropriate 
analysis and testing must demonstrate that the device is electrically 
safe and electromagnetically compatible in its intended use environment.
    (4) Human factors testing and analysis must validate that the device 
design and labeling are sufficient for effective use by the intended 
user, including an evaluation for the time necessary to deploy the 
device.
    (5) For devices containing software, software verification, 
validation, and hazard analysis must be performed.
    (6) Components of the device that come into human contact must be 
demonstrated to be biocompatible.

[81 FR 33133, May 25, 2016]



Sec. 870.5210  Cardiopulmonary resuscitation (CPR) aid.

    (a) CPR aid without feedback--(1) Identification. A CPR aid without 
feedback is a device that performs a simple function such as proper hand 
placement and/or simple prompting for rate and/or timing of 
compressions/breathing for the professionally trained rescuer, but 
offers no feedback related to the quality of the CPR being provided. 
These devices are intended for use by persons professionally trained in 
CPR to assure proper use and the delivery of optimal CPR to the victim.
    (2) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 870.9.
    (b) CPR aid with feedback--(1) Identification. A CPR Aid device with 
feedback is a device that provides real-time feedback to the rescuer 
regarding the quality of CPR being delivered to the

[[Page 488]]

victim, and provides either audio and/or visual information to encourage 
the rescuer to continue the consistent application of effective manual 
CPR in accordance with current accepted CPR guidelines (to include, but 
not be limited to, parameters such as compression rate, compression 
depth, ventilation, recoil, instruction for one or multiple rescuers, 
etc.). These devices may also perform a coaching function to aid 
rescuers in the sequence of steps necessary to perform effective CPR on 
a victim.
    (2) Classification. Class II (special controls). The special 
controls for this device are:
    (i) Nonclinical performance testing under simulated physiological or 
use conditions must demonstrate the accuracy and reliability of the 
feedback to the user on specific compression rate, depth and/or 
respiration over the intended duration, and environment of use.
    (ii) Labeling must include the clinical training, if needed, for the 
safe use of this device and information on the patient population for 
which the device has been demonstrated to be effective (including 
patient size and/or age limitations, e.g., adult, pediatric and/or 
infant).
    (iii) For devices that incorporate electrical components, 
appropriate analysis and testing must demonstrate that the device is 
electrically safe and electromagnetically compatible in its intended use 
environment.
    (iv) For devices containing software, software verification, 
validation, and hazard analysis must be performed.
    (v) Components of the device that come into human contact must be 
demonstrated to be biocompatible.
    (vi) Human factors testing and analysis must validate that the 
device design and labeling are sufficient for effective use by the 
intended user.
    (3) Premarket notification. The CPR Aid with feedback device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter if it does not contain software (e.g., is mechanical 
or electro-mechanical) and is in compliance with the special controls 
under paragraph (b)(2) of this section, subject to the limitations of 
exemptions in Sec. 870.9.

[81 FR 33134, May 25, 2016]



Sec. 870.5225  External counter-pulsating device.

    (a) Identification. An external counter-pulsating device is a 
noninvasive, prescription device used to assist the heart by applying 
positive or negative pressure to one or more of the body's limbs in 
synchrony with the heart cycle.
    (b) Classification. (1) Class II (special controls) when the device 
is intended for the treatment of chronic stable angina that is 
refractory to optimal anti-anginal medical therapy and without options 
for revascularization. The special controls for this device are:
    (i) Nonclinical performance evaluation of the device must 
demonstrate a reasonable assurance of safety and effectiveness for 
applied pressure, synchronization of therapy with the appropriate phase 
of the cardiac cycle, and functionality of alarms during a device 
malfunction or an abnormal patient condition;
    (ii) Reliabilities of the mechanical and electrical systems must be 
established through bench testing under simulated use conditions and 
matched by appropriate maintenance schedules;
    (iii) Software design and verification and validation must be 
appropriately documented;
    (iv) The skin-contacting components of the device must be 
demonstrated to be biocompatible;
    (v) Appropriate analysis and testing must be conducted to verify 
electrical safety and electromagnetic compatibility of the device; and
    (vi) Labeling must include a detailed summary of the device-related 
and procedure-related complications pertinent to use of the device.
    (2) Class III (premarket approval) for the following intended uses: 
Unstable angina pectoris; acute myocardial infarction; cardiogenic 
shock; congestive heart failure; postoperative treatment of patients who 
have undergone coronary artery bypass surgery; peripheral arterial 
disease associated with ischemic ulcers rest pain or

[[Page 489]]

claudication, threatened gangrene, insufficient blood supply at an 
amputation site, persisting ischemia after embolectomy or bypass 
surgery, and/or pre- and post-arterial reconstruction to improve runoff; 
diabetes complicated by peripheral arterial disease or other conditions 
possibly related to arterial insufficiency including nocturnal leg 
cramps and/or necrobiosis diabeticorum; venous diseases, including 
prophylaxis of deep vein thrombophlebitis, edema (e.g., chronic 
lymphedema) and/or induration (e.g., stasis dermatitis) associated with 
chronic venous stasis, venous stasis ulcers, and/or thrombophlebitis; 
athletic injuries, including Charley horses, pulled muscles and/or 
edematous muscles; necrotizing cellulitis.
    (c) Date premarket approval application (PMA) or notice of 
completion of product development protocol (PDP) is required. A PMA or 
notice of completion of a PDP is required to be filed with FDA on or 
before March 31, 2014, for any external counter-pulsating device, with 
an intended use described in paragraph (b)(2) of this section, that was 
in commercial distribution before May 28, 1976, or that has, on or 
before March 31, 2014, been found to be substantially equivalent to any 
external counter-pulsating device, with an intended use described in 
paragraph (b)(2) of this section, that was in commercial distribution 
before May 28, 1976. Any other external counter-pulsating device with an 
intended use described in paragraph (b)(2) of this section shall have an 
approved PMA or declared completed PDP in effect before being placed in 
commercial distribution.

[78 FR 79307, Dec. 30, 2013]



Sec. 870.5300  DC-defibrillator (including paddles).

    (a) Low-energy DC-defibrillator--(1) Identification. A low-energy 
DC-defibrillator is a device that delivers into a 50 ohm test load an 
electrical shock of a maximum of 360 joules of energy used for 
defibrillating (restoring normal heart rhythm) the atria or ventricles 
of the heart or to terminate other cardiac arrhythmias. This generic 
type of device includes low energy defibrillators with a maximum 
electrical output of less than 360 joules of energy that are used in 
pediatric defibrillation or in cardiac surgery. The device may either 
synchronize the shock with the proper phase of the electrocardiogram or 
may operate asynchronously. The device delivers the electrical shock 
through paddles placed either directly across the heart or on the 
surface of the body.
    (2) Classification. Class II (performance standards).
    (b) High-energy DC-defibrillator--(1) Identification. A high-energy 
DC-defibrillator is a device that delivers into a 50 ohm test load an 
electrical shock of greater than 360 joules of energy used for 
defibrillating the atria or ventricles of the heart or to terminate 
other cardiac arrhythmias. The device may either synchronize the shock 
with the proper phase of the electrocardiogram or may operate 
asynchronously. The device delivers the electrical shock through paddles 
placed either directly across the heart or on the surface of the body.
    (2) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any DC-
defibrillator (including paddles) described in paragraph (b)(1) of this 
section that was in commercial distribution before May 28, 1976, or that 
has, on or before December 26, 1996 been found to be substantially 
equivalent to a DC-defibrillator (including paddles) described in 
paragraph (b)(1) of this section that was in commercial distribution 
before May 28, 1976. Any other DC-defibrillator (including paddles) 
described in paragraph (b)(1) of this section shall have an approved PMA 
or declared completed PDP in effect before being placed in commercial 
distribution.

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 61 
FR 50706, Sept. 27, 1996]



Sec. 870.5310  Automated external defibrillator system.

    (a) Identification. An automated external defibrillator (AED) system 
consists of an AED and those accessories

[[Page 490]]

necessary for the AED to detect and interpret an electrocardiogram and 
deliver an electrical shock (e.g., battery, pad electrode, adapter, and 
hardware key for pediatric use). An AED system analyzes the patient's 
electrocardiogram, interprets the cardiac rhythm, and automatically 
delivers an electrical shock (fully automated AED), or advises the user 
to deliver the shock (semi-automated or shock advisory AED) to treat 
ventricular fibrillation or pulseless ventricular tachycardia.
    (b) Classification. Class III (premarket approval)
    (c) Date PMA or notice of completion of PDP is required. A PMA will 
be required to be submitted to the Food and Drug Administration by April 
29, 2015, for any AED that was in commercial distribution before May 28, 
1976, or that has, by April 29, 2015, been found to be substantially 
equivalent to any AED that was in commercial distribution before May 28, 
1976. A PMA will be required to be submitted to the Food and Drug 
Administration by April 29, 2015, for any AED accessory described in 
paragraph (a) that was in commercial distribution before May 28, 1976, 
or that has, by April 29, 2015, been found to be substantially 
equivalent to any AED accessory described in paragraph (a) that was in 
commercial distribution before May 28, 1976. Any other AED and AED 
accessory described in paragraph (a), shall have an approved PMA or 
declared completed PDP in effect before being placed in commercial 
distribution.

[68 FR 61344, Oct. 28, 2003; 69 FR 10615, Mar. 8, 2004, as amended at 80 
FR 5682, Feb. 3, 2015]



Sec. 870.5325  Defibrillator tester.

    (a) Identification. A defibrillator tester is a device that is 
connected to the output of a defibrillator and is used to measure the 
energy delivered by the defibrillator into a standard resistive load. 
Some testers also provide waveform information.
    (b) Classification. Class II (performance standards).



Sec. 870.5550  External transcutaneous cardiac pacemaker (noninvasive).

    (a) Identification. An external transcutaneous cardiac pacemaker 
(noninvasive) is a device used to supply a periodic electrical pulse 
intended to pace the heart. The pulse from the device is usually applied 
to the surface of the chest through electrodes such as defibrillator 
paddles.
    (b) Classification. Class II. The special controls for this device 
are:
    (1) ``American National Standards Institute/American Association for 
Medical Instrumentation's DF-21 `Cardiac Defibrillator Devices' '' 2d 
ed., 1996, and
    (2) ``The maximum pulse amplitude should not exceed 200 
milliamperes. The maximum pulse duration should not exceed 50 
milliseconds.''

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 65 
FR 17144, Mar. 31, 2000]



Sec. 870.5700  Steerable cardiac ablation catheter remote control system.

    (a) Identification. A steerable cardiac ablation catheter remote 
control system is a prescription device that is external to the body and 
interacts with the manual handle of a steerable cardiac ablation 
catheter to remotely control the advancement, retraction, rotation, and 
deflection of a compatible, steerable ablation catheter used for the 
treatment of cardiac arrhythmias in the right side of the heart. The 
device allows reversion to manual control of the steerable cardiac 
ablation catheter without withdrawal of the catheter and interruption of 
the procedure.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical mechanical performance testing must demonstrate 
that the device performs as intended under anticipated conditions of 
use. The following performance testing must be performed:
    (i) Mechanical performance of the system (without catheter 
connected);
    (ii) Mechanical performance of the system with compatible catheters 
connected to verify that the system does not impact catheter function or 
performance. Assessments must include the following:
    (A) Side-by-side remote control and manual comparisons of catheter 
manipulation (including all ranges of motion of catheter deflection and 
tip curl) for all compatible catheters; must include testing for worst-
case conditions, and

[[Page 491]]

    (B) Evaluation of the accuracy and function of all device control 
safety features; and
    (iii) Simulated-use testing in a bench anatomic model or animal 
model.
    (2) Non-clinical electrical testing must include validation of 
electromagnetic compatibility (EMC), electrical safety, thermal safety, 
and electrical system performance. The following performance testing 
must be performed:
    (i) Electrical performance of the system with compatible catheters 
connected to verify that the system does not impact catheter function or 
performance. Assessments must include the following:
    (A) Side-by-side remote control and manual comparisons of catheter 
manipulation (including all ranges of motion of catheter deflection and 
tip curl) for all compatible catheters; must include testing for worst-
case conditions, and
    (B) Evaluation of the accuracy and function of all device control 
safety features; and
    (ii) Electrical safety between the device and ablation catheter 
system and with other electrical equipment expected in the catheter lab 
or operating room.
    (3) In vivo testing must demonstrate that the device performs as 
intended under anticipated conditions of use, including an assessment of 
the system impact on the functionality and performance of compatible 
catheters, and documentation of the adverse event profile associated 
with clinical use. Evidence must be submitted to address the following:
    (i) Manipulation and Positioning: Ability to manipulate compatible 
catheters to pre-specified cardiac locations and confirm proper anatomic 
placement and tissue contact, in accordance with the system indications 
for use and the compatible catheter indications for use;
    (ii) Safety: Assess device-related complication rate and major 
procedural complication rate (regardless of device relatedness) in 
comparison to literature and/or a manual comparison group for compatible 
ablation catheters to support the indications for use;
    (iii) Efficacy: Assess ablation success in comparison to literature 
and/or a manual comparison group for compatible ablation catheters to 
support the indications for use; and
    (iv) User assessment of device remote controls and safety features.
    (4) Post-market surveillance (PMS) must be conducted and completed 
in accordance with FDA agreed upon PMS protocol.
    (5) A training program must be included with sufficient educational 
elements that, upon completion of the training program, the clinician 
and supporting staff can:
    (i) Identify the safe environments for device use,
    (ii) Use all safety features of device, and
    (iii) Operate the device in simulated or actual use environments 
representative of indicated environments and use for the indication of 
compatible catheters.
    (6) Performance data must demonstrate the sterility of the sterile 
disposable components of the system.
    (7) Performance data must support shelf life by demonstrating 
continued sterility of the device (of the sterile disposable 
components), package integrity, and device functionality over the 
requested shelf life.
    (8) Labeling must include the following:
    (i) Appropriate instructions, warnings, cautions, limitations, and 
information related to the intended patient population, compatible 
ablation catheters, and the device safeguards for the safe use of the 
device;
    (ii) Specific instructions and the clinical training needed for the 
safe use of the device, which includes:
    (A) Instructions on assembling the device in all available 
configurations, including installation and removal of compatible 
catheters;
    (B) Instructions and explanation of all controls, inputs, and 
outputs;
    (C) Instructions on all available modes or states of the device;
    (D) Instructions on all safety features of the device; and
    (E) Validated methods and instructions for reprocessing/disinfecting 
any reusable components;

[[Page 492]]

    (iii) A detailed summary of the mechanical compatibility testing 
including:
    (A) A table with a complete list of compatible catheters tested 
(manufacturer trade name and model number), and
    (B) A table with detailed test results, including type of test, 
acceptance criteria, and test results (i.e., pass for meeting acceptance 
criteria);
    (iv) A detailed summary of the in vivo testing including:
    (A) A table with a complete list of compatible catheters used during 
testing (manufacturer trade name and model number);
    (B) Adverse events encountered pertinent to use of the device under 
use conditions;
    (C) A detailed summary of the device- and procedure-related 
complications; and
    (D) A summary of study outcomes and endpoints. Information pertinent 
to the fluoroscopy times/exposure for the procedure, patient, and 
operator fluoroscopic exposure;
    (v) Other labeling items:
    (A) A detailed summary of pertinent non-clinical testing 
information: EMC, mechanical, electrical, and sterilization of device 
and components;
    (B) A detailed summary of the device technical parameters; and
    (C) An expiration date/shelf life and storage conditions for the 
sterile accessories; and
    (vi) When available, and according to the timeframe included in the 
PMS protocol agreed upon with FDA, provide a detailed summary of the PMS 
data including:
    (A) Updates to the labeling to accurately reflect outcomes or 
necessary modifications based upon data collected during the PMS 
experience, and
    (B) Inclusion of results and adverse events associated with 
utilization of the device during the PMS.

[80 FR 58606, Sept. 30, 2015]



Sec. 870.5800  Compressible limb sleeve.

    (a) Identification. A compressible limb sleeve is a device that is 
used to prevent pooling of blood in a limb by inflating periodically a 
sleeve around the limb.
    (b) Classification. Class II (performance standards).



Sec. 870.5900  Thermal regulating system.

    (a) Identification. A thermal regulating system is an external 
system consisting of a device that is placed in contact with the patient 
and a temperature controller for the device. The system is used to 
regulate patient temperature.
    (b) Classification. Class II (performance standards).



Sec. 870.5910  Esophageal thermal regulation device.

    (a) Identification. An esophageal thermal regulation device is a 
prescription device used to apply a specified temperature to the 
endoluminal surface of the esophagus via an external controller. This 
device may incorporate a mechanism for gastric decompression and 
suctioning. The device is used to regulate patient temperature.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient contacting materials must be demonstrated to be 
biocompatible.
    (2) Non-clinical performance evaluation must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be tested:
    (i) Mechanical integrity testing.
    (ii) Testing to determine temperature change rate(s).
    (iii) Testing to demonstrate compatibility with the indicated 
external controller.
    (iv) Shelf life testing.
    (3) Animal testing must demonstrate that the device does not cause 
esophageal injury and that body temperature remains within appropriate 
boundaries under anticipated conditions of use.
    (4) Labeling must include the following:
    (i) Detailed insertion instructions.
    (ii) Warning against attaching the device to unintended connections, 
such as external controllers for which the device is not indicated, or 
pressurized air outlets instead of vacuum outlets for those devices, 
including gastric suction.

[[Page 493]]

    (iii) The operating parameters, name, and model number of the 
indicated external controller.
    (iv) The intended duration of use.

[80 FR 49896, Aug. 18, 2015]



Sec. 870.5925  Automatic rotating tourniquet.

    (a) Identification. An automatic rotating tourniquet is a device 
that prevents blood flow in one limb at a time, which temporarily 
reduces the total blood volume, thereby reducing the normal workload of 
the heart.
    (b) Classification. Class II (performance standards).



PART 872_DENTAL DEVICES--Table of Contents



                      Subpart A_General Provisions

Sec.
872.1 Scope.
872.3 Effective dates of requirement for premarket approval.
872.9 Limitations of exemptions from section 510(k) of the Federal Food, 
          Drug, and Cosmetic Act (the act).

                      Subpart B_Diagnostic Devices

872.1500 Gingival fluid measurer.
872.1720 Pulp tester.
872.1730 Electrode gel for pulp testers.
872.1740 Caries detection device.
872.1745 Laser fluorescence caries detection device.
872.1800 Extraoral source x-ray system.
872.1810 Intraoral source x-ray system.
872.1820 Dental x-ray exposure alignment device.
872.1830 Cephalometer.
872.1840 Dental x-ray position indicating device.
872.1850 Lead-lined position indicator.
872.1870 Sulfide detection device.
872.1905 Dental x-ray film holder.
872.2050 Dental sonography device.
872.2060 Jaw tracking device.

Subpart C [Reserved]

                      Subpart D_Prosthetic Devices

872.3060 Noble metal alloy.
872.3070 Dental amalgam, mercury, and amalgam alloy.
872.3080 Mercury and alloy dispenser.
872.3100 Dental amalgamator.
872.3110 Dental amalgam capsule.
872.3130 Preformed anchor.
872.3140 Resin applicator.
872.3150 Articulator.
872.3165 Precision attachment.
872.3200 Resin tooth bonding agent.
872.3220 Facebow.
872.3240 Dental bur.
872.3250 Calcium hydroxide cavity liner.
872.3260 Cavity varnish.
872.3275 Dental cement.
872.3285 Preformed clasp.
872.3300 Hydrophilic resin coating for dentures.
872.3310 Coating material for resin fillings.
872.3330 Preformed crown.
872.3350 Gold or stainless steel cusp.
872.3360 Preformed cusp.
872.3400 Karaya and sodium borate with or without acacia denture 
          adhesive.
872.3410 Ethylene oxide homopolymer and/or carboxymethylcellulose sodium 
          denture adhesive.
872.3420 Carboxymethylcellulose sodium and cationic polyacrylamide 
          polymer denture adhesive.
872.3450 Ethylene oxide homopolymer and/or karaya denture adhesive.
872.3480 Polyacrylamide polymer (modified cationic) denture adhesive.
872.3490 Carboxymethylcellulose sodium and/or polyvinylmethylether 
          maleic acid calcium-sodium double salt denture adhesive.
872.3500 Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, 
          and carboxymethylcellulose sodium (NACMC) denture adhesive.
872.3520 OTC denture cleanser.
872.3530 Mechanical denture cleaner.
872.3540 OTC denture cushion or pad.
872.3560 OTC denture reliner.
872.3570 OTC denture repair kit.
872.3580 Preformed gold denture tooth.
872.3590 Preformed plastic denture tooth.
872.3600 Partially fabricated denture kit.
872.3630 Endosseous dental implant abutment.
872.3640 Endosseous dental implant.
872.3645 Subperiosteal implant material.
872.3660 Impression material.
872.3661 Optical Impression Systems for CAD/CAM.
872.3670 Resin impression tray material.
872.3680 Polytetrafluoroethylene (PTFE) vitreous carbon materials.
872.3690 Tooth shade resin material.
872.3710 Base metal alloy.
872.3730 Pantograph.
872.3740 Retentive and splinting pin.
872.3750 Bracket adhesive resin and tooth conditioner.
872.3760 Denture relining, repairing, or rebasing resin.
872.3765 Pit and fissure sealant and conditioner.
872.3770 Temporary crown and bridge resin.
872.3810 Root canal post.
872.3820 Root canal filling resin.
872.3830 Endodontic paper point.
872.3840 Endodontic silver point.
872.3850 Gutta percha.

[[Page 494]]

872.3890 Endodontic stabilizing splint.
872.3900 Posterior artificial tooth with a metal insert.
872.3910 Backing and facing for an artificial tooth.
872.3920 Porcelain tooth.
872.3930 Bone grafting material.
872.3940 Total temporomandibular joint prosthesis.
872.3950 Glenoid fossa prosthesis.
872.3960 Mandibular condyle prosthesis.
872.3970 Interarticular disc prosthesis (interpositional implant).
872.3980 Endosseous dental implant accessories.

                       Subpart E_Surgical Devices

872.4120 Bone cutting instrument and accessories.
872.4130 Intraoral dental drill.
872.4200 Dental handpiece and accessories.
872.4465 Gas-powered jet injector.
872.4475 Spring-powered jet injector.
872.4535 Dental diamond instrument.
872.4565 Dental hand instrument.
872.4600 Intraoral ligature and wire lock.
872.4620 Fiber optic dental light.
872.4630 Dental operating light.
872.4730 Dental injecting needle.
872.4760 Bone plate.
872.4770 Temporary mandibular condyle reconstruction plate.
872.4840 Rotary scaler.
872.4850 Ultrasonic scaler.
872.4880 Intraosseous fixation screw or wire.
872.4920 Dental electrosurgical unit and accessories.

                      Subpart F_Therapeutic Devices

872.5410 Orthodontic appliance and accessories.
872.5470 Orthodontic plastic bracket.
872.5500 Extraoral orthodontic headgear.
872.5525 Preformed tooth positioner.
872.5550 Teething ring.
872.5560 Electrical salivary stimulatory system.
872.5570 Intraoral devices for snoring and intraoral devices for snoring 
          and obstructive sleep apnea.
872.5571 Auto titration device for oral appliances.
872.5580 Oral rinse to reduce the adhesion of dental plaque.

                     Subpart G_Miscellaneous Devices

872.6010 Abrasive device and accessories.
872.6030 Oral cavity abrasive polishing agent.
872.6050 Saliva absorber.
872.6070 Ultraviolet activator for polymerization.
872.6080 Airbrush.
872.6100 Anesthetic warmer.
872.6140 Articulation paper.
872.6200 Base plate shellac.
872.6250 Dental chair and accessories.
872.6290 Prophylaxis cup.
872.6300 Rubber dam and accessories.
872.6350 Ultraviolet detector.
872.6390 Dental floss.
872.6475 Heat source for bleaching teeth.
872.6510 Oral irrigation unit.
872.6570 Impression tube.
872.6640 Dental operative unit and accessories.
872.6650 Massaging pick or tip for oral hygiene.
872.6660 Porcelain powder for clinical use.
872.6670 Silicate protector.
872.6710 Boiling water sterilizer.
872.6730 Endodontic dry heat sterilizer.
872.6770 Cartridge syringe.
872.6855 Manual toothbrush.
872.6865 Powered toothbrush.
872.6870 Disposable fluoride tray.
872.6880 Preformed impression tray.
872.6890 Intraoral dental wax.

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    Source: 52 FR 30097, Aug. 12, 1987, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 872 appear at 73 FR 
35341, June 23, 2008.



                      Subpart A_General Provisions



Sec. 872.1  Scope.

    (a) This part sets forth the classification of dental devices 
intended for human use that are in commercial distribution.
    (b) The identification of a device in a regulation in this part is 
not a precise description of every device that is, or will be, subject 
to the regulation. A manufacturer who submits a premarket notification 
submission for a device under part 807 cannot show merely that the 
device is accurately described by the section title and identification 
provisions of a regulation in this part, but shall state why the device 
is substantially equivalent to other devices, as required by Sec. 
807.87.
    (c) To avoid duplicative listings, a dental device that has two or 
more types of uses (e.g., used both as a diagnostic device and as a 
therapeutic device) is listed in one subpart only.
    (d) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21 unless otherwise noted.
    (e) Guidance documents referenced in this part are available on the 
Internet

[[Page 495]]

at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.

[52 FR 30097, Aug. 12, 1987, as amended at 68 FR 19737, Apr. 22, 2003; 
79 FR 50552, Aug. 25, 2014]



Sec. 872.3  Effective dates of requirement for premarket approval.

    A device included in this part that is classified into class III 
(premarket approval) shall not be commercially distributed after the 
date shown in the regulation classifying the device unless the 
manufacturer has an approval under section 515 of the act (unless an 
exemption has been granted under section 520(g)(2) of the act). An 
approval under section 515 of the act consists of FDA's issuance of an 
order approving an application for premarket approval (PMA) for the 
device or declaring completed a product development protocol (PDP) for 
the device.
    (a) Before FDA requires that a device commercially distributed 
before the enactment date of the amendments, or a device that has been 
found substantially equivalent to such a device, has an approval under 
section 515 of the act, FDA must promulgate a regulation under section 
515(b) of the act requiring such approval, except as provided in 
paragraphs (b) and (c) of this section. Such a regulation under section 
515(b) of the act shall not be effective during the grace period ending 
on the 90th day after its promulgation or on the last day of the 30th 
full calendar month after the regulation that classifies the device into 
class III is effective, whichever is later. See section 501(f)(2)(B) of 
the act. Accordingly, unless an effective date of the requirement for 
premarket approval is shown in the regulation for a device classified 
into class III in this part, the device may be commercially distributed 
without FDA's issuance of an order approving a PMA or declaring 
completed a PDP for the device. If FDA promulgates a regulation under 
section 515(b) of the act requiring premarket approval for a device, 
section 501(f)(1)(A) of the act applies to the device.
    (b) Any new, not substantially equivalent, device introduced into 
commercial distribution on or after May 28, 1976, including a device 
formerly marketed that has been substantially altered, is classified by 
statute (section 513(f) of the act) into class III without any grace 
period and FDA must have issued an order approving a PMA or declaring 
completed a PDP for the device before the device is commercially 
distributed unless it is reclassified. If FDA knows that a device being 
commercially distributed may be a ``new'' device as defined in this 
section because of any new intended use or other reasons, FDA may codify 
the statutory classification of the device into class III for such new 
use. Accordingly, the regulation for such a class III device states that 
as of the enactment date of the amendments, May 28, 1976, the device 
must have an approval under section 515 of the act before commercial 
distribution.
    (c) A device identified in a regulation in this part that is 
classified into class III and that is subject to the transitional 
provisions of section 520(1) of the act is automatically classified by 
statute into class III and must have an approval under section 515 of 
the act before being commercially distributed. Accordingly, the 
regulation for such a class III transitional device states that as of 
the enactment date of the amendments, May 28, 1976, the device must have 
an approval under section 515 of the act before commercial distribution.



Sec. 872.9  Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).

    The exemption from the requirement of premarket notification 
(section 510(k) of the act) for a generic type of class I or II device 
is only to the extent that the device has existing or reasonably 
foreseeable characteristics of commercially distributed devices within 
that generic type or, in the case of in vitro diagnostic devices, only 
to the extent that misdiagnosis as a result of using the device would 
not be associated with high morbidity or mortality. Accordingly, 
manufacturers of any commercially distributed class I or II device for 
which FDA has granted an exemption from the requirement of premarket 
notification must still submit a premarket notification to FDA before 
introducing or delivering for introduction into interstate commerce

[[Page 496]]

for commercial distribution the device when:
    (a) The device is intended for a use different from the intended use 
of a legally marketed device in that generic type of device; e.g., the 
device is intended for a different medical purpose, or the device is 
intended for lay use where the former intended use was by health care 
professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro diagnostic 
device detects or identifies infectious agents by using deoxyribonucleic 
acid (DNA) probe or nucleic acid hybridization technology rather than 
culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of neoplastic 
diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial or acquired 
genetic disorders, including inborn errors of metabolism;
    (3) For measuring an analyte that serves as a surrogate marker for 
screening, diagnosis, or monitoring life-threatening diseases such as 
acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, 
tuberculosis, or myocardial infarction or to monitor therapy;
    (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) or IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is intended 
for use in matrices other than serum or plasma;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).

[65 FR 2314, Jan. 14, 2000]



                      Subpart B_Diagnostic Devices



Sec. 872.1500  Gingival fluid measurer.

    (a) Identification. A gingival fluid measurer is a gauge device 
intended to measure the amount of fluid in the gingival sulcus 
(depression between the tooth and gums) to determine if there is a 
gingivitis condition.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63007, Dec. 7, 1994; 66 
FR 38797, July 25, 2001]



Sec. 872.1720  Pulp tester.

    (a) Identification. A pulp tester is an AC or battery powered device 
intended to evaluate the pulpal vitality of teeth by employing high 
frequency current transmitted by an electrode to stimulate the nerve 
tissue in the dental pulp.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 84 FR 71812, Dec. 30, 2019]



Sec. 872.1730  Electrode gel for pulp testers.

    (a) Identification. An electrode gel for pulp testers is a device 
intended to be applied to the surface of a tooth before use of a pulp 
tester to aid conduction of electrical current.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 
FR 38797, July 25, 2001]



Sec. 872.1740  Caries detection device.

    (a) Identification. The caries detection device is a device intended 
to show the existence of decay in a patient's tooth by use of electrical 
current.
    (b) Classification. Class II.

[[Page 497]]



Sec. 872.1745  Laser fluorescence caries detection device.

    (a) Identification. A laser fluorescence caries detection device is 
a laser, a fluorescence detector housed in a dental handpiece, and a 
control console that performs device calibration, as well as variable 
tone emitting and fluorescence measurement functions. The intended use 
of the device is to aid in the detection of tooth decay by measuring 
increased laser induced fluorescence.
    (b) Classification. Class II, subject to the following special 
controls:
    (1) Sale, distribution, and use of this device are restricted to 
prescription use in accordance with Sec. 801.109 of this chapter;
    (2) Premarket notifications must include clinical studies, or other 
relevant information, that demonstrates that the device aids in the 
detection of tooth decay by measuring increased laser induced 
fluorescence; and
    (3) The labeling must include detailed use instructions with 
precautions that urge users to:
    (i) Read and understand all directions before using the device,
    (ii) Store probe tips under proper conditions,
    (iii) Properly sterilize the emitter-detector handpick before each 
use, and
    (iv) Properly maintain and handle the instrument in the specified 
manner and condition.

[65 FR 18235, Apr. 7, 2000]



Sec. 872.1800  Extraoral source x-ray system.

    (a) Identification. An extraoral source x-ray system is an AC-
powered device that produces x-rays and is intended for dental 
radiographic examination and diagnosis of diseases of the teeth, jaw, 
and oral structures. The x-ray source (a tube) is located outside the 
mouth. This generic type of device may include patient and equipment 
supports and component parts.
    (b) Classification. Class II.



Sec. 872.1810  Intraoral source x-ray system.

    (a) Identification. An intraoral source x-ray system is an 
electrically powered device that produces x-rays and is intended for 
dental radiographic examination and diagnosis of diseases of the teeth, 
jaw, and oral structures. The x-ray source (a tube) is located inside 
the mouth. This generic type of device may include patient and equipment 
supports and component parts.
    (b) Classification. Class II.



Sec. 872.1820  Dental x-ray exposure alignment device.

    (a) Identification. A dental x-ray exposure alignment device is a 
device intended to position x-ray film and to align the examination site 
with the x-ray beam.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 
FR 38797, July 25, 2001]



Sec. 872.1830  Cephalometer.

    (a) Identification. A cephalometer is a device used in dentistry 
during x-ray procedures. The device is intended to place and to hold a 
patient's head in a standard position during dental x-rays.
    (b) Classification. Class II.



Sec. 872.1840  Dental x-ray position indicating device.

    (a) Identification. A dental x-ray position indicating device is a 
device, such as a collimator, cone, or aperture, that is used in dental 
radiographic examination. The device is intended to align the 
examination site with the x-ray beam and to restrict the dimensions of 
the dental x-ray field by limiting the size of the primary x-ray beam.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 61 FR 1121, Jan. 16, 1996; 66 
FR 38797, July 25, 2001]



Sec. 872.1850  Lead-lined position indicator.

    (a) Identification. A lead-lined position indicator is a cone-shaped 
device lined with lead that is attached to a dental x-ray tube and 
intended to aid in positioning the tube, to prevent the misfocusing of 
the x-rays by absorbing

[[Page 498]]

divergent radiation, and to prevent leakage of radiation.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 61 FR 1121, Jan. 16, 1996; 66 
FR 38797, July 25, 2001]



Sec. 872.1870  Sulfide detection device.

    (a) Identification. A sulfide detection device is a device 
consisting of an AC-powered control unit, probe handle, probe tips, 
cables, and accessories. This device is intended to be used in vivo, to 
manually measure periodontal pocket probing depths, detect the presence 
or absence of bleeding on probing, and detect the presence of sulfides 
in periodontal pockets, as an adjunct in the diagnosis of periodontal 
diseases in adult patients.
    (b) Classification. Class II (special controls) prescription use in 
accordance with Sec. 801.109 of this chapter; conformance with 
recognized standards of biocompatibility, electrical safety, and 
sterility; clinical and analytical performance testing, and proper 
labeling.

[63 FR 59717, Nov. 5, 1998]



Sec. 872.1905  Dental x-ray film holder.

    (a) Identification. A dental x-ray film holder is a device intended 
to position and to hold x-ray film inside the mouth.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9. If the device is 
not labeled or otherwise represented as sterile, it is also exempt from 
the current good manufacturing practice requirements of the quality 
system regulation in part 820 of this chapter, with the exceptions of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 
FR 38797, July 25, 2001]



Sec. 872.2050  Dental sonography device.

    (a) Dental sonography device for monitoring--(1) Identification. A 
dental sonography device for monitoring is an electrically powered 
device, intended to be used to monitor temporomandibular joint sounds. 
The device detects and records sounds made by the temporomandibular 
joint.
    (2) Classification. Class I. The device is exempt from the premarket 
notification provisions of subpart E of part 807 of this chapter subject 
to Sec. 872.9.
    (b) Dental sonography device for interpretation and diagnosis--(1) 
Identification. A dental sonography device for interpretation and 
diagnosis is an electrically powered device, intended to interpret 
temporomandibular joint sounds for the diagnosis of temporomandibular 
joint disorders and associated orofacial pain. The device detects, 
records, displays, and stores sounds made by the temporomandibular joint 
during jaw movement. The device interprets these sounds to generate 
meaningful output, either directly or by connection to a personal 
computer. The device may be part of a system of devices, contributing 
joint sound information to be considered with data from other diagnostic 
components.
    (2) Classification. Class II (special controls). The special control 
for this device is FDA's guidance document entitled ``Class II Special 
Controls Guidance Document: Dental Sonography and Jaw Tracking 
Devices.''

[68 FR 67367, Dec. 2, 2003]



Sec. 872.2060  Jaw tracking device.

    (a) Jaw tracking device for monitoring mandibular jaw positions 
relative to the maxilla--(1) Identification. A jaw tracking device for 
monitoring mandibular jaw positions relative to the maxilla is a 
nonpowered or electrically powered device that measures and records 
anatomical distances and angles in three dimensional space, to determine 
the relative position of the mandible with respect to the location and 
position of the maxilla, while at rest and during jaw movement.
    (2) Classification. Class I (general controls). The device is exempt 
from the premarket notification provisions of

[[Page 499]]

subpart E of part 807 of this chapter subject to Sec. 872.9.
    (b) Jaw tracking device for interpretation of mandibular jaw 
positions for the diagnosis--(1) Identification. A jaw tracking device 
for interpretation of mandibular jaw positions relative to the maxilla 
for the diagnosis of temporomandibular joint disorders and associated 
orofacial pain is a nonpowered or electrically powered device that 
measures and records anatomical distances and angles to determine the 
relative position of the mandible in three dimensional space, with 
respect to the location and position of the maxilla, while at rest and 
during jaw movement. The device records, displays, and stores 
information about jaw position. The device interprets jaw position to 
generate meaningful output, either directly or by connection to a 
personal computer. The device may be a part of a system of devices, 
contributing jaw position information to be considered with data from 
other diagnostic components.
    (2) Classification. Class II (special controls). The special control 
for this device is FDA's guidance document entitled ``Class II Special 
Controls Guidance Document: Dental Sonography and Jaw Tracking 
Devices.''

[68 FR 67367, Dec. 2, 2003]

Subpart C [Reserved]



                      Subpart D_Prosthetic Devices



Sec. 872.3060  Noble metal alloy.

    (a) Identification. A noble metal alloy is a device composed 
primarily of noble metals, such as gold, palladium, platinum, or silver, 
that is intended for use in the fabrication of cast or porcelain-fused-
to-metal crown and bridge restorations.
    (b) Classification. Class II (special controls). The special control 
for these devices is FDA's ``Class II Special Controls Guidance 
Document: Dental Noble Metal Alloys.'' The devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 872.9. See Sec. 872.1(e) 
for availability of guidance information.

[69 FR 51766, Aug. 23, 2004]



Sec. 872.3070  Dental amalgam, mercury, and amalgam alloy.

    (a) Identification. Dental amalgam is a device that consists of a 
combination of elemental mercury, supplied as a liquid in bulk, sachet, 
or predosed capsule form, and amalgam alloy composed primarily of 
silver, tin, and copper, supplied as a powder in bulk, tablet, or 
predosed capsule form, for the direct filling of carious lesions or 
structural defects in teeth. This device also includes the individual 
component devices, mercury and amalgam alloy, when intended to be 
combined with each other to form dental amalgam.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's ``Class II Special Controls Guidance Document: 
Dental Amalgam, Mercury, and Amalgam Alloy.'' See Sec. 872.1(e) for the 
availability of this guidance document.

[74 FR 38714, Aug. 4, 2009]



Sec. 872.3080  Mercury and alloy dispenser.

    (a) Identification. A mercury and alloy dispenser is a device with a 
spring-activated valve intended to measure and dispense into a mixing 
capsule a predetermined amount of dental mercury in droplet form and a 
premeasured amount of alloy pellets.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 
FR 38797, July 25, 2001]



Sec. 872.3100  Dental amalgamator.

    (a) Identification. A dental amalgamator is a device, usually AC-
powered, intended to mix, by shaking, amalgam capsules containing 
mercury and dental alloy particles, such as silver, tin, zinc, and 
copper. The mixed dental amalgam material is intended for filling dental 
caries.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 500]]

subpart E of part 807 of this chapter subject to the limitations in 
Sec. 872.9.

[55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63008, Dec. 7, 1994; 66 
FR 38797, July 25, 2001]



Sec. 872.3110  Dental amalgam capsule.

    (a) Identification. A dental amalgam capsule is a container device 
in which silver alloy is intended to be mixed with mercury to form 
dental amalgam.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 
FR 38797, July 25, 2001]



Sec. 872.3130  Preformed anchor.

    (a) Identification. A preformed anchor is a device made of 
austenitic alloys or alloys containing 75 percent or greater gold or 
metals of the platinum group intended to be incorporated into a dental 
appliance, such as a denture, to help stabilize the appliance in the 
patient's mouth.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 
FR 38797, July 25, 2001]



Sec. 872.3140  Resin applicator.

    (a) Identification. A resin applicator is a brushlike device 
intended for use in spreading dental resin on a tooth during application 
of tooth shade material.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9. If the device is 
not labeled or otherwise represented as sterile, the device is exempt 
from the current good manufacturing practice requirements of the quality 
system regulation in part 820 of this chapter, with the exceptions of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 
FR 38797, July 25, 2001]



Sec. 872.3150  Articulator.

    (a) Identification. An articulator is a mechanical device intended 
to simulate movements of a patient's upper and lower jaws. Plaster casts 
of the patient's teeth and gums are placed in the device to reproduce 
the occlusion (bite) and articulation of the patient's jaws. An 
articulator is intended to fit dentures or provide orthodontic 
treatment.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9. If the device is 
not labeled or otherwise represented as sterile, the device is exempt 
from the current good manufacturing practice requirements of the quality 
system regulation in part 820 of this chapter, with the exceptions of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 
FR 38797, July 25, 2001]



Sec. 872.3165  Precision attachment.

    (a) Identification. A precision attachment or preformed bar is a 
device made of austenitic alloys or alloys containing 75 percent or 
greater gold and metals of the platinum group intended for use in 
prosthetic dentistry in conjunction with removable partial dentures. 
Various forms of the device are intended to connect a lower partial 
denture with another lower partial denture, to connect an upper partial 
denture with another upper partial denture, to connect either an upper 
or lower partial denture to a tooth or a crown, or to connect a fixed 
bridge to a partial denture.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 501]]

subpart E of part 807 of this chapter subject to the limitations in 
Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 
FR 38797, July 25, 2001]



Sec. 872.3200  Resin tooth bonding agent.

    (a) Identification. A resin tooth bonding agent is a device 
material, such as methylmethacrylate, intended to be painted on the 
interior of a prepared cavity of a tooth to improve retention of a 
restoration, such as a filling.
    (b) Classification. Class II.



Sec. 872.3220  Facebow.

    (a) Identification. A facebow is a device intended for use in 
denture fabrication to determine the spatial relationship between the 
upper and lower jaws. This determination is intended for use in placing 
denture casts accurately into an articulator (Sec. 872.3150) and 
thereby aiding correct placement of artificial teeth into a denture 
base.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9. If the device is 
not labeled or otherwise represented as sterile, the device is exempt 
from the current good manufacturing practice requirements of the quality 
system regulation in part 820 of this chapter, with the exceptions of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 
FR 38797, July 25, 2001]



Sec. 872.3240  Dental bur.

    (a) Identification. A dental bur is a rotary cutting device made 
from carbon steel or tungsten carbide intended to cut hard structures in 
the mouth, such as teeth or bone. It is also intended to cut hard 
metals, plastics, porcelains, and similar materials intended for use in 
the fabrication of dental devices.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 
FR 38798, July 25, 2001]



Sec. 872.3250  Calcium hydroxide cavity liner.

    (a) Identification. A calcium hydroxide cavity liner is a device 
material intended to be applied to the interior of a prepared cavity 
before insertion of restorative material, such as amalgam, to protect 
the pulp of a tooth.
    (b) Classification. Class II.



Sec. 872.3260  Cavity varnish.

    (a) Identification. Cavity varnish is a device that consists of a 
compound intended to coat a prepared cavity of a tooth before insertion 
of restorative materials. The device is intended to prevent penetration 
of restorative materials, such as amalgam, into the dentinal tissue.
    (b) Classification. Class II (special controls). The device, when it 
is an external cleaning solution, is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 84 FR 71812, Dec. 30, 2019]



Sec. 872.3275  Dental cement.

    (a) Zinc oxide-eugenol--(1) Identification. Zinc oxide-eugenol is a 
device composed of zinc oxide-eugenol intended to serve as a temporary 
tooth filling or as a base cement to affix a temporary tooth filling, to 
affix dental devices such as crowns or bridges, or to be applied to a 
tooth to protect the tooth pulp.
    (2) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 872.9.
    (b) Dental cement other than zinc oxide-eugenol--(1) Identification. 
Dental cement other than zinc oxide-eugenol is a device composed of 
various materials other than zinc oxide-eugenol intended to serve as a 
temporary tooth filling or as a base cement to affix a temporary tooth 
filling, to affix dental

[[Page 502]]

devices such as crowns or bridges, or to be applied to a tooth to 
protect the tooth pulp.
    (2) Classification. Class II.

[52 FR 30097, Aug. 12, 1987, as amended at 65 FR 2314, Jan. 14, 2000]



Sec. 872.3285  Preformed clasp.

    (a) Identification. A preformed clasp or a preformed wire clasp is a 
prefabricated device made of austenitic alloys or alloys containing 75 
percent or greater gold and metals of the platinum group intended to be 
incorporated into a dental appliance, such as a partial denture, to help 
stabilize the appliance in the patient's mouth by fastening the 
appliance to an adjacent tooth.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 
FR 38798, July 25, 2001]



Sec. 872.3300  Hydrophilic resin coating for dentures.

    (a) Identification. A hydrophilic resin coating for dentures is a 
device that consists of a water-retaining polymer that is intended to be 
applied to the base of a denture before the denture is inserted into the 
patient's mouth to improve denture retention and comfort.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 84 FR 71812, Dec. 30, 2019]



Sec. 872.3310  Coating material for resin fillings.

    (a) Identification. A coating material for resin fillings is a 
device intended to be applied to the surface of a restorative resin 
dental filling to attain a smooth, glaze-like finish on the surface of 
the filling.
    (b) Classification. Class II.



Sec. 872.3330  Preformed crown.

    (a) Identification. A preformed crown is a prefabricated device made 
of plastic or austenitic alloys or alloys containing 75 percent or 
greater gold and metals of the platinum group intended to be affixed 
temporarily to a tooth after removal of, or breakage of, the natural 
crown (that portion of the tooth that normally protrudes above the 
gums). It is intended for use as a functional restoration until a 
permanent crown is constructed. The device also may be intended for use 
as a functional restoration for a badly decayed deciduous (baby) tooth 
until the adult tooth erupts.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 
FR 38798, July 25, 2001]



Sec. 872.3350  Gold or stainless steel cusp.

    (a) Identification. A gold or stainless steel cusp is a 
prefabricated device made of austenitic alloys or alloys containing 75 
percent or greater gold and metals of the platinum group or stainless 
steel intended to provide a permanent cusp (a projection on the chewing 
surface of a tooth) to achieve occlusal harmony (a proper bite) between 
the teeth and a removable denture.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 
FR 38798, July 25, 2001]



Sec. 872.3360  Preformed cusp.

    (a) Identification. A performed cusp is a prefabricated device made 
of plastic or austenitic alloys or alloys containing 75 percent or 
greater gold and metals of the platinum group intended to be used as a 
temporary cusp (a projection on the chewing surface of a tooth) to 
achieve occlusal harmony (a proper bite) before permanent restoration of 
a tooth.

[[Page 503]]

    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 
FR 38798, July 25, 2001]



Sec. 872.3400  Karaya and sodium borate with or without acacia denture adhesive.

    (a) Identification. A karaya and sodium borate with or without 
acacia denture adhesive is a device composed of karaya and sodium borate 
with or without acacia intended to be applied to the base of a denture 
before the denture is inserted into patient's mouth to improve denture 
retention and comfort.
    (b) Classification. (1) Class I (general controls) if the device 
contains less than 12 percent by weight of sodium borate. The class I 
device is exempt from the premarket notification procedures in subpart E 
of part 807 of this chapter subject to Sec. 872.9.
    (2) Class III if the device contains 12 percent or more by weight of 
sodium borate.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any karaya 
and sodium borate with or without acacia denture adhesive that was in 
commercial distribution before May 28, 1976, or that has, on or before 
December 26, 1996 been found to be substantially equivalent to a karaya 
and sodium borate with or without acacia denture adhesive that was in 
commercial distribution before May 28, 1976. Any other karaya and sodium 
borate with or without acacia denture adhesive shall have an approved 
PMA or a declared completed PDP in effect before being placed in 
commercial distribution.

[52 FR 30097, Aug. 12, 1987, as amended at 61 FR 50706, Sept. 27, 1996; 
65 FR 2315, Jan. 14, 2000]



Sec. 872.3410  Ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive.

    (a) Identification. An ethylene oxide homopolymer and/or 
carboxymethylcellulose sodium denture adhesive is a device containing 
ethylene oxide homopolymer and/or carboxymethylcellulose sodium intended 
to be applied to the base of a denture before the denture is inserted in 
a patient's mouth to improve denture retention and comfort.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 
FR 38798, July 25, 2001]



Sec. 872.3420  Carboxymethylcellulose sodium and cationic 
polyacrylamide polymer denture adhesive.

    (a) Identification. A carboxymethylcellulose sodium and cationic 
polyacrylamide polymer denture adhesive is a device composed of 
carboxymethylcellulose sodium and cationic polyacrylamide polymer 
intended to be applied to the base of a denture before the denture is 
inserted in a patient's mouth to improve denture retention and comfort.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any 
carboxymethylcellulose sodium and cationic polyacrylamide polymer 
denture adhesive that was in commercial distribution before May 28, 
1976, or that has, on or before December 26, 1996 been found to be 
substantially equivalent to a carboxymethylcellulose sodium and cationic 
polyacrylamide polymer denture adhesive that was in commercial 
distribution before May 28, 1976. Any other carboxymethylcellulose 
sodium and cationic polyacrylamide polymer denture adhesive shall have 
an approved PMA or a declared completed

[[Page 504]]

PDP in effect before being placed in commercial distribution.

[52 FR 30097, Aug. 12, 1987, as amended at 61 FR 50707, Sept. 27, 1996]



Sec. 872.3450  Ethylene oxide homopolymer and/or karaya denture adhesive.

    (a) Identification. Ethylene oxide homopolymer and/or karaya denture 
adhesive is a device composed of ethylene oxide homopolymer and/or 
karaya intended to be applied to the base of a denture before the 
denture is inserted in a patient's mouth to improve denture retention 
and comfort.
    (b) Classification. (1) Class I if the device is made of wax-
impregnated cotton cloth that the patient applies to the base or inner 
surface of a denture before inserting the denture into the mouth. The 
device is intended to be discarded following 1 day's use. The class I 
device is exempt from the premarket notification procedures in subpart E 
of part 807 of this chapter subject to Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 65 
FR 2315, Jan. 14, 2000]



Sec. 872.3480  Polyacrylamide polymer (modified cationic) 
denture adhesive.

    (a) Identification. A polyacrylamide polymer (modified cationic) 
denture adhesive is a device composed of polyacrylamide polymer 
(modified cationic) intended to be applied to the base of a denture 
before the denture is inserted in a patient's mouth to improve denture 
retention and comfort.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any 
polyacrylamide polymer (modified cationic) denture adhesive that was in 
commercial distribution before May 28, 1976, or that has, on or before 
December 26, 1996 been found to be substantially equivalent to a 
polyacrylamide polymer (modified cationic) denture adhesive that was in 
commercial distribution before May 28, 1976. Any other polyacrylamide 
polymer (modified cationic) denture adhesive shall have an approved PMA 
or a declared completed PDP in effect before being place in commercial 
distribution.

[52 FR 30097, Aug. 12, 1987, as amended at 61 FR 50707, Sept. 27, 1996]



Sec. 872.3490  Carboxymethylcellulose sodium and/or
polyvinylmethylether maleic acid calcium-sodium double salt denture
adhesive.

    (a) Identification. A carboxymethylcellulose sodium and/or 
polyvinylmethylether maleic acid calcium-sodium double salt denture 
adhesive is a device composed of carboxymethylcellulose sodium and/or 
polyvinylmethylether maleic acid calcium-sodium double salt intended to 
be applied to the base of a denture before the denture is inserted in a 
patient's mouth to improve denture retention and comfort.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 
FR 38798, July 25, 2001]



Sec. 872.3500  Polyvinylmethylether maleic anhydride (PVM-MA),
acid copolymer, and carboxymethylcellulose sodium (NACMC) 
denture adhesive.

    (a) Identification. Polyvinylmethylether maleic anhydride (PVM-MA), 
acid copolymer, and carboxymethylcellulose sodium (NACMC) denture 
adhesive is a device composed of polyvinylmethylether maleic anhydride, 
acid copolymer, and carboxymethylcellulose sodium intended to be applied 
to the base of a denture before the denture is inserted in a patient's 
mouth to improve denture retention and comfort.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any 
polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and 
carboxymethylcellulose sodium (NACMC) denture adhesive that was in

[[Page 505]]

commercial distribution before May 28, 1976, or that has, on or before 
December 26, 1996 been found to be substantially equivalent to a 
polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and 
carboxymethylcellulose sodium (NACMC) denture adhesive that was in 
commercial distribution before May 28, 1976. Any other 
polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and 
carboxymethylcellulose sodium (NACMC) denture adhesive shall have an 
approved PMA or a declared completed PDP in effect before being placed 
in commercial distribution.

[52 FR 30097, Aug. 12, 1987, as amended at 61 FR 50707, Sept. 27, 1996]



Sec. 872.3520  OTC denture cleanser.

    (a) Identification. An OTC denture cleanser is a device that 
consists of material in the form of a powder, tablet, or paste that is 
intended to remove debris from removable prosthetic dental appliances, 
such as bridges or dentures. The dental appliance is removed from the 
patient's mouth when the appliance is cleaned.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 
FR 38798, July 25, 2001]



Sec. 872.3530  Mechanical denture cleaner.

    (a) Identification. A mechanical denture cleaner is a device, 
usually AC-powered, that consists of a container for mechanically 
agitating a denture cleansing solution. The device is intended to clean 
a denture by submersion in the agitating cleansing solution in the 
container.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63008, Dec. 7, 1994; 66 
FR 38798, July 25, 2001]



Sec. 872.3540  OTC denture cushion or pad.

    (a) Identification. An OTC denture cushion or pad is a prefabricated 
or noncustom made disposable device that is intended to improve the fit 
of a loose or uncomfortable denture, and may be available for purchase 
over-the-counter.
    (b) Classification. (1) Class I if the device is made of wax-
impregnated cotton cloth that the patient applies to the base or inner 
surface of a denture before inserting the denture into the mouth. The 
device is intended to be discarded following 1 day's use. The class I 
device is exempt from the premarket notification procedures in subpart E 
of part 807 of this chapter subject to Sec. 872.9.
    (2) Class II (special controls) if the OTC denture cushion or pad is 
made of a material other than wax-impregnated cotton cloth or if the 
intended use of the device differs from that described in paragraph 
(b)(1) of this section. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 872.9. The special controls for this device 
are FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological Evaluation 
of Medical--Devices Part I: Evaluation and Testing,' '' and
    (ii) ``OTC Denture Reliners, Repair Kits, and Partially Fabricated 
Denture Kits.''

[52 FR 30097, Aug. 12, 1987, as amended at 65 FR 2315, 2000; 65 FR 
17144, Mar. 31, 2000; 84 FR 71812, Dec. 30, 2019]



Sec. 872.3560  OTC denture reliner.

    (a) Identification. An OTC denture reliner is a device consisting of 
a material such as plastic resin that is intended to be applied as a 
permanent coating or lining on the base or tissue-contacting surface of 
a denture. The device is intended to replace a worn denture lining and 
may be available for purchase over the counter.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 872.9. The 
special controls for this device are FDA's:

[[Page 506]]

    (1) ``Use of International Standard ISO 10993 `Biological Evaluation 
of Medical Devices--Part I: Evaluation and Testing,' '' and
    (2) ``OTC Denture Reliners, Repair Kits, and Partially Fabricated 
Denture Kits.''

[52 FR 30097, Aug. 12, 1987, as amended at 61 FR 50707, Sept. 27, 1996; 
65 FR 17144, Mar. 31, 2000; 84 FR 71812, Dec. 30, 2019]



Sec. 872.3570  OTC denture repair kit.

    (a) Identification. An OTC denture repair kit is a device consisting 
of a material, such as a resin monomer system of powder and liquid 
glues, that is intended to be applied permanently to a denture to mend 
cracks or breaks. The device may be available for purchase over-the 
counter.
    (b) Classification. Class II. The OTC denture repair kit is exempt 
from premarket notification procedures in subpart E of part 807 of this 
chapter, subject to Sec. 872.9. The special controls for this device 
are FDA's:
    (1) ``Use of International Standard ISO 10993 `Biological Evaluation 
of Medical Devices--Part I: Evaluation and Testing,' '' and
    (2) ``OTC Denture Reliners, Repair Kits, and Partially Fabricated 
Denture Kits.''

[52 FR 30097, Aug. 12, 1987, as amended at 65 FR 17144, Mar. 31, 2000; 
83 FR 11145, Mar. 14, 2018]



Sec. 872.3580  Preformed gold denture tooth.

    (a) Identification. A preformed gold denture tooth is a device 
composed of austenitic alloys or alloys containing 75 percent or greater 
gold and metals of the platinum group intended for use as a tooth or a 
portion of a tooth in a fixed or removable partial denture.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 
FR 38798, July 25, 2001]



Sec. 872.3590  Preformed plastic denture tooth.

    (a) Identification. A preformed plastic denture tooth is a 
prefabricated device, composed of materials such as methyl methacrylate, 
that is intended for use as a tooth in a denture.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 84 FR 71812, Dec. 30, 2019]



Sec. 872.3600  Partially fabricated denture kit.

    (a) Identification. A partially fabricated denture kit is a device 
composed of connected preformed teeth that is intended for use in 
construction of a denture. A denture base is constructed using the 
patient's mouth as a mold, by partially polymerizing the resin denture 
base materials while the materials are in contact with the oral tissues. 
After the denture base is constructed, the connected preformed teeth are 
chemically bonded to the base.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 872.9. The 
special controls for this device are FDA's:
    (1) ``Use of International Standard ISO 10993 `Biological Evaluation 
of Medical Devices--Part I: Evaluation and Testing,' '' and
    (2) ``OTC Denture Reliners, Repair Kits, and Partially Fabricated 
Denture Kits.''

[52 FR 30097, Aug. 12, 1987, as amended at 65 FR 17144, Mar. 31, 2000; 
84 FR 71812, Dec. 30, 2019]



Sec. 872.3630  Endosseous dental implant abutment.

    (a) Identification. An endosseous dental implant abutment is a 
premanufactured prosthetic component directly connected to the 
endosseous dental implant and is intended for use as an aid in 
prosthetic rehabilitation.

[[Page 507]]

    (b) Classification. Class II (special controls). The guidance 
document entitled ``Class II Special Controls Guidance Document: Root-
Form Endosseous Dental Implants and Endosseous Dental Implant 
Abutments'' will serve as the special control. (See Sec. 872.1(e) for 
the availability of this guidance document.)

[69 FR 26304, May 12, 2004]



Sec. 872.3640  Endosseous dental implant.

    (a) Identification. An endosseous dental implant is a prescription 
device made of a material such as titanium or titanium alloy that is 
intended to be surgically placed in the bone of the upper or lower jaw 
arches to provide support for prosthetic devices, such as artificial 
teeth, in order to restore a patient's chewing function.
    (b) Classification. (1) Class II (special controls). The device is 
classified as class II if it is a root-form endosseous dental implant. 
The root-form endosseous dental implant is characterized by four 
geometrically distinct types: Basket, screw, solid cylinder, and hollow 
cylinder. The guidance document entitled ``Class II Special Controls 
Guidance Document: Root-Form Endosseous Dental Implants and Endosseous 
Dental Implant Abutments'' will serve as the special control. (See Sec. 
872.1(e) for the availability of this guidance document.)
    (2) Classification. Class II (special controls). The device is 
classified as class II if it is a blade-form endosseous dental implant. 
The special controls for this device are:
    (i) The design characteristics of the device must ensure that the 
geometry and material composition are consistent with the intended use;
    (ii) Mechanical performance (fatigue) testing under simulated 
physiological conditions to demonstrate maximum load (endurance limit) 
when the device is subjected to compressive and shear loads;
    (iii) Corrosion testing under simulated physiological conditions to 
demonstrate corrosion potential of each metal or alloy, couple potential 
for an assembled dissimilar metal implant system, and corrosion rate for 
an assembled dissimilar metal implant system;
    (iv) The device must be demonstrated to be biocompatible;
    (v) Sterility testing must demonstrate the sterility of the device;
    (vi) Performance testing to evaluate the compatibility of the device 
in a magnetic resonance (MR) environment;
    (vii) Labeling must include a clear description of the technological 
features, how the device should be used in patients, detailed surgical 
protocol and restoration procedures, relevant precautions and warnings 
based on the clinical use of the device, and qualifications and training 
requirements for device users including technicians and clinicians;
    (viii) Patient labeling must contain a description of how the device 
works, how the device is placed, how the patient needs to care for the 
implant, possible adverse events and how to report any complications; 
and
    (ix) Documented clinical experience must demonstrate safe and 
effective use and capture any adverse events observed during clinical 
use.

[69 FR 26304, May 12, 2004, as amended at 79 FR 34625, June 18, 2014]



Sec. 872.3645  Subperiosteal implant material.

    (a) Identification. Subperiosteal implant material is a device 
composed of titanium or cobalt chrome molybdenum intended to construct 
custom prosthetic devices which are surgically implanted into the lower 
or upper jaw between the periosteum (connective tissue covering the 
bone) and supporting bony structures. The device is intended to provide 
support for prostheses, such as dentures.
    (b) Classification. Class II.



Sec. 872.3660  Impression material.

    (a) Identification. Impression material is a device composed of 
materials such as alginate or polysulfide intended to be placed on a 
preformed impression tray and used to reproduce the structure of a 
patient's teeth and gums. The device is intended to provide models for 
study and for production of restorative prosthetic devices, such as gold 
inlays and dentures.

[[Page 508]]

    (b) Classification. Class II (Special Controls).

[52 FR 30097, Aug. 12, 1987, as amended at 68 FR 19738, Apr. 22, 2003]



Sec. 872.3661  Optical Impression Systems for CAD/CAM.

    (a) Identification. An optical impression system for computer 
assisted design and manufacturing (CAD/CAM) is a device used to record 
the topographical characteristics of teeth, dental impressions, or stone 
models by analog or digital methods for use in the computer-assisted 
design and manufacturing of dental restorative prosthetic devices. Such 
systems may consist of a camera, scanner, or equivalent type of sensor 
and a computer with software.
    (b) Classification. Class II (Special Controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of the chapter subject to the limitations in Sec. 872.9. The 
special control for these devices is the FDA guidance document entitled 
``Class II Special Controls Guidance Document: Optical Impression 
Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of 
Dental Restorations; Guidance for Industry and FDA.'' For the 
availability of this guidance document, see Sec. 872.1(e).

[68 FR 19738, Apr. 22, 2003]



Sec. 872.3670  Resin impression tray material.

    (a) Identification. Resin impression tray material is a device 
intended for use in a two-step dental mold fabricating process. The 
device consists of a resin material, such as methyl methacrylate, and is 
used to form a custom impression tray for use in cases in which a 
preformed impression tray is not suitable, such as the fabrication of 
crowns, bridges, or full dentures. A preliminary plaster or stone model 
of the patient's teeth and gums is made. The resin impression tray 
material is applied to this preliminary study model to form a custom 
tray. This tray is then filled with impression material and inserted 
into the patient's mouth to make an impression, from which a final, more 
precise, model of the patient's mouth is cast.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9. If the device is 
not labeled or otherwise represented as sterile, it is exempt from the 
current good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180, with respect to general requirements concerning records, and 
Sec. 820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 
FR 38798, July 25, 2001]



Sec. 872.3680  Polytetrafluoroethylene (PTFE) vitreous carbon materials.

    (a) Identification. Polytetrafluoroethylene (PTFE) vitreous carbon 
material is a device composed of polytetrafluoroethylene (PTFE) vitreous 
carbon intended for use in maxillofacial alveolar ridge augmentation 
(building up the upper or lower jaw area that contains the sockets in 
which teeth are rooted) or intended to coat metal surgical implants to 
be placed in the alveoli (sockets in which the teeth are rooted) or the 
temporomandibular joints (the joint between the upper and lower jaws).
    (b) Classification. Class II.

[52 FR 30097, Aug. 12, 1987; 52 FR 34456, Sept. 11, 1987]



Sec. 872.3690  Tooth shade resin material.

    (a) Identification. Tooth shade resin material is a device composed 
of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) 
intended to restore carious lesions or structural defects in teeth.
    (b) Classification. Class II.



Sec. 872.3710  Base metal alloy.

    (a) Identification. A base metal alloy is a device composed 
primarily of base metals, such as nickel, chromium, or cobalt, that is 
intended for use in fabrication of cast or porcelain-fused-to-metal 
crown and bridge restorations.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's ``Class II Special Controls Guidance Document: 
Dental Base

[[Page 509]]

Metal Alloys.'' The device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec. 872.9. See Sec. 872.1(e) for availability of 
guidance information.

[69 FR 51766, Aug. 23, 2004]



Sec. 872.3730  Pantograph.

    (a) Identification. A pantograph is a device intended to be attached 
to a patient's head to duplicate lower jaw movements to aid in 
construction of restorative and prosthetic dental devices. A marking pen 
is attached to the lower jaw component of the device and, as the 
patient's mouth opens, the pen records on graph paper the angle between 
the upper and the lower jaw.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9. If the device is 
not labeled or otherwise represented as sterile, it is exempt from the 
current good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180, with respect to general requirements concerning records, and 
Sec. 820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 66 FR 38798, July 25, 2001]



Sec. 872.3740  Retentive and splinting pin.

    (a) Identification. A retentive and splinting pin is a device made 
of austenitic alloys or alloys containing 75 percent or greater gold and 
metals of the platinum group intended to be placed permanently in a 
tooth to provide retention and stabilization for a restoration, such as 
a crown, or to join two or more teeth together.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9

[52 FR 30097, Aug. 12, 1987, as amended at 60 FR 38900, July 28, 1995; 
66 FR 38798, July 25, 2001]



Sec. 872.3750  Bracket adhesive resin and tooth conditioner.

    (a) Identification. A bracket adhesive resin and tooth conditioner 
is a device composed of an adhesive compound, such as 
polymethylmethacrylate, intended to cement an orthodontic bracket to a 
tooth surface.
    (b) Classification. Class II.



Sec. 872.3760  Denture relining, repairing, or rebasing resin.

    (a) Identification. A denture relining, repairing, or rebasing resin 
is a device composed of materials such as methylmethacrylate, intended 
to reline a denture surface that contacts tissue, to repair a fractured 
denture, or to form a new denture base. This device is not available for 
over-the-counter (OTC) use.
    (b) Classification. Class II.



Sec. 872.3765  Pit and fissure sealant and conditioner.

    (a) Identification. A pit and fissure sealant and conditioner is a 
device composed of resin, such as polymethylmethacrylate, intended for 
use primarily in young children to seal pit and fissure depressions 
(faults in the enamel) in the biting surfaces of teeth to prevent 
cavities.
    (b) Classification. Class II.



Sec. 872.3770  Temporary crown and bridge resin.

    (a) Identification. A temporary crown and bridge resin is a device 
composed of a material, such as polymethylmethacrylate, intended to make 
a temporary prosthesis, such as a crown or bridge, for use until a 
permanent restoration is fabricated.
    (b) Classification. Class II.



Sec. 872.3810  Root canal post.

    (a) Identification. A root canal post is a device made of austenitic 
alloys or alloys containing 75 percent or greater gold and metals of the 
platinum group intended to be cemented into the root canal of a tooth to 
stabilize and support a restoration.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 510]]

subpart E of part 807 of this chapter subject to the limitations in 
Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 60 FR 38900, July 28, 1995; 
66 FR 38798, July 25, 2001]



Sec. 872.3820  Root canal filling resin.

    (a) Identification. A root canal filling resin is a device composed 
of material, such as methylmethacrylate, intended for use during 
endodontic therapy to fill the root canal of a tooth.
    (b) Classification. (1) Class II if chloroform is not used as an 
ingredient in the device.
    (2) Class III if chloroform is used as an ingredient in the device.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any root 
canal filling resin described in paragraph (b)(2) of this section that 
was in commercial distribution before May 28, 1976, or that has, on or 
before December 26, 1996 been found to be substantially equivalent to a 
root canal filling resin described in paragraph (b)(2) of this section 
that was in commercial distribution before May 28, 1976. Any other root 
canal filling resin shall have an approved PMA or a declared completed 
PDP in effect before being placed in commercial distribution.

[52 FR 30097, Aug. 12, 1987, as amended at 61 FR 50707, Sept. 27, 1996]



Sec. 872.3830  Endodontic paper point.

    (a) Identification. An endodontic paper point is a device made of 
paper intended for use during endodontic therapy to dry, or apply 
medication to, the root canal of a tooth.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 
FR 38798, July 25, 2001]



Sec. 872.3840  Endodontic silver point.

    (a) Identification. An endodontic silver point is a device made of 
silver intended for use during endodontic therapy to fill permanently 
the root canal of a tooth.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 
FR 38798, July 25, 2001]



Sec. 872.3850  Gutta percha.

    (a) Identification. Gutta percha is a device made from coagulated 
sap of certain tropical trees intended to fill the root canal of a 
tooth. The gutta percha is softened by heat and inserted into the root 
canal, where it hardens as it cools.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 
FR 38798, July 25, 2001]



Sec. 872.3890  Endodontic stabilizing splint.

    (a) Identification. An endodontic stabilizing splint is a device 
made of a material, such as titanium, intended to be inserted through 
the root canal into the upper or lower jaw bone to stabilize a tooth.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 84 FR 71812, Dec. 30, 2019]



Sec. 872.3900  Posterior artificial tooth with a metal insert.

    (a) Identification. A posterior artificial tooth with a metal insert 
is a porcelain device with an insert made of austenitic alloys or alloys 
containing 75 percent or greater gold and metals of the platinum group 
intended to replace a natural tooth. The device is attached to 
surrounding teeth by a bridge and is intended to provide both an 
improvement in appearance and functional occlusion (bite).

[[Page 511]]

    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 
FR 38798, July 25, 2001]



Sec. 872.3910  Backing and facing for an artificial tooth.

    (a) Identification. A backing and facing for an artificial tooth is 
a device intended for use in fabrication of a fixed or removable dental 
appliance, such as a crown or bridge. The backing, which is made of 
gold, is attached to the dental appliance and supports the tooth-colored 
facing, which is made of porcelain or plastic.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 
FR 38799, July 25, 2001]



Sec. 872.3920  Porcelain tooth.

    (a) Identification. A porcelain tooth is a prefabricated device made 
of porcelain powder for clinical use (Sec. 872.6660) intended for use 
in construction of fixed or removable prostheses, such as crowns and 
partial dentures.
    (b) Classification. Class II.



Sec. 872.3930  Bone grafting material.

    (a) Identification. Bone grafting material is a material such as 
hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, 
or collagen, that is intended to fill, augment, or reconstruct 
periodontal or bony defects of the oral and maxillofacial region.
    (b) Classification. (1) Class II (special controls) for bone 
grafting materials that do not contain a drug that is a therapeutic 
biologic. The special control is FDA's ``Class II Special Controls 
Guidance Document: Dental Bone Grafting Material Devices.'' (See Sec. 
872.1(e) for the availability of this guidance document.)
    (2) Class III (premarket approval) for bone grafting materials that 
contain a drug that is a therapeutic biologic. Bone grafting materials 
that contain a drug that is a therapeutic biologic, such as biological 
response modifiers, require premarket approval.
    (c) Date premarket approval application (PMA) or notice of product 
development protocol (PDP) is required. Devices described in paragraph 
(b)(2) of this section shall have an approved PMA or a declared 
completed PDP in effect before being placed in commercial distribution.

[70 FR 21949, Apr. 28, 2005]



Sec. 872.3940  Total temporomandibular joint prosthesis.

    (a) Identification. A total temporomandibular joint prosthesis is a 
device that is intended to be implanted in the human jaw to replace the 
mandibular condyle and augment the glenoid fossa to functionally 
reconstruct the temporomandibular joint.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before March 30, 1999, for any total 
temporomandibular joint prosthesis that was in commercial distribution 
before May 28, 1976, or that has, on or before March 30, 1999, been 
found to be substantially equivalent to a total temporomandibular joint 
prosthesis that was in commercial distribution before May 28, 1976. Any 
other total temporomandibular joint prosthesis shall have an approved 
PMA or a declared completed PDP in effect before being placed in 
commercial distribution.

[59 FR 65478, Dec. 20, 1994, as amended at 63 FR 71746, Dec. 30, 1998]



Sec. 872.3950  Glenoid fossa prosthesis.

    (a) Identification. A glenoid fossa prosthesis is a device that is 
intended to be implanted in the temporomandibular joint to augment a 
glenoid fossa or to provide an articulation surface for the head of a 
mandibular condyle.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be

[[Page 512]]

filed with the Food and Drug Administration on or before March 30, 1999, 
for any glenoid fossa prosthesis that was in commercial distribution 
before May 28, 1976, or that has on or before March 30, 1999, been found 
to be substantially equivalent to a glenoid fossa prosthesis that was in 
commercial distribution before May 28, 1976. Any other glenoid fossa 
prosthesis shall have an approved PMA or a declared completed PDP in 
effect before being placed in commercial distribution.

[59 FR 65478, Dec. 20, 1994, as amended at 63 FR 71746, Dec. 30, 1998]



Sec. 872.3960  Mandibular condyle prosthesis.

    (a) Identification. A mandibular condyle prosthesis is a device that 
is intended to be implanted in the human jaw to replace the mandibular 
condyle and to articulate within a glenoid fossa.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before March 30, 1999, for any mandibular 
condyle prosthesis that was in commercial distribution before May 28, 
1976, or that has, on or before March 30, 1999, been found to be 
substantially equivalent to a mandibular condyle prosthesis that was in 
commercial distribution before May 28, 1976. Any other mandibular 
condyle prosthesis shall have an approved PMA or a declared completed 
PDP in effect before being placed in commercial distribution.

[59 FR 65478, Dec. 20, 1994, as amended at 63 FR 71746, Dec. 30, 1998; 
78 FR 79310, Dec. 30, 2013]



Sec. 872.3970  Interarticular disc prosthesis (interpositional implant).

    (a) Identification. An interarticular disc prosthesis 
(interpositional implant) is a device that is intended to be an 
interface between the natural articulating surface of the mandibular 
condyle and glenoid fossa.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before March 30, 1999, for any 
interarticular disc prosthesis (interpositional implant) that was in 
commercial distribution before May 28, 1976, or that has on or before 
March 30, 1999, been found to be substantially equivalent to an 
interarticular disc prosthesis (interpositional implant) that was in 
commercial distribution before May 28, 1976. Any other interarticular 
disc prosthesis (interpositional implant) shall have an approved PMA or 
a declared completed PDP in effect before being placed in commercial 
distribution.

[59 FR 65478, Dec. 20, 1994, as amended at 63 FR 71746, Dec. 30, 1998]



Sec. 872.3980  Endosseous dental implant accessories.

    (a) Identification. Endosseous dental implant accessories are 
manually powered devices intended to aid in the placement or removal of 
endosseous dental implants and abutments, prepare the site for placement 
of endosseous dental implants or abutments, aid in the fitting of 
endosseous dental implants or abutments, aid in the fabrication of 
dental prosthetics, and be used as an accessory with endosseous dental 
implants when tissue contact will last less than 1 hour. These devices 
include drill bits, screwdrivers, countertorque devices, placement and 
removal tools, laboratory pieces used for fabrication of dental 
prosthetics, and trial abutments.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[65 FR 60099, Oct. 10, 2000]



                       Subpart E_Surgical Devices



Sec. 872.4120  Bone cutting instrument and accessories.

    (a) Identification. A bone cutting instrument and accessories is a 
metal device intended for use in reconstructive oral surgery to drill or 
cut into the upper or lower jaw and may be used to prepare bone to 
insert a wire, pin, or screw. The device includes the manual bone drill 
and wire driver, powered

[[Page 513]]

bone drill, rotary bone cutting handpiece, and AC-powered bone saw.
    (b) Classification. Class II.



Sec. 872.4130  Intraoral dental drill.

    (a) Identification. An intraoral dental drill is a rotary device 
intended to be attached to a dental handpiece to drill holes in teeth to 
secure cast or preformed pins to retain operative dental appliances.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 
FR 38799, July 25, 2001]



Sec. 872.4200  Dental handpiece and accessories.

    (a) Identification. A dental handpiece and accessories is an AC-
powered, water-powered, air-powered, or belt-driven, hand-held device 
that may include a foot controller for regulation of speed and direction 
of rotation or a contra-angle attachment for difficult to reach areas 
intended to prepare dental cavities for restorations, such as fillings, 
and for cleaning teeth.
    (b) Classification. Class I.

[55 FR 48439, Nov. 20, 1990]



Sec. 872.4465  Gas-powered jet injector.

    (a) Identification. A gas-powered jet injector is a syringe device 
intended to administer a local anesthetic. The syringe is powered by a 
cartridge containing pressurized carbon dioxide which provides the 
pressure to force the anesthetic out of the syringe.
    (b) Classification. Class II.



Sec. 872.4475  Spring-powered jet injector.

    (a) Identification. A spring-powered jet injector is a syringe 
device intended to administer a local anesthetic. The syringe is powered 
by a spring mechanism which provides the pressure to force the 
anesthetic out of the syringe.
    (b) Classification. Class II.



Sec. 872.4535  Dental diamond instrument.

    (a) Identification. A dental diamond instrument is an abrasive 
device intended to smooth tooth surfaces during the fitting of crowns or 
bridges. The device consists of a shaft which is inserted into a 
handpiece and a head which has diamond chips imbedded into it. Rotation 
of the diamond instrument provides an abrasive action when it contacts a 
tooth.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994]



Sec. 872.4565  Dental hand instrument.

    (a) Identification. A dental hand instrument is a hand-held device 
intended to perform various tasks in general dentistry and oral surgery 
procedures. The device includes the operative burnisher, operative 
amalgam carrier, operative dental amalgam carver, surgical bone chisel, 
operative amalgam and foil condenser, endodontic curette, operative 
curette, periodontic curette, surgical curette, dental surgical 
elevator, operative dental excavator, operative explorer surgical bone 
file, operative margin finishing file, periodontic file, periodontic 
probe, surgical rongeur forceps, surgical tooth extractor forceps, 
surgical hemostat, periodontic hoe, operative matrix contouring 
instrument, operative cutting instrument, operative margin finishing 
periodontic knife, periodontic marker, operative pliers, endodontic root 
canal plugger, endodontic root canal preparer, surgical biopsy punch, 
endodontic pulp canal reamer, crown remover, periodontic scaler, collar 
and crown scissors, endodontic pulp canal filling material spreader, 
surgical osteotome chisel, endodontic broach, dental wax carver, 
endodontic pulp canal file, hand instrument for calculus removal, dental 
depth gauge instrument, plastic dental filling instrument, dental 
instrument handle, surgical tissue scissors, mouth mirror, orthodontic 
band driver, orthodontic band pusher, orthodontic band setter, 
orthodontic bracket aligner, orthodontic pliers, orthodontic ligature 
tucking instrument, forceps, for articulation

[[Page 514]]

paper, forceps for dental dressing, dental matrix band, matrix retainer, 
dental retractor, dental retractor accessories, periodontic or 
endodontic irrigating syringe, and restorative or impression material 
syringe.
    (b) Classification. Class I (general controls). If the device is 
made of the same materials that were used in the device before May 28, 
1976, it is exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 
FR 38799, July 25, 2001]



Sec. 872.4600  Intraoral ligature and wire lock.

    (a) Identification. An intraoral ligature and wire lock is a metal 
device intended to constrict fractured bone segments in the oral cavity. 
The bone segments are stabilized by wrapping the ligature (wire) around 
the fractured bone segments and locking the ends together.
    (b) Classification. Class II.



Sec. 872.4620  Fiber optic dental light.

    (a) Identification. A fiber optic dental light is a device that is a 
light, usually AC-powered, that consists of glass or plastic fibers 
which have special optical properties. The device is usually attached to 
a dental handpiece and is intended to illuminate a patient's oral 
structures.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63008, Dec. 7, 1994; 66 
FR 38799, July 25, 2001]



Sec. 872.4630  Dental operating light.

    (a) Identification. A dental operating light, including the surgical 
headlight, is an AC-powered device intended to illuminate oral 
structures and operating areas.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 61 FR 1121, Jan. 16, 1996; 66 
FR 38799, July 25, 2001]



Sec. 872.4730  Dental injecting needle.

    (a) Identification. A dental injecting needle is a slender, hollow 
metal device with a sharp point intended to be attached to a syringe to 
inject local anesthetics and other drugs.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 
FR 38799, July 25, 2001]



Sec. 872.4760  Bone plate.

    (a) Identification. A bone plate is a metal device intended to 
stabilize fractured bone structures in the oral cavity. The bone 
segments are attached to the plate with screws to prevent movement of 
the segments.
    (b) Classification. Class II.



Sec. 872.4770  Temporary mandibular condyle reconstruction plate.

    (a) Identification. A temporary mandibular condyle reconstruction 
plate is a device that is intended to stabilize mandibular bone and 
provide for temporary reconstruction of the mandibular condyle until 
permanent reconstruction is completed in patients who have undergone 
resective surgical procedures requiring removal of the mandibular 
condyle and mandibular bone. This device is not intended for treatment 
of temporomandibular joint disorders.
    (b) Classification. Class II (special controls). The special 
controls for this device is FDA's guideline entitled ``Temporary 
Mandibular Condyle Reconstruction Plate Class II Special Controls 
Guideline.'' See Sec. 872.1(e) for the availability of this guidance 
document.

[78 FR 79310, Dec. 30, 2013]

[[Page 515]]



Sec. 872.4840  Rotary scaler.

    (a) Identification. A rotary scaler is an abrasive device intended 
to be attached to a powered handpiece to remove calculus deposits from 
teeth during dental cleaning and periodontal (gum) therapy.
    (b) Classification. Class II.



Sec. 872.4850  Ultrasonic scaler.

    (a) Identification. An ultrasonic scaler is a device intended for 
use during dental cleaning and periodontal (gum) therapy to remove 
calculus deposits from teeth by application of an ultrasonic vibrating 
scaler tip to the teeth.
    (b) Classification. Class II.



Sec. 872.4880  Intraosseous fixation screw or wire.

    (a) Identification. An intraosseous fixation screw or wire is a 
metal device intended to be inserted into fractured jaw bone segments to 
prevent their movement.
    (b) Classification. Class II.



Sec. 872.4920  Dental electrosurgical unit and accessories.

    (a) Identification. A dental electrosurgical unit and accessories is 
an AC-powered device consisting of a controlled power source and a set 
of cutting and coagulating electrodes. This device is intended to cut or 
remove soft tissue or to control bleeding during surgical procedures in 
the oral cavity. An electrical current passes through the tip of the 
electrode into the tissue and, depending upon the operating mode 
selected, cuts through soft tissue or coagulates the tissue.
    (b) Classification. Class II.



                      Subpart F_Therapeutic Devices



Sec. 872.5410  Orthodontic appliance and accessories.

    (a) Identification. An orthodontic appliance and accessories is a 
device intended for use in orthodontic treatment. The device is affixed 
to a tooth so that pressure can be exerted on the teeth. This device 
includes the preformed orthodontic band, orthodontic band material, 
orthodontic elastic band, orthodontic metal bracket, orthodontic wire 
clamp, preformed orthodontic space maintainer, orthodontic expansion 
screw retainer, orthodontic spring, orthodontic tube, and orthodontic 
wire.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994; 66 
FR 38799, July 25, 2001]



Sec. 872.5470  Orthodontic plastic bracket.

    (a) Identification. An orthodontic plastic bracket is a plastic 
device intended to be bonded to a tooth to apply pressure to a tooth 
from a flexible orthodontic wire to alter its position.
    (b) Classification. Class II.



Sec. 872.5500  Extraoral orthodontic headgear.

    (a) Identification. An extraoral orthodontic headgear is a device 
intended for use with an orthodontic appliance to exert pressure on the 
teeth from outside the mouth. The headgear has a strap intended to wrap 
around the patient's neck or head and an inner bow portion intended to 
be fastened to the orthodontic appliance in the patient's mouth.
    (b) Classification. Class II.



Sec. 872.5525  Preformed tooth positioner.

    (a) Identification. A preformed tooth positioner is a plastic device 
that is an impression of a perfected bite intended to prevent a 
patient's teeth from shifting position or to move teeth to a final 
position after orthodontic appliances (braces) have been removed. The 
patient bites down on the device for several hours a day to force the 
teeth into a final position or to maintain the teeth in their corrected 
position.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994; 66 
FR 38799, July 25, 2001]

[[Page 516]]



Sec. 872.5550  Teething ring.

    (a) Identification. A teething ring is a divice intended for use by 
infants for medical purposes to soothe gums during the teething process.
    (b)(1) Classification. Class I if the teething ring does not contain 
a fluid, such as water. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
    (2) Class II (special controls) if the teething ring contains a 
fluid, such as water. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994; 84 
FR 71812, Dec. 30, 2019]



Sec. 872.5560  Electrical salivary stimulatory system.

    (a) Identification. An electrical salivary stimulatory system is a 
prescription intraoral device that is intended to electrically stimulate 
a relative increase in saliva production.
    (b) Classification--Class II (special controls). The special 
controls for this device are:
    (1) The design characteristics of the device must ensure that the 
device design, material composition, and electrical output 
characteristics are consistent with the intended use;
    (2) Any element of the device that contacts the patient must be 
demonstrated to be biocompatible;
    (3) Appropriate analysis and/or testing must validate 
electromagnetic compatibility and electrical safety, including the 
safety of any battery used in the device;
    (4) Software validation, verification, and hazard testing must be 
performed; and
    (5) Documented clinical experience must demonstrate safe and 
effective use for stimulating saliva production by addressing the risks 
of damage to intraoral tissue and of ineffective treatment and must 
capture any adverse events observed during clinical use.

[80 FR 72586, Nov. 22, 2015]



Sec. 872.5570  Intraoral devices for snoring and intraoral devices 
for snoring and obstructive sleep apnea.

    (a) Identification. Intraoral devices for snoring and intraoral 
devices for snoring and obstructive sleep apnea are devices that are 
worn during sleep to reduce the incidence of snoring and to treat 
obstructive sleep apnea. The devices are designed to increase the 
patency of the airway and to decrease air turbulence and airway 
obstruction. The classification includes palatal lifting devices, tongue 
retaining devices, and mandibular repositioning devices.
    (b) Classification. Class II (special controls). The special control 
for these devices is the FDA guidance document entitled ``Class II 
Special Controls Guidance Document: Intraoral Devices for Snoring and/or 
Obstructive Sleep Apnea; Guidance for Industry and FDA.''

[67 FR 68512, Nov. 12, 2002]



Sec. 872.5571  Auto titration device for oral appliances.

    (a) Identification. An auto-titration device for oral appliances is 
a prescription home use device that determines a target position to be 
used for a final oral appliance for the reduction of snoring and mild to 
moderate obstructive sleep apnea.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must evaluate the following:
    (i) Performance characteristics of the algorithm; and
    (ii) All adverse events.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions for use, 
including the following:
    (i) Validation of the closed loop algorithm;
    (ii) Mechanical integrity over the expected use life;
    (iii) Characterization of maximum force, distance, and speed of 
device movement; and
    (iv) Movement accuracy of intraoral components.
    (3) Performance testing must demonstrate the wireless compatibility, 
electrical safety, and electromagnetic

[[Page 517]]

compatibility of the device in its intended use environment.
    (4) Software verification, validation, and hazard analysis must be 
performed.
    (5) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (6) Performance data must validate the reprocessing instructions for 
any reusable components.
    (7) Patient labeling must include:
    (i) Information on device use, including placement of sensors and 
mouthpieces;
    (ii) A description of all alarms; and
    (iii) Instructions for reprocessing any reusable components.
    (8) A human factors assessment must evaluate simulated use of the 
device in a home use setting.

[84 FR 5000, Feb. 20, 2019]



Sec. 872.5580  Oral rinse to reduce the adhesion of dental plaque.

    (a) Identification. The device is assigned the generic name oral 
rinse to reduce the adhesion of dental plaque and is identified as a 
device intended to reduce the presence of bacterial plaque on teeth and 
oral mucosal surfaces by physical means. The device type includes those 
devices that act by reducing the attachment and inhibiting the growth of 
bacterial plaque.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance document entitled ``Class II Special Controls Guidance 
Document: Oral Rinse to Reduce the Adhesion of Dental Plaque.'' See 
Sec. 872.1(e) for the availability of this guidance document.

[70 FR 55028, Sept. 20, 2005]



                     Subpart G_Miscellaneous Devices



Sec. 872.6010  Abrasive device and accessories.

    (a) Identification. An abrasive device and accessories is a device 
constructed of various abrasives, such as diamond chips, that are glued 
to shellac-based paper. The device is intended to remove excessive 
restorative materials, such as gold, and to smooth rough surfaces from 
oral restorations, such as crowns. The device is attached to a shank 
that is held by a handpiece. The device includes the abrasive disk, 
guard for an abrasive disk, abrasive point, polishing agent strip, and 
polishing wheel.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9. If the device is 
not labeled or otherwise represented as sterile, it is exempt from the 
current good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180, with respect to general requirements concerning records, and 
Sec. 820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 
FR 38799, July 25, 2001]



Sec. 872.6030  Oral cavity abrasive polishing agent.

    (a) Identification. An oral cavity abrasive polishing agent is a 
device in paste or powder form that contains an abrasive material, such 
as silica pumice, intended to remove debris from the teeth. The abrasive 
polish is applied to the teeth by a handpiece attachment (prophylaxis 
cup).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994; 66 
FR 38799, July 25, 2001]



Sec. 872.6050  Saliva absorber.

    (a) Identification. A saliva absorber is a device made of paper or 
cotton intended to absorb moisture from the oral cavity during dental 
procedures.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9. If the device is 
not labeled or otherwise represented as sterile, it is exempt from the 
current good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180, with respect to general requirements

[[Page 518]]

concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 
FR 38799, July 25, 2001]



Sec. 872.6070  Ultraviolet activator for polymerization.

    (a) Identification. An ultraviolet activator for polymerization is a 
device that produces ultraviolet radiation intended to polymerize (set) 
resinous dental pit and fissure sealants or restorative materials by 
transmission of light through a rod.
    (b) Classification. Class II.



Sec. 872.6080  Airbrush.

    (a) Identification. An airbrush is an AC-powered device intended for 
use in conjunction with articulation paper. The device uses air-driven 
particles to roughen the surfaces of dental restorations. Uneven areas 
of the restorations are then identified by use of articulation paper.
    (b) Classification. Class II. The special control for this device is 
International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), 
Amendment 2, ``Medical Electrical Equipment--Part 1: General 
Requirements for Safety.''

[52 FR 30097, Aug. 12, 1987; 52 FR 49250, Dec. 30, 1987, as amended at 
71 FR 17144, Mar. 31, 2006]



Sec. 872.6100  Anesthetic warmer.

    (a) Identification. An anesthetic warmer is an AC-powered device 
into which tubes containing anesthetic solution are intended to be 
placed to warm them prior to administration of the anesthetic.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 60 FR 38900, July 28, 1995; 
66 FR 38799, July 25, 2001]



Sec. 872.6140  Articulation paper.

    (a) Identification. Articulation paper is a device composed of paper 
coated with an ink dye intended to be placed between the patient's upper 
and lower teeth when the teeth are in the bite position to locate uneven 
or high areas.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9. If the device is 
not labeled or otherwise represented as sterile, it is exempt from the 
current good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180, with respect to general requirements concerning records, and 
Sec. 820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994; 66 
FR 38799, July 25, 2001]



Sec. 872.6200  Base plate shellac.

    (a) Identification. Base plant shellac is a device composed of 
shellac intended to rebuild the occlusal rim of full or partial 
dentures.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9. If the device is 
not labeled or otherwise represented as sterile, it is exempt from the 
current good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180, with respect to general requirements concerning records, and 
Sec. 820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 
FR 38799, July 25, 2001]



Sec. 872.6250  Dental chair and accessories.

    (a) Identification. A dental chair and accessories is a device, 
usually AC-powered, in which a patient sits. The device is intended to 
properly position a patient to perform dental procedures. A dental 
operative unit may be attached.
    (b) Classification. Class I. The dental chair without the operative 
unit device

[[Page 519]]

is exempt from the premarket notification procedures in subpart E of 
part 807 of this chapter.

[55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994]



Sec. 872.6290  Prophylaxis cup.

    (a) Identification. A prophylaxis cup is a device made of rubber 
intended to be held by a dental handpiece and used to apply polishing 
agents during prophylaxis (cleaning). The dental handpiece spins the 
rubber cup holding the polishing agent and the user applies it to the 
teeth to remove debris.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9. If the device is 
not labeled or otherwise represented as sterile, it is exempt from the 
current good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180, with respect to general requirements concerning records, and 
Sec. 820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989; 66 
FR 38799, July 25, 2001]



Sec. 872.6300  Rubber dam and accessories.

    (a) Identification. A rubber dam and accessories is a device 
composed of a thin sheet of latex with a hole in the center intended to 
isolate a tooth from fluids in the mouth during dental procedures, such 
as filling a cavity preparation. The device is stretched around a tooth 
by inserting a tooth through a hole in the center. The device includes 
the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a 
rubber dam clamp. This classification does not include devices intended 
for use in preventing transmission of sexually transmitted diseases 
through oral sex; those devices are classified as condoms in Sec. 
884.5300 of this chapter.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 872.9. If the device is not labeled or 
otherwise represented as sterile, it is exempt from the current good 
manufacturing practice requirements of the quality system regulation in 
part 820 of this chapter, with the exception of Sec. 820.180 of this 
chapter, with respect to general requirements concerning records, and 
Sec. 820.198 of this chapter, with respect to complaint files.

[65 FR 2315, Jan. 14, 2000]



Sec. 872.6350  Ultraviolet detector.

    (a) Identification. An ultraviolet detector is a device intended to 
provide a source of ultraviolet light which is used to identify 
otherwise invisible material, such as dental plaque, present in or on 
teeth.
    (b) Classification. Class II.



Sec. 872.6390  Dental floss.

    (a) Identification. Dental floss is a string-like device made of 
cotton or other fibers intended to remove plaque and food particles from 
between the teeth to reduce tooth decay. The fibers of the device may be 
coated with wax for easier use.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 61 FR 1121, Jan. 16, 1996; 65 
FR 2315, Jan. 14, 2000]



Sec. 872.6475  Heat source for bleaching teeth.

    (a) Identification. A heat source for bleaching teeth is an AC-
powered device that consists of a light or an electric heater intended 
to apply heat to a tooth after it is treated with a bleaching agent.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994; 66 
FR 38799, July 25, 2001]



Sec. 872.6510  Oral irrigation unit.

    (a) Identification. An oral irrigation unit is an AC-powered device 
intended to provide a pressurized stream of

[[Page 520]]

water to remove food particles from between the teeth and promote good 
periodontal (gum) condition.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994; 66 
FR 38800, July 25, 2001]



Sec. 872.6570  Impression tube.

    (a) Identification. An impression tube is a device consisting of a 
hollow copper tube intended to take an impression of a single tooth. The 
hollow tube is filled with impression material. One end of the tube is 
sealed with a softened material, such as wax, the remaining end is 
slipped over the tooth to make the impression.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9. If the device is 
not labeled or otherwise represented as sterile, it is exempt from the 
current good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180, with respect to general requirements concerning records, and 
Sec. 820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989; 66 
FR 38800, July 25, 2001]



Sec. 872.6640  Dental operative unit and accessories.

    (a) Identification. A dental operative unit and accessories is an 
AC-powered device that is intended to supply power to and serve as a 
base for other dental devices, such as a dental handpiece, a dental 
operating light, an air or water syringe unit, and oral cavity 
evacuator, a suction operative unit, and other dental devices and 
accessories. The device may be attached to a dental chair.
    (b) Classification. Class I (general controls). Except for dental 
operative unit, accessories are exempt from premarket notification 
procedures in subpart E of part 807 of this chapter subject to Sec. 
872.9.

[55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994; 65 
FR 2315, Jan. 14, 2000]



Sec. 872.6650  Massaging pick or tip for oral hygiene.

    (a) Identification. A massaging pick or tip for oral hygiene is a 
rigid, pointed device intended to be used manually to stimulate and 
massage the gums to promote good periodontal (gum) condition.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9. If the device is 
not labeled or otherwise represented as sterile, it is exempt from the 
current good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180, with respect to general requirements concerning records, and 
Sec. 820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989; 66 
FR 38800, July 25, 2001]



Sec. 872.6660  Porcelain powder for clinical use.

    (a) Identification. Porcelain powder for clinical use is a device 
consisting of a mixture of kaolin, felspar, quartz, or other substances 
intended for use in the production of artificial teeth in fixed or 
removable dentures, of jacket crowns, facings, and veneers. The device 
is used in prosthetic dentistry by heating the powder mixture to a high 
temperature in an oven to produce a hard prosthesis with a glass-like 
finish.
    (b) Classification. Class II.



Sec. 872.6670  Silicate protector.

    (a) Identification. A silicate protector is a device made of 
silicone intended to be applied with an absorbent tipped applicator to 
the surface of a new restoration to exclude temporarily fluids from its 
surface.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9. If

[[Page 521]]

the device is not labeled or otherwise represented as sterile, it is 
exempt from the current good manufacturing practice requirements of the 
quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989; 66 
FR 38800, July 25, 2001]



Sec. 872.6710  Boiling water sterilizer.

    (a) Identification. A boiling water sterilizer is an AC-powered 
device that consists of a container for boiling water. The device is 
intended to sterilize dental and surgical instruments by submersion in 
the boiling water in the container.
    (b) Classification. Class I (general controls).

[55 FR 48439, Nov. 20, 1990, as amended at 66 FR 46952, Sept. 10, 2001]



Sec. 872.6730  Endodontic dry heat sterilizer.

    (a) Identification. An endodontic dry heat sterilizer is a device 
intended to sterilize endodontic and other dental instruments by the 
application of dry heat. The heat is supplied through glass beads which 
have been heated by electricity.
    (b) Classification. Class III.
    (c) Date premarket approval application (PMA) or notice of 
completion of product development protocol (PDP) is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before April 21, 1997, for any endodontic dry 
heat sterilizer that was in commercial distribution before May 28, 1976, 
or that has on or before April 21, 1997, been found to be substantially 
equivalent to the endodontic dry heat sterilizer that was in commercial 
distribution before May 28, 1976. Any other endodontic dry heat 
sterilizer shall have an approved PMA or declared completed PDP in 
effect before being placed in commercial distribution.

[52 FR 30097, Aug. 12, 1987, as amended at 62 FR 2902, Jan. 21, 1997; 62 
FR 31512, June 10, 1997]



Sec. 872.6770  Cartridge syringe.

    (a) Identification. A cartridge syringe is a device intended to 
inject anesthetic agents subcutaneously or intramuscularly. The device 
consists of a metal syringe body into which a disposable, previously 
filled, glass carpule (a cylindrical cartridge) containing anesthetic is 
placed. After attaching a needle to the syringe body and activating the 
carpule by partially inserting the plunger on the syringe, the device is 
used to administer an injection to the patient.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 84 FR 71813, Dec. 30, 2019]



Sec. 872.6855  Manual toothbrush.

    (a) Identification. A manual toothbrush is a device composed of a 
shaft with either natural or synthetic bristles at one end intended to 
remove adherent plaque and food debris from the teeth to reduce tooth 
decay.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9. If the device is 
not labeled or otherwise represented as sterile, it is exempt from the 
current good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180, with respect to general requirements concerning records, and 
Sec. 820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989; 66 
FR 38800, July 25, 2001]



Sec. 872.6865  Powered toothbrush.

    (a) Identification. A powered toothbrush is an AC-powered or 
battery-powered device that consists of a handle containing a motor that 
provides mechanical movement to a brush intended to be applied to the 
teeth. The device is intended to remove adherent plaque and food debris 
from the teeth to reduce tooth decay.

[[Page 522]]

    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994; 66 
FR 38800, July 25, 2001]



Sec. 872.6870  Disposable fluoride tray.

    (a) Identification. A disposable fluoride tray is a device made of 
styrofoam intended to apply fluoride topically to the teeth. To use the 
tray, the patient bites down on the tray which has been filled with a 
fluoride solution.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9. If the device is 
not labeled or otherwise represented as sterile, it is exempt from the 
current good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180, with respect to general requirements concerning records, and 
Sec. 820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989; 66 
FR 38800, July 25, 2001]



Sec. 872.6880  Preformed impression tray.

    (a) Identification. A preformed impression tray is a metal or 
plastic device intended to hold impression material, such as alginate, 
to make an impression of a patient's teeth or alveolar process (bony 
tooth sockets) to reproduce the structure of a patient's teeth and gums.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9. If the device is 
not labeled or otherwise represented as sterile, it is exempt from the 
current good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180, with respect to general requirements concerning records, and 
Sec. 820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13832, Apr. 5, 1989; 66 
FR 38800, July 25, 2001]



Sec. 872.6890  Intraoral dental wax.

    (a) Identification. Intraoral dental wax is a device made of wax 
intended to construct patterns from which custom made metal dental 
prostheses, such as crowns and bridges, are cast. In orthodontic 
dentistry, the device is intended to make a pattern of a patient's bite 
to make study models of the teeth.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9. If the device is 
not labeled or otherwise represented as sterile, it is exempt from the 
current good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180, with respect to general requirements concerning records, and 
Sec. 820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994; 66 
FR 38800, July 25, 2001]



PART 874_EAR, NOSE, AND THROAT DEVICES--Table of Contents



                      Subpart A_General Provisions

Sec.
874.1 Scope.
874.3 Effective dates of requirement for premarket approval.
874.9 Limitations of exemptions from section 510(k) of the Federal Food, 
          Drug, and Cosmetic Act (the act).

                      Subpart B_Diagnostic Devices

874.1050 Audiometer.
874.1060 Acoustic chamber for audiometric testing.
874.1070 Short increment sensitivity index (SISI) adapter.
874.1080 Audiometer calibration set.
874.1090 Auditory impedance tester.
874.1100 Earphone cushion for audiometric testing.
874.1120 Electronic noise generator for audiometric testing.
874.1325 Electroglottograph.
874.1500 Gustometer.
874.1600 Olfactory test device.

[[Page 523]]

874.1800 Air or water caloric stimulator.
874.1820 Surgical nerve stimulator/locator.
874.1925 Toynbee diagnostic tube.

Subpart C [Reserved]

                      Subpart D_Prosthetic Devices

874.3300 Air-conduction hearing aid.
874.3302 Bone-conduction hearing aid.
874.3305 Wireless air-conduction hearing aid.
874.3310 Hearing aid calibrator and analysis system.
874.3315 Tympanic membrane contact hearing aid.
874.3320 Group hearing aid or group auditory trainer.
874.3325 Self-fitting air-conduction hearing aid.
874.3330 Master hearing aid.
874.3340 Active implantable bone conduction hearing system.
874.3375 Battery-powered artificial larynx.
874.3400 Tinnitus masker.
874.3430 Middle ear mold.
874.3450 Partial ossicular replacement prosthesis.
874.3495 Total ossicular replacement prosthesis.
874.3540 Prosthesis modification instrument for ossicular replacement 
          surgery.
874.3620 Ear, nose, and throat synthetic polymer material.
874.3695 Mandibular implant facial prosthesis.
874.3730 Laryngeal prosthesis (Taub design).
874.3760 Sacculotomy tack (Cody tack).
874.3820 Endolymphatic shunt.
874.3850 Endolymphatic shunt tube with valve.
874.3880 Tympanostomy tube.
874.3900 Nasal dilator.
874.3930 Tympanostomy tube with semipermeable membrane.
874.3950 Transcutaneous air conduction hearing aid system.

                       Subpart E_Surgical Devices

874.4100 Epistaxis balloon.
874.4140 Ear, nose, and throat bur.
874.4175 Nasopharyngeal catheter.
874.4180 Eustachian tube balloon dilation system.
874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
874.4350 Ear, nose, and throat fiberoptic light source and carrier.
874.4420 Ear, nose, and throat manual surgical instrument.
874.4450 Powered insertion system for a cochlear implant electrode 
          array.
874.4490 Argon laser for otology, rhinology, and laryngology.
874.4500 Ear, nose, and throat microsurgical carbon dioxide laser.
874.4680 Bronchoscope (flexible or rigid) and accessories.
874.4710 Esophagoscope (flexible or rigid) and accessories.
874.4720 Mediastinoscope and accessories.
874.4750 Laryngostroboscope.
874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
874.4770 Otoscope.
874.4780 Intranasal splint.
874.4800 Bone particle collector.

                      Subpart F_Therapeutic Devices

874.5220 Ear, nose, and throat drug administration device.
874.5300 Ear, nose, and throat examination and treatment unit.
874.5350 Suction antichoke device.
874.5370 Tongs antichoke device.
874.5550 Powered nasal irrigator.
874.5800 External nasal splint.
874.5840 Antistammering device.
874.5900 External upper esophageal sphincter compression device.

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 874 appear at 73 FR 
35341, June 23, 2008.



                      Subpart A_General Provisions



Sec. 874.1  Scope.

    (a) This part sets forth the classification of ear, nose, and throat 
devices intended for human use that are in commercial distribution.
    (b) The identification of a device in a regulation in this part is 
not a precise description of every device that is, or will be, subject 
to the regulation. A manufacturer who submits a premarket notification 
submission for a device under part 807 cannot show merely that the 
device is accurately described by the section title and identification 
provision of a regulation in this part, but shall state why the device 
is substantially equivalent to other devices, as required by Sec. 
807.87.
    (c) To avoid duplicative listings, an ear, nose, and throat device 
that has two or more types of uses (e.g., used both as a diagnostic 
device and as a therapeutic device) is listed in one subpart only.
    (d) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21 unless otherwise noted.

[[Page 524]]

    (e) Guidance documents referenced in this part are available on the 
Internet at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/default.htm..

[51 FR 40389, Nov. 6, 1986, as amended at 67 FR 67790, Nov. 7, 2002; 78 
FR 18233, Mar. 26, 2013]



Sec. 874.3  Effective dates of requirement for premarket approval.

    A device included in this part that is classified into class III 
(premarket approval) shall not be commercially distributed after the 
date shown in the regulation classifying the device unless the 
manufacturer has an approval under section 515 of the act (unless an 
exemption has been granted under section 520(g)(2) of the act). An 
approval under section 515 of the act consists of FDA's issuance of an 
order approving an application for premarket approval (PMA) for the 
device or declaring completed a product development protocol (PDP) for 
the device.
    (a) Before FDA requires that a device commercially distributed 
before the enactment date of the amendments, or a device that has been 
found substantially equivalent to such a device, has an approval under 
section 515 of the act FDA must promulgate a regulation under section 
515(b) of the act requiring such approval, except as provided in 
paragraph (b) of this section. Such a regulation under section 515(b) of 
the act shall not be effective during the grace period ending on the 
90th day after its promulgation or on the last day of the 30th full 
calendar month after the regulation that classifies the device into 
class III is effective, whichever is later. See section 501(f)(2)(B) of 
the act. Accordingly, unless an effective date of the requirement for 
premarket approval is shown in the regulation for a device classified 
into class III in this part, the device may be commercially distributed 
without FDA's issuance of an order approving a PMA declaring completed a 
PDP for the device. If FDA promulgates a regulation under section 515(b) 
of the act requiring premarket approval for a device, section 
501(f)(1)(A) of the act applies to the device.
    (b) Any new, not substantially equivalent, device introduced into 
commercial distribution on or after May 28, 1976, including a device 
formerly marketed that has been substantially altered, is classified by 
statute (section 513(f) of the act) into class III without any grace 
period and FDA must have issued an order approving a PMA or declaring 
completed a PDP for the device before the device is commercially 
distributed unless it is reclassified. If FDA knows that a device being 
commercially distributed may be a ``new'' device as defined in this 
section because of any new intended use or other reasons, FDA may codify 
the statutory classification of the device into class III for such new 
use. Accordingly, the regulation for such a class III device states that 
as of the enactment date of the amendments, May 28, 1976, the device 
must have an approval under section 515 of the act before commercial 
distribution.



Sec. 874.9  Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

    The exemption from the requirement of premarket notification 
(section 510(k) of the act) for a generic type of class I or II device 
is only to the extent that the device has existing or reasonably 
foreseeable characteristics of commercially distributed devices within 
that generic type or, in the case of in vitro diagnostic devices, only 
to the extent that misdiagnosis as a result of using the device would 
not be associated with high morbidity or mortality. Accordingly, 
manufacturers of any commercially distributed class I or II device for 
which FDA has granted an exemption from the requirement of premarket 
notification must still submit a premarket notification to FDA before 
introducing or delivering for introduction into interstate commerce for 
commercial distribution the device when:
    (a) The device is intended for a use different from the intended use 
of a legally marketed device in that generic type of device; e.g., the 
device is intended for a different medical purpose, or the device is 
intended for lay use where the former intended use was by health care 
professionals only;

[[Page 525]]

    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro diagnostic 
device detects or identifies infectious agents by using deoxyribonucleic 
acid (DNA) probe or nucleic acid hybridization technology rather than 
culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of neoplastic 
diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial or acquired 
genetic disorders, including inborn errors of metabolism;
    (3) For measuring an analyte that serves as a surrogate marker for 
screening, diagnosis, or monitoring life-threatening diseases such as 
acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, 
tuberculosis, or myocardial infarction or to monitor therapy;
    (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) or IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is intended 
for use in matrices other than serum or plasma;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).

[65 FR 2315, Jan. 14, 2000]



                      Subpart B_Diagnostic Devices



Sec. 874.1050  Audiometer.

    (a) Identification. An audiometer or automated audiometer is an 
electroacoustic device that produces controlled levels of test tones and 
signals intended for use in conducting diagnostic hearing evaluations 
and assisting in the diagnosis of possible otologic disorders.
    (b) Classification. Class II. Except for the otoacoustic emission 
device, the device is exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter, if it is in compliance with 
American National Standard Institute S3.6-1996, ``Specification for 
Audiometers,'' and subject to the limitations in Sec. 874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 64 FR 14831, Mar. 29, 1999]



Sec. 874.1060  Acoustic chamber for audiometric testing.

    (a) Identification. An acoustic chamber for audiometric testing is a 
room that is intended for use in conducting diagnostic hearing 
evaluations and that eliminates sound reflections and provides isolation 
from outside sounds.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1121, Jan. 16, 1996; 66 
FR 38800, July 25, 2001]



Sec. 874.1070  Short increment sensitivity index (SISI) adapter.

    (a) Identification. A short increment sensitivity index (SISI) 
adapter is a device used with an audiometer in diagnostic hearing 
evaluations. A SISI adapter provides short periodic sound pulses in 
specific small decibel increments that are intended to be superimposed 
on the audiometer's output tone frequency.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 874.9.

[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2315, Jan. 14, 2000]



Sec. 874.1080  Audiometer calibration set.

    (a) Identification. An audiometer calibration set is an electronic 
reference device that is intended to calibrate an audiometer. It 
measures the sound frequency and intensity characteristics

[[Page 526]]

that emanate from an audiometer earphone. The device consists of an 
acoustic cavity of known volume, a sound level meter, a microphone with 
calibration traceable to the National Bureau of Standards, oscillators, 
frequency counters, microphone amplifiers, and a recorder. The device 
can measure selected audiometer test frequencies at a given intensity 
level, and selectable audiometer attenuation settings at a given test 
frequency.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1121, Jan. 16, 1996; 66 
FR 38800, July 25, 2001]



Sec. 874.1090  Auditory impedance tester.

    (a) Identification. An auditory impedance tester is a device that is 
intended to change the air pressure in the external auditory canal and 
measure and graph the mobility characteristics of the tympanic membrane 
to evaluate the functional condition of the middle ear. The device is 
used to determine abnormalities in the mobility of the tympanic membrane 
due to stiffness, flaccidity, or the presence of fluid in the middle ear 
cavity. The device is also used to measure the acoustic reflex threshold 
from contractions of the stapedial muscle, to monitor healing of 
tympanic membrane grafts or stapedectomies, or to monitor followup 
treatment for inflammation of the middle ear.
    (b) Classification. Class II (special controls). The device, when it 
is a tympanometer or auditory impedance tester that complies with FDA-
recognized consensus standard ANSI S3.39, is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019]



Sec. 874.1100  Earphone cushion for audiometric testing.

    (a) Identification. An earphone cushion for audiometric testing is a 
device that is used to cover an audiometer earphone during audiometric 
testing to provide an acoustic coupling (sound connection path) between 
the audiometer earphone and the patient's ear.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 874.9.

[51 FR 40389, Nov. 9, 1986; 52 FR 18495, May 15, 1987, as amended at 52 
FR 32111, Aug. 25, 1987; 65 FR 2315, Jan. 14, 2000]



Sec. 874.1120  Electronic noise generator for audiometric testing.

    (a) Identification. An electronic noise generator for audiometric 
testing is a device that consists of a swept frequency generator, an 
amplifier, and an earphone. It is intended to introduce a masking noise 
into the non-test ear during an audiometric evaluation. The device 
minimizes the non-test ear's sensing of test tones and signals being 
generated for the ear being tested.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019]



Sec. 874.1325  Electroglottograph.

    (a) Identification. An electroglottograph is an AC-powered device 
that employs a pair of electrodes that are placed in contact with the 
skin on both sides of the larynx and held in place by a collar. It is 
intended to measure the electrical impedance of the larynx to aid in 
assessing the degree of closure of the vocal cords, confirm larygeal 
diagnosis, aid behavioral treatment of voice disorders, and aid research 
concerning the laryngeal mechanism.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019]



Sec. 874.1500  Gustometer.

    (a) Identification. A gustometer is a battery-powered device that 
consists of two electrodes that are intended to be

[[Page 527]]

placed on both sides of the tongue at different taste centers and that 
provides a galvanic stimulus resulting in taste sensation. It is used 
for assessing the sense of taste.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 874.9. If the device is not labeled or 
otherwise represented as sterile, it is exempt from the current good 
manufacturing practice requirements of the quality system regulation in 
part 820 of this chapter, with the exception of Sec. 820.180 of this 
chapter, with respect to general requirements concerning records, and 
Sec. 820.198 of this chapter, with respect to complaint files.

[51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000]



Sec. 874.1600  Olfactory test device.

    (a) Identification. An olfactory test device is used to determine 
whether an olfactory loss is present. The device includes one or more 
odorants that are presented to the patient's nose to subjectively assess 
the patient's ability to perceive odors.
    (b) Classification. Class II (special controls). The special control 
for these devices is the FDA guidance document entitled ``Class II 
Special Controls Guidance Document: Olfactory Test Device.'' For the 
availability of this guidance document, see Sec. 874.1(e). The device 
is exempt from the premarket notification procedures in subpart E of 
part 807 of this chapter subject to the limitations in Sec. 874.9. When 
indicated for the screening or diagnosis of diseases or conditions other 
than the loss of olfactory function, the device is not exempt from 
premarket notification procedures.

[71 FR 32835, June 7, 2006]



Sec. 874.1800  Air or water caloric stimulator.

    (a) Identification. An air or water caloric stimulator is a device 
that delivers a stream of air or water to the ear canal at controlled 
rates of flow and temperature and that is intended for vestibular 
function testing of a patient's body balance system. The vestibular 
stimulation of the semicircular canals produce involuntary eye movements 
that are measured and recorded by a nystagmograph.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 874.9.

[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2316, Jan. 14, 2000]



Sec. 874.1820  Surgical nerve stimulator/locator.

    (a) Identification. A surgical nerve stimulator/locator is a device 
that is intended to provide electrical stimulation to the body to locate 
and identify nerves and to test their excitability.
    (b) Classification. Class II.



Sec. 874.1925  Toynbee diagnostic tube.

    (a) Identification. The toynbee diagnostic tube is a listening 
device intended to determine the degree of openness of the eustachian 
tube.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000]

Subpart C [Reserved]



                      Subpart D_Prosthetic Devices



Sec. 874.3300  Air-conduction hearing aid.

    (a) Identification. An air-conduction hearing aid is a wearable 
sound-amplifying device intended to compensate for impaired hearing that 
conducts sound to the ear through the air. An air-conduction hearing aid 
is subject to the requirements in Sec. 800.30 or Sec. 801.422 of this 
chapter, as applicable. The air-conduction hearing aid generic type 
excludes the group hearing aid or group auditory trainer, master hearing 
aid, and the tinnitus masker, regulated under Sec. Sec. 874.3320, 
874.3330, and 874.3400, respectively.

[[Page 528]]

    (b) Classification. Class I (general controls). This device is 
exempt from premarket notification procedures in subpart E of part 807 
of this chapter, subject to the limitations in Sec. 874.9.

[87 FR 50762, Aug. 17, 2022]



Sec. 874.3302  Bone-conduction hearing aid.

    (a) Identification. A bone-conduction hearing aid is a wearable 
sound-amplifying device intended to compensate for impaired hearing and 
that conducts sound to the inner ear through the skull. The non-
implantable components of a bone-conduction hearing aid, such as the 
external sound processor, are subject to the requirements in Sec. 
801.422 of this chapter.
    (b) Classification. Class II.

[87 FR 50762, Aug. 17, 2022]



Sec. 874.3305  Wireless air-conduction hearing aid.

    (a) Identification. A wireless air-conduction hearing aid is a 
wearable sound-amplifying device, intended to compensate for impaired 
hearing that incorporates wireless technology in its programming or use. 
A wireless air-conduction hearing aid is subject to the requirements in 
Sec. 800.30 or Sec. 801.422 of this chapter, as applicable.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Performance data must demonstrate the electromagnetic 
compatibility (EMC), electrical safety, and thermal safety of the 
device;
    (2) Performance testing must validate safety of exposure to non-
ionizing radiation; and
    (3) Performance data must validate wireless technology functions.
    (c) Premarket notification. The wireless air-conduction hearing aid 
is exempt from the premarket notification procedures in subpart E of 
part 807 of this chapter subject to Sec. 874.9.

[76 FR 34846, June 15, 2011, as amended at 87 FR 50762, Aug. 17, 2022]



Sec. 874.3310  Hearing aid calibrator and analysis system.

    (a) Identification. A hearing aid calibrator and analysis system is 
an electronic reference device intended to calibrate and assess the 
electroacoustic frequency and sound intensity characteristics emanating 
from a hearing aid, master hearing aid, group hearing aid or group 
auditory trainer. The device consists of an acoustic complex of known 
cavity volume, a sound level meter, a microphone, oscillators, frequency 
counters, microphone amplifiers, a distoration analyzer, a chart 
recorder, and a hearing aid test box.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019]



Sec. 874.3315  Tympanic membrane contact hearing aid.

    (a) Identification. A tympanic membrane contact hearing aid is a 
prescription wearable device that compensates for impaired hearing. 
Amplified sound is transmitted by vibrating the tympanic membrane 
through a transducer that is in direct contact with the tympanic 
membrane. A tympanic membrane contact hearing aid is subject to the 
requirements in Sec. 801.422 of this chapter.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient contacting components must be demonstrated to be 
biocompatible.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use, and 
must include:
    (i) Mechanical integrity testing;
    (ii) Electrical and thermal safety testing;
    (iii) Software verification, validation, and hazard analysis;
    (iv) Reliability testing consistent with expected device life;
    (v) Electromagnetic compatibility testing; and
    (vi) Validation testing of device output and mechanical force 
applied to the tympanic membrane in a clinically appropriate model.

[[Page 529]]

    (3) Clinical performance testing must characterize any adverse 
events observed during clinical use, and demonstrate that the device 
performs as intended under anticipated conditions of use.
    (4) Professional training must include the ear impression procedure, 
correct placement, fitting, monitoring, care, and maintenance of the 
device.
    (5) Labeling must include the following:
    (i) A detailed summary of the adverse events and effectiveness 
outcomes from the clinical performance testing;
    (ii) Detailed instructions on how to fit the device to the patient;
    (iii) Instructions for periodic cleaning of any reusable components;
    (iv) Information related to electromagnetic compatibility; and
    (v) Patient labeling that includes:
    (A) A patient card that identifies if a patient has been fitted with 
any non-self- removable components of the device and provides relevant 
information in cases of emergency;
    (B) Information on how to correctly use and maintain the device;
    (C) The potential risks and benefits associated with the use of the 
device; and
    (D) Alternative treatments.

[81 FR 3326, Jan. 21, 2015, as amended at 87 FR 50762, Aug. 17, 2022]



Sec. 874.3320  Group hearing aid or group auditory trainer.

    (a) Identification. A group hearing aid or group auditory trainer is 
a hearing aid that is intended for use in communicating simultaneously 
with one or more listeners having hearing impairment. The device is used 
with an associated transmitter microphone. It may be either monaural or 
binaural, and it provides coupling to the ear through either earphones 
or earmolds. The generic type of device includes three types of 
applications: hardwire systems, inductance loop systems, and wireless 
systems.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019]



Sec. 874.3325  Self-fitting air-conduction hearing aid.

    (a) Identification. A self-fitting air-conduction hearing aid is a 
wearable sound amplifying device that is intended to compensate for 
impaired hearing and incorporates technology, including software, that 
allows users to program their hearing aids. This technology integrates 
user input with a self-fitting strategy and enables users to 
independently derive and customize their hearing aid fitting and 
settings. A self-fitting air-conduction hearing aid is subject to the 
requirements in Sec. 800.30 or Sec. 801.422 of this chapter, as 
applicable.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical data must evaluate the effectiveness of the self-
fitting strategy.
    (2) Electroacoustic parameters, including maximum output limits, 
distortion levels, self-generated noise levels, latency, and frequency 
response, must be specified and tested.
    (3) Performance data must demonstrate the electromagnetic 
compatibility (EMC), electrical safety, and thermal safety of the 
device.
    (4) Software verification, validation, and hazard analysis must be 
performed.
    (5) If the device incorporates wireless technology:
    (i) Performance testing must validate safety of exposure to non-
ionizing radiation; and
    (ii) Performance data must validate wireless technology functions.
    (6) Usability testing must demonstrate that users can correctly use 
the device as intended under anticipated conditions of use.

[84 FR 57612, Oct. 28, 2019, as amended at 87 FR 50762, Aug. 17, 2022]



Sec. 874.3330  Master hearing aid.

    (a) Identification. A master hearing aid is an electronic device 
intended to simulate a hearing aid during audiometric testing. It has 
adjustable acoustic output levels, such as those for gain, output, and 
frequency response. The device is used to select and adjust a person's 
wearable hearing aid.
    (b) Classification. Class II (special controls). The device is 
exempt from

[[Page 530]]

the premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019]



Sec. 874.3340  Active implantable bone conduction hearing system.

    (a) Identification. An active implantable bone conduction hearing 
system is a prescription device consisting of an implanted transducer, 
implanted electronics components, and an audio processor. The active 
implantable bone conduction hearing system is intended to compensate for 
conductive or mixed hearing losses by conveying amplified acoustic 
signals to the cochlea via mechanical vibrations on the skull bone.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must characterize any adverse 
events observed during implantation and clinical use, and must also 
demonstrate that the device performs as intended under anticipated 
conditions of use.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use, 
including the following:
    (i) Performance data must validate force output in a clinically 
relevant model.
    (ii) Impact testing in a clinically relevant anatomic model must be 
performed.
    (iii) Mechanical integrity testing must be performed.
    (iv) Reliability testing consistent with expected device life must 
be performed.
    (3) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (4) Performance data must demonstrate the sterility of the patient-
contacting components of the device.
    (5) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the identified shelf life.
    (6) Performance data must demonstrate the wireless compatibility, 
electromagnetic compatibility, and electrical safety of the device.
    (7) Software verification, validation, and hazard analysis must be 
performed.
    (8) Labeling must include:
    (i) A summary of clinical testing conducted with the device that 
includes a summary of device-related complications and adverse events;
    (ii) Instructions for use;
    (iii) A surgical guide for implantation, which includes instructions 
for imaging to assess bone dimensions;
    (iv) A shelf life, for device components provided sterile;
    (v) A patient identification card; and
    (vi) A patient user manual.

[83 FR 54009, Oct. 26, 2018]



Sec. 874.3375  Battery-powered artificial larynx.

    (a) Identification. A battery-powered artificial larynx is an 
externally applied device intended for use in the absence of the larynx 
to produce sound. When held against the skin in the area of the 
voicebox, the device generates mechanical vibrations which resonate in 
the oral and nasal cavities and can be modulated by the tongue and lips 
in a normal manner, thereby allowing the production of speech.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 59 FR 63009, Dec. 7, 1994; 66 
FR 38800, July 25, 2001]



Sec. 874.3400  Tinnitus masker.

    (a) Identification. A tinnitus masker is an electronic device 
intended to generate noise of sufficient intensity and bandwidth to mask 
ringing in the ears or internal head noises. Because the device is able 
to mask internal noises, it is also used as an aid in hearing external 
noises and speech.
    (b) Classification. Class II. The special control for this device is 
patient labeling regarding:
    (1) Hearing health care professional diagnosis, fitting of the 
device, and followup care,
    (2) Risks,
    (3) Benefits,
    (4) Warnings for safe use, and

[[Page 531]]

    (5) Specifications.

[51 FR 40389, Nov. 6, 1986, as amended at 65 FR 17145, Mar. 31, 2000]



Sec. 874.3430  Middle ear mold.

    (a) Identification. A middle ear mold is a preformed device that is 
intended to be implanted to reconstruct the middle ear cavity during 
repair of the tympanic membrane. The device permits an ample air-filled 
cavity to be maintained in the middle ear and promotes regeneration of 
the mucous membrane lining of the middle ear cavity. A middle ear mold 
is made of materials such as polyamide, polytetrafluoroethylene, 
silicone elastomer, or polyethylene, but does not contain porous 
polyethylene.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019]



Sec. 874.3450  Partial ossicular replacement prosthesis.

    (a) Identification. A partial ossicular replacement prosthesis is a 
device intended to be implanted for the functional reconstruction of 
segments of the ossicular chain and facilitates the conduction of sound 
wave from the tympanic membrane to the inner ear. The device is made of 
materials such as stainless steel, tantalum, polytetrafluoroethylene, 
polyethylene, polytetrafluoroethylene with carbon fibers composite, 
absorbable gelatin material, porous polyethylene, or from a combination 
of these materials.
    (b) Classification. Class II.



Sec. 874.3495  Total ossicular replacement prosthesis.

    (a) Identification. A total ossicular replacement prosthesis is a 
device intended to be implanted for the total functional reconstruction 
of the ossicular chain and facilitates the conduction of sound waves 
from the tympanic membrance to the inner ear. The device is made of 
materials such as polytetrafluoroethylene, polytetrafluoroethylene with 
vitreous carbon fibers composite, porous polyethylene, or from a 
combination of these materials.
    (b) Classification. Class II.



Sec. 874.3540  Prosthesis modification instrument for ossicular replacement surgery.

    (a) Identification. A prosthesis modification instrument for 
ossicular replacement surgery is a device intended for use by a surgeon 
to construct ossicular replacements. This generic type of device 
includes the ear, nose, and throat cutting block; wire crimper, wire 
bending die; wire closure forceps; piston cutting jib; gelfoam \TM\ 
punch; wire cutting scissors; and ossicular finger vise.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 874.9. If the device is not labeled or 
otherwise represented as sterile, it is exempt from the current good 
manufacturing practice requirements of the quality system regulation in 
part 820 of this chapter, with the exception of Sec. 820.180 of this 
chapter, with respect to general requirements concerning records, and 
Sec. 820.198 of this chapter, with respect to complaint files.

[51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987; 65 
FR 2316, Jan. 14, 2000]



Sec. 874.3620  Ear, nose, and throat synthetic polymer material.

    (a) Identification. Ear, nose, and throat synthetic polymer material 
is a device material that is intended to be implanted for use as a 
space-occupying substance in the reconstructive surgery of the head and 
neck. The device is used, for example, in augmentation rhinoplasty and 
in tissue defect closures in the esophagus. The device is shaped and 
formed by the suregon to conform to the patient's needs. This generic 
type of device is made of material such as polyamide mesh or foil and 
porous polyethylene.
    (b) Classification. Class II.



Sec. 874.3695  Mandibular implant facial prosthesis.

    (a) Identification. A mandibular implant facial prosthesis is a 
device that

[[Page 532]]

is intended to be implanted for use in the functional reconstruction of 
mandibular deficits. The device is made of materials such as stainless 
steel, tantalum, titanium, cobalt-chromium based alloy, 
polytetrafluoroethylene, silicone elastomer, polyethylene, polyurethane, 
or polytetrafluoroethylene with carbon fibers composite.
    (b) Classification. Class II.



Sec. 874.3730  Laryngeal prosthesis (Taub design).

    (a) Identification. A laryngeal prosthesis (Taub design) is a device 
intended to direct pulmonary air flow to the pharynx in the absence of 
the larynx, thereby permitting esophageal speech. The device is 
interposed between openings in the trachea and the esophagus and may be 
removed and replaced each day by the patient. During phonation, air from 
the lungs is directed to flow through the device and over the esophageal 
mucosa to provide a sound source that is articulated as speech.
    (b) Classification. Class II (special controls). The device, when it 
is a voice amplification device, is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019]



Sec. 874.3760  Sacculotomy tack (Cody tack)

    (a) Identification. A sacculotomy tack (Cody tack) is a device that 
consists of a pointed stainless steel tack intended to be implanted to 
relieve the symptoms of vertigo. The device repetitively ruptures the 
utricular membrane as the membrane expands under increased endolymphatic 
pressure.
    (b) Classification. Class II.



Sec. 874.3820  Endolymphatic shunt.

    (a) Identification. An endolymphatic shunt is a device that consists 
of a tube or sheet intended to be implanted to relieve the symptons of 
vertigo. The device permits the unrestricted flow of excess endolymph 
from the distended end of the endolymphatic system into the mastoid 
cavity where resorption occurs. This device is made of 
polytetrafluoroethylene or silicone elastomer.
    (b) Classification. Class II.



Sec. 874.3850  Endolymphatic shunt tube with valve.

    (a) Identification. An endolymphatic shunt tube with valve is a 
device that consists of a pressure-limiting valve associated with a tube 
intended to be implanted in the inner ear to relieve symptoms of vertigo 
and hearing loss due to endolymphatic hydrops (increase in endolymphatic 
fluid) of Meniere's disease.
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA guidance document ``Class II Special Controls 
Guidance Document: Endolymphatic Shunt Tube With Valve; Guidance for 
Industry and FDA.''

[67 FR 20894, Apr. 29, 2002]



Sec. 874.3880  Tympanostomy tube.

    (a) Identification. A tympanostomy tube is a device that is intended 
to be implanted for ventilation or drainage of the middle ear. The 
device is inserted through the tympanic membrane to permit a free 
exchange of air between the outer ear and middle ear. A type of 
tympanostomy tube known as the malleous clip tube attaches to the 
malleous to provide middle ear ventilation. The device is made of 
materials such as polytetrafluoroethylene, polyethylene, silicon 
elastomer, or porous polyethylene.
    (b) Classification. Class II.



Sec. 874.3900  Nasal dilator.

    (a) Identification. A nasal dilator is a device intended to provide 
temporary relief from transient causes of breathing difficulties 
resulting from structural abnormalities and/or transient causes of nasal 
congestion associated with reduced nasal airflow. The device decreases 
airway resistance and increases nasal airflow. The external nasal 
dilator is constructed from one or more layers of material upon which a 
spring material is attached, with a skin adhesive applied to adhere to 
the skin of the nose; it acts with a pulling action to open the nares. 
The internal nasal dilator is constructed from metal

[[Page 533]]

or plastic and is placed inside the nostrils; it acts by pushing the 
nostrils open or by gently pressing on the columella.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 874.9.

[64 FR 10949, Mar. 8, 1999]



Sec. 874.3930  Tympanostomy tube with semipermeable membrane.

    (a) Identification. A tympanostomy tube with a semipermeable 
membrane is a device intended to be implanted for ventilation or 
drainage of the middle ear and for preventing fluids from entering the 
middle ear cavity. The device is inserted through the tympanic membrane 
to permit a free exchange of air between the outer ear and middle ear. 
The tube portion of the device is made of silicone elastomer or porous 
polyethylene, and the membrane portion is made of 
polytetrafluoroethylene.
    (b) Classification. Class II. The special control for this device is 
FDA's ``Tympanostomy Tubes, Submission Guidance for a 510(k).''

[51 FR 40389, Nov. 6, 1986, as amended at 65 FR 17145, Mar. 31, 2000]



Sec. 874.3950  Transcutaneous air conduction hearing aid system.

    (a) Identification. A transcutaneous air conduction hearing aid 
system is a wearable sound-amplifying device intended to compensate for 
impaired hearing without occluding the ear canal. The device consists of 
an air conduction hearing aid attached to a surgically fitted tube 
system, which is placed through soft tissue between the post auricular 
region and the outer ear canal. A transcutaneous air conduction hearing 
aid system is subject to the requirements in Sec. 801.422 of this 
chapter.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's guidance document entitled ``Class II Special 
Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid 
System (TACHAS); Guidance for Industry and FDA.'' See Sec. 874.1 for 
the availability of this guidance document.

[67 FR 67790, Nov. 7, 2002, as amended at 87 FR 50762, Aug. 17, 2022]



                       Subpart E_Surgical Devices



Sec. 874.4100  Epistaxis balloon.

    (a) Identification. An epistaxis balloon is a device consisting of 
an inflatable balloon intended to control internal nasal bleeding by 
exerting pressure against the sphenopalatine artery.
    (b) Classification Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000]



Sec. 874.4140  Ear, nose, and throat bur.

    (a) Identification. An ear, nose, and throat bur is a device 
consisting of an interchangeable drill bit that is intended for use in 
an ear, nose, and throat electric or pneumatic surgical drill (Sec. 
874.4250) for incising or removing bone in the ear, nose, or throat 
area. The bur consists of a carbide cutting tip on a metal shank or a 
coating of diamond on a metal shank. The device is used in mastoid 
surgery, frontal sinus surgery, and surgery of the facial nerves.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1122, Jan. 16, 1996; 66 
FR 38800, July 25, 2001]



Sec. 874.4175  Nasopharyngeal catheter.

    (a) Identification. A nasopharyngeal catheter is a device consisting 
of a bougie or filiform catheter that is intended for use in probing or 
dilating the eustachian tube. This generic type of device includes 
eustachian catheters.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 534]]

subpart E of part 807 of this chapter subject to the limitations in 
Sec. 874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1122, Jan. 16, 1996; 66 
FR 38801, July 25, 2001]



Sec. 874.4180  Eustachian tube balloon dilation system.

    (a) Identification. A Eustachian tube balloon dilation system is a 
prescription device that includes a flexible catheter attached to an 
inflatable balloon. The system is intended for use in dilating the 
cartilaginous portion of the Eustachian tube for treating persistent 
Eustachian tube dysfunction.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be evaluated:
    (i) Mechanical testing, including tensile and flexural testing of 
catheter joints and materials.
    (ii) Durability testing, including fatigue and burst pressure 
testing of the balloon materials and components.
    (iii) Inflation and deflation characterization testing, including 
time and pressure measurements, and leak testing of the balloon.
    (iv) Verification testing of safety features built into the device 
must be performed, including the characterization of catheter geometries 
and distal tip insertion limitation mechanisms.
    (2) Simulated use testing in a clinically relevant model must 
demonstrate the reliability of the device to remain mechanically 
functional throughout the anticipated conditions of use, and validate 
that the design features limit access to only the cartilaginous portion 
of the Eustachian tube.
    (3) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (4) Performance data must demonstrate the sterility of the device.
    (5) Performance data must support shelf life by demonstrating 
continued sterility of the device, package integrity, and device 
functionality over the identified shelf life.
    (6) Training must include simulated use on cadavers to ensure users 
can follow the instructions for use to allow safe use of the device.
    (7) Labeling must include:
    (i) Detailed instructions for use.
    (ii) A detailed summary of the device technical parameters, 
including maximum allowed inflation pressure, allowable catheter 
geometries, and available balloon sizes.
    (iii) A shelf life.

[81 FR 73041, Oct. 24, 2016]



Sec. 874.4250  Ear, nose, and throat electric or pneumatic surgical drill.

    (a) Identification. An ear, nose, and throat electric or pneumatic 
surgical drill is a rotating drilling device, including the handpiece, 
that is intended to drive various accessories, such as an ear, nose, and 
throat bur (Sec. 874.4140), for the controlled incision or removal of 
bone in the ear, nose, and throat area.
    (b) Classification. Class II.



Sec. 874.4350  Ear, nose, and throat fiberoptic light source and carrier.

    (a) Identification. An ear, nose, and throat fiberoptic light source 
and carrier is an AC-powered device that generates and transmits light 
through glass of plastic fibers and that is intended to provide 
illumination at the tip of an ear, nose, or throat endoscope. Endoscopic 
devices which utilize fiberoptic light sources and carriers include the 
bronchoscope, esophagoscope, laryngoscope, mediastinoscope, laryngeal-
bronchial telescope, and nasopharyngoscope.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1122, Jan. 16, 1996; 66 
FR 38801, July 25, 2001]



Sec. 874.4420  Ear, nose, and throat manual surgical instrument.

    (a) Identification. An ear, nose, and throat manual surgical 
instrument is one of a variety of devices intended for use in surgical 
procedures to examine or treat the bronchus, esophagus, trachea, larynx, 
pharynx, nasal and paranasal sinus, or ear. This generic type of

[[Page 535]]

device includes the esophageal dilator; tracheal bistour (a long, narrow 
surgical knife); tracheal dilator; tracheal hook; laryngeal injection 
set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy 
tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; 
oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil 
screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom 
reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal 
rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus 
irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear 
scissor, ear snare; ear spoon; ear suction tube; malleous ripper; 
mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; 
ossici holding clamp; sacculotomy tack inserter; vein press; wire ear 
loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, 
nose and throat knife; and ear, nose, and throat trocar.
    (b) Classification Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 874.9.

[51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987; 65 
FR 2316, Jan. 14, 2000; 72 FR 17400, Apr. 9, 2007]



Sec. 874.4450  Powered insertion system for a cochlear implant electrode array.

    (a) Identification. A powered insertion system for a cochlear 
implant electrode array is a prescription device used to assist in 
placing an electrode array into the cochlea.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must demonstrate that the device 
performs as intended under anticipated conditions of use, including 
evaluation of all adverse events.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. Testing 
must include:
    (i) Verification of cochlear implant attachment force, release 
force, and insertion speed;
    (ii) Testing to demonstrate the device does not damage or degrade 
the cochlear implant (including the lead and array portions of the 
cochlear implant); and
    (iii) Comparison testing with manual insertion to evaluate:
    (A) Differences in cochlear implant array insertion force associated 
with use of the device; and
    (B) Intracochlear placement of the cochlear implant array (intended 
scala placement and array insertion depth, together with minimal array 
tip foldover and cochlear scala translocation).
    (3) Usability testing in a simulated hospital environment with an 
anatomically relevant model (e.g., cadaver testing) that evaluates the 
following:
    (i) Successful use to aid in placement of the electrode array into 
the cochlea; and
    (ii) Harms caused by use errors observed.
    (4) Changes in cochlear implant compatibility are determined to 
significantly affect the safety or effectiveness of the device and must 
be validated through performance testing or a rationale for omission of 
any testing.
    (5) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (6) Performance testing must demonstrate the electromagnetic 
compatibility, electrical safety, and thermal safety of the device.
    (7) The patient-contacting components of the device must be 
demonstrated to be sterile and non-pyrogenic.
    (8) Performance testing must support the shelf life of device 
components provided sterile by demonstrating continued sterility, 
package integrity, and device functionality over the labeled shelf life.
    (9) Software verification, validation, and hazard analysis must be 
performed for any software components of the device.
    (10) Labeling must include:
    (i) The recommended training for the safe use of the device;
    (ii) Summary of the relevant clinical and non-clinical testing 
pertinent to use of the device with compatible electrode arrays; and

[[Page 536]]

    (iii) A shelf life.

[88 FR 979, Jan. 6, 2023]



Sec. 874.4490  Argon laser for otology, rhinology, and laryngology.

    (a) Identification. The argon laser device for use in otology, 
rhinology, and laryngology is an electro-optical device which produces 
coherent, electromagnetic radiation with principal wavelength peaks of 
488 and 514 nanometers. In otology, the device is used for the purpose 
of coagulating and vaporizing soft and fibrous tissues, including 
osseous tissue. In rhinology and laryngology, the device is used to 
coagulate and vaporize soft and fibrous tissues, but not including 
osseous tissues.
    (b) Classification. Class II.

[58 FR 29534, May 21, 1993]



Sec. 874.4500  Ear, nose, and throat microsurgical carbon dioxide laser.

    (a) Identification. An ear, nose, and throat microsurgical carbon 
dioxide laser is a device intended for the surgical excision of tissue 
from the ear, nose, and throat area. The device is used, for example, in 
microsurgical procedures to excise lesions and tumors of the vocal cords 
and adjacent areas.
    (b) Classification. Class II.



Sec. 874.4680  Bronchoscope (flexible or rigid) and accessories.

    (a) Identification. A bronchoscope (flexible or rigid) and 
accessories is a tubular endoscopic device with any of a group of 
accessory devices which attach to the bronchoscope and is intended to 
examine or treat the larynx and tracheobronchial tree. It is typically 
used with a fiberoptic light source and carrier to provide illumination. 
The device is made of materials such as stainless steel or flexible 
plastic. This generic type of device includes the rigid ventilating 
bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, 
laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope 
tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy 
brush, rigid biopsy forceps, flexible biopsy curette, and rigid 
bronchoscope aspirating tube, but excludes the fiberoptic light source 
and carrier.
    (b) Classification. Class II.



Sec. 874.4710  Esophagoscope (flexible or rigid) and accessories.

    (a) Identification. An esophagoscope (flexible or rigid) and 
accessories is a tubular endoscopic device with any of a group of 
accessory devices which attach to the esophagoscope and is intended to 
examine or treat esophageal malfunction symptoms, esophageal or 
mediastinal disease, or to remove foreign bodies from the esophagus. 
When inserted, the device extends from the area of the hypopharynx to 
the stomach. It is typically used with a fiberoptic light source and 
carrier to provide illumination. The device is made of materials such as 
stainless steel or flexible plastic. This generic type of device 
includes the flexible foreign body claw, flexible biopsy forceps, rigid 
biopsy curette, flexible biopsy brush, rigid biopsy forceps and flexible 
biopsy curette, but excludes the fiberoptic light source and carrier.
    (b) Classification. Class II.



Sec. 874.4720  Mediastinoscope and accessories.

    (a) Identification. A mediastinoscope and accessories is a tubular 
tapered electrical endoscopic device with any of a group of accessory 
devices which attach to the mediastinoscope and is intended to examine 
or treat tissue in the area separating the lungs. The device is inserted 
transthoracicly and is used in diagnosis of tumors and lesions and to 
determine whether excision of certain organs or tissues is indicated. It 
is typically used with a fiberoptic light source and carrier to provide 
illumination. The device is made of materials such as stainless steel. 
This generic type of device includes the flexible foreign body claw, 
flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, 
rigid biopsy forceps, and flexible biopsy curette, but excludes the 
fiberoptic light source and carrier.
    (b) Classification. Class II.



Sec. 874.4750  Laryngostroboscope.

    (a) Identification. A laryngostroboscope is a device that is 
intended to allow observation of glottic

[[Page 537]]

action during phonation. The device operates by focusing a stroboscopic 
light through a lens for direct or mirror reflected viewing of glottic 
action. The light and microphone that amplifies acoustic signals from 
the glottic area may or may not contact the patient.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 874.9.

[55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994; 66 
FR 38801, July 25, 2001]



Sec. 874.4760  Nasopharyngoscope (flexible or rigid) and accessories.

    (a) Identification. A nasopharyngoscope (flexible or rigid) and 
accessories is a tubular endoscopic device with any of a group of 
accessory devices which attach to the nasopharyngoscope and is intended 
to examine or treat the nasal cavity and nasal pharynx. It is typically 
used with a fiberoptic light source and carrier to provide illumination. 
The device is made of materials such as stainless steel and flexible 
plastic. This generic type of device includes the antroscope, 
nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, 
rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy 
forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy 
forceps and flexible biopsy curette, but excludes the fiberoptic light 
source and carrier.
    (b) Classification. Class II.



Sec. 874.4770  Otoscope.

    (a) Identification. An otoscope is a device intended to allow 
inspection of the external ear canal and tympanic membrane under 
magnification. The device provides illumination of the ear canal for 
observation by using an AC- or battery-powered light source and an 
optical magnifying system.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 874.9 only when used in 
the external ear canal.

[55 FR 48440, Nov. 20, 1990, as amended at 61 FR 1122, Jan. 16, 1996; 66 
FR 38801, July 25, 2001]



Sec. 874.4780  Intranasal splint.

    (a) Identification. An intranasal splint is intended to minimize 
bleeding and edema and to prevent adhesions between the septum and the 
nasal cavity. It is placed in the nasal cavity after surgery or trauma. 
The intranasal splint is constructed from plastic, silicone, or 
absorbent material.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 874.9.

[64 FR 10949, Mar. 8, 1999]



Sec. 874.4800  Bone particle collector.

    (a) Identification. A bone particle collector is a filtering device 
intended to be inserted into a suction tube during the early stages of 
otologic surgery to collect bone particles for future use.
    (b) Classification. Class I (general controls). The device is exempt 
from premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 874.9.

[64 FR 10949, Mar. 8, 1999]



                      Subpart F_Therapeutic Devices



Sec. 874.5220  Ear, nose, and throat drug administration device.

    (a) Identification. An ear, nose, and throat drug administration 
device is one of a group of ear, nose, and throat devices intended 
specifically to administer medicinal substances to treat ear, nose, and 
throat disorders. These instruments include the powder blower, dropper, 
ear wick, manual nebulizer pump, and nasal inhaler.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 874.9. If the device is 
not labeled or otherwise represented as sterile, it is exempt from the 
current good manufacturing practice requirements of the quality system 
regulation in part 820 of this

[[Page 538]]

chapter, with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.

[51 FR 40389, Nov. 6, 1986, as amended at 59 FR 63009, Dec. 7, 1994; 66 
FR 38801, July 25, 2001]



Sec. 874.5300  Ear, nose, and throat examination and treatment unit.

    (a) Identification. An ear, nose, and throat examination and 
treatment unit is an AC-powered device intended to support a patient 
during an otologic examination while providing specialized features for 
examination and treatment. The unit consists of a patient chair and 
table, drawers for equipment, suction and blowing apparatus, and 
receptacles for connection of specialized lights and examining 
instruments.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 874.9.

[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2316, Jan. 14, 2000]



Sec. 874.5350  Suction antichoke device.

    (a) Identification. A suction antichoke device is a device intended 
to be used in an emergency situation to remove, by the application of 
suction, foreign objects that obstruct a patient's airway to prevent 
asphyxiation to the patient.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of PDP is required. A PMA or a 
notice of completion of a PDP for a device is required to be filed with 
the Food and Drug Administration on or before July 13, 1999 for any 
suction antichoke device that was in commercial distribution before May 
28, 1976, or that has, on or before July 13, 1999, been found to be 
substantially equivalent to a suction antichoke device that was in 
commercial distribution before May 28, 1976. Any other suction antichoke 
device shall have an approved PMA or declared completed PDP in effect 
before being placed in commercial distribution.

[51 FR 40389, Nov. 6, 1986, as amended at 64 FR 18329, Apr. 14, 1999; 65 
FR 2316, Jan. 14, 2000]



Sec. 874.5370  Tongs antichoke device.

    (a) Identification. A tongs antichoke device is a device that is 
intended to be used in an emergency situation to grasp and remove 
foreign objects that obstruct a patient's airway to prevent asphyxiation 
of the patient. This generic type of device includes a plastic 
instrument with serrated ends that is inserted into the airway in a 
blind manner to grasp and extract foreign objects, and a stainless steel 
forceps with spoon ends that is inserted under tactile guidance to grasp 
and extract foreign objects from the airway.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of PDP is required. A PMA or a 
notice of completion of a PDP for a device is required to be filed with 
the Food and Drug Administration on or before July 13, 1999 for any 
tongs antichoke device that was in commercial distribution before May 
28, 1976, or that has, on or before July 13, 1999, been found to be 
substantially equivalent to a tongs antichoke device that was in 
commercial distribution before May 28, 1976. Any other tongs antichoke 
device shall have an approved PMA or declared completed PDP in effect 
before being placed in commercial distribution.

[51 FR 40389, Nov. 6, 1986, as amended at 64 FR 18329, Apr. 14, 1999]



Sec. 874.5550  Powered nasal irrigator.

    (a) Identification. A powered nasal irrigator is an AC-powered 
device intended to wash the nasal cavity by means of a pressure-
controlled pulsating stream of water. The device consists of a control 
unit and pump connected to a spray tube and nozzle.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 874.9.

[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2316, Jan. 14, 2000]

[[Page 539]]



Sec. 874.5800  External nasal splint.

    (a) Identification. An external nasal splint is a rigid or partially 
rigid device intended for use externally for immobilization of parts of 
the nose.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 874.9.

[51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987; 59 
FR 63009, Dec. 7, 1994; 66 FR 38801, July 25, 2001]



Sec. 874.5840  Antistammering device.

    (a) Identification. An antistammering device is a device that 
electronically generates a noise when activated or when it senses the 
user's speech and that is intended to prevent the user from hearing the 
sounds of his or her own voice. The device is used to minimize a user's 
involuntary hesitative or repetitive speech.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000]



Sec. 874.5900  External upper esophageal sphincter compression device.

    (a) Identification. An external upper esophageal sphincter 
compression device is a prescription device used to apply external 
pressure on the cricoid cartilage for the purpose of reducing the 
symptoms of laryngopharyngeal reflux disease.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient contacting components must be demonstrated to be 
biocompatible.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be demonstrated:
    (i) Mechanical integrity testing (e.g., tensile strength testing, 
fatigue testing) and
    (ii) Shelf life testing.
    (3) The technical specifications must include pressure measurement 
accuracy to characterize device performance.
    (4) Clinical performance testing must document any adverse events 
observed during clinical use, and demonstrate that the device performs 
as intended under anticipated conditions of use.
    (5) Labeling must include the following:
    (i) Appropriate warnings and precautions,
    (ii) A detailed summary of the clinical testing pertinent to use of 
the device including a detailed summary of the device-related 
complications or adverse events,
    (iii) Detailed instructions on how to fit the device to the patient, 
and
    (iv) Instructions for reprocessing of any reusable components.
    (6) Patient labeling must be provided and must include:
    (i) Relevant warnings, precautions, and adverse effects/
complications,
    (ii) Information on how to correctly wear the device,
    (iii) The potential risks and benefits associated with the use of 
the device,
    (iv) Alternative treatments, and
    (v) Reprocessing instructions.

[80 FR 46194, Aug. 4, 2015]



PART 876_GASTROENTEROLOGY-UROLOGY DEVICES--Table of Contents



                      Subpart A_General Provisions

Sec.
876.1 Scope.
876.3 Effective dates of requirement for premarket approval.
876.9 Limitations of exemptions from section 510(k) of the Federal Food, 
          Drug, and Cosmetic Act (the act).

                      Subpart B_Diagnostic Devices

876.1050 Endoscopic transhepatic venous access needle.
876.1075 Gastroenterology-urology biopsy instrument.
876.1080 Gastroenterology-urology accessories to a biopsy instrument.
876.1300 Ingestible telemetric gastrointestinal capsule imaging system.
876.1310 Magnetically maneuvered capsule endoscopy system.
876.1330 Colon capsule endoscopy system.
876.1400 Stomach pH electrode.

[[Page 540]]

876.1450 Esophageal tissue characterization system.
876.1500 Endoscope and accessories.
876.1520 Gastrointestinal lesion software detection system.
876.1620 Urodynamics measurement system.
876.1725 Gastrointestinal motility monitoring system.
876.1735 Electrogastrography system.
876.1800 Urine flow or volume measuring system.

                      Subpart C_Monitoring Devices

876.2040 Enuresis alarm.
876.2050 Prostate lesion documentation system.
876.2100 Pressure ulcer management tool.

                      Subpart D_Prosthetic Devices

876.3350 Penile inflatable implant.
876.3500 Penile implant surgical accessories.
876.3630 Penile rigidity implant.
876.3750 Testicular prosthesis.

                       Subpart E_Surgical Devices

876.4020 Fiberoptic light ureteral catheter.
876.4270 Colostomy rod.
876.4300 Endoscopic electrosurgical unit and accessories.
876.4310 Endoscopic electrosurgical clip cutting system.
876.4340 High intensity ultrasound system for prostate tissue ablation.
876.4350 Fluid jet system for prostate tissue removal.
876.4370 Gastroenterology-urology evacuator.
876.4400 Hemorrhoidal ligator.
876.4480 Electrohydraulic lithotriptor.
876.4500 Mechanical lithotriptor.
876.4530 Gastroenterology-urology fiberoptic retractor.
876.4560 Ribdam.
876.4590 Interlocking urethral sound.
876.4620 Ureteral stent.
876.4630 Ureteral stent accessories.
876.4650 Water jet renal stone dislodger system.
876.4680 Ureteral stone dislodger.
876.4730 Manual gastroenterology-urology surgical instrument and 
          accessories.
876.4770 Urethrotome.
876.4890 Urological table and accessories.

                      Subpart F_Therapeutic Devices

876.5010 Biliary catheter and accessories.
876.5011 Metallic biliary stent system for benign strictures.
876.5012 Biliary stent, drain, and dilator accessories.
876.5015 Pancreatic drainage stent and delivery system.
876.5020 External penile rigidity devices.
876.5025 Vibrator for climax control of premature ejaculation.
876.5026 Non-implanted electrical stimulation device for management of 
          premature ejaculation.
876.5030 Continent ileostomy catheter.
876.5090 Suprapubic urological catheter and accessories.
876.5100 Suprapubic catheter accessories.
876.5130 Urological catheter and accessories.
876.5140 Urethral insert with pump for bladder drainage.
876.5160 Urological clamp.
876.5210 Enema kit.
876.5220 Colonic irrigation system.
876.5250 Urine collector and accessories.
876.5270 Implanted electrical urinary continence device.
876.5280 Implanted mechanical/hydraulic urinary continence device.
876.5290 Implanted mechanical/hydraulic urinary continence device 
          surgical accessories.
876.5310 Nonimplanted, peripheral electrical continence device.
876.5320 Nonimplanted electrical continence device.
876.5330 Transcutaneous electrical continence device.
876.5340 Nonimplanted nerve stimulator for functional abdominal pain 
          relief.
876.5365 Esophageal dilator.
876.5450 Rectal dilator.
876.5470 Ureteral dilator.
876.5520 Urethral dilator.
876.5530 Implantable transprostatic tissue retractor system.
876.5540 Blood access device and accessories.
876.5550 Prostatic artery embolization device.
876.5600 Sorbent regenerated dialysate delivery system for hemodialysis.
876.5630 Peritoneal dialysis system and accessories.
876.5665 Water purification system for hemodialysis.
876.5820 Hemodialysis system and accessories.
876.5830 Hemodialyzer with disposable insert (Kiil type).
876.5860 High permeability hemodialysis system.
876.5870 Sorbent hemoperfusion system.
876.5880 Isolated kidney perfusion and transport system and accessories.
876.5885 Tissue culture media for human ex vivo tissue and cell culture 
          processing applications.
876.5895 Ostomy irrigator.
876.5900 Ostomy pouch and accessories.
876.5920 Protective garment for incontinence.
876.5930 Rectal control system.
876.5955 Peritoneo-venous shunt.
876.5960 Computerized behavioral therapy device for treating symptoms of 
          gastrointestinal conditions.

[[Page 541]]

876.5970 Hernia support.
876.5980 Gastrointestinal tube and accessories.
876.5981 Oral removable palatal space occupying device for weight 
          management and/or weight loss.
876.5982 Ingested, transient, space occupying device for weight 
          management and/or weight loss.
876.5985 Enzyme packed cartridge.
876.5990 Extracorporeal shock wave lithotripter.

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    Source: 48 FR 53023, Nov. 23, 1983, unless otherwise noted.



                      Subpart A_General Provisions

    Editorial Note: Nomenclature changes to part 876 appear at 73 FR 
35341, June 23, 2008.



Sec. 876.1  Scope.

    (a) This part sets forth the classification of gastroenterology-
urology devices intended for human use that are in commercial 
distribution.
    (b) The identification of a device in a regulation in this part is 
not a precise description of every device that is, or will be, subject 
to the regulation. A manufacturer who submits a premarket notification 
submission for a device under part 807 may not show merely that the 
device is accurately described by the section title and identification 
provisions of a regulation in this part, but shall state why the device 
is substantially equivalent to other devices, as required by Sec. 
807.87.
    (c) To avoid duplicative listings, a gastroenterology-urology device 
that has two or more types of uses (e.g., used both as a diagnostic 
device and as a therapeutic device) is listed only in one subpart.
    (d) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.
    (e) Guidance documents referenced in this part are available on the 
Internet at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/default.htm..

[52 FR 17737, May 11, 1987; 52 FR 22577, June 12, 1987, as amended at 69 
FR 77623, Dec. 28, 2004; 78 FR 18233, Mar. 26, 2013]



Sec. 876.3  Effective dates of requirement for premarket approval.

    A device included in this part that is classified into class III 
(premarket approval) shall not be commercially distributed after the 
date shown in the regulation classifying the device unless the 
manufacturer has an approval under section 515 of the act (unless an 
exemption has been granted under section 520(g)(2) of the act). An 
approval under section 515 of the act consists of FDA's issuance of an 
order approving an application for premarket approval (PMA) for the 
device or declaring completed a product development protocol (PDP) for 
the device.
    (a) Before FDA requires that a device commercially distributed 
before the enactment date of the amendments, or a device that has been 
found substantially equivalent to such a device, has an approval under 
section 515 of the act FDA must promulgate a regulation under section 
515(b) of the act requiring such approval, except as provided in 
paragraph (b) of this section. Such a regulation under section 515(b) of 
the act shall not be effective during the grace period ending on the 
90th day after its promulgation or on the last day of the 30th full 
calendar month after the regulation that classifies the device into 
class III is effective, whichever is later. See section 501(f)2)(B) of 
the act. Accordingly, unless an effective date of the requirement for 
premarket approval is shown in the regulation for a device classified 
into class III in this part, the device may be commercially distributed 
without FDA's issuance of an order approving a PMA or declaring 
completed a PDP for the device. If FDA promulgates a regulation under 
section 515(b) of the act requiring premarket approval for a device, 
section 501(f)(1)(A) of the act applies to the device.
    (b) Any new, not substantially equivalent, device introduced into 
commercial distribution on or after May 28, 1976, including a device 
formerly marketed that has been substantially altered, is classified by 
statute (section 513(f) of the act) into class III without any grace 
period and FDA must have issued an order approving a PMA or declaring 
completed a PDP for the device

[[Page 542]]

before the device is commercially distributed unless it is reclassified. 
If FDA knows that a device being commercially distributed may be a 
``new'' device as defined in this section because of any new intended 
use or other reasons, FDA may codify the statutory classification of the 
device into class III for such new use. Accordingly, the regulation for 
such a class III device states that as of the enactment date of the 
amendments, May 28, 1976, the device must have an approval under section 
515 of the act before commercial distribution.

[52 FR 17737, May 11, 1987]



Sec. 876.9  Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).

    The exemption from the requirement of premarket notification 
(section 510(k) of the act) for a generic type of class I or II device 
is only to the extent that the device has existing or reasonably 
foreseeable characteristics of commercially distributed devices within 
that generic type or, in the case of in vitro diagnostic devices, only 
to the extent that misdiagnosis as a result of using the device would 
not be associated with high morbidity or mortality. Accordingly, 
manufacturers of any commercially distributed class I or II device for 
which FDA has granted an exemption from the requirement of premarket 
notification must still submit a premarket notification to FDA before 
introducing or delivering for introduction into interstate commerce for 
commercial distribution the device when:
    (a) The device is intended for a use different from the intended use 
of a legally marketed device in that generic type of device; e.g., the 
device is intended for a different medical purpose, or the device is 
intended for lay use where the former intended use was by health care 
professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro diagnostic 
device detects or identifies infectious agents by using deoxyribonucleic 
acid (DNA) probe or nucleic acid hybridization technology rather than 
culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of neoplastic 
diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial or acquired 
genetic disorders, including inborn errors of metabolism;
    (3) For measuring an analyte that serves as a surrogate marker for 
screening, diagnosis, or monitoring life-threatening diseases such as 
acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, 
tuberculosis, or myocardial infarction or to monitor therapy;
    (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) or IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is intended 
for use in matrices other than serum or plasma;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).

[65 FR 2316, Jan. 14, 2000]



                      Subpart B_Diagnostic Devices



Sec. 876.1050  Endoscopic transhepatic venous access needle.

    (a) Identification. An endoscopic transhepatic venous access needle 
is inserted through the liver into the patient's portal/hepatic venous 
system under endoscopic ultrasound guidance. It is connected to a 
separate device intended to measure a physiological parameter.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient-contacting components of the device must be 
demonstrated to be biocompatible.

[[Page 543]]

    (2) Performance data must demonstrate the sterility of the patient-
contacting components of the device.
    (3) The patient-contacting components of the device must be 
demonstrated to be non-pyrogenic.
    (4) Performance testing must support the shelf life of device 
components provided sterile by demonstrating continued sterility and 
package integrity over the labeled shelf life.
    (5) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following must be tested:
    (i) Needle crumple testing;
    (ii) Tensile testing;
    (iii) Dimensional verification for all components; and
    (iv) Simulated use testing.
    (6) Labeling must include the following:
    (i) Instructions for use, including specific instructions regarding 
device preparation;
    (ii) The recommended training for safe use of the device; and
    (iii) A shelf life for any sterile components.

[86 FR 71145, Dec. 15, 2021]



Sec. 876.1075  Gastroenterology-urology biopsy instrument.

    (a) Identification. A gastroenterology-urology biopsy instrument is 
a device used to remove, by cutting or aspiration, a specimen of tissue 
for microscopic examination. This generic type of device includes the 
biopsy punch, gastrointestinal mechanical biopsy instrument, suction 
biopsy instrument, gastro-urology biopsy needle and needle set, and 
nonelectric biopsy forceps. This section does not apply to biopsy 
instruments that have specialized uses in other medical specialty areas 
and that are covered by classification regulations in other parts of the 
device classification regulations.
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for the biopsy forceps cover and the non-electric biopsy 
forceps. The devices subject to this paragraph (b)(2) are exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 
FR 38801, July 25, 2001]



Sec. 876.1080  Gastroenterology-urology accessories to a biopsy instrument.

    (a) Identification. A gastroenterology-urology accessory to a biopsy 
instrument is an accessory used to remove a specimen of tissue for 
microscopic examination by cutting or aspiration. This generic type of 
device includes a syringe for specimen aspiration and a biopsy channel 
adaptor. This device does not include accessories to biopsy instruments 
used in other medical specialty areas.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 876.9.

[84 FR 14869, Apr. 12, 2019]



Sec. 876.1300  Ingestible telemetric gastrointestinal capsule imaging system.

    (a) Identification. An ingestible telemetric gastrointestinal 
capsule imaging system is used for visualization of the small bowel 
mucosa as an adjunctive tool in the detection of abnormalities of the 
small bowel. The device captures images of the small bowel with a 
wireless camera contained in a capsule. This device includes an 
ingestible capsule (containing a light source, camera, transmitter, and 
battery), an antenna array, a receiving/recording unit, a data storage 
device, computer software to process the images, and accessories.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance, ``Class II Special Controls Guidance Document: 
Ingestible Telemetric Gastrointestinal Capsule Imaging Systems; Final 
Guidance for Industry and FDA.''

[67 FR 3433, Jan. 24, 2002]



Sec. 876.1310  Magnetically maneuvered capsule endoscopy system.

    (a) Identification. A magnetically maneuvered capsule endoscopy 
system consists of an ingestible capsule and

[[Page 544]]

magnetic controller and is used for visualization of the stomach and 
duodenum. The ingestible capsule contains a camera that wirelessly 
captures images of the mucosa. The magnetic controller is used outside 
of the patient and is magnetically coupled with the capsule to control 
its location and viewing direction.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing with the device under anticipated 
conditions of use must evaluate visualization of the intended region and 
document the adverse event profile.
    (2) Non-clinical testing data must demonstrate the optical, 
mechanical, and functional integrity of the device under physically 
stressed conditions. The following performance characteristics must be 
tested, and detailed protocols must be provided for each test:
    (i) A bite test must be performed to ensure that the capsule can 
withstand extreme cases of biting;
    (ii) A pH resistance test must be performed to evaluate integrity of 
the capsule when exposed to a physiological relevant range of pH values;
    (iii) A battery life test must be performed to demonstrate that the 
capsule's operating time is not constrained by the battery capacity;
    (iv) A shelf life test must be performed to demonstrate that the 
device performs as intended at the proposed shelf life date;
    (v) Optical testing must be performed to evaluate fundamental image 
quality characteristics such as resolution, field of view, depth of 
field, geometric distortion, signal to noise ratio, dynamic range, and 
image intensity uniformity;
    (vi) A color performance test must be performed to compare the color 
differences between the input scene and output image;
    (vii) A photobiological safety analysis must be performed based on 
maximum (worst-case) light exposure to internal gastrointestinal mucosa, 
and covering ultraviolet, visible, and near-infrared ranges, as 
appropriate. A mitigation analysis must be provided;
    (viii) Performance testing must demonstrate that the viewing 
software clearly presents the current frame rate, which is either 
adjustable manually by the user or automatically by the device. Testing 
must demonstrate that the viewing software alerts the user when the 
video quality is reduced from nominal due to imaging data communication 
or computation problems;
    (ix) A data transmission test must be performed to verify the 
robustness of the data transmission between the capsule and the 
receiver. This test must include controlled signal attenuation for 
simulating a non-ideal environment; and
    (x) Magnetic field strength testing characterization must be 
performed to identify the distances from the magnet that are safe for 
patients and users with ferromagnetic implants, devices, or objects.
    (3) Software validation, verification, and hazard analysis must be 
provided.
    (4) Electrical safety, thermal safety, mechanical safety, and 
electromagnetic compatibility testing must be performed.
    (5) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (6) Performance data must validate the reprocessing instructions for 
the reusable components of the device.
    (7) Performance data must demonstrate the sterility of any device 
components labeled sterile.
    (8) Human factors testing must demonstrate that the intended users 
can safely and correctly use the device, based solely on reading the 
instructions for use.
    (9) Clinician labeling must include:
    (i) Specific instructions and the clinical and technical expertise 
needed for the safe use of the device;
    (ii) A detailed summary of the clinical testing pertinent to use of 
the device, including information on effectiveness and device- and 
procedure-related complications;
    (iii) The patient preparation procedure;
    (iv) A detailed summary of the device technical parameters;
    (v) Magnetic field safe zones;
    (vi) A screening checklist to ensure that all patients and operating 
staff

[[Page 545]]

are screened from bringing ferromagnetic implants, devices, or objects 
near the external magnet;
    (vii) Reprocessing instructions for reusable components;
    (viii) Shelf life for single use components; and
    (ix) Use life for reusable components.
    (10) Patient labeling must include:
    (i) An explanation of the device and the mechanism of operation;
    (ii) The patient preparation procedure;
    (iii) A brief summary of the clinical study; and
    (iv) A summary of the device- and procedure-related complications 
pertinent to use of the device.

[87 FR 26993, May 6, 2022]



Sec. 876.1330  Colon capsule endoscopy system.

    (a) Identification. A prescription, single-use ingestible capsule 
designed to acquire video images during natural propulsion through the 
digestive system. It is specifically designed to visualize the colon for 
the detection of polyps. It is intended for use only in patients who had 
an incomplete optical colonoscopy with adequate preparation, and a 
complete evaluation of the colon was not technically possible.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The capsule must be demonstrated to be biocompatible.
    (2) Non-clinical testing data must demonstrate the mechanical and 
functional integrity of the device under physically stressed conditions. 
The following performance characteristics must be tested and detailed 
protocols must be provided for each test:
    (i) Bite test to ensure that the capsule can withstand extreme cases 
of biting.
    (ii) pH resistance test to evaluate integrity of the capsule when 
exposed to a range of pH values.
    (iii) Battery life test to demonstrate that the capsule's operating 
time is not constrained by the battery capacity.
    (iv) Shelf-life testing to demonstrate that the device performs as 
intended at the proposed shelf-life date.
    (v) Optical testing to evaluate fundamental image quality 
characteristics such as resolution, field of view, depth of field, 
distortion, signal-to-noise ratio, uniformity, and image artifacts. A 
test must be performed to evaluate the potential of scratches, caused by 
travelling through the gastrointestinal tract, on the transparent window 
of the capsule and their impact on the optical and color performance.
    (vi) An optical safety analysis must be performed based on maximum 
(worst-case) light exposure to internal gastrointestinal mucosa, and 
covering ultraviolet, visible, and near-infrared ranges, as appropriate. 
A mitigation analysis must be provided.
    (vii) A color performance test must be provided to compare the color 
differences between the input scene and output image.
    (viii) The video viewer must clearly present the temporal or spatial 
relationship between any two frames as a real-time lapse or a travel 
distance. The video viewer must alert the user when the specific video 
interval is captured at a frame rate lower than the nominal one due to 
communication errors.
    (ix) A performance test evaluating the latency caused by any 
adaptive algorithm such as adjustable frame rate must be provided.
    (x) If the capsule includes a localization module, a localization 
performance test must be performed to verify the accuracy and precision 
of locating the capsule position within the colon.
    (xi) A data transmission test must be performed to verify the 
robustness of the data transmission between the capsule and the 
recorder. Controlled signal attenuation should be included for 
simulating a non-ideal environment.
    (xii) Software validation, verification, and hazards analysis must 
be provided.
    (xiii) Electrical equipment safety, including thermal and mechanical 
safety and electromagnetic compatibility (EMC) testing must be 
performed. If the environments of intended use include locations outside 
of hospitals and clinics, appropriate higher immunity test levels must 
be used. Labeling must include appropriate EMC information.
    (xiv) Information demonstrating immunity from wireless hazards.

[[Page 546]]

    (3) The clinical performance characteristics of the device for the 
detection of colon polyps must be established. Demonstration of the 
performance characteristics must include assessment of positive percent 
agreement and negative percent agreement compared to a clinically 
acceptable alternative structural imaging method.
    (4) Clinician labeling must include:
    (i) Specific instructions and the clinical and technical expertise 
needed for the safe use of the device.
    (ii) A detailed summary of the clinical testing pertinent to use of 
the device, including the percentage of patients in which a polyp was 
correctly identified by capsule endoscopy, but also the percent of 
patients in which the capsule either missed or falsely identified a 
polyp with respect to the clinically acceptable alternative structural 
imaging method.
    (iii) The colon cleansing procedure.
    (iv) A detailed summary of the device technical parameters.
    (v) A detailed summary of the device- and procedure-related 
complications pertinent to use of the device.
    (vi) An expiration date/shelf life.
    (5) Patient labeling must include:
    (i) An explanation of the device and the mechanism of operation.
    (ii) Patient preparation procedure.
    (iii) A brief summary of the clinical study. The summary should not 
only include the percentage of patients in which a polyp was correctly 
identified by capsule endoscopy, but also the percent of patients in 
which the capsule either missed or falsely identified a polyp with 
respect to the clinically acceptable alternative structural imaging 
method.
    (iv) A summary of the device- and procedure-related complications 
pertinent to use of the device.

[79 FR 28403, May 16, 2014]



Sec. 876.1400  Stomach pH electrode.

    (a) Identification. A stomach pH electrode is a device used to 
measure intragastric and intraesophageal pH (hydrogen ion 
concentration). The pH electrode is at the end of a flexible lead which 
may be inserted into the esophagus or stomach through the patient's 
mouth. The device may include an integral gastrointestinal tube.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996]



Sec. 876.1450  Esophageal tissue characterization system.

    (a) Identification. An esophageal tissue characterization system is 
a device intended for obtaining measurements of electrical properties 
within esophageal tissue.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) All patient contacting components of the device must be 
demonstrated to be biocompatible.
    (2) Performance testing must demonstrate the device can accurately 
measure the designated electrical characteristics.
    (3) Mechanical safety testing must demonstrate that the device will 
withstand forces encountered during use.
    (4) Software verification, validation, and hazard analysis must be 
performed.
    (5) Electromagnetic compatibility and electrical safety, mechanical 
safety, and thermal safety of the device must be performed.
    (6) Performance data must validate the reprocessing instructions for 
any reusable components of the device.
    (7) Labeling must include:
    (i) Specific instructions regarding the proper placement and use of 
the device;
    (ii) Instructions for reprocessing of any reusable components; and
    (iii) An expiration date for single use components.

[86 FR 68399, Dec. 2, 2021]



Sec. 876.1500  Endoscope and accessories.

    (a) Identification. An endoscope and accessories is a device used to 
provide access, illumination, and allow observation or manipulation of 
body cavities, hollow organs, and canals. The device consists of various 
rigid or flexible instruments that are inserted into body spaces and may 
include an optical system for conveying an image to the user's eye and 
their accessories may assist in gaining access or increase the

[[Page 547]]

versatility and augment the capabilities of the devices. Examples of 
devices that are within this generic type of device include cleaning 
accessories for endoscopes, photographic accessories for endoscopes, 
nonpowered anoscopes, binolcular attachments for endoscopes, pocket 
battery boxes, flexible or rigid choledochoscopes, colonoscopes, 
diagnostic cystoscopes, cystourethroscopes, enteroscopes, 
esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic 
illuminators for endoscopes, incandescent endoscope lamps, biliary 
pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, 
sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, 
cytology brushes for endoscopes, and lubricating jelly for transurethral 
surgical instruments. This section does not apply to endoscopes that 
have specialized uses in other medical specialty areas and that are 
covered by classification regulations in other parts of the device 
classification regulations.
    (b) Classification--(1) Class II (special controls). The device, 
when it is an endoscope disinfectant basin, which consists solely of a 
container that holds disinfectant and endoscopes and accessories; an 
endoscopic magnetic retriever intended for single use; sterile scissors 
for cystoscope intended for single use; a disposable, non-powered 
endoscopic grasping/cutting instrument intended for single use; a 
diagnostic incandescent light source; a fiberoptic photographic light 
source; a routine fiberoptic light source; an endoscopic sponge carrier; 
a xenon arc endoscope light source; an endoscope transformer; an LED 
light source; or a gastroenterology-urology endoscopic guidewire, is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 876.9.
    (2) Class I for the photographic accessories for endoscope, 
miscellaneous bulb adapter for endoscope, binocular attachment for 
endoscope, eyepiece attachment for prescription lens, teaching 
attachment, inflation bulb, measuring device for panendoscope, 
photographic equipment for physiologic function monitor, special lens 
instrument for endoscope, smoke removal tube, rechargeable battery box, 
pocket battery box, bite block for endoscope, and cleaning brush for 
endoscope. The devices subject to this paragraph (b)(2) are exempt from 
the premarket notification procedures in subpart E of part 807of this 
chapter, subject to the limitations in Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 
FR 38801, July 25, 2001; 83 FR 25914, June 5, 2018; 84 FR 71813, Dec. 
30, 2019]



Sec. 876.1520  Gastrointestinal lesion software detection system.

    (a) Identification. A gastrointestinal lesion software detection 
system is a computer-assisted detection device used in conjunction with 
endoscopy for the detection of abnormal lesions in the gastrointestinal 
tract. This device with advanced software algorithms brings attention to 
images to aid in the detection of lesions. The device may contain 
hardware to support interfacing with an endoscope.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must demonstrate that the device 
performs as intended under anticipated conditions of use, including 
detection of gastrointestinal lesions and evaluation of all adverse 
events.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. Testing 
must include:
    (i) Standalone algorithm performance testing;
    (ii) Pixel-level comparison of degradation of image quality due to 
the device;
    (iii) Assessment of video delay due to marker annotation; and
    (iv) Assessment of real-time endoscopic video delay due to the 
device.
    (3) Usability assessment must demonstrate that the intended user(s) 
can safely and correctly use the device.
    (4) Performance data must demonstrate electromagnetic compatibility 
and electrical safety, mechanical safety, and thermal safety testing for 
any hardware components of the device.

[[Page 548]]

    (5) Software verification, validation, and hazard analysis must be 
provided. Software description must include a detailed, technical 
description including the impact of any software and hardware on the 
device's functions, the associated capabilities and limitations of each 
part, the associated inputs and outputs, mapping of the software 
architecture, and a description of the video signal pipeline.
    (6) Labeling must include:
    (i) Instructions for use, including a detailed description of the 
device and compatibility information;
    (ii) Warnings to avoid overreliance on the device, that the device 
is not intended to be used for diagnosis or characterization of lesions, 
and that the device does not replace clinical decision making;
    (iii) A summary of the clinical performance testing conducted with 
the device, including detailed definitions of the study endpoints and 
statistical confidence intervals; and
    (iv) A summary of the standalone performance testing and associated 
statistical analysis.

[88 FR 10, Jan. 3, 2023]



Sec. 876.1620  Urodynamics measurement system.

    (a) Identification. A urodynamics measurement system is a device 
used to measure volume and pressure in the urinary bladder when it is 
filled through a catheter with carbon dioxide or water. The device 
controls the supply of carbon dioxide or water and may also record the 
electrical activity of the muscles associated with urination. The device 
system may include transducers, electronic signal conditioning and 
display equipment, a catheter withdrawal device to enable a urethral 
pressure profile to be obtained, and special catheters for urethral 
profilometry and electrodes for electromyography. This generic type of 
device includes the cystometric gas (carbon dioxide) device, the 
cystometric hydrualic device, and the electrical recording cystometer, 
but excludes any device that uses air to fill the bladder.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998]



Sec. 876.1725  Gastrointestinal motility monitoring system.

    (a) Identification. A gastrointestinal motility monitoring system is 
a device used to measure peristalic activity or pressure in the stomach 
or esophagus by means of a probe with transducers that is introduced 
through the mouth into the gastrointestinal tract. The device may 
include signal conditioning, amplifying, and recording equipment. This 
generic type of device includes the esophageal motility monitor and 
tube, the gastrointestinal motility (electrical) system, and certain 
accessories, such as a pressure transducer, amplifier, and external 
recorder.
    (b) Classification. Class II (performance standards).



Sec. 876.1735  Electrogastrography system.

    (a) Identification. An electrogastrography system (EGG) is a device 
used to measure gastric myoelectrical activity as an aid in the 
diagnosis of gastric motility disorders. The device system includes the 
external recorder, amplifier, skin electrodes, strip chart, cables, 
analytical software, and other accessories.
    (b) Classification. Class II (Special Controls). The special 
controls are as follows:
    (1) The sale, distribution and use of this device are restricted to 
prescription use in accordance with Sec. 801.109 of this chapter.
    (2) The labeling must include specific instructions:
    (i) To describe proper patient set-up prior to the start of the 
test, including the proper placement of electrodes;
    (ii) To describe how background data should be gathered and used to 
eliminate artifact in the data signal;
    (iii) To describe the test protocol (including the measurement of 
baseline data) that may be followed to obtain the EGG signal; and
    (iv) To explain how data results may be interpreted.
    (3) The device design should ensure that the EGG signal is 
distinguishable

[[Page 549]]

from background noise that may interfere with the true gastric 
myoelectric signal.
    (4) Data should be collected to demonstrate that the device has 
adequate precision and the EGG signal is reproducible and is 
interpretable.

[64 FR 51444, Sept. 23, 1999]



Sec. 876.1800  Urine flow or volume measuring system.

    (a) Identification. A urine flow or volume measuring system is a 
device that measures directly or indirectly the volume or flow of urine 
from a patient, either during the course of normal urination or while 
the patient is catheterized. The device may include a drip chamber to 
reduce the risk of retrograde bacterial contamination of the bladder and 
a transducer and electrical signal conditioning and display equipment. 
This generic type of device includes the electrical urinometer, 
mechanical urinometer, nonelectric urinometer, disposable nonelectric 
urine flow rate measuring device, and uroflowmeter.
    (b) Classification. (1) Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 63 
FR 59228, Nov. 3, 1998]



                      Subpart C_Monitoring Devices



Sec. 876.2040  Enuresis alarm.

    (a) Identification. An enuresis alarm is a device intended for use 
in treatment of bedwetting. Through an electrical trigger mechanism, the 
device sounds an alarm when a small quantity of urine is detected on a 
sensing pad. This generic type of device includes conditioned response 
enuresis alarms.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998]



Sec. 876.2050  Prostate lesion documentation system.

    (a) Identification. A prostate lesion documentation system is a 
prescription device intended for use in producing an image of the 
prostate as an aid in documenting prostate abnormalities previously 
identified during a digital rectal examination. The device uses pressure 
sensors and image reconstruction software to produce a prostate image 
that highlights regional differences in intraprostatic tissue elasticity 
or stiffness. The device is limited to use as a documentation tool and 
is not intended for diagnostic purposes or for influencing any clinical 
decisions.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical and clinical performance testing must demonstrate 
the accuracy and reproducibility of the constructed image.
    (2) Appropriate analysis/testing must validate electromagnetic 
compatibility, electrical safety, thermal safety, and mechanical safety.
    (3) Appropriate software verification, validation, and hazard 
analysis must be performed.
    (4) All elements of the device that may contact the patient must be 
demonstrated to be biocompatible.
    (5) Methods and instructions for reprocessing of any reusable 
components must be properly validated.
    (6) The labeling must include specific information needed to ensure 
proper use of the device.

[80 FR 72900, Nov. 23, 2015]



Sec. 876.2100  Pressure ulcer management tool.

    (a) Identification. A pressure ulcer management tool is a 
prescription device intended for patients at risk of developing pressure 
ulcers. The device provides output that supports a user's decision to 
increase intervention. The device is an adjunct tool for pressure ulcer 
management that is not intended for detection or diagnostic purposes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 550]]

subpart E of part 807 of this chapter, subject to the limitations in 
Sec. 876.9.

[86 FR 70735, Dec. 13, 2021]



                      Subpart D_Prosthetic Devices



Sec. 876.3350  Penile inflatable implant.

    (a) Identification. A penile inflatable implant is a device that 
consists of two inflatable cylinders implanted in the penis, connected 
to a reservoir filled with radiopaque fluid implanted in the abdomen, 
and a subcutaneous manual pump implanted in the scrotum. When the 
cylinders are inflated, they provide rigidity to the penis. This device 
is used in the treatment of erectile impotence.
    (b) Classification. Class III (premarket approval).
    (c) Date premarket approval application (PMA) or notice of 
completion of a product development protocol (PDP) is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before July 11, 2000, for any penile 
inflatable implant that was in commercial distribution before May 28, 
1976, or that has, on or before July 11, 2000, been found to be 
substantially equivalent to a penile inflatable implant that was in 
commercial distribution before May 28, 1976. Any other penile inflatable 
implant shall have an approved PMA or a declared completed PDP in effect 
before being placed in commercial distribution.

[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 65 
FR 19658, Apr. 12, 2000]



Sec. 876.3500  Penile implant surgical accessories.

    (a) Identification. Penile implant surgical accessories are manual 
devices designed to be used for surgical procedures associated with the 
implantation of a penile inflatable implant or penile rigidity implant. 
This generic type of device includes the cylinder sizer, cylinder 
insertion tool and needle, device placement tool, connector assembly 
tool, incision closing tool, corporeal dilator, tubing passer, 
measurement tool or tape, tubing plug, blunt needle, and hemostat shod 
tubing.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 876.9.

[84 FR 14869, Apr. 12, 2019]



Sec. 876.3630  Penile rigidity implant.

    (a) Identification. A penile rigidity implant is a device that 
consists of a pair of semi-rigid rods implanted in the corpora cavernosa 
of the penis to provide rigidity. It is intended to be used in men 
diagnosed as having erectile dysfunction.
    (b) Classification. Class II. The special control for this device is 
the FDA guidance entitled ``Guidance for the Content of Premarket 
Notifications for Penile Rigidity Implants.''

[65 FR 4882, Feb. 2, 2000]



Sec. 876.3750  Testicular prosthesis.

    (a) Identification. A testicular prosthesis is an implanted device 
that consists of a solid or gel-filled silicone rubber prosthesis that 
is implanted surgically to resemble a testicle.
    (b) Classification. Class III (premarket approval).
    (c) Date premarket approval application (PMA) or notice of product 
development protocol (PDP) is required. A PMA or notice of completion of 
a PDP is required to be filed with the Food and Drug Administration on 
or before July 5, 1995, for any testicular prosthesis that was in 
commercial distribution before May 28, 1976, or that has on or before 
July 5, 1995, been found to be substantially equivalent to a testicular 
prosthesis that was in commercial distribution before May 28, 1976. Any 
other testicular prosthesis shall have an approved PMA or a declared 
completed PDP in effect before being placed in commercial distribution.

[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 60 
FR 17216, Apr. 5, 1995]



                       Subpart E_Surgical Devices



Sec. 876.4020  Fiberoptic light ureteral catheter.

    (a) Identification. A fiberoptic light ureteral catheter is a device 
that consists of a fiberoptic bundle that emits

[[Page 551]]

light throughout its length and is shaped so that it can be inserted 
into the ureter to enable the path of the ureter to be seen during lower 
abdominal or pelvic surgery.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71813, Dec. 30, 2019]



Sec. 876.4270  Colostomy rod.

    (a) Identification. A colostomy rod is a device used during the loop 
colostomy procedure. A loop of colon is surgically brought out through 
the abdominal wall and the stiff colostomy rod is placed through the 
loop temporarily to keep the colon from slipping back through the 
surgical opening.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71813, Dec. 30, 2019]



Sec. 876.4300  Endoscopic electrosurgical unit and accessories.

    (a) Identification. An endoscopic electrosurgical unit and 
accessories is a device used to perform electrosurgical procedures 
through an endoscope. This generic type of device includes the 
electrosurgical generator, patient plate, electric biopsy forceps, 
electrode, flexible snare, electrosurgical alarm system, electrosurgical 
power supply unit, electrical clamp, self-opening rigid snare, flexible 
suction coagulator electrode, patient return wristlet, contact jelly, 
adaptor to the cord for transurethral surgical instruments, the electric 
cord for transurethral surgical instruments, and the transurethral 
desiccator.
    (b) Classification. Class II (performance standards).



Sec. 876.4310  Endoscopic electrosurgical clip cutting system.

    (a) Identification. An endoscopic electrosurgical clip cutting 
system is a prescription device that applies electrical energy to 
fragment metallic clips, which are devices placed in the digestive tract 
to close gastrointestinal perforations, hemorrhages, or perform 
resection. The system includes instruments that are then used to remove 
the fragmented clips from the digestive tract.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be tested:
    (i) Performance bench testing to evaluate the functionality 
(including stress, compatibility, usability, and reliability) of the 
device during use;
    (ii) Electrical and thermal safety testing; and
    (iii) Electromagnetic compatibility testing.
    (2) Animal testing must evaluate tissue damage, including thermal 
effects, during the clip removal procedure. This testing must also 
evaluate usability and effectiveness of the device.
    (3) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (4) Performance data must demonstrate the sterility of the device 
components intended to be provided sterile.
    (5) Performance data must support shelf life by demonstrating 
continued sterility of the device (or the sterile components), package 
integrity, and device functionality over the labeled shelf life.
    (6) Labeling of the device must include:
    (i) Instructions for use, and
    (ii) A shelf life for single use components.

[83 FR 27703, June 14, 2018]



Sec. 876.4340  High intensity ultrasound system for prostate tissue ablation.

    (a) Identification. A high intensity ultrasound system for prostate 
tissue ablation is a prescription device that transmits high intensity 
therapeutic ultrasound energy into the prostate to thermally ablate a 
defined, targeted volume of tissue, performed under imaging guidance. 
This classification

[[Page 552]]

does not include devices that are intended for the treatment of any 
specific prostate disease and does not include devices that are intended 
to ablate non-prostatic tissues/organs.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance data must demonstrate that the device 
performs as intended under anticipated conditions of use. The following 
performance characteristics must be tested:
    (i) Characterization of acoustic pressure and power output at 
clinically relevant levels;
    (ii) Measurement of targeting accuracy and reproducibility of high 
intensity ultrasound output;
    (iii) Ultrasound-induced heating verification testing at target and 
non-target tissues;
    (iv) Electrical safety testing; and
    (v) Electromagnetic compatibility testing.
    (2) Software verification, validation, and hazard analysis must be 
performed.
    (3) The elements of the device that may contact the patient's 
mucosal tissue must be demonstrated to be biocompatible.
    (4) Performance data must demonstrate the sterility of the device 
components that contact the patient's mucosal tissue.
    (5) Performance data must support shelf life by demonstrating 
continued sterility of the device or the sterile components, package 
integrity, and device functionality over the identified shelf life.
    (6) Performance data must support the instructions for reprocessing 
all reusable components.
    (7) In vivo testing must demonstrate that the device thermally 
ablates targeted tissue in a controlled manner without thermal injury to 
adjacent, non-target tissues.
    (8) Clinical testing must document the adverse event profile, 
provide evidence of prostatic ablation, and demonstrate that the device 
performs as intended under anticipated conditions of use.
    (9) Training must be provided so that upon completion of the 
training program, the physician can:
    (i) Use all safety features of the device;
    (ii) Accurately target the high intensity ultrasound energy within 
the desired region of the prostate; and
    (iii) Perform the ablation procedure in a manner that minimizes 
damage to non-target tissues.
    (10) Labeling must include:
    (i) A section that summarizes the clinical testing results, 
including the adverse event profile and evidence of prostate ablation 
achieved; and
    (ii) An expiration date or shelf life for single use components.

[82 FR 45727, Oct. 2, 2017]



Sec. 876.4350  Fluid jet system for prostate tissue removal.

    (a) Identification. A fluid jet system for prostate tissue removal 
is a prescription device intended for the resection and removal of 
prostatic tissue for the treatment of benign prostatic hyperplasia. The 
device cuts tissue by using a pressurized jet of fluid delivered to the 
prostatic urethra. The device is able to image the treatment area, or 
pairs with an imaging modality, to monitor treatment progress.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must evaluate the following:
    (i) All adverse events associated with the device, and
    (ii) Improvement in lower urinary tract symptoms (LUTS).
    (2) Physician training must be provided that includes:
    (i) Information on key aspects and use of the device, and
    (ii) Information on how to override or stop resection.
    (3) Animal testing must demonstrate that the device resects targeted 
tissue in a controlled manner without injury to adjacent non-target 
tissues.
    (4) Non-clinical performance data must demonstrate that the device 
performs as intended under anticipated conditions of use. The following 
performance characteristics must be tested:
    (i) Measurement of targeting accuracy and reproducibility of high 
velocity fluid jet, and

[[Page 553]]

    (ii) High pressure fluid jet verification testing at target and non-
target tissues.
    (5) Software verification, validation, and hazard analysis must be 
performed.
    (6) The patient-contacting elements of the device must be 
demonstrated to be biocompatible.
    (7) Performance data must demonstrate the electrical safety and 
electromagnetic compatibility of the device.
    (8) Performance data must demonstrate the sterility of the patient-
contacting components of the device.
    (9) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the identified shelf life.
    (10) Performance data must validate the instructions for 
reprocessing and reliability of reusable components.
    (11) Labeling must include the following:
    (i) A section that summarizes the clinical testing results, 
including the adverse event profile and improvement in LUTS;
    (ii) A shelf life for single use components;
    (iii) A use life for reusable components; and
    (iv) Reprocessing instructions for reusable components.

[83 FR 27897, June 15, 2018]



Sec. 876.4370  Gastroenterology-urology evacuator.

    (a) Identification. A gastroenterology-urology evacuator is a device 
used to remove debris and fluids during gastroenterological and 
urological procedures by drainage, aspiration, or irrigation. This 
generic type of device includes the fluid evacuator system, manually 
powered bladder evacuator, and the AC-powered vacuum pump.
    (b) Classification. (1) Class II (special controls) for the 
gastroenterology-urology evacuator when other than manually powered. The 
device is exempt from the premarket notification procedures in subpart E 
of part 807 of this chapter subject to Sec. 876.9.
    (2) Class I for the gastroenterology-urology evacuator when manually 
powered. The device subject to this paragraph (b)(2) is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

[48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25049, June 12, 1989; 
63 FR 59228, Nov. 3, 1998]



Sec. 876.4400  Hemorrhoidal ligator.

    (a) Identification. A hemorrhoidal ligator is a device used to cut 
off the blood flow to hemorrhoidal tissue by means of a ligature or band 
placed around the hemorrhoid.
    (b) Classification. Class II (special controls). Except for a 
hemostatic metal clip intended for use in the gastrointestinal tract, 
the device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71813, Dec. 30, 2019]



Sec. 876.4480  Electrohydraulic lithotriptor.

    (a) Identification. An electrohydraulic lithotriptor is an AC-
powered device used to fragment urinary bladder stones. It consists of a 
high voltage source connected by a cable to a bipolar electrode that is 
introduced into the urinary bladder through a cystoscope. The electrode 
is held against the stone in a water-filled bladder and repeated 
electrical discharges between the two poles of the electrode cause 
electrohydraulic shock waves which disintegrate the stone.
    (b) Classification. Class II. The special control for this device is 
FDA's ``Guidance for the Content of Premarket Notifications for 
Intracorporeal Lithotripters.''

[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 65 
FR 17145, Mar. 31, 2000]



Sec. 876.4500  Mechanical lithotriptor.

    (a) Identification. A mechanical lithotriptor is a device with steel 
jaws that is inserted into the urinary bladder through the urethra to 
grasp and crush bladder stones.
    (b) Classification. Class II (special controls). The device, when it 
is a biliary mechanical lithotripter, is exempt from the premarket 
notification procedures in subpart E of part 807 of this

[[Page 554]]

chapter subject to the limitations in Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71813, Dec. 30, 2019]



Sec. 876.4530  Gastroenterology-urology fiberoptic retractor.

    (a) Identification. A gastroenterology-urology fiberoptic retractor 
is a device that consists of a mechanical retractor with a fiberoptic 
light system that is used to illuminate deep surgical sites.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25049, June 12, 1989; 
66 FR 38801, July 25, 2001]



Sec. 876.4560  Ribdam.

    (a) Identification. A ribdam is a device that consists of a broad 
strip of latex with supporting ribs used to drain surgical wounds where 
copious urine drainage is expected.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25049, June 12, 1989; 
66 FR 38801, July 25, 2001]



Sec. 876.4590  Interlocking urethral sound.

    (a) Identification. An interlocking urethral sound is a device that 
consists of two metal sounds (elongated instruments for exploring or 
sounding body cavities) with interlocking ends, such as with male and 
female threads or a rounded point and mating socket, used in the repair 
of a ruptured urethra. The device may include a protective cap to fit 
over the metal threads.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 
FR 38801, July 25, 2001]



Sec. 876.4620  Ureteral stent.

    (a) Identification. A ureteral stent is a tube-like implanted device 
that is inserted into the ureter to provide ureteral rigidity and allow 
the passage of urine. The device may have finger-like protrusions or 
hooked ends to keep the tube in place. It is used in the treatment of 
ureteral injuries and ureteral obstruction.
    (b) Classification. Class II (performance standards).



Sec. 876.4630  Ureteral stent accessories.

    (a) Identification. Ureteral stent accessories aid in the insertion 
of the ureteral stent that is placed into the ureter to provide ureteral 
rigidity and allow the passage of urine. This generic type of device 
includes the stent positioner, wire guide, and pigtail straightener.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 876.9.

[84 FR 14870, Apr. 12, 2019]



Sec. 876.4650  Water jet renal stone dislodger system.

    (a) Identification. A water jet renal stone dislodger system is a 
device used to dislodge stones from renal calyces (recesses of the 
pelvis of the kidney) by means of a pressurized stream of water through 
a conduit. The device is used in the surgical removal of kidney stones.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998]



Sec. 876.4680  Ureteral stone dislodger.

    (a) Identification. A ureteral stone dislodger is a device that 
consists of a bougie or a catheter with an expandable wire basket near 
the tip, a special flexible tip, or other special construction. It is 
inserted through a cystoscope and used to entrap and remove stones from 
the ureter. This generic

[[Page 555]]

type of device includes the metal basket and the flexible ureteral stone 
dislodger.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998]



Sec. 876.4730  Manual gastroenterology-urology surgical instrument
and accessories.

    (a) Identification. A manual gastroenterology-urology surgical 
instrument and accessories is a device designed to be used for 
gastroenterological and urological surgical procedures. The device may 
be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-
urology surgical instruments include the biopsy forceps cover, biopsy 
tray without biopsy instruments, line clamp, nonpowered rectal probe, 
nonelectrical clamp, colostomy spur-crushers, locking device for 
intestinal clamp, needle holder, gastro-urology hook, gastro-urology 
probe and director, nonself-retaining retractor, laparotomy rings, 
nonelectrical snare, rectal specula, bladder neck spreader, self-
retaining retractor, and scoop. A manual surgical instrument that is 
intended specifically for use as an aid in the insertion, placement, 
fixation, or anchoring of surgical mesh during urogynecologic procedures 
are classified under Sec. 884.4910 of this chapter.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25049, June 12, 1989; 
66 FR 38801, July 25, 2001; 82 FR 12171, Mar. 1, 2017]



Sec. 876.4770  Urethrotome.

    (a) Identification. A urethrotome is a device that is inserted into 
the urethra and used to cut urethral strictures and enlarge the urethra. 
It is a metal instrument equipped with a dorsal-fin cutting blade which 
can be elevated from its sheath. Some urethrotomes incorporate an 
optical channel for visual control.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71813, Dec. 30, 2019]



Sec. 876.4890  Urological table and accessories.

    (a) Identification. A urological table and accessories is a device 
that consists of a table, stirrups, and belts used to support a patient 
in a suitable position for endoscopic procedures of the lower urinary 
tract. The table can be adjusted into position manually or electrically.
    (b) Classification. (1) Class II (special controls) for the 
electrically powered urological table and accessories. The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 876.9.
    (2) Class I for the manually powered table and accessories, and for 
stirrups for electrically powered table. The device subject to this 
paragraph (b)(2) is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 63 
FR 59228, Nov. 3, 1998; 66 FR 38801, July 25, 2001]



                      Subpart F_Therapeutic Devices



Sec. 876.5010  Biliary catheter and accessories.

    (a) Identification. A biliary catheter and accessories is a tubular 
flexible device used for temporary or prolonged drainage of the biliary 
tract, for splinting of the bile duct during healing, or for preventing 
stricture of the bile duct. This generic type of device may include a 
bile collecting bag that is attached to the biliary catheter by a 
connector and fastened to the patient with a strap.
    (b) Classification. Class II (special controls). The device, when it 
is a bile collecting bag or a surgical biliary catheter that does not 
include a balloon component, is exempt from the premarket notification 
procedures in

[[Page 556]]

subpart E of part 807 of this chapter subject to the limitations in 
Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71814, Dec. 30, 2019]



Sec. 876.5011  Metallic biliary stent system for benign strictures.

    (a) Identification. A metallic biliary stent system for benign 
strictures is a prescription device intended for the treatment of benign 
biliary strictures. The biliary stents are intended to be left 
indwelling for a limited amount of time and subsequently removed. The 
device consists of a metallic stent and a delivery system intended to 
place the biliary stent in the bile duct. This device type is not 
intended for use in the vasculature.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must demonstrate or provide the 
following:
    (i) The ability to safely place and subsequently remove the stent 
after the maximum labeled indwell period.
    (ii) All adverse event data including bile duct obstruction and 
trauma to the bile duct.
    (iii) The stent resolves strictures during the maximum labeled 
indwell period.
    (iv) Stricture resolution is maintained post-stent removal.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be demonstrated:
    (i) Corrosion testing to demonstrate that the stent maintains its 
integrity during indwell and does not release potentially toxic levels 
of leachables.
    (ii) Stent dimensional testing supports the intended use.
    (iii) Compression and expansion forces must be characterized.
    (iv) The delivery catheter must deliver the stent to the intended 
location and the stent must not be adversely impacted by the delivery 
catheter during deployment and catheter withdrawal.
    (v) The delivery system must withstand clinically anticipated 
forces.
    (vi) Compatibility in a magnetic resonance environment.
    (3) All patient contacting components of the device must be 
demonstrated to be biocompatible.
    (4) Performance data must demonstrate the sterility of the device 
components intended to be provided sterile.
    (5) Shelf life testing must demonstrate that the device maintains 
its performance characteristics and that packaging maintains sterility 
for the duration of the labeled shelf life.
    (6) Labeling for the device must include:
    (i) A detailed summary of the clinical testing including device 
effectiveness, and device- and procedure-related adverse events.
    (ii) Appropriate warning(s) to accurately ensure usage of the device 
for the intended patient population.
    (iii) Shelf life.
    (iv) Compatibility information for use in the magnetic resonance 
environment.
    (v) Stent foreshortening information supported by dimensional 
testing.

[81 FR 45231, July 13, 2016]



Sec. 876.5012  Biliary stent, drain, and dilator accessories.

    (a) Identification. Biliary stent, drain, and dilator accessories 
are manual devices that aid in the introduction and connection of 
biliary stents, drains, or dilators. This generic type of device 
includes the guiding catheter, pushing catheter, pigtail straightener, 
flap protector, nasal transfer tube, and drainage connecting tube.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 876.9.

[84 FR 14870, Apr. 12, 2019]



Sec. 876.5015  Pancreatic drainage stent and delivery system.

    (a) Identification. A pancreatic drainage stent is a prescription 
device that consists of a self-expanding, covered, metallic stent, 
intended for placement to facilitate transmural endoscopic drainage of 
pancreatic pseudocysts. This stent is intended to be removed

[[Page 557]]

upon confirmation of pseudocyst resolution. This device may also include 
a delivery system.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The device and elements of the delivery device that may contact 
the patient must be demonstrated to be biocompatible.
    (2) Performance data must demonstrate the sterility of patient-
contacting components of the device.
    (3) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the requested shelf life.
    (4) Non-clinical testing data must demonstrate that the stent and 
delivery system perform as intended under anticipated conditions of use. 
The following performance characteristics must be tested:
    (i) Deployment testing of the stent and delivery system must be 
conducted under simulated use conditions.
    (ii) Removal force testing must be conducted. The removal force 
testing must demonstrate that the stent can be safely removed, and that 
the stent will remain in place when subjected to forces encountered 
during use.
    (iii) Expansion force testing must be conducted. The expansion force 
must demonstrate that the forces exerted by the stent will not damage 
the tissue surrounding the stent.
    (iv) Compression force testing must be conducted. The compression 
force must demonstrate that the stent will withstand the forces 
encountered during use.
    (v) Dimensional verification testing must be conducted.
    (vi) Tensile testing of joints and materials must be conducted. The 
minimum acceptance criteria must be adequate for its intended use.
    (vii) Fatigue testing must be conducted. Material strength must 
demonstrate that the stent will withstand forces encountered during use.
    (viii) Corrosion testing must be conducted. Corrosion resistance 
must demonstrate that the stent will withstand conditions encountered 
during use.
    (5) Non-clinical testing must evaluate the compatibility of the 
stent in a magnetic resonance (MR) environment.
    (6) Well-documented clinical experience must demonstrate safe and 
effective use, and capture any adverse events observed during clinical 
use.
    (7) Labeling must include the following:
    (i) Appropriate instructions, warnings, cautions, limitations, and 
information related to the safe use of the device, including deployment 
of the device, maintenance of the drainage lumen, and removal of the 
device.
    (ii) A warning that the safety and patency of the stent has not been 
established beyond the duration of the documented clinical experience.
    (iii) Specific instructions and the qualifications and clinical 
training needed for the safe use of the device, including deployment of 
the device, maintenance of the drainage lumen, and removal of the 
device.
    (iv) Information on the patient population for which the device has 
been demonstrated to be effective.
    (v) A detailed summary of the clinical experience pertinent to use 
of the device.
    (vi) A detailed summary of the device technical parameters.
    (vii) A detailed summary of the device- and procedure-related 
complications pertinent to use of the device.
    (viii) An expiration date/shelf life.

[79 FR 30724, May 29, 2014]



Sec. 876.5020  External penile rigidity devices.

    (a) Identification. External penile rigidity devices are devices 
intended to create or maintain sufficient penile rigidity for sexual 
intercourse. External penile rigidity devices include vacuum pumps, 
constriction rings, and penile splints which are mechanical, powered, or 
pneumatic devices.
    (b) Classification. Class II (special controls). The devices are 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 876.9. The 
special control for these devices is the FDA guidance document entitled 
``Class II Special Controls Guidance Document: External Penile Rigidity

[[Page 558]]

Devices.'' See Sec. 876.1(e) for the availability of this guidance 
document.

[69 FR 77623, Dec. 28, 2004]



Sec. 876.5025  Vibrator for climax control of premature ejaculation.

    (a) Identification. A vibrator for climax control of premature 
ejaculation is used for males who suffer from premature ejaculation. It 
is designed to increase the time between arousal and ejaculation using 
the stimulating vibratory effects of the device on the penis.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 876.9. The 
special controls for this device are:
    (1) The labeling must include specific instructions regarding the 
proper placement and use of the device.
    (2) The portions of the device that contact the patient must be 
demonstrated to be biocompatible.
    (3) Appropriate analysis/testing must demonstrate electromagnetic 
compatibility safety, electrical safety, and thermal safety of the 
device.
    (4) Mechanical safety testing must demonstrate that the device will 
withstand forces encountered during use.

[80 FR 30355, May 28, 2015, as amended at 84 FR 71814, Dec. 30, 2019]



Sec. 876.5026  Non-implanted electrical stimulation device for
management of premature ejaculation.

    (a) Identification. A non-implanted electrical stimulation device 
for management of premature ejaculation is intended to be used in 
patients with premature ejaculation by delivery of electrical 
stimulation to the perineal muscles and nerves.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The device must be demonstrated to be biocompatible.
    (2) Performance testing must demonstrate the electromagnetic 
compatibility, electrical safety, and thermal safety of the device.
    (3) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be tested:
    (i) Mechanical performance;
    (ii) Electrical stimulation parameters; and
    (iii) Battery performance.
    (4) Performance testing must support shelf life by demonstrating 
continued device functionality over the identified shelf life.
    (5) Software verification, validation, and hazard analysis must be 
performed.
    (6) Labeling must include:
    (i) Specific instructions regarding safe placement and correct use 
of the device;
    (ii) Warning(s) against use by patients with active implanted 
medical devices; and
    (iii) A shelf life.

[87 FR 34166, Apr. 5, 2022]



Sec. 876.5030  Continent ileostomy catheter.

    (a) Identification. A continent ileostomy catheter is a flexible 
tubular device used as a form during surgery for continent ileostomy and 
it provides drainage after surgery. Additionally, the device may be 
inserted periodically by the patient for routine care to empty the ileal 
pouch. This generic type of device includes the rectal catheter for 
continent ileostomy.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25050, June 12, 1989; 
66 FR 38801, July 25, 2001]



Sec. 876.5090  Suprapubic urological catheter and accessories.

    (a) Identification. A suprapubic urological catheter and accessories 
is a flexible tubular device that is inserted through the abdominal wall 
into the urinary bladder with the aid of a trocar and cannula. The 
device is used to pass fluids to and from the urinary tract. This 
generic type of device includes the suprapubic catheter and tube, 
Malecot catheter, catheter punch instrument, suprapubic drainage tube, 
and the suprapubic cannula and trocar.
    (b) Classification. (1) Class II (performance standards).

[[Page 559]]

    (2) Class I for the catheter punch instrument, nondisposable cannula 
and trocar, and gastro-urological trocar. The devices subject to this 
paragraph (b)(2) are exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter subject to the limitations in 
Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 
FR 38801, July 25, 2001]



Sec. 876.5100  Suprapubic catheter accessories.

    (a) Identification. Suprapubic catheter accessories are manual 
devices that are used to facilitate the placement of a suprapubic 
catheter. This generic type of device includes the introducer, access 
dilator, and peel-away sheath.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 876.9.

[84 FR 14870, Apr. 12, 2019]



Sec. 876.5130  Urological catheter and accessories.

    (a) Identification. A urological catheter and accessories is a 
flexible tubular device that is inserted through the urethra and used to 
pass fluids to or from the urinary tract. This generic type of device 
includes radiopaque urological catheters, ureteral catheters, urethral 
catheters, coud[eacute] catheters, balloon retention type catheters, 
straight catheters, upper urinary tract catheters, double lumen female 
urethrographic catheters, disposable ureteral catheters, male 
urethrographic catheters, and urological catheter accessories including 
ureteral catheter stylets, ureteral catheter adapters, ureteral catheter 
holders, ureteral catheter stylets, ureteral catheterization trays, and 
the gastro-urological irrigation tray (for urological use).
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for the ureteral stylet (guidewire), stylet for 
gastrourological catheter, ureteral catheter adapter, ureteral catheter 
connector, and ureteral catheter holder. The devices subject to this 
paragraph (b)(2) are exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter subject to the limitations in 
Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 
FR 38801, July 25, 2001]



Sec. 876.5140  Urethral insert with pump for bladder drainage.

    (a) Identification. A urethral insert with pump for bladder drainage 
is a catheter-like device with internal pump mechanism that is placed in 
the urethra. Under patient control the internal pump draws urine out of 
the bladder when voiding is desired, and blocks urine flow when 
continence is desired. The device is intended for use by women who 
cannot empty their bladder due to impaired detrusor contractility.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The elements of the device that may contact the urinary tract 
must be demonstrated to be biocompatible.
    (2) Performance data must demonstrate the sterility of the device 
components that contact the urinary tract.
    (3) Performance data must support shelf life by demonstrating 
continued sterility of the device (or the sterile components), package 
integrity, and device functionality over the requested shelf life.
    (4) Non-clinical testing data must demonstrate that the device 
performs as intended under anticipated conditions of use. The following 
performance characteristics must be tested:
    (i) Urine flow rate testing.
    (ii) Valve integrity testing.
    (iii) Bladder neck retention force testing.
    (iv) Pump/valve endurance testing.
    (v) Encrustation testing.
    (vi) Remote control reliability, mechanical integrity, and battery 
life testing.
    (5) Clinical testing must demonstrate safe and effective use, 
document the device acceptance rate and the adverse event profile 
associated with clinical use, and demonstrate that the device performs 
as intended under anticipated conditions of use.
    (6) Labeling must include:

[[Page 560]]

    (i) Specific instructions, contraindications, warnings, cautions, 
limitations, and the clinical training needed for the safe use of the 
device.
    (ii) Statement of the maximum insert indwelling period.
    (iii) Information on the patient education and support program prior 
to and during initial device use.
    (iv) Information on the patient population for which the device has 
been demonstrated to be safe and effective.
    (v) Information on how the device operates and the recommended 
treatment regimen.
    (vi) A detailed summary of the device- and procedure-related 
complications or adverse events pertinent to use of the device.
    (vii) An expiration date/shelf life.
    (7) Patient labeling must be provided and must include:
    (i) Relevant contraindications, warnings, precautions, and adverse 
events/complications.
    (ii) Information on how the device operates and the recommended 
treatment regimen.
    (iii) Information on the patient education and support program prior 
to and during initial device use.
    (iv) Information on the patient population for which there is 
clinical evidence of safety and effectiveness.
    (v) The potential risks and benefits associated with the use of the 
device.
    (vi) Post-insertion care instructions.
    (vii) Alternative treatments.

[80 FR 18309, Apr. 6, 2015]



Sec. 876.5160  Urological clamp.

    (a) Identification. A urological clamp for males is a device used to 
close the urethra of a male to control urinary incontinence or to hold 
anesthetic or radiography contrast media in the urethra temporarily. It 
is an external clamp.
    (b) Classification. Class I (general controls). Except when intended 
for internal use, the device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec. 876.9.

[48 FR 53023, Nov. 23, 1963, as amended at 65 FR 2317, Jan. 14, 2000; 84 
FR 71814, Dec. 30, 2019]



Sec. 876.5210  Enema kit.

    (a) Identification. An enema kit is a device intended to instill 
water or other fluids into the colon through a nozzle inserted into the 
rectum to promote evacuation of the contents of the lower colon. The 
device consists of a container for fluid connected to the nozzle either 
directly or via tubing. This device does not include the colonic 
irrigation system (Sec. 876.5220).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 876.9. The device is exempt from the 
current good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180 of this chapter, with respect to general requirements concerning 
records, and Sec. 820.198 of this chapter, with respect to complaint 
files.

[48 FR 53023, Nov. 23, 1963, as amended at 65 FR 2317, Jan. 14, 2000]



Sec. 876.5220  Colonic irrigation system.

    (a) Identification. A colonic irrigation system is a device intended 
to instill water into the colon through a nozzle inserted into the 
rectum to cleanse (evacuate) the contents of the lower colon. The system 
is designed to allow evacuation of the contents of the colon during the 
administration of the colonic irrigation. The device consists of a 
container for fluid connected to the nozzle via tubing and includes a 
system which enables the pressure, temperature, or flow of water through 
the nozzle to be controlled. The device may include a console-type 
toilet and necessary fittings to allow the device to be connected to 
water and sewer pipes. The device may use electrical power to heat the 
water. The device does not include the enema kit (Sec. 876.5210).
    (b) Classification. (1) Class II (performance standards) when the 
device is intended for colon cleansing when medically indicated, such as 
before radiological or endoscopic examinations.
    (2) Class III (premarket approval) when the device is intended for 
other uses, including colon cleansing routinely for general well being.

[[Page 561]]

    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any colonic 
irrigation system described in paragraph (b)(2) of this section that was 
in commercial distribution before May 28, 1976, or that has, on or 
before December 26, 1996 been found to be substantially equivalent to a 
colonic irrigation system described in paragraph (b)(2) of this section 
that was in commercial distribution before May 28, 1976. Any other 
colonic irrigation system shall have an approved PMA in effect before 
being placed in commercial distribution.

[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 61 
FR 50707, Sept. 27, 1996]



Sec. 876.5250  Urine collector and accessories.

    (a) Identification. A urine collector and accessories is a device 
intended to collect urine. The device and accessories consist of tubing, 
a suitable receptacle, connectors, mechanical supports, and may include 
a means to prevent the backflow of urine or ascent of infection. The two 
kinds of urine collectors are:
    (1) A urine collector and accessories intended to be connected to an 
indwelling catheter, which includes the urinary drainage collection kit 
and the closed urine drainage system and drainage bag; and
    (2) A urine collector and accessories not intended to be connected 
to an indwelling catheter, which includes the corrugated rubber sheath, 
pediatric urine collector, leg bag for external use, urosheath type 
incontinence device, and the paste-on device for incontinence.
    (b) Classification--(1) Class II (special controls) for a urine 
collector and accessories intended to be connected to an indwelling 
catheter. The device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to Sec. 
876.9.
    (2) Class I (general controls). For a urine collector and 
accessories not intended to be connected to an indwelling catheter, the 
device is exempt from the premarket notification procedures in subpart E 
of part 807 of this chapter subject to the limitations in Sec. 876.9. 
If the device is not labeled or otherwise represented as sterile, it is 
exempt from the current good manufacturing practice requirements of the 
quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998; 65 
FR 2317, Jan. 14, 2000; 66 FR 38802, July 25, 2001; 73 FR 34860, June 
19, 2008]



Sec. 876.5270  Implanted electrical urinary continence device.

    (a) Identification. An implanted electrical urinary device is a 
device intended for treatment of urinary incontinence that consists of a 
receiver implanted in the abdomen with electrodes for pulsed-stimulation 
that are implanted either in the bladder wall or in the pelvic floor, 
and a battery-powered transmitter outside the body.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any implanted 
electrical urinary continence device that was in commercial distribution 
before May 28, 1976, or that has, on or before December 26, 1996 been 
found to be substantially equivalent to an implanted electrical urinary 
continence device that was in commercial distribution before May 28, 
1976. Any other implanted electrical urinary continence device shall 
have an approved PMA or a declared completed PDP in effect before being 
placed in commercial distribution.

[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 61 
FR 50707, Sept. 27, 1996]



Sec. 876.5280  Implanted mechanical/hydraulic urinary continence device.

    (a) Identification. An implanted mechanical/hydraulic urinary 
continence device is a device used to treat urinary

[[Page 562]]

incontinence by the application of continuous or intermittent pressure 
to occlude the urethra. The totally implanted device may consist of a 
static pressure pad, or a system with a container of radiopaque fluid in 
the abdomen and a manual pump and valve under the skin surface that is 
connected by tubing to an adjustable pressure pad or to a cuff around 
the urethra. The fluid is pumped as needed from the container to inflate 
the pad or cuff to pass on the urethra.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 2000, for any 
implanted mechanical/hydraulic urinary continence device that was in 
commercial distribution before May 28, 1976, or that has, on or before 
December 26, 2000, been found to be substantially equivalent to an 
implanted mechanical/hydraulic urinary continence device that was in 
commercial distribution before May 28, 1976. Any other implanted 
mechanical/hydraulic urinary continence device shall have an approved 
PMA or a declared completed PDP in effect before being placed in 
commercial distribution.

[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 65 
FR 57731, Sept. 26, 2000]



Sec. 876.5290  Implanted mechanical/hydraulic urinary continence 
device surgical accessories.

    (a) Identification. Implanted mechanical/hydraulic urinary 
continence device surgical accessories are manual devices designed to be 
used for surgical procedures associated with the implantation of an 
implanted mechanical/hydraulic urinary continence device. This generic 
type of device includes the measurement tool or tape, connector assembly 
tool, tubing plug, incision closing tool, tubing passer, blunt needle, 
and hemostat shod tubing.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 876.9.

[84 FR 14870, Apr. 12, 2019]



Sec. 876.5310  Nonimplanted, peripheral electrical continence device.

    (a) Identification. A nonimplanted, peripheral electrical continence 
device is a device that consists of an electrode that is connected by an 
electrical cable to a battery-powered pulse source. The electrode is 
placed onto or inserted into the body at a peripheral location and used 
to stimulate the nerves associated with pelvic floor function to 
maintain urinary continence. When necessary, the electrode may be 
removed by the user.
    (b) Classification. Class II, subject to the following special 
controls:
    (1) That sale, distribution, and use of this device are restricted 
to prescription use in accordance with Sec. 801.109 of this chapter.
    (2) That the labeling must bear all information required for the 
safe and effective use of the device as outlined in Sec. 801.109(c) of 
this chapter, including a detailed summary of the clinical information 
upon which the instructions are based.

[65 FR 18237, Apr. 7, 2000]



Sec. 876.5320  Nonimplanted electrical continence device.

    (a) Identification. A nonimplanted electrical continence device is a 
device that consists of a pair of electrodes on a plug or a pessary that 
are connected by an electrical cable to a battery-powered pulse source. 
The plug or pessary is inserted into the rectum or into the vagina and 
used to stimulate the muscles of the pelvic floor to maintain urinary or 
fecal continence. When necessary, the plug or pessary may be removed by 
the user. This device excludes an AC-powered nonimplanted electrical 
continence device and the powered vaginal muscle stimulator for 
therapeutic use (Sec. 884.5940).
    (b) Classification. Class II (performance standards).



Sec. 876.5330  Transcutaneous electrical continence device.

    (a) Identification. A transcutaneous electrical continence device 
consists of cutaneous electrodes that are used to apply external 
stimulation to reduce urinary incontinence.

[[Page 563]]

    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance testing must characterize the 
electrical stimulation, including the following: Waveforms, output 
modes, maximum output voltage, maximum output current, pulse duration, 
frequency, net charge per pulse, maximum phase charge at 500 ohms, 
maximum current density, maximum average current, and maximum average 
power density.
    (2) The patient-contacting materials must be demonstrated to be 
biocompatible.
    (3) Performance data must demonstrate the electromagnetic 
compatibility (EMC), electrical safety, thermal safety, and mechanical 
safety of the device.
    (4) Software verification, validation, and hazard analysis must be 
performed.
    (5) Labeling must include the following:
    (i) Instructions for use, including specific instructions regarding 
the proper placement of electrodes;
    (ii) A summary of electrical stimulation parameters; and
    (iii) Cleaning instructions and reuse information.

[86 FR 73971, Dec. 29, 2021]



Sec. 876.5340  Nonimplanted nerve stimulator for functional abdominal pain relief.

    (a) Identification. A nonimplanted nerve stimulator for functional 
abdominal pain relief is a device that stimulates nerves remotely from 
the source of pain with the intent to relieve functional abdominal pain. 
This generic type of device does not include devices designed to relieve 
pelvic pain.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (2) Electromagnetic compatibility and electrical, mechanical, and 
thermal safety testing must be performed.
    (3) Electrical performance testing of the device and electrodes must 
be conducted to validate the specified electrical output and duration of 
stimulation of the device.
    (4) Software verification, validation, and hazard analysis must be 
performed.
    (5) Sterility testing of the percutaneous components of the device 
must be performed.
    (6) Shelf life testing must be performed to demonstrate continued 
sterility, package integrity, and device functionality over the labeled 
shelf life.
    (7) Labeling must include the following:
    (i) A detailed summary of the device technical parameters;
    (ii) A warning stating that the device is only for use on clean, 
intact skin;
    (iii) Instructions for use, including placement of the device on the 
patient; and
    (iv) A shelf life.

[86 FR 71143, Dec. 15, 2021]



Sec. 876.5365  Esophageal dilator.

    (a) Identification. An esophageal dilator is a device that consists 
of a cylindrical instrument that may be hollow and weighted with mercury 
or a metal olive-shaped weight that slides on a guide, such as a string 
or wire and is used to dilate a stricture of the esophagus. This generic 
type of device includes esophageal or gastrointestinal bougies and the 
esophageal dilator (metal olive).
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71814, Dec. 30, 2019]



Sec. 876.5450  Rectal dilator.

    (a) Identification. A rectal dilator is a device designed to dilate 
the anal sphincter and canal when the size of the anal opening may 
interfere with its function or the passage of an examining instrument.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 
FR 38802, July 25, 2001]

[[Page 564]]



Sec. 876.5470  Ureteral dilator.

    (a) Identification. A ureteral dilator is a device that consists of 
a specially shaped catheter or bougie and is used to dilate the ureter 
at the place where a stone has become lodged or to dilate a ureteral 
stricture.
    (b) Classification. Class II (performance standards).



Sec. 876.5520  Urethral dilator.

    (a) Identification. A urethral dilator is a device that consists of 
a slender hollow or solid instrument made of metal, plastic, or other 
suitable material in a cylindrical form and in a range of sizes and 
flexibilities. The device may include a mechanism to expand the portion 
of the device in the urethra and indicate the degree of expansion on a 
dial. It is used to dilate the urethra. This generic type of device 
includes the mechanical urethral dilator, urological bougies, metal or 
plastic urethral sound, urethrometer, filiform, and filiform follower.
    (b) Classification. (1) Class II (special controls). Except when it 
is a mechanical urethral dilator, the device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 876.9.
    (2) Class I for the urethrometer, urological bougie, filiform and 
filiform follower, and metal or plastic urethral sound. The devices 
subject to this paragraph (b)(2) are exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 
FR 38802, July 25, 2001; 84 FR 71814, Dec. 30, 2019]



Sec. 876.5530  Implantable transprostatic tissue retractor system.

    (a) Identification. An implantable transprostatic tissue retractor 
system is a prescription use device that consists of a delivery device 
and implant. The delivery device is inserted transurethrally and deploys 
the implant through the prostate. It is designed to increase prostatic 
urethral patency by providing prostate lobe tissue retraction while 
preserving the potential for future prostate procedures and is intended 
for the treatment of symptoms due to urinary outflow obstruction 
secondary to benign prostatic hyperplasia in men.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The elements of the device that may contact the patient must be 
demonstrated to be biocompatible.
    (2) Performance data must demonstrate the sterility of the patient-
contacting components of the device.
    (3) Performance data must support shelf life by demonstrating 
continued sterility of the device (of the patient-contacting 
components), package integrity, and device functionality over the 
requested shelf life.
    (4) Non-clinical testing data must demonstrate that the device 
performs as intended under anticipated conditions of use. The following 
performance characteristics must be tested:
    (i) Deployment testing must be conducted.
    (ii) Mechanical strength must be conducted.
    (iii) Resistance-to-degradation testing must be conducted.
    (5) Non-clinical testing must evaluate the compatibility of the 
device in a magnetic resonance environment.
    (6) In vivo testing must demonstrate safe and effective use, assess 
the impact of the implants on the ability to perform subsequent 
treatments, document the adverse event profile associated with clinical 
use, and demonstrate that the device performs as intended under 
anticipated conditions of use. The following performance characteristics 
must be tested:
    (i) Deployment testing must be conducted.
    (ii) Implant migration must be conducted.
    (7) Labeling must bear all information required for safe and 
effective use of the device, and must include:
    (i) Specific instructions, warnings, cautions, limitations, and the 
clinical training needed for the safe use of the device.
    (ii) Information on the patient population for which the device has 
been demonstrated to be effective.
    (iii) A detailed summary of the device technical parameters.

[[Page 565]]

    (iv) Information on how the device operates and the typical course 
of treatment.
    (v) An expiration date/shelf life.
    (vi) A detailed summary of the device- and procedure-related 
complications or adverse events pertinent to use of the device.

[79 FR 43249, July 25, 2014]



Sec. 876.5540  Blood access device and accessories.

    (a) Identification. A blood access device and accessories is a 
device intended to provide access to a patient's blood for hemodialysis 
or other chronic uses. When used in hemodialysis, it is part of an 
artificial kidney system for the treatment of patients with renal 
failure or toxemic conditions and provides access to a patient's blood 
for hemodialysis. The device includes implanted blood access devices, 
nonimplanted blood access devices, and accessories for both the 
implanted and nonimplanted blood access devices.
    (1) The implanted blood access device is a prescription device and 
consists of various flexible or rigid tubes, such as catheters, or 
cannulae, which are surgically implanted in appropriate blood vessels, 
may come through the skin, and are intended to remain in the body for 30 
days or more. This generic type of device includes various catheters, 
shunts, and connectors specifically designed to provide access to blood. 
Examples include single and double lumen catheters with cuff(s), fully 
subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel 
tips). The implanted blood access device may also contain coatings or 
additives which may provide additional functionality to the device.
    (2) The nonimplanted blood access device consists of various 
flexible or rigid tubes, such as catheters, cannulae or hollow needles, 
which are inserted into appropriate blood vessels or a vascular graft 
prosthesis (Sec. Sec. 870.3450 and 870.3460), and are intended to 
remain in the body for less than 30 days. This generic type of device 
includes fistula needles, the single needle dialysis set (coaxial flow 
needle), and the single needle dialysis set (alternating flow needle).
    (3) Accessories common to either type include the shunt adaptor, 
cannula clamp, shunt connector, shunt stabilizer, vessel dilator, 
disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, 
joint ring, fistula adaptor, and declotting tray (including contents).
    (b) Classification. (1) Class II (special controls) for the 
implanted blood access device. The special controls for this device are:
    (i) Components of the device that come into human contact must be 
demonstrated to be biocompatible. Material names and specific 
designation numbers must be provided.
    (ii) Performance data must demonstrate that the device performs as 
intended under anticipated conditions of use. The following performance 
characteristics must be tested:
    (A) Pressure versus flow rates for both arterial and venous lumens, 
from the minimum flow rate to the maximum flow rate in 100 milliliter 
per minute increments, must be established. The fluid and its viscosity 
used during testing must be stated.
    (B) Recirculation rates for both forward and reverse flow 
configurations must be established, along with the protocol used to 
perform the assay, which must be provided.
    (C) Priming volumes must be established.
    (D) Tensile testing of joints and materials must be conducted. The 
minimum acceptance criteria must be adequate for its intended use.
    (E) Air leakage testing and liquid leakage testing must be 
conducted.
    (F) Testing of the repeated clamping of the extensions of the 
catheter that simulates use over the life of the device must be 
conducted, and retested for leakage.
    (G) Mechanical hemolysis testing must be conducted for new or 
altered device designs that affect the blood flow pattern.
    (H) Chemical tolerance of the device to repeated exposure to 
commonly used disinfection agents must be established.
    (iii) Performance data must demonstrate the sterility of the device.

[[Page 566]]

    (iv) Performance data must support the shelf life of the device for 
continued sterility, package integrity, and functionality over the 
requested shelf life that must include tensile, repeated clamping, and 
leakage testing.
    (v) Labeling of implanted blood access devices for hemodialysis must 
include the following:
    (A) Labeling must provide arterial and venous pressure versus flow 
rates, either in tabular or graphical format. The fluid and its 
viscosity used during testing must be stated.
    (B) Labeling must specify the forward and reverse recirculation 
rates.
    (C) Labeling must provide the arterial and venous priming volumes.
    (D) Labeling must specify an expiration date.
    (E) Labeling must identify any disinfecting agents that cannot be 
used to clean any components of the device.
    (F) Any contraindicated disinfecting agents due to material 
incompatibility must be identified by printing a warning on the 
catheter. Alternatively, contraindicated disinfecting agents must be 
identified by a label affixed to the patient's medical record and with 
written instructions provided directly to the patient.
    (G) Labeling must include a patient implant card.
    (H) The labeling must contain comprehensive instructions for the 
following:
    (1) Preparation and insertion of the device, including recommended 
site of insertion, method of insertion, and a reference on the proper 
location for tip placement;
    (2) Proper care and maintenance of the device and device exit site;
    (3) Removal of the device;
    (4) Anticoagulation;
    (5) Management of obstruction and thrombus formation; and
    (6) Qualifications for clinical providers performing the insertion, 
maintenance, and removal of the devices.
    (vi) In addition to Special Controls in paragraphs (b)(1)(i) through 
(v) of this section, implanted blood access devices that include 
subcutaneous ports must include the following:
    (A) Labeling must include the recommended type of needle for access 
as well as detailed instructions for care and maintenance of the port, 
subcutaneous pocket, and skin overlying the port.
    (B) Performance testing must include results on repeated use of the 
ports that simulates use over the intended life of the device.
    (C) Clinical performance testing must demonstrate safe and effective 
use and capture any adverse events observed during clinical use.
    (vii) In addition to Special Controls in paragraphs (b)(1)(i) 
through (v) of this section, implanted blood access devices with 
coatings or additives must include the following:
    (A) A description and material characterization of the coating or 
additive material, the purpose of the coating or additive, duration of 
effectiveness, and how and where the coating is applied.
    (B) An identification in the labeling of any coatings or additives 
and a summary of the results of performance testing for any coating or 
material with special characteristics, such as decreased thrombus 
formation or antimicrobial properties.
    (C) A Warning Statement in the labeling for potential allergic 
reactions including anaphylaxis if the coating or additive contains 
known allergens.
    (D) Performance data must demonstrate efficacy of the coating or 
additive and the duration of effectiveness.
    (viii) The following must be included for A-V shunt cannulae (with 
vessel tips):
    (A) The device must comply with Special Controls in paragraphs 
(b)(1)(i) through (v) of this section with the exception of paragraphs 
(b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do 
not apply.
    (B) Labeling must include Warning Statements to address the 
potential for vascular access steal syndrome, arterial stenosis, 
arterial thrombosis, and hemorrhage including exsanguination given that 
the device accesses the arterial circulation.
    (C) Clinical performance testing must demonstrate safe and effective 
use and capture any adverse events observed during clinical use.
    (2) Class II (performance standards) for the nonimplanted blood 
access device.

[[Page 567]]

    (3) Class II (performance standards) for accessories for both the 
implanted and the nonimplanted blood access devices not listed in 
paragraph (b)(4) of this section.
    (4) Class I for the cannula clamp, disconnect forceps, crimp plier, 
tube plier, crimp ring, and joint ring, accessories for both the 
implanted and nonimplanted blood access device. The devices subject to 
this paragraph (b)(4) are exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 61 
FR 1122, Jan. 16, 1996; 66 FR 38802, July 25, 2001; 79 FR 43245, July 
25, 2014]



Sec. 876.5550  Prostatic artery embolization device.

    (a) Identification. A prostatic artery embolization device is an 
intravascular implant intended to occlude the prostatic arteries to 
prevent blood flow to the targeted area of the prostate, resulting in a 
reduction of lower urinary tract symptoms related to benign prostatic 
hyperplasia. This does not include cyanoacrylates and other embolic 
agents which act by in situ polymerization or precipitation, or 
embolization devices used in neurovascular applications (see 21 CFR 
882.5950).
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The device must be demonstrated to be biocompatible.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be tested:
    (i) Evaluation of suitability for injection through catheters 
intended for use in embolization; and
    (ii) Evaluation of the size distribution of the device.
    (3) Performance data must support the sterility and pyrogenicity of 
the device.
    (4) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the identified shelf life.
    (5) Clinical data must evaluate post-embolization damage due to non-
target embolization under anticipated use conditions.
    (6) The labeling must include:
    (i) Specific instructions on safe device preparation and use;
    (ii) The device shelf life;
    (iii) Data regarding urinary retention; and
    (iv) Data regarding post-prostatic artery embolization syndrome.

[82 FR 52651, Nov. 14, 2017]



Sec. 876.5600  Sorbent regenerated dialysate delivery system for hemodialysis.

    (a) Identification. A sorbent regenerated dialysate delivery system 
for hemodialysis is a device that is part of an artificial kidney system 
for the treatment of patients with renal failure or toxemic conditions, 
and that consists of a sorbent cartridge and the means to circulate 
dialysate through this cartridge and the dialysate compartment of the 
dialyzer. The device is used with the extracorporeal blood system and 
the dialyzer of the hemodialysis system and accessories (Sec. 
876.5820). The device includes the means to maintain the temperature, 
conductivity, electrolyte balance, flow rate and pressure of the 
dialysate, and alarms to indicate abnormal dialysate conditions. The 
sorbent cartridge may include absorbent, ion exchange and catalytic 
materials.
    (b) Classification. Class II (performance standards).



Sec. 876.5630  Peritoneal dialysis system and accessories.

    (a) Identification. (1) A peritoneal dialysis system and accessories 
is a device that is used as an artificial kidney system for the 
treatment of patients with renal failure or toxemic conditions, and that 
consists of a peritoneal access device, an administration set for 
peritoneal dialysis, a source of dialysate, and, in some cases, a water 
purification mechanism. After the dialysate is instilled into the 
patient's peritoneal cavity, it is allowed to dwell there so that 
undesirable substances from the patient's blood pass through the lining 
membrane of the peritoneal

[[Page 568]]

cavity into this dialysate. These substances are then removed when the 
dialysate is drained from the patient. The peritoneal dialysis system 
may regulate and monitor the dialysate temperature, volume, and delivery 
rate together with the time course of each cycle of filling, dwell time, 
and draining of the peritoneal cavity or manual controls may be used. 
This generic device includes the semiautomatic and the automatic 
peritoneal delivery system.
    (2) The peritoneal access device is a flexible tube that is 
implanted through the abdominal wall into the peritoneal cavity and that 
may have attached cuffs to provide anchoring and a skin seal. The device 
is either a single use peritioneal catheter, intended to remain in the 
peritoneal cavity for less than 30 days, or a long term peritoneal 
catheter. Accessories include stylets and trocars to aid in the 
insertion of the catheter and an obturator to maintain the patency of 
the surgical fistula in the abdominal wall between treatments.
    (3) The disposable administration set for peritoneal dialysis 
consists of tubing, an optional reservoir bag, and appropriate 
connectors. It may include a peritoneal dialysate filter to trap and 
remove contaminating particles.
    (4) The source of dialysate may be sterile prepackaged dialysate 
(for semiautomatic peritoneal dialysate delivery systems or ``cycler 
systems'') or dialysate prepared from dialysate concentrate and sterile 
purified water (for automatic peritoneal dialysate delivery systems or 
``reverse osmosis'' systems). Prepackaged dialysate intended for use 
with either of the peritoneal dialysate delivery systems is regulated by 
FDA as a drug.
    (b) Classification. Class II (special controls). The following 
accessories are exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec. 876.9: A catheter finger grip that is non-patient contacting and 
intended for single use with a peritoneal catheter; a continuous 
ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that 
does not include weigh scales.

[48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71814, Dec. 30, 2019]



Sec. 876.5665  Water purification system for hemodialysis.

    (a) Identification. A water purification system for hemodialysis is 
a device that is intended for use with a hemodialysis system and that is 
intended to remove organic and inorganic substances and microbial 
contaminants from water used to dilute dialysate concentrate to form 
dialysate. This generic type of device may include a water softener, 
sediment filter, carbon filter, and water distillation system.
    (b) Classification. Class II (special controls). The device, when it 
is a water purification subsystem disinfectant, is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71814, Dec. 30, 2019]



Sec. 876.5820  Hemodialysis system and accessories.

    (a) Identification. A hemodialysis system and accessories is a 
device that is used as an artificial kidney system for the treatment of 
patients with renal failure or toxemic conditions and that consists of 
an extracorporeal blood system, a conventional dialyzer, a dialysate 
delivery system, and accessories. Blood from a patient flows through the 
tubing of the extracorporeal blood system and accessories to the blood 
compartment of the dialyzer, then returns through further tubing of the 
extracorporeal blood system to the patient. The dialyzer has two 
compartments that are separated by a semipermeable membrane. While the 
blood is in the blood compartment, undesirable substances in the blood 
pass through the semipermeable membrane into the dialysate in the 
dialysate compartment. The dialysate delivery system controls and 
monitors the dialysate circulating through the dialysate compartment of 
the dialyzer.
    (1) The extracorporeal blood system and accessories consists of 
tubing, pumps, pressure monitors, air foam or bubble detectors, and 
alarms to keep

[[Page 569]]

blood moving safely from the blood access device and accessories for 
hemodialysis (Sec. 876.5540) to the blood compartment of the dialyzer 
and back to the patient.
    (2) The conventional dialyzer allows a transfer of water and solutes 
between the blood and the dialysate through the semipermeable membrane. 
The semipermeable membrane of the conventional dialyzer has a 
sufficiently low permeability to water that an ultrafiltration 
controller is not required to prevent excessive loss of water from the 
patient's blood. This conventional dialyzer does not include 
hemodialyzers with the disposable inserts (Kiil type) (Sec. 876.5830) 
or dialyzers of high permeability (Sec. 876.5860).
    (3) The dialysate delivery system consists of mechanisms that 
monitor and control the temperature, conductivity, flow rate, and 
pressure of the dialysate and circulates dialysate through the dialysate 
compartment of the dialyzer. The dialysate delivery system includes the 
dialysate concentrate for hemodialysis (liquid or powder) and alarms to 
indicate abnormal dialysate conditions. This dialysate delivery system 
does not include the sorbent regenerated dialysate delivery system for 
hemodialysis (Sec. 876.5600), the dialysate delivery system of the 
peritoneal dialysis system and accessories (Sec. 876.5630), or the 
controlled dialysate delivery system of the high permeability 
hemodialysis system Sec. 876.5860).
    (4) Remote accessories to the hemodialysis system include the 
unpowered dialysis chair without a scale, the powered dialysis chair 
without a scale, the dialyzer holder set, dialysis tie gun and ties, and 
hemodialysis start/stop tray.
    (b) Classification. (1) Class II (performance standards) for 
hemodialysis systems and all accessories directly associated with the 
extracorporeal blood system and the dialysate delivery system.
    (2) Class I for other accessories of the hemodialysis system remote 
from the extracorporeal blood system and the dialysate delivery system, 
such as the unpowered dialysis chair, hemodialysis start/stop tray, 
dialyzer holder set, and dialysis tie gun and ties. The devices subject 
to this paragraph (b)(2) are exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25050, June 12, 1989; 
66 FR 38802, July 25, 2001]



Sec. 876.5830  Hemodialyzer with disposable insert (Kiil type).

    (a) Identification. A hemodialyzer with disposable inserts (Kiil 
type) is a device that is used as a part of an artificial kidney system 
for the treatment of patients with renal failure or toxemic conditions 
and that includes disposable inserts consisting of layers of 
semipermeable membranes which are sandwiched between support plates. The 
device is used with the extracorporeal blood system and the dialysate 
delivery system of the hemodialysis system and accessories (Sec. 
876.5820).
    (b) Classification. Class II (performance standards).

[48 FR 53023, Nov. 23, 1983, as amended at 53 FR 11253, Apr. 6, 1988]



Sec. 876.5860  High permeability hemodialysis system.

    (a) Identification. A high permeability hemodialysis system is a 
device intended for use as an artificial kidney system for the treatment 
of patients with renal failure, fluid overload, or toxemic conditions by 
performing such therapies as hemodialysis, hemofiltration, 
hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a 
semipermeable membrane that is more permeable to water than the 
semipermeable membrane of the conventional hemodialysis system (Sec. 
876.5820), the high permeability hemodialysis system removes toxins or 
excess fluid from the patient's blood using the principles of convection 
(via a high ultrafiltration rate) and/or diffusion (via a concentration 
gradient in dialysate). During treatment, blood is circulated from the 
patient through the hemodialyzer's blood compartment, while the 
dialysate solution flows countercurrent through the dialysate 
compartment. In this process, toxins and/or fluid are transferred across 
the membrane from

[[Page 570]]

the blood to the dialysate compartment. The hemodialysis delivery 
machine controls and monitors the parameters related to this processing, 
including the rate at which blood and dialysate are pumped through the 
system, and the rate at which fluid is removed from the patient. The 
high permeability hemodialysis system consists of the following devices:
    (1) The hemodialyzer consists of a semipermeable membrane with an in 
vitro ultrafiltration coefficient (Kuf) greater than 8 
milliliters per hour per conventional millimeter of mercury, as measured 
with bovine or expired human blood, and is used with either an automated 
ultrafiltration controller or anther method of ultrafiltration control 
to prevent fluid imbalance.
    (2) The hemodialysis delivery machine is similar to the 
extracorporeal blood system and dialysate delivery system of the 
hemodialysis system and accessories (Sec. 876.5820), with the addition 
of an ultrafiltration controller and mechanisms that monitor and/or 
control such parameters as fluid balance, dialysate composition, and 
patient treatment parameters (e.g., blood pressure, hematocrit, urea, 
etc.).
    (3) The high permeability hemodialysis system accessories include, 
but are not limited to, tubing lines and various treatment related 
monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood 
recirculation monitors).
    (b) Classification. Class II. The special controls for this device 
are FDA's:
    (1) ``Use of International Standard ISO 10993 `Biological Evaluation 
of Medical Device--Part I: Evaluation and Testing,' ''
    (2) ``Guidance for the Content of 510(k)s for Conventional and High 
Permeability Hemodialyzers,''
    (3) ``Guidance for Industry and CDRH Reviewers on the Content of 
Premarket Notifications for Hemodialysis Delivery Systems,''
    (4) ``Guidance for the Content of Premarket Notifications for Water 
Purification Components and Systems for Hemodialysis,'' and
    (5) ``Guidance for Hemodialyzer Reuse Labeling.''

[65 FR 17145, Mar. 31, 2000]



Sec. 876.5870  Sorbent hemoperfusion system.

    (a) Identification. A sorbent hemoperfusion system is a prescription 
device that consists of an extracorporeal blood system similar to that 
identified in the hemodialysis system and accessories (Sec. 876.5820) 
and a container filled with adsorbent material that removes a wide range 
of substances, both toxic and normal, from blood flowing through it. The 
adsorbent materials are usually activated-carbon or resins which may be 
coated or immobilized to prevent fine particles entering the patient's 
blood. The generic type of device may include lines and filters 
specifically designed to connect the device to the extracorporeal blood 
system. The device is used in the treatment of poisoning, drug overdose, 
hepatic coma, or metabolic disturbances.
    (b) Classification. (1) Class II (special controls) when the device 
is intended for the treatment of poisoning and drug overdose. The 
special controls for this device are:
    (i) The device must be demonstrated to be biocompatible;
    (ii) Performance data must demonstrate the mechanical integrity of 
the device (e.g., tensile, flexural, and structural strength), including 
testing for the possibility of leaks, ruptures, release of particles, 
and/or disconnections under anticipated conditions of use;
    (iii) Performance data must demonstrate device sterility and shelf 
life;
    (iv) Bench performance testing must demonstrate device functionality 
in terms of substances, toxins, and drugs removed by the device, and the 
extent that these are removed when the device is used according to its 
labeling, and to validate the device's safeguards;
    (v) A summary of clinical experience with the device that discusses 
and analyzes device safety and performance, including a list of adverse 
events observed during the testing, must be provided;
    (vi) Labeling must include the following:
    (A) A detailed summary of the device-related and procedure-related 
complications pertinent to the use of the device;

[[Page 571]]

    (B) A summary of the performance data provided for the device, 
including a list of the drugs and/or poisons the device has been 
demonstrated to remove, and the extent for removal/depletion; and
    (vii) For those devices that incorporate electrical components, 
appropriate analysis and testing must be conducted to verify electrical 
safety and electromagnetic compatibility of the device.
    (2) Class III (premarket approval) when the device is intended for 
the treatment of hepatic coma and metabolic disturbances.
    (c) Date premarket approval application (PMA) or notice of 
completion of product development protocol (PDP) is required. A PMA or 
notice of completion of a PDP is required to be filed with FDA by April 
17, 2014, for any sorbent hemoperfusion system indicated for treatment 
of hepatic coma or metabolic disturbances that was in commercial 
distribution before May 28, 1976, or that has, by April 17, 2014, been 
found to be substantially equivalent to any sorbent hemoperfusion device 
indicated for treatment of hepatic coma or metabolic disturbances that 
was in commercial distribution before May 28, 1976. Any other sorbent 
hemoperfusion system device indicated for treatment of hepatic coma or 
metabolic disturbances shall have an approved PMA or declared completed 
PDP in effect before being placed in commercial distribution.

[79 FR 3094, Jan. 17, 2014]



Sec. 876.5880  Isolated kidney perfusion and transport system
and accessories.

    (a) Identification. An isolated kidney perfusion and transport 
system and accessories is a device that is used to support a donated or 
a cadaver kidney and to maintain the organ in a near-normal physiologic 
state until it is transplanted into a recipient patient. This generic 
type of device may include tubing, catheters, connectors, an ice storage 
or freezing container with or without bag or preservatives, pulsatile or 
nonpulsatile hypothermic isolated organ perfusion apparatus with or 
without oxygenator, and disposable perfusion set.
    (b) Classification. Class II (performance standards).



Sec. 876.5885  Tissue culture media for human ex vivo tissue and
cell culture processing applications.

    (a) Identification. Tissue culture media for human ex vivo tissue 
and cell culture processing applications consist of cell and tissue 
culture media and components that are composed of chemically defined 
components (e.g., amino acids, vitamins, inorganic salts) that are 
essential for the ex vivo development, survival, and maintenance of 
tissues and cells of human origin. The solutions are indicated for use 
in human ex vivo tissue and cell culture processing applications.
    (b) Classification. Class II (special controls): FDA guidance 
document, ``Class II Special Controls Guidance Document: Tissue Culture 
Media for Human Ex Vivo Processing Applications; Final Guidance for 
Industry and FDA Reviewers.''

[66 FR 27025, May 16, 2001]



Sec. 876.5895  Ostomy irrigator.

    (a) Identification. An ostomy irrigator is a device that consists of 
a container for fluid, tubing with a cone-shaped tip or a soft and 
flexible catheter with a retention shield and that is used to wash out 
the colon through a colostomy, a surgically created opening of the colon 
on the surface of the body.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71814, Dec. 30, 2019]



Sec. 876.5900  Ostomy pouch and accessories.

    (a) Identification. An ostomy pouch and accessories is a device that 
consists of a bag that is attached to the patient's skin by an adhesive 
material and that is intended for use as a receptacle for collection of 
fecal material or urine following an ileostomy, colostomy, or 
ureterostomy (a surgically created opening of the small intestine, large 
intestine, or the ureter on the surface of the body). This generic type

[[Page 572]]

of device and its accessories includes the ostomy pouch, ostomy 
adhesive, the disposable colostomy appliance, ostomy collector, 
colostomy pouch, urinary ileostomy bag, urine collecting ureterostomy 
bag, ostomy drainage bag with adhesive, stomal bag, ostomy protector, 
and the ostomy size selector, but excludes ostomy pouches which 
incorporate arsenic-containing compounds.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25050, June 12, 1989; 
66 FR 38802, July 25, 2001]



Sec. 876.5920  Protective garment for incontinence.

    (a) Identification. A protective garment for incontinence is a 
device that consists of absorbent padding and a fluid barrier and that 
is intended to protect an incontinent patient's garment from the 
patient's excreta. This generic type of device does not include diapers 
for infants.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 876.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general requirements concerning 
records, and Sec. 820.198, regarding complaint files.

[48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25050, June 12, 1989; 
66 FR 38802, July 25, 2001]



Sec. 876.5930  Rectal control system.

    (a) Identification. A rectal control system is a prescription device 
intended to treat fecal incontinence by controlling the size of the 
rectal lumen. The device is inserted in the vagina and includes a 
portion that expands to reduce the rectal lumen to prevent stool leakage 
and retracts to allow normal passage of stool. The device includes an 
external regulator to control the state of expansion.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical testing must document the device acceptance data and 
the adverse event profile associated with clinical use, and demonstrate 
that the device performs as intended under anticipated conditions of 
use.
    (2) The elements of the device that contact vaginal tissue must be 
demonstrated to be biocompatible.
    (3) The cleaning and disinfection instructions for the device must 
be validated.
    (4) Non-clinical (bench) testing must demonstrate that the device 
performs as intended under anticipated conditions of use.
    (5) Non-clinical (bench) testing must demonstrate that the device 
does not:
    (i) Enhance the growth of Staphylococcus aureus.
    (ii) Increase production of Toxic Shock Syndrome Toxin-1 by S. 
aureus.
    (iii) Alter the growth of normal vaginal flora.
    (6) Labeling must include:
    (i) Specific instructions, contraindications, warnings, cautions, 
limitations, and the clinical training needed for the safe use of the 
device.
    (ii) The intended patient population and the intended use 
environment.
    (iii) Information on how the device is to be fitted, how the device 
operates, and recommendations on device maintenance.
    (iv) A detailed summary of the clinical testing pertinent to the use 
of the device, including a summary of the device- and procedure-related 
complications or adverse events related to use of the device, as well as 
relevant safety and performance information.
    (7) Patient labeling must be provided and must include:
    (i) Relevant contraindications, warnings, precautions, and adverse 
events/complications.
    (ii) Information on how the device operates and the recommended 
device maintenance (i.e., care instructions), including cleaning and 
disinfection.
    (iii) Information on the patient population for which there was a 
favorable benefit/risk assessment.

[[Page 573]]

    (iv) The potential risks and benefits associated with the use of the 
device.

[80 FR 30933, June 1, 2015]



Sec. 876.5955  Peritoneo-venous shunt.

    (a) Identification. A peritoneo-venous shunt is an implanted device 
that consists of a catheter and a pressure activated one-way valve. The 
catheter is implanted with one end in the peritoneal cavity and the 
other in a large vein. This device enables ascitic fluid in the 
peritoneal cavity to flow into the venous system for the treatment of 
intractable ascites.
    (b) Classification. Class II. The special controls for this device 
are FDA's:
    (1) ``Use of International Standard ISO 10993 `Biological Evaluation 
of Medical Devices--Part I: Evaluation and Testing,' ''
    (2) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),'' and
    (3) Backflow specification and testing to prevent reflux of blood 
into the shunt.

[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 65 
FR 17145, Mar. 31, 2000]



Sec. 876.5960  Computerized behavioral therapy device for 
treating symptoms of gastrointestinal conditions.

    (a) Identification. A computerized behavioral therapy device for 
treating symptoms of gastrointestinal conditions is a prescription 
device intended to provide a computerized version of condition-specific 
therapy as an adjunct to standard of care treatments to patients with 
gastrointestinal conditions.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical data must be provided to fulfill the following:
    (i) Describe a model of therapy for the indicated gastrointestinal 
conditions;
    (ii) Validate the model of therapy as implemented by the device 
using a clinically defined endpoint; and
    (iii) Evaluate all adverse events.
    (2) Software must be described in detail in the software 
requirements specification and software design specification. Software 
verification, validation, and hazard analysis must be performed. 
Software documentation must demonstrate that the device effectively 
implements the behavioral therapy model.
    (3) Usability assessment must demonstrate that the intended user(s) 
can safely and correctly use the device.
    (4) Labeling:
    (i) Labeling must include instructions for use, including images 
that demonstrate how to interact with the device;
    (ii) Patient and physician labeling must list the minimum operating 
system requirements that support the software of the device;
    (iii) Patient and physician labeling must include a warning that the 
device is not intended for use in lieu of a standard therapeutic 
intervention or to represent a substitution for the patient's 
medication;
    (iv) Patient and physician labeling must include a warning to seek 
medical care if a patient has feelings or thoughts of harming themselves 
or others; and
    (v) Physician and patient labeling must include a summary of the 
clinical testing with the device.

[88 FR 3636, Jan. 20, 2023]



Sec. 876.5970  Hernia support.

    (a) Identification. A hernia support is a device, usually made of 
elastic, canvas, leather, or metal, that is intended to be placed over a 
hernial opening (a weakness in the abdominal wall) to prevent protrusion 
of the abdominal contents. This generic type of device includes the 
umbilical truss.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 876.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general requirements concerning 
records, and Sec. 820.198, regarding complaint files.

[48 FR 53023, Nov. 23, 1983, as amended at 59 FR 63010, Dec. 7, 1994; 66 
FR 38802, July 25, 2001]

[[Page 574]]



Sec. 876.5980  Gastrointestinal tube and accessories.

    (a) Identification. A gastrointestinal tube and accessories is a 
device that consists of flexible or semi-rigid tubing used for 
instilling fluids into, withdrawing fluids from, splinting, or 
suppressing bleeding of the alimentary tract. This device may 
incorporate an integral inflatable balloon for retention or hemostasis. 
This generic type of device includes the hemostatic bag, irrigation and 
aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile 
infant gavage set, gastrointestinal string and tubes to locate internal 
bleeding, double lumen tube for intestinal decompression or intubation, 
feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, 
single lumen tube with mercury weight balloon for intestinal intubation 
or decompression, and gastro-urological irrigation tray (for 
gastrological use).
    (b) Classification. (1) Class II (special controls). The barium 
enema retention catheter and tip with or without a bag that is a 
gastrointestinal tube and accessory or a gastronomy tube holder 
accessory is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec. 876.9.
    (2) Class I (general controls) for the dissolvable nasogastric feed 
tube guide for the nasogastric tube. The class I device is exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 876.9.

[49 FR 573, Jan. 5, 1984, as amended at 65 FR 2317, Jan. 14, 2000; 65 FR 
76932, Dec. 8, 2000; 84 FR 71814, Dec. 30, 2019]



Sec. 876.5981  Oral removable palatal space occupying device for
weight management and/or weight loss.

    (a) Identification. An oral removable palatal space occupying device 
for weight management and/or weight loss is a prescription device that 
is worn during meals to limit bite size, thereby reducing the amount of 
food that is consumed. The device may contain recording sensors for 
monitoring patient use. This classification does not include devices 
that are intended to treat any dental diseases or conditions
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient-contacting components of the device must be 
demonstrated to be biocompatible for its intended use.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions for use, as 
follows:
    (i) Mechanical testing must demonstrate that the device performs as 
intended for the labeled use life and does not create forces that result 
in movement of teeth and damage to teeth.
    (ii) Electrical safety and electromagnetic compatibility testing 
must demonstrate that the device performs as intended.
    (iii) Software verification and validation must demonstrate that the 
device performs as intended.
    (iv) Battery testing must demonstrate that the device battery 
performs as intended.
    (3) Clinical performance testing must demonstrate the device 
performs as intended and must include an evaluation for choking.
    (4) Device labeling must address the following:
    (i) Patient labeling must state:
    (A) The clinical benefit of weight management and/or weight loss as 
assessed by using percent total body weight loss;
    (B) Treatment must be offered in combination with a behavioral 
modification program;
    (C) Instructions on how to use the device as intended; and
    (D) The use life of the device.
    (ii) Physician labeling must state:
    (A) The clinical benefit of weight management and/or weight loss as 
assessed by using percent total body weight loss;
    (B) Treatment must be offered in combination with a behavioral 
modification program;
    (C) Instructions on how to use the device as intended; and
    (D) The use life of the device.
    (5) Training must be provided to health professionals that includes 
procedures for determining a patient's oral health status, instructions 
for

[[Page 575]]

making the palatal mold, and assessment of issues with the device that 
may require service by the manufacturer.

[82 FR 35069, July 28, 2017]



Sec. 876.5982  Ingested, transient, space occupying device 
for weight management and/or weight loss.

    (a) Identification. This device is an ingested material that 
transiently occupies space in the stomach. The device passes from the 
body via the natural gastrointestinal tract.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient-contacting components of the device must be 
demonstrated to be biocompatible for its intended use.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions for use, as 
follows:
    (i) Performance bench testing in a simulated use model must evaluate 
device disintegration and device hydration state throughout the 
gastrointestinal tract;
    (ii) Bioburden and moisture content assessments must evaluate device 
infection risk throughout the labeled shelf life; and
    (iii) Performance data must support the shelf life of the device by 
demonstrating continued package integrity and device functionality over 
the labeled shelf life.
    (3) Clinical performance testing must demonstrate the device 
performs as intended and evaluate the following:
    (i) Weight change;
    (ii) All adverse events, including obstruction, dilation, diarrhea, 
constipation, and dehydration; and
    (iii) Interaction with representative medications.
    (4) Physician and patient device labeling must state:
    (i) The clinical benefit of the device as assessed by using percent 
total body weight loss;
    (ii) Treatment must be offered in combination with diet and 
exercise;
    (iii) Instructions on how to use the device as intended including 
how to avoid interaction with medication; and
    (iv) The shelf life of the device.

[86 FR 70372, Dec. 10, 2021]



Sec. 876.5985  Enzyme packed cartridge.

    (a) Identification. An enzyme packed cartridge is an ex vivo 
prescription device that is used in enzymatic hydrolysis of 
macronutrients into their essential nutrient forms at the time of 
delivery. The device consists of an outer casing containing an inert 
polymer with a covalently bound enzyme through which nutritional formula 
is directed. The device fits in line with enteral feeding systems.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient contacting components of the device must be 
demonstrated to be biocompatible.
    (2) In vivo testing must be performed and must demonstrate that the 
device causes neither an adverse tissue response nor adverse 
performance.
    (3) Non-clinical testing must demonstrate that the device performs 
as intended under anticipated conditions of use. The following 
performance characteristics must be demonstrated:
    (i) Mechanical testing to demonstrate that the device can withstand 
clinical forces;
    (ii) Flow rate and leakage testing to demonstrate that the device 
does not impede the flow of enteral formula;
    (iii) Demonstration of enzymatic effect on intended macronutrient;
    (iv) The amount of enzyme that exits the cartridge must be 
characterized;
    (v) Validation that the device does not adversely impact the 
nutritional composition of enteral formula; and
    (vi) Validation that the device does not impede flow alarms on 
enteral feeding pumps.
    (4) Human factors testing must be performed to characterize use 
error risks.
    (5) Performance data must support shelf life by demonstrating 
package integrity and device functionality over the identified shelf 
life.
    (6) Labeling must include the following:
    (i) A detailed summary of in vivo testing pertinent to use of the 
device, including device-related adverse events;

[[Page 576]]

    (ii) A detailed summary of compatible formulas that is supported by 
non-clinical testing, including the expected enzymatic conversion as a 
percentage;
    (iii) Detailed instructions on how to place the device into an 
enteral feeding circuit;
    (iv) A warning regarding the possibility for misconnections; and
    (v) Expiration date or shelf life.
    (7) Patient labeling must be provided and must include:
    (i) Relevant warnings, precautions, adverse effects, and 
complications;
    (ii) A description of the device and how it operates;
    (iii) Instructions on how to correctly use the device; and
    (iv) The benefits and risks associated with the use of the device.

[82 FR 47971, Oct. 16, 2017]



Sec. 876.5990  Extracorporeal shock wave lithotripter.

    (a) Identification. An extracorporeal shock wave lithotripter is a 
device that focuses ultrasonic shock waves into the body to 
noninvasively fragment urinary calculi within the kidney or ureter. The 
primary components of the device are a shock wave generator, high 
voltage generator, control console, imaging/localization system, and 
patient table. Prior to treatment, the urinary stone is targeted using 
either an integral or stand-alone localization/imaging system. Shock 
waves are typically generated using electrostatic spark discharge (spark 
gap), electromagnetically repelled membranes, or piezoelectric crystal 
arrays, and focused onto the stone with either a specially designed 
reflector, dish, or acoustic lens. The shock waves are created under 
water within the shock wave generator, and are transferred to the 
patient's body using an appropriate acoustic interface. After the stone 
has been fragmented by the focused shock waves, the fragments pass out 
of the body with the patient's urine.
    (b) Classification. Class II (special controls) (FDA guidance 
document: ``Guidance for the Content of Premarket Notifications 
(510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the 
Fragmentation of Kidney and Ureteral Calculi.'')

[65 FR 48612, Aug. 9, 2000]



PART 878_GENERAL AND PLASTIC SURGERY DEVICES--Table of Contents



                      Subpart A_General Provisions

Sec.
878.1 Scope.
878.3 Effective dates of requirement for premarket approval.
878.9 Limitations of exemptions from section 510(k) of the Federal Food, 
          Drug, and Cosmetic Act (the act).

                      Subpart B_Diagnostic Devices

878.1800 Speculum and accessories.

Subpart C [Reserved]

                      Subpart D_Prosthetic Devices

878.3250 External facial fracture fixation appliance.
878.3300 Surgical mesh.
878.3500 Polytetrafluoroethylene with carbon fibers composite implant 
          material.
878.3510 Carbon dioxide gas controlled tissue expander.
878.3530 Silicone inflatable breast prosthesis.
878.3540 Silicone gel-filled breast prosthesis.
878.3550 Chin prosthesis.
878.3590 Ear prosthesis.
878.3610 Esophageal prosthesis.
878.3680 Nose prosthesis.
878.3720 Tracheal prosthesls.
878.3750 External prosthesis adhesive.
878.3800 External aesthetic restoration prosthesis.
878.3900 Inflatable extremity splint.
878.3910 Noninflatable extremity splint.
878.3925 Plastic surgery kit and accessories.

                       Subpart E_Surgical Devices

878.4010 Tissue adhesive.
878.4011 Tissue adhesive with adjunct wound closure device for topical 
          approximation of skin.
878.4014 Nonresorbable gauze/sponge for external use.
878.4015 Wound dressing with poly (diallyl dimethyl ammonium chloride) 
          (pDADMAC) additive.
878.4018 Hydrophilic wound dressing.
878.4020 Occlusive wound dressing.
878.4022 Hydrogel wound dressing and burn dressing.
878.4025 Silicone sheeting.
878.4040 Surgical apparel.
878.4100 Organ bag.
878.4160 Surgical camera and accessories.

[[Page 577]]

878.4165 Wound autofluorescence imaging device.
878.4200 Introduction/drainage catheter and accessories.
878.4300 Implantable clip.
878.4320 Removable skin clip.
878.4340 Contact cooling system for aesthetic use.
878.4350 Cryosurgical unit and accessories.
878.4360 Scalp cooling system to reduce the likelihood of chemotherapy-
          induced alopecia.
878.4370 Surgical drape and drape accessories.
878.4371 Irrigating wound retractor device.
878.4380 Drape adhesive.
878.4400 Electrosurgical cutting and coagulation device and accessories.
878.4410 Low energy ultrasound wound cleaner.
878.4420 Electrosurgical device for over-the-counter aesthetic use.
878.4430 Microneedling device for aesthetic use.
878.4440 Eye pad.
878.4450 Nonabsorbable gauze for internal use.
878.4452 Nonabsorbable expandable hemostatic sponge for temporary 
          internal use.
878.4454 Non-absorbable, hemostatic gauze for temporary internal use.
878.4456 Hemostatic device for intraluminal gastrointestinal use.
878.4460 Non-powdered surgeon's glove.
878.4470 Surgeon's gloving cream.
878.4490 Absorbable hemostatic agent and dressing.
878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by 
          recombinant DNA technology.
878.4495 Stainless steel suture.
878.4520 Polytetrafluoroethylene injectable.
878.4550 Autofluorescence detection device for general surgery and 
          dermatological use.
878.4580 Surgical lamp.
878.4590 Focused ultrasound stimulator system for aesthetic use.
878.4630 Ultraviolet lamp for dermatologic disorders.
878.4635 Sunlamp products and ultraviolet lamps intended for use in 
          sunlamp products.
878.4660 Skin marker.
878.4670 Internal tissue marker.
878.4680 Nonpowered, single patient, portable suction apparatus.
878.4683 Non-Powered suction apparatus device intended for negative 
          pressure wound therapy.
878.4685 Extracorporeal shock wave device for treatment of chronic 
          wounds.
878.4700 Surgical microscope and accessories.
878.4730 Surgical skin degreaser or adhesive tape solvent.
878.4740 Surgical stapler.
878.4750 Implantable staple.
878.4755 Absorbable lung biopsy plug.
878.4760 Removable skin staple.
878.4780 Powered suction pump.
878.4783 Negative pressure wound therapy device for reduction of wound 
          complications.
878.4790 Powered surgical instrument for improvement in the appearance 
          of cellulite.
878.4800 Manual surgical instrument for general use.
878.4805 Manual percutaneous surgical set assembled in the abdomen.
878.4810 Laser surgical instrument for use in general and plastic 
          surgery and in dermatology.
878.4815 Magnetic surgical instrument system.
878.4820 Surgical instrument motors and accessories/attachments.
878.4825 General laparoscopic power morcellation containment system.
878.4830 Absorbable surgical gut suture.
878.4840 Absorbable polydioxanone surgical suture.
878.4850 Blood lancets.
878.4860 Light based energy source device for topical application.
878.4930 Suture retention device.
878.4950 Manual operating table and accessories and manual operating 
          chair and accessories.
878.4960 Operating tables and accessories and operating chairs and 
          accessories.
878.4961 Mountable electromechanical surgical system for transluminal 
          approaches.
878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
878.5010 Nonabsorbable polypropylene surgical suture.
878.5020 Nonabsorbable polyamide surgical suture.
878.5030 Natural nonabsorbable silk surgical suture.
878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.
878.5040 Suction lipoplasty system.
878.5050 Surgical smoke precipitator.

                      Subpart F_Therapeutic Devices

878.5070 Air-handling apparatus for a surgical operating room.
878.5080 Air-handling apparatus accessory.
878.5350 Needle-type epilator.
878.5360 Tweezer-type epilator.
878.5400 Low level laser system for aesthetic use
878.5650 Topical oxygen chamber for extremities.
878.5900 Nonpneumatic tourniquet.
878.5910 Pneumatic tourniquet.


[[Page 578]]


    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    Source: 53 FR 23872, June 24, 1988, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 878 appear at 73 FR 
35341, June 23, 2008.



                      Subpart A_General Provisions



Sec. 878.1  Scope.

    (a) This part sets forth the classification of general and plastic 
surgery devices intended for human use that are in commercial 
distribution.
    (b) The identification of a device in a regulation in this part is 
not a precise description of every device that is, or will be, subject 
to the regulation. A manufacturer who submits a premarket notification 
submission for a device under part 807 cannot show merely that the 
device is accurately described by the section title and identification 
provision of a regulation in this part, but shall state why the device 
is substantially equivalent to other devices, as required by Sec. 
807.87 of this chapter.
    (c) To avoid duplicative listings, a general and plastic surgery 
device that has two or more types of uses (e.g., used both as a 
diagnostic device and as a therapeutic device) is listed in one subpart 
only.
    (d) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21 unless otherwise noted.
    (e) Guidance documents referenced in this part are available on the 
Internet at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/default.htm..

[53 FR 23872, June 24, 1988, as amended at 67 FR 77676, Dec. 19, 2002; 
78 FR 18233, Mar. 26, 2013]



Sec. 878.3  Effective dates of requirement for premarket approval.

    A device included in this part that is classified into class III 
(premarket approval) shall not be commercially distributed after the 
date shown in the regulation classifying the device unless the 
manufacturer has an approval under section 515 of the act (unless an 
exemption has been granted under section 520(g)(2) of the act). An 
approval under section 515 of the act consists of FDA's issuance of an 
order approving an application for premarket approval (PMA) for the 
device or declaring completed a product development protocol (PDP) for 
the device.
    (a) Before FDA requires that a device commercially distributed 
before the enactment date of the amendments, or a device that has been 
found substantially equivalent to such a device, has an approval under 
section 515 of the act, FDA must promulgate a regulation under section 
515(b) of the act requiring such approval, except as provided in 
paragraphs (b) and (c) of this section. Such a regulation under section 
515(b) of the act shall not be effective during the grace period ending 
on the 90th day after its promulgation or on the last day of the 30th 
full calendar month after the regulation that classifies the device into 
class III is effective, whichever is later. See section 501(f)(2)(B) of 
the act. Accordingly, unless an effective date of the requirement for 
premarket approval is shown in the regulation for a device classified 
into class III in this part, the device may be commercially distributed 
without FDA's issuance of an order approving a PMA or declaring 
completed a PDP for the device. If FDA promulgates a regulation under 
section 515(b) of the act requiring premarket approval for a device, 
section 501(f)(1)(A) of the act applies to the device.
    (b) Any new, not substantially equivalent, device introduced into 
commercial distribution on or after May 28, 1976, including a device 
formerly marketed that has been substantially altered, is classified by 
statute (section 513(f) of the act) into class III without any grace 
period and FDA must have issued an order approving a PMA or declaring 
completed a PDP for the device before the device is commercially 
distributed unless it is reclassified. If FDA knows that a device being 
commercially distributed may be a ``new'' device as defined in this 
section because of any new intended use or other reasons, FDA may codify 
the statutory classification of the device into class III for such new 
use. Accordingly, the regulation for such a class III device states that 
as of the enactment date of

[[Page 579]]

the amendments, May 28, 1976, the device must have an approval under 
section 515 of the act before commercial distribution.
    (c) A device identified in a regulation in this part that is 
classified into class III and that is subject to the transitional 
provisions of section 520(l) of the act is automatically classified by 
statute into class III and must have an approval under section 515 of 
the act before being commercially distributed. Accordingly, the 
regulation for such a class III transitional device states that as of 
the enactment date of the amendments, May 28, 1976, the device must have 
an approval under section 515 of the act before commercial distribution.



Sec. 878.9  Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

    The exemption from the requirement of premarket notification 
(section 510(k) of the act) for a generic type of class I or II device 
is only to the extent that the device has existing or reasonably 
foreseeable characteristics of commercially distributed devices within 
that generic type or, in the case of in vitro diagnostic devices, only 
to the extent that misdiagnosis as a result of using the device would 
not be associated with high morbidity or mortality. Accordingly, 
manufacturers of any commercially distributed class I or II device for 
which FDA has granted an exemption from the requirement of premarket 
notification must still submit a premarket notification to FDA before 
introducing or delivering for introduction into interstate commerce for 
commercial distribution the device when:
    (a) The device is intended for a use different from the intended use 
of a legally marketed device in that generic type of device; e.g., the 
device is intended for a different medical purpose, or the device is 
intended for lay use where the former intended use was by health care 
professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro diagnostic 
device detects or identifies infectious agents by using deoxyribonucleic 
acid (DNA) probe or nucleic acid hybridization technology rather than 
culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of neoplastic 
diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial or acquired 
genetic disorders, including inborn errors of metabolism;
    (3) For measuring an analyte that serves as a surrogate marker for 
screening, diagnosis, or monitoring life-threatening diseases such as 
acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, 
tuberculosis, or myocardial infarction or to monitor therapy;
    (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) or IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is intended 
for use in matrices other than serum or plasma;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).

[65 FR 2317, Jan. 14, 2000]



                      Subpart B_Diagnostic Devices



Sec. 878.1800  Speculum and accessories.

    (a) Identification. A speculum is a device intended to be inserted 
into a body cavity to aid observation. It is either nonilluminated or 
illuminated and may have various accessories.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 580]]

subpart E of part 807 of this chapter, subject to the limitations in 
Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 59 
FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, 2001]

Subpart C [Reserved]



                      Subpart D_Prosthetic Devices



Sec. 878.3250  External facial fracture fixation appliance.

    (a) Identification. An external facial fracture fixation appliance 
is a metal apparatus intended to be used during surgical reconstruction 
and repair to immobilize maxillofacial bone fragments in their proper 
facial relationship.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 65 
FR 2317, Jan. 14, 2000]



Sec. 878.3300  Surgical mesh.

    (a) Identification. Surgical mesh is a metallic or polymeric screen 
intended to be implanted to reinforce soft tissue or bone where weakness 
exists. Examples of surgical mesh are metallic and polymeric mesh for 
hernia repair, and acetabular and cement restrictor mesh used during 
orthopedic surgery.
    (b) Classification. Class II.



Sec. 878.3500  Polytetrafluoroethylene with carbon fibers 
composite implant material.

    (a) Identification. A polytetrafluoroethylene with carbon fibers 
composite implant material is a porous device material intended to be 
implanted during surgery of the chin, jaw, nose, or bones or tissue near 
the eye or ear. The device material serves as a space-occupying 
substance and is shaped and formed by the surgeon to conform to the 
patient's need.
    (b) Classification. Class II.



Sec. 878.3510  Carbon dioxide gas controlled tissue expander.

    (a) Identification. A carbon dioxide gas controlled tissue expander 
is a prescription device intended for temporary subcutaneous or 
submuscular implantation to stretch the skin for surgical applications, 
specifically to develop surgical flaps and additional tissue coverage. 
The device is made of an inflatable elastomer shell and is filled with 
carbon dioxide gas. The device utilizes a remote controller to 
administer doses of carbon dioxide gas from an implanted canister inside 
the device.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) In-vivo performance testing must be conducted to obtain the 
adverse event profile associated with use, and demonstrate that the 
device performs as intended under anticipated conditions of use.
    (2) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (3) Performance data must demonstrate the sterility of patient-
contacting components of the device.
    (4) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be tested:
    (i) Cycle testing of expander showing that there are no leaks or 
tears after repeated cycling;
    (ii) Mechanical assessment of implanted carbon dioxide 
(CO2) canister including high impact testing;
    (iii) Leak testing of expander showing that device does not leak 
CO2;
    (iv) Assessment of gas permeability during expansion and after full 
expansion; and
    (v) Mechanical assessment of expander (tensile set, breaking force, 
shell joint test, and fused or adhered joint testing).
    (5) Performance data must be provided to demonstrate the 
electromagnetic compatibility, electrical safety, and wireless 
compatibility of the device.
    (6) Software verification, validation, and hazard analysis must be 
performed.
    (7) Performance data must support shelf life by demonstrating 
continued sterility of the device or the sterile

[[Page 581]]

components, package integrity, and device functionality over the 
identified shelf life.
    (8) Human factors testing and analysis must validate that the device 
design and labeling are sufficient for the end user.
    (9) Physician labeling must include:
    (i) The operating parameters, name, and model number of the 
indicated external dosage controller;
    (ii) Information on how the device operates and the typical course 
of treatment;
    (iii) Information on the population for which the device has been 
demonstrated to be effective;
    (iv) A detailed summary of the device technical parameters; and
    (v) Provisions for choosing an appropriate size implant that would 
be exchanged for the tissue expander.
    (10) Patient labeling must include:
    (i) Warnings, precautions, and contraindications, and adverse 
events/complications;
    (ii) Information on how the device operates and the typical course 
of treatment;
    (iii) The probable risks and benefits associated with the use of the 
device;
    (iv) Post-operative care instructions; and
    (v) Alternative treatments.
    (11) Patient training must include instructions for device use, when 
it may be necessary to contact a physician, and cautionary measures to 
take when the device is implanted.

[87 FR 6421, Feb. 4, 2022]



Sec. 878.3530  Silicone inflatable breast prosthesis.

    (a) Identification. A silicone inflatable breast prosthesis is a 
silicone rubber shell made of polysiloxane(s), such as 
polydimethylsiloxane and polydiphenylsiloxane, that is inflated to the 
desired size with sterile isotonic saline before or after implantation. 
The device is intended to be implanted to augment or reconstruct the 
female breast.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before November 17, 1999, for any silicone 
inflatable breast prosthesis that was in commercial distribution before 
May 28, 1976, or that has, on or before November 17, 1999, been found to 
be substantially equivalent to a silicone inflatable breast prosthesis 
that was in commercial distribution before May 28, 1976. Any other 
silicone inflatable breast prosthesis shall have an approved PMA or a 
declared completed PDP in effect before being placed in commercial 
distribution.

[53 FR 23872, June 24, 1988, as amended at 64 FR 45161, Aug. 19, 1999]



Sec. 878.3540  Silicone gel-filled breast prosthesis.

    (a) Identification--(1) Single-lumen silicone gel-filled breast 
prosthesis. A single-lumen silicone gel-filled breast prosthesis is a 
silicone rubber shell made of polysiloxane(s), such as 
polydimethylsiloxane and polydiphenylsiloxane. The shell either contains 
a fixed amount cross-linked polymerized silicone gel, filler, and 
stabilizers or is filled to the desired size with injectable silicone 
gel at time of implantation. The device is intended to be implanted to 
augment or reconstruct the female breast.
    (2) Double-lumen silicone gel-filled breast prosthesis. A double 
lumen silicone gel-filled breast prosthesis is a silicone rubber inner 
shell and a silicone rubber outer shell, both shells made of 
polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane. 
The inner shell contains fixed amounts of cross-linked polymerized 
silicone gel, fillers, and stabilizers. The outer shell is inflated to 
the desired size with sterile isotonic saline before or after 
implantation. The device is intended to be implanted to augment or 
reconstruct the female breast.
    (3) Polyurethane covered silicone gel-filled breast prosthesis. A 
polyurethane covered silicone gel-filled breast prosthesis is an inner 
silicone rubber shell made of polysiloxane(s), such as 
polydimethylsiloxane and polydiphenylsiloxane, with an outer silicone 
adhesive layer and an outer covering of polyurethane; contained within 
the inner shell is a fixed amount of cross-linked polymerized silicone 
gel, fillers, and stabilizers and an inert

[[Page 582]]

support structure compartmentalizing the silicone gel. The device is 
intended to be implanted to augment or reconstruct the female breast.
    (b) Classification. Class III.
    (c) Date premarket approval application (PMA) is required. A PMA is 
required to be filed with the Food and Drug Administration on or before 
July 9, 1991 for any silicone gel-filled breast prosthesis that was in 
commercial distribution before May 28, 1976, or that has on or before 
July 9, 1991 been found to be substantially equivalent to a silicone 
gel-filled breast prosthesis that was in commercial distribution before 
May 28, 1976. Any other silicone gel-filled breast prosthesis shall have 
an approved PMA in effect before being placed in commercial 
distribution.

[53 FR 23872, June 24, 1988, as amended at 56 FR 14627, Apr. 10, 1991]



Sec. 878.3550  Chin prosthesis.

    (a) Identification. A chin prosthesis is a silicone rubber solid 
device intended to be implanted to augment or reconstruct the chin.
    (b) Classification. Class II.



Sec. 878.3590  Ear prosthesis.

    (a) Identification. An ear prosthesis is a silicone rubber solid 
device intended to be implanted to reconstruct the external ear.
    (b) Classification. Class II.



Sec. 878.3610  Esophageal prosthesis.

    (a) Identification. An esophageal prosthesis is a rigid, flexible, 
or expandable tubular device made of a plastic, metal, or polymeric 
material that is intended to be implanted to restore the structure and/
or function of the esophagus. The metal esophageal prosthesis may be 
uncovered or covered with a polymeric material. This device may also 
include a device delivery system.
    (b) Classification. Class II. The special control for this device is 
FDA's ``Guidance for the Content of Premarket Notification Submissions 
for Esophageal and Tracheal Prostheses.''

[65 FR 17145, Mar. 31, 2000]



Sec. 878.3680  Nose prosthesis.

    (a) Identification. A nose prosthesis is a silicone rubber solid 
device intended to be implanted to augment or reconstruct the nasal 
dorsum.
    (b) Classification. Class II.



Sec. 878.3720  Tracheal prosthesis.

    (a) Identification. The tracheal prosthesis is a rigid, flexible, or 
expandable tubular device made of a silicone, metal, or polymeric 
material that is intended to be implanted to restore the structure and/
or function of the trachea or trachealbronchial tree. It may be 
unbranched or contain one or two branches. The metal tracheal prosthesis 
may be uncovered or covered with a polymeric material. This device may 
also include a device delivery system.
    (b) Classification. Class II. The special control for this device is 
FDA's ``Guidance for the Content of Premarket Notification Submissions 
for Esophageal and Tracheal Prostheses.''

[65 FR 17146, Mar. 31, 2000]



Sec. 878.3750  External prosthesis adhesive.

    (a) Identification. An external prosthesis adhesive is a silicone-
type adhesive intended to be used to fasten to the body an external 
aesthetic restoration prosthesis, such as an artificial nose.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 
FR 38802, July 25, 2001]



Sec. 878.3800  External aesthetic restoration prosthesis.

    (a) Identification. An external aesthetic restoration prosthesis is 
a device intended to be used to construct an external artificial body 
structure, such as an ear, breast, or nose. Usually the device is made 
of silicone rubber and it may be fastened to the body with an external 
prosthesis adhesive. The device is not intended to be implanted.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 878.9. If

[[Page 583]]

the device is intended for use without an external prosthesis adhesive 
to fasten it to the body, the device is exempt from the current good 
manufacturing practice requirements of the quality system regulation in 
part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.

[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 
FR 38802, July 25, 2001]



Sec. 878.3900  Inflatable extremity splint.

    (a) Identification. An inflatable extremity splint is a device 
intended to be inflated to immobilize a limb or an extremity.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 
FR 38802, July 25, 2001]



Sec. 878.3910  Noninflatable extremity splint.

    (a) Identification. A noninflatable extremity splint is a device 
intended to immobilize a limb or an extremity. It is not inflatable.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 878.9. If the device is not labeled or 
otherwise represented as sterile, it is exempt from the current good 
manufacturing practice requirements of the quality system regulation in 
part 820 of this chapter, with the exception of Sec. 820.180 of this 
chapter, with respect to general requirements concerning records, and 
Sec. 820.198 of this chapter, with respect to complaint files.

[53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 65 
FR 2317, Jan. 14, 2000]



Sec. 878.3925  Plastic surgery kit and accessories.

    (a) Identification. A plastic surgery kit and accessories is a 
device intended to be used to reconstruct maxillofacial deficiencies. 
The kit contains surgical instruments and materials used to make 
maxillofacial impressions before molding an external prosthesis.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 65 
FR 2317, Jan. 14, 2000]



                       Subpart E_Surgical Devices



Sec. 878.4010  Tissue adhesive.

    (a) Tissue adhesive for the topical approximation of skin--(1) 
Identification. A tissue adhesive for the topical approximation of skin 
is a device intended for topical closure of surgical incisions, 
including laparoscopic incisions, and simple traumatic lacerations that 
have easily approximated skin edges. Tissue adhesives for the topical 
approximation of skin may be used in conjunction with, but not in place 
of, deep dermal stitches.
    (2) Classification. Class II (special controls). The special control 
for this device is FDA's ``Class II Special Controls Guidance Document: 
``Tissue Adhesive for the Topical Approximation of Skin.'' See Sec. 
878.1(e) of this chapter for the availability of this guidance document.
    (b) Tissue adhesive for non-topical use--(1) Identification. A 
tissue adhesive for non-topical use, including adhesives intended for 
use in the embolization of brain arteriovenous malformation or for use 
in ophthalmic surgery, is a device used for adhesion of internal tissues 
and vessels.
    (2) Classification. Class III (premarket approval). As of May 28, 
1976, an approval under section 515 of the act is required before this 
device may be commercially distributed. See Sec. 878.3 of this chapter.

[73 FR 31033, May 30, 2008]



Sec. 878.4011  Tissue adhesive with adjunct wound closure device
for topical approximation of skin.

    (a) Identification. A tissue adhesive with adjunct wound closure 
device intended for the topical approximation of

[[Page 584]]

skin is a device indicated for topical application only to hold closed 
easily approximated skin edges of wounds from surgical incisions, 
including punctures from minimally invasive surgery, and simple, 
thoroughly cleansed, trauma-induced lacerations. It may be used in 
conjunction with, but not in place of, deep dermal stitches. 
Additionally, the adjunct wound closure device component maintains 
temporary skin edge alignment along the length of wound during 
application of the liquid adhesive.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's ``Guidance for Industry and FDA Staff; Class II 
Special Controls Guidance Document: Tissue Adhesive with Adjunct Wound 
Closure Device Intended for the Topical Approximation of Skin.'' See 
Sec. 878.1(e) for the availability of this guidance document.

[75 FR 68794, Nov. 10, 2010]



Sec. 878.4014  Nonresorbable gauze/sponge for external use.

    (a) Identification. A nonresorbable gauze/sponge for external use is 
a sterile or nonsterile device intended for medical purposes, such as to 
be placed directly on a patient's wound to absorb exudate. It consists 
of a strip, piece, or pad made from open woven or nonwoven mesh cotton 
cellulose or a simple chemical derivative of cellulose. This 
classification does not include a nonresorbable gauze/sponge for 
external use that contains added drugs such as antimicrobial agents, 
added biologics such as growth factors, or is composed of materials 
derived from animal sources.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in part 807, subpart E of 
this chapter subject to the limitations in Sec. 878.9.

[64 FR 53929, Oct. 5, 1999]



Sec. 878.4015  Wound dressing with poly (diallyl dimethyl 
ammonium chloride) (pDADMAC) additive.

    (a) Identification. A wound dressing with pDADMAC additive is 
intended for use as a primary dressing for exuding wounds, 1st and 2d 
degree burns, and surgical wounds, to secure and prevent movement of a 
primary dressing, and as a wound packing.
    (b) Classification. Class II (special controls). The special control 
is: the FDA guidance document entitled ``Class II Special Controls 
Guidance Document: Wound Dressing With Poly (Diallyl Dimethyl Ammonium 
Chloride) (pDADMAC) Additive.'' See Sec. 878.1(e) for availability of 
this guidance document.

[74 FR 53167, Oct. 16, 2009]



Sec. 878.4018  Hydrophilic wound dressing.

    (a) Identification. A hydrophilic wound dressing is a sterile or 
non-sterile device intended to cover a wound and to absorb exudate. It 
consists of nonresorbable materials with hydrophilic properties that are 
capable of absorbing exudate (e.g., cotton, cotton derivatives, 
alginates, dextran, and rayon). This classification does not include a 
hydrophilic wound dressing that contains added drugs such as 
antimicrobial agents, added biologics such as growth factors, or is 
composed of materials derived from animal sources.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in part 807, subpart E of 
this chapter subject to the limitations in Sec. 878.9.

[64 FR 53929, Oct. 5, 1999]



Sec. 878.4020  Occlusive wound dressing.

    (a) Identification. An occlusive wound dressing is a nonresorbable, 
sterile or non-sterile device intended to cover a wound, to provide or 
support a moist wound environment, and to allow the exchange of gases 
such as oxygen and water vapor through the device. It consists of a 
piece of synthetic polymeric material, such as polyurethane, with or 
without an adhesive backing. This classification does not include an 
occlusive wound dressing that contains added drugs such as antimicrobial 
agents, added biologics such as growth factors, or is composed of 
materials derived from animal sources.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 585]]

part 807, subpart E of this chapter subject to the limitations in Sec. 
878.9.

[64 FR 53929, Oct. 5, 1999]



Sec. 878.4022  Hydrogel wound dressing and burn dressing.

    (a) Identification. A hydrogel wound dressing is a sterile or non-
sterile device intended to cover a wound, to absorb wound exudate, to 
control bleeding or fluid loss, and to protect against abrasion, 
friction, desiccation, and contamination. It consists of a nonresorbable 
matrix made of hydrophilic polymers or other material in combination 
with water (at least 50 percent) and capable of absorbing exudate. This 
classification does not include a hydrogel wound dressing that contains 
added drugs such as antimicrobial agents, added biologics such as growth 
factors, or is composed of materials derived from animal sources.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in part 807, subpart E of 
this chapter subject to the limitations in Sec. 878.9.

[64 FR 53929, Oct. 5, 1999]



Sec. 878.4025  Silicone sheeting.

    (a) Identification. Silicone sheeting is intended for use in the 
management of closed hyperproliferative (hypertrophic and keloid) scars.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 878.9.

[69 FR 48148, Aug. 9, 2004]



Sec. 878.4040  Surgical apparel.

    (a) Identification. Surgical apparel are devices that are intended 
to be worn by operating room personnel during surgical procedures to 
protect both the surgical patient and the operating room personnel from 
transfer of microorganisms, body fluids, and particulate material. 
Examples include surgical caps, hoods, masks, gowns, operating room 
shoes and shoe covers, and isolation masks and gowns. Surgical suits and 
dresses, commonly known as scrub suits, are excluded.
    (b) Classification. (1) Class II (special controls) for surgical 
gowns and surgical masks. A surgical N95 respirator or N95 filtering 
facepiece respirator is not exempt if it is intended to prevent specific 
diseases or infections, or it is labeled or otherwise represented as 
filtering surgical smoke or plumes, filtering specific amounts of 
viruses or bacteria, reducing the amount of and/or killing viruses, 
bacteria, or fungi, or affecting allergenicity, or it contains coating 
technologies unrelated to filtration (e.g., to reduce and or kill 
microorganisms). Surgical N95 respirators and N95 filtering facepiece 
respirators are exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to Sec. 878.9, and the 
following conditions for exemption:
    (i) The user contacting components of the device must be 
demonstrated to be biocompatible.
    (ii) Analysis and nonclinical testing must:
    (A) Characterize flammability and be demonstrated to be appropriate 
for the intended environment of use; and
    (B) Demonstrate the ability of the device to resist penetration by 
fluids, such as blood and body fluids, at a velocity consistent with the 
intended use of the device.
    (iii) NIOSH approved under its regulation.
    (2) Class I (general controls) for surgical apparel other than 
surgical gowns and surgical masks. The class I device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 65 FR 2317, Jan. 14, 2000; 83 
FR 22848, May 17, 2018]



Sec. 878.4100  Organ bag.

    (a) Identification. An organ bag is a device that is a flexible 
plastic bag intended to be used as a temporary receptacle for an organ 
during surgical procedures to prevent moisture loss.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 65 
FR 2318, Jan. 14, 2000]

[[Page 586]]



Sec. 878.4160  Surgical camera and accessories.

    (a) Identification. A surgical camera and accessories is a device 
intended to be used to record operative procedures.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 66 
FR 38802, July 25, 2001]



Sec. 878.4165  Wound autofluorescence imaging device.

    (a) Identification. A wound autofluorescence imaging device is a 
tool to view autofluorescence images from skin wounds that are exposed 
to an excitation light. The device is not intended to provide 
quantitative or diagnostic information.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 878.9.

[83 FR 52968, Oct. 19, 2018]



Sec. 878.4200  Introduction/drainage catheter and accessories.

    (a) Identification. An introduction/drainage catheter is a device 
that is a flexible single or multilumen tube intended to be used to 
introduce nondrug fluids into body cavities other than blood vessels, 
drain fluids from body cavities, or evaluate certain physiologic 
conditions. Examples include irrigation and drainage catheters, 
pediatric catheters, peritoneal catheters (including dialysis), and 
other general surgical catheters. An introduction/drainage catheter 
accessory is intended to aid in the manipulation of or insertion of the 
device into the body. Examples of accessories include adaptors, 
connectors, and catheter needles.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 65 FR 2318, Jan. 14, 2000]



Sec. 878.4300  Implantable clip.

    (a) Identification. An implantable clip is a clip-like device 
intended to connect internal tissues to aid healing. It is not 
absorbable.
    (b) Classification. Class II.



Sec. 878.4320  Removable skin clip.

    (a) Identification. A removable skin clip is a clip-like device 
intended to connect skin tissues temporarily to aid healing. It is not 
absorbable.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 65 FR 2318, Jan. 14, 2000]



Sec. 878.4340  Contact cooling system for aesthetic use.

    (a) Identification. A contact cooling system for aesthetic use is a 
device that is a combination of a cooling pad associated with a vacuum 
or mechanical massager intended for the disruption of adipocyte cells 
intended for non-invasive aesthetic use.
    (b) Classification. Class II (special controls). The special 
controls for this device is FDA's ``Guidance for Industry and FDA Staff; 
Class II Special Controls Guidance Document: Contact Cooling System for 
Aesthetic Use.'' See Sec. 878.1(e) for the availability of this 
guidance document.

[76 FR 6553, Feb. 7, 2011]



Sec. 878.4350  Cryosurgical unit and accessories.

    (a) Identification--(1) Cryosurgical unit with a liquid nitrogen 
cooled cryoprobe and accessories. A cryosurgical unit with a liquid 
nitrogen cooled cryoprobe and accessories is a device intended to 
destroy tissue during surgical procedures by applying extreme cold.
    (2) Cryosurgical unit with a nitrous oxide cooled cryoprobe and 
accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe 
and accessories is a device intended to destroy tissue during surgical 
procedures, including urological applications, by applying extreme cold.
    (3) Cryosurgical unit with a carbon dioxide cooled cryoprobe or a 
carbon dioxide

[[Page 587]]

dry ice applicator and accessories. A cryosurgical unit with a carbon 
dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and 
accessories is a device intended to destroy tissue during surgical 
procedures by applying extreme cold. The device is intended to treat 
disease conditions such as tumors, skin cancers, acne scars, or 
hemangiomas (benign tumors consisting of newly formed blood vessels) and 
various benign or malignant gynecological conditions affecting vulvar, 
vaginal, or cervical tissue. The device is not intended for urological 
applications.
    (b) Classification. Class II.



Sec. 878.4360  Scalp cooling system to reduce the likelihood
of chemotherapy-induced alopecia.

    (a) Identification. A scalp cooling system to reduce the likelihood 
of chemotherapy-induced alopecia is a prescription device intended to 
reduce the frequency and severity of alopecia during chemotherapy in 
which alopecia-inducing chemotherapeutic agents are used.
    (b) Classification--Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance testing must demonstrate that the 
device meets all design specifications and performance requirements, and 
that the device performs as intended under anticipated conditions of 
use. This information must include testing to demonstrate accuracy of 
the temperature control mechanism.
    (2) Performance testing must demonstrate the electromagnetic 
compatibility and electrical safety of the device.
    (3) Software verification, validation, and hazard analysis must be 
performed.
    (4) The patient contacting components of the device must be 
demonstrated to be biocompatible. Material names must be provided.
    (5) Labeling must include the following:
    (i) A statement describing the potential risk of developing scalp 
metastasis.
    (ii) Information on the patient population and chemotherapeutic 
agents/regimen for which the device has been demonstrated to be 
effective.
    (iii) A summary of the non-clinical and/or clinical testing 
pertinent to use of the device.
    (iv) A summary of the device technical parameters, including 
temperature cooling range and duration of cooling.
    (v) A summary of the device- and procedure-related adverse events 
pertinent to use of the device.
    (vi) Information on how the device operates and the typical course 
of treatment.
    (6) Patient labeling must be provided and must include:
    (i) Relevant contraindications, warnings, precautions, and adverse 
effects/complications.
    (ii) Information on how the device operates and the typical course 
of treatment.
    (iii) Information on the patient population for which there is 
clinical evidence of effectiveness.
    (iv) The potential risks and benefits associated with use of the 
device.
    (v) Postoperative care instructions.
    (vi) A statement describing the potential risk of developing scalp 
metastasis.

[81 FR 7453, Feb. 12, 2016]



Sec. 878.4370  Surgical drape and drape accessories.

    (a) Identification. A surgical drape and drape accessories is a 
device made of natural or synthetic materials intended to be used as a 
protective patient covering, such as to isolate a site of surgical 
incision from microbial and other contamination. The device includes a 
plastic wound protector that may adhere to the skin around a surgical 
incision or be placed in a wound to cover its exposed edges, and a latex 
drape with a self-retaining finger cot that is intended to allow 
repeated insertion of the surgeon's finger into the rectum during 
performance of a transurethral prostatectomy.
    (b) Classification. Class II (special controls). The device, when it 
is an ear, nose, and throat surgical drape, a latex sheet drape with 
self-retaining finger cot, a disposable urological drape, a Kelly pad, 
an ophthalmic patient drape, an ophthalmic microscope drape, an internal 
drape retention ring (wound protector), or a surgical drape

[[Page 588]]

that does not include an antimicrobial agent, is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 84 FR 71814, Dec. 30, 2019]



Sec. 878.4371  Irrigating wound retractor device.

    (a) Identification. An irrigating wound retractor device is a 
prescription device intended to be used by a surgeon to retract the 
surgical incision, to provide access to the surgical wound, to protect 
and irrigate the surgical wound, and to serve as a conduit for removal 
of fluid from the surgical wound.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient-contacting components of the device must be 
demonstrated to be biocompatible and evaluated for particulate matter.
    (2) Performance data must demonstrate the sterility and pyrogenicity 
of the patient-contacting components of the device.
    (3) Performance data must support shelf life by demonstrating 
continued functionality and sterility of the device over the identified 
shelf life.
    (4) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. 
Performance testing must:
    (i) Characterize the tear resistance, tensile strength, and 
elongation properties of the barrier material;
    (ii) Demonstrate that the liquid barrier material is resistant to 
penetration by blood, and is non-flammable;
    (iii) Characterize the forces required to deploy the device;
    (iv) Characterize the device's ranges of operation, including flow 
rates and maximum suction pressures;
    (v) Demonstrate the ability of the device irrigation apparatus to 
maintain a user defined or preset flow rate to the surgical wound; and
    (vi) Demonstrate the ability of the device to maintain user defined 
or preset removal rates of fluid from the surgical wound.
    (5) The labeling must include or state the following information:
    (i) Device size or incision length range;
    (ii) Method of sterilization;
    (iii) Flammability classification;
    (iv) Non-pyrogenic;
    (v) Shelf life; and
    (vi) Maximum flow rate and suction pressure.

[83 FR 24, Jan. 2, 2018]



Sec. 878.4380  Drape adhesive.

    (a) Identification. A drape adhesive is a device intended to be 
placed on the skin to attach a surgical drape.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 
FR 38802, July 25, 2001]



Sec. 878.4400  Electrosurgical cutting and coagulation device and accessories.

    (a) Identification. An electrosurgical cutting and coagulation 
device and accessories is a device intended to remove tissue and control 
bleeding by use of high-frequency electrical current.
    (b) Classification. Class II.



Sec. 878.4410  Low energy ultrasound wound cleaner.

    (a) Identification. A low energy ultrasound wound cleaner is a 
device that uses ultrasound energy to vaporize a solution and generate a 
mist that is used for the cleaning and maintenance debridement of 
wounds. Low levels of ultrasound energy may be carried to the wound by 
the saline mist.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance document entitled ``Class II Special Controls Guidance 
Document: Low Energy Ultrasound Wound Cleaner.'' See Sec. 878.1(e) for 
the availability of this guidance document.

[70 FR 67355, Nov. 7, 2005]



Sec. 878.4420  Electrosurgical device for over-the-counter aesthetic use.

    (a) Identification. An electrosurgical device for over-the-counter 
aesthetic

[[Page 589]]

use is a device using radiofrequency energy to produce localized heating 
within tissues for non-invasive aesthetic use.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance data must demonstrate that the device 
meets all design specifications and performance requirements. The 
following performance characteristics must be tested: Over-heating, 
power accuracy radiofrequency, pulse cycle, waveform, pulse duration, 
and device characterization parameters.
    (2) Label comprehension and self-selection performance evaluation 
must demonstrate that the intended over-the-counter users can understand 
the package labeling and correctly choose the device for the indicated 
aesthetic use.
    (3) Usability performance evaluation must demonstrate that the over-
the-counter user can correctly use the device, based solely on reading 
the directions for use, to treat the indicated aesthetic use.
    (4) Clinical performance evaluation must demonstrate that the device 
performs as intended under anticipated conditions of use to achieve the 
intended aesthetic results.
    (5) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (6) Instructions for cleaning the device must be validated.
    (7) Performance data must be provided to demonstrate the 
electromagnetic compatibility and electrical safety, including the 
mechanical integrity, of the device.
    (8) Software verification, validation, and hazard analysis must be 
performed.
    (9) Labeling must include:
    (i) Warnings, precautions, and contraindications to ensure the safe 
use of the device for the over-the-counter users.
    (ii) A statement that the safety and effectiveness of the device's 
use for uses other than the indicated aesthetic use are not known.
    (iii) A summary of the clinical information used to establish 
effectiveness for each indicated aesthetic usage and observed adverse 
events.

[81 FR 42244, June 29, 2016]



Sec. 878.4430  Microneedling device for aesthetic use.

    (a) Identification. A microneedling device for aesthetic use is a 
device using one or more needles to mechanically puncture and injure 
skin tissue for aesthetic use. This classification does not include 
devices intended for transdermal delivery of topical products such as 
cosmetics, drugs, or biologics.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The technical specifications and needle characteristics must be 
identified, including needle length, geometry, maximum penetration 
depth, and puncture rate.
    (2) Non-clinical performance data must demonstrate that the device 
performs as intended under anticipated conditions of use. The following 
performance characteristics must be tested:
    (i) Accuracy of needle penetration depth and puncture rate;
    (ii) Safety features built into the device to protect against cross-
contamination, including fluid ingress protection; and
    (iii) Identification of the maximum safe needle penetration depth 
for the device for the labeled indications for use.
    (3) Performance data must demonstrate the sterility of the patient-
contacting components of the device.
    (4) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the intended shelf life.
    (5) Performance data must demonstrate the electrical safety and 
electromagnetic compatibility (EMC) of all electrical components of the 
device.
    (6) Software verification, validation, and hazard analysis must be 
performed for all software components of the device.
    (7) The patient-contacting components of the device must be 
demonstrated to be biocompatible.

[[Page 590]]

    (8) Performance data must validate the cleaning and disinfection 
instructions for reusable components of the device.
    (9) Labeling must include the following:
    (i) Information on how to operate the device and its components and 
the typical course of treatment;
    (ii) A summary of the device technical parameters, including needle 
length, needle geometry, maximum penetration depth, and puncture rate;
    (iii) Validated methods and instructions for reprocessing of any 
reusable components;
    (iv) Disposal instructions; and
    (v) A shelf life.
    (10) Patient labeling must be provided and must include:
    (i) Information on how the device operates and the typical course of 
treatment;
    (ii) The probable risks and benefits associated with use of the 
device; and
    (iii) Postoperative care instructions.

[83 FR 26577, June 8, 2018]



Sec. 878.4440  Eye pad.

    (a) Identification. An eye pad is a device that consists of a pad 
made of various materials, such as gauze and cotton, intended for use as 
a bandage over the eye for protection or absorption of secretions.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 
FR 38803, July 25, 2001]



Sec. 878.4450  Nonabsorbable gauze for internal use.

    (a) Identification. Nonabsorbable gauze for internal use is a device 
made of an open mesh fabric intended to be used inside the body or a 
surgical incision or applied to internal organs or structures, to 
control bleeding, absorb fluid, or protect organs or structures from 
abrasion, drying, or contamination. The device is woven from material 
made of not less than 50 percent by mass cotton, cellulose, or a simple 
chemical derivative of cellulose, and contains x-ray detectable 
elements.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996; 66 
FR 38803, July 25, 2001]



Sec. 878.4452  Nonabsorbable expandable hemostatic sponge for
temporary internal use.

    (a) Identification. A nonabsorbable expandable hemostatic sponge for 
temporary internal use is a prescription device intended to be placed 
temporarily into junctional, non-compressible wounds, which are not 
amenable to tourniquet use, to control bleeding until surgical care is 
acquired. The sponges expand upon contact with blood to fill the wound 
cavity and provide a physical barrier and pressure that facilitates 
formation of a clot. The device consists of sterile, nonabsorbable 
radiopaque compressed sponges and may include an applicator to 
facilitate delivery into a wound.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Performance data must demonstrate the biocompatibility of 
patient-contacting components.
    (2) Performance data must demonstrate the sterility of patient-
contacting components including endotoxin and pyrogenicity assessments.
    (3) Performance data must support device stability by demonstrating 
continued sterility of the patient-contacting components of the device, 
package integrity, and device functionality over the requested shelf 
life.
    (4) Assessment of material characteristics must be sufficient to 
support safety under anticipated conditions of use. Assessments must 
include the following:
    (i) Material specifications.
    (ii) Immunogenicity.
    (iii) Viral inactivation for animal-derived materials.
    (5) Non-clinical performance data must demonstrate that the device 
performs as intended under anticipated

[[Page 591]]

conditions of use. The following performance characteristics must be 
tested:
    (i) Absorption capacity.
    (ii) Extent of swelling.
    (iii) Mechanical properties.
    (iv) Expansion force/pressure.
    (v) Radiopacity.
    (vi) Deployment/applicator functionality.
    (6) In vivo performance data must demonstrate safe and effective use 
by verifying that the device performs as intended under anticipated 
conditions of use. Appropriate analysis/testing must demonstrate that 
the product: Controls bleeding, does not promote adverse local or 
systemic effects, and can be completely removed from the wound. The 
following performance characteristics must be tested:
    (i) Deployment.
    (ii) Control of bleeding.
    (iii) Radiopacity.
    (iv) Retrieval.
    (v) Assessment of local and systemic effects.
    (7) Human factors testing and analysis must validate that the device 
design and labeling are sufficient for appropriate use by emergency 
responders deploying the device as well as surgeons retrieving the 
device from wounds.
    (8) Labeling must include:
    (i) Specific instructions for deployment by emergency responders and 
retrieval by surgeons.
    (ii) Warnings, cautions, and limitations needed for safe use of the 
device.
    (iii) Information on how the device operates and the typical course 
of treatment.
    (iv) A detailed summary of the in vivo and human factors testing 
pertinent to use of the device.
    (v) Appropriate imaging information to ensure complete retrieval of 
device.
    (vi) An expiration date/shelf life.

[79 FR 34224, June 16, 2014]



Sec. 878.4454  Non-absorbable, hemostatic gauze for temporary internal use.

    (a) Identification. A non-absorbable, hemostatic gauze for temporary 
internal use is a prescription device intended to be placed temporarily 
for control of severely bleeding wounds such as surgical wounds and 
traumatic injuries. The gauze is coated or impregnated with a hemostatic 
material which may enhance hemostasis by physical means. The device is 
intended to be removed once the patient is stabilized.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Animal performance testing must demonstrate that the device 
performs as intended under anticipated conditions of use. Specifically 
testing must:
    (i) Demonstrate that the device is able to achieve hemostasis;
    (ii) Demonstrate that the device can be radiographically detected; 
and
    (iii) Assess pertinent safety endpoints including vascular 
obstruction and adhesion formation.
    (2) The device must be demonstrated to be biocompatible.
    (3) Non-clinical performance data must demonstrate that the device 
performs as intended under anticipated conditions of use. The following 
tests must be performed:
    (i) In vitro clot assessment;
    (ii) Particulate release testing;
    (iii) Physical characterization, including swelling percent and 
particulate size;
    (iv) Chemical characterization;
    (v) Radiopacity testing; and
    (vi) Mechanical integrity testing, including tensile strength and 
tear strength.
    (4) Performance data must demonstrate the sterility of the device.
    (5) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the identified shelf life.
    (6) Labeling must include the following:
    (i) Instructions for use, including an instruction to remove all 
visible device components by irrigation;
    (ii) The maximum amount of time the device may be left within the 
body;
    (iii) A shelf life;
    (iv) A contraindication for intravascular use of the device; and
    (v) A warning regarding the potential for adhesion formation.

[83 FR 6794, Feb. 15, 2018]

[[Page 592]]



Sec. 878.4456  Hemostatic device for intraluminal gastrointestinal use.

    (a) Identification. A hemostatic device for intraluminal 
gastrointestinal use is a prescription device that is endoscopically 
applied to the upper and/or lower gastrointestinal tract and is intended 
to produce hemostasis via absorption of fluid or by other physical 
means.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The device must be demonstrated to be biocompatible.
    (2) Performance data must support the sterility and pyrogenicity of 
the device.
    (3) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the identified shelf life.
    (4) In vivo performance testing must demonstrate that the device 
performs as intended under anticipated conditions of use. The testing 
must evaluate the following:
    (i) The ability to deliver the hemostatic material to the bleeding 
site;
    (ii) The ability to achieve hemostasis in a clinically relevant 
model of gastrointestinal bleeding; and
    (iii) Safety endpoints, including thromboembolic events, local and 
systemic toxicity, tissue trauma, gastrointestinal tract obstruction, 
and bowel distension and perforation.
    (5) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be evaluated:
    (i) Materials characterization of all components must demonstrate 
the device meets established specifications, which must include 
compositional identity and purity, characterization of impurities, 
physical characteristics, and reactivity with fluids.
    (ii) Performance testing must demonstrate the mechanical integrity 
and functionality of the system used to deliver the device and 
demonstrate the device meets established specifications, including 
output pressure for propellant-based systems.
    (6) Labeling must include:
    (i) Information identifying and explaining how to use the device and 
its components; and
    (ii) A shelf life.

[83 FR 52971, Oct. 19, 2018]



Sec. 878.4460  Non-powdered surgeon's glove.

    (a) Identification. A non-powdered surgeon's glove is a device 
intended to be worn on the hands of operating room personnel to protect 
a surgical wound from contamination. A non-powdered surgeon's glove does 
not incorporate powder for purposes other than manufacturing. The final 
finished glove includes only residual powder from manufacturing.
    (b) Classification. Class I (general controls).

[53 FR 23872, June 24, 1988, as amended at 66 FR 46952, Sept. 10, 2001; 
81 FR 91730, Dec. 19, 2016]



Sec. 878.4470  Surgeon's gloving cream.

    (a) Identification. Surgeon's gloving cream is an ointment intended 
to be used to lubricate the user's hand before putting on a surgeon's 
glove.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 
FR 38803, July 25, 2001]



Sec. 878.4490  Absorbable hemostatic agent and dressing.

    (a) Identification. An absorbable hemostatic agent or dressing is a 
device intended to produce hemostasis by accelerating the clotting 
process of blood. It is absorbable.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. As of May 
28, 1976, an approval under section 515 of the act is required before 
this device may be commercially distributed. See Sec. 878.3.



Sec. 878.4493  Absorbable poly(glycolide/l-lactide) surgical suture.

    (a) Identification. An absorbable poly(glycolide/l-lactide) surgical 
suture (PGL suture) is an absorbable sterile,

[[Page 593]]

flexible strand as prepared and synthesized from homopolymers of 
glycolide and copolymers made from 90 percent glycolide and 10 percent 
l-lactide, and is indicated for use in soft tissue approximation. A PGL 
suture meets United States Pharmacopeia (U.S.P.) requirements as 
described in the U.S.P. ``Monograph for Absorbable Surgical Sutures;'' 
it may be monofilament or multifilament (braided) in form; it may be 
uncoated or coated; and it may be undyed or dyed with an FDA-approved 
color additive. Also, the suture may be provided with or without a 
standard needle attached.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's ``Class II Special Controls Guidance Document: 
Surgical Sutures; Guidance for Industry and FDA.'' See Sec. 878.1(e) 
for the availability of this guidance document.

[56 FR 47151, Sept. 18, 1991, as amended at 68 FR 32984, June 3, 2003]



Sec. 878.4494  Absorbable poly(hydroxybutyrate) surgical suture
produced by recombinant DNA technology.

    (a) Identification. An absorbable poly(hydroxybutyrate) surgical 
suture is an absorbable surgical suture made of material isolated from 
prokaryotic cells produced by recombinant deoxyribonucleic acid (DNA) 
technology. The device is intended for use in general soft tissue 
approximation and ligation.
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA guidance document entitled ``Class II Special 
Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical 
Suture Produced by Recombinant DNA Technology.'' For the availability of 
this guidance document see Sec. 878.1(e).

[72 FR 43146, Aug. 3, 2007]



Sec. 878.4495  Stainless steel suture.

    (a) Identification. A stainless steel suture is a needled or 
unneedled nonabsorbable surgical suture composed of 316L stainless 
steel, in USP sizes 12-0 through 10, or a substantially equivalent 
stainless steel suture, intended for use in abdominal wound closure, 
intestinal anastomosis, hernia repair, and sternal closure.
    (b) Classification. Class II (special controls). The device, when it 
is a steel monofilament suture that is uncoated and does not incorporate 
barbs, is exempt from the premarket notification procedures in subpart E 
of part 807 of this chapter subject to the limitations in Sec. 878.9. 
The special control for this device is FDA's ``Class II Special Controls 
Guidance Document: Surgical Sutures; Guidance for Industry and FDA.'' 
See Sec. 878.1(e) for the availability of this guidance document.

[65 FR 19836, Apr. 13, 2000, as amended at 68 FR 32984, June 3, 2003; 84 
FR 71814, Dec. 30, 2019]



Sec. 878.4520  Polytetrafluoroethylene injectable.

    (a) Identification. Polytetrafluoroethylene injectable is an 
injectable paste prosthetic device composed of polytetrafluoroethylene 
intended to be used to augment or reconstruct a vocal cord.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. As of May 
28, 1976, an approval under section 515 of the act is required before 
this device may be commercially distributed. See Sec. 878.3.



Sec. 878.4550  Autofluorescence detection device for general 
surgery and dermatological use.

    (a) Identification. An autofluorescence detection device for general 
surgery and dermatological use is an adjunct tool that uses 
autofluorescence to detect tissues or structures. This device is not 
intended to provide a diagnosis.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) In vivo testing under anticipated conditions of use must 
characterize the ability of the device to detect autofluorescent signals 
from tissues or structures consistent with the indications for use.
    (2) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (3) Performance testing must demonstrate the electromagnetic 
compatibility and electrical, mechanical, and thermal safety of the 
device.

[[Page 594]]

    (4) Software verification, validation, and hazard analysis must be 
performed.
    (5) Performance testing must demonstrate the sterility of patient-
contacting components of the device.
    (6) Performance testing must support the shelf life of device 
components provided sterile by demonstrating continued sterility and 
package integrity over the labeled shelf life.
    (7) Performance testing must demonstrate laser and light safety for 
eye, tissue, and skin.
    (8) Labeling must include the following:
    (i) Instructions for use;
    (ii) The detection performance characteristics of the device when 
used as intended; and
    (iii) A shelf life for any sterile components.

[87 FR 24273, Apr. 25, 2022]



Sec. 878.4580  Surgical lamp.

    (a) Identification. A surgical lamp (including a fixture) is a 
device intended to be used to provide visible illumination of the 
surgical field or the patient.
    (b) Classification. Class II (special controls). The device, when it 
is an operating room lamp, a surgical instrument light, a surgical floor 
standing light, an endoscopic surgical light, a surgical light 
connector, a ceiling mounted surgical light, a surgical light carrier, 
surgical light accessories, a surgical lamp, a remote illuminator, or an 
incandescent surgical lamp, is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 84 FR 71814, Dec. 30, 2019]



Sec. 878.4590  Focused ultrasound stimulator system for aesthetic use.

    (a) Identification. A Focused Ultrasound Stimulator System for 
Aesthetic Use is a device using focused ultrasound to produce localized, 
mechanical motion within tissues and cells for the purpose of producing 
either localized heating for tissue coagulation or for mechanical 
cellular membrane disruption intended for noninvasive aesthetic use.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's ``Class II Special Controls Guidance Document: 
Focused Ultrasound Stimulator System for Aesthetic Use.'' See Sec. 
878.1(e) for the availability of this guidance document.

[76 FR 43121, July 20, 2011]



Sec. 878.4630  Ultraviolet lamp for dermatologic disorders.

    (a) Identification. An ultraviolet lamp for dermatologic disorders 
is a device (including a fixture) intended to provide ultraviolet 
radiation of the body to photoactivate a drug in the treatment of a 
dermatologic disorder if the labeling of the drug intended for use with 
the device bears adequate directions for the device's use with that 
drug.
    (b) Classification. Class II.



Sec. 878.4635  Sunlamp products and ultraviolet lamps intended
for use in sunlamp products.

    (a) Identification. A sunlamp product is any device designed to 
incorporate one or more ultraviolet (UV) lamps intended for irradiation 
of any part of the living human body, by UV radiation with wavelengths 
in air between 200 and 400 nanometers, to induce skin tanning. This 
definition includes tanning beds and tanning booths. A UV lamp intended 
for use in sunlamp products is any lamp that produces UV radiation in 
the wavelength interval of 200 to 400 nanometers in air.
    (b) Classification. Class II (special controls). The special 
controls for sunlamp products and UV lamps intended for use in sunlamp 
products are:
    (1) Conduct performance testing that demonstrates the following:
    (i) Device meets appropriate output performance specifications such 
as wavelengths, energy density, and lamp life; and
    (ii) Device's safety features, such as timers to limit UV exposure 
and alarms, function properly.
    (2) Demonstrate that device is mechanically safe to prevent user 
injury.
    (3) Demonstrate software verification, validation, and hazard 
analysis.
    (4) Demonstrate that device is biocompatible.

[[Page 595]]

    (5) Demonstrate that device is electrically safe and 
electromagnetically compatible in its intended use environment.
    (6) Labeling--(i) Sunlamp products. (A) The warning statement below 
must appear on all sunlamp products and must be placed in a black box. 
This statement must be permanently affixed or inscribed on the product 
when fully assembled for use so as to be legible and readily accessible 
to view by the person who will be exposed to UV radiation immediately 
before the use of the product. It shall be of sufficient durability to 
remain legible throughout the expected lifetime of the product. It shall 
appear on a part or panel displayed prominently under normal conditions 
of use so that it is readily accessible to view whether the tanning bed 
canopy (or tanning booth door) is open or closed when the person who 
will be exposed approaches the equipment and the text shall be at least 
10 millimeters (height). Labeling on the device must include the 
following statement:

------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Attention: This sunlamp product should not be used on persons under the
 age of 18 years.
------------------------------------------------------------------------

    (B) Manufacturers shall provide validated instructions on cleaning 
and disinfection of sunlamp products between uses in the user 
instructions.
    (ii) Sunlamp products and UV lamps intended for use in sunlamp 
products. Manufacturers of sunlamp products and UV lamps intended for 
use in sunlamp products shall provide or cause to be provided in the 
user instructions, as well as all consumer-directed catalogs, 
specification sheets, descriptive brochures, and Web pages in which 
sunlamp products or UV lamps intended for use in sunlamp products are 
offered for sale, the following contraindication and warning statements:
    (A) ``Contraindication: This product is contraindicated for use on 
persons under the age of 18 years.''
    (B) ``Contraindication: This product must not be used if skin 
lesions or open wounds are present.''
    (C) ``Warning: This product should not be used on individuals who 
have had skin cancer or have a family history of skin cancer.''
    (D) ``Warning: Persons repeatedly exposed to UV radiation should be 
regularly evaluated for skin cancer.''
    (c) Performance standard. Sunlamp products and UV lamps intended for 
use in sunlamp products are subject to the electronic product 
performance standard at Sec. 1040.20 of this chapter.

[79 FR 31213, June 2, 2014]



Sec. 878.4660  Skin marker.

    (a) Identification. A skin marker is a pen-like device intended to 
be used to write on the patient's skin, e.g., to outline surgical 
incision sites or mark anatomical sites for accurate blood pressure 
measurement.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 
FR 38803, July 25, 2001]



Sec. 878.4670  Internal tissue marker.

    (a) Identification. An internal tissue marker is a prescription use 
device that is intended for use prior to or during general surgical 
procedures to demarcate selected sites on internal tissues.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The device must be demonstrated to be biocompatible. Material 
names and specific designation numbers must be provided.
    (2) Performance testing must demonstrate that the device performs as 
intended to mark the tissue for which it is indicated.
    (3) Performance data must demonstrate the sterility of the device.
    (4) Performance data must support the shelf life of the device by 
demonstrating sterility, package integrity, device functionality, and 
material stability over the requested shelf life.
    (5) Labeling must include:
    (i) A warning that the device must not be used on a non-sterile 
surface prior to use internally.
    (ii) An expiration date/shelf life.

[[Page 596]]

    (iii) Single use only labeling must be labeled directly on the 
device.

[80 FR 46486, Aug. 5, 2015]



Sec. 878.4680  Nonpowered, single patient, portable suction apparatus.

    (a) Identification. A nonpowered, single patient, portable suction 
apparatus is a device that consists of a manually operated plastic, 
disposable evacuation system intended to provide a vacuum for suction 
drainage of surgical wounds.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 65 FR 2318, Jan. 14, 2000]



Sec. 878.4683  Non-Powered suction apparatus device intended 
for negative pressure wound therapy.

    (a) Identification. A non-powered suction apparatus device intended 
for negative pressure wound therapy is a device that is indicated for 
wound management via application of negative pressure to the wound for 
removal of fluids, including wound exudate, irrigation fluids, and 
infectious materials. It is further indicated for management of wounds, 
burns, flaps, and grafts.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's ``Class II Special Controls Guidance Document: 
Non-powered Suction Apparatus Device Intended for Negative Pressure 
Wound Therapy (NPWT).'' See Sec. 878.1(e) for the availability of this 
guidance document.

[75 FR 70114, Nov. 17, 2010]



Sec. 878.4685  Extracorporeal shock wave device for
treatment of chronic wounds.

    (a) Identification. An extracorporeal shock wave device for 
treatment of chronic wounds is a prescription device that focuses 
acoustic shock waves onto the dermal tissue. The shock waves are 
generated inside the device and transferred to the body using an 
acoustic interface.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance testing must be conducted to 
demonstrate that the system produces anticipated and reproducible 
acoustic pressure shock waves.
    (2) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (3) Performance data must demonstrate that the reusable components 
of the device can be reprocessed for subsequent use.
    (4) Performance data must be provided to demonstrate the 
electromagnetic compatibility and electrical safety of the device.
    (5) Software verification, validation, and hazard analysis must be 
performed.
    (6) Performance data must support the use life of the system by 
demonstrating continued system functionality over the labeled use life.
    (7) Physician labeling must include:
    (i) Information on how the device operates and the typical course of 
treatment;
    (ii) A detailed summary of the device's technical parameters;
    (iii) Validated methods and instructions for reprocessing of any 
reusable components; and
    (iv) Instructions for preventing hearing loss by use of hearing 
protection.
    (8) Patient labeling must include:
    (i) Relevant contraindications, warnings, precautions, adverse 
effects, and complications;
    (ii) Information on how the device operates and the typical course 
of treatment;
    (iii) The probable risks and benefits associated with the use of the 
device;
    (iv) Post-procedure care instructions; and
    (v) Alternative treatments.

[83 FR 9699, Mar. 7, 2018]



Sec. 878.4700  Surgical microscope and accessories.

    (a) Identification. A surgical microscope and accessories is an AC-
powered device intended for use during surgery to provide a magnified 
view of the surgical field.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 597]]

subpart E of part 807 of this chapter, subject to the limitations in 
Sec. 878.9.

[55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63010, Dec. 7, 1994; 66 
FR 38803, July 25, 2001]



Sec. 878.4730  Surgical skin degreaser or adhesive tape solvent.

    (a) Identification. A surgical skin degreaser or an adhesive tape 
solvent is a device that consists of a liquid such as 1,1,2-trichloro-
1,2,2-trifluoroethane; 1,1,1-trichloroethane; and 1,1,1-trichloroethane 
with mineral spirits intended to be used to dissolve surface skin oil or 
adhesive tape.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 
FR 38803, July 25, 2001]



Sec. 878.4740  Surgical stapler.

    (a) Surgical stapler for external use.
    (1) Identification. A surgical stapler for external use is a 
specialized prescription device used to deliver compatible staples to 
skin during surgery.
    (2) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 878.9.
    (b) Surgical stapler for internal use.
    (1) Identification. A surgical stapler for internal use is a 
specialized prescription device used to deliver compatible staples to 
internal tissues during surgery for resection, transection, and creating 
anastomoses.
    (2) Classification. Class II (special controls). The special 
controls for this device are:
    (i) Performance testing must demonstrate that the stapler, when used 
with compatible staples, performs as intended under anticipated 
conditions of use. Performance testing must include the following:
    (A) Evaluation of staple formation characteristics in the maximum 
and minimum tissue thicknesses for each staple type;
    (B) For manual staplers only, measurement of the worst-case 
deployment pressures on stapler firing force;
    (C) Measurement of staple line strength;
    (D) Confirmation of staple line integrity; and
    (E) In vivo confirmation of staple line hemostasis.
    (ii) For powered staplers only, appropriate analysis/testing must 
demonstrate the electromagnetic compatibility and electrical, thermal, 
and mechanical safety of the device.
    (iii) For powered staplers only, appropriate software verification, 
validation, and hazard analysis must be performed.
    (iv) Human factors testing must demonstrate that the clinician can 
correctly select and safely use the device, as identified in the 
labeling, based on reading the directions for use.
    (v) The elements of the device that may contact the patient must be 
demonstrated to be biocompatible.
    (vi) Performance data must demonstrate the sterility of the device.
    (vii) Validation of cleaning and sterilization instructions must 
demonstrate that any reusable device components can be safely and 
effectively reprocessed per the recommended cleaning and sterilization 
protocol in the labeling.
    (viii) Performance data must support the shelf life of the device by 
demonstrating continued device functionality, sterility, and package 
integrity over the identified shelf life.
    (ix) Labeling of the device must include the following:
    (A) Unless data demonstrates the safety of doing so, 
contraindications must be identified regarding use of the device on 
tissues for which the risk of stapling outweighs any reasonably 
foreseeable benefit due to known complications, including the stapling 
of tissues that are necrotic, friable, or have altered integrity.
    (B) Unless available information demonstrates that the specific 
warnings do not apply, the labeling must provide appropriate warnings 
regarding how to avoid known hazards associated with device use 
including:
    (1) Avoidance of use of the stapler to staple tissue outside of the 
labeled limits for maximum and minimum tissue thickness;

[[Page 598]]

    (2) Avoidance of obstructions to the creation of the staple line and 
the unintended stapling of other anatomic structures;
    (3) Avoidance of clamping and unclamping of delicate tissue 
structures to prevent tissue damage;
    (4) Avoidance of use of the stapler on the aorta;
    (5) Establishing proximal control of blood vessels prior to stapling 
where practical and methods of blood vessel control in the event of 
stapler failure;
    (6) Ensuring stapler compatibility with staples; and
    (7) Risks specifically associated with the crossing of staple lines.
    (C) Specific user instructions for proper device use including 
measures associated with the prevention of device malfunction, and 
evaluation of the appropriateness of the target tissue for stapling.
    (D) List of staples with which the stapler has been demonstrated to 
be compatible.
    (E) Identification of key performance parameters and technical 
characteristics of the stapler and the compatible staples needed for 
safe use of the device.
    (F) Information regarding tissues on which the stapler is intended 
to be used.
    (G) Identification of safety mechanisms of the stapler.
    (H) Validated methods and instructions for reprocessing of any 
reusable device components.
    (I) An expiration date/shelf life.
    (x) Package labels must include critical information and technical 
characteristics necessary for proper device selection.

[86 FR 16204, Oct. 8, 2021]



Sec. 878.4750  Implantable staple.

    (a) Identification. An implantable staple is a staple-like device 
intended to connect internal tissues to aid healing. It is not 
absorbable.
    (b) Classification. Class II.



Sec. 878.4755  Absorbable lung biopsy plug.

    (a) Identification. A preformed (polymerized) absorbable lung biopsy 
plug is intended to provide accuracy in marking a biopsy location for 
visualization during surgical resection and closure of pleural punctures 
associated with percutaneous, transthoracic needle lung biopsies. Upon 
deployment into the biopsy tract, the plug expands to fill the biopsy 
void and remains in place until resorbed.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The design characteristics of the device must ensure that the 
geometry and material composition are consistent with the intended use.
    (2) Performance testing must demonstrate deployment as indicated in 
the accompanying labeling, including the indicated introducer needles, 
and demonstrate expansion and resorption characteristics in a clinically 
relevant environment.
    (3) In vivo evaluation must demonstrate performance characteristics 
of the device, including the ability of the plug to not prematurely 
resorb or migrate and the rate of pneumothorax.
    (4) Sterility testing must demonstrate the sterility of the device 
and the effects of the sterilization process on the physical 
characteristics of the plug.
    (5) Shelf-life testing must demonstrate the shelf-life of the device 
including the physical characteristics of the plug.
    (6) The device must be demonstrated to be biocompatible.
    (7) Labeling must include a detailed summary of the device-related 
and procedure-related complications pertinent to the use of the device 
and appropriate warnings. Labeling must include identification of 
compatible introducer needles.

[79 FR 13219, Mar. 10, 2014]



Sec. 878.4760  Removable skin staple.

    (a) Identification. A removable skin staple is a staple-like device 
intended to connect external tissues temporarily to aid healing. It is 
not absorbable.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 65 FR 2318, Jan. 14, 2000]

[[Page 599]]



Sec. 878.4780  Powered suction pump.

    (a) Identification. A powered suction pump is a portable, AC-powered 
or compressed air-powered device intended to be used to remove 
infectious materials from wounds or fluids from a patient's airway or 
respiratory support system. The device may be used during surgery in the 
operating room or at the patient's bedside. The device may include a 
microbial filter.
    (b) Classification. Class II.



Sec. 878.4783  Negative pressure wound therapy device for reduction of wound complications.

    (a) Identification. A negative pressure wound therapy device for 
reduction of wound complications is a powered suction pump intended for 
wound management and reduction of wound complications via application of 
negative pressure to the wound, which removes fluids, including wound 
exudate, irrigation fluids, and infectious materials. This device type 
is intended for use with wound dressings classified under Sec. 
878.4780. This classification does not include devices intended for 
organ space wounds.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical data must demonstrate that the device performs as 
intended under anticipated conditions of use and evaluate the following:
    (i) Wound complication rates; and
    (ii) All adverse events.
    (2) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (3) Performance data must demonstrate the sterility of the patient-
contacting components of the device.
    (4) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the labeled shelf life.
    (5) Usability testing must demonstrate that intended users can 
correctly use the device, based solely on reading the instructions for 
use.
    (6) Non-clinical performance data must demonstrate that the device 
performs as intended under anticipated conditions of use. The following 
performance characteristics must be tested in a worst-case scenario for 
the intended use life:
    (i) Ability to maintain pressure levels at the wound site under a 
worst-case scenario for the intended use life;
    (ii) Fluid removal rate consistent with the wound types specified in 
the indications for use; and
    (iii) Timely triggering of all alarms.
    (7) Performance data must demonstrate the electrical safety and 
electromagnetic compatibility (EMC) of the device.
    (8) Software verification, validation, and hazard analysis must be 
performed.
    (9) Labeling must include the following:
    (i) Instructions for use;
    (ii) A summary of the device technical specifications, including 
pressure settings, modes (e.g., continuous or intermittent), alarms, and 
safety features;
    (iii) Compatible components and devices;
    (iv) A summary of the clinical evidence for the indications for use;
    (v) A shelf life for sterile components; and
    (vi) Use life and intended use environments.
    (10) For devices intended for use outside of a healthcare facility, 
patient labeling must include the following:
    (i) Information on how to operate the device and its components and 
the typical course of treatment;
    (ii) Information on when to contact a healthcare professional; and
    (iii) Use life.

[86 FR 70734, Dec. 10, 2021]



Sec. 878.4790  Powered surgical instrument for improvement in
the appearance of cellulite.

    (a) Identification. A powered surgical instrument for improvement in 
the appearance of cellulite is a prescription device that is used for 
the controlled release of subcutaneous tissue for improvement in the 
appearance of cellulite. The device consists of a cutting tool powered 
by a motor and a means for instrument guidance to control the areas of 
subcutaneous tissue cutting underneath the cellulite depressions or 
dimples.

[[Page 600]]

    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical testing must be performed to demonstrate that the 
device meets all design specifications and performance requirements, and 
to demonstrate durability and mechanical integrity of the device.
    (2) In vivo evaluation of the device must demonstrate device 
performance, including the safety of the release methodology and blood 
loss at the treatment sites.
    (3) All elements of the device that may contact the patient must be 
demonstrated to be biocompatible.
    (4) Electrical safety and electromagnetic compatibility of the 
device must be demonstrated.
    (5) The labeling must include a summary of in vivo evaluation data 
and all the device specific warnings, precautions, and/or 
contraindications.
    (6) Sterility and shelf-life testing for the device must demonstrate 
the sterility of patient contacting components and the shelf life of 
these components.

[79 FR 31861, June 3, 2014]



Sec. 878.4800  Manual surgical instrument for general use.

    (a) Identification. A manual surgical instrument for general use is 
a nonpowered, hand-held, or hand manipulated device, either reusable or 
disposable, intended to be used in various general surgical procedures. 
The device includes the applicator, clip applier, biopsy brush, manual 
dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, 
clamp, contractor, curette, cutter, dissector, elevator, skin graft 
expander, file, forceps, gouge, instrument guide, needle guide, hammer, 
hemostat, amputation hook, ligature passing and knot-tying instrument, 
knife, mallet, disposable or reusable aspiration and injection needle, 
disposable or reusable suturing needle, osteotome, pliers, rasp, 
retainer, retractor, saw, scalpel blade, scalpel handle, one-piece 
scalpel, snare, spatula, stapler, disposable or reusable stripper, 
stylet, suturing apparatus for the stomach and intestine, measuring 
tape, and calipers. A surgical instrument that has specialized uses in a 
specific medical specialty is classified in separate regulations in 
parts 868 through 892 of this chapter.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989; 59 
FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001; 86 FR 56204, Oct. 8, 
2021; 86 FR 66188, Nov. 22, 2021]



Sec. 878.4805  Manual percutaneous surgical set assembled in the abdomen.

    (a) Identification. A manual percutaneous surgical set assembled in 
the abdomen is a prescription device consisting of a percutaneous 
surgical set used as a means to penetrate soft tissue to access certain 
areas of the abdomen. The device's effectors or attachments are provided 
separately from the percutaneous shaft and are introduced to the site 
via a traditional conduit such as a trocar. The attachment or effectors 
are connected to the shaft once the tip of the shaft is inside the 
abdomen. Once inside the abdomen, the surgical set is used to grasp, 
hold, and manipulate soft tissues. A surgical instrument that has 
specialized uses in a specific medical specialty is classified in 
separate regulations in parts 868 through 892 of this chapter.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (2) Performance data must demonstrate the sterility of patient-
contacting components of the device.
    (3) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the requested shelf life.
    (4) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be tested:
    (i) Dimensional verification testing must be conducted.
    (ii) Force verification testing must be conducted. The force testing 
must

[[Page 601]]

demonstrate the forces necessary to insert and operate each component of 
the device during use as intended.
    (iii) Functional verification testing of the device components must 
be conducted.
    (5) Simulated use testing in an anatomically relevant animal model 
must demonstrate the device's ability to penetrate soft tissue, be 
assembled in situ, and to grasp, hold and manipulate soft tissues in the 
intended treatment area.
    (6) The labeling must include the following:
    (i) Instructions for use, including detailed instructions for 
instrument assembly, disassembly, and removal; and
    (ii) A shelf life.

[86 FR 71569, Dec. 17, 2021]



Sec. 878.4810  Laser surgical instrument for use in general
and plastic surgery and in dermatology.

    (a) Identification. (1) A carbon dioxide laser for use in general 
surgery and in dermatology is a laser device intended to cut, destroy, 
or remove tissue by light energy emitted by carbon dioxide.
    (2) An argon laser for use in dermatology is a laser device intended 
to destroy or coagulate tissue by light energy emitted by argon.
    (b) Classification. (1) Class II.
    (2) Class I for special laser gas mixtures used as a lasing medium 
for this class of lasers. The devices subject to this paragraph (b)(2) 
are exempt from the premarket notification procedures in subpart E of 
part 807 of this chapter, subject to the limitations in Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996; 66 
FR 38803, July 25, 2001]



Sec. 878.4815  Magnetic surgical instrument system.

    (a) Identification. A magnetic surgical instrument system is a 
prescription device used in laparoscopic surgical procedures consisting 
of several components, such as surgical instruments, and a magnetic 
controller. The magnetic controller is provided separately from the 
surgical instrument and is used outside the patient. The external 
magnetic controller is magnetically coupled with the internal surgical 
instrument(s) at the surgical site to grasp, hold, retract, mobilize, or 
manipulate soft tissue and organs.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) In vivo performance data must demonstrate that the device 
performs as intended under anticipated conditions of use. Testing must 
demonstrate the ability of the device to grasp, hold, retract, mobilize, 
or manipulate soft tissue and organs.
    (2) Non-clinical performance data must demonstrate that the system 
performs as intended under anticipated conditions of use. The following 
performance characteristics must be tested:
    (i) Magnetic field strength testing characterization to identify the 
distances from the magnet that are safe for patients and users with 
ferromagnetic implants, devices, or objects.
    (ii) Ability of the internal surgical instrument(s) to be coupled, 
de-coupled, and re-coupled with the external magnet over the external 
magnet use life.
    (3) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (4) Performance data must demonstrate the sterility of the device 
components that are patient-contacting.
    (5) Methods and instructions for reprocessing reusable components 
must be validated.
    (6) Performance data must support shelf life by demonstrating 
continued sterility of the device or the sterile components and device 
functionality over the labeled shelf life.
    (7) Training must be developed and validated by human factors 
testing and analysis to ensure users can follow the instructions for use 
to allow safe use of the device.
    (8) Labeling must include:
    (i) Magnetic field safe zones.
    (ii) Instructions for proper device use.
    (iii) A screening checklist to ensure that all patients and 
operating staff are screened from bringing ferromagnetic implants, 
devices, or objects near the external magnet.
    (iv) Reprocessing instructions for any reusable components.

[[Page 602]]

    (v) Shelf life.
    (vi) Use life.

[81 FR 64763, Sept. 21, 2016]



Sec. 878.4820  Surgical instrument motors and accessories/attachments.

    (a) Identification. Surgical instrument motors and accessories are 
AC-powered, battery-powered, or air-powered devices intended for use 
during surgical procedures to provide power to operate various 
accessories or attachments to cut hard tissue or bone and soft tissue. 
Accessories or attachments may include a bur, chisel (osteotome), 
dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and 
saw blade.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 878.9.

[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2318, 2000]



Sec. 878.4825  General laparoscopic power morcellation containment system.

    (a) Identification. A general laparoscopic power morcellation 
containment system is a prescription device consisting of an instrument 
port and tissue containment method that creates a working space allowing 
for direct visualization during a power morcellation procedure following 
a laparoscopic procedure for the excision of benign tissue that is not 
suspected to contain malignancy.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (2) Performance testing must demonstrate the sterility of patient-
contacting components of the device.
    (3) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the intended shelf life.
    (4) Non-clinical performance data must demonstrate that the device 
performs as intended under anticipated conditions of use. The following 
performance characteristics must be tested:
    (i) Demonstration of the device impermeability to tissue, cells, and 
fluids;
    (ii) Demonstration that the device allows for the insertion/
withdrawal of laparoscopic instruments while maintaining 
pneumoperitoneum;
    (iii) Demonstration that the containment system provides adequate 
space to perform morcellation and adequate visualization of the 
laparoscopic instruments and tissue specimen relative to the external 
viscera;
    (iv) Demonstration that compatible laparoscopic instruments and 
morcellators do not compromise the integrity of the containment system; 
and
    (v) Demonstration that users can adequately deploy the device, 
morcellate a specimen without compromising the integrity of the device, 
and remove the device without spillage of contents.
    (5) Training must be developed and validated to ensure users can 
follow the instructions for use.
    (6) Labeling must include:
    (i) A contraindication for use in gynecological procedures;
    (ii) A contraindication against use of tissue that is known or 
suspected to contain malignancy;
    (iii) The following boxed warning: ``Warning: Information regarding 
the potential risks of a procedure with this device should be shared 
with patients. The use of laparoscopic power morcellators may spread 
cancer. The use of this containment system has not been clinically 
demonstrated to reduce this risk;''
    (iv) A statement limiting use of device to physicians who have 
completed the training program; and
    (v) A shelf life.

[86 FR 66458, Nov. 23, 2021]



Sec. 878.4830  Absorbable surgical gut suture.

    (a) Identification. An absorbable surgical gut suture, both plain 
and chromic, is an absorbable, sterile, flexible thread prepared from 
either the serosal connective tissue layer of beef (bovine) or the 
submucosal fibrous tissue of

[[Page 603]]

sheep (ovine) intestine, and is intended for use in soft tissue 
approximation.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's ``Class II Special Controls Guidance Document: 
Surgical Sutures; Guidance for Industry and FDA.'' See Sec. 878.1(e) 
for the availability of this guidance document.

[54 FR 50738, Dec. 11, 1989, as amended at 68 FR 32984, June 3, 2003]



Sec. 878.4840  Absorbable polydioxanone surgical suture.

    (a) Identification. An absorbable polydioxanone surgical suture is 
an absorbable, flexible, sterile, monofilament thread prepared from 
polyester polymer poly (p-dioxanone) and is intended for use in soft 
tissue approximation, including pediatric cardiovascular tissue where 
growth is expected to occur, and ophthalmic surgery. It may be coated or 
uncoated, undyed or dyed, and with or without a standard needle 
attached.
    (b) Classification. Class II (special controls). The special control 
for the device is FDA's ``Class II Special Controls Guidance Document: 
Surgical Sutures; Guidance for Industry and FDA.'' See Sec. 878.1(e) 
for the availability of this guidance document.

[67 FR 77676, Dec. 19, 2002]



Sec. 878.4850  Blood lancets.

    (a) Single use only blood lancet with an integral sharps injury 
prevention feature--(1) Identification. A disposable blood lancet 
intended for a single use that is comprised of a single use blade 
attached to a solid, non-reusable base (including an integral sharps 
injury prevention feature) that is used to puncture the skin to obtain a 
drop of blood for diagnostic purposes. The integral sharps injury 
prevention feature allows the device to be used once and then renders it 
inoperable and incapable of further use.
    (2) Classification. Class II (special controls). The special 
controls are:
    (i) The design characteristics of the device must ensure that the 
structure and material composition are consistent with the intended use 
and must include a sharps injury prevention feature.
    (ii) Mechanical performance testing must demonstrate that the device 
will withstand forces encountered during use and that the integral 
sharps injury prevention feature will irreversibly disable the device 
after one use.
    (iii) The device must be demonstrated to be biocompatible.
    (iv) Sterility testing must demonstrate the sterility of any device 
component that breaches the skin (e.g., blade).
    (v) Labeling must include:
    (A) Detailed descriptions, with illustrations, of the proper use of 
the device and its sharps injury prevention feature.
    (B) Handwashing instructions for the user before and after use of 
the device.
    (C) Instructions on preparation (e.g., cleaning, disinfection) of 
the skin to be pierced.
    (D) Instructions for the safe disposal of the device.
    (E) Labeling must be appropriate for the intended use environment.
    (1) For those devices intended for health care settings, labeling 
must address the health care facility use of these devices, including 
how these lancets are to be used with personal protective equipment, 
such as gloves.
    (2) For those devices intended for use in the home, labeling must be 
written so that it is understandable to lay users.
    (vi) Labeling must also include the following statements, 
prominently placed:
    (A) ``For use only on a single patient. Discard the entire device 
after use.''
    (B) ``Warning: Not intended for more than one use. Do not use on 
more than one patient. Improper use of blood lancets can increase the 
risk of inadvertent transmission of bloodborne pathogens, particularly 
in settings where multiple patients are tested.''
    (b) Single use only blood lancet without an integral sharps injury 
prevention feature--(1) Identification. A disposable blood lancet 
intended for a single use that is comprised of a single use blade 
attached to a solid, non-reusable base that is used to puncture the skin 
to obtain a drop of blood for diagnostic purposes.
    (2) Classification. Class II (special controls). The special 
controls are:

[[Page 604]]

    (i) The design characteristics of the device must ensure that the 
structure and material composition are consistent with the intended use 
and address the risk of sharp object injuries and bloodborne pathogen 
transmissions.
    (ii) Mechanical performance testing must demonstrate that the device 
will withstand forces encountered during use.
    (iii) The device must be demonstrated to be biocompatible.
    (iv) Sterility testing must demonstrate the sterility of any device 
component that breaches the skin (e.g., blade).
    (v) Labeling must include:
    (A) Detailed descriptions, with illustrations, of the proper use of 
the device.
    (B) Handwashing instructions for the user before and after use of 
the device.
    (C) Instructions on preparation (e.g., cleaning, disinfection) of 
the skin to be pierced.
    (D) Instructions for the safe disposal of the device.
    (E) Labeling must be appropriate for the intended use environment.
    (1) For those devices intended for health care settings, labeling 
must address the health care facility use of these devices, including 
how these lancets are to be used with personal protective equipment, 
such as gloves.
    (2) For those devices intended for use in the home, labeling must be 
written so that it is understandable to lay users.
    (vi) Labeling must also include the following statements, 
prominently placed:
    (A) ``For use only on a single patient. Discard the entire device 
after use.''
    (B) ``Warning: Not intended for more than one use. Do not use on 
more than one patient. Improper use of blood lancets can increase the 
risk of inadvertent transmission of bloodborne pathogens, particularly 
in settings where multiple patients are tested.''
    (c) Multiple use blood lancet for single patient use only--(1) 
Identification. A multiple use capable blood lancet intended for use on 
a single patient that is comprised of a single use blade attached to a 
solid, reusable base that is used to puncture the skin to obtain a drop 
of blood for diagnostic purposes.
    (2) Classification. Class II (special controls). The special 
controls are:
    (i) The design characteristics of the device must ensure that:
    (A) The lancet blade can be changed with every use, either manually 
or by triggering a blade storage unit to discard the used blade and 
reload an unused blade into the reusable base; and
    (B) The structure and material composition are consistent with the 
intended use and address the risk of sharp object injuries and 
bloodborne pathogen transmissions and allow for validated cleaning and 
disinfection.
    (ii) Mechanical performance testing must demonstrate that the device 
will withstand forces encountered during use.
    (iii) The device must be demonstrated to be biocompatible.
    (iv) Sterility testing must demonstrate the sterility of any device 
component that breaches the skin (e.g., blade).
    (v) Validation testing must demonstrate that the cleaning and 
disinfection instructions are adequate to ensure that the reusable 
lancet base can be cleaned and low level disinfected.
    (vi) Labeling must include:
    (A) Detailed descriptions, with illustrations, of the proper use of 
the device.
    (B) The Environmental Protection Agency (EPA) registered 
disinfectant's contact time for disinfectant use.
    (C) Handwashing instructions for the user before and after use of 
the device.
    (D) Instructions on preparation (e.g., cleaning, disinfection) of 
the skin to be pierced.
    (E) Instructions on the cleaning and disinfection of the device.
    (F) Instructions for the safe disposal of the device.
    (G) Instructions for use must address the safe storage of the 
reusable blood lancet base between uses to minimize contamination or 
damage and the safe storage and disposal of the refill lancet blades.
    (H) Labeling must be appropriate for the intended use environment.
    (1) For those devices intended for health care settings, labeling 
must address the health care facility use of

[[Page 605]]

these devices, including how these lancets are to be used with personal 
protective equipment, such as gloves.
    (2) For those devices intended for use in the home, labeling must be 
written so that it is understandable to lay users.
    (vii) Labeling must also include the following statements, 
prominently placed:
    (A) ``For use only on a single patient. Disinfect reusable 
components according to manufacturer's instructions between each use.''
    (B) ``Used lancet blades must be safely discarded after a single 
use.''
    (C) ``Warning: Do not use on more than one patient. Improper use of 
blood lancets can increase the risk of inadvertent transmission of 
bloodborne pathogens, particularly in settings where multiple patients 
are tested. The cleaning and disinfection instructions for this device 
are intended only to reduce the risk of local use site infection; they 
cannot render this device safe for use for more than one patient.''
    (d) Multiple use blood lancet for multiple patient use--(1) 
Identification. A multiple use capable blood lancet intended for use on 
multiple patients that is comprised of a single use blade attached to a 
solid, reusable base that is used to puncture the skin to obtain a drop 
of blood for diagnostic purposes.
    (2) Classification. Class III (premarket approval).
    (3) Date PMA or notice of completion of a PDP is required: A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before May 22, 2024, for any multiple use 
blood lancet for multiple patient use described in paragraph (d)(1) of 
this section that was in commercial distribution before May 28, 1976, or 
that has, on or before May 22, 2024, been found to be substantially 
equivalent to a multiple use blood lancet for multiple patient use 
described in paragraph (d)(1) of this section that was in commercial 
distribution before May 28, 1976. Any other multiple use blood lancet 
for multiple patient use shall have an approved PMA or a declared 
completed PDP in effect before being placed in commercial distribution.

[86 FR 66188, Nov. 22, 2021, as amended at 86 FR 66179, Nov. 22, 2021]



Sec. 878.4860  Light based energy source device for topical application.

    (a) Identification. The device emits light energy at near infrared 
spectrum and is applied externally to the surface of herpes simplex 
labialis lesions on or around the lips.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The technical parameters of the device, including wavelength, 
treatment time, treatment area, energy density, spot size, and power, 
must be characterized.
    (2) The cleaning and disinfection instructions for the device must 
be validated.
    (3) The device must be demonstrated to be biocompatible.
    (4) Performance testing must validate electromagnetic compatibility 
(EMC), ocular safety, and electrical safety of the device.
    (5) Labeling must direct end-users to contact the device 
manufacturer and MedWatch if they experience any adverse events when 
using this device.
    (6) Labeling must include specific information pertinent to use of 
the device by the intended patient population and the treatment regimen.
    (7) Simulated use testing must include information from a usability, 
label comprehension and self-selection study to demonstrate that the 
device can be used by the intended patient population without any 
assistance.
    (8) Clinical data must show adequate reduction in time to healing 
and assess risks of redness, discomfort, burns, and blisters.

[83 FR 52969, Oct. 19, 2018]



Sec. 878.4930  Suture retention device.

    (a) Identification. A suture retention device is a device, such as a 
retention bridge, a surgical button, or a suture bolster, intended to 
aid wound healing by distributing suture tension over a larger area in 
the patient.
    (b) Classification. Class I (general controls). The device is exempt 
from the

[[Page 606]]

premarket notification procedures in subpart E of part 807 of this 
chapter, subject to the limitations in Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 
FR 38803, July 25, 2001]



Sec. 878.4950  Manual operating table and accessories and manual
operating chair and accessories.

    (a) Identification. A manual operating table and accessories and a 
manual operating chair and accessories are nonpowered devices, usually 
with movable components, intended to be used to support a patient during 
diagnostic examinations or surgical procedures.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989; 59 
FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001]



Sec. 878.4960  Operating tables and accessories and operating 
chairs and accessories.

    (a) Identification. Operating tables and accessories and operating 
chairs and accessories are AC-powered or air-powered devices, usually 
with movable components, intended for use during diagnostic examinations 
or surgical procedures to support and position a patient.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 878.9.

[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2318, Jan. 14, 2000]



Sec. 878.4961  Mountable electromechanical surgical system for
transluminal approaches.

    (a) Identification. A mountable electromechanical surgical system 
for transluminal approaches is a software-controlled, patient bed- and/
or operating table-mounted electromechanical surgical system with human/
device interfaces that allows a qualified user to perform transluminal 
endoscopic or laparoscopic surgical procedures using surgical 
instruments attached to an electromechanical arm.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The device manufacturer must develop, and update as necessary, a 
device-specific use training program that ensures proper device setup/
use/shutdown, accurate control of instruments to perform the intended 
surgical procedures, troubleshooting and handling during unexpected 
events or emergencies, and safe practices to mitigate use error.
    (2) The device manufacturer may only distribute the device to 
facilities that implement and maintain the device-specific use training 
program and ensure that users of the device have completed the device-
specific use training program.
    (3) The device manufacturer must conduct and complete post-market 
surveillance, including an impact of the training program on user 
learning, behavior, and performance, in accordance with an FDA-agreed-
upon protocol. The device manufacturer must submit post-market 
surveillance reports that contain current data and findings in 
accordance with the FDA-agreed-upon protocol.
    (4) The device manufacturer must submit a report to FDA annually on 
the anniversary of initial marketing authorization for the device, until 
such time as FDA may terminate such reporting, which comprises the 
following information:
    (i) Cumulative summary, by year, of complaints and adverse events 
since date of initial marketing authorization; and
    (ii) Identification and rationale for changes made to the device, 
labeling or device-specific use training program, which did not require 
submission of a premarket notification during the reporting period.
    (5) Labeling must include:
    (i) A detailed summary of clinical performance testing conducted 
with the device, including study population, results, adverse events, 
and comparisons to any comparator groups identified;

[[Page 607]]

    (ii) A statement in the labeling that the safety and effectiveness 
of the device has not been evaluated for outcomes related to the 
treatment or prevention of cancer, including but not limited to risk 
reduction, overall survival, disease-free survival and local recurrence, 
unless FDA determines that it can be removed or modified based on 
clinical performance data submitted to FDA;
    (iii) Identification of compatible devices;
    (iv) The list of surgical procedures for which the device has been 
determined to be safe with clinical justification;
    (v) Reprocessing instructions for reusable components;
    (vi) A shelf life for any sterile components;
    (vii) A description of the device-specific use training program;
    (viii) A statement that the device is only for distribution to 
facilities that implement and maintain the device-specific use training 
program and ensure that users of the device have completed the device-
specific use training program; and
    (ix) A detailed summary of the post-market surveillance data 
collected under paragraph (b)(3) of this section and any necessary 
modifications to the labeling to accurately reflect outcomes based upon 
the post-market surveillance data collected under paragraph (b)(3) of 
this section.
    (6) Clinical performance testing must demonstrate that the device 
performs as intended under anticipated conditions of use.
    (7) Human factors validation testing must be performed and must 
demonstrate that the user interfaces of the system support safe use in 
an operating room environment.
    (8) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use and must 
include:
    (i) Device motion accuracy and precision;
    (ii) System testing;
    (iii) Instrument reliability;
    (iv) Thermal effects on tissue;
    (v) Human-device interface;
    (vi) Mounting hardware testing;
    (vii) Workspace access testing; and
    (viii) Performance testing with compatible devices.
    (9) Software verification, validation, and hazard analysis must be 
performed. Software documentation must include an assessment of the 
impact of threats and vulnerabilities on device functionality and end 
users/patients as part of cybersecurity review.
    (10) Electromagnetic compatibility and electrical, thermal, and 
mechanical safety testing must be performed.
    (11) Performance data must demonstrate the sterility of all patient-
contacting device components.
    (12) Performance data must support the shelf life of the device 
components provided sterile by demonstrating continued sterility and 
package integrity over the labeled shelf life.
    (13) Performance data must validate the reprocessing instructions 
for the reusable components of the device.
    (14) Performance data must demonstrate that all patient-contacting 
components of the device are biocompatible.
    (15) Performance data must demonstrate that all patient-contacting 
components of the device are non-pyrogenic.

[87 FR 26995, May 6, 2022]



Sec. 878.5000  Nonabsorbable poly(ethylene terephthalate) surgical suture.

    (a) Identification. Nonabsorbable poly(ethylene terephthalate) 
surgical suture is a multifilament, nonabsorbable, sterile, flexible 
thread prepared from fibers of high molecular weight, long-chain, linear 
polyesters having recurrent aromatic rings as an integral component and 
is indicated for use in soft tissue approximation. The poly(ethylene 
terephthalate) surgical suture meets U.S.P. requirements as described in 
the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be 
provided uncoated or coated; and it may be undyed or dyed with an 
appropriate FDA listed color additive. Also, the suture may be provided 
with or without a standard needle attached.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's ``Class II Special Controls Guidance Document: 
Surgical Sutures; Guidance for Industry and

[[Page 608]]

FDA.'' See Sec. 878.1(e) for the availability of this guidance 
document.

[56 FR 24685, May 31, 1991, as amended at 68 FR 32984, June 3, 2003]



Sec. 878.5010  Nonabsorbable polypropylene surgical suture.

    (a) Identification. Nonabsorbable polypropylene surgical suture is a 
monofilament, nonabsorbable, sterile, flexible thread prepared from 
long-chain polyolefin polymer known as polypropylene and is indicated 
for use in soft tissue approximation. The polypropylene surgical suture 
meets United States Pharmacopeia (U.S.P.) requirements as described in 
the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be 
undyed or dyed with an FDA approved color additive; and the suture may 
be provided with or without a standard needle attached.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's ``Class II Special Controls Guidance Document: 
Surgical Sutures; Guidance for Industry and FDA.'' See Sec. 878.1(e) 
for the availability of this guidance document.

[56 FR 24685, May 31, 1991, as amended at 68 FR 32984, June 3, 2003]



Sec. 878.5020  Nonabsorbable polyamide surgical suture.

    (a) Identification. Nonabsorbable polyamide surgical suture is a 
nonabsorbable, sterile, flexible thread prepared from long-chain 
aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in 
soft tissue approximation. The polyamide surgical suture meets United 
States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. 
monograph for nonabsorbable surgical sutures; it may be monofilament or 
multifilament in form; it may be provided uncoated or coated; and it may 
be undyed or dyed with an appropriate FDA listed color additive. Also, 
the suture may be provided with or without a standard needle attached.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's ``Class II Special Controls Guidance Document: 
Surgical Sutures; Guidance for Industry and FDA.'' See Sec. 878.1(e) 
for the availability of this guidance document.

[56 FR 24685, May 31, 1991, as amended at 68 FR 32985, June 3, 2003]



Sec. 878.5030  Natural nonabsorbable silk surgical suture.

    (a) Identification. Natural nonabsorbable silk surgical suture is a 
nonabsorbable, sterile, flexible multifilament thread composed of an 
organic protein called fibroin. This protein is derived from the 
domesticated species Bombyx mori (B. mori) of the family Bombycidae. 
Natural nonabsorbable silk surgical suture is indicated for use in soft 
tissue approximation. Natural nonabsorbable silk surgical suture meets 
the United States Pharmacopeia (U.S.P.) monograph requirements for 
Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk 
surgical suture may be braided or twisted; it may be provided uncoated 
or coated; and it may be undyed or dyed with an FDA listed color 
additive.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's ``Class II Special Controls Guidance Document: 
Surgical Sutures; Guidance for Industry and FDA.'' See Sec. 878.1(e) 
for the availability of this guidance document.

[58 FR 57558, Oct. 26, 1993, as amended at 68 FR 32985, June 3, 2003]



Sec. 878.5035  Nonabsorbable expanded polytetrafluoroethylene 
surgical suture.

    (a) Identification. Nonabsorbable expanded polytetrafluoroethylene 
(ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, 
flexible thread prepared from ePTFE and is intended for use in soft 
tissue approximation and ligation, including cardiovascular surgery. It 
may be undyed or dyed with an approved color additive and may be 
provided with or without an attached needle(s).
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's ``Class II Special Controls Guidance Document: 
Surgical Sutures; Guidance for Industry and

[[Page 609]]

FDA.'' See Sec. 878.1(e) for the availability of this guidance 
document.

[65 FR 20735, Apr. 18, 2000, as amended at 68 FR 32985, June 3, 2003]



Sec. 878.5040  Suction lipoplasty system.

    (a) Identification. A suction lipoplasty system is a device intended 
for aesthetic body contouring. The device consists of a powered suction 
pump (containing a microbial filter on the exhaust and a microbial in-
line filter in the connecting tubing between the collection bottle and 
the safety trap), collection bottle, cannula, and connecting tube. The 
microbial filters, tubing, collection bottle, and cannula must be 
capable of being changed between patients. The powered suction pump has 
a motor with a minimum of \1/3\ horsepower, a variable vacuum range from 
0 to 29.9 inches of mercury, vacuum control valves to regulate the 
vacuum with accompanying vacuum gauges, a single or double rotary vane 
(with or without oil), a single or double diaphragm, a single or double 
piston, and a safety trap.
    (b) Classification. Class II (special controls). Consensus standards 
and labeling restrictions.

[63 FR 7705, Feb. 17, 1998]



Sec. 878.5050  Surgical smoke precipitator.

    (a) Identification. A surgical smoke precipitator is a prescription 
device intended for clearance of the visual field by precipitation of 
surgical smoke and other aerosolized particulate matter created during 
laparoscopic surgery.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Adverse tissue reaction must be mitigated through the following:
    (i) Chemical characterization and toxicological risk assessment of 
the treated surgical smoke.
    (ii) Demonstration that the elements of the device that may contact 
the patient are biocompatible.
    (2) Electrical safety and electromagnetic compatibility testing must 
demonstrate that the device performs as intended.
    (3) Software verification, validation, and hazard analysis must be 
performed.
    (4) Performance data must demonstrate the sterility of the patient 
contacting components of the device.
    (5) Performance data must support the shelf life of the sterile 
components of the device by demonstrating continued functionality, 
sterility, and package integrity over the identified shelf life.
    (6) Animal simulated-use testing must demonstrate that the device 
performs as intended under anticipated conditions of use. The following 
performance characteristics must be tested:
    (i) Device must be demonstrated to be effectively inserted, 
positioned, and removed from the site of use.
    (ii) Device must be demonstrated to precipitate surgical smoke 
particulates to clear the visual field for laparoscopic surgeries.
    (iii) Device must be demonstrated to be non-damaging to the site of 
use and animal subject.
    (7) Labeling must identify the following:
    (i) Detailed instructions for use.
    (ii) Electrical safety and electromagnetic compatibility 
information.
    (iii) A shelf life.

[83 FR 4143, Jan. 30, 2018]



                      Subpart F_Therapeutic Devices



Sec. 878.5070  Air-handling apparatus for a surgical operating room.

    (a) Identification. Air-handling apparatus for a surgical operating 
room is a device intended to produce a directed, nonturbulent flow of 
air that has been filtered to remove particulate matter and 
microorganisms to provide an area free of contaminants to reduce the 
possibility of infection in the patient.
    (b) Classification. Class II (special controls). The device, when it 
is an air handling bench apparatus, an air handling room apparatus, or 
an air handling enclosure apparatus, is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 84 FR 71814, Dec. 30, 2019]

[[Page 610]]



Sec. 878.5080  Air-handling apparatus accessory.

    (a) Identification. An air-handling apparatus accessory is a 
supplementary device that is intended to be used with an air-handling 
apparatus for a surgical operating room. This device provides an 
interface between the components of the device or can be used to switch 
electrical power. This generic type of device includes fittings, 
adapters, couplers, remote switches, and footswitches.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 878.9.

[84 FR 14870, Apr. 12, 2019]



Sec. 878.5350  Needle-type epilator.

    (a) Identification. A needle-type epilator is a device intended to 
destroy the dermal papilla of a hair by applying electric current at the 
tip of a fine needle that has been inserted close to the hair shaft, 
under the skin, and into the dermal papilla. The electric current may be 
high-frequency AC current, high-frequency AC combined with DC current, 
or DC current only.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996; 66 
FR 38803, July 25, 2001]



Sec. 878.5360  Tweezer-type epilator.

    (a) Identification. The tweezer-type epilator is an electrical 
device intended to remove hair. The energy provided at the tip of the 
tweezer used to remove hair may be radio frequency, galvanic (direct 
current), or a combination of radio frequency and galvanic energy.
    (b) Classification. Class I (general controls). The device is exempt 
from premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 878.9.

[63 FR 57060, Oct. 26, 1998]



Sec. 878.5400  Low level laser system for aesthetic use

    (a) Identification. A Low Level Laser System for Aesthetic Use is a 
device using low level laser energy for the disruption of adipocyte 
cells within the fat layer for the release of fat and lipids from these 
cells for noninvasive aesthetic use.
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA guidance document entitled ``Guidance for 
Industry and Food and Drug Administration Staff; Class II Special 
Controls Guidance Document: Low Level Laser System for Aesthetic Use.'' 
See Sec. 878.1(e) for the availability of this guidance document.

[76 FR 20842, Apr. 14, 2011]



Sec. 878.5650  Topical oxygen chamber for extremities.

    (a) Identification. A topical oxygen chamber for extremities is a 
device that is intended to surround a patient's limb and apply 
humidified oxygen topically at a pressure slightly greater than 
atmospheric pressure to aid healing of chronic skin ulcers such as 
bedsores.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's ``Class II Special Controls Guidance: Topical 
Oxygen Chamber for Extremities.'' See Sec. 878.1(e) for the 
availability of this guidance document.

[76 FR 22807, Apr. 25, 2011]



Sec. 878.5900  Nonpneumatic tourniquet.

    (a) Identification. A nonpneumatic tourniquet is a device consisting 
of a strap or tubing intended to be wrapped around a patient's limb and 
tightened to reduce circulation.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989; 59 
FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001]



Sec. 878.5910  Pneumatic tourniquet.

    (a) Identification. A pneumatic tourniquet is an air-powered device 
consisting of a pressure-regulating unit,

[[Page 611]]

connecting tubing, and an inflatable cuff. The cuff is intended to be 
wrapped around a patient's limb and inflated to reduce or totally 
occlude circulation during surgery.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996; 66 
FR 38803, July 25, 2001]



PART 880_GENERAL HOSPITAL AND PERSONAL USE DEVICES--Table of Contents



                      Subpart A_General Provisions

Sec.
880.1 Scope.
880.3 Effective dates of requirement for premarket approval.
880.9 Limitations of exemptions from section 510(k) of the Federal Food, 
          Drug, and Cosmetic Act (the act).

Subpart B [Reserved]

     Subpart C_General Hospital and Personal Use Monitoring Devices

880.2200 Liquid crystal forehead temperature strip.
880.2400 Bed-patient monitor.
880.2420 Electronic monitor for gravity flow infusion systems.
880.2460 Electrically powered spinal fluid pressure monitor.
880.2500 Spinal fluid manometer.
880.2700 Stand-on patient scale.
880.2720 Patient scale.
880.2740 Surgical sponge scale.
880.2750 Image processing device for estimation of external blood loss.
880.2800 Sterilization process indicator.
880.2900 Clinical color change thermometer.
880.2910 Clinical electronic thermometer.
880.2920 Clinical mercury thermometer.
880.2930 Apgar timer.

Subparts D-E [Reserved]

     Subpart F_General Hospital and Personal Use Therapeutic Devices

880.5025 I.V. container.
880.5045 Medical recirculating air cleaner.
880.5075 Elastic bandage.
880.5090 Liquid bandage.
880.5100 AC-powered adjustable hospital bed.
880.5110 Hydraulic adjustable hospital bed.
880.5120 Manual adjustable hospital bed.
880.5130 Infant radiant warmer.
880.5140 Pediatric medical crib.
880.5145 Medical bassinet.
880.5150 Nonpowered flotation therapy mattress.
880.5160 Therapeutic medical binder.
880.5180 Burn sheet.
880.5200 Intravascular catheter.
880.5210 Intravascular catheter securement device.
880.5240 Medical adhesive tape and adhesive bandage.
880.5270 Neonatal eye pad.
880.5300 Medical absorbent fiber.
880.5400 Neonatal incubator.
880.5410 Neonatal transport incubator.
880.5420 Pressure infusor for an I.V. bag.
880.5430 Nonelectrically powered fluid injector.
880.5440 Intravascular administration set.
880.5445 Intravascular administration set, automated air removal system.
880.5450 Patient care reverse isolation chamber.
880.5475 Jet lavage.
880.5500 AC-powered patient lift.
880.5510 Non-AC-powered patient lift.
880.5550 Alternating pressure air flotation mattress.
880.5560 Temperature regulated water mattress.
880.5570 Hypodermic single lumen needle.
880.5580 Acupuncture needle.
880.5630 Nipple shield.
880.5640 Lamb feeding nipple.
880.5680 Pediatric position holder.
880.5700 Neonatal phototherapy unit.
880.5725 Infusion pump.
880.5730 Alternate controller enabled infusion pump.
880.5740 Suction snakebite kit.
880.5760 Chemical cold pack snakebite kit.
880.5780 Medical support stocking.
880.5820 Therapeutic scrotal support.
880.5860 Piston syringe.
880.5950 Umbilical occlusion device.
880.5960 Lice removal kit.
880.5965 Subcutaneous, implanted, intravascular infusion port and 
          catheter.
880.5970 Percutaneous, implanted, long-term intravascular catheter.

    Subpart G_General Hospital and Personal Use Miscellaneous Devices

880.6025 Absorbent tipped applicator.
880.6050 Ice bag.
880.6060 Medical disposable bedding.
880.6070 Bed board.
880.6080 Cardiopulmonary resuscitation board.
880.6085 Hot/cold water bottle.
880.6100 Ethylene oxide gas aerator cabinet.
880.6140 Medical chair and table.
880.6150 Ultrasonic cleaner for medical instruments.
880.6175 [Reserved]
880.6185 Cast cover.

[[Page 612]]

880.6190 Mattress cover for medical purposes.
880.6200 Ring cutter.
880.6210 Sharps needle destruction device.
880.6230 Tongue depressor.
880.6250 Non-powdered patient examination glove.
880.6260 Filtering facepiece respirator for use by the general public in 
          public health medical emergencies.
880.6265 Examination gown.
880.6280 Medical insole.
880.6300 Implantable radiofrequency transponder system for patient 
          identification and health information.
880.6305 Ingestible event marker.
880.6310 Medical device data system.
880.6315 Remote medication management system.
880.6320 AC-powered medical examination light.
880.6350 Battery-powered medical examination light.
880.6375 Patient lubricant.
880.6430 Liquid medication dispenser.
880.6450 Skin pressure protectors.
880.6500 Medical ultraviolet air purifier.
880.6600 Ultraviolet (UV) radiation chamber disinfection device.
880.6710 Medical ultraviolet water purifier.
880.6730 Body waste receptacle.
880.6740 Vacuum-powered body fluid suction apparatus.
880.6760 Protective restraint.
880.6775 Powered patient transfer device.
880.6785 Manual patient transfer device.
880.6800 Washers for body waste receptacles.
880.6820 Medical disposable scissors.
880.6850 Sterilization wrap.
880.6860 Ethylene oxide gas sterilizer.
880.6870 Dry-heat sterilizer.
880.6880 Steam sterilizer.
880.6885 Liquid chemical sterilants/high level disinfectants.
880.6887 Spore test strip.
880.6890 General purpose disinfectants.
880.6900 Hand-carried stretcher.
880.6910 Wheeled stretcher.
880.6920 Syringe needle introducer.
880.6960 Irrigating syringe.
880.6970 Liquid crystal vein locator.
880.6980 Vein stabilizer.
880.6990 Infusion stand.
880.6991 Medical washer.
880.6992 Medical washer-disinfector.

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 880 appear at 73 FR 
35341, June 23, 2008.



                      Subpart A_General Provisions



Sec. 880.1  Scope.

    (a) This part sets forth the classification of general hospital and 
personal use devices intended for human use that are in commercial 
distribution.
    (b) The identification of a device in a regulation in this part is 
not a precise description of every device that is, or will be, subject 
to the regulation. A manufacturer who submits a premarket notification 
submission for a device under part 807 may not show merely that the 
device is accurately described by the section title and identification 
provisions of a regulation in this part, but shall state why the device 
is substantially equivalent to other devices, as required by Sec. 
807.87.
    (c) To avoid duplicative listings, a general hospital and personal 
use device that has two or more types of uses (e.g., used both as a 
diagnostic device and as a therapeutic device) is listed only in one 
subpart.
    (d) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.
    (e) Guidance documents referenced in this part are available on the 
Internet at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/default.htm..

[52 FR 17738, May 11, 1987, as amended at 69 FR 71704, Dec. 8, 2004; 78 
FR 18233, Mar. 26, 2013]



Sec. 880.3  Effective dates of requirement for premarket approval.

    A device included in this part that is classified into class III 
(premarket approval) shall not be commercially distributed after the 
date shown in the regulation classifying the device unless the 
manufacturer has an approval under section 515 of the act (unless an 
exemption has been granted under section 520(g)(2) of the act). An 
approval under section 515 of the act consists of FDA's issuance of an 
order approving an application for premarket approval (PMA) for the 
device or declaring completed a product development protocol (PDP) for 
the device.
    (a) Before FDA requires that a device commercially distributed 
before the enactment date of the amendments, or

[[Page 613]]

a device that has been found substantially equivalent to such a device, 
has an approval under section 515 of the act FDA must promulgate a 
regulation under section 515(b) of the act requiring such approval, 
except as provided in paragraph (b) of this section. Such a regulation 
under section 515(b) of the act shall not be effective during the grace 
period ending on the 90th day after its promulgation or on the last day 
of the 30th full calendar month after the regulation that classifies the 
device into class III is effective, whichever is later. See section 
501(f)(2)(B) of the act. Accordingly, unless an effective date of the 
requirement for premarket approval is shown in the regulation for a 
device classified into class III in this part, the device may be 
commercially distributed without FDA's issuance of an order approving a 
PMA or declaring completed a PDP for the device. If FDA promulgates a 
regulation under section 515(b) of the act requiring premarket approval 
for a device, section 501(f)(1)(A) of the act applies to the device.
    (b) Any new, not substantially equivalent, device introduced into 
commercial distribution on or after May 28, 1976, including a device 
formerly marketed that has been substantially altered, is classified by 
statute (section 513(f) of the act) into class III without any grace 
period and FDA must have issued an order approving a PMA or declaring 
completed a PDP for the device before the device is commercially 
distributed unless it is reclassified. If FDA knows that a device being 
commercially distributed may be a ``new'' devices defined in this 
section because of any new intended use or other reasons, FDA may codify 
the statutory classification of the device into class III for such new 
use. Accordingly, the regulation for such a class III device states that 
as of the enactment date of the amendments, May 28, 1976, the device 
must have an approval under section 515 of the act before commercial 
distribution.

[52 FR 17738, May 11, 1987]



Sec. 880.9  Limitations of exemptions from section 510(k) of 
the Federal Food, Drug, and Cosmetic Act (the act).

    The exemption from the requirement of premarket notification 
(section 510(k) of the act) for a generic type of class I or II device 
is only to the extent that the device has existing or reasonably 
foreseeable characteristics of commercially distributed devices within 
that generic type or, in the case of in vitro diagnostic devices, only 
to the extent that misdiagnosis as a result of using the device would 
not be associated with high morbidity or mortality. Accordingly, 
manufacturers of any commercially distributed class I or II device for 
which FDA has granted an exemption from the requirement of premarket 
notification must still submit a premarket notification to FDA before 
introducing or delivering for introduction into interstate commerce for 
commercial distribution the device when:
    (a) The device is intended for a use different from the intended use 
of a legally marketed device in that generic type of device; e.g., the 
device is intended for a different medical purpose, or the device is 
intended for lay use where the former intended use was by health care 
professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro diagnostic 
device detects or identifies infectious agents by using deoxyribonucleic 
acid (DNA) probe or nucleic acid hybridization technology rather than 
culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of neoplastic 
diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial or acquired 
genetic disorders, including inborn errors of metabolism;
    (3) For measuring an analyte that serves as a surrogate marker for 
screening, diagnosis, or monitoring

[[Page 614]]

life-threatening diseases such as acquired immune deficiency syndrome 
(AIDS), chronic or active hepatitis, tuberculosis, or myocardial 
infarction or to monitor therapy;
    (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) or IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is intended 
for use in matrices other than serum or plasma;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).

[65 FR 2318, Jan. 14, 2000]

Subpart B [Reserved]



     Subpart C_General Hospital and Personal Use Monitoring Devices



Sec. 880.2200  Liquid crystal forehead temperature strip.

    (a) Identification. A liquid crystal forehead temperature strip is a 
device applied to the forehead that is used to indicate the presence or 
absence of fever, or to monitor body temperature changes. The device 
displays the color changes of heat sensitive liquid crystals 
corresponding to the variation in the surface temperature of the skin. 
The liquid crystals, which are cholesteric esters, are sealed in 
plastic.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59228, Nov. 3, 1998]



Sec. 880.2400  Bed-patient monitor.

    (a) Identification. A bed-patient monitor is a battery-powered 
device placed under a mattress and used to indicate by an alarm or other 
signal when a patient attempts to leave the bed.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63010, Dec. 7, 1994; 66 
FR 38803, July 25, 2001]



Sec. 880.2420  Electronic monitor for gravity flow infusion systems.

    (a) Identification. An electronic monitor for gravity flow infusion 
systems is a device used to monitor the amount of fluid being infused 
into a patient. The device consists of an electronic transducer and 
equipment for signal amplification, conditioning, and display.
    (b) Classification. Class II (performance standards).



Sec. 880.2460  Electrically powered spinal fluid pressure monitor.

    (a) Identification. An electrically powered spinal fluid pressure 
monitor is an electrically powered device used to measure spinal fluid 
pressure by the use of a transducer which converts spinal fluid pressure 
into an electrical signal. The device includes signal amplification, 
conditioning, and display equipment.
    (b) Classification. Class II (performance standards).



Sec. 880.2500  Spinal fluid manometer.

    (a) Identification. A spinal fluid manometer is a device used to 
measure spinal fluid pressure. The device uses a hollow needle, which is 
inserted into the spinal column fluid space, to connect the spinal fluid 
to a graduated column so that the pressure can be measured by reading 
the height of the fluid.
    (b) Classification. Class II (performance standards).



Sec. 880.2700  Stand-on patient scale.

    (a) Identification. A stand-on patient scale is a device intended 
for medical purposes that is used to weigh a patient who is able to 
stand on the scale platform.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. The device also 
is exempt from the current

[[Page 615]]

good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180, with respect to general requirements concerning records, and 
Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38803, July 25, 2001]



Sec. 880.2720  Patient scale.

    (a) Identification. A patient scale is a device intended for medical 
purposes that is used to measure the weight of a patient who cannot 
stand on a scale. This generic device includes devices placed under a 
bed or chair to weigh both the support and the patient, devices where 
the patient is lifted by a sling from a bed to be weighed, and devices 
where the patient is placed on the scale platform to be weighed. The 
device may be mechanical, battery powered, or AC-powered and may include 
transducers, electronic signal amplification, conditioning and display 
equipment.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 
FR 38803, July 25, 2001]



Sec. 880.2740  Surgical sponge scale.

    (a) Identification. A surgical sponge scale is a nonelectrically 
powered device used to weigh surgical sponges that have been used to 
absorb blood during surgery so that, by comparison with the known dry 
weight of the sponges, an estimate may be made of the blood lost by the 
patient during surgery.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. The device also 
is exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001]



Sec. 880.2750  Image processing device for estimation of external blood loss.

    (a) Identification. An image processing device for estimation of 
external blood loss is a device to be used as an aid in estimation of 
patient external blood loss. The device may include software and/or 
hardware that is used to process images capturing externally lost blood 
to estimate the hemoglobin mass and/or the blood volume present in the 
images.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance data must demonstrate that the device 
performs as intended under anticipated conditions of use. Demonstration 
of the performance characteristics must include a comparison to a 
scientifically valid alternative method for measuring deposited 
hemoglobin mass. The following use conditions must be tested:
    (i) Lighting conditions;
    (ii) Range of expected hemoglobin concentrations;
    (iii) Range of expected blood volume absorption; and
    (iv) Presence of other non-sanguineous fluids (e.g., saline 
irrigation fluid).
    (2) Human factors testing and analysis must validate that the device 
design and labeling are sufficient for appropriate use by intended users 
of the device.
    (3) Appropriate analysis and non-clinical testing must validate the 
electromagnetic compatibility (EMC) and wireless performance of the 
device.
    (4) Appropriate software verification, validation, and hazard 
analysis must be performed.
    (5) Software display must include an estimate of the cumulative 
error associated with estimated blood loss values.
    (6) Labeling must include:
    (i) Warnings, cautions, and limitations needed for safe use of the 
device;
    (ii) A detailed summary of the performance testing pertinent to use 
of the device, including a description of

[[Page 616]]

the bias and variance the device exhibited during testing;
    (iii) The validated surgical materials, range of hemoglobin mass, 
software, hardware, and accessories that the device is intended to be 
used with; and
    (iv) EMC and wireless technology instructions and information.

[82 FR 60307, Dec. 20, 2017]



Sec. 880.2800  Sterilization process indicator.

    (a) Biological sterilization process indicator--(1) Identification. 
A biological sterilization process indicator is a device intended for 
use by a health care provider to accompany products being sterilized 
through a sterilization procedure and to monitor adequacy of 
sterilization. The device consists of a known number of microorganisms, 
of known resistance to the mode of sterilization, in or on a carrier and 
enclosed in a protective package. Subsequent growth or failure of the 
microorganisms to grow under suitable conditions indicates the adequacy 
of sterilization.
    (2) Classification. Class II (performance standards).
    (b) Physical/chemical sterilization process indicator--(1) 
Identification. A physical/chemical sterilization process indicator is a 
device intended for use by a health care provider to accompany products 
being sterilized through a sterilization procedure and to monitor one or 
more parameters of the sterilization process. The adequacy of the 
sterilization conditions as measured by these parameters is indicated by 
a visible change in the device.
    (2) Classification. Class II (performance standards).



Sec. 880.2900  Clinical color change thermometer.

    (a) Identification. A clinical color change thermometer is a 
disposable device used to measure a patient's oral, rectal, or axillary 
(armpit) body temperature. The device records body temperature by use of 
heat sensitive chemicals which are sealed at the end of a plastic or 
metal strip. Body heat causes a stable color change in the heat 
sensitive chemicals.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 
FR 38804, July 25, 2001]



Sec. 880.2910  Clinical electronic thermometer.

    (a) Identification. A clinical electronic thermometer is a device 
used to measure the body temperature of a patient by means of a 
transducer coupled with an electronic signal amplification, 
conditioning, and display unit. The transducer may be in a detachable 
probe with or without a disposable cover.
    (b) Classification. Class II (performance standards).



Sec. 880.2920  Clinical mercury thermometer.

    (a) Identification. A clinical mercury thermometer is a device used 
to measure oral, rectal, or axillary (armpit) body temperature using the 
thermal expansion of mercury.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59228, Nov. 3, 1998]



Sec. 880.2930  Apgar timer.

    (a) Identification. The Apgar timer is a device intended to alert a 
health care provider to take the Apgar score of a newborn infant.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 880.9. The device is 
also exempt from the current good manufacturing practice requirements in 
part 820 of this chapter, with the exception of Sec. 820.180 of this 
chapter, with respect to general requirements concerning records, and 
Sec. 820.198 of this chapter, with respect to complaint files.

[63 FR 59718, Nov. 5, 1998]

Subparts D-E [Reserved]

[[Page 617]]



     Subpart F_General Hospital and Personal Use Therapeutic Devices



Sec. 880.5025  I.V. container.

    (a) Identification. An I.V. container is a container made of plastic 
or glass used to hold a fluid mixture to be administered to a patient 
through an intravascular administration set.
    (b) Classification. Class II (performance standards).



Sec. 880.5045  Medical recirculating air cleaner.

    (a) Identification. A medical recirculating air cleaner is a device 
used to remove particles from the air for medical purposes. The device 
may function by electrostatic precipitation or filtration.
    (b) Classification. Class II (performance standards).



Sec. 880.5075  Elastic bandage.

    (a) Identification. An elastic bandage is a device consisting of 
either a long flat strip or a tube of elasticized material that is used 
to support and compress a part of a patient's body.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. The device also 
is exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001]



Sec. 880.5090  Liquid bandage.

    (a) Identification. A liquid bandage is a sterile device that is a 
liquid, semiliquid, or powder and liquid combination used to cover an 
opening in the skin or as a dressing for burns. The device is also used 
as a topical skin protectant.
    (b) Classification. Class I (general controls). When used only as a 
skin protectant, the device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to Sec. 
880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 65 FR 2318, Jan. 14, 2000]



Sec. 880.5100  AC-powered adjustable hospital bed.

    (a) Identification. An AC-powered adjustable hospital bed is a 
device intended for medical purposes that consists of a bed with a 
built-in electric motor and remote controls that can be operated by the 
patient to adjust the height and surface contour of the bed. The device 
includes movable and latchable side rails.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]



Sec. 880.5110  Hydraulic adjustable hospital bed.

    (a) Identification. A hydraulic adjustable hospital bed is a device 
intended for medical purposes that consists of a bed with a hydraulic 
mechanism operated by an attendant to adjust the height and surface 
contour of the bed. The device includes movable and latchable side 
rails.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001]



Sec. 880.5120  Manual adjustable hospital bed.

    (a) Identification. A manual adjustable hospital bed is a device 
intended for medical purposes that consists of a bed with a manual 
mechanism operated by an attendant to adjust the height and surface 
contour of the bed. The device includes movable and latchable side 
rails.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. The device is 
also exempt from the current

[[Page 618]]

good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180, with respect to general requirements concerning records, and 
Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989; 
66 FR 38804, July 25, 2001]



Sec. 880.5130  Infant radiant warmer.

    (a) Identification. The infant radiant warmer is a device consisting 
of an infrared heating element intended to be placed over an infant to 
maintain the infant's body temperature by means of radiant heat. The 
device may also contain a temperature monitoring sensor, a heat output 
control mechanism, and an alarm system (infant temperature, manual mode 
if present, and failure alarms) to alert operators of a temperature 
condition over or under the set temperature, manual mode time limits, 
and device component failure, respectively. The device may be placed 
over a pediatric hospital bed or it may be built into the bed as a 
complete unit.
    (b) Classification. Class II (Special Controls):
    (1) The Association for the Advancement of Medical Instrumentation 
(AAMI) Voluntary Standard for the Infant Radiant Warmer;
    (2) A prescription statement in accordance with Sec. 801.109 of 
this chapter (restricted to use by or upon the order of qualified 
practitioners as determined by the States); and
    (3) Labeling for use only in health care facilities and only by 
persons with specific training and experience in the use of the device.

[62 FR 33350, June 19, 1997]



Sec. 880.5140  Pediatric medical crib.

    (a) Identification. A pediatric medical crib is a prescription 
device intended for medical purposes for use with a pediatric patient 
that consists of an open crib, fixed end rails, movable and latchable 
side rail components, and possibly an accompanying mattress. The contour 
of the crib surface may be adjustable.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 880.9. The special controls for 
this device are:
    (1) Crib design and performance testing shall demonstrate the 
mechanical and structural stability of the crib under expected 
conditions of use, including the security of latches and other locking 
mechanisms when engaged;
    (2) Materials used shall be appropriate for the conditions of use, 
allow for proper sanitation, and be free from surface defects that could 
result in injuries;
    (3) The height of the rail and end panel as measured from the top of 
the rail or panel in its highest position to the top of the mattress 
support in its lowest position shall be at least 26 inches (66 
centimeters). Any mattress used in this crib must not exceed a thickness 
of 6 inches;
    (4) Hardware and fasteners shall be designed and constructed to 
eliminate mechanical hazards to the patient;
    (5) The distance between components of the side rail (i.e., slats, 
spindles, and corner posts) shall not be greater than 2\3/8\ inches (6 
centimeters) apart at any point;
    (6) The mattress must fit tightly around all four sides of the crib 
base, such that entrapment or impingement of occupant is prevented;
    (7) The mattress for the crib shall meet the Consumer Product Safety 
Commission (CPSC) Standard for the flammability of mattresses and 
mattress pads (FF 4-72, amended) and Standard for the flammability (open 
flame) of mattress sets, 16 CFR parts 1632 and 1633, respectively; and
    (8) Each device must have the following label(s) affixed:
    (i) Adequate instructions for users to care for, maintain, and clean 
the crib; and
    (ii) A warning label on at least two sides of the medical crib with 
the following language in text of at least 9 millimeters in height:

WARNING: Never leave a child unsupervised when the moveable side is open 
    or not secured.

[81 FR 91737, Dec. 19, 2016]

[[Page 619]]



Sec. 880.5145  Medical bassinet.

    (a) Identification. A medical bassinet is a prescription device that 
is a small bed intended for use with pediatric patients, generally from 
birth to approximately 5 months of age. It is intended for medical 
purposes for use in a nursery, labor and delivery unit, or patient room, 
but may also be used outside of traditional health care settings. A 
medical bassinet is a non-powered device that consists of two 
components: The plastic basket or bed component and a durable frame with 
wheels, which holds the basket or bed component. The basket or bed 
component is a box-like structure, generally made of a clear, high 
impact-resistant plastic material, with an open top and four stationary 
walls to hold the pediatric patient. The frame can include drawers, 
shelving, or cabinetry that provides space to hold infant care items. 
The wheels or casters allow the bassinet to transport the infant 
throughout the care setting.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 880.9. The special controls for 
this device are:
    (1) The manufacturer must conduct performance testing to determine 
material compatibility with cleansing products labeled to clean the 
device. Testing must demonstrate that the cleaning instructions provided 
by the manufacturer do not cause crazing, cracking, or deterioration of 
the device;
    (2) Manufacturers shall conduct performance testing to ensure the 
mechanical and structural stability of the bassinet under expected 
conditions of use, including transport of patients in the bassinet. 
Testing must demonstrate that failures such as wheel or caster breakage 
do not occur and that the device does not present a tipping hazard due 
to any mechanical failures under expected conditions of use; and
    (3) Each device must have the following label(s) affixed:
    (i) Adequate instructions for users to care for, maintain, and clean 
the bassinet; and
    (ii) A warning label on at least two sides of the plastic basket or 
bed component with the following language in text of at least 9 
millimeters in height:

WARNING: To avoid tipping hazards of this device, make sure that the 
    basket or bed component sits firmly in the base and that all doors, 
    drawers, and casters are secure.

[81 FR 91737, Dec. 19, 2016]



Sec. 880.5150  Nonpowered flotation therapy mattress.

    (a) Identification. A nonpowered flotation therapy mattress is a 
mattress intended for medical purposes which contains air, fluid, or 
other materials that have the functionally equivalent effect of 
supporting a patient and avoiding excess pressure on local body areas. 
The device is intended to treat or prevent decubitus ulcers (bed sores).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. The device also 
is exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001]



Sec. 880.5160  Therapeutic medical binder.

    (a) Identification. A therapeutic medical binder is a device, 
usually made of cloth, that is intended for medical purposes and that 
can be secured by ties so that it supports the underlying part of the 
body or holds a dressing in place. This generic type of device includes 
the abdominal binder, breast binder, and perineal binder.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. If the device 
is not labeled or otherwise represented as sterile, it is also exempt 
from the current good manufacturing practice requirements of the quality 
system regulation in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements

[[Page 620]]

concerning records, and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001]



Sec. 880.5180  Burn sheet.

    (a) Identification. A burn sheet is a device made of a porous 
material that is wrapped aroung a burn victim to retain body heat, to 
absorb wound exudate, and to serve as a barrier against contaminants.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 
FR 38804, July 25, 2001]



Sec. 880.5200  Intravascular catheter.

    (a) Identification. An intravascular catheter is a device that 
consists of a slender tube and any necessary connecting fittings and 
that is inserted into the patient's vascular system for short term use 
(less than 30 days) to sample blood, monitor blood pressure, or 
administer fluids intravenously. The device may be constructed of metal, 
rubber, plastic, or a combination of these materials.
    (b) Classification. Class II (performance standards).



Sec. 880.5210  Intravascular catheter securement device.

    (a) Identification. An intravascular catheter securement device is a 
device with an adhesive backing that is placed over a needle or catheter 
and is used to keep the hub of the needle or the catheter flat and 
securely anchored to the skin.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 
FR 38804, July 25, 2001]



Sec. 880.5240  Medical adhesive tape and adhesive bandage.

    (a) Identification. A medical adhesive tape or adhesive bandage is a 
device intended for medical purposes that consists of a strip of fabric 
material or plastic, coated on one side with an adhesive, and may 
include a pad of surgical dressing without a disinfectant. The device is 
used to cover and protect wounds, to hold together the skin edges of a 
wound, to support an injured part of the body, or to secure objects to 
the skin.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 
FR 38804, July 25, 2001]



Sec. 880.5270  Neonatal eye pad.

    (a) Identification. A neonatal eye pad is an opaque device used to 
cover and protect the eye of an infant during therapeutic procedures, 
such as phototherapy.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 880.9. If the device is not labeled or 
otherwise represented as sterile, it is exempt from the current good 
manufacturing practice requirements of the quality system regulation in 
part 820 of this chapter, with the exception of Sec. 820.180 of this 
chapter, with respect to general requirements concerning records, and 
Sec. 820.198 of this chapter, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 65 FR 2318, Jan. 14, 2000]



Sec. 880.5300  Medical absorbent fiber.

    (a) Identification. A medical absorbent fiber is a device intended 
for medical purposes that is made from cotton or synthetic fiber in the 
shape of a ball or a pad and that is used for applying medication to, or 
absorbing small amounts of body fluids from, a patient's body surface. 
Absorbent fibers intended solely for cosmetic purposes are not included 
in this generic device category.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 621]]

subpart E of part 807 of this chapter, subject to the limitations in 
Sec. 880.9. If the device is not labeled or otherwise represented as 
sterile, it is also exempt from the current good manufacturing practice 
requirements of the quality system regulation in part 820 of this 
chapter, with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001]



Sec. 880.5400  Neonatal incubator.

    (a) Identification. A neonatal incubator is a device consisting of a 
rigid boxlike enclosure in which an infant may be kept in a controlled 
environment for medical care. The device may include an AC-powered 
heater, a fan to circulate the warmed air, a container for water to add 
humidity, a control valve through which oxygen may be added, and access 
ports for nursing care.
    (b) Classification. Class II (performance standards).



Sec. 880.5410  Neonatal transport incubator.

    (a) Identification. A neonatal transport incubator is a device 
consisting of a portable rigid boxlike enclosure with insulated walls in 
which an infant may be kept in a controlled environment while being 
transported for medical care. The device may include straps to secure 
the infant, a battery-operated heater, an AC-powered battery charger, a 
fan to circulate the warmed air, a container for water to add humidity, 
and provision for a portable oxygen bottle.
    (b) Classification. Class II (performance standards).



Sec. 880.5420  Pressure infusor for an I.V. bag.

    (a) Identification. A pressure infusor for an I.V. bag is a device 
consisting of an inflatable cuff which is placed around an I.V. bag. 
When the device is inflated, it increases the pressure on the I.V. bag 
to assist the infusion of the fluid.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 65 FR 2318, Jan. 14, 2000]



Sec. 880.5430  Nonelectrically powered fluid injector.

    (a) Identification. A nonelectrically powered fluid injector is a 
nonelectrically powered device used by a health care provider to give a 
hypodermic injection by means of a narrow, high velocity jet of fluid 
which can penetrate the surface of the skin and deliver the fluid to the 
body. It may be used for mass inoculations.
    (b) Classification. Class II (performance standards).



Sec. 880.5440  Intravascular administration set.

    (a) Identification. An intravascular administration set is a device 
used to administer fluids from a container to a patient's vascular 
system through a needle or catheter inserted into a vein. The device may 
include the needle or catheter, tubing, a flow regulator, a drip 
chamber, an infusion line filter, an I.V. set stopcock, fluid delivery 
tubing, connectors between parts of the set, a side tube with a cap to 
serve as an injection site, and a hollow spike to penetrate and connect 
the tubing to an I.V. bag or other infusion fluid container.
    (b) Classification. Class II (special controls). The special control 
for pharmacy compounding systems within this classification is the FDA 
guidance document entitled ``Class II Special Controls Guidance 
Document: Pharmacy Compounding Systems; Final Guidance for Industry and 
FDA Reviewers.'' Pharmacy compounding systems classified within the 
intravascular administration set are exempt from the premarket 
notification procedures in subpart E of this part and subject to the 
limitations in Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 15798, Mar. 21, 2001]



Sec. 880.5445  Intravascular administration set, automated air removal system.

    (a) Identification. An intravascular administration set, automated 
air removal system, is a prescription device

[[Page 622]]

used to detect and automatically remove air from an intravascular 
administration set with minimal to no interruption in the flow of the 
intravascular fluid. The device may include an air identification 
mechanism, software, an air removal mechanism, tubing, apparatus to 
collect removed air, and safety control mechanisms to address hazardous 
situations.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Provide an argument demonstrating that all reasonably 
foreseeable hazards have been adequately addressed with respect to the 
persons for whose use the device is represented or intended and the 
conditions of use for the device, which includes the following:
    (i) Description of the device indications for use, design, and 
technology, use environments, and users in sufficient detail to 
determine that the device complies with all special controls.
    (ii) Demonstrate that controls are implemented to address device 
system hazards and their causes.
    (iii) Include a justification supporting the acceptability criteria 
for each hazard control.
    (iv) A traceability analysis demonstrating that all credible hazards 
have at least one corresponding control and that all controls have been 
verified and validated in the final device design.
    (2) Appropriate software verification, validation, and hazard 
analysis must be performed.
    (3) The device parts that directly or indirectly contact the patient 
must be demonstrated to be biocompatible.
    (4) Performance data must demonstrate the sterility of fluid path 
contacting components and the shelf life of these components.
    (5) The device must be designed and tested for electrical safety and 
electromagnetic compatibility (EMC).
    (6) Nonclinical performance testing data must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be tested:
    (i) Device system and component reliability testing must be 
conducted.
    (ii) Fluid ingress protection testing must be conducted.
    (iii) Testing of safety controls must be performed to demonstrate 
adequate mitigation of hazardous situations, including sensor failure, 
flow control failure, improper device position, device malfunction, 
infusion delivery error, and release of air to the patient.
    (7) A human factors validation study must demonstrate that use 
hazards are adequately addressed.
    (8) The labeling must include the following:
    (i) The device's air identification and removal response time.
    (ii) The device's minimum air volume identification sensitivity.
    (iii) The minimum and maximum flow rates at which the device is 
capable of reliably detecting and removing air.
    (iv) Quantification of any fluid loss during device air removal 
operations as a function of flow rate.

[79 FR 28406, May 16, 2014]



Sec. 880.5450  Patient care reverse isolation chamber.

    (a) Identification. A patient care reverse isolation chamber is a 
device consisting of a roomlike enclosure designed to prevent the entry 
of harmful airborne material. This device protects a patient who is 
undergoing treatment for burns or is lacking a normal immunosuppressive 
defense due to therapy or congenital abnormality. The device includes 
fans and air filters which maintain an atmosphere of clean air at a 
pressure greater than the air pressure outside the enclosure.
    (b) Classification. Class II (performance standards).



Sec. 880.5475  Jet lavage.

    (a) Identification. A jet lavage is a device used to clean a wound 
by a pulsatile jet of sterile fluid. The device consists of the pulsing 
head, tubing to connect to a container of sterile fluid, and a means of 
propelling the fluid through the tubing, such as an electric roller 
pump.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures

[[Page 623]]

in subpart E of part 807 of this chapter subject to Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]



Sec. 880.5500  AC-powered patient lift.

    (a) Identification. An AC-powered lift is an electrically powered 
device either fixed or mobile, used to lift and transport patients in 
the horizontal or other required position from one place to another, as 
from a bed to a bath. The device includes straps and slings to support 
the patient.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]



Sec. 880.5510  Non-AC-powered patient lift.

    (a) Identification. A non-AC-powered patient lift is a hydraulic, 
battery, or mechanically powered device, either fixed or mobile, used to 
lift and transport a patient in the horizontal or other required 
position from one place to another, as from a bed to a bath. The device 
includes straps and a sling to support the patient.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989; 
66 FR 38804, July 25, 2001]



Sec. 880.5550  Alternating pressure air flotation mattress.

    (a) Identification. An alternating pressure air flotation mattress 
is a device intended for medical purposes that consists of a mattress 
with multiple air cells that can be filled and emptied in an alternating 
pattern by an associated control unit to provide regular, frequent, and 
automatic changes in the distribution of body pressure. The device is 
used to prevent and treat decubitus ulcers (bed sores).
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]



Sec. 880.5560  Temperature regulated water mattress.

    (a) Identification. A temperature regulated water mattress is a 
device intended for medical purposes that consists of a mattress of 
suitable size, filled with water which can be heated or in some cases 
cooled. The device includes electrical heating and water circulating 
components, and an optional cooling component. The temperature control 
may be manual or automatic.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 
FR 38804, July 25, 2001]



Sec. 880.5570  Hypodermic single lumen needle.

    (a) Identification. A hypodermic single lumen needle is a device 
intended to inject fluids into, or withdraw fluids from, parts of the 
body below the surface of the skin. The device consists of a metal tube 
that is sharpened at one end and at the other end joined to a female 
connector (hub) designed to mate with a male connector (nozzle) of a 
piston syringe or an intravascular administration set.
    (b) Classification. Class II (performance standards).



Sec. 880.5580  Acupuncture needle.

    (a) Identification. An acupuncture needle is a device intended to 
pierce the skin in the practice of acupuncture. The device consists of a 
solid, stainless steel needle. The device may have a handle attached to 
the needle to facilitate the delivery of acupuncture treatment.
    (b) Classification. Class II (special controls). The device, when it 
is an acupuncture point locator or a single use acupuncture needle, is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 880.9.

[[Page 624]]

Acupuncture needles must comply with the following special controls:
    (1) Labeling for single use only and conformance to the requirements 
for prescription devices set out in 21 CFR 801.109,
    (2) Device material biocompatibility, and
    (3) Device sterility.

[61 FR 64617, Dec. 6, 1996, as amended at 84 FR 71815, Dec. 30, 2019]



Sec. 880.5630  Nipple shield.

    (a) Identification. A nipple shield is a device consisting of a 
cover used to protect the nipple of a nursing woman. This generic device 
does not include nursing pads intended solely to protect the clothing of 
a nursing woman from milk.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 
FR 33804, July 25, 2001]



Sec. 880.5640  Lamb feeding nipple.

    (a) Identification. A lamb feeding nipple is a device intended for 
use as a feeding nipple for infants with oral or facial abnormalities.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. If the device 
is not labeled or otherwise represented as sterile, it is also exempt 
from the current good manufacturing practice requirements of the quality 
system regulation in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001]



Sec. 880.5680  Pediatric position holder.

    (a) Identification. A pediatric position holder is a device used to 
hold an infant or a child in a desired position for therapeutic or 
diagnostic purposes, e.g., in a crib under a radiant warmer, or to 
restrain a child while an intravascular injection is administered.
    (b) Classification. Class I (general controls). Except when the 
device is an infant positioner for prescription use in highly monitored 
settings or an infant sleep position holder, it is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 880.9. The device is exempt 
from the good manufacturing practice regulation in part 820 of this 
chapter, with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 46952, Sept. 10, 2001; 
84 FR 71815, Dec. 30, 2019]



Sec. 880.5700  Neonatal phototherapy unit.

    (a) Identification. A neonatal phototherapy unit is a device used to 
treat or prevent hyperbilirubinemia (elevated serum bilirubin level). 
The device consists of one or more lamps that emit a specific spectral 
band of light, under which an infant is placed for therapy. This generic 
type of device may include supports for the patient and equipment and 
component parts.
    (b) Classification. Class II (performance standards).



Sec. 880.5725  Infusion pump.

    (a) Identification. An infusion pump is a device used in a health 
care facility to pump fluids into a patient in a controlled manner. The 
device may use a piston pump, a roller pump, or a peristaltic pump and 
may be powered electrically or mechanically. The device may also operate 
using a constant force to propel the fluid through a narrow tube which 
determines the flow rate. The device may include means to detect a fault 
condition, such as air in, or blockage of, the infusion line and to 
activate an alarm.
    (b) Classification. Class II (performance standards).



Sec. 880.5730  Alternate controller enabled infusion pump.

    (a) Identification. An alternate controller enabled infusion pump 
(ACE pump) is a device intended for the infusion of drugs into a 
patient. The ACE

[[Page 625]]

pump may include basal and bolus drug delivery at set or variable rates. 
ACE pumps are designed to reliably and securely communicate with 
external devices, such as automated drug dosing systems, to allow drug 
delivery commands to be received, executed, and confirmed. ACE pumps are 
intended to be used both alone and in conjunction with digitally 
connected medical devices for the purpose of drug delivery.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Design verification and validation must include the following:
    (i) Evidence demonstrating that device infusion delivery accuracy 
conforms to defined user needs and intended uses and is validated to 
support safe use under actual use conditions.
    (A) Design input requirements must include delivery accuracy 
specifications under reasonably foreseeable use conditions, including 
ambient temperature changes, pressure changes (e.g., head-height, 
backpressure, atmospheric), and, as appropriate, different drug fluidic 
properties.
    (B) Test results must demonstrate that the device meets the design 
input requirements for delivery accuracy under use conditions for the 
programmable range of delivery rates and volumes. Testing shall be 
conducted with a statistically valid number of devices to account for 
variation between devices.
    (ii) Validation testing results demonstrating the ability of the 
pump to detect relevant hazards associated with drug delivery and the 
route of administration (e.g., occlusions, air in line, etc.) within a 
clinically relevant timeframe across the range of programmable drug 
delivery rates and volumes. Hazard detection must be appropriate for the 
intended use of the device and testing must validate appropriate 
performance under the conditions of use for the device.
    (iii) Validation testing results demonstrating compatibility with 
drugs that may be used with the pump based on its labeling. Testing must 
include assessment of drug stability under reasonably foreseeable use 
conditions that may affect drug stability (e.g., temperature, light 
exposure, or other factors as needed).
    (iv) The device parts that directly or indirectly contact the 
patient must be demonstrated to be biocompatible. This shall include 
chemical and particulate characterization on the final, finished, fluid 
contacting device components demonstrating that risk of harm from 
device-related residues is reasonably low.
    (v) Evidence verifying and validating that the device is reliable 
over the ACE pump use life, as specified in the design file, in terms of 
all device functions and in terms of pump performance.
    (vi) The device must be designed and tested for electrical safety, 
electromagnetic compatibility, and radio frequency wireless safety and 
availability consistent with patient safety requirements in the intended 
use environment.
    (vii) For any device that is capable of delivering more than one 
drug, the risk of cross-channeling drugs must be adequately mitigated.
    (viii) For any devices intended for multiple patient use, testing 
must demonstrate validation of reprocessing procedures and include 
verification that the device meets all functional and performance 
requirements after reprocessing.
    (2) Design verification and validation activities must include 
appropriate design inputs and design outputs that are essential for the 
proper functioning of the device that have been documented and include 
the following:
    (i) Risk control measures shall be implemented to address device 
system hazards and the design decisions related to how the risk control 
measures impact essential performance shall be documented.
    (ii) A traceability analysis demonstrating that all hazards are 
adequately controlled and that all controls have been validated in the 
final device design.
    (3) The device shall include validated interface specifications for 
digitally connected devices. These interface specifications shall, at a 
minimum, provide for the following:
    (i) Secure authentication (pairing) to external devices.

[[Page 626]]

    (ii) Secure, accurate, and reliable means of data transmission 
between the pump and connected devices.
    (iii) Sharing of necessary state information between the pump and 
any digitally connected alternate controllers (e.g., battery level, 
reservoir level, pump status, error conditions).
    (iv) Ensuring that the pump continues to operate safely when data is 
received in a manner outside the bounds of the parameters specified.
    (v) A detailed process and procedure for sharing the pump interface 
specification with digitally connected devices and for validating the 
correct implementation of that protocol.
    (4) The device must include appropriate measures to ensure that safe 
therapy is maintained when communications with digitally connected 
alternate controller devices is interrupted, lost, or re-established 
after an interruption (e.g., reverting to a pre-programmed, safe drug 
delivery rate). Validation testing results must demonstrate that 
critical events that occur during a loss of communications (e.g., 
commands, device malfunctions, occlusions, etc.) are handled 
appropriately during and after the interruption.
    (5) The device design must ensure that a record of critical events 
is stored and accessible for an adequate period to allow for auditing of 
communications between digitally connected devices and to facilitate the 
sharing of pertinent information with the responsible parties for those 
connected devices. Critical events to be stored by the system must, at a 
minimum, include:
    (i) A record of all drug delivery
    (ii) Commands issued to the pump and pump confirmations
    (iii) Device malfunctions
    (iv) Alarms and alerts and associated acknowledgements
    (v) Connectivity events (e.g., establishment or loss of 
communications)
    (6) Design verification and validation must include results obtained 
through a human factors study that demonstrates that an intended user 
can safely use the device for its intended use.
    (7) Device labeling must include the following:
    (i) A prominent statement identifying the drugs that are compatible 
with the device, including the identity and concentration of those drugs 
as appropriate.
    (ii) A description of the minimum and maximum basal rates, minimum 
and maximum bolus volumes, and the increment size for basal and bolus 
delivery, or other similarly applicable information about drug delivery 
parameters.
    (iii) A description of the pump accuracy at minimum, intermediate, 
and maximum bolus delivery volumes and the method(s) used to establish 
bolus delivery accuracy. For each bolus volume, pump accuracy shall be 
described in terms of the number of bolus doses measured to be within a 
given range as compared to the commanded volume. An acceptable accuracy 
description (depending on the drug delivered and bolus volume) may be 
provided as follows for each bolus volume tested, as applicable: Number 
of bolus doses with volume that is <25 percent, 25 percent to <75 
percent, 75 percent to <95 percent, 95 percent to <105 percent, 105 
percent to <125 percent, 125 percent to <175 percent, 175 to 250 
percent, and 250 percent of the commanded amount.
    (iv) A description of the pump accuracy at minimum, intermediate, 
and maximum basal delivery rates and the method(s) used to establish 
basal delivery accuracy. For each basal rate, pump accuracy shall be 
described in terms of the amount of drug delivered after the basal 
delivery was first commanded, without a warmup period, up to various 
time points. The information provided must include typical pump 
performance, as well as worst-case pump performance observed during 
testing in terms of both over-delivery and under-delivery. An acceptable 
accuracy description (depending on the drug delivered) may be provided 
as follows, as applicable: The total volume delivered 1 hour, 6 hours, 
and 12 hours after starting delivery for a typical pump tested, as well 
as for the pump that delivered the least and the pump that delivered the 
most at each time point.
    (v) A description of delivery hazard alarm performance, as 
applicable. For

[[Page 627]]

occlusion alarms, performance shall be reported at minimum, 
intermediate, and maximum delivery rates and volumes. This description 
must include the specification for the longest time period that may 
elapse before an occlusion alarm is triggered under each delivery 
condition, as well as the typical results observed during performance 
testing of the pumps.
    (vi) For wireless connection enabled devices, a description of the 
wireless quality of service required for proper use of the device.
    (vii) For any infusion pumps intended for multiple patient reuse, 
instructions for safely reprocessing the device between uses.

[87 FR 6424, Feb. 4, 2022]



Sec. 880.5740  Suction snakebite kit.

    (a) Identification. A suction snakebite kit is a device consisting 
of a knife, suction device, and tourniquet used for first-aid treatment 
of snakebites by removing venom from the wound.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 
FR 38805, July 25, 2001]



Sec. 880.5760  Chemical cold pack snakebite kit.

    (a) Identification. A chemical cold pack snakebit kit is a device 
consisting of a chemical cold pack and tourniquet used for first-aid 
treatment of snakebites.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any chemical 
cold pack snakebite kit that was in commercial distribution before May 
28, 1976, or that has, on or before December 26, 1996 been found to be 
substantially equivalent to a chemical cold pack snakebite kit that was 
in commercial distribution before May 28, 1976. Any other chemical cold 
pack snakebite kit shall have an approved PMA or a declared completed 
PDP in effect before being placed in commercial distribution.

[45 FR 69682, Oct. 21, 1980, as amended at 52 FR 17739, May 11, 1987; 61 
FR 50708, Sept. 27, 1996]



Sec. 880.5780  Medical support stocking.

    (a) Medical support stocking to prevent the pooling of blood in the 
legs--(1) Identification. A medical support stocking to prevent the 
pooling of blood in the legs is a device that is constructed of elastic 
material and designed to apply controlled pressure to the leg and that 
is intended for use in the prevention of pooling of blood in the leg.
    (2) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 880.9.
    (b) Medical support stocking for general medical purposes--(1) 
Identification. A medical support stocking for general medical purposes 
is a device that is constructed of elastic material and designed to 
apply controlled pressure to the leg and that is intended for medical 
purposes other than the prevention of pooling of blood in the leg.
    (2) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter, 
subject to the limitations in Sec. 880.9. The device is also exempt 
from the current good manufacturing practice requirements of the quality 
system regulation in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 
FR 38805, July 25, 2001; 84 FR 71815, Dec. 30, 2019]



Sec. 880.5820  Therapeutic scrotal support.

    (a) Identification. A therapeutic scrotal support is a device 
intended for medical purposes that consist of a pouch attached to an 
elastic waistband and that is used to support the scrotum (the sac that 
contains the testicles).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter,

[[Page 628]]

subject to the limitations in Sec. 880.9. The device also is exempt 
from the current good manufacturing practice requirements of the quality 
system regulation in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38805, July 25, 2001]



Sec. 880.5860  Piston syringe.

    (a) Identification. A piston syringe is a device intended for 
medical purposes that consists of a calibrated hollow barrel and a 
movable plunger. At one end of the barrel there is a male connector 
(nozzle) for fitting the female connector (hub) of a hypodermic single 
lumen needle. The device is used to inject fluids into, or withdraw 
fluids from, the body.
    (b) Classification. Class II (performance standards).



Sec. 880.5950  Umbilical occlusion device.

    (a) Identification. An umbilical occlusion device is a clip, tie, 
tape, or other article used to close the blood vessels in the umbilical 
cord of a newborn infant.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 
FR 38805, July 25, 2001]



Sec. 880.5960  Lice removal kit.

    (a) Identification. The lice removal kit is a comb or comb-like 
device intended to remove and/or kill lice and nits from head and body 
hair. It may or may not be battery operated.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 880.9.

[63 FR 59718, Nov. 5, 1998]



Sec. 880.5965  Subcutaneous, implanted, intravascular infusion port and catheter.

    (a) Identification. A subcutaneous, implanted, intravascular 
infusion port and catheter is a device that consists of a subcutaneous, 
implanted reservoir that connects to a long-term intravascular catheter. 
The device allows for repeated access to the vascular system for the 
infusion of fluids and medications and the sampling of blood. The device 
consists of a portal body with a resealable septum and outlet made of 
metal, plastic, or combination of these materials and a long-term 
intravascular catheter is either preattached to the port or attached to 
the port at the time of device placement. The device is available in 
various profiles and sizes and can be of a single or multiple lumen 
design.
    (b) Classification. Class II (special controls) Guidance Document: 
``Guidance on 510(k) Submissions for Implanted Infusion Ports,'' FDA 
October 1990.

[65 FR 37043, June 13, 2000]



Sec. 880.5970  Percutaneous, implanted, long-term intravascular catheter.

    (a) Identification. A percutaneous, implanted, long-term 
intravascular catheter is a device that consists of a slender tube and 
any necessary connecting fittings, such as luer hubs, and accessories 
that facilitate the placement of the device. The device allows for 
repeated access to the vascular system for long-term use of 30 days or 
more, and it is intended for administration of fluids, medications, and 
nutrients; the sampling of blood; and monitoring blood pressure and 
temperature. The device may be constructed of metal, rubber, plastic, 
composite materials, or any combination of these materials and may be of 
single or multiple lumen design.
    (b) Classification. Class II (special controls) Guidance Document: 
``Guidance on Premarket Notification [510(k)] Submission for Short-Term 
and Long-Term Intravascular Catheters.''

[65 FR 37043, June 13, 2000]

[[Page 629]]



    Subpart G_General Hospital and Personal Use Miscellaneous Devices



Sec. 880.6025  Absorbent tipped applicator.

    (a) Identification. An absorbent tipped applicator is a device 
intended for medical purposes that consists of an absorbent swab on a 
wooden, paper, or plastic stick. The device is used to apply medications 
to, or to take specimens from, a patient.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. If the device 
is not labeled or otherwise represented as sterile, it is also exempt 
from the current good manufacturing practice requirements of the quality 
system regulation in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38805, July 25, 2001]



Sec. 880.6050  Ice bag.

    (a) Identification. An ice bag is a device intended for medical 
purposes that is in the form of a container intended to be filled with 
ice that is used to apply dry cold therapy to an area of the body. The 
device may include a holder that keeps the bag in place against an 
external area of the patient.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. If the device 
is not labeled or otherwise represented as sterile, it is also exempt 
from the current good manufacturing practice requirements of the quality 
system regulation in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38805, July 25, 2001]



Sec. 880.6060  Medical disposable bedding.

    (a) Identification. Medical disposable bedding is a device intended 
for medical purposes to be used by one patient for a period of time and 
then discarded. This generic type of device may include disposable 
bedsheets, bedpads, pillows and pillowcases, blankets, emergency rescue 
blankets, or waterproof sheets.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. If the device 
is not labeled or otherwise represented as sterile, it is also exempt 
from the current good manufacturing practice requirements of the quality 
system regulation in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 
FR 38805, July 25, 2001]



Sec. 880.6070  Bed board.

    (a) Identification. A bed board is a device intended for medical 
purposes that consists of a stiff board used to increase the firmness of 
a bed.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38805, July 25, 2001]



Sec. 880.6080  Cardiopulmonary resuscitation board.

    (a) Identification. A cardiopulmonary resuscitation board is a 
device consisting of a rigid board which is placed under a patient to 
act as a support during cardiopulmonary resuscitation.
    (b) Classification. Class I (general controls). The device is exempt 
from the

[[Page 630]]

premarket notification procedures in subpart E of part 807 of this 
chapter, subject to the limitations in Sec. 880.9. The device is also 
exempt from the current good manufacturing practice requirements of the 
quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38805, July 25, 2001]



Sec. 880.6085  Hot/cold water bottle.

    (a) Identification. A hot/cold water bottle is a device intended for 
medical purposes that is in the form of a container intended to be 
filled with hot or cold water to apply heat or cold to an area of the 
body.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38805, July 25, 2001]



Sec. 880.6100  Ethylene oxide gas aerator cabinet.

    (a) Identification. An ethyene oxide gas aerator cabinet is a device 
that is intended for use by a health care provider and consists of a 
cabinet with a ventilation system designed to circulate and exchange the 
air in the cabinet to shorten the time required to remove residual 
ethylene oxide (ETO) from wrapped medical devices that have undergone 
ETO sterilization. The device may include a heater to warm the 
circulating air.
    (b) Classification. Class II (performance standards).



Sec. 880.6140  Medical chair and table.

    (a) Identification. A medical chair or table is a device intended 
for medical purposes that consists of a chair or table without wheels 
and not electrically powered which, by reason of special shape or 
attachments, such as food trays or headrests, or special features such 
as a built-in raising and lowering mechanism or removable arms, is 
intended for use of blood donors, geriatric patients, or patients 
undergoing treatment or examination.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38805, July 25, 2001]



Sec. 880.6150  Ultrasonic cleaner for medical instruments.

    (a) Identification. An ultrasonic cleaner for medical instruments is 
a device intended for cleaning medical instruments by the emission of 
high frequency soundwaves.
    (b) Classification. Class I. The device, including any solutions 
intended for use with the device for cleaning and sanitizing the 
instruments, is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter, subject to the limitations in 
Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989; 
59 FR 63011, Dec. 7, 1994; 66 FR 38805, July 25, 2001]



Sec. 880.6175  [Reserved]



Sec. 880.6185  Cast cover.

    (a) Identification. A cast cover is a device intended for medical 
purposes that is made of waterproof material and placed over a cast to 
protect it from getting wet during a shower or a bath.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. If the device 
is not labeled or otherwise represented as sterile, it is also exempt

[[Page 631]]

from the current good manufacturing practice requirements of the quality 
system regulation in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001]



Sec. 880.6190  Mattress cover for medical purposes.

    (a) Identification. A mattress cover for medical purposes is a 
device intended for medical purposes that is used to protect a mattress. 
It may be electrically conductive or contain a germicide.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. If the device 
is not labeled or otherwise represented as sterile, it is also exempt 
from the current good manufacturing practice requirements of the quality 
system regulation in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 
FR 38806, July 25, 2001]



Sec. 880.6200  Ring cutter.

    (a) Identification. A ring cutter is a device intended for medical 
purposes that is used to cut a ring on a patient's finger so that the 
ring can be removed. The device incorporates a guard to prevent injury 
to the patient's finger.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. The device also 
is exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001]



Sec. 880.6210  Sharps needle destruction device.

    (a) Identification. A sharps needle destruction device is a 
prescription device that is intended to destroy needles or sharps used 
for medical purposes by incineration or mechanical means.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Performance testing must demonstrate the following during 
operation of the device:
    (i) The device safely contains or ventilates aerosols or fumes from 
device operation.
    (ii) Excessive heat or sparks are not generated that may injure 
users or patients.
    (iii) Simulated use testing must demonstrate sharps and/or needles 
are completely destroyed using a range of types and sizes of sharps 
sufficient to represent actual use.
    (iv) Simulated use testing must demonstrate that the device is 
physically stable on the surface for which it is intended to be mounted 
to ensure the risk of harm to the patient/user as a result of the device 
falling is minimized.
    (2) Validation of cleaning and disinfection instructions must 
demonstrate that the device can be safely and effectively reprocessed 
after use per the recommended cleaning and disinfection protocol in the 
instructions for use.
    (3) Analysis and/or testing must validate electromagnetic 
compatibility and electrical safety, including the safety of any battery 
used in the device, under conditions which are consistent with the 
intended environment of device use.
    (4) Software verification, validation, and hazard analysis must be 
performed.
    (5) Labeling must include:
    (i) A clear description of the device and its technological 
features;
    (ii) How the device is to be used, including validated cleaning and 
disinfection instructions;
    (iii) Relevant precautions and warnings based on performance and in-
use testing to ensure proper use of the device; and

[[Page 632]]

    (iv) Instructions to install device in adequately ventilated area 
and stable area.

[83 FR 19628, May 4, 2018]



Sec. 880.6230  Tongue depressor.

    (a) Identification. A tongue depressor is a device intended to 
displace the tongue to facilitate examination of the surrounding organs 
and tissues.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. If the device 
is not labeled or otherwise represented as sterile, it is also exempt 
from the current good manufacturing practice requirements of the quality 
system regulation in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001]



Sec. 880.6250  Non-powdered patient examination glove.

    (a) Identification. A non-powdered patient examination glove is a 
disposable device intended for medical purposes that is worn on the 
examiner's hand or finger to prevent contamination between patient and 
examiner. A non-powdered patient examination glove does not incorporate 
powder for purposes other than manufacturing. The final finished glove 
includes only residual powder from manufacturing.
    (b) Classification. Class I (general controls). The device, when it 
is a finger cot, is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 54 FR 1604, Jan. 13, 1989; 66 
FR 46952, Sept. 10, 2001; 81 FR 91730, Dec. 19, 2016; 84 FR 71815, Dec. 
30, 2019]



Sec. 880.6260  Filtering facepiece respirator for use by the general
public in public health medical emergencies.

    (a) Identification. A filtering facepiece respirator for use by the 
general public in public health medical emergencies is a device that is 
a disposable half-facepiece non-powered air-purifying particulate 
respirator intended for use to cover the nose and mouth of the wearer to 
help reduce wearer exposure to pathogenic biological airborne 
particulates during a public health medical emergency. The device is 
made of polymeric materials and is intended to fit closely to the face 
and to function by filtering particulate material.
    (b) Classification. Class II (special controls). The special 
controls are:
    (1) Certification by the National Institute for Occupational Safety 
and Health (NIOSH) as a non-powered air-purifying particulate respirator 
with a minimum filtration efficiency classification of N95, in 
accordance with 42 CFR part 84.
    (2) The FDA guidance document entitled: ``Guidance for Industry and 
Food and Drug Administration Staff; Class II Special Controls Guidance 
Document: Filtering Facepiece Respirator for use by the General Public 
in Public Health Medical Emergencies.'' See Sec. 880.1(e) for 
information on obtaining a copy of this guidance document.

[72 FR 36362, July 3, 2007]



Sec. 880.6265  Examination gown.

    (a) Identification. An examination gown is a device intended for 
medical purposes that is made of cloth, paper, or other material that is 
draped over or worn by a patient as a body covering during a medical 
examination.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. If the device 
is not labeled or otherwise represented as sterile, it is also exempt 
from the current good manufacturing practice requirements of the quality 
system regulation in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001]



Sec. 880.6280  Medical insole.

    (a) Identification. A medical insole is a device intended for 
medical purposes

[[Page 633]]

that is placed inside a shoe to relieve the symptoms of athlete's foot 
infection by absorbing moisture.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989; 
66 FR 38806, July 25, 2001]



Sec. 880.6300  Implantable radiofrequency transponder system for
patient identification and health information.

    (a) Identification. An implantable radiofrequency transponder system 
for patient identification and health information is a device intended 
to enable access to secure patient identification and corresponding 
health information. This system may include a passive implanted 
transponder, inserter, and scanner. The implanted transponder is used 
only to store a unique electronic identification code that is read by 
the scanner. The identification code is used to access patient identity 
and corresponding health information stored in a database.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance document entitled ``Class II Special Controls Guidance 
Document: Implantable Radiofrequency Transponder System for Patient 
Identification and Health Information.'' See Sec. 880.1(e) for the 
availability of this guidance document. This device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 880.9.

[69 FR 71704, Dec. 10, 2004]



Sec. 880.6305  Ingestible event marker.

    (a) Identification. An ingestible event marker is a prescription 
device used to record time-stamped, patient-logged events. The 
ingestible component links wirelessly through intrabody communication to 
an external recorder which records the date and time of ingestion as 
well as the unique serial number of the ingestible device.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The device must be demonstrated to be biocompatible and non-
toxic;
    (2) Nonclinical, animal, and clinical testing must provide a 
reasonable assurance of safety and effectiveness, including device 
performance, durability, compatibility, usability (human factors 
testing), event recording, and proper excretion of the device;
    (3) Appropriate analysis and nonclinical testing must validate 
electromagnetic compatibility performance, wireless performance, and 
electrical safety; and
    (4) Labeling must include a detailed summary of the nonclinical and 
clinical testing pertinent to use of the device and the maximum number 
of daily device ingestions.

[78 FR 28734, May 16, 2013]



Sec. 880.6310  Medical device data system.

    (a) Identification. (1) A medical device data system (MDDS) is a 
hardware device that is intended to provide one or more of the following 
uses, without controlling or altering the functions or parameters of any 
connected medical devices:
    (i) The electronic transfer of medical device data;
    (ii) The electronic storage of medical device data;
    (iii) The electronic conversion of medical device data from one 
format to another format in accordance with a preset specification; or
    (iv) The electronic display of medical device data.
    (2) An MDDS may include electronic or electrical hardware such as a 
physical communications medium (including wireless hardware), modems, 
and interfaces. This identification does not include hardware devices 
intended to be used in connection with active patient monitoring. 
Hardware devices for active patient monitoring are classified under 
other regulations and are not included in this regulation.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9.

[76 FR 8649, Feb. 15, 2011, as amended at 86 FR 20283, Apr. 19, 2021]

[[Page 634]]



Sec. 880.6315  Remote Medication Management System.

    (a) Identification. A remote medication management system is a 
device composed of clinical and communications software, a medication 
delivery unit, and medication packaging. The system is intended to store 
the patient's prescribed medications in a delivery unit, to permit a 
health care professional to remotely schedule the patient's prescribed 
medications, to notify the patient when the prescribed medications are 
due to be taken, to release the prescribed medications to a tray of the 
delivery unit accessible to the patient on the patient's command, and to 
record a history of the event for the health care professional. The 
system is intended for use as an aid to health care professionals in 
managing therapeutic regimens for patients in the home or clinic.
    (b) Classification. Class II (special controls). The special control 
is: The FDA guidance document entitled ``Guidance for Industry and Food 
and Drug Administration Staff; Class II Special Controls Guidance 
Document: Remote Medication Management System.'' See Sec. 880.1(e) for 
availability of this guidance document.

[72 FR 59177, Oct. 19, 2007]



Sec. 880.6320  AC-powered medical examination light.

    (a) Identification. An AC-powered medical examination light is an 
AC-powered device intended for medical purposes that is used to 
illuminate body surfaces and cavities during a medical examination.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 
FR 38806, July 25, 2001]



Sec. 880.6350  Battery-powered medical examination light.

    (a) Identification. A battery-powered medical examination light is a 
battery-powered device intended for medical purposes that is used to 
illuminate body surfaces and cavities during a medical examination.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. The device also 
is exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001]



Sec. 880.6375  Patient lubricant.

    (a) Identification. A patient lubricant is a device intended for 
medical purposes that is used to lubricate a body orifice to facilitate 
entry of a diagnostic or therapeutic device.
    (b) Classification. Class I (general controls). Except when the 
device is a vaginal patient lubricant or an oral lubricant, it is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 46952, Sept. 10, 2001; 
84 FR 71815, Dec. 30, 2019]



Sec. 880.6430  Liquid medication dispenser.

    (a) Identification. A Liquid medication dispenser is a device 
intended for medical purposes that is used to issue a measured amount of 
liquid medication.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001]

[[Page 635]]



Sec. 880.6450  Skin pressure protectors.

    (a) Identification. A skin pressure protector is a device intended 
for medical purposes that is used to reduce pressure on the skin over a 
bony prominence to reduce the likelihood of the patient's developing 
decubitus ulcers (bedsores).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001]



Sec. 880.6500  Medical ultraviolet air purifier.

    (a) Identification. A medical ultraviolet air purifier is a device 
intended for medical purposes that is used to destroy bacteria in the 
air by exposure to ultraviolet radiation.
    (b) Classification. Class II (performance standards).



Sec. 880.6600  Ultraviolet (UV) radiation chamber disinfection device.

    (a) Identification. An ultraviolet (UV) radiation chamber 
disinfection device is intended for the low-level surface disinfection 
of non-porous equipment surfaces by dose-controlled UV irradiation. This 
classification does not include self-contained open chamber UV radiation 
disinfection devices intended for whole room disinfection in a health 
care environment.
    (b) Classification--Class II (special controls). The special 
controls for this device are:
    (1) Performance testing must demonstrate the following:
    (i) The chamber's ability to control the UV radiation dose during 
operation.
    (ii) The chamber's disinfection performance through microbial 
challenge testing.
    (iii) Evidence that the equipment intended to be processed is UV 
compatible.
    (iv) Validation of the cleaning and disinfection procedures.
    (v) The ability of the device to continue to perform to all 
specification after cleaning and disinfection.
    (vi) Whether the device generates ozone (if so, 21 CFR 801.415, 
Maximum acceptable level of ozone, applies).
    (2) Appropriate software verification, validation, and hazard 
analysis must be performed.
    (3) Appropriate analysis and/or testing must validate electrical 
safety, mechanical safety, and electromagnetic compatibility of the 
device in its intended use environment.
    (4) The labeling must include:
    (i) UV hazard warning labels.
    (ii) Explanation of all displays and/or labeling on user interface.
    (iii) Explanation of device safety interlocks.
    (iv) Explanation of all disinfection cycle signals, cautions and 
warnings.
    (v) Device operating procedures.
    (vi) Identification of the expected UV lamp operational life and 
instructions for procedures on replacement of the UV lamp when needed.
    (vii) Procedures to follow in case of UV lamp malfunction or 
failure.
    (viii) Procedures for disposing of mercury-containing UV lamps, if 
applicable.
    (ix) Identification of specific equipment that is compatible with 
the UV radiation dose generated by the device and that can safely 
undergo UV radiation low-level disinfection in the chamber device.
    (x) Description of the required preparation of equipment for 
disinfection in the UV radiation chamber device.
    (xi) Identification of the specific microbes used in successful 
performance testing of the device.
    (xii) Validated instructions for cleaning and disinfection of the 
device.

[80 FR 72588, Nov. 20, 2015]



Sec. 880.6710  Medical ultraviolet water purifier.

    (a) Identification. A medical ultraviolet water purifier is a device 
intended for medical purposes that is

[[Page 636]]

used to destroy bacteria in water by exposure to ultraviolet radiation.
    (b) Classification. Class II (performance standards). The device is 
exempt from the premarket notification procedures in part 807, subpart 
E, of this chapter subject to the limitations in Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 83 FR 25915, June 5, 2018]



Sec. 880.6730  Body waste receptacle.

    (a) Identification. A body waste receptacle is a device intended for 
medical purposes that is not attached to the body and that is used to 
collect the body wastes of a bed patient.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. The device also 
is exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[66 FR 38806, July 25, 2001]



Sec. 880.6740  Vacuum-powered body fluid suction apparatus.

    (a) Identification. A vacuum-powered body fluid suction apparatus is 
a device used to aspirate, remove, or sample body fluids. The device is 
powered by an external source of vacuum. This generic type of device 
includes vacuum regulators, vacuum collection bottles, suction catheters 
and tips, connecting flexible aspirating tubes, rigid suction tips, 
specimen traps, noninvasive tubing, and suction regulators (with gauge).
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]



Sec. 880.6760  Protective restraint.

    (a) Identification. A protective restraint is a device, including 
but not limited to a wristlet, anklet, vest, mitt, straight jacket, 
body/limb holder, or other type of strap, that is intended for medical 
purposes and that limits the patient's movements to the extent necessary 
for treatment, examination, or protection of the patient or others.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 880.9.

[61 FR 8439, Mar. 4, 1996, as amended at 66 FR 46952, Sept. 10, 2001; 84 
FR 71815, Dec. 30, 2019]



Sec. 880.6775  Powered patient transfer device.

    (a) Identification. A powered patient transfer device is a device 
consisting of a wheeled stretcher and a powered mechanism that has a 
broad, flexible band stretched over long rollers that can advance itself 
under a patient and transfer the patient with minimal disturbance in a 
horizontal position to the stretcher.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]



Sec. 880.6785  Manual patient transfer device.

    (a) Identification. A manual patient transfer device is a device 
consisting of a wheeled stretcher and a mechanism on which a patient can 
be placed so that the patient can be transferred with minimal 
disturbance in a horizontal position to the stretcher.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38807, July 25, 2001]

[[Page 637]]



Sec. 880.6800  Washers for body waste receptacles.

    (a) Identification. A washer for body waste receptacles is a device 
intended for medical purposes that is used to clean and sanitize a body 
waste receptacle, such as a bedpan. The device consists of a wall-
mounted plumbing fixture with a door through which a body waste 
receptacle is inserted. When the door is closed the body waste 
receptacle is cleaned by hot water, steam, or germicide.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. The device also 
is exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38807, July 25, 2001]



Sec. 880.6820  Medical disposable scissors.

    (a) Identification. Medical disposable scissors are disposable type 
general cutting devices intended for medical purposes. This generic type 
of device does not include surgical scissors.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38807, July 25, 2001]



Sec. 880.6850  Sterilization wrap.

    (a) Identification. A sterilization wrap (pack, sterilization 
wrapper, bag, or accessories, is a device intended to be used to enclose 
another medical device that is to be sterilized by a health care 
provider. It is intended to allow sterilization of the enclosed medical 
device and also to maintain sterility of the enclosed device until used.
    (b) Classification. Class II (performance standards).



Sec. 880.6860  Ethylene oxide gas sterilizer.

    (a) Identification. An ethylene gas sterilizer is a nonportable 
device intended for use by a health care provider that uses ethylene 
oxide (ETO) to sterilize medical products.
    (b) Classification. Class II (performance standards).



Sec. 880.6870  Dry-heat sterilizer.

    (a) Identification. A dry-heat sterilizer is a device that is 
intended for use by a health care provider to sterilize medical products 
by means of dry heat.
    (b) Classification. Class II (performance standards).



Sec. 880.6880  Steam sterilizer.

    (a) Identification. A steam sterilizer (autoclave) is a device that 
is intended for use by a health care provider to sterilize medical 
products by means of pressurized steam.
    (b) Classification. Class II (performance standards).



Sec. 880.6885  Liquid chemical sterilants/high level disinfectants.

    (a) Identification. A liquid chemical sterilant/high level 
disinfectant is a germicide that is intended for use as the terminal 
step in processing critical and semicritical medical devices prior to 
patient use. Critical devices make contact with normally sterile tissue 
or body spaces during use. Semicritical devices make contact during use 
with mucous membranes or nonintact skin.
    (b) Classification. Class II (special controls). Guidance on the 
Content and Format of Premarket Notification (510(k)) Submissions for 
Liquid Chemical Sterilants/High Level Disinfectants, and user 
information and training.

[65 FR 36325, June 8, 2000]



Sec. 880.6887  Spore test strip.

    (a) Identification. The spore test strip consists of a carrier or 
strip with a known number of spores, at least 5 log10 per 
strip, of known resistance to a particular liquid chemical sterilant in 
a liquid chemical sterilant processing system. A ``no growth'' result 
from the spore test strip after the specified predetermined incubation 
period indicates

[[Page 638]]

that the liquid chemical sterilization process achieved the conditions 
necessary to kill the specified minimum number of viable spores on the 
test strip which is 5 log10 spores/strip; it does not confirm 
the expected full performance of the liquid chemical sterilant 
processing cycle because full performance is a 6 log10 spore 
kill in a full liquid chemical sterilization cycle.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Spore strip characterization. (i) Population of viable spores on 
strip shall be a minimum of 5 log10 after physical wash off 
of spores from the strip by exposure to liquid chemical sterilant in the 
liquid chemical sterilant processing system, which should be validated 
over the claimed shelf life.
    (ii) The resistance characteristics of the viable spores on the 
strip should be defined and be validated over the claimed shelf life.
    (iii) The spore strip description should address the carrier 
material, how the spores are placed on the carrier, and whether there is 
any feature that minimizes spore wash off. Bacteriostasis of the spore 
strip materials should be evaluated.
    (iv) Incubation time for viable spores on the strip should be 
validated under the specified incubation conditions over the claimed 
shelf life.
    (2) Simulated Use Testing. Simulated use testing should demonstrate 
performance of spore test strip in liquid chemical sterilant/high level 
disinfectant under worst case in use conditions over the claimed shelf 
life.
    (3) Labeling. Labeling should specify appropriate instructions, 
warnings, cautions, limitations, and information relating to viable 
spore population, resistance characteristics, and interpretation of a 
``no growth'' result.

[87 FR 8194, Feb. 14, 2022]



Sec. 880.6890  General purpose disinfectants.

    (a) Identification. A general purpose disinfectant is a germicide 
intended to process noncritical medical devices and equipment surfaces. 
A general purpose disinfectant can be used to preclean or decontaminate 
critical or semicritical medical devices prior to terminal sterilization 
or high level disinfection. Noncritical medical devices make only 
topical contact with intact skin.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 880.9.

[65 FR 36326, June 8, 2000]



Sec. 880.6900  Hand-carried stretcher.

    (a) Identification. A hand-carried stretcher is a device consisting 
of a lightweight frame, or of two poles with a cloth or metal platform, 
on which a patient can be carried.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 
FR 38807, July 25, 2001]



Sec. 880.6910  Wheeled stretcher.

    (a) Identification. A wheeled stretcher is a device consisting of a 
platform mounted on a wheeled frame that is designed to transport 
patients in a horizontal position. The device may have side rails, 
supports for fluid infusion equipment, and patient securement straps. 
The frame may be fixed or collapsible for use in an ambulance.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]



Sec. 880.6920  Syringe needle introducer.

    (a) Identification. A syringe needle introducer is a device that 
uses a spring-loaded mechanism to drive a hypodermic needle into a 
patient to a predetermined depth below the skin surface.

[[Page 639]]

    (b) Classification. Class II (performance standards).



Sec. 880.6960  Irrigating syringe.

    (a) Identification. An irrigating syringe is a device intended for 
medical purposes that consists of a bulb or a piston syringe with an 
integral or a detachable tube. The device is used to irrigate, withdraw 
fluid from, or instill fluid into, a body cavity or wound.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. If the device 
is not labeled or otherwise represented as sterile, it is also exempt 
from the current good manufacturing practice requirements of the quality 
system regulation in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38807, July 25, 2001]



Sec. 880.6970  Liquid crystal vein locator.

    (a) Identification. A liquid crystal vein locator is a device used 
to indicate the location of a vein by revealing variations in the 
surface temperature of the skin by displaying the color changes of heat 
sensitive liquid crystals (cholesteric esters).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989; 
66 FR 38807, July 25, 2001]



Sec. 880.6980  Vein stabilizer.

    (a) Identification. A vein stabilizer is a device consisting of a 
flat piece of plastic with two noninvasive prongs. The device is placed 
on the skin so that the prongs are on either side of a vein and hold it 
stable while a hypodermic needle is inserted into the vein.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 880.9. If the device 
is not labeled or otherwise represented as sterile, it is also exempt 
from the current good manufacturing practice requirements of the quality 
system regulation in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38807, July 25, 2001]



Sec. 880.6990  Infusion stand.

    (a) Identification. The infusion stand is a stationary or movable 
stand intended to hold infusion liquids, infusion accessories, and other 
medical devices.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 880.9.

[63 FR 59718, Nov. 5, 1998]



Sec. 880.6991  Medical washer.

    (a) Identification. A medical washer is a device that is intended 
for general medical purposes to clean and dry surgical instruments, 
anesthesia equipment, hollowware, and other medical devices.
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA guidance document entitled ``Class II Special 
Controls Guidance Document: Medical Washers and Medical Washer-
Disinfectors.'' The device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to Sec. 
880.9.

[67 FR 69121, Nov. 15, 2002]



Sec. 880.6992  Medical washer-disinfector.

    (a) Identification. A medical washer-disinfector is a device that is 
intended for general medical purposes to clean, decontaminate, 
disinfect, and dry surgical instruments, anesthesia equipment, 
hollowware, and other medical devices.
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA guidance document entitled ``Class II Special 
Controls Guidance Document: Medical Washers and Medical Washer-
Disinfectors.''

[[Page 640]]

    (1) Medical washer-disinfectors that are intended to clean, high 
level disinfect, and dry surgical instruments, anesthesia equipment, 
hollowware, and other medical devices.
    (2) Medical washer-disinfectors that are intended to clean, low or 
intermediate level disinfect, and dry surgical instruments, anesthesia 
equipment, hollowware, and other medical devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 880.9.

[67 FR 69121, Nov. 15, 2002]



PART 882_NEUROLOGICAL DEVICES--Table of Contents



                      Subpart A_General Provisions

Sec.
882.1 Scope.
882.3 Effective dates of requirement for premarket approval.
882.9 Limitations of exemptions from section 510(k) of the Federal Food, 
          Drug, and Cosmetic Act (the act).

                Subpart B_Neurological Diagnostic Devices

882.1020 Rigidity analyzer.
882.1030 Ataxiagraph.
882.1200 Two-point discriminator.
882.1240 Echoencephalograph.
882.1275 Electroconductive media.
882.1310 Cortical electrode.
882.1320 Cutaneous electrode.
882.1330 Depth electrode.
882.1340 Nasopharyngeal electrode.
882.1350 Needle electrode.
882.1400 Electroencephalograph.
882.1410 Electroencephalograph electrode/lead tester.
882.1420 Electroencephalogram (EEG) signal spectrum analyzer.
882.1430 Electroencephalograph test signal generator.
882.1440 Neuropsychiatric interpretive electroencephalograph assessment 
          aid.
882.1450 Brain injury adjunctive interpretive electroencephalograph 
          assessment aid.
882.1455 Traumatic brain injury eye movement assessment aid.
882.1460 Nystagmograph.
882.1470 Computerized cognitive assessment aid.
882.1471 Computerized cognitive assessment aid for concussion.
882.1480 Neurological endoscope.
882.1491 Pediatric Autism Spectrum Disorder diagnosis aid.
882.1500 Esthesiometer.
882.1525 Tuning fork.
882.1540 Galvanic skin response measurement device.
882.1550 Nerve conduction velocity measurement device.
882.1560 Skin potential measurement device.
882.1561 Evoked photon image capture device.
882.1570 Powered direct-contact temperature measurement device.
882.1580 Non-electroencephalogram (EEG) physiological signal based 
          seizure monitoring system.
882.1610 Alpha monitor.
882.1620 Intracranial pressure monitoring device.
882.1630 Cranial motion measurement device.
882.1700 Percussor.
882.1750 Pinwheel.
882.1790 Ocular plethysmograph.
882.1825 Rheoencephalograph.
882.1835 Physiological signal amplifier.
882.1845 Physiological signal conditioner.
882.1855 Electroencephalogram (EEG) telemetry system.
882.1870 Evoked response electrical stimulator.
882.1880 Evoked response mechanical stimulator.
882.1890 Evoked response photic stimulator.
882.1900 Evoked response auditory stimulator.
882.1925 Ultrasonic scanner calibration test block.
882.1935 Near Infrared (NIR) Brain Hematoma Detector.
882.1950 Tremor transducer.

Subparts C-D [Reserved]

                 Subpart E_Neurological Surgical Devices

882.4030 Skull plate anvil.
882.4060 Ventricular cannula.
882.4100 Ventricular catheter.
882.4125 Neurosurgical chair.
882.4150 Scalp clip.
882.4175 Aneurysm clip applier.
882.4190 Clip forming/cutting instrument.
882.4200 Clip removal instrument.
882.4215 Clip rack.
882.4250 Cryogenic surgical device.
882.4275 Dowel cutting instrument.
882.4300 Manual cranial drills, burrs, trephines, and their accessories.
882.4305 Powered compound cranial drills, burrs, trephines, and their 
          accessories.
882.4310 Powered simple cranial drills, burrs, trephines, and their 
          accessories.
882.4325 Cranial drill handpiece (brace).
882.4360 Electric cranial drill motor.
882.4370 Pneumatic cranial drill motor.
882.4400 Radiofrequency lesion generator.
882.4440 Neurosurgical headrests.

[[Page 641]]

882.4460 Neurosurgical head holder (skull clamp).
882.4500 Cranioplasty material forming instrument.
882.4525 Microsurgical instrument.
882.4535 Nonpowered neurosurgical instrument.
882.4545 Shunt system implantation instrument.
882.4560 Stereotaxic instrument.
882.4600 Leukotome.
882.4650 Neurosurgical suture needle.
882.4700 Neurosurgical paddie.
882.4725 Radiofrequency lesion probe.
882.4750 Skull punch.
882.4800 Self-retaining retractor for neurosurgery.
882.4840 Manual rongeur.
882.4845 Powered rongeur.
882.4900 Skullplate screwdriver.
882.4950 Diagnostic neurosurgical microscope filter.

               Subpart F_Neurological Therapeutic Devices

882.5030 Methyl methacrylate for aneurysmorrhaphy.
882.5050 Biofeedback device.
882.5060 Conditioning tool for eating disorders.
882.5070 Bite block.
882.5150 Intravascular occluding catheter.
882.5175 Carotid artery clamp.
882.5200 Aneurysm clip.
882.5225 Implanted malleable clip.
882.5235 Aversive conditioning device.
882.5250 Burr hole cover.
882.5275 Nerve cuff.
882.5300 Methyl methacrylate for cranioplasty.
882.5320 Preformed alterable cranioplasty plate.
882.5330 Preformed nonalterable cranioplasty plate.
882.5360 Cranioplasty plate fastener.
882.5500 Lesion temperature monitor.
882.5550 Central nervous system fluid shunt and components.
882.5560 Cerebrospinal fluid shunt system.
882.5600 Neurovascular mechanical thrombectomy device for acute ischemic 
          stroke treatment.
882.5700 Thermal system for insomnia.
882.5705 Digital therapy device to reduce sleep disturbance for 
          psychiatric conditions.
882.5800 Cranial electrotherapy stimulator.
882.5801 Computerized behavioral therapy device for psychiatric 
          disorders.
882.5802 Transcranial magnetic stimulation system for neurological and 
          psychiatric disorders and conditions.
882.5805 Repetitive transcranial magnetic stimulation system.
882.5808 Transcranial magnetic stimulator for headache.
882.5810 External functional neuromuscular stimulator.
882.5820 Implanted cerebellar stimulator.
882.5830 Implanted diaphragmatic/phrenic nerve stimulator.
882.5840 Implanted intracerebral/subcortical stimulator for pain relief.
882.5850 Implanted spinal cord stimulator for bladder evacuation.
882.5855 Brain stimulation programming planning software.
882.5860 Implanted neuromuscular stimulator.
882.5870 Implanted peripheral nerve stimulator for pain relief.
882.5880 Implanted spinal cord stimulator for pain relief.
882.5890 Transcutaneous electrical nerve stimulator for pain relief.
882.5891 Transcutaneous electrical nerve stimulator to treat headache.
882.5892 External vagal nerve stimulator for headache.
882.5893 Thermal vestibular stimulator for headache.
882.5894 Limited output transcutaneous piezoelectric stimulator for skin 
          reactions associated with insect bites.
882.5895 Vibratory counter-stimulation device.
882.5896 Percutaneous nerve stimulator for substance use disorders.
882.5897 External upper limb tremor stimulator.
882.5898 Transcutaneous electrical nerve stimulator for attention 
          deficit hyperactivity disorder.
882.5899 Trunk and limb electrical stimulator to treat headache.
882.5900 Preformed craniosynostosis strip.
882.5910 Dura substitute.
882.5940 Electroconvulsive therapy device.
882.5950 Neurovascular embolization device.
882.5955 Temporary coil embolization assist device.
882.5960 Skull tongs for traction.
882.5970 Cranial orthosis.

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 882 appear at 73 FR 
35341, June 23, 2008.



                      Subpart A_General Provisions



Sec. 882.1  Scope.

    (a) This part sets forth the classification of neurological devices 
intended for human use that are in commercial distribution.
    (b) The identification of a device in a regulation in this part is 
not a precise description of every device that is, or

[[Page 642]]

will be, subject to the regulation. A manufacturer who submits a 
premarket notification submission for a device under part 807 may not 
show merely that the device is accurately described by the section title 
and identification provisions of a regulation in this part, but shall 
state why the device is substantially equivalent to other devices, as 
required by Sec. 807.87.
    (c) To avoid duplicative listings, a neurological device that has 
two or more types of uses (e.g., used both as a diagnostic device and as 
a therapeutic device) is listed only in one subpart.
    (d) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.
    (e) Guidance documents referenced in this part are available on the 
Internet at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/default.htm..

[52 FR 17739, May 11, 1987, as amended at 68 FR 70436, Dec. 18, 2003; 78 
FR 18233, Mar. 26, 2013]



Sec. 882.3  Effective dates of requirement for premarket approval.

    A device included in this part that is classified into class III 
(premarket approval) shall not be commercially distributed after the 
date shown in the regulation classifying the device unless the 
manufacturer has an approval under section 515 of the act (unless an 
exemption has been granted under section 520(g)(2) of the act). An 
approval under section 515 of the act consists of FDA's issuance of an 
order approving an application for premarket approval (PMA) for the 
device or declaring completed a product development protocol (PDP) for 
the device.
    (a) Before FDA requires that a device commercially distributed 
before the enactment date of the amendments, or a device that has been 
found substantially equivalent to such a device, has an approval under 
section 515 of the act FDA must promulgate a regulation under section 
515(b) of the act requiring such approval, except as provided in 
paragraph (b) of this section. Such a regulation under section 515(b) of 
the act shall not be effective during the grace period ending on the 
90th day after its promulgation or on the last day of the 30th full 
calendar month after the regulation that classifies the device into 
class III is effective, whichever is later. See section 501(f)(2)(B) of 
the act. Accordingly, unless an effective date of the requirement for 
premarket approval is shown in the regulation for a device classified 
into class III in this part, the device may be commercially distributed 
without FDA's issuance of an order approving a PMA or declaring 
completed a PDP for the device. If FDA promulgates a regulation under 
section 515(b) of the act requiring premarket approval for a device, 
section, 501(f)(1)(A) of the act applies to the device.
    (b) Any new, not substantially equivalent, device introduced into 
commercial distribution on or after May 28, 1976, including a device 
formerly marketed that has been substantially altered, is classified by 
statute (section 513(f) of the act) into class III without any grace 
period and FDA must have issued an order approving a PMA or declaring 
completed a PDP for the device before the device is commercially 
distributed unless it is reclassified. If FDA knows that a device being 
commercially distributed may be a ``new'' device as defined in this 
section because of any new intended use or other reasons, FDA may codify 
the statutory classification of the device into class III for such new 
use. Accordingly, the regulation for such a class III device states that 
as of the enactment date of the amendments, May 28, 1976, the device 
must have an approval under section 515 of the act before commercial 
distribution.

[52 FR 17739, May 11, 1987]



Sec. 882.9  Limitations of exemptions from section 510(k) 
of the Federal Food, Drug, and Cosmetic Act (the act).

    The exemption from the requirement of premarket notification 
(section 510(k) of the act) for a generic type of class I or II device 
is only to the extent that the device has existing or reasonably 
foreseeable characteristics of commercially distributed devices within 
that generic type or, in the case of in vitro diagnostic devices, only 
to the extent that misdiagnosis as a result of using the device would 
not be associated with high morbidity or mortality.

[[Page 643]]

Accordingly, manufacturers of any commercially distributed class I or II 
device for which FDA has granted an exemption from the requirement of 
premarket notification must still submit a premarket notification to FDA 
before introducing or delivering for introduction into interstate 
commerce for commercial distribution the device when:
    (a) The device is intended for a use different from the intended use 
of a legally marketed device in that generic type of device; e.g., the 
device is intended for a different medical purpose, or the device is 
intended for lay use where the former intended use was by health care 
professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro diagnostic 
device detects or identifies infectious agents by using deoxyribonucleic 
acid (DNA) probe or nucleic acid hybridization technology rather than 
culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of neoplastic 
diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial or acquired 
genetic disorders, including inborn errors of metabolism;
    (3) For measuring an analyte that serves as a surrogate marker for 
screening, diagnosis, or monitoring life-threatening diseases such as 
acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, 
tuberculosis, or myocardial infarction or to monitor therapy;
    (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) or IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is intended 
for use in matrices other than serum or plasma;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).

[65 FR 2319, Jan. 14, 2000]



                Subpart B_Neurological Diagnostic Devices



Sec. 882.1020  Rigidity analyzer.

    (a) Identification. A rigidity analyzer is a device for quantifying 
the extent of the rigidity of a patient's limb to determine the 
effectiveness of drugs or other treatments.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019]



Sec. 882.1030  Ataxiagraph.

    (a) Identification. An ataxiagraph is a device used to determine the 
extent of ataxia (failure of muscular coordination) by measuring the 
amount of swaying of the body when the patient is standing erect and 
with eyes closed.
    (b) Classification. Class I (general controls). Except when the 
device is intended to provide an interpretation or a clinical 
implication of the measurement, it is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 66 FR 46952, Sept. 10, 2001; 
84 FR 71815, Dec. 30, 2019]



Sec. 882.1200  Two-point discriminator.

    (a) Identification. A two-point discriminator is a device with 
points used for testing a patient's touch discrimination.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 882.9. The device is also exempt from the 
current good manufacturing practice requirements of the quality system 
regulation in part 820 of

[[Page 644]]

this chapter, with the exception of Sec. 820.180 of this chapter, with 
respect to general requirements concerning records, and Sec. 820.198 of 
this chapter, with respect to complaint files.

[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 
65 FR 2319, Jan. 14, 2000]



Sec. 882.1240  Echoencephalograph.

    (a) Identification. An echoencephalograph is an ultrasonic scanning 
device (including A-scan, B-scan, and doppler systems) that uses 
noninvasive transducers for measuring intracranial interfaces and blood 
flow velocity to and in the head.
    (b) Classification. Class II (performance standards).



Sec. 882.1275  Electroconductive media.

    (a) Identification. Electroconductive media are the conductive 
creams or gels used with external electrodes to reduce the impedance 
(resistance to alternating current) of the contact between the electrode 
surface and the skin.
    (b) Classification. Class II (performance standards).



Sec. 882.1310  Cortical electrode.

    (a) Identification. A cortical electrode is an electrode which is 
temporarily placed on the surface of the brain for stimulating the brain 
or recording the brain's electrical activity.
    (b) Classification. Class II (performance standards).



Sec. 882.1320  Cutaneous electrode.

    (a) Identification. A cutaneous electrode is an electrode that is 
applied directly to a patient's skin either to record physiological 
signals (e.g., the electroencephalogram) or to apply electrical 
stimulation.
    (b) Classification. Class II (performance standards).



Sec. 882.1330  Depth electrode.

    (a) Identification. A depth electrode is an electrode used for 
temporary stimulation of, or recording electrical signals at, subsurface 
levels of the brain.
    (b) Classification. Class II (performance standards).



Sec. 882.1340  Nasopharyngeal electrode.

    (a) Identification. A nasopharyngeal electrode is an electrode which 
is temporarily placed in the nasopharyngeal region for the purpose of 
recording electrical activity.
    (b) Classification. Class II (performance standards).



Sec. 882.1350  Needle electrode.

    (a) Identification. A needle electrode is a device which is placed 
subcutaneously to stimulate or to record electrical signals.
    (b) Classification. Class II (performance standards).



Sec. 882.1400  Electroencephalograph.

    (a) Identification. An electroencephalograph is a device used to 
measure and record the electrical activity of the patient's brain 
obtained by placing two or more electrodes on the head.
    (b) Classification. Class II (performance standards).



Sec. 882.1410  Electroencephalograph electrode/lead tester.

    (a) Identification. An electroencephalograph electrode/lead tester 
is a device used for testing the impedance (resistance to alternating 
current) of the electrode and lead system of an electroencephalograph to 
assure that an adequate contact is made between the electrode and the 
skin.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 61 FR 1123, Jan. 16, 1996; 66 
FR 38807, July 25, 2001]



Sec. 882.1420  Electroencephalogram (EEG) signal spectrum analyzer.

    (a) Identification. An electroencephalogram (EEG) signal spectrum 
analyzer is a device used to display the frequency content or power 
spectral density of the electroencephalogram (EEG) signal.
    (b) Classification. Class I (general controls).

[44 FR 51730, Sept. 4, 1979, as amended at 66 FR 46953, Sept. 10, 2001]

[[Page 645]]



Sec. 882.1430  Electroencephalograph test signal generator.

    (a) Identification. An electroencephalograph test signal generator 
is a device used to test or calibrate an electroencephalograph.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 1994; 66 
FR 38807, July 25, 2001]



Sec. 882.1440  Neuropsychiatric interpretive electroencephalograph assessment aid.

    (a) Identification. The neuropsychiatric interpretive 
electroencephalograph assessment aid is a prescription device that uses 
a patient's electroencephalograph (EEG) to provide an interpretation of 
the patient's neuropsychiatric condition. The neuropsychiatric 
interpretive EEG assessment aid is used only as an assessment aid for a 
medical condition for which there exists other valid methods of 
diagnosis.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The technical parameters of the device, hardware and software, 
must be fully characterized and must demonstrate a reasonable assurance 
of safety and effectiveness.
    (i) Hardware specifications must be provided. Appropriate 
verification, validation, and hazard analysis must be performed.
    (ii) Software, including any proprietary algorithm(s) used by the 
device to arrive at its interpretation of the patient's condition, must 
be described in detail in the software requirements specification and 
software design specification. Appropriate software verification, 
validation, and hazard analysis must be performed.
    (2) The device parts that contact the patient must be demonstrated 
to be biocompatible.
    (3) The device must be designed and tested for electrical safety, 
electromagnetic compatibility, thermal, and mechanical safety.
    (4) Clinical performance testing must demonstrate the accuracy, 
precision, reproducibility, of determining the EEG-based interpretation, 
including any specified equivocal zones (cutoffs).
    (5) Clinical performance testing must demonstrate the ability of the 
device to function as an assessment aid for the medical condition for 
which the device is indicated. Performance measures must demonstrate 
device performance characteristics per the intended use in the intended 
use environment. Performance measurements must include sensitivity, 
specificity, positive predictive value, and negative predictive value 
per the device intended use. Repeatability of measurements must be 
demonstrated using interclass correlation coefficients and illustrated 
by qualitative scatter plot(s).
    (6) The device design must include safeguards to prevent use of the 
device as a stand-alone diagnostic.
    (7) The labeling must include the following information:
    (i) A warning that the device is not to be used as a stand-alone 
diagnostic.
    (ii) A detailed summary of the clinical performance testing, 
including any adverse events and complications.
    (iii) The qualifications and training requirements for device users 
including technicians and clinicians.
    (iv) The intended use population and the intended use environment.
    (v) Any instructions technicians should convey to patients regarding 
the collection of EEG data.
    (vi) Information allowing clinicians to gauge clinical risk 
associated with integrating the EEG interpretive assessment aid into 
their diagnostic pathway.
    (vii) Where appropriate, validated methods and instructions for 
reprocessing of any reusable components.

[79 FR 9085, Feb. 18, 2014]



Sec. 882.1450  Brain injury adjunctive interpretive electroencephalograph 
assessment aid.

    (a) Identification. A brain injury adjunctive interpretive 
electroencephalograph assessment aid is a prescription device that uses 
a patient's electroencephalograph (EEG) to provide an interpretation of 
the structural condition of the patient's brain in

[[Page 646]]

the setting of trauma. A brain injury adjunctive interpretive EEG 
assessment aid is for use as an adjunct to standard clinical practice 
only as an assessment aid for a medical condition for which there exists 
other valid methods of diagnosis.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The technical parameters of the device, hardware and software, 
must be fully characterized and include the following information:
    (i) Hardware specifications must be provided. Appropriate 
verification, validation, and hazard analysis must be performed.
    (ii) Software, including any proprietary algorithm(s) used by the 
device to arrive at its interpretation of the patient's condition, must 
be described in detail in the software requirements specification (SRS) 
and software design specification (SDS). Appropriate software 
verification, validation, and hazard analysis must be performed.
    (2) The device parts that contact the patient must be demonstrated 
to be biocompatible.
    (3) The device must be designed and tested for electrical safety, 
electromagnetic compatibility (EMC), thermal, and mechanical safety.
    (4) Clinical performance testing must demonstrate the accuracy, 
precision-repeatability and reproducibility, of determining the EEG-
based interpretation, including any specified equivocal zones (cutoffs).
    (5) Clinical performance testing must demonstrate the ability of the 
device to function as an assessment aid for the medical condition for 
which the device is indicated. Performance measures must demonstrate 
device performance characteristics per the intended use in the intended 
use environment. Performance measurements must include sensitivity, 
specificity, positive predictive value (PPV), and negative predictive 
value (NPV) with respect to the study prevalence per the device intended 
use.
    (6) The device design must include safeguards to ensure appropriate 
clinical interpretation of the device output (e.g., use in appropriate 
patient population, or for appropriate clinical decision).
    (7) The labeling and training information must include:
    (i) A warning that the device is not to be used as a stand-alone 
diagnostic.
    (ii) A detailed summary of the clinical performance testing, 
including any adverse events and complications.
    (iii) The intended use population and the intended use environment.
    (iv) Any instructions technicians should convey to patients 
regarding the collection of EEG data.
    (v) Information allowing clinicians to gauge clinical risk 
associated with integrating the EEG interpretive assessment aid into 
their diagnostic pathway.
    (vi) Information allowing clinicians to understand how to integrate 
the device output into their diagnostic pathway when the device is 
unable to provide a classification or final result.

[80 FR 16268, Mar. 27, 2015]



Sec. 882.1455  Traumatic brain injury eye movement assessment aid.

    (a) Identification. A traumatic brain injury eye movement assessment 
aid is a prescription device that uses a patient's tracked eye movements 
to provide an interpretation of the functional condition of the 
patient's brain. This device is an assessment aid that is not intended 
for standalone detection or diagnostic purposes.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance data under anticipated conditions of use 
must evaluate tracked eye movement in supporting the indications for use 
and include the following:
    (i) Evaluation of sensitivity, specificity, positive predictive 
value, and negative predictive value using a reference method of 
diagnosis;
    (ii) Evaluation of device test-retest reliability; and
    (iii) A description of the development of the reference method of 
diagnosis, which may include a normative database, to include the 
following:
    (A) A discussion of how the clinical work-up was completed to 
establish the

[[Page 647]]

reference method of diagnosis, including the establishment of inclusion 
and exclusion criteria; and
    (B) If using a normative database, a description of how the 
``normal'' population was established, and the statistical methods and 
model assumptions used.
    (2) Software verification, validation, and hazard analysis must be 
performed. Software documentation must include a description of the 
algorithms used to generate device output.
    (3) Performance testing must demonstrate the electrical safety and 
electromagnetic compatibility (EMC) of the device.
    (4) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (5) A light hazard assessment must be performed for all eye-tracking 
and visual display light sources.
    (6) Labeling must include:
    (i) A summary of clinical performance testing conducted with the 
device, including sensitivity, specificity, positive predictive value, 
negative predictive value, and test-retest reliability;
    (ii) A description of any normative database that includes the 
following:
    (A) The clinical definition used to establish a ``normal'' 
population and the specific selection criteria;
    (B) The format for reporting normal values;
    (C) Examples of screen displays and reports generated to provide the 
user results and normative data;
    (D) Statistical methods and model assumptions; and
    (E) Any adjustments for age and gender.
    (iii) A warning that the device should only be used by trained 
healthcare professionals;
    (iv) A warning that the device does not identify the presence or 
absence of traumatic brain injury or other clinical diagnoses;
    (v) A warning that the device is not a standalone diagnostic; and
    (vi) Any instructions to convey to patients regarding the 
administration of the test and collection of test data.

[86 FR 71384, Dec. 16, 2021]



Sec. 882.1460  Nystagmograph.

    (a) Identification. A nystagmograph is a device used to measure, 
record, or visually display the involuntary movements (nystagmus) of the 
eyeball.
    (b) Classification. Class II (performance standards).



Sec. 882.1470  Computerized cognitive assessment aid.

    (a) Identification. The computerized cognitive assessment aid is a 
prescription device that uses an individual's score(s) on a battery of 
cognitive tasks to provide an interpretation of the current level of 
cognitive function. The computerized cognitive assessment aid is used 
only as an assessment aid to determine level of cognitive functioning 
for which there exists other valid methods of cognitive assessment and 
does not identify the presence or absence of clinical diagnoses. The 
computerized cognitive assessment aid is not intended as a stand-alone 
or adjunctive diagnostic device.
    (b) Classification. Class II (special controls). Except when the 
computerized cognitive assessment aid is intended for diagnostic 
assessment of specific diseases or conditions and relies on inputs from 
visual cues, auditory cues, and/or functional use of the hand, the 
device is exempt from the premarket notification procedures in subpart E 
of part 807 of this chapter subject to the limitations in Sec. 882.9. 
The special control(s) for this device are:
    (1) The technical parameters of the device's hardware and software 
must be fully characterized and be accompanied by appropriate non-
clinical testing:
    (i) Hardware specifications must be provided. Appropriate 
verification, validation, and hazard analysis must be performed.
    (ii) Software, including any proprietary algorithm(s) used by the 
device to arrive at its interpretation of the patient's cognitive 
function, must be described in detail in the software requirements 
specification (SRS) and software design specification (SDS). Appropriate 
software verification, validation, and hazard analysis must be 
performed.
    (2) The device must be designed and tested for electrical safety.
    (3) The labeling must include:

[[Page 648]]

    (i) A summary of any testing conducted to demonstrate how the device 
functions as an interpretation of the current level of cognitive 
function. The summary of testing must include the following, if 
available: Any expected or observed adverse events and complications; 
any performance measurements including sensitivity, specificity, 
positive predictive value (PPV), and negative predictive value (NPV) per 
the devices intended use; a description of the repeatability of 
measurements; a description of how the cut-off values for categorization 
of measurements were determined; and a description of the construct 
validity of the device.
    (ii) A warning that the device does not identify the presence or 
absence of clinical diagnoses.
    (iii) A warning that the device is not a stand-alone diagnostic.
    (iv) The intended use population and the intended use environment.
    (v) Any instructions technicians must convey to patients regarding 
the administration of the test and collection of cognitive test data.

[80 FR 49138, Aug. 17, 2015, as amended at 84 FR 71815, Dec. 30, 2019]



Sec. 882.1471  Computerized cognitive assessment aid for concussion.

    (a) Identification. The computerized cognitive assessment aid for 
concussion is a prescription device that uses an individual's score(s) 
on a battery of cognitive tasks to provide an indication of the current 
level of cognitive function in response to concussion. The computerized 
cognitive assessment aid for concussion is used only as an assessment 
aid in the management of concussion to determine cognitive function for 
patients after a potential concussive event where other diagnostic tools 
are available and does not identify the presence or absence of 
concussion. It is not intended as a stand-alone diagnostic device.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Software, including any proprietary algorithm(s) used by the 
device to arrive at its interpretation of the patient's cognitive 
function, must be described in detail in the software requirements 
specification (SRS) and software design specification (SDS). Software 
verification, validation, and hazard analysis must be performed.
    (2) Clinical performance data must be provided that demonstrates how 
the device functions as an interpretation of the current level of 
cognitive function in an individual that has recently received an injury 
that causes concern about a possible concussion. The testing must:
    (i) Evaluate device output and clinical interpretation.
    (ii) Evaluate device test-retest reliability of the device output.
    (iii) Evaluate construct validity of the device cognitive 
assessments.
    (iv) Describe the construction of the normative database, which 
includes the following:
    (A) How the clinical workup was completed to establish a ``normal'' 
population, including the establishment of inclusion and exclusion 
criteria.
    (B) Statistical methods and model assumptions used.
    (3) The labeling must include:
    (i) A summary of any clinical testing conducted to demonstrate how 
the device functions as an interpretation of the current level of 
cognitive function in a patient that has recently received an injury 
that causes concern about a possible concussion. The summary of testing 
must include the following:
    (A) Device output and clinical interpretation.
    (B) Device test-retest reliability of the device output.
    (C) Construct validity of the device cognitive assessments.
    (D) A description of the normative database, which includes the 
following:
    (1) How the clinical workup was completed to establish a ``normal'' 
population, including the establishment of inclusion and exclusion 
criteria.
    (2) How normal values will be reported to the user.
    (3) Representative screen shots and reports that will be generated 
to provide the user results and normative data.
    (4) Statistical methods and model assumptions used.
    (5) Whether or not the normative database was adjusted due to 
differences in age and gender.

[[Page 649]]

    (ii) A warning that the device should only be used by health care 
professionals who are trained in concussion management.
    (iii) A warning that the device does not identify the presence or 
absence of concussion or other clinical diagnoses.
    (iv) A warning that the device is not a stand-alone diagnostic.
    (v) Any instructions technicians must convey to patients regarding 
the administration of the test and collection of cognitive test data.

[81 FR 87811, Dec. 6, 2016]



Sec. 882.1480  Neurological endoscope.

    (a) Identification. A neurological endoscope is an instrument with a 
light source used to view the inside of the ventricles of the brain.
    (b) Classification. Class II (performance standards).



Sec. 882.1491  Pediatric Autism Spectrum Disorder diagnosis aid.

    (a) Identification. A pediatric Autism Spectrum Disorder diagnosis 
aid is a prescription device that is intended for use as an aid in the 
diagnosis of Autism Spectrum Disorder in pediatric patients.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must demonstrate that the device 
performs as intended under anticipated conditions of use, including an 
evaluation of sensitivity, specificity, positive predictive value, and 
negative predictive value using a reference method of diagnosis and 
assessment of patient behavioral symptomology.
    (2) Software verification, validation, and hazard analysis must be 
provided. Software documentation must include a detailed, technical 
description of the algorithm(s) used to generate device output(s), and a 
cybersecurity assessment of the impact of threats and vulnerabilities on 
device functionality and user(s).
    (3) Usability assessment must demonstrate that the intended user(s) 
can safely and correctly use the device.
    (4) Labeling must include:
    (i) Instructions for use, including a detailed description of the 
device, compatibility information, and information to facilitate 
clinical interpretation of all device outputs; and
    (ii) A summary of any clinical testing conducted to demonstrate how 
the device functions as an interpretation of patient behavioral 
symptomology associated with Autism Spectrum Disorder. The summary must 
include the following:
    (A) A description of each device output and clinical interpretation;
    (B) Any performance measures, including sensitivity, specificity, 
positive predictive value (PPV) and negative predictive value (NPV);
    (C) A description of how the cutoff values used for categorical 
classification of diagnoses were determined; and
    (D) Any expected or observed adverse events and complications.
    (iii) A statement that the device is not intended for use as a 
stand-alone diagnostic.

[87 FR 80445, Dec. 30, 2022]



Sec. 882.1500  Esthesiometer.

    (a) Identification. An esthesiometer is a mechanical device which 
usually consists of a single rod or fiber which is held in the fingers 
of the physician or other examiner and which is used to determine 
whether a patient has tactile sensitivity.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 882.9. The device is also exempt from the 
current good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180 of this chapter, with respect to general requirements concerning 
records, and Sec. 820.198 of this chapter, with respect to complaint 
files.

[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 
65 FR 2319, Jan. 14, 2000]



Sec. 882.1525  Tuning fork.

    (a) Identification. A tuning fork is a mechanical device which 
resonates at a given frequency and is used to diagnose hearing disorders 
and to test for vibratory sense.
    (b) Classification. Class I (general controls). The device is exempt 
from the

[[Page 650]]

premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 882.9. The device is also 
exempt from the current good manufacturing practice requirements of the 
quality system regulation in part 820 of this chapter, of this chapter, 
with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.

[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 
66 FR 38807, July 25, 2001]



Sec. 882.1540  Galvanic skin response measurement device.

    (a) Identification. A galvanic skin response measurement device is a 
device used to determine autonomic responses as psychological indicators 
by measuring the electrical resistance of the skin and the tissue path 
between two electrodes applied to the skin.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019]



Sec. 882.1550  Nerve conduction velocity measurement device.

    (a) Identification. A nerve conduction velocity measurement device 
is a device which measures nerve conduction time by applying a stimulus, 
usually to a patient's peripheral nerve. This device includes the 
stimulator and the electronic processing equipment for measuring and 
displaying the nerve conduction time.
    (b) Classification. Class II (performance standards).



Sec. 882.1560  Skin potential measurement device.

    (a) Identification. A skin potential measurement device is a general 
diagnostic device used to measure skin voltage by means of surface skin 
electrodes.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019]



Sec. 882.1561  Evoked photon image capture device.

    (a) Identification. An evoked photon image capture device is a 
prescription, electrically powered device intended for use as a 
noninvasive measurement tool that applies electricity to detect 
electrophysiological signals emanating from the skin, which are reported 
numerically and as images without clinical interpretation. The device is 
not intended for diagnostic purposes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 882.9.

[81 FR 67155, Sept. 30, 2016]



Sec. 882.1570  Powered direct-contact temperature measurement device.

    (a) Identification. A powered direct-contact temperature measurement 
device is a device which contains a power source and is used to measure 
differences in temperature between two points on the body.
    (b) Classification. Class II (performance standards).



Sec. 882.1580  Non-electroencephalogram (EEG) physiological signal 
based seizure monitoring system.

    (a) Identification. A non-electroencephalogram (non-EEG) 
physiological signal based seizure monitoring system is a noninvasive 
prescription device that collects physiological signals other than EEG 
to identify physiological signals that may be associated with a seizure.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The technical parameters of the device, hardware and software, 
must be fully characterized and include the following information:
    (i) Hardware specifications must be provided. Appropriate 
verification, validation, and hazard analysis must be performed.
    (ii) Software, including any proprietary algorithm(s) used by the 
device

[[Page 651]]

to achieve its intended use, must be described in detail in the Software 
Requirements Specification (SRS) and Software Design Specification 
(SDS). Appropriate software verification, validation, and hazard 
analysis must be performed.
    (2) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (3) The device must be designed and tested for electrical, thermal, 
and mechanical safety and electromagnetic compatibility (EMC).
    (4) Clinical performance testing must demonstrate the ability of the 
device to function as an assessment aid for monitoring for seizure-
related activity in the intended population and for the intended use 
setting. Performance measurements must include positive percent 
agreement and false alarm rate.
    (5) Training must be provided for intended users that includes 
information regarding the proper use of the device and factors that may 
affect the collection of the physiologic data.
    (6) The labeling must include health care professional labeling and 
patient-caregiver labeling. The health care professional and the 
patient-caregiver labeling must include the following information:
    (i) A detailed summary of the clinical performance testing, 
including any adverse events and complications.
    (ii) Any instructions technicians and clinicians should convey to 
patients and caregivers regarding the proper use of the device and 
factors that may affect the collection of the physiologic data.
    (iii) Instructions to technicians and clinicians regarding how to 
set the device threshold to achieve the intended performance of the 
device.

[82 FR 50082, Oct. 30, 2017]



Sec. 882.1610  Alpha monitor.

    (a) Identification. An alpha monitor is a device with electrodes 
that are placed on a patient's scalp to monitor that portion of the 
electroencephalogram which is referred to as the alpha wave.
    (b) Classification. Class II (performance standards).



Sec. 882.1620  Intracranial pressure monitoring device.

    (a) Identification. An intracranial pressure monitoring device is a 
device used for short-term monitoring and recording of intracranial 
pressures and pressure trends. The device includes the transducer, 
monitor, and interconnecting hardware.
    (b) Classification. Class II (performance standards).



Sec. 882.1630  Cranial motion measurement device.

    (a) Identification. A cranial motion measurement device is a 
prescription device that utilizes accelerometers to measure the motion 
or acceleration of the skull. These measurements are not to be used for 
diagnostic purposes.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The technical parameters of the device, hardware and software, 
must be fully characterized and include the following information:
    (i) Hardware specifications must be provided. Additionally, 
verification and validation testing as well as a hazard analysis must be 
performed.
    (ii) Software must be described in detail in the Software 
Requirements Specification (SRS) and Software Design Specification 
(SDS). Additionally, software verification and validation testing as 
well as a hazard analysis must be performed.
    (2) The device parts that contact the patient must be demonstrated 
to be biocompatible.
    (3) The device must be designed and tested for electrical, thermal, 
and mechanical safety, and electromagnetic compatibility (EMC).
    (4) Clinical performance testing must demonstrate the accuracy, 
precision, stability, and repeatability of measuring cranial motion per 
the intended use in the intended use environment.
    (5) The labeling must include:
    (i) The intended use population and the intended use environment.
    (ii) Instructions for technicians to convey to patients regarding 
the collection of cranial acceleration data to ensure device measurement 
accuracy, precision, stability, and repeatability.

[[Page 652]]

    (iii) Information allowing clinicians to understand potential 
sources of variability in the measurement to help recognize and identify 
changes in the measurement.

[82 FR 35071, July 28, 2017]



Sec. 882.1700  Percussor.

    (a) Identification. A percussor is a small hammerlike device used by 
a physician to provide light blows to a body part. A percussor is used 
as a diagnostic aid during physical examinations.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 882.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 
59 FR 63011, Dec. 7, 1994; 66 FR 38807, July 25, 2001]



Sec. 882.1750  Pinwheel.

    (a) Identification. A pinwheel is a device with sharp points on a 
rotating wheel used for testing pain sensation.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 
65 FR 2319, Jan. 14, 2000]



Sec. 882.1790  Ocular plethysmograph.

    (a) Identification. An ocular plethysmograph is a device used to 
measure or detect volume changes in the eye produced by pulsations of 
the artery, to diagnose carotid artery occlusive disease (restrictions 
on blood flow in the carotid artery).
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before September 21, 2004, for any ocular 
plethysmograph that was in commercial distribution before May 28, 1976. 
Any other ocular plethysmograph shall have an approved PMA or declared 
completed PDP in effect before being placed in commercial distribution.

[44 FR 51730, Sept. 4, 1979, as amended at 52 FR 17739, May 11, 1987; 69 
FR 34920, June 23, 2004]



Sec. 882.1825  Rheoencephalograph.

    (a) Identification. A rheoencephalograph is a device used to 
estimate a patient's cerebral circulation (blood flow in the brain) by 
electrical impedance methods with direct electrical connections to the 
scalp or neck area.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any 
rheoencephalograph that was in commercial distribution before May 28, 
1976, or that has, on or before December 26, 1996 been found to be 
substantially equivalent to a rheoencephalograph that was in commercial 
distribution before May 28, 1976. Any other rheoencephalograph shall 
have an approved PMA or a declared completed PDP in effect before being 
placed in commercial distribution.

[44 FR 51730, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 61 
FR 50708, Sept. 27, 1996]



Sec. 882.1835  Physiological signal amplifier.

    (a) Identification. A physiological signal amplifier is a general 
purpose device used to electrically amplify signals derived from various 
physiological sources (e.g., the electroencephalogram).
    (b) Classification. Class II (performance standards).



Sec. 882.1845  Physiological signal conditioner.

    (a) Identification. A physiological signal conditioner is a device 
such as an integrator or differentiator used to

[[Page 653]]

modify physiological signals for recording and processing.
    (b) Classification. Class II (performance standards).



Sec. 882.1855  Electroencephalogram (EEG) telemetry system.

    (a) Identification. An electroencephalogram (EEG) telemetry system 
consists of transmitters, receivers, and other components used for 
remotely monitoring or measuring EEG signals by means of radio or 
telephone transmission systems.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019]



Sec. 882.1870  Evoked response electrical stimulator.

    (a) Identification. An evoked response electrical stimulator is a 
device used to apply an electrical stimulus to a patient by means of 
skin electrodes for the purpose of measuring the evoked response.
    (b) Classification. Class II (performance standards).



Sec. 882.1880  Evoked response mechanical stimulator.

    (a) Identification. An evoked response mechanical stimulator is a 
device used to produce a mechanical stimulus or a series of mechanical 
stimuli for the purpose of measuring a patient's evoked response.
    (b) Classification. Class II (performance standards).



Sec. 882.1890  Evoked response photic stimulator.

    (a) Identification. An evoked response photic stimulator is a device 
used to generate and display a shifting pattern or to apply a brief 
light stimulus to a patient's eye for use in evoked response 
measurements or for electroencephalogram (EEG) activation.
    (b) Classification. Class II (performance standards).



Sec. 882.1900  Evoked response auditory stimulator.

    (a) Identification. An evoked response auditory stimulator is a 
device that produces a sound stimulus for use in evoked response 
measurements or electroencephalogram activation.
    (b) Classification. Class II (performance standards).



Sec. 882.1925  Ultrasonic scanner calibration test block.

    (a) Identification. An ultrasonic scanner calibration test block is 
a block of material with known properties used to calibrate ultrasonic 
scanning devices (e.g., the echoencephalograph).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 1994; 66 
FR 38807, July 25, 2001]



Sec. 882.1935  Near Infrared (NIR) Brain Hematoma Detector.

    (a) Identification. A Near Infrared (NIR) Brain Hematoma Detector is 
a noninvasive device that employs near-infrared spectroscopy that is 
intended to be used to evaluate suspected brain hematomas.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The sale, distribution, and use of this device are restricted to 
prescription use in accordance with Sec. 801.109 of this chapter;
    (2) The labeling must include specific instructions and the clinical 
training needed for the safe use of this device;
    (3) Appropriate analysis/testing should validate electromagnetic 
compatibility (EMC), electrical safety, and battery characteristics;
    (4) Performance data should validate accuracy and precision and 
safety features;
    (5) Any elements of the device that may contact the patient should 
be demonstrated to be biocompatible; and,
    (6) Appropriate software verification, validation, and hazard 
analysis should be performed.

[77 FR 16927, Mar. 23, 2012]

[[Page 654]]



Sec. 882.1950  Tremor transducer.

    (a) Identification. A tremor transducer is a device used to measure 
the degree of tremor caused by certain diseases.
    (b) Classification. Class II (performance standards).

Subparts C-D [Reserved]



                 Subpart E_Neurological Surgical Devices



Sec. 882.4030  Skull plate anvil.

    (a) Identification. A skull plate anvil is a device used to form 
alterable skull plates in the proper shape to fit the curvature of a 
patient's skull.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 1994; 66 
FR 38808, July 25, 2001]



Sec. 882.4060  Ventricular cannula.

    (a) Identification. A ventricular cannula is a device used to 
puncture the ventricles of the brain for aspiration or for injection. 
This device is frequently referred to as a ventricular needle.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000; 84 
FR 71815, Dec. 30, 2019]



Sec. 882.4100  Ventricular catheter.

    (a) Identification. A ventricular catheter is a device used to gain 
access to the cavities of the brain for injection of material into, or 
removal of material from, the brain.
    (b) Classification. Class II (performance standards).



Sec. 882.4125  Neurosurgical chair.

    (a) Identification. A neurosurgical chair is an operating room chair 
used to position and support a patient during neurosurgery.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 
FR 38808, July 25, 2001]



Sec. 882.4150  Scalp clip.

    (a) Identification. A scalp clip is a plastic or metal clip used to 
stop bleeding during surgery on the scalp.
    (b) Classification. Class II (performance standards).



Sec. 882.4175  Aneurysm clip applier.

    (a) Identification. An aneurysm clip applier is a device used by the 
surgeon for holding and applying intracranial aneurysm clips.
    (b) Classification. Class II (performance standards).



Sec. 882.4190  Clip forming/cutting instrument.

    (a) Identification. A clip forming/cutting instrument is a device 
used by the physician to make tissue clips from wire stock.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994]



Sec. 882.4200  Clip removal instrument.

    (a) Identification. A clip removal instrument is a device used to 
remove surgical clips from the patient.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 
FR 38808, July 25, 2001]



Sec. 882.4215  Clip rack.

    (a) Identification. A clip rack is a device used to hold or store 
surgical clips during surgery.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 655]]

subpart E of part 807 of this chapter subject to the limitations in 
Sec. 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 
59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001]



Sec. 882.4250  Cryogenic surgical device.

    (a) Identification. A cryogenic surgical device is a device used to 
destroy nervous tissue or produce lesions in nervous tissue by the 
application of extreme cold to the selected site.
    (b) Classification. Class II (performance standards).



Sec. 882.4275  Dowel cutting instrument.

    (a) Identification. A dowel cutting instrument is a device used to 
cut dowels of bone for bone grafting.
    (b) Classification. Class II (performance standards).



Sec. 882.4300  Manual cranial drills, burrs, trephines, and their accessories

    (a) Identification. Manual cranial drills, burrs, trephines, and 
their accessories are bone cutting and drilling instruments that are 
used without a power source on a patient's skull.
    (b) Classification. Class II (performance standards).



Sec. 882.4305  Powered compound cranial drills, burrs, trephines,
and their accessories.

    (a) Identification. Powered compound cranial drills, burrs, 
trephines, and their accessories are bone cutting and drilling 
instruments used on a patient's skull. The instruments employ a clutch 
mechanism to disengage the tip of the instrument after penetrating the 
skull to prevent plunging of the tip into the brain.
    (b) Classification. Class II (performance standards).



Sec. 882.4310  Powered simple cranial drills, burrs, trephines, and their accessories.

    (a) Identification. Powered simple cranial drills, burrs, trephines, 
and their accessories are bone cutting and drilling instruments used on 
a patient's skull. The instruments are used with a power source but do 
not have a clutch mechanism to disengage the tip after penetrating the 
skull.
    (b) Classification. Class II (performance standards).



Sec. 882.4325  Cranial drill handpiece (brace).

    (a) Identification. A cranial drill handpiece (brace) is a hand 
holder, which is used without a power source, for drills, burrs, 
trephines, or other cutting tools that are used on a patient's skull.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 61 FR 1123, Jan. 16, 1996; 66 
FR 38808, July 25, 2001]



Sec. 882.4360  Electric cranial drill motor.

    (a) Identification. An electric cranial drill motor is an 
electrically operated power source used with removable rotating surgical 
cutting tools or drill bits on a patient's skull.
    (b) Classification. Class II (performance standards).



Sec. 882.4370  Pneumatic cranial drill motor.

    (a) Identification. A pneumatic cranial drill motor is a 
pneumatically operated power source used with removable rotating 
surgical cutting tools or drill bits on a patient's skull.
    (b) Classification. Class II (performance standards).



Sec. 882.4400  Radiofrequency lesion generator.

    (a) Identification. A radiofrequency lesion generator is a device 
used to produce lesions in the nervous system or other tissue by the 
direct application of radiofrequency currents to selected sites.
    (b) Classification. Class II (performance standards).



Sec. 882.4440  Neurosurgical headrests.

    (a) Identification. A neurosurgical headrest is a device used to 
support the patient's head during a surgical procedure.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 656]]

subpart E of part 807 of this chapter subject to the limitations in 
Sec. 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 
FR 38808, July 25, 2001]



Sec. 882.4460  Neurosurgical head holder (skull clamp).

    (a) Identification. A neurosurgical head holder (skull clamp) is a 
device used to clamp the patient's skull to hold head and neck in a 
particular position during surgical procedures.
    (b) Classification. Class II (performance standards).



Sec. 882.4500  Cranioplasty material forming instrument.

    (a) Identification. A cranioplasty material forming instrument is a 
roller used in the preparation and forming of cranioplasty (skull 
repair) materials.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 
FR 38808, July 25, 2001]



Sec. 882.4525  Microsurgical instrument.

    (a) Identification. A microsurgical instrument is a nonpowered 
surgical instrument used in neurological microsurgery procedures.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 
FR 38808, July 25, 2001]



Sec. 882.4535  Nonpowered neurosurgical instrument.

    (a) Identification. A nonpowered neurosurgical instrument is a hand 
instrument or an accessory to a hand instrument used during 
neurosurgical procedures to cut, hold, or manipulate tissue. It includes 
specialized chisels, osteotomes, curettes, dissectors, elevators, 
forceps, gouges, hooks, surgical knives, rasps, scissors, separators, 
spatulas, spoons, blades, blade holders, blade breakers, probes, etc.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 
FR 38808, July 25, 2001]



Sec. 882.4545  Shunt system implantation instrument.

    (a) Identification. A shunt system implantation instrument is an 
instrument used in the implantation of cerebrospinal fluid shunts, and 
includes tunneling instruments for passing shunt components under the 
skin.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000; 84 
FR 71815, Dec. 30, 2019]



Sec. 882.4560  Stereotaxic instrument.

    (a) Identification. A stereotaxic instrument is a device consisting 
of a rigid frame with a calibrated guide mechanism for precisely 
positioning probes or other devices within a patient's brain, spinal 
cord, or other part of the nervous system.
    (b) Classification. Class II (performance standards).



Sec. 882.4600  Leukotome.

    (a) Identification. A leukotome is a device used to cut sections out 
of the brain.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 
FR 38808, July 25, 2001]



Sec. 882.4650  Neurosurgical suture needle.

    (a) Identification. A neurosurgical suture needle is a needle used 
in suturing during neurosurgical procedures or in the repair of nervous 
tissue.
    (b) Classification. Class I (general controls). The device is exempt 
from the

[[Page 657]]

premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 
65 FR 2319, Jan. 14, 2000]



Sec. 882.4700  Neurosurgical paddie.

    (a) A neurosurgical paddie is a pad used during surgery to protect 
nervous tissue, absorb fluids, or stop bleeding.
    (b) Classification. Class II (performance standards).

[44 FR 51730, Sept. 4, 1979, as amended at 69 FR 10332, Mar. 5, 2004]



Sec. 882.4725  Radiofrequency lesion probe.

    (a) Identification. A radiofrequency lesion probe is a device 
connected to a radiofrequency (RF) lesion generator to deliver the RF 
energy to the site within the nervous system where a lesion is desired.
    (b) Classification. Class II (performance standards).



Sec. 882.4750  Skull punch.

    (a) Identification. A skull punch is a device used to punch holes 
through a patient's skull to allow fixation of cranioplasty plates or 
bone flaps by wire or other means.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 882.9. This exemption does not apply to 
powered compound cranial drills, burrs, trephines, and their accessories 
classified under Sec. 882.4305.

[44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000]



Sec. 882.4800  Self-retaining retractor for neurosurgery.

    (a) Identification. A self-retaining retractor for neurosurgery is a 
self-locking device used to hold the edges of a wound open during 
neurosurgery.
    (b) Classification. Class II (performance standards).



Sec. 882.4840  Manual rongeur.

    (a) Identification. A manual rongeur is a manually operated 
instrument used for cutting or biting bone during surgery involving the 
skull or spinal column.
    (b) Classification. Class II (performance standards).



Sec. 882.4845  Powered rongeur.

    (a) Identification. A powered rongeur is a powered instrument used 
for cutting or biting bone during surgery involving the skull or spinal 
column.
    (b) Classification. Class II (performance standards).



Sec. 882.4900  Skullplate screwdriver.

    (a) Identification. A skullplate screwdriver is a tool used by the 
surgeon to fasten cranioplasty plates or skullplates to a patient's 
skull by screws.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 
FR 38808, July 25, 2001]



Sec. 882.4950  Diagnostic neurosurgical microscope filter.

    (a) Identification. A diagnostic neurosurgical microscope filter is 
a device intended for use during neurosurgery to visualize fluorescence 
and enhance visualization of tissue associated with a specific disease 
or condition.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use, and 
verify and validate filter specifications and functional 
characteristics, including the following:
    (i) Spectrum and intensity of the illumination source;
    (ii) Spectrum of the excitation and emission filter modules when 
integrated in the surgical operating microscope;
    (iii) Excitation power and power density;
    (iv) Optical path loss from illumination source to objective lens or 
microscope camera;

[[Page 658]]

    (v) Homogeneity of the excitation light at the focal plane;
    (vi) Fluorescence detection sensitivity;
    (vii) Verification of calibration or preoperative procedures; and
    (viii) If camera-based, spectral sensitivity of the camera.
    (2) Labeling must include:
    (i) Identification of the filter characteristics in conjunction with 
a compatible surgical operating microscope, to include the following:
    (A) Illumination spectrum and power density; and
    (B) Excitation and emission filter spectra.
    (ii) Instructions for calibration or preoperative checks to ensure 
device functionality prior to each use;
    (iii) Instructions for use with compatible surgical operating 
microscopes, external light sources, and cameras;
    (iv) A warning that the device should only be used with fluorophores 
approved for use within the specified spectral ranges; and
    (v) A warning that the device is not a standalone diagnostic.

[86 FR 73973, Dec. 29, 2021]



               Subpart F_Neurological Therapeutic Devices



Sec. 882.5030  Methyl methacrylate for aneurysmorrhaphy.

    (a) Identification. Methyl methacrylate for aneurysmorrhaphy (repair 
of aneurysms, which are balloonlike sacs formed on blood vessels) is a 
self-curing acrylic used to encase and reinforce intracranial aneurysms 
that are not amenable to conservative management, removal, or 
obliteration by aneurysm clip.
    (b) Classification. Class II (performance standards).



Sec. 882.5050  Biofeedback device.

    (a) Identification. A biofeedback device is an instrument that 
provides a visual or auditory signal corresponding to the status of one 
or more of a patient's physiological parameters (e.g., brain alpha wave 
activity, muscle activity, skin temperature, etc.) so that the patient 
can control voluntarily these physiological parameters.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter when it is a prescription battery powered device 
that is indicated for relaxation training and muscle reeducation and 
prescription use, subject to Sec. 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 63 FR 59229, Nov. 3, 1998]



Sec. 882.5060  Conditioning tool for eating disorders.

    (a) Identification. A conditioning tool for eating disorders is a 
prescription device that non-invasively measures the mass of food eaten 
during a meal and provides feedback in the form of eating rate, patient 
satiety, and eating pattern information to the patient.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Nonclinical performance testing must demonstrate:
    (i) Device measurement accuracy and repeatability; and
    (ii) Device feedback accuracy.
    (2) Software verification, validation, and hazard analysis must be 
performed.
    (3) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (4) Performance testing must demonstrate the electromagnetic 
compatibility (EMC) and electrical safety of the device.
    (5) Labeling and patient labeling must be provided which includes 
the following:
    (i) Information identifying and explaining how to use the device and 
its components; and
    (ii) Information on how the device operates and the typical course 
of treatment.

[86 FR 68403, Dec. 2, 2021]



Sec. 882.5070  Bite block.

    (a) Identification. A bite block is a device inserted into a 
patient's mouth to protect the tongue and teeth while the patient is 
having convulsions.
    (b) Classification. Class II (performance standards).

[[Page 659]]



Sec. 882.5150  Intravascular occluding catheter.

    (a) Identification. An intravascular occluding catheter is a 
catheter with an inflatable or detachable balloon tip that is used to 
block a blood vessel to treat malformations, e.g., aneurysms 
(balloonlike sacs formed on blood vessels) of intracranial blood 
vessels.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any 
intravascular occluding catheter that was in commercial distribution 
before May 28, 1976, or that has, on or before December 26, 1996 been 
found to be substantially equivalent to an intravascular occluding 
catheter that was in commercial distribution before May 28, 1976. Any 
other intravascular occluding catheter shall have an approved PMA or a 
declared completed PDP in effect before being placed in commercial 
distribution.

[44 FR 51730, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 61 
FR 50708, Sept. 27, 1996]



Sec. 882.5175  Carotid artery clamp.

    (a) Identification. A carotid artery clamp is a device that is 
surgically placed around a patient's carotid artery (the principal 
artery in the neck that supplies blood to the brain) and has a removable 
adjusting mechanism that protrudes through the skin of the patient's 
neck. The clamp is used to occlude the patient's carotid artery to treat 
intracranial aneurysms (balloonlike sacs formed on blood vessels) or 
other intracranial vascular malformations that are difficult to attach 
directly by reducing the blood pressure and blood flow to the aneurysm 
or malformation.
    (b) Classification. Class II (performance standards).



Sec. 882.5200  Aneurysm clip.

    (a) Identification. An aneurysm clip is a device used to occlude an 
intracranial aneurysm (a balloonlike sac formed on a blood vessel) to 
prevent it from bleeding or bursting.
    (b) Classification. Class II (performance standards).



Sec. 882.5225  Implanted malleable clip.

    (a) Identification. An implanted malleable clip is a bent wire or 
staple that is forcibly closed with a special instrument to occlude an 
intracranial blood vessel or aneurysm (a balloonlike sac formed on a 
blood vessel), stop bleeding, or hold tissue or a mechanical device in 
place in a patient.
    (b) Classification. Class II (performance standards).



Sec. 882.5235  Aversive conditioning device.

    (a) Identification. An aversive conditioning device is an instrument 
used to administer an electrical shock or other noxious stimulus to a 
patient to modify undesirable behavioral characteristics.
    (b) Classification. Class II (special controls), except for 
electrical stimulation devices for self-injurious or aggressive 
behavior. Electrical stimulation devices for self-injurious or 
aggressive behavior are banned. See Sec. 895.105 of this chapter.

[44 FR 51730, Sept. 4, 1979, as amended at 85 FR 13354, Mar. 6, 2020]



Sec. 882.5250  Burr hole cover.

    (a) Identification. A burr hole cover is a plastic or metal device 
used to cover or plug holes drilled into the skull during surgery and to 
reattach cranial bone removed during surgery.
    (b) Classification. Class II (performance standards).



Sec. 882.5275  Nerve cuff.

    (a) Identification. A nerve cuff is a tubular silicone rubber sheath 
used to encase a nerve for aid in repairing the nerve (e.g., to prevent 
ingrowth of scar tissue) and for capping the end of the nerve to prevent 
the formation of neuroma (tumors).
    (b) Classification. Class II (performance standards).



Sec. 882.5300  Methyl methacrylate for cranioplasty.

    (a) Identification. Methyl methacrylate for cranioplasty (skull 
repair) is a self-curing acrylic that a surgeon uses to repair a skull 
defect in a patient. At

[[Page 660]]

the time of surgery, the surgeon initiates polymerization of the 
material and forms it into a plate or other appropriate shape to repair 
the defect.
    (b) Classification. Class II (performance standards).



Sec. 882.5320  Preformed alterable cranioplasty plate.

    (a) Identification. A preformed alterable cranioplasty plate is a 
device that is implanted into a patient to repair a skull defect. It is 
constructed of a material, e.g., tantalum, that can be altered or 
reshaped at the time of surgery without changing the chemical behavior 
of the material.
    (b) Classification. Class II (performance standards).



Sec. 882.5330  Preformed nonalterable cranioplasty plate.

    (a) Identification. A preformed nonalterable cranioplasty plate is a 
device that is implanted in a patient to repair a skull defect and is 
constructed of a material, e.g., stainless steel or vitallium, that 
cannot be altered or reshaped at the time of surgery without changing 
the chemical behavior of the material.
    (b) Classification. Class II (performance standards).



Sec. 882.5360  Cranioplasty plate fastener.

    (a) Identification. A cranioplasty plate fastener is a screw, wire, 
or other article made of tantalum, vitallium, or stainless steel used to 
secure a plate to the patient's skull to repair a skull defect.
    (b) Classification. Class II (performance standards).



Sec. 882.5500  Lesion temperature monitor.

    (a) Identification. A lesion temperature monitor is a device used to 
monitor the tissue temperature at the site where a lesion (tissue 
destruction) is to be made when a surgeon uses a radiofrequency (RF) 
lesion generator and probe.
    (b) Classification. Class II (performance standards).



Sec. 882.5550  Central nervous system fluid shunt and components.

    (a) Identification. A central nervous system fluid shunt is a device 
or combination of devices used to divert fluid from the brain or other 
part of the central nervous system to an internal delivery site or an 
external receptacle for the purpose of relieving elevated intracranial 
pressure or fluid volume (e.g., due to hydrocephalus). Components of a 
central nervous system shunt include catheters, valved catheters, 
valves, connectors, and other accessory components intended to 
facilitate use of the shunt or evaluation of a patient with a shunt.
    (b) Classification. Class II (performance standards).



Sec. 882.5560  Cerebrospinal fluid shunt system.

    (a) Identification. A cerebrospinal fluid shunt system is a 
prescription device used to monitor and divert fluid from the brain or 
other part of the central nervous system to an internal delivery site or 
an external receptacle for the purpose of preventing spinal cord 
ischemia or injury during procedures that require reduction in central 
nervous system pressure. A cerebrospinal fluid shunt system may include 
catheters, valved catheters, valves, connectors, and pressure monitors 
intended to facilitate use of the shunt or evaluation of a patient with 
a shunt.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The device description must include a detailed summary of the 
device technical parameters, including design configuration, dimensions, 
engineering drawings, and a list of all components with identification 
of their materials of construction.
    (2) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (3) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be tested:
    (i) Simulated use testing must be conducted to characterize fluid 
flow and resistance to leakage; and

[[Page 661]]

    (ii) Mechanical integrity testing of all connections must be 
conducted.
    (4) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the specified shelf life.
    (5) Performance data must demonstrate the sterility and pyrogenicity 
of patient-contacting components of the device.
    (6) The labeling must include:
    (i) Contraindications with respect to patients who should not 
receive a lumbar drain;
    (ii) A warning that the device should have 24-hour-a-day 
availability of trained personnel to supervise monitoring and drainage;
    (iii) Instructions on proper device setup, positioning, and 
monitoring;
    (iv) Warnings and precautions to inform the user of serious hazards 
and special care associated with the use of the device;
    (v) A statement that the device is not to be reused, reprocessed, or 
resterilized when open but unused; and
    (vi) Cleaning instructions for the injection sites.

[86 FR 73975, Dec. 29, 2021]



Sec. 882.5600  Neurovascular mechanical thrombectomy device for 
acute ischemic stroke treatment.

    (a) Identification. A neurovascular mechanical thrombectomy device 
for acute ischemic stroke treatment is a prescription device used in the 
treatment of acute ischemic stroke to improve clinical outcomes. The 
device is delivered into the neurovasculature with an endovascular 
approach, mechanically removes thrombus from the body, and restores 
blood flow in the neurovasculature.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient contacting components of the device must be 
demonstrated to be biocompatible.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use, 
including:
    (i) Mechanical testing to demonstrate the device can withstand 
anticipated tensile, torsional, and compressive forces.
    (ii) Mechanical testing to evaluate the radial forces exerted by the 
device.
    (iii) Non-clinical testing to verify the dimensions of the device.
    (iv) Non-clinical testing must demonstrate the device can be 
delivered to the target location in the neurovasculature and retrieve 
simulated thrombus under simulated use conditions.
    (v) Non-clinical testing must demonstrate the device is radiopaque 
and can be visualized.
    (vi) Non-clinical testing must evaluate the coating integrity and 
particulates under simulated use conditions.
    (vii) Animal testing must evaluate the safety of the device, 
including damage to the vessels or tissue under anticipated use 
conditions.
    (3) Performance data must support the sterility and pyrogenicity of 
the patient contacting components of the device.
    (4) Performance data must support the shelf-life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the specified shelf-life.
    (5) Clinical performance testing of the device must demonstrate the 
device performs as intended for use in the treatment of acute ischemic 
stroke and must capture any adverse events associated with the device 
and procedure.
    (6) The labeling must include:
    (i) Information on the specific patient population for which the 
device is intended for use in the treatment of acute ischemic stroke, 
including but not limited to, specifying time from symptom onset, 
vessels or location of the neurovasculature that can be accessed for 
treatment, and limitations on core infarct size.
    (ii) Detailed instructions on proper device preparation and use for 
thrombus retrieval from the neurovasculature.
    (iii) A summary of the clinical testing results, including a 
detailed summary of the device- and procedure-related complications and 
adverse events.
    (iv) A shelf life.

[81 FR 94253, Dec. 23, 2016]

[[Page 662]]



Sec. 882.5700  Thermal system for insomnia.

    (a) Identification. A thermal system for insomnia is a prescription 
device for use in patients with insomnia that is used to apply a 
specified temperature to the skin surface.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (2) Performance testing must demonstrate electromagnetic 
compatibility and electrical safety.
    (3) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be evaluated:
    (i) Thermal performance of the device, including maintenance of the 
target temperature, must be evaluated under simulated use conditions.
    (ii) Mechanical testing to demonstrate the device can withstand 
forces under anticipated use conditions.
    (iii) Mechanical testing to demonstrate the device is resistant to 
leakage under anticipated use conditions.
    (4) Software verification, validation, and hazard analysis must be 
performed.
    (5) Patient labeling must be provided to convey information 
regarding safe use of the device, including instructions for assembly.

[81 FR 44772, July 11, 2016]



Sec. 882.5705  Digital therapy device to reduce sleep disturbance
for psychiatric conditions.

    (a) Identification. A digital therapy device to reduce sleep 
disturbance for psychiatric conditions is a prescription device that is 
intended to provide stimulation using a general purpose computing 
platform to reduce sleep disturbance in patients who experience this 
symptom due to psychiatric conditions such as nightmare disorder or 
post-traumatic stress disorder.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing under the labeled conditions for 
use must evaluate the following:
    (i) The ability of the device to provide therapy for patients with 
sleep disturbance due to psychiatric conditions, using a validated 
measure;
    (ii) Worsening of any condition-specific symptoms using a validated 
measure for assessment of the particular condition; and
    (iii) Increase in symptoms of disturbed sleep or sleepiness using a 
validated measure.
    (2) Software must clearly describe all features and functions of the 
software implementing the digital therapy. Software verification, 
validation, and hazard analysis must also be provided.
    (3) The labeling must include the following:
    (i) Patient and physician labeling must include instructions for 
use, including images that demonstrate how to interact with the device;
    (ii) Patient and physician labeling must list the minimum operating 
system and general purpose computing requirements that support the 
software of the device;
    (iii) Patient and physician labeling must include a warning that the 
digital therapy device is not intended for use as a stand-alone 
therapeutic device;
    (iv) Patient and physician labeling must include a warning that the 
digital therapy device does not represent a substitution for the 
patient's medication; and
    (v) Physician labeling must include a summary of the clinical 
performance testing conducted with the device.

[88 FR 2223, Jan. 13, 2023]



Sec. 882.5800  Cranial electrotherapy stimulator.

    (a) Identification. A cranial electrotherapy stimulator is a 
prescription device that applies electrical current that is not intended 
to induce a seizure to a patient's head to treat psychiatric conditions.
    (b) Classification. (1) Class II (special controls) when intended to 
treat insomnia and/or anxiety. The special controls for this device are:
    (i) A detailed summary of the clinical testing pertinent to use of 
the device to demonstrate the effectiveness of the

[[Page 663]]

device to treat insomnia and/or anxiety.
    (ii) Components of the device that come into human contact must be 
demonstrated to be biocompatible.
    (iii) The device must be designed and tested for electrical safety 
and electromagnetic compatibility (EMC) in its intended use environment.
    (iv) Appropriate software verification, validation, and hazard 
analysis must be performed.
    (v) The technical parameters of the device, including waveform, 
output mode, pulse duration, frequency, train delivery, maximum charge, 
and energy, must be fully characterized and verified.
    (vi) The labeling for the device must include the following:
    (A) The intended use population and the intended use environment;
    (B) A warning that patients should be monitored by their physician 
for signs of worsening;
    (C) A warning that instructs patients on how to mitigate the risk of 
headaches, and what to do should a headache occur;
    (D) A warning that instructs patients on how to mitigate the risk of 
dizziness, and what to do should dizziness occur;
    (E) A detailed summary of the clinical testing, which includes the 
clinical outcomes associated with the use of the device, and a summary 
of adverse events and complications that occurred with the device;
    (F) Instructions for use that address where to place the electrodes, 
what stimulation parameters to use, and duration and frequency of 
treatment sessions. This information must be based on the results of 
clinical studies for the device;
    (G) A detailed summary of the device technical parameters, including 
waveform, output mode, pulse duration, frequency, train delivery, and 
maximum charge and energy; and
    (H) Information on validated methods for reprocessing any reusable 
components between uses.
    (vii) Cranial electrotherapy stimulator devices marketed prior to 
the effective date of this reclassification must have an amendment 
submitted to the previously cleared premarket notification (510(k)) 
demonstrating compliance with these special controls.
    (2) Class III (premarket approval) when intended to treat 
depression.
    (c) Date premarket approval application (PMA) or notice of 
completion of product development protocol (PDP) is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before March 19, 2020, for any cranial 
electrotherapy stimulator device with an intended use described in 
paragraph (b)(2) of this section, that was in commercial distribution 
before May 28, 1976, or that has, on or before March 19, 2020, been 
found to be substantially equivalent to any cranial electrotherapy 
stimulator device with an intended use described in paragraph (b)(2) of 
this section, that was in commercial distribution before May 28, 1976. 
Any other cranial electrotherapy stimulator device with an intended use 
described in paragraph (b)(2) of this section shall have an approved PMA 
or declared completed PDP in effect before being placed in commercial 
distribution.

[84 FR 70013, Dec. 20, 2019]



Sec. 882.5801  Computerized behavioral therapy device for psychiatric disorders.

    (a) Identification. A computerized behavioral therapy device for 
psychiatric disorders is a prescription only device intended to provide 
a computerized version of condition-specific behavioral therapy as an 
adjunct to clinician supervised outpatient treatment to patients with 
psychiatric conditions. The digital therapy is intended to provide 
patients access to therapy tools used during treatment sessions to 
improve recognized treatment outcomes.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical data must be provided to fulfill the following:
    (i) Describe a validated model of behavioral therapy for the 
psychiatric disorder; and
    (ii) Validate the model of behavioral therapy as implemented by the 
device.
    (2) Software must be described in detail in the software 
requirements specification (SRS) and software design

[[Page 664]]

specification (SDS). Software verification, validation, and hazard 
analysis must be performed. Software documentation must demonstrate that 
the device effectively implements the behavioral therapy model.
    (3) The following labeling must be provided:
    (i) Patient and physician labeling must include instructions for 
use, including images that demonstrate how to interact with the device.
    (ii) Patient and physician labeling must list compatible devices.
    (iii) Patient and physician labeling must include a warning that the 
device is not intended for use as a standalone therapy.
    (iv) Patient and physician labeling must include a warning that the 
device does not represent a substitution for the patient's medication.
    (v) Physician labeling must include a summary of the clinical 
testing with the device.

[82 FR 61167, Dec. 27, 2017]



Sec. 882.5802  Transcranial magnetic stimulation system for
neurological and psychiatric disorders and conditions.

    (a) Identification. A transcranial magnetic stimulation system for 
neurological and psychiatric disorders and conditions is a prescription, 
non-implantable device that uses brief duration, rapidly alternating, or 
pulsed, magnetic fields to induce neural activity in the cerebral 
cortex. It is not intended for applying or focusing magnetic fields 
towards brain areas outside cerebral cortex (e.g., cerebellum). A 
repetitive transcranial magnetic stimulation system that is intended to 
treat major depressive disorder is classified in Sec. 882.5805. A 
transcranial magnetic stimulation system for headache is classified in 
Sec. 882.5808.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Performance testing must demonstrate electromagnetic 
compatibility, electrical safety, and thermal safety.
    (2) Software verification, validation, and hazard analysis must be 
performed.
    (3) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (4) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be tested:
    (i) Magnetic pulse output testing;
    (ii) Magnetic and electrical field testing;
    (iii) Testing of the safety features built into the device; and
    (iv) Testing of the sound levels patients are exposed to during 
device use.
    (5) The physician and patient labeling must include the following:
    (i) The risks and benefits associated with use of the device;
    (ii) Detailed instructions to prevent seizures, to monitor the 
patient for seizure activity during treatment, and to provide seizure 
management care if one were to occur during treatment; and
    (iii) A description of the ear protection to be worn by the patient 
during use of the device, including the type of protection and its noise 
reduction rating.

[84 FR 9230, Mar. 14, 2019]



Sec. 882.5805  Repetitive transcranial magnetic stimulation system.

    (a) Identification. A repetitive transcranial magnetic stimulation 
system is an external device that delivers transcranial repetitive 
pulsed magnetic fields of sufficient magnitude to induce neural action 
potentials in the prefrontal cortex to treat the symptoms of major 
depressive disorder without inducing seizure in patients who have failed 
at least one antidepressant medication and are currently not on any 
antidepressant therapy.
    (b) Classification. Class II (special controls). The special control 
is FDA's ``Class II Special Controls Guidance Document: Repetitive 
Transcranial Magnetic Stimulation System.'' See Sec. 882.1(e) for the 
availability of this guidance document.

[76 FR 44491, July 26, 2011]

[[Page 665]]



Sec. 882.5808  Transcranial magnetic stimulator for headache.

    (a) Identification. A transcranial magnetic stimulator device for 
headache is a device that delivers brief duration, rapidly alternating, 
or pulsed, magnetic fields that are externally directed at spatially 
discrete regions of the brain to induce electrical currents for the 
treatment of headache.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Appropriate analysis/testing must demonstrate electromagnetic 
compatibility, electrical safety, and thermal safety.
    (2) Appropriate verification, validation, and hazard analysis must 
be performed on the device software and firmware.
    (3) The elements of the device that contact the patient must be 
assessed to be biocompatible.
    (4) Non-clinical testing data must demonstrate that the device 
performs as intended under anticipated conditions of use. This includes 
full characterization of the magnetic pulse output and resulting 
magnetic field map. This also includes characterization of the sound 
level of the device during use.
    (5) Clinical testing must demonstrate that the device is safe and 
effective for treating headache in the indicated patient population.
    (6) The physician and patient labeling must include the following:
    (i) A summary of the clinical performance testing, including any 
adverse events and complications.
    (ii) The intended use population in terms of the types of headaches 
appropriate for use with the device.
    (iii) Information on how to report adverse events and device 
malfunctions.
    (iv) A diagram or picture depicting the proper placement of the 
device on the user.

[78 FR 38458, July 8, 2014]



Sec. 882.5810  External functional neuromuscular stimulator.

    (a) Identification. An external functional neuromuscular stimulator 
is an electrical stimulator that uses external electrodes for 
stimulating muscles in the leg and ankle of partially paralyzed patients 
(e.g., after stroke) to provide flexion of the foot and thus improve the 
patient's gait.
    (b) Classification. Class II (performance standards).



Sec. 882.5820  Implanted cerebellar stimulator.

    (a) Identification. An implanted cerebellar stimulator is a device 
used to stimulate electrically a patient's cerebellar cortex for the 
treatment of intractable epilepsy, spasticity, and some movement 
disorders. The stimulator consists of an implanted receiver with 
electrodes that are placed on the patient's cerebellum and an external 
transmitter for transmitting the stimulating pulses across the patient's 
skin to the implanted receiver.
    (b) Classification. Class III (premarket approval).
    (c) Date premarket approval application (PMA) or notice of 
completion of a product development protocol (PDP) is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before September 26, 1984. Any implanted 
cerebellar stimulator that was not in commercial distribution before May 
28, 1976, or that has not on or before September 26, 1984 been found by 
FDA to be substantially equivalent to an implanted cerebellar stimulator 
that was in commercial distribution before May 28, 1976 shall have an 
approved PMA or declared completed PDP in effect before beginning 
commercial distribution.

[44 FR 51730, Sept. 4, 1979, as amended at 49 FR 26574, June 28, 1984]



Sec. 882.5830  Implanted diaphragmatic/phrenic nerve stimulator.

    (a) Identification. An implanted diaphragmatic/phrenic nerve 
stimulator is a device that provides electrical stimulation of a 
patient's phrenic nerve to contract the diaphragm rhythmically and 
produce breathing in patients who have hypoventilation (a state in which 
an abnormally low amount of air enters the lungs) caused by brain stem 
disease, high cervical spinal cord injury, or chronic lung disease. The 
stimulator consists of an implanted receiver with electrodes that are 
placed around the patient's phrenic nerve and

[[Page 666]]

an external transmitter for transmitting the stimulating pulses across 
the patient's skin to the implanted receiver.
    (b) Classification. Class III (premarket approval).
    (c) Date premarket approval application (PMA) or notice of 
completion of a product development protocol (PDP) is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before July 7, 1986 for any implanted 
diaphragmatic/phrenic nerve stimulator that was in commercial 
distribution before May 28, 1976, or that has on or before July 7, 1986 
been found to be substantially equivalent to an implanted diaphragmatic/
phrenic nerve stimulator that was in commercial distribution before May 
28, 1976. Any other implanted diaphragmatic/phrenic nerve stimulator 
shall have an approved PMA or a declared completed PDP in effect before 
being placed in commercial distribution.

[44 FR 51730, Sept. 4, 1979, as amended at 51 FR 12101, Apr. 8, 1986]



Sec. 882.5840  Implanted intracerebral/subcortical stimulator
for pain relief.

    (a) Identification. An implanted intracerebral/subcortical 
stimulator for pain relief is a device that applies electrical current 
to subsurface areas of a patient's brain to treat severe intractable 
pain. The stimulator consists of an implanted receiver with electrodes 
that are placed within a patient's brain and an external transmitter for 
transmitting the stimulating pulses across the patient's skin to the 
implanted receiver.
    (b) Classification. Class III (premarket approval).
    (c) Date premarket approval application (PMA) or notice of 
completion of a product development protocol (PDP) is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before March 1, 1989, for any implanted 
intracerebral/subcortical stimulator for pain relief that was in 
commercial distribution before May 28, 1976, or that has on or before 
March 1, 1989, been found to be substantially equivalent to an implanted 
intracerebral/subcortical stimulator for pain relief that was in 
commercial distribution before May 28, 1976. Any other implanted 
intracerebral/subcortical stimulator for pain relief shall have an 
approved PMA or a declared completed PDP in effect before being placed 
in commercial distribution.

[44 FR 51730, Sept. 4, 1979, as amended at 53 FR 48621, Dec. 1, 1988]



Sec. 882.5850  Implanted spinal cord stimulator for bladder evacuation.

    (a) Identification. An implanted spinal cord stimulator for bladder 
evacuation is an electrical stimulator used to empty the bladder of a 
paraplegic patient who has a complete transection of the spinal cord and 
who is unable to empty his or her bladder by reflex means or by the 
intermittent use of catheters. The stimulator consists of an implanted 
receiver with electrodes that are placed on the conus medullaris portion 
of the patient's spinal cord and an external transmitter for 
transmitting the stimulating pulses across the patient's skin to the 
implanted receiver.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any implanted 
spinal cord stimulator for bladder evacuation that was in commercial 
distribution before May 28, 1976, or that has, on or before December 26, 
1996 been found to be substantially equivalent to an implanted spinal 
cord stimulator for bladder evacuation that was in commercial 
distribution before May 28, 1976. Any other implanted spinal cord 
stimulator for bladder evacuation shall have an approved PMA or a 
declared completed PDP in effect before being placed in commercial 
distribution.

[44 FR 51730, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 61 
FR 50708, Sept. 27, 1996]



Sec. 882.5855  Brain stimulation programming planning software.

    (a) Identification. The brain stimulation programming planning 
software is a prescription device intended to assist

[[Page 667]]

in planning stimulation programming for implanted brain stimulators.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Software verification, validation, and hazard analysis must be 
performed.
    (2) Usability assessment must demonstrate that the intended user(s) 
can safely and correctly use the device.
    (3) Labeling must include:
    (i) The implanted brain stimulators for which the device is 
compatible.
    (ii) Instructions for use.
    (iii) Instructions and explanations of all user-interface 
components.
    (iv) A warning regarding use of the data with respect to not 
replacing clinical judgment.

[88 FR 751, Jan. 5, 2023]



Sec. 882.5860  Implanted neuromuscular stimulator.

    (a) Identification. An implanted neuromuscular stimulator is a 
device that provides electrical stimulation to a patient's peroneal or 
femoral nerve to cause muscles in the leg to contract, thus improving 
the gait in a patient with a paralyzed leg. The stimulator consists of 
an implanted receiver with electrodes that are placed around a patient's 
nerve and an external transmitter for transmitting the stimulating 
pulses across the patient's skin to the implanted receiver. The external 
transmitter is activated by a switch in the heel in the patient's shoe.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of PDP is required. A PMA or 
notice of completion of a PDP for a device described in paragraph (b) of 
this section is required to be filed with the Food and Drug 
Administration on or before July 13, 1999 for any implanted 
neuromuscular stimulator that was in commercial distribution before May 
28, 1976, or that has, on or before July 13, 1999, been found to be 
substantially equivalent to an implanted neuromuscular stimulator that 
was in commercial distribution before May 28, 1976. Any other implanted 
neuromuscular stimulator shall have an approved PMA or declared 
completed PDP in effect before being placed in commercial distribution.

[44 FR 51730, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 64 
FR 18329, Apr. 14, 1999]



Sec. 882.5870  Implanted peripheral nerve stimulator for pain relief.

    (a) Identification. An implanted peripheral nerve stimulator for 
pain relief is a device that is used to stimulate electrically a 
peripheral nerve in a patient to relieve severe intractable pain. The 
stimulator consists of an implanted receiver with electrodes that are 
placed around a peripheral nerve and an external transmitter for 
transmitting the stimulating pulses across the patient's skin to the 
implanted receiver.
    (b) Classification. Class II (performance standards).

[44 FR 51730, Sept. 4, 1979, as amended at 78 FR 18234, Mar. 26, 2013]



Sec. 882.5880  Implanted spinal cord stimulator for pain relief.

    (a) Identification. An implanted spinal cord stimulator for pain 
relief is a device that is used to stimulate electrically a patient's 
spinal cord to relieve severe intractable pain. The stimulator consists 
of an implanted receiver with electrodes that are placed on the 
patient's spinal cord and an external transmitter for transmitting the 
stimulating pulses across the patient's skin to the implanted receiver.
    (b) Classification. Class II (performance standards).



Sec. 882.5890  Transcutaneous electrical nerve stimulator for pain relief.

    (a) Identification. A transcutaneous electrical nerve stimulator for 
pain relief is a device used to apply an electrical current to 
electrodes on a patient's skin to treat pain.
    (b) Classification. Class II (performance standards).



Sec. 882.5891  Transcutaneous electrical nerve stimulator to treat headache.

    (a) Identification. A transcutaneous electrical nerve stimulator to 
treat headache is a device used to apply an electrical current to a 
patient's cranium through electrodes placed on the skin.

[[Page 668]]

    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (2) Appropriate analysis/testing must validate electromagnetic 
compatibility and electrical, mechanical, and thermal safety.
    (3) The technical parameters of the device, including waveform, 
output modes, maximum output voltage and current (with 500, 2,000, and 
10,000 ohm loads), pulse duration, frequency, net charge ([micro]C) per 
pulse, maximum phase charge at 500 ohms, maximum current density (mA/
cm\2\, r.m.s.), maximum average current (mA), maximum average power 
density (W/cm\2\), and the type of impedance monitoring system must be 
fully characterized.
    (4) Electrical performance, adhesive integrity, shelf life, 
reusability, and current distribution testing of the electrodes must be 
conducted.
    (5) Appropriate software verification, validation, and hazard 
analysis must be performed.
    (6) Clinical performance data must demonstrate that the device is 
safe and effective as a treatment for headache in the indicated patient 
population.
    (7) Labeling must include the following:
    (i) Appropriate contraindications such as not for use in subjects 
with an implanted metallic or electronic device in the head, a cardiac 
pacemaker, or an implanted or wearable defibrillator.
    (ii) Appropriate warnings such as not to apply the device on the 
neck or chest, not to use the device in the presence of electronic 
monitoring equipment, not to use in the bath or shower, not to use while 
sleeping, not to use while driving, not to use while operating 
machinery.
    (iii) Appropriate precautions such as the long-term effects of 
chronic use of the device are unknown.
    (iv) A summary of the expected risks and benefits of using the 
device.
    (v) A summary of the clinical performance data, including 
information on the patient population for which the device has and has 
not been demonstrated to be effective, and any adverse events and 
complications.
    (vi) Information on how the device operates and the typical 
sensations experienced during treatment.
    (vii) A detailed summary of the device technical parameters.
    (viii) An expiration date/shelf life for the electrodes and the 
number of times they can be reused.
    (ix) Disposal instructions.

[79 FR 37948, July 3, 2014]



Sec. 882.5892  External vagal nerve stimulator for headache.

    (a) Identification. An external vagal nerve stimulator for headache 
is a prescription device used to apply an electrical current to a 
patient's vagus nerve through electrodes placed on the skin for the 
treatment of headache.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The technical parameters of the device, including waveform, 
output modes, maximum output voltage and current (with 500, 2,000, and 
10,000 ohm loads), pulse duration, frequency, net charge ([micro]C) per 
pulse, maximum phase charge at 500 ohms, maximum current density (mA/
cm\2\, r.m.s.), maximum average current (mA), maximum average power 
density (W/cm\2\), and the type of impedance monitoring system shall be 
fully characterized through non-clinical performance testing.
    (2) Software verification, validation, and hazard analysis shall be 
performed.
    (3) Biocompatibility evaluation of the patient-contacting components 
of the device shall be performed.
    (4) The device shall be tested for electrical, thermal, and 
mechanical safety, and for electromagnetic compatibility (EMC).
    (5) The labeling must include:
    (i) Instructions for proper use of the device, including placement 
of the device on the patient; and
    (ii) Instructions on care and cleaning of the device.

[82 FR 61169, Dec. 27, 2017]



Sec. 882.5893  Thermal vestibular stimulator for headache.

    (a) Identification. The thermal vestibular stimulator for headache 
is a prescription device used to stimulate the vestibular system by 
applying thermal

[[Page 669]]

waveforms through earpieces placed in a patient's ear canal for the 
treatment of headache.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (2) Performance testing must validate electromagnetic compatibility 
and electrical, mechanical, and thermal safety.
    (3) The technical parameters of the device, including waveform 
outputs and temperature limits, must be identified.
    (4) Cleaning validation of earpieces must be conducted.
    (5) Software verification, validation, and hazard analysis must be 
performed.
    (6) Labeling must include the following:
    (i) Information on how the device operates and the typical 
sensations experienced during treatment;
    (ii) A detailed summary of the device's technical parameters; and
    (iii) Instructions for maintenance and cleaning of the device.

[83 FR 52973, Oct. 19, 2018]



Sec. 882.5894  Limited output transcutaneous piezoelectric stimulator 
for skin reactions associated with insect bites.

    (a) Identification. A limited output transcutaneous piezoelectric 
stimulator for skin reactions associated with insect bites is a device 
intended to alleviate skin reactions associated with insect bites via 
cutaneous, piezoelectric stimulation at the local site of the bite.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Appropriate testing to characterize the electrical output 
specifications of the device (i.e., total charge delivered, maximum 
instantaneous output current, maximum instantaneous output voltage, 
pulse duration, charge density) must be conducted.
    (2) Mechanical bench testing must demonstrate that the device will 
withstand the labeled number duration of uses.
    (3) All elements of the device that may contact the patient must be 
assessed to be biocompatible.
    (4) Labeling must include:
    (i) Validated instructions which addresses the following:
    (A) Identification of areas of the body which are appropriate and 
not appropriate for contact with the device.
    (B) Whether use of the device in conjunction with flammable 
materials (e.g., insect repellent) is appropriate.
    (C) Use of the device on or near implanted devices.
    (D) How to identify the correct type of skin condition.
    (ii) Technical parameters of the device (maximum output voltage 
(instantaneous), maximum output current (instantaneous), and pulse 
duration).
    (iii) Language to direct end users to contact the device 
manufacturer and MedWatch if they experience any adverse events with 
this device.
    (iv) The anticipated number of device uses prior to failure.

[80 FR 15165, Mar. 23, 2015]



Sec. 882.5895  Vibratory counter-stimulation device.

    (a) Identification. A vibratory counter-stimulation device is a 
prescription device that provides electrically powered mechanical 
vibration to improve the quality of sleep in patients with primary 
Restless Legs Syndrome.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 882.9. The 
special controls for this device are:
    (1) Appropriate analysis/testing must demonstrate electromagnetic 
compatibility (EMC), electrical safety, and thermal safety.
    (2) If the device contains software or firmware, appropriate 
verification, validation, and hazard analysis must be performed.
    (3) The elements of the device that contact the patient must be 
assessed to be biocompatible.
    (4) Non-clinical testing data (including vibration frequency, 
amplitude, and acceleration) must demonstrate that the device performs 
as intended under anticipated conditions of use.

[[Page 670]]

    (5) Labeling must include:
    (i) Specific information pertinent to use of the device by the 
intended patient population and the treatment regimen;
    (ii) Warning to only use the device on normal, intact, clean, 
healthy skin;
    (iii) Warning to not use the device if the user has leg skin 
disorders, such as eczema, psoriasis, cellulitis, non-healing wounds;
    (iv) Warning to discontinue use if Restless Leg Syndrome symptoms 
worsen; and
    (v) Instructions for end users to contact the device manufacturer 
and MedWatch in case they experience any adverse events when using this 
device.

[82 FR 13554, Mar. 14, 2017, as amended at 84 FR 71815, Dec. 30, 2019]



Sec. 882.5896  Percutaneous nerve stimulator for substance use disorders.

    (a) Identification. A percutaneous nerve stimulator for substance 
use disorders is a device that stimulates nerves percutaneously to aid 
in the reduction of withdrawal symptoms associated with substance use 
disorders.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (2) Electromagnetic compatibility and electrical, mechanical, and 
thermal safety testing must be performed.
    (3) Electrical performance testing of the device and electrodes must 
be conducted to validate the specified electrical output and duration of 
stimulation of the device.
    (4) Software verification, validation, and hazard analysis must be 
performed.
    (5) Sterility testing of the percutaneous components of the device 
must be performed.
    (6) Shelf life testing must be performed to demonstrate continued 
sterility, package integrity, and device functionality over the 
specified shelf life.
    (7) Labeling must include the following:
    (i) A detailed summary of the device technical parameters;
    (ii) A warning stating that the device is only for use on clean, 
intact skin;
    (iii) Instructions for use, including placement of the device on the 
patient; and
    (iv) A shelf life.

[83 FR 5034, Feb. 5, 2018]



Sec. 882.5897  External upper limb tremor stimulator.

    (a) Identification. An external upper limb tremor stimulator is a 
prescription device which is placed externally on the upper limb and 
designed to aid in tremor symptom relief of the upper limb.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance testing must assess the following:
    (i) Characterization of the electrical stimulation, including the 
following, must be performed: Waveforms, output modes, maximum output 
voltage, maximum output current, pulse duration, frequency, net charge 
per pulse, maximum phase charge at 500 ohms, maximum current density, 
maximum average current, and maximum average power density.
    (ii) Impedance testing, current distribution across the electrode 
surface area, adhesive integrity, and shelf life testing of the 
electrodes and gels must be conducted.
    (iii) Simulated use testing of sensor performance and the associated 
algorithms that determine the stimulation output must be conducted.
    (2) Patient-contacting components of the device must be demonstrated 
to be biocompatible.
    (3) Performance testing must demonstrate electrical, thermal, and 
mechanical safety along with electromagnetic compatibility (EMC) of the 
device in the intended use environment.
    (4) Software verification, validation, and hazard analysis must be 
performed.
    (5) Physician and patient labeling must include:
    (i) Summaries of electrical stimulation parameters;
    (ii) Instructions on how to correctly use and maintain the device;
    (iii) Instructions and explanations of all user-interface 
components;
    (iv) Instructions on how to clean the device;

[[Page 671]]

    (v) A shelf life for the electrodes and gel; and
    (vi) Reuse information.

[83 FR 52316, Oct. 17, 2018]



Sec. 882.5898  Transcutaneous electrical nerve stimulator 
for attention deficit hyperactivity disorder.

    (a) Identification. A transcutaneous electrical nerve stimulator for 
attention deficit hyperactivity disorder (ADHD) is a prescription device 
that stimulates transcutaneously or percutaneously through electrodes 
placed on the forehead.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (2) Performance testing must demonstrate the electromagnetic 
compatibility and electrical, mechanical, and thermal safety of the 
device.
    (3) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following must be performed:
    (i) Electrical performance testing must validate electrical output 
and duration of stimulation;
    (ii) Battery performance testing must be performed; and
    (iii) Adhesive integrity testing of the electrodes must be 
conducted.
    (4) The technical parameters of the device including waveform, 
maximum output current and voltage, pulse duration, frequency, net 
charge per pulse, maximum current density, maximum average current, and 
maximum average power density must be fully characterized.
    (5) Software verification, validation, and hazard analysis must be 
performed.
    (6) Shelf life testing of the electrodes must be performed to 
demonstrate continued package integrity and component functionality over 
the labeled shelf life.
    (7) Labeling must include the following:
    (i) A contraindication for patients with an implanted metallic or 
electronic device in the head, a cardiac pacemaker, or an implanted or 
wearable defibrillator;
    (ii) A warning that the device is only for use on clean, intact 
skin;
    (iii) Information on how the device operates and the typical 
sensations experienced during treatment;
    (iv) A detailed summary of the device technical parameters;
    (v) A shelf life for the electrodes;
    (vi) Instructions for use, including placement of the device on the 
patient; and
    (vii) Cleaning instructions.

[86 FR 70377, Dec. 10, 2021]



Sec. 882.5899  Trunk and limb electrical stimulator to treat headache.

    (a) Identification. A trunk and limb electrical stimulator to treat 
headache is a device intended to treat headache through the application 
of electrical stimulation anywhere on the body of the patient apart from 
the patient's head or neck through electrodes placed on the skin. The 
stimulation may be provided transcutaneously or percutaneously.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. This 
testing must include:
    (i) Characterization of the electrical stimulation, including the 
following: Waveforms; output modes; maximum output voltage and maximum 
output current (at 500[Omega], 2k[Omega], and 10k[Omega] loads); pulse 
duration; frequency; net charge per pulse; and maximum phase charge, 
maximum current density, maximum average current, and maximum average 
power density (at 500[Omega]);
    (ii) Characterization of the impedance monitoring system; and
    (iii) Characterization of the electrode performance including the 
electrical performance, adhesive integrity, shelf-life, reusability, and 
current distribution of the electrode surface area.
    (2) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (3) Performance testing must demonstrate electromagnetic 
compatibility and electrical, mechanical, and thermal safety in the 
intended use environment.

[[Page 672]]

    (4) Software verification, validation, and hazard analysis must be 
performed.
    (5) Labeling must include the following:
    (i) Instructions for use, including the typical sensations 
experienced during treatment;
    (ii) A detailed summary of the electrical stimulation output, and 
the device technical parameters, including any wireless specifications;
    (iii) A shelf life for the electrodes and reuse information; and
    (iv) Instructions on care and cleaning of the device.

[86 FR 68401, Dec. 2, 2021]



Sec. 882.5900  Preformed craniosynostosis strip.

    (a) Identification. A preformed craniosynostosis strip is a plastic 
strip used to cover bone edges of craniectomy sites (sites where the 
skull has been cut) to prevent the bone from regrowing in patients whose 
skull sutures are abnormally fused together.
    (b) Classification. Class II (performance standards).



Sec. 882.5910  Dura substitute.

    (a) Identification. A dura substitute is a sheet or material that is 
used to repair the dura mater (the membrane surrounding the brain).
    (b) Classification. Class II (performance standards).



Sec. 882.5940  Electroconvulsive therapy device.

    (a) Identification. An electroconvulsive therapy device is a 
prescription device, including the pulse generator and its stimulation 
electrodes, used for treating severe psychiatric disturbances by 
inducing in the patient a major motor seizure by applying a brief 
intense electrical current to the patient's head.
    (b) Classification. (1) Class II (special controls) when the device 
is intended to treat catatonia or a severe major depressive episode 
(MDE) associated with major depressive disorder (MDD) or bipolar 
disorder (BPD) in patients age 13 years and older who are treatment-
resistant or who require a rapid response due to the severity of their 
psychiatric or medical condition. The special controls for this device 
are:
    (i) The technical parameters of the device, including waveform, 
output mode, pulse duration, frequency, train delivery, maximum charge 
and energy, and the type of impedance monitoring system must be fully 
characterized to ensure that the device performance characteristics are 
consistent with existing clinical performance data.
    (ii) Non-clinical testing data must confirm the electrical 
characteristics of the output waveform.
    (iii) Components of the device that come into human contact must be 
demonstrated to be biocompatible.
    (iv) Performance data must demonstrate electrical and mechanical 
safety and the functioning of all safety features built into the device 
including the static and dynamic impedance monitoring system.
    (v) Appropriate analysis/testing must validate electromagnetic 
compatibility.
    (vi) Appropriate software verification, validation, and hazard 
analysis must be performed.
    (vii) Performance data must demonstrate electrical performance, 
adhesive integrity, and physical and chemical stability of the 
stimulation electrodes.
    (viii) The labeling for the device must include the following:
    (A) Information related to generic adverse events associated with 
electroconvulsive therapy device (ECT) treatment;
    (B) Instructions must contain the following specific recommendations 
to the user of the device:
    (1) Conduct of pre-ECT medical and psychiatric assessment (including 
pertinent medical and psychiatric history, physical examination, 
anesthesia assessment, dental assessment, and other studies as 
clinically appropriate);
    (2) Use of patient monitoring during the procedure;
    (3) Use of general anesthesia and neuromuscular blocking agents;
    (4) Use of mouth/dental protection during the procedure;
    (5) Use of EEG monitoring until seizure termination;
    (6) Instructions on electrode placement, including adequate skin 
preparation and use of conductive gel; and

[[Page 673]]

    (7) Cognitive status monitoring prior to beginning ECT and during 
the course of treatment via formal neuropsychological assessment for 
evaluating specific cognitive functions (e.g., orientation, attention, 
memory, executive function).
    (C) Clinical training needed by users of the device;
    (D) Information on the patient population in which the device is 
intended to be used;
    (E) Information on how the device operates and the typical course of 
treatment;
    (F) A detailed summary of the clinical testing, which includes the 
clinical outcomes associated with the use of the device, and a summary 
of adverse events and complications that occurred with the device;
    (G) A detailed summary of the device technical parameters;
    (H) Where appropriate, validated methods and instructions for 
reprocessing of any reusable components;
    (I) The following statement, prominently placed: ``Warning: ECT 
device use may be associated with: disorientation, confusion, and memory 
problems''; and
    (J) Absent performance data demonstrating a beneficial effect of 
longer term use, generally considered treatment in excess of 3 months, 
the following statement, prominently placed: ``Warning: When used as 
intended this device provides short-term relief of symptoms. The long-
term safety and effectiveness of ECT treatment has not been 
demonstrated.''
    (ix) Patient labeling must be provided and include:
    (A) Relevant contraindications, warnings, precautions;
    (B) A summation of the clinical testing, which includes the clinical 
outcomes associated with the use of the device, and a summary of adverse 
events and complications that occurred with the device;
    (C) Information on how the device operates and the typical course of 
treatment;
    (D) The potential benefits;
    (E) Alternative treatments;
    (F) The following statement, prominently placed: ``Warning: ECT 
device use may be associated with: Disorientation, confusion, and memory 
problems'';
    (G) Absent performance data demonstrating a beneficial effect of 
longer term use, generally considered treatment in excess of 3 months, 
the following statement, prominently placed: ``Warning: When used as 
intended this device provides short-term relief of symptoms. The long-
term safety and effectiveness of ECT treatment has not been 
demonstrated''; and
    (H) The following statements on known risks of ECT, absent 
performance data demonstrating that these risks do not apply:
    (1) ECT treatment may be associated with disorientation, confusion 
and memory loss, including short-term (anterograde) and long-term 
(autobiographical) memory loss following treatment. Based on the 
majority of clinical evidence, these side effects tend to go away within 
a few days to a few months after the last treatment with ECT. Although 
the incidence of permanent cognitive memory loss was not supported by 
the clinical literature, some patients have reported a permanent loss of 
memories of personal life events (i.e., autobiographical memory);
    (2) Patients treated with ECT may experience manic symptoms 
(including euphoria and/or irritability, impulsivity, racing thoughts, 
distractibility, grandiosity, increased activity, talkativeness, and 
decreased need for sleep) or a worsening of the psychiatric symptoms 
they are being treated for; and
    (3) The physical risks of ECT may include the following (in order of 
frequency of occurrence):
    (i) Pain/somatic discomfort (including headache, muscle soreness, 
and nausea);
    (ii) Skin burns;
    (iii) Physical trauma (including fractures, contusions, injury from 
falls, dental and oral injury);
    (iv) Prolonged or delayed onset seizures;
    (v) Pulmonary complications (hypoxemia, hypoventilation, aspiration, 
upper-airway obstruction);
    (vi) Cardiovascular complications (cardiac arrhythmias, heart 
attack,

[[Page 674]]

high or low blood pressure, and stroke); and
    (vii) Death.
    (2) Classification: Class III (premarket approval) for the following 
intended uses: schizophrenia, bipolar manic states, schizoaffective 
disorder, schizophreniform disorder, and catatonia or a severe MDE 
associated with MDD or BPD in:
    (i) Patients under 13 years or
    (ii) Patients 13 years and older who are not treatment-resistant or 
who do not require a rapid response due to the severity of their 
psychiatric or medical condition.
    (c) Date premarket approval application (PMA) or notice of 
completion of product development protocol (PDP) is required. A PMA or 
notice of completion of a PDP is required to be filed with FDA on or 
before March 26, 2019, for any electroconvulsive therapy device with an 
intended use described in paragraph (b)(2) of this section, that was in 
commercial distribution before May 28, 1976, or that has, on or before 
March 26, 2019, been found to be substantially equivalent to any 
electroconvulsive therapy device with an intended use described in 
paragraph (b)(2) of this section, that was in commercial distribution 
before May 28, 1976. Any other electroconvulsive therapy device with an 
intended use described in paragraph (b)(2) of this section shall have an 
approved PMA or declared completed PDP in effect before being placed in 
commercial distribution.

[83 FR 66123, Dec. 26, 2018]



Sec. 882.5950  Neurovascular embolization device.

    (a) Identification. A neurovascular embolization device is an 
intravascular implant intended to permanently occlude blood flow to 
cerebral aneurysms and cerebral ateriovenous malformations. This does 
not include cyanoacrylates and other embolic agents, which act by 
polymerization or precipitation. Embolization devices used in other 
vascular applications are also not included in this classification, see 
Sec. 870.3300.
    (b) Classification. Class II (special controls.) The special control 
for this device is the FDA guidance document entitled ``Class II Special 
Controls Guidance Document: Vascular and Neurovascular Embolization 
Devices.'' For availability of this guidance document, see Sec. 
882.1(e).

[69 FR 77900, Dec. 29, 2004]



Sec. 882.5955  Temporary coil embolization assist device.

    (a) Identification. A temporary coil embolization assist device is a 
prescription device intended for temporary use in the neurovasculature 
to mechanically assist in the embolization of intracranial aneurysms 
with embolic coils. The device is delivered into the neurovasculature 
with an endovascular approach. This device is not intended to be 
permanently implanted and is removed from the body when the procedure is 
completed.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing of the device must demonstrate the 
device performs as intended for temporary use as an endovascular device 
to assist in the coil embolization of intracranial aneurysms and must 
evaluate all adverse events, including tissue or vessel damage that 
could lead to dissection, perforation, hemorrhage, or vasospasm, 
thrombo-embolic events, and coil entanglement.
    (2) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (3) Non-clinical performance testing must demonstrate the device 
performs as intended under anticipated conditions of use, including:
    (i) Mechanical testing to demonstrate the device can withstand 
anticipated tensile, torsional, compressive, and tip deflection forces;
    (ii) Mechanical testing to evaluate the radial forces exerted by the 
device;
    (iii) Simulated use testing to demonstrate the device can be 
delivered to the target location in the neurovasculature and is 
compatible with embolic coils;
    (iv) Dimensional verification testing;
    (v) Radiopacity testing; and
    (vi) Performance testing to evaluate the coating integrity and 
particulates under simulated use conditions.

[[Page 675]]

    (4) Animal testing under anticipated use conditions must evaluate 
all adverse events, including damage to vessels or tissues.
    (5) Performance data must support the sterility and pyrogenicity of 
the device.
    (6) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the labeled shelf life.
    (7) The labeling must include:
    (i) Instructions for use;
    (ii) A detailed summary of the device technical parameters, 
including compatible delivery catheter dimensions and device sizing 
information;
    (iii) A summary of the clinical testing results, including a 
detailed summary of the device- and procedure-related complications and 
adverse events; and
    (iv) A shelf life.

[86 FR 70733, Dec. 13, 2021]



Sec. 882.5960  Skull tongs for traction.

    (a) Identification. Skull tongs for traction is an instrument used 
to immobilize a patient with a cervical spine injury (e.g., fracture or 
dislocation). The device is caliper shaped with tips that penetrate the 
skin. It is anchored to the skull and has a heavy weight attached to it 
that maintains, by traction, the patient's position.
    (b) Classification. Class II (performance standards).



Sec. 882.5970  Cranial orthosis.

    (a) Identification. A cranial orthosis is a device that is intended 
for medical purposes to apply pressure to prominent regions of an 
infant's cranium in order to improve cranial symmetry and/or shape in 
infants from 3 to 18 months of age, with moderate to severe 
nonsynostotic positional plagiocephaly, including infants with 
plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
    (b) Classification. Class II (special controls) (prescription use in 
accordance with Sec. 801.109 of this chapter, biocompatibility testing, 
and labeling (contraindications, warnings, precautions, adverse events, 
instructions for physicians and parents)).

[63 FR 40651, July 30, 1998]



PART 884_OBSTETRICAL AND GYNECOLOGICAL DEVICES--Table of Contents



                      Subpart A_General Provisions

Sec.
884.1 Scope.
884.3 Effective dates of requirement for premarket approval.
884.9 Limitations of exemptions from section 510(k) of the Federal Food, 
          Drug, and Cosmetic Act (the act).

       Subpart B_Obstetrical and Gynecological Diagnostic Devices

884.1040 Viscometer for cervical mucus.
884.1050 Endocervical aspirator.
884.1060 Endometrial aspirator.
884.1100 Endometrial brush.
884.1175 Endometrial suction curette and accessories.
884.1185 Endometrial washer.
884.1300 Uterotubal carbon dioxide insufflator and accessories.
884.1425 Perineometer.
884.1550 Amniotic fluid sampler (amniocentesis tray).
884.1560 Fetal blood sampler.
884.1600 Transabdominal amnioscope (fetoscope) and accessories.
884.1630 Colposcope.
884.1640 Culdoscope and accessories.
884.1660 Transcervical endoscope (amnioscope) and accessories.
884.1690 Hysteroscope and accessories.
884.1700 Hysteroscopic insufflator.
884.1710 Closed loop hysteroscopic insufflator with cutter-coagulator.
884.1720 Gynecologic laparoscope and accessories.
884.1730 Laparoscopic insufflator.

       Subpart C_Obstetrical and Gynecological Monitoring Devices

884.2050 Obstetric data analyzer.
884.2225 Obstetric-gynecologic ultrasonic imager.
884.2600 Fetal cardiac monitor.
884.2620 Fetal electroencephalographic monitor.
884.2640 Fetal phonocardiographic monitor and accessories.
884.2660 Fetal ultrasonic monitor and accessories.
884.2675 Fetal scalp circular (spiral) electrode and applicator.
884.2685 Fetal scalp clip electrode and applicator.
884.2700 Intrauterine pressure monitor and accessories.

[[Page 676]]

884.2720 External uterine contraction monitor and accessories.
884.2730 Home uterine activity monitor.
884.2740 Perinatal monitoring system and accessories.
884.2800 Computerized labor monitoring system.
884.2900 Fetal stethoscope.
884.2960 Obstetric ultrasonic transducer and accessories.
884.2980 Telethermographic system.
884.2982 Liquid crystal thermographic system.
884.2990 Breast lesion documentation system.

       Subpart D_Obstetrical and Gynecological Prosthetic Devices

884.3200 Cervical drain.
884.3575 Vaginal pessary.
884.3650 Fallopian tube prosthesis.
884.3900 Vaginal stent.

        Subpart E_Obstetrical and Gynecological Surgical Devices

884.4050 Gynecologic laparoscopic power morcellation containment system.
884.4100 Endoscopic electrocautery and accessories.
884.4120 Gynecologic electrocautery and accessories.
884.4150 Bipolar endoscopic coagulator-cutter and accessories.
884.4160 Unipolar endoscopic coagulator-cutter and accessories.
884.4250 Expandable cervical dilator.
884.4260 Hygroscopic Laminaria cervical dilator.
884.4270 Vibratory cervical dilators.
884.4340 Fetal vacuum extractor.
884.4350 Fetal head elevator.
884.4400 Obstetric forceps.
884.4500 Obstetric fetal destructive instrument.
884.4520 Obstetric-gynecologic general manual instrument.
884.4530 Obstetric-gynecologic specialized manual instrument.
884.4550 Gynecologic surgical laser.
884.4900 Obstetric table and accessories.
884.4910 Specialized surgical instrumentation for use with 
          urogynecologic surgical mesh.

       Subpart F_Obstetrical and Gynecological Therapeutic Devices

884.5050 Metreurynter-balloon abortion system.
884.5070 Vacuum abortion system.
884.5100 Obstetric anesthesia set.
884.5150 Nonpowered breast pump.
884.5160 Powered breast pump.
884.5200 Hemorrhoid prevention pressure wedge.
884.5210 Pressure wedge for the reduction of cesarean delivery.
884.5225 Abdominal decompression chamber.
884.5250 Cervical cap.
884.5300 Condom.
884.5310 Condom with spermicidal lubricant.
884.5320 Glans sheath.
884.5330 Multiple-use female condom.
884.5340 Single-use internal condom.
884.5350 Contraceptive diaphragm and accessories.
884.5360 Contraceptive intrauterine device (IUD) and introducer.
884.5370 Software application for contraception.
884.5380 Contraceptive tubal occlusion device (TOD) and introducer.
884.5390 Perineal heater.
884.5400 Menstrual cup.
884.5425 Scented or scented deodorized menstrual pad.
884.5435 Unscented menstrual pad.
884.5460 Scented or scented deodorized menstrual tampon.
884.5470 Unscented menstrual tampon.
884.5900 Therapeutic vaginal douche apparatus.
884.5920 Vaginal insufflator.
884.5940 Powered vaginal muscle stimulator for therapeutic use.
884.5960 Genital vibrator for therapeutic use.
884.5970 Clitoral engorgement device.
884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.

                 Subpart G_Assisted Reproduction Devices

884.6100 Assisted reproduction needles.
884.6110 Assisted reproduction catheters.
884.6120 Assisted reproduction accessories.
884.6130 Assisted reproduction microtools.
884.6140 Assisted reproduction micropipette fabrication instruments.
884.6150 Assisted reproduction micromanipulators and microinjectors.
884.6160 Assisted reproduction labware.
884.6165 Intravaginal culture system.
884.6170 Assisted reproduction water and water purification systems.
884.6180 Reproductive media and supplements.
884.6190 Assisted reproductive microscopes and microscope accessories.
884.6195 Assisted reproduction embryo image assessment system.
884.6200 Assisted reproduction laser system.

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.

[[Page 677]]



                      Subpart A_General Provisions



Sec. 884.1  Scope.

    (a) This part sets forth the classification of obstetrical and 
gynecological devices intended for human use that are in commercial 
distribution.
    (b) The identification of a device in a regulation in this part is 
not a precise description of every device that is, or will be, subject 
to the regulation. A manufacturer who submits a premarket notification 
submission for a device under part 807 may not show merely that the 
device is accurately described by the section title and identification 
provisions of a regulation in this part, but shall state why the device 
is substantially equivalent to other devices, as required by Sec. 
807.87.
    (c) To avoid duplicative listings, an obstetrical and gynecological 
device that has two or more types of uses (e.g., used both as a 
diagnostic device and as a therapeutic device) is listed only in one 
subpart.
    (d) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.
    (e) Guidance documents referenced in this part are available on the 
Internet at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/default.htm.

[52 FR 17740, May 11, 1987, as amended at 68 FR 44415, Aug. 27, 2003; 78 
FR 18233, Mar. 26, 2013]



Sec. 884.3  Effective dates of requirement for premarket approval.

    A device included in this part that is classified into class III 
(premarket approval) shall not be commercially distributed after the 
date shown in the regulation classifying the device unless the 
manufacturer has an approval under section 515 of the act (unless an 
exemption has been granted under section 520(g)(2) of the act). An 
approval under section 515 of the act consists of FDA's issuance of an 
order approving an application for premarket approval (PMA) for the 
device or declaring completed a product development protocol (PDP) for 
the device.
    (a) Before FDA requires that a device commercially distributed 
before the enactment date of the amendments, or a device that has been 
found substantially equivalent to such a device, has an approval under 
section 515 of the act FDA must promulgate a regulation under section 
515(b) of the act requiring such approval, except as provided in 
paragraph (b) of this section. Such a regulation under section 515(b) of 
the act shall not be effective during the grace period ending on the 
90th day after its promulgation or on the last day of the 30th full 
calendar month after the regulation that classifies the device into 
class III is effective, whichever is later. See section 501(f)(2)(B) of 
the act. Accordingly, unless an effective date of the requirement for 
premarket approval is shown in the regulation for a device classified 
into class III in this part, the device may be commercially distributed 
without FDA's issuance of an order approving a PMA or declaring 
completed a PDP for the device. If FDA promulgates a regulation under 
section 515(b) of the act requiring premarket approval for a device, 
section 501(f)(1)(A) of the act applies to the device.
    (b) Any new, not substantially equivalent, device introduced into 
commercial distribution on or after May 28, 1976, including a device 
formerly marketed that has been substantially altered, is classified by 
statute (section 513(f) of the act) into class III without any grace 
period and FDA must have issued an order approving a PMA or declaring 
completed a PDP for the device before the device is commercially 
distributed unless it is reclassified. If FDA knows that a device being 
commercially distributed may be a ``new'' device as defined in this 
section because of any new intended use or other reasons, FDA may codify 
the statutory classification of the device into class III for such new 
use. Accordingly, the regulation for such a class III device states that 
as of the enactment date of the amendments, May 28, 1976, the device 
must have an approval under section 515 of the act before commercial 
distribution.

[52 FR 17740, May 11, 1987]

[[Page 678]]



Sec. 884.9  Limitations of exemptions from section 510(k) of
the Federal Food, Drug, and Cosmetic Act (the act).

    The exemption from the requirement of premarket notification 
(section 510(k) of the act) for a generic type of class I or II device 
is only to the extent that the device has existing or reasonably 
foreseeable characteristics of commercially distributed devices within 
that generic type or, in the case of in vitro diagnostic devices, only 
to the extent that misdiagnosis as a result of using the device would 
not be associated with high morbidity or mortality. Accordingly, 
manufacturers of any commercially distributed class I or II device for 
which FDA has granted an exemption from the requirement of premarket 
notification must still submit a premarket notification to FDA before 
introducing or delivering for introduction into interstate commerce for 
commercial distribution the device when:
    (a) The device is intended for a use different from the intended use 
of a legally marketed device in that generic type of device; e.g., the 
device is intended for a different medical purpose, or the device is 
intended for lay use where the former intended use was by health care 
professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro diagnostic 
device detects or identifies infectious agents by using deoxyribonucleic 
acid (DNA) probe or nucleic acid hybridization technology rather than 
culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of neoplastic 
diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial or acquired 
genetic disorders, including inborn errors of metabolism;
    (3) For measuring an analyte that serves as a surrogate marker for 
screening, diagnosis, or monitoring life-threatening diseases such as 
acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, 
tuberculosis, or myocardial infarction or to monitor therapy;
    (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) or IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is intended 
for use in matrices other than serum or plasma;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).

[65 FR 2319, Jan. 14, 2000]



       Subpart B_Obstetrical and Gynecological Diagnostic Devices



Sec. 884.1040  Viscometer for cervical mucus.

    (a) Identification. A viscometer for cervical mucus is a device that 
is intended to measure the relative viscoelasticity of cervical mucus 
collected from a female patient. Measurements of relative 
viscoelasticity are intended for use as an adjunct in the clinical 
evaluation of a female with chronic infertility, to determine the time 
of ovulation and the penetrability of cervical mucus to motile sperm.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 884.9.

[47 FR 14706, Apr. 6, 1982, as amended at 65 FR 2320, Jan. 14, 2000]



Sec. 884.1050  Endocervical aspirator.

    (a) Identification. An endocervical aspirator is a device designed 
to remove tissue from the endocervix (mucous membrane lining the canal 
of the cervix of the uterus) by suction with a syringe, bulb and 
pipette, or catheter. This device is used to evaluate endocervical 
tissue to detect malignant and premalignant lesions.

[[Page 679]]

    (b) Classification. Class II (performance standards).



Sec. 884.1060  Endometrial aspirator.

    (a) Identification. An endometrial aspirator is a device designed to 
remove materials from the endometrium (the mucosal lining of the uterus) 
by suction with a syringe, bulb and pipette, or catheter. This device is 
used to study endometrial cytology (cells).
    (b) Classification. Class II. The special controls for this device 
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological Evaluation 
of Medical Devices--Part I: Evaluation and Testing,' '' and
    (ii) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),''
    (2) Labeling:
    (i) Indication: Only to evaluate the endometrium, and
    (ii) Contraindications: Pregnancy, history of uterine perforation, 
or a recent cesarean section, and
    (3) The sampling component is covered within vagina.

[45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 
FR 17146, Mar. 31, 2000]



Sec. 884.1100  Endometrial brush.

    (a) Identification. An endometrial brush is a device designed to 
remove samples of the endometrium (the mucosal lining of the uterus) by 
brushing its surface. This device is used to study endometrial cytology 
(cells).
    (b) Classification. Class II. The special controls for this device 
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological Evaluation 
of Medical Devices--Part I: Evaluation and Testing,' '' and
    (ii) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),''
    (2) Labeling:
    (i) Indication: Only to evaluate the endometrium, and
    (ii) Contraindications: Pregnancy, history of uterine perforation, 
or a recent cesarean section, and
    (3) Design and testing:
    (i) The sampling component is covered within the vagina, and
    (ii) For adherence of the bristles and brush head.

[45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 
FR 17146, Mar. 31, 2000]



Sec. 884.1175  Endometrial suction curette and accessories.

    (a) Identification. An endometrial suction curette is a device used 
to remove material from the uterus and from the mucosal lining of the 
uterus by scraping and vacuum suction. This device is used to obtain 
tissue for biopsy or for menstrual extraction. This generic type of 
device may include catheters, syringes, and tissue filters or traps.
    (b) Classification. Class II (performance standards).



Sec. 884.1185  Endometrial washer.

    (a) Identification. An endometrial washer is a device used to remove 
materials from the endometrium (the mucosal lining of the uterus) by 
washing with water or saline solution and then aspirating with negative 
pressure. This device is used to study endometrial cytology (cells).
    (b) Classification. Class II. The special controls for this device 
are:
    (1) FDA's:
    (i) ``Use of International Organization for Standardization's ISO 
10993 `Biological Evaluation of Medical Devices--Part I: Evaluation and 
Testing,' '' and
    (ii) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),''
    (2) Labeling:
    (i) Indication: Only to evaluate the endometrium,
    (ii) Contraindications: Pregnancy, history of uterine perforation, 
or a recent cesarean section, and
    (iii) Warning: Do not attach to a wall or any external suction, and
    (3) Design and Testing:
    (i) The sampling component is covered within the vagina, and
    (ii) Intrauterine pressure should not exceed 50 millimeters of 
mercury.

[45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 
FR 17146, Mar. 31, 2000]

[[Page 680]]



Sec. 884.1300  Uterotubal carbon dioxide insufflator and accessories.

    (a) Identification. A uterotubal carbon dioxide insufflator and 
accessories is a device used to test the patency (lack of obstruction) 
of the fallopian tubes by pressurizing the uterus and fallopian tubes 
and filling them with carbon dioxide gas.
    (b) Classification. Class II (performance standards).



Sec. 884.1425  Perineometer.

    (a) Identification. A perineometer is a device consisting of a 
fluid-filled sack for intravaginal use that is attached to an external 
manometer. The devices measure the strength of the perineal muscles by 
offering resistence to a patient's voluntary contractions of these 
muscles and is used to diagnose and to correct, through exercise, 
uninary incontinence or sexual dysfunction.
    (b) Classification. Class II (performance standards).



Sec. 884.1550  Amniotic fluid sampler (amniocentesis tray).

    (a) Identification. The amniotic fluid sampler (amniocentesis tray) 
is a collection of devices used to aspirate amniotic fluid from the 
amniotic sac via a transabdominal approach. Components of the 
amniocentesis tray include a disposable 3 inch 20 gauge needle with 
stylet and a 30 cc. syringe, as well as the various sample collection 
accessories, such as vials, specimen containers, medium, drapes, etc. 
The device is used at 16-18 weeks gestation for antepartum diagnosis of 
certain congenital abnormalities or anytime after 24 weeks gestation 
when used to assess fetal maturity.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 884.9.

[61 FR 1123, Jan. 16, 1996, as amended at 66 FR 33808, July 25, 2001]



Sec. 884.1560  Fetal blood sampler.

    (a) Identification. A fetal blood sampler is a device used to obtain 
fetal blood transcervically through an endoscope by puncturing the fetal 
skin with a short blade and drawing blood into a heparinized tube. The 
fetal blood pH is determined and used in the diagnosis of fetal distress 
and fetal hypoxia.
    (b) Classification. Class II (performance standards).



Sec. 884.1600  Transabdominal amnioscope (fetoscope) and accessories.

    (a) Identification. A transabdominal amnioscope is a device designed 
to permit direct visual examination of the fetus by a telescopic system 
via abdominal entry. The device is used to ascertain fetal 
abnormalities, to obtain fetal blood samples, or to obtain fetal tissue. 
This generic type of device may include the following accessories: 
trocar and cannula, instruments used through an operating channel or 
through a separate cannula associated with the amnioscope, light source 
and cables, and component parts.
    (b) Classification. Class III (premarket approval).
    (c) Date premarket approval application (PMA) or notice of 
completion of a product development protocol (PDP) is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before January 29, 1987 for any 
transabdominal amnioscope (fetoscope) and accessories that was in 
commercial distribution before May 28, 1976, or that has on or before 
January 29, 1987 been found to be substantially equivalent to a 
transabdominal amnioscope (fetoscope) and accessories that was in 
commercial distribution before May 28, 1976. Any other transabdominal 
amnioscope (fetoscope) and accessories shall have an approved PMA or a 
declared completed PDP in effect before being placed in commercial 
distribution.

[45 FR 12684, Feb. 26, 1980, as amended at 51 FR 39845, Oct. 31, 1986]



Sec. 884.1630  Colposcope.

    (a) Identification. A colposcope is a device designed to permit 
direct viewing of the tissues of the vagina and cervix by a telescopic 
system located outside the vagina. It is used to diagnose abnormalities 
and select areas for biopsy. This generic type of device may include a 
light source, cables, and component parts.

[[Page 681]]

    (b) Classification. Class II (special controls). The device, when it 
is a standard colposcope (or colpomicroscope) that uses only a white 
light source, does not use filters other than a green filter, does not 
include image analysis software, and is not smartphone-based, is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019]



Sec. 884.1640  Culdoscope and accessories.

    (a) Identification. A culdoscope is a device designed to permit 
direct viewing of the organs within the peritoneum by a telescopic 
system introduced into the pelvic cavity through the posterior vaginal 
fornix. It is used to perform diagnostic and surgical procedures on the 
female genital organs. This generic type of device may include trocar 
and cannula, instruments used through an operating channel, scope 
preheaters, light source and cables, and component parts.
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for culdoscope accessories that are not part of a 
specialized instrument or device delivery system; do not have adapters, 
connectors, channels, or do not have portals for electrosurgical, laser, 
or other power sources. Such culdoscope accessory instruments include: 
lens cleaning brush, biopsy brush, clip applier (without clips), 
applicator, cannula (without trocar or valves), ligature carrier/needle 
holder, clamp/hemostat/grasper, curette, instrument guide, ligature 
passing and knotting instrument, suture needle (without suture), 
retractor, mechanical (noninflatable), snare, stylet, forceps, 
dissector, mechanical (noninflatable) scissors, and suction/irrigation 
probe. The devices subject to this paragraph (b)(2) are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter, subject to the limitations in Sec. 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 
FR 38808, July 25, 2001]



Sec. 884.1660  Transcervical endoscope (amnioscope) and accessories.

    (a) Identification. A transcervical endoscope is a device designed 
to permit direct viewing of the fetus and amniotic sac by means of an 
open tube introduced into the uterus through the cervix. The device may 
be used to visualize the fetus or amniotic fluid and to sample fetal 
blood or amniotic fluid. This generic type of device may include 
obturators, instruments used through an operating channel, light sources 
and cables, and component parts.
    (b) Classification. Class II (performance standards).



Sec. 884.1690  Hysteroscope and accessories.

    (a) Identification. A hysteroscope is a device used to permit direct 
viewing of the cervical canal and the uterine cavity by a telescopic 
system introduced into the uterus through the cervix. It is used to 
perform diagnostic and surgical procedures other than sterilization. 
This generic type of device may include obturators and sheaths, 
instruments used through an operating channel, scope preheaters, light 
sources and cables, and component parts.
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for hysteroscope accessories that are not part of a 
specialized instrument or device delivery system; do not have adapters, 
connectors, channels, or do not have portals for electrosurgical, laser, 
or other power sources. Such hysteroscope accessory instruments include: 
lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/
grasper, curette, instrument guide, forceps, dissector, mechanical 
(noninflatable), and scissors. The devices subject to this paragraph 
(b)(2) are exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter, subject to the limitations in Sec. 
884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 
FR 38808, July 25, 2001]



Sec. 884.1700  Hysteroscopic insufflator.

    (a) Identification. A hysteroscopic insufflator is a device designed 
to distend the uterus by filling the uterine

[[Page 682]]

cavity with a liquid or gas to facilitate viewing with a hysteroscope.
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for tubing and tubing/filter fits which only include 
accessory instruments that are not used to effect intrauterine access, 
e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits 
used for only intrauterine insufflation. The devices subject to this 
paragraph (b)(2) are exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter, subject to the limitations in 
Sec. 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996; 66 
FR 38808, July 25, 2001]



Sec. 884.1710  Closed loop hysteroscopic insufflator with cutter-coagulator.

    (a) Identification. A closed loop hysteroscopic insufflator with 
cutter-coagulator is a prescription device configured for hysteroscopic 
insufflation, resection, and coagulation. It is used to perform 
diagnostic and surgical procedures (i.e., resection and coagulation). 
This device type contains a closed-loop recirculating fluid management 
system for the controlled delivery of filtered distension fluid. This 
device type also contains a bipolar radiofrequency device used in 
conjunction with a hysteroscope for resection and coagulation of 
intrauterine tissues.
    (b) Classification. Class II (special controls). The special 
control(s) for this device are:
    (1) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (2) Software validation, verification, and hazard analysis must be 
provided.
    (3) Electrical equipment safety, including appropriate thermal and 
mechanical safety and electromagnetic compatibility (EMC) testing must 
be performed.
    (4) Device components that are labeled sterile must be validated to 
a sterility assurance level of 10-6.
    (5) Shelf-life testing that demonstrates the device packaging 
maintains sterility and the functionality of the device is maintained 
following simulated shipping and handling must be provided to support 
the proposed shelf life.
    (6) Non-clinical testing data must demonstrate the performance 
characteristics of the device. Detailed protocols and the test reports 
must be provided for each test.
    (i) The following tests must be performed for the resection portion 
of the device:
    (A) Mechanical testing to assess critical joint strength.
    (B) Device electrode temperature testing.
    (C) Coagulation depth testing.
    (D) Simulated use testing.
    (E) Device durability testing.
    (ii) The following tests must be performed for the fluid management 
portion of the device:
    (A) Mechanical testing to assess tensile strength of connections.
    (B) Pressure testing that demonstrates the following parameters, 
including accuracy of the pressure displayed; appropriate detection and 
response to overpressure conditions; activation of a secondary 
overpressure relief valve at the maximum safe level; and all accessories 
within the fluid path meet the pressure requirements.
    (C) Fluid delivery volume testing that demonstrates that the maximum 
fluid volume delivered is below a predefined level.
    (D) Flow rate testing.
    (E) Simulated use testing.
    (F) Filtration testing.
    (G) Blood filtration capacity testing.
    (H) Tissue collection capacity testing.
    (I) Filtrate characterization and testing that demonstrates that the 
continuous reintroduction of filtrate into the uterus does not pose a 
safety risk.
    (7) Clinician labeling must include:
    (i) Specific instructions and the clinical training needed for the 
safe use of the device.
    (ii) Appropriate warnings, precautions, and information related to 
overpressurization.
    (iii) Appropriate EMC information.
    (iv) An expiration date/shelf life.

[82 FR 35073, July 28, 2017]



Sec. 884.1720  Gynecologic laparoscope and accessories.

    (a) Identification. A gynecologic laparoscope is a device used to 
permit direct viewing of the organs within the

[[Page 683]]

peritoneum by a telescopic system introduced through the abdominal wall. 
It is used to perform diagnostic and surgical procedures on the female 
genital organs. This generic type of device may include: Trocar and 
cannula, instruments used through an operating channel, scope preheater, 
light source and cables, and component parts.
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for gynecologic laparoscope accessories that are not 
part of a specialized instrument or device delivery system, do not have 
adapters, connector channels, or do not have portals for 
electrosurgical, lasers, or other power sources. Such gynecologic 
laparosope accessory instruments include: the lens cleaning brush, 
biopsy brush, clip applier (without clips), applicator, cannula (without 
trocar or valves), ligature carrier/needle holder, clamp/hemostat/
grasper, curette, instrument guide, ligature passing and knotting 
instrument, suture needle (without suture), retractor, mechanical 
(noninflatable), snare, stylet, forceps, dissector, mechanical 
(noninflatable), scissors, and suction/irrigation probe. The devices 
subject to this paragraph (b)(2) are exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter, 
subject to the limitations in Sec. 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996; 66 
FR 38808, July 25, 2001]



Sec. 884.1730  Laparoscopic insufflator.

    (a) Identification. A laparoscopic insufflator is a device used to 
facilitate the use of the laparoscope by filling the peritoneal cavity 
with gas to distend it.
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for tubing and tubing/filter kits which include 
accessory instruments that are not used to effect intra-abdominal 
insufflation (pneumoperitoneum). The devices subject to this paragraph 
(b)(2) are exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter, subject to the limitations in Sec. 
884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996; 66 
FR 38809, July 25, 2001]



       Subpart C_Obstetrical and Gynecological Monitoring Devices



Sec. 884.2050  Obstetric data analyzer.

    (a) Identification. An obstetric data analyzer (fetal status data 
analyzer) is a device used during labor to analyze electronic signal 
data obtained from fetal and maternal monitors. The obstetric data 
analyzer provides clinical diagnosis of fetal status and recommendations 
for labor management and clinical interventions. This generic type of 
device may include signal analysis and display equipment, electronic 
interfaces for other equipment, and power supplies and component parts.
    (b) Classification: Class III (premarket approval).
    (c) Date PMA or notice of completion of PDP is required. A PMA or a 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before October 3, 2000, for any obstetric data 
analyzer described in paragraph (a) of this section that was in 
commercial distribution before May 28, 1976, or that has been found, on 
or before October 3, 2000, to be substantially equivalent to an 
obstetric data analyzer described in paragraph (a) of this section that 
was in commercial distribution before May 28, 1976. Any other obstetric 
data analyzer described in paragraph (a) of this section shall have an 
approved PMA or declared completed PDP in effect before being placed in 
commercial distribution.

[65 FR 41332, July 5, 2000]



Sec. 884.2225  Obstetric-gynecologic ultrasonic imager.

    (a) Identification. An obstetric-gynecologic ultrasonic imager is a 
device designed to transmit and receive ultrasonic energy into and from 
a female patient by pulsed echoscopy. This device is used to provide a 
visual representation of some physiological or

[[Page 684]]

artificial structure, or of a fetus, for diagnostic purposes during a 
limited period of time. This generic type of device may include the 
following: signal analysis and display equipment, electronic interfaces 
for other equipment, patient and equipment supports, coupling gel, and 
component parts. This generic type of device does not include devices 
used to monitor the changes in some physiological condition over long 
periods of time.
    (b) Classification. Class II (performance standards).



Sec. 884.2600  Fetal cardiac monitor.

    (a) Identification. A fetal cardiac monitor is a device used to 
ascertain fetal heart activity during pregnancy and labor. The device is 
designed to separate fetal heart signals from maternal heart signals by 
analyzing electrocardiographic signals (electrical potentials generated 
during contraction and relaxation of heart muscle) obtained from the 
maternal abdomen with external electrodes. This generic type of device 
may include an alarm that signals when the heart rate crosses a preset 
threshold. This generic type of device includes the ``fetal 
cardiotachometer (with sensors)'' and the ``fetal electrocardiographic 
monitor.''
    (b) Classification. Class II (performance standards).



Sec. 884.2620  Fetal electroencephalographic monitor.

    (a) Identification. A fetal electroencephalographic monitor is a 
device used to detect, measure, and record in graphic form (by means of 
one or more electrodes placed transcervically on the fetal scalp during 
labor) the rhythmically varying electrical skin potentials produced by 
the fetal brain.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any fetal 
electroencephalographic monitor that was in commercial distribution 
before May 28, 1976, or that has, on or before December 26, 1996 been 
found to be substantially equivalent to a fetal electroencephalographic 
monitor in commercial distribution before May 28, 1976. Any other fetal 
electroencephalographic monitor shall have an approved PMA or a declared 
completed PDP in effect before being placed in commercial distribution.

[45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 61 
FR 50708, Sept. 27, 1996]



Sec. 884.2640  Fetal phonocardiographic monitor and accessories.

    (a) Identification. A fetal phonocardiographic monitor is a device 
designed to detect, measure, and record fetal heart sounds 
electronically, in graphic form, and noninvasively, to ascertain fetal 
condition during labor. This generic type of device includes the 
following accessories: signal analysis and display equipment, patient 
and equipment supports, and other component parts.
    (b) Classification. Class II (performance standards).



Sec. 884.2660  Fetal ultrasonic monitor and accessories.

    (a) Identification. A fetal ultrasonic monitor is a device designed 
to transmit and receive ultrasonic energy into and from the pregnant 
woman, usually by means of continuous wave (doppler) echoscopy. The 
device is used to represent some physiological condition or 
characteristic in a measured value over a period of time (e.g., 
perinatal monitoring during labor) or in an immediately perceptible form 
(e.g., use of the ultrasonic stethoscope). This generic type of device 
may include the following accessories: signal analysis and display 
equipment, electronic interfaces for other equipment, patient and 
equipment supports, and component parts. This generic type of device 
does not include devices used to image some relatively unchanging 
physiological structure or interpret a physiological condition, but does 
include devices which may be set to alarm automatically at a 
predetermined threshold value.
    (b) Classification. Class II (performance standards).

[[Page 685]]



Sec. 884.2675  Fetal scalp circular (spiral) electrode and applicator.

    (a) Identification. A fetal scalp circular (spiral) electrode and 
applicator is a device used to obtain a fetal electrocardiogram during 
labor and delivery. It establishes electrical contact between fetal skin 
and an external monitoring device by a shallow subcutaneous puncture of 
fetal scalp tissue with a curved needle or needles. This generic type of 
device includes nonreusable spiral electrodes and reusable circular 
electrodes.
    (b) Classification. Class II (performance standards).



Sec. 884.2685  Fetal scalp clip electrode and applicator.

    (a) Identification. A fetal scalp clip electrode and applicator is a 
device designed to establish electrical contact between fetal skin and 
an external monitoring device by means of pinching skin tissue with a 
nonreusable clip. This device is used to obtain a fetal 
electrocardiogram. This generic type of device may include a clip 
electrode applicator.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any fetal 
scalp clip electrode and applicator that was in commercial distribution 
before May 28, 1976, or that has, on or before December 26, 1996 been 
found to be substantially equivalent to a fetal scalp clip electrode and 
applicator that was in commercial distribution before May 28, 1976. Any 
other fetal scalp clip electrode and applicator shall have an approved 
PMA or a declared completed PDP in effect before being placed in 
commercial distribution.

[45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 61 
FR 50708, Sept. 27, 1996]



Sec. 884.2700  Intrauterine pressure monitor and accessories.

    (a) Identification. An intrauterine pressure monitor is a device 
designed to detect and measure intrauterine and amniotic fluid pressure 
with a catheter placed transcervically into the uterine cavity. The 
device is used to monitor intensity, duration, and frequency of uterine 
contractions during labor. This generic type of device may include the 
following accessories: signal analysis and display equipment, patient 
and equipment supports, and component parts.
    (b) Classification. Class II (performance standards).



Sec. 884.2720  External uterine contraction monitor and accessories.

    (a) Identification. An external uterine contraction monitor (i.e., 
the tokodynamometer) is a device used to monitor the progress of labor. 
It measures the duration, frequency, and relative pressure of uterine 
contractions with a transducer strapped to the maternal abdomen. This 
generic type of device may include an external pressure transducer, 
support straps, and other patient and equipment supports.
    (b) Classification. Class II (performance standards).



Sec. 884.2730  Home uterine activity monitor.

    (a) Identification. A home uterine activity monitor (HUAM) is an 
electronic system for at home antepartum measurement of uterine 
contractions. The HUAM system comprises a tocotransducer and an at-home 
recorder. This device is intended for use in women with a previous 
preterm delivery to aid in the detection of preterm labor.
    (b) Classification. Class II (special controls); guidance document 
(Class II Special Controls Guidance for Home Uterine Activity Monitors).

[66 FR 14076, Mar. 9, 2001, as amended at 86 FR 20283, Apr. 19, 2021]



Sec. 884.2740  Perinatal monitoring system and accessories.

    (a) Identification. A perinatal monitoring system is a device used 
to show graphically the relationship between maternal labor and the 
fetal heart rate by means of combining and coordinating uterine 
contraction and fetal heart monitors with appropriate displays of the 
well-being of the fetus during pregnancy, labor, and delivery.

[[Page 686]]

This generic type of device may include any of the devices subject to 
Sec. Sec. 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 
884.2720. This generic type of device may include the following 
accessories: Central monitoring system and remote repeaters, signal 
analysis and display equipment, patient and equipment supports, and 
component parts.
    (b) Classification. Class II (performance standards).



Sec. 884.2800  Computerized Labor Monitoring System.

    (a) Identification. A computerized labor monitoring system is a 
system intended to continuously measure cervical dilation and fetal head 
descent and provide a display that indicates the progress of labor. The 
computerized labor monitoring system includes a monitor and ultrasound 
transducers. Ultrasound transducers are placed on the maternal abdomen 
and cervix and on the fetal scalp to provide the matrix of measurements 
used to produce the display.
    (b) Classification. Class II (special controls). The special 
controls are the FDA guidance document entitled: ``Guidance for Industry 
and Food and Drug Administration Staff; Class II Special Controls 
Guidance Document: Computerized Labor Monitoring Systems.'' See Sec. 
884.1(e) for availability of this guidance document.

[72 FR 20227, Apr. 24, 2007]



Sec. 884.2900  Fetal stethoscope.

    (a) Identification. A fetal stethoscope is a device used for 
listening to fetal heart sounds. It is designed to transmit the fetal 
heart sounds not only through sound channels by air conduction, but also 
through the user's head by tissue conduction into the user's ears. It 
does not use ultrasonic energy. This device is designed to eliminate 
noise interference commonly caused by handling conventional 
stethoscopes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 66 FR 38809, July 25, 2001]



Sec. 884.2960  Obstetric ultrasonic transducer and accessories.

    (a) Identification. An obstetric ultrasonic transducer is a device 
used to apply ultrasonic energy to, and to receive ultrasonic energy 
from, the body in conjunction with an obstetric monitor or imager. The 
device converts electrical signals into ultrasonic energy, and vice 
versa, by means of an assembly distinct from an ultrasonic generator. 
This generic type of device may include the following accessories: 
coupling gel, preamplifiers, amplifiers, signal conditioners with their 
power supply, connecting cables, and component parts. This generic type 
of device does not include devices used to generate the ultrasonic 
frequency electrical signals for application.
    (b) Classification. Class II (performance standards).



Sec. 884.2980  Telethermographic system.

    (a) Telethermographic system intended for adjunctive diagnostic 
screening for detection of breast cancer or other uses--(1) 
Identification. A telethermographic system for adjunctive diagnostic 
screening for detection of breast cancer or other uses is an 
electrically powered device with a detector that is intended to measure, 
without touching the patient's skin, the self-emanating infrared 
radiation that reveals the temperature variations of the surface of the 
body. This generic type of device may include signal analysis and 
display equipment, patient and equipment supports, component parts, and 
accessories.
    (2) Classification. Class I (general controls).
    (b) Telethermographic system intended for use alone in diagnostic 
screening for detection of breast cancer or other uses--(1) 
Identification. A telethermographic system for use as the sole 
diagnostic screening tool for detection of breast cancer or other uses 
is an electrically powered device with a detector that is intended to 
measure, without touching the patient's skin, the self-emanating 
infrared radiation that reveals the temperature variations of the 
surface of the body. This generic type of device may include signal 
analysis and display equipment, patient and equipment

[[Page 687]]

supports, component parts, and accessories.
    (2) Classification. Class III.
    (3) Date PMA or notice of completion of a PDP is required. As of the 
enactment date of the amendments, May 28, 1976, an approval under 
section 515 of the act is required before the device described in 
paragraph (b)(1) may be commercially distributed. See Sec. 884.3.

[53 FR 1566, Jan. 20, 1988, as amended at 55 FR 48440, Nov. 20, 1990; 66 
FR 46953, Sept. 10, 2001]



Sec. 884.2982  Liquid crystal thermographic system.

    (a) A nonelectrically powered or an AC-powered liquid crystal 
thermographic system intended for adjunctive use in diagnostic screening 
for detection of breast cancer or other uses--(1) Identification. A 
nonelectrically powered or an AC-powered liquid crystal thermographic 
system intended for use as an adjunct to physical palpation or 
mammography in diagnostic screening for detection of breast cancer or 
other uses is a nonelectrically powered or an AC-powered device applied 
to the skin that displays the color patterns of heat sensitive 
cholesteric liquid crystals that respond to temperature variations of 
the surface of the body. This generic type of device may include patient 
and equipment supports, a means to ensure thermal contact between the 
patient's skin and the liquid crystals, component parts, and 
accessories.
    (2) Classification. Class I (general controls).
    (b) A nonelectrically powered or an AC-powered liquid crystal 
thermographic system intended for use alone in diagnostic screening for 
detection of breast cancer or other uses--
    (1) Identification. A nonelectrically powered or an AC-powered 
liquid crystal thermographic system intended for use as the sole 
diagnostic screening tool for detection of breast cancer or other uses 
is a nonelectrically powered or an AC-powered device applied to the skin 
that displays the color patterns of heat sensitive cholesteric liquid 
crystals that respond to temperature variations of the surface of the 
body. This generic type of device may include image display and 
recording equipment, patient and equipment supports, a means to ensure 
thermal contact between the patient's skin and the liquid crystals, 
component parts, and accessories.
    (2) Classification. Class III.
    (3) Date PMA or notice of completion of a PDP is required. As of the 
enactment date of the amendments, May 28, 1976, an approval under 
section 515 of the act is required before the device described in 
paragraph (b)(1) may be commercially distributed. See Sec. 884.3.

[53 FR 1566, Jan. 20, 1988, as amended at 55 FR 48441, Nov. 20, 1990; 66 
FR 46953, Sept. 10, 2001]



Sec. 884.2990  Breast lesion documentation system.

    (a) Identification. A breast lesion documentation system is a device 
for use in producing a surface map of the breast as an aid to document 
palpable breast lesions identified during a clinical breast examination.
    (b) Classification. Class II (special controls). The device, when it 
is a breast examination recording sheet, is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 884.9. The special control is FDA's guidance 
entitled ``Class II Special Controls Guidance Document: Breast Lesion 
Documentation System.'' See Sec. 884.1(e) for the availability of this 
guidance document.

[68 FR 44415, Aug. 27, 2003, as amended at 84 FR 71816, Dec. 30, 2019]



       Subpart D_Obstetrical and Gynecological Prosthetic Devices



Sec. 884.3200  Cervical drain.

    (a) Identification. A cervical drain is a device designed to provide 
an exit channel for draining discharge from the cervix after pelvic 
surgery.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019]

[[Page 688]]



Sec. 884.3575  Vaginal pessary.

    (a) Identification. A vaginal pessary is a removable structure 
placed in the vagina to support the pelvic organs and is used to treat 
conditions such as uterine prolapse (falling down of uterus), uterine 
retroposition (backward displacement), or gynecologic hernia.
    (b) Classification. Class II (performance standards).



Sec. 884.3650  Fallopian tube prosthesis.

    (a) Identification. A fallopian tube prosthesis is a device designed 
to maintain the patency (openness) of the fallopian tube and is used 
after reconstructive surgery.
    (b) Classification. Class II (performance standards).



Sec. 884.3900  Vaginal stent.

    (a) Identification. A vaginal stent is a device used to enlarge the 
vagina by stretching, or to support the vagina and to hold a skin graft 
after reconstructive surgery.
    (b) Classification. Class II (performance standards).



        Subpart E_Obstetrical and Gynecological Surgical Devices



Sec. 884.4050  Gynecologic laparoscopic power morcellation containment system.

    (a) Identification. A gynecologic laparoscopic power morcellation 
containment system is a prescription device consisting of an instrument 
port and tissue containment method that creates a working space allowing 
for direct visualization during a power morcellation procedure following 
a laparoscopic procedure for the excision of benign gynecologic tissue 
that is not suspected to contain malignancy.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient-contacting components of the device must be 
demonstrated to be biocompatible;
    (2) Device components that are labeled sterile must be validated to 
a sterility assurance level of 10-6;
    (3) Performance data must support shelf life by demonstrating 
continued sterility of the device or the sterile components, package 
integrity, and device functionality over the intended shelf life;
    (4) Non-clinical performance data must demonstrate that the device 
meets all design specifications and performance requirements. The 
following performance characteristics must be tested:
    (i) Demonstration of the device impermeability to tissue, cells, and 
fluids;
    (ii) Demonstration that the device allows for the insertion and 
withdrawal of laparoscopic instruments while maintaining 
pneumoperitoneum;
    (iii) Demonstration that the containment system provides adequate 
space to perform morcellation and adequate visualization of the 
laparoscopic instruments and tissue specimen relative to the external 
viscera;
    (iv) Demonstration that intended laparoscopic instruments and 
morcellators do not compromise the integrity of the containment system; 
and
    (v) Demonstration that intended users can adequately deploy the 
device, morcellate a specimen without compromising the integrity of the 
device, and remove the device without spillage of contents;
    (5) Training must be developed and validated to ensure users can 
follow the instructions for use; and
    (6) Labeling must include the following:
    (i) A contraindication for use in gynecologic surgery in which the 
tissue to be morcellated is known or suspected to contain malignancy;
    (ii) Unless clinical performance data demonstrates that it can be 
removed or modified, a contraindication for removal of uterine tissue 
containing suspected fibroids in patients who are: Peri- or 
postmenopausal, or candidates for en bloc tissue removal, for example, 
through the vagina or via a mini-laparotomy incision;
    (iii) The following boxed warning: ``Warning: Information regarding 
the potential risks of a procedure with this device should be shared 
with patients. Uterine tissue may contain unsuspected cancer. The use of 
laparoscopic power morcellators during fibroid surgery may spread 
cancer. The

[[Page 689]]

use of this containment system has not been clinically demonstrated to 
reduce this risk.''
    (iv) A statement limiting use of device to physicians who have 
completed the training program; and
    (v) An expiration date or shelf life.

[81 FR 40183, June 21, 2016]



Sec. 884.4100  Endoscopic electrocautery and accessories.

    (a) Identification. An endoscopic electrocautery is a device used to 
perform female sterilization under endoscopic observation. It is 
designed to coagulate fallopian tube tissue with a probe heated by low-
voltage energy. This generic type of device may include the following 
accessories: electrical generators, probes, and electrical cables.
    (b) Classification. Class II. The special controls for this device 
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological Evaluation 
of Medical Devices--Part I: Evaluation and Testing,' ''
    (ii) ``510(k) Sterility Review Guidance 2/12/90 (K-90),'' and
    (iii) ``Guidance (`Guidelines') for Evaluation of Laproscopic 
Bipolar and Thermal Coagulators (and Accessories),''
    (2) International Electrotechnical Commission's IEC 60601-1-AM2 
(1995-03), Amendment 2, ``Medical Electrical Equipment--Part 1: General 
Requirements for Safety,''
    (3) American National Standards Institute/American Association for 
Medical Instrumentation's HF-18, 1993, ``Electrosurgical Devices,''
    (4) Labeling:
    (i) Indication: For female tubal sterilization, and
    (ii) Instructions for use:
    (A) Destroy at least 2 centimeters of the fallopian tubes,
    (B) Use a cut or undampened sinusoidal waveform,
    (C) Use a minimum power of 25 watts, and
    (D) For devices with ammeters: continue electrode activation for 5 
seconds after the visual endpoint (tissue blanching) is reached or 
current flow ceases indicating adequate tissue destruction.

[45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 
FR 17146, Mar. 31, 2000]



Sec. 884.4120  Gynecologic electrocautery and accessories.

    (a) Identification. A gynecologic electrocautery is a device 
designed to destroy tissue with high temperatures by tissue contact with 
an electrically heated probe. It is used to excise cervical lesions, 
perform biopsies, or treat chronic cervicitis under direct visual 
observation. This generic type of device may include the following 
accessories: an electrical generator, a probe, and electrical cables.
    (b) Classification. Class II (performance standards).



Sec. 884.4150  Bipolar endoscopic coagulator-cutter and accessories.

    (a) Identification. A bipolar endoscopic coagulator-cutter is a 
device used to perform female sterilization and other operative 
procedures under endoscopic observation. It destroys tissue with high 
temperatures by directing a high frequency electrical current through 
tissue between two electrical contacts of a probe. This generic type of 
device may include the following accessories: an electrical generator, 
probes, and electrical cables.
    (b) Classification. Class II. The special controls for this device 
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological Evaluation 
of Medical Devices--Part I: Evaluation and Testing,' ''
    (ii) ``510(k) Sterility Review Guidance 2/12/90 (K-90),'' and
    (iii) ``Guidance (`Guidelines') for Evaluation of Laproscopic 
Bipolar and Thermal Coagulators (and Accessories),''
    (2) International Electrotechnical Commission's IEC 60601-1-AM2 
(1995-03), Amendment 2, ``Medical Electrical Equipment--Part 1: General 
Requirements for Safety,''
    (3) American National Standards Institute/American Association for 
Medical Instrumentation's HF-18, 1993, ``Electrosurgical Devices,''

[[Page 690]]

    (4) Labeling:
    (i) Indication: For female tubal sterilization, and
    (ii) Instructions for use:
    (A) Destroy at least 2 centimeters of the fallopian tubes,
    (B) Use a cut or undampened sinusoidal waveform,
    (C) Use a minimum power of 25 watts, and
    (D) For devices with ammeters: continue electrode activation for 5 
seconds after the visual endpoint (tissue blanching) is reached or 
current flow ceases indicating adequate tissue destruction.

[45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 
FR 17146, Mar. 31, 2000]



Sec. 884.4160  Unipolar endoscopic coagulator-cutter and accessories.

    (a) Identification. A unipolar endoscopic coagulator-cutter is a 
device designed to destroy tissue with high temperatures by directing a 
high frequency electrical current through the tissue between an 
energized probe and a grounding plate. It is used in female 
sterilization and in other operative procedures under endoscopic 
observation. This generic type of device may include the following 
accessories: an electrical generator, probes and electrical cables, and 
a patient grounding plate. This generic type of device does not include 
devices used to perform female sterilization under hysteroscopic 
observation.
    (b) Classification. Class II (performance standards).



Sec. 884.4250  Expandable cervical dilator.

    (a) Identification. An expandable cervical dilator is an instrument 
with two handles and two opposing blades used manually to dilate 
(stretch open) the cervical os.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any 
expandable cervical dilator that was in commercial distribution before 
May 28, 1976, or that has, on or before December 26, 1996 been found to 
be substantially equivalent to an expandable cervical dilator that was 
in commercial distribution before May 28, 1976. Any other expandable 
cervical dilator shall have an approved PMA or a declared completed PDP 
in effect before being placed in commercial distribution.

[45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 61 
FR 50708, Sept. 27, 1996]



Sec. 884.4260  Hygroscopic Laminaria cervical dilator.

    (a) Identification. A hygroscopic Laminaria cervical dilator is a 
device designed to dilate (stretch open) the cervical os by cervical 
insertion of a conical and expansible material made from the root of a 
seaweed (Laminaria digitata or Laminaria japonica). The device is used 
to induce abortion.
    (b) Classification. Class II (performance standards).



Sec. 884.4270  Vibratory cervical dilators.

    (a) Identification. A vibratory cervical dilator is a device 
designed to dilate the cervical os by stretching it with a power-driven 
vibrating probe head. The device is used to gain access to the uterus or 
to induce abortion, but is not to be used during labor when a viable 
fetus is desired or anticipated.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any vibratory 
cervical dilator that was in commercial distribution before May 28, 
1976, or that has, on or before December 26, 1996 been found to be 
substantially equivalent to a vibratory cervical dilator that was in 
commercial distribution before May 28, 1976. Any other vibratory 
cervical dilator shall have an approved PMA or a declared completed PDP 
in effect before being placed in commercial distribution.

[45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 61 
FR 50708, Sept. 27, 1996]

[[Page 691]]



Sec. 884.4340  Fetal vacuum extractor.

    (a) Identification. A fetal vacuum extractor is a device used to 
facilitate delivery. The device enables traction to be applied to the 
fetal head (in the birth canal) by means of a suction cup attached to 
the scalp and is powered by an external vacuum source. This generic type 
of device may include the cup, hosing, vacuum source, and vacuum 
control.
    (b) Classification. Class II (performance standards).



Sec. 884.4350  Fetal head elevator.

    (a) Identification. A fetal head elevator is a prescription device 
consisting of a mechanism that elevates the fetal head to facilitate 
delivery during a Caesarean section.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (2) Performance data must demonstrate the sterility of patient-
contacting components of the device.
    (3) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the identified shelf life.
    (4) Non-clinical performance data must demonstrate that the device 
performs as intended under anticipated conditions of use. The following 
performance characteristics must be tested:
    (i) Reliability testing of device deployment and retrieval under 
relevant use conditions must be conducted.
    (ii) Testing of the maximum force applied to the fetal head in an 
anatomic model must be conducted.
    (iii) Testing of uniform application of the elevator mechanism on 
the fetal head must be conducted.
    (5) Labeling must include the following:
    (i) Contraindication for use in the presence of active genital 
infection;
    (ii) Specific instructions regarding the proper placement and use of 
the device; and
    (iii) A shelf life.

[82 FR 60114, Dec. 19, 2017]



Sec. 884.4400  Obstetric forceps.

    (a) Identification. An obstetric forceps is a device consisting of 
two blades, with handles, designed to grasp and apply traction to the 
fetal head in the birth passage and facilitate delivery.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019]



Sec. 884.4500  Obstetric fetal destructive instrument.

    (a) Identification. An obstetric fetal destructive instrument is a 
device designed to crush or pull the fetal body to facilitate the 
delivery of a dead or anomalous (abnormal) fetus. This generic type of 
device includes the cleidoclast, cranioclast, craniotribe, and 
destructive hook.
    (b) Classification. Class II (performance standards).



Sec. 884.4520  Obstetric-gynecologic general manual instrument.

    (a) Identification. An obstetric-gynecologic general manual 
instrument is one of a group of devices used to perform simple obstetric 
and gynecologic manipulative functions. This generic type of device 
consists of the following:
    (1) An episiotomy scissors is a cutting instrument, with two opposed 
shearing blades, used for surgical incision of the vulvar orifice for 
obstetrical purposes.
    (2) A fiberoptic metal vaginal speculum is a metal instrument, with 
fiberoptic light, used to expose and illuminate the interior of the 
vagina.
    (3) A metal vaginal speculum is a metal instrument used to expose 
the interior of the vagina.
    (4) An umbilical scissors is a cutting instrument, with two opposed 
shearing blades, used to cut the umbilical cord.
    (5) A uterine clamp is an instrument used to hold the uterus by 
compression.
    (6) A uterine packer is an instrument used to introduce dressing 
into the uterus or vagina.

[[Page 692]]

    (7) A vaginal applicator is an instrument used to insert medication 
into the vagina.
    (8) A vaginal retractor is an instrument used to maintain vaginal 
exposure by separating the edges of the vagina and holding back the 
tissue.
    (9) A gynecological fibroid hook is an instrument used to exert 
traction upon a fibroid.
    (10) A pelvimeter (external) is an instrument used to measure the 
external diameters of the pelvis.
    (b) Classification. Class I (general controls). The devices are 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter, subject to the limitations in Sec. 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 54 FR 25052, June 12, 1989; 
66 FR 38809, July 25, 2001]



Sec. 884.4530  Obstetric-gynecologic specialized manual instrument.

    (a) Identification. An obstetric-gynecologic specialized manual 
instrument is one of a group of devices used during obstetric-
gynecologic procedures to perform manipulative diagnostic and surgical 
functions (e.g., dilating, grasping, measuring, and scraping), where 
structural integrity is the chief criterion of device performance. This 
type of device consists of the following:
    (1) An amniotome is an instrument used to rupture the fetal 
membranes.
    (2) A circumcision clamp is an instrument used to compress the 
foreskin of the penis during circumcision of a male infant.
    (3) An umbilical clamp is an instrument used to compress the 
umbilical cord.
    (4) A uterine curette is an instrument used to scrape and remove 
material from the uterus.
    (5) A fixed-size cervical dilator is any of a series of bougies of 
various sizes used to dilate the cervical os by stretching the cervix.
    (6) A uterine elevator is an instrument inserted into the uterus 
used to lift and manipulate the uterus.
    (7) A gynecological surgical forceps is an instrument with two 
blades and handles used to pull, grasp, or compress during gynecological 
examination.
    (8) A cervical cone knife is a cutting instrument used to excise and 
remove tissue from the cervix.
    (9) A gynecological cerclage needle is a looplike instrument used to 
suture the cervix.
    (10) A hook-type contraceptive intrauterine device (IUD) remover is 
an instrument used to remove an IUD from the uterus.
    (11) A gynecological fibroid screw is an instrument used to hold 
onto a fibroid.
    (12) A uterine sound is an instrument used to determine the depth of 
the uterus by inserting it into the uterine cavity.
    (13) A cytological cervical spatula is a blunt instrument used to 
scrape and remove cytological material from the surface of the cervix or 
vagina.
    (14) A gynecological biopsy forceps is an instrument with two blades 
and handles used for gynecological biopsy procedures.
    (15) A uterine tenaculum is a hooklike instrument used to seize and 
hold the cervix or fundus.
    (16) An internal pelvimeter is an instrument used within the vagina 
to measure the diameter and capacity of the pelvis.
    (17) A nonmetal vaginal speculum is a nonmetal instrument used to 
expose the interior of the vagina.
    (18) A fiberoptic nonmetal vaginal speculum is a nonmetal 
instrument, with fiberoptic light, used to expose and illuminate the 
interior of the vagina.
    (b) Classification. (1) Class II (special controls). The device, 
when it is an umbilical clamp with or without a cutter, a uterine 
tenaculum which is sterile and does not use suction and is intended for 
single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal 
vaginal speculum, is exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter subject to the limitations in 
Sec. 884.9.
    (2) Class I for the amniotome, uterine curette, cervical dilator 
(fixed-size bougies), cerclage needle, IUD remover, uterine sound, and 
gynecological biopsy forceps. The devices subject to this paragraph 
(b)(2) are exempt from the premarket notification procedures

[[Page 693]]

in subpart E of part 807 of this chapter, subject to the limitations in 
Sec. 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996; 66 
FR 38809, July 25, 2001; 84 FR 71816, Dec. 30, 2019]



Sec. 884.4550  Gynecologic surgical laser.

    (a) Identification. A gynecologic surgical laser is a continuous 
wave carbon dioxide laser designed to destroy tissue thermally or to 
remove tissue by radiant light energy. The device is used only in 
conjunction with a colposcope as part of a gynecological surgical 
system. A colposcope is a magnifying lens system used to examine the 
vagina and cervix.
    (b) Classification. Class II (performance standards).



Sec. 884.4900  Obstetric table and accessories.

    (a) Identification. An obstetric table is a device with adjustable 
sections designed to support a patient in the various positions required 
during obstetric and gynecologic procedures. This generic type of device 
may include the following accessories: patient equipment, support 
attachments, and cabinets for warming instruments and disposing of 
wastes.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019]



Sec. 884.4910  Specialized surgical instrumentation for use with
urogynecologic surgical mesh.

    (a) Identification. Specialized surgical instrumentation for use 
with urogynecologic surgical mesh is a prescription device specifically 
intended for use as an aid in the insertion, placement, fixation, or 
anchoring of surgical mesh during urogynecologic procedures. These 
procedures include transvaginal pelvic organ prolapse repair, 
sacrocolpopexy (transabdominal pelvic organ prolapse repair), and 
treatment of female stress urinary incontinence. Examples of specialized 
surgical instrumentation include needle passers and trocars, needle 
guides, fixation tools, and tissue anchors. This device is not a manual 
gastroenterology-urology surgical instrument and accessories (Sec. 
876.4730) or a manual surgical instrument for general use (Sec. 
878.4800).
    (b) Classification. Class II (special controls). The special 
controls for specialized surgical instrumentation for use with 
urogynecologic surgical mesh are:
    (1) The device must be demonstrated to be biocompatible;
    (2) The device must be demonstrated to be sterile and, if reusable, 
it must be demonstrated that the device can be adequately reprocessed;
    (3) Performance data must support the shelf life of the device by 
demonstrating package integrity and device functionality over the 
requested shelf life;
    (4) Non-clinical performance testing must demonstrate that the 
device meets all design specifications and performance requirements, and 
that the device performs as intended under anticipated conditions of 
use; and
    (5) Labeling must include:
    (i) Information regarding the mesh design that may be used with the 
device;
    (ii) Detailed summary of the clinical evaluations pertinent to use 
of the device;
    (iii) Expiration date; and
    (iv) Where components are intended to be sterilized by the user 
prior to initial use and/or are reusable, validated methods and 
instructions for sterilization and/or reprocessing of any reusable 
components.

[82 FR 1603, Jan. 6, 2017]



       Subpart F_Obstetrical and Gynecological Therapeutic Devices



Sec. 884.5050  Metreurynter-balloon abortion system.

    (a) Identification. A metreurynter-balloon abortion system is a 
device used to induce abortion. The device is inserted into the uterine 
cavity, inflated, and slowly extracted. The extraction of the balloon 
from the uterus causes dilation of the cervical os. This generic type of 
device may include pressure sources and pressure controls.

[[Page 694]]

    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any 
metreurynter-balloon abortion system that was in commercial distribution 
before May 28, 1976, or that has, on or before December 26, 1996 been 
found to be substantially equivalent to a metreurynter-balloon abortion 
system that was in commercial distribution before May 28, 1976. Any 
other metreurynter-balloon abortion system shall have an approved PMA or 
a declared completed PDP in effect before being placed in commercial 
distribution.

[45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 61 
FR 50709, Sept. 27, 1996]



Sec. 884.5070  Vacuum abortion system.

    (a) Identification. A vacuum abortion system is a device designed to 
aspirate transcervically the products of conception or menstruation from 
the uterus by using a cannula connected to a suction source. This device 
is used for pregnancy termination or menstrual regulation. This type of 
device may include aspiration cannula, vacuum source, and vacuum 
controller.
    (b) Classification. Class II (performance standards).



Sec. 884.5100  Obstetric anesthesia set.

    (a) Identification. An obstetric anesthesia set is an assembly of 
antiseptic solution, needles, needle guides, syringes, and other 
accessories, intended for use with an anesthetic drug. This device is 
used to administer regional blocks (e.g., paracervical, uterosacral, and 
pudendal) that may be used during labor, delivery, or both.
    (b) Classification. Class II (performance standards).



Sec. 884.5150  Nonpowered breast pump.

    (a) Identification. A nonpowered breast pump is a manual suction 
device used to express milk from the breast.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter, 
subject to the limitations in Sec. 884.9, if the device is using either 
a bulb or telescoping mechanism which does not develop more than 250 mm 
Hg suction, and the device materials that contact breast or breast milk 
do not produce cytotoxicity, irritation, or sensitization effects.

[45 FR 12684, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996; 66 
FR 38809, July 25, 2001]



Sec. 884.5160  Powered breast pump.

    (a) Identification. A powered breast pump in an electrically powered 
suction device used to express milk from the breast.
    (b) Classification. Class II (performance standards).



Sec. 884.5200  Hemorrhoid prevention pressure wedge.

    (a) Identification. A hemorrhoid prevention pressure wedge provides 
mechanical support to the perianal region during the labor and delivery 
process. External mechanical support of the perianal region is intended 
to help prevent the occurrence of external hemorrhoids associated with 
vaginal childbirth.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 884.9. The 
special controls for this device are:
    (1) The sale, distribution, and use of this device are restricted to 
prescription use in accordance with Sec. 801.109 of this chapter.
    (2) The labeling must include specific instructions regarding the 
proper placement and use of the device.
    (3) The device must be demonstrated to be biocompatible.
    (4) Mechanical bench testing of material strength must demonstrate 
that the device will withstand forces encountered during use.
    (5) Safety and effectiveness data must demonstrate that the device 
prevents hemorrhoids in women undergoing spontaneous vaginal delivery, 
in addition to general controls.

[76 FR 21238, Apr. 15, 2011, as amended at 84 FR 71816, Dec. 30, 2019]

[[Page 695]]



Sec. 884.5210  Pressure wedge for the reduction of cesarean delivery.

    (a) Identification. A pressure wedge for the reduction of cesarean 
delivery is a prescription device that provides external mechanical 
support to the perianal region during the labor and vaginal delivery 
process. External mechanical support of the perianal region is intended 
to help reduce the occurrence of cesarean delivery.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient contacting materials must be evaluated to be 
biocompatible.
    (2) Nonclinical performance data must demonstrate that the device 
will not break when subjected to the forces it will be exposed to during 
labor.
    (3) Performance data must validate the sterility of the device.
    (4) Performance data must support the shelf life of the device by 
demonstrating continued sterility and package integrity over the labeled 
shelf life.
    (5) Clinical performance data must be provided that characterizes 
the rate of skin/tissue trauma.
    (6) The labeling must include:
    (i) Specific instructions regarding the proper placement and use of 
the device.
    (ii) A shelf life.

[82 FR 61448, Dec. 28, 2017]



Sec. 884.5225  Abdominal decompression chamber.

    (a) Identification. An abdominal decompression chamber is a hoodlike 
device used to reduce pressure on the pregnant patient's abdomen for the 
relief of abdominal pain during pregnancy or labor.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any abdominal 
decompression chamber that was in commercial distribution before May 28, 
1976, or that has, on or before December 26, 1996 been found to be 
substantially equivalent to an abdominal decompression chamber that was 
in commercial distribution before May 28, 1976. Any other abdominal 
decompression chamber shall have an approved PMA or a declared completed 
PDP in effect before being placed in commercial distribution.

[45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 61 
FR 50709, Sept. 27, 1996]



Sec. 884.5250  Cervical cap.

    (a) Identification. A cervical cap is a flexible cuplike receptacle 
that fits over the cervix to collect menstrual flow or to aid artificial 
insemination. This generic type of device is not for contraceptive use.
    (b) Classification. Class II (performance standards).



Sec. 884.5300  Condom.

    (a) Identification. A condom is a sheath which completely covers the 
penis with a closely fitting membrane. The condom is used for 
contraceptive and for prophylactic purposes (preventing transmission of 
sexually transmitted infections). The device may also be used to collect 
semen to aid in the diagnosis of infertility.
    (b) Classification. (1) Class II (special controls) for condoms made 
of materials other than natural rubber latex, including natural membrane 
(skin) or synthetic.
    (2) Class II (special controls) for natural rubber latex condoms. 
The guidance document entitled ``Class II Special Controls Guidance 
Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 
CFR 884.5300'' will serve as the special control. See Sec. 884.1(e) for 
the availability of this guidance document.

[73 FR 66538, Nov. 10, 2008]



Sec. 884.5310  Condom with spermicidal lubricant.

    (a) Identification. A condom with spermicidal lubricant is a sheath 
which completely covers the penis with a closely fitting membrane with a 
lubricant that contains a spermicidal agent, nonoxynol-9. This condom is 
used for contraceptive and prophylactic purposes (preventing 
transmission of venereal disease).

[[Page 696]]

    (b) Classification. Class II (performance standards).

[47 FR 49022, Oct. 29, 1982]



Sec. 884.5320  Glans sheath.

    (a) Identification. A glans sheath device is a sheath which covers 
only the glans penis or part thereof and may also cover the area in the 
immediate proximity thereof, the corona and frenulum, but not the entire 
shaft of the penis. It is indicated only for the prevention of pregnancy 
and not for the prevention of sexually-transmitted diseases.
    (b) Classification. Class III (premarket approval).
    (c) Date premarket approval application (PMA) or notice of 
completion of a product development protocol (PDP) is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before September 12, 2002, for any glans 
sheath that was in commercial distribution before May 28, 1976, or that 
has, on or before September 12, 2002, been found to be substantially 
equivalent to a glans sheath that was in commercial distribution before 
May 28, 1976. Any other glans sheath shall have an approved PMA or 
declared completed PDP in effect before being placed in commercial 
distribution.

[59 FR 67187, Dec. 29, 1994, as amended at 67 FR 40849, June 14, 2002]



Sec. 884.5330  Multiple-use female condom.

    (a) Identification. A multiple-use female condom is a sheath-like 
device that lines the vaginal wall and is inserted into the vagina prior 
to the initiation of coitus. At the conclusion of coitus, the device can 
be reused. It is indicated for contraception and prophylactic 
(preventing the transmission of sexually transmitted infections) 
purposes.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before November 21, 2011, for any female 
condom that was in commercial distribution before May 28, 1976, or that 
has, on or before November 21, 2011, been found to be substantially 
equivalent to any female condom that was in commercial distribution 
before May 28, 1976. Any other female condom shall have an approved PMA 
or declared completed PDP in effect before being placed in commercial 
distribution.

[65 FR 31455, May 18, 2000, as amended at 76 FR 50667, Aug. 16, 2011; 83 
FR 48714, Sept. 27, 2018]



Sec. 884.5340  Single-use internal condom.

    (a) Identification. A single-use internal condom is an over-the-
counter sheath-like device that lines the vaginal or anal wall and is 
inserted into the vagina or anus prior to the initiation of coitus. At 
the conclusion of coitus, it is removed and discarded. It is indicated 
for contraception and/or prophylactic (preventing the transmission of 
sexually transmitted infections) purposes.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must evaluate the following:
    (i) Rate of clinical failure of the device and rate of individual 
failure modes of the device based on an acute failure modes study 
evaluating the intended use (vaginal and/or anal intercourse); and
    (ii) Cumulative pregnancy rate when using the device based on a 
contraceptive effectiveness study (when the device is indicated for 
vaginal intercourse).
    (2) Viral penetration testing must demonstrate the device is an 
effective barrier to sexually transmitted infections.
    (3) Nonclinical performance testing must demonstrate that the device 
performs as intended under anticipated conditions of use. The following 
performance characteristics must be evaluated:
    (i) Mechanical testing must demonstrate the device can withstand 
forces under anticipated use conditions, include evaluation of tensile, 
tear, and burst properties of the device; and
    (ii) Compatibility testing with personal lubricants must determine 
whether the physical properties of the

[[Page 697]]

device are adversely affected by use of additional lubricants.
    (4) The device must be demonstrated to be biocompatible.
    (5) Shelf-life testing must demonstrate that the device maintains 
its performance characteristics and the packaging of the device must 
maintain integrity for the duration of the shelf-life.
    (6) Labeling of the device must include:
    (i) Contraceptive effectiveness table comparing typical use and 
perfect use pregnancy rates with the device to other available methods 
of birth control;
    (ii) Statement regarding the adverse events associated with the 
device, including potential transmission of infection, adverse tissue 
reaction, and ulceration or other physical trauma;
    (iii) Expiration date; and
    (iv) Statement regarding compatibility with additional types of 
personal lubricants.

[83 FR 48714, Sept. 27, 2018]



Sec. 884.5350  Contraceptive diaphragm and accessories.

    (a) Identification. A contraceptive diaphragm is a closely fitting 
membrane placed between the posterior aspect of the pubic bone and the 
posterior vaginal fornix. The device covers the cervix completely and is 
used with a spermicide to prevent pregnancy. This generic type of device 
may include an introducer.
    (b) Classification. Class II (performance standards).



Sec. 884.5360  Contraceptive intrauterine device (IUD) and introducer.

    (a) Identification. A contraceptive intrauterine device (IUD) is a 
device used to prevent pregnancy. The device is placed high in the 
uterine fundus with a string extending from the device through the 
cervical os into the vagina. This generic type of device includes the 
introducer, but does not include contraceptive IUD's that function by 
drug activity, which are subject to the new drug provisions of the 
Federal Food, Drug, and Cosmetic Act (see Sec. 310.502).
    (b) Classification. Class III (premarket approval).
    (c) [Reserved]
    (d) Date premarket approval application (PMA) or notice of 
completion of a product development protocol (PDP) is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before August 4, 1986, for any IUD and 
introducer that was in commercial distribution before May 28, 1976, or 
that has on or before August 4, 1986, been found to be substantially 
equivalent to an IUD and introducer that was in commercial distribution 
before May 28, 1976. Any other IUD and introducer shall have an approved 
PMA or a declared completed PDP in effect before being placed in 
commercial distribution.

[45 FR 12684, Feb. 26, 1980, as amended at 51 FR 16649, May 5, 1986; 85 
FR 18443, Apr. 2, 2020]



Sec. 884.5370  Software application for contraception.

    (a) Identification. A software application for contraception is a 
device that provides user-specific fertility information for preventing 
a pregnancy. This device includes an algorithm that performs analysis of 
patient-specific data (e.g., temperature, menstrual cycle dates) to 
distinguish between fertile and non-fertile days, then provides patient-
specific recommendations related to contraception.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must demonstrate the contraceptive 
effectiveness of the software in the intended use population.
    (2) Human factors performance evaluation must be provided to 
demonstrate that the intended users can self-identify that they are in 
the intended use population and can correctly use the application, based 
solely on reading the directions for use for contraception.
    (3) Software verification, validation, and hazard analysis must be 
performed. Documentation must include the following:
    (i) A cybersecurity vulnerability and management process to assure 
software functionality; and

[[Page 698]]

    (ii) A description of the technical parameters of the software, 
including the algorithm used to determine fertility status and alerts 
for user inputs outside of expected ranges.
    (4) Labeling must include:
    (i) The following warnings and precautions:
    (A) A statement that no contraceptive method is 100% effective.
    (B) A statement that another form of contraception (or abstinence) 
must be used on days specified by the application.
    (C) Statements of any factors that may affect the accuracy of the 
contraceptive information.
    (D) A warning that the application cannot protect against sexually 
transmitted infections.
    (ii) Hardware platform and operating system requirements.
    (iii) Instructions identifying and explaining how to use the 
software application, including required user inputs and how to 
interpret the application outputs.
    (iv) A summary of the clinical validation study and results, 
including effectiveness of the application as a stand-alone 
contraceptive and how this effectiveness compares to other forms of 
legally marketed contraceptives.

[84 FR 7995, Mar. 6, 2019]



Sec. 884.5380  Contraceptive tubal occlusion device (TOD) and introducer.

    (a) Identification. A contraceptive tubal occlusion device (TOD) and 
introducer is a device designed to close a fallopian tube with a 
mechanical structure, e.g., a band or clip on the outside of the 
fallopian tube or a plug or valve on the inside. The devices are used to 
prevent pregnancy.
    (b) Classification. Class III (premarket approval).
    (c) Date premarket approval application (PMA) or notice of 
completion of a product development protocol (PDP) is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 30, 1987, for any TOD and 
introducer that was in commercial distribution before May 28, 1976, or 
that has on or before December 30, 1987, been found to be substantially 
equivalent to a TOD and introducer that was in commercial distribution 
before May 28, 1976. Any other TOD and introducer shall have an approved 
PMA or a declared completed PDP in effect before being placed in 
commercial distribution.

[45 FR 12684, Feb. 26, 1980, as amended at 52 FR 36883, Oct. 1, 1987]



Sec. 884.5390  Perineal heater.

    (a) Identification. A perineal heater is a device designed to apply 
heat directly by contact, or indirectly from a radiant source, to the 
surface of the perineum (the area between the vulva and the anus) and is 
used to soothe or to help heal the perineum after an episiotomy 
(incision of the vulvar orifice for obstetrical purposes).
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019]



Sec. 884.5400  Menstrual cup.

    (a) Identification. A menstrual cup is a receptacle placed in the 
vagina to collect menstrual flow.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019]



Sec. 884.5425  Scented or scented deodorized menstrual pad.

    (a) Identification. A scented or scented deodorized menstrual pad is 
a device that is a pad made of cellulosic or synthetic material which is 
used to absorb menstrual or other vaginal discharge. It has scent (i.e., 
fragrance materials) added for aesthetic purposes (scented menstrual 
pad) or for deodorizing purposes (scented deodorized menstrual pad). 
This generic type of device includes sterile scented menstrual pads used 
for medically indicated conditions, but does not include menstrual pads 
treated with added antimicrobial agents or other drugs.
    (b) Classification. (1) Class I (general controls) for menstrual 
pads made of

[[Page 699]]

common cellulosic and synthetic material with an established safety 
profile. The devices subject to this paragraph (b)(1) are exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter, subject to the limitations in Sec. 884.9. This exemption does 
not include the intralabial pads and reusable menstrual pads.
    (2) Class II (special controls) for scented or scented deodorized 
menstrual pads made of materials not described in paragraph (b)(1). The 
device is exempt from the premarket notification procedures in subpart E 
of part 807 of this chapter subject to the limitations in Sec. 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 45 FR 51185, Aug. 1, 1980; 61 
FR 67714, Dec. 24, 1996; 66 FR 38809, July 25, 2001; 84 FR 71816, Dec. 
30, 2019]



Sec. 884.5435  Unscented menstrual pad.

    (a) Identification. An unscented menstrual pad is a device that is a 
pad made of cellulosic or synthetic material which is used to absorb 
menstrual or other vaginal discharge. This generic type of device 
includes sterile unscented menstrual pads used for medically indicated 
conditions, but does not include menstrual pads treated with scent 
(i.e., fragrance materials) or those with added antimicrobial agents or 
other drugs.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 884.9 only when the 
device is made of common cellulosic and synthetic material with an 
established safety profile.

[45 FR 12684, Feb. 26, 1980, as amended at 61 FR 67714, Dec. 24, 1996; 
65 FR 2320, Jan. 14, 2000; 73 FR 34860, June 19, 2008; 84 FR 71816, Dec. 
30, 2019]



Sec. 884.5460  Scented or scented deodorized menstrual tampon.

    (a) Identification. A scented or scented deodorized menstrual tampon 
is a device that is a plug made of cellulosic or synthetic material that 
is inserted into the vagina and used to absorb menstrual or other 
vaginal discharge. It has scent (i.e., fragrance materials) added for 
aesthetic purposes (scented menstrual tampon) or for deodorizing 
purposes (scented deodorized menstrual tampon). This generic type of 
device does not include menstrual tampons treated with added 
antimicrobial agents or other drugs.
    (b) Classification. Class II (performance standards).

[45 FR 12684, Feb. 26, 1980, as amended at 45 FR 51186, Aug. 1, 1980]



Sec. 884.5470  Unscented menstrual tampon.

    (a) Identification. An unscented menstrual tampon is a device that 
is a plug made of cellulosic or synthetic material that is inserted into 
the vagina and used to absorb menstrual or other vaginal discharge. This 
generic type of device does not include menstrual tampons treated with 
scent (i.e., fragrance materials) or those with added antimicrobial 
agents or other drugs.
    (b) Classification. Class II (performance standards).



Sec. 884.5900  Therapeutic vaginal douche apparatus.

    (a) Identification. A therapeutic vaginal douche apparatus is a 
device that is a bag or bottle with tubing and a nozzle. The apparatus 
does not include douche solutions. The apparatus is intended and labeled 
for use in the treatment of medical conditions except it is not for 
contraceptive use. After filling the therapeutic vaginal douche 
apparatus with a solution, the patient uses the device to direct a 
stream of solution into the vaginal cavity.
    (b) Classification. (1) Class II (performance standards).
    (2) Class I if the device is operated by gravity feed. Devices 
subject to this paragraph (b)(2) are exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter, 
subject to the limitations in Sec. 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996; 66 
FR 38809, July 25, 2001]



Sec. 884.5920  Vaginal insufflator.

    (a) Identification. A vaginal insufflator is a device used to treat 
vaginitis by introducing medicated powder from a hand-held bulb into the 
vagina through an open speculum.

[[Page 700]]

    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter, 
subject to the limitations in Sec. 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 54 FR 25052, June 12, 1989; 
66 FR 38809, July 25, 2001]



Sec. 884.5940  Powered vaginal muscle stimulator for therapeutic use.

    (a) Identification. A powered vaginal muscle stimulator is an 
electrically powered device designed to stimulate directly the muscles 
of the vagina with pulsating electrical current. This device is intended 
and labeled for therapeutic use in increasing muscular tone and strength 
in the treatment of sexual dysfunction. This generic type of device does 
not include devices used to treat urinary incontinence.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP for a device is required to be filed 
with the Food and Drug Administration on or before July 12, 2000, for 
any powered vaginal muscle stimulator for therapeutic use that was in 
commercial distribution before May 28, 1976, or that has, on or before 
July 12, 2000, been found to be substantially equivalent to a powered 
vaginal muscle stimulator that was in commercial distribution before May 
28, 1976. Any other powered vaginal muscle stimulator for therapeutic 
use shall have an approved PMA or declared completed PDP in effect 
before being placed in commercial distribution.

[45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 
FR 19834, Apr. 13, 2000]



Sec. 884.5960  Genital vibrator for therapeutic use.

    (a) Identification. A genital vibrator for therapeutic use is an 
electrically operated device intended and labeled for therapeutic use in 
the treatment of sexual dysfunction or as an adjunct to Kegel's exercise 
(tightening of the muscles of the pelvic floor to increase muscle tone).
    (b) Classification. Class II (performance standards). The device is 
exempt from the premarket notification procedures in part 807, subpart 
E, of this chapter subject to the limitations in Sec. 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 83 FR 29215, June 5, 2018]



Sec. 884.5970  Clitoral engorgement device.

    (a) Identification. A clitoral engorgement device is designed to 
apply a vacuum to the clitoris. It is intended for use in the treatment 
of female sexual arousal disorder.
    (b) Classification. Class II (special controls). The special control 
is a guidance document entitled: ``Guidance for Industry and FDA 
Reviewers: Class II Special Controls Guidance Document for Clitoral 
Engorgement Devices.''

[65 FR 47306, Aug. 2, 2000]



Sec. 884.5980  Surgical mesh for transvaginal pelvic organ prolapse repair.

    (a) Identification. Surgical mesh for transvaginal pelvic organ 
prolapse repair is a prescription device intended to reinforce soft 
tissue in the pelvic floor. This device is a porous implant that is made 
of synthetic material, non-synthetic material, or a combination of 
synthetic and non-synthetic materials. This device does not include 
surgical mesh for other intended uses (Sec. 878.3300 of this chapter).
    (b) Classification. Class III (premarket approval).
    (c) Date premarket application approval or notice of completion of a 
product development protocol is required. A premarket application 
approval or notice of completion of a product development protocol for a 
device is required to be filed with the Food and Drug Administration on 
or before July 5, 2018, for any surgical mesh described in paragraph (a) 
of this section that was in commercial distribution before May 28, 1976, 
or that has, on or before July 5, 2018, been found substantially 
equivalent to a surgical mesh described in paragraph (a) of this section 
that was in commercial distribution before May 28, 1976. Any other 
surgical mesh for transvaginal pelvic organ prolapse repair shall have 
an approved premarket application or declared completed product 
development protocol in effect

[[Page 701]]

before being placed in commercial distribution.

[81 FR 361, Jan. 5, 2016, as amended at 81 FR 369, Jan. 5, 2016]



                 Subpart G_Assisted Reproduction Devices

    Source: 63 FR 48436, Sept. 10, 1998, unless otherwise noted.



Sec. 884.6100  Assisted reproduction needles.

    (a) Identification. Assisted reproduction needles are devices used 
in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), 
or other assisted reproduction procedures to obtain gametes from the 
body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into 
the body. This generic type of device may include a single or double 
lumen needle and component parts, including needle guides, such as those 
used with ultrasound.
    (b) Classification. Class II (special controls) (mouse embryo assay 
information, endotoxin testing, sterilization validation, design 
specifications, labeling requirements, biocompatibility testing, and 
clinical testing).



Sec. 884.6110  Assisted reproduction catheters.

    (a) Identification. Assisted reproduction catheters are devices used 
in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), 
or other assisted reproduction procedures to introduce or remove 
gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the 
body. This generic type of device may include catheters, cannulae, 
introducers, dilators, sheaths, stylets, and component parts.
    (b) Classification. Class II (special controls) (mouse embryo assay 
information, endotoxin testing, sterilization validation, design 
specifications, labeling requirements, biocompatibility testing, and 
clinical testing).



Sec. 884.6120  Assisted reproduction accessories.

    (a) Identification. Assisted reproduction accessories are a group of 
devices used during assisted reproduction procedures, in conjunction 
with assisted reproduction needles and/or assisted reproduction 
catheters, to aspirate, incubate, infuse, and/or maintain temperature. 
This generic type of device may include:
    (1) Powered aspiration pumps used to provide low flow, intermittent 
vacuum for the aspiration of eggs (ova).
    (2) Syringe pumps (powered or manual) used to activate a syringe to 
infuse or aspirate small volumes of fluid during assisted reproduction 
procedures.
    (3) Collection tube warmers, used to maintain the temperature of egg 
(oocyte) collection tubes at or near body temperature. A dish/plate/
microscope stage warmer is a device used to maintain the temperature of 
the egg (oocyte) during manipulation.
    (4) Embryo incubators, used to store and preserve gametes and/or 
embryos at or near body temperature.
    (5) Cryopreservation instrumentation and devices, used to contain, 
freeze, and maintain gametes and/or embryos at an appropriate freezing 
temperature.
    (b) Classification. Class II (special controls) (design 
specifications, labeling requirements, and clinical testing). The 
device, when it is a simple embryo incubator with only temperature, gas, 
and humidity control; a syringe pump; a collection tube warmer; a dish/
plate/microscope stage warmer; a controlled-rate cryopreservation 
freezer; or an assisted reproduction laminar flow workstation is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019; 
85 FR 44188, July 22, 2020]



Sec. 884.6130  Assisted reproduction microtools.

    (a) Identification. Assisted reproduction microtools are pipettes or 
other devices used in the laboratory to denude, micromanipulate, hold, 
or transfer human gametes or embryos for assisted hatching, 
intracytoplasmic sperm injection (ICSI), or other assisted reproduction 
methods.
    (b) Classification. Class II (special controls) (mouse embryo assay 
information, endotoxin testing, sterilization

[[Page 702]]

validation, design specifications, labeling requirements, and clinical 
testing). The device, when the assisted reproduction microtools 
(pipettes) are manufactured from glass, is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019]



Sec. 884.6140  Assisted reproduction micropipette fabrication 
instruments.

    (a) Identification. Assisted reproduction micropipette fabrication 
devices are instruments intended to pull, bevel, or forge a micropipette 
or needle for intracytoplasmic sperm injection (ICSI), in vitro 
fertilization (IVF) or other similar assisted reproduction procedures.
    (b) Classification. Class II (special controls) (design 
specifications, labeling requirements, and clinical testing).



Sec. 884.6150  Assisted reproduction micromanipulators and
microinjectors.

    (a) Identification. Assisted reproduction micromanipulators are 
devices intended to control the position of an assisted reproduction 
microtool. Assisted reproduction microinjectors are any device intended 
to control aspiration or expulsion of the contents of an assisted 
reproduction microtool.
    (b) Classification. Class II (special controls) (design 
specifications, labeling requirements, and clinical testing). The device 
is exempt from the premarket notification procedures in subpart E of 
part 807 of this chapter subject to the limitations in Sec. 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019]



Sec. 884.6160  Assisted reproduction labware.

    (a) Identification. Assisted reproduction labware consists of 
laboratory equipment or supplies intended to prepare, store, manipulate, 
or transfer human gametes or embryos for in vitro fertilization (IVF), 
gamete intrafallopian transfer (GIFT), or other assisted reproduction 
procedures. These include syringes, IVF tissue culture dishes, IVF 
tissue culture plates, pipette tips, dishes, plates, and other vessels 
that come into physical contact with gametes, embryos or tissue culture 
media.
    (b) Classification. Class II (special controls) (mouse embryo assay 
information, endotoxin testing, sterilization validation, design 
specifications, labeling requirements, and clinical testing). The 
device, when it is a dish or plate intended for general assisted 
reproduction technology procedures, is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019]



Sec. 884.6165  Intravaginal culture system.

    (a) Identification. An intravaginal culture system is a prescription 
device intended for preparing, holding, and transferring human gametes 
or embryos during intravaginal in vitro fertilization or intravaginal 
culture procedures.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must demonstrate the following:
    (i) Comfort and retention of the intravaginal culture device;
    (ii) Adverse vaginal tissue reactions associated with intravaginal 
culture;
    (iii) Maximum number of gametes and/or embryos that can be placed in 
a device; and
    (iv) Rates of embryo development to the designated stage, 
implantation rates, clinical pregnancy rates, live birth rates, and any 
adverse events or outcomes.
    (2) Nonclinical performance testing must demonstrate that the device 
performs as intended under anticipated conditions of use. The following 
performance characteristics must be demonstrated:
    (i) Mouse embryo assay testing to assess embryotoxicity by 
evaluating the gamete and embryo-contacting device components effect on 
the growth and development of mouse embryos to the blastocyst stage;
    (ii) Endotoxin testing on gamete and embryo-contacting components of 
the device;

[[Page 703]]

    (iii) Cleaning and disinfection validation of reusable device 
components;
    (iv) Sterility maintenance of the culture media within the device 
throughout the vaginal incubation period and subsequent embryo 
extraction; and
    (v) Ability of the device to permit oxygen and carbon dioxide 
exchange between the media contained within the device and the external 
environment throughout the vaginal incubation period.
    (3) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (4) Performance data must demonstrate the sterility of the device 
components intended to be provided sterile.
    (5) Shelf life testing must demonstrate that the device maintains 
its performance characteristics and the packaging of device components 
labeled as sterile maintain integrity and sterility for the duration of 
the shelf life.
    (6) Labeling for the device must include:
    (i) A detailed summary of the clinical testing, including device 
effectiveness, device-related complications, and adverse events;
    (ii) Validated methods and instructions for reprocessing of reusable 
components;
    (iii) The maximum number of gametes or embryos that can be loaded 
into the device;
    (iv) A warning that informs users that the embryo development is 
first evaluated following intravaginal culture; and
    (v) A statement that instructs the user to use legally marketed 
assisted reproductive technology media that contain elements to mitigate 
the contamination risk (e.g., antibiotics) and to support continued 
embryonic development over the intravaginal culture period.
    (7) Patient labeling must be provided and must include:
    (i) Relevant warnings, precautions, and adverse effects and 
complications;
    (ii) Information on how to use the device;
    (iii) The risks and benefits associated with the use of the device; 
and
    (iv) A summary of the principal clinical device effectiveness 
results.

[81 FR 379, Jan. 6, 2016]



Sec. 884.6170  Assisted reproduction water and water purification systems.

    (a) Identification. Assisted reproduction water purification systems 
are devices specifically intended to generate high quality, sterile, 
pyrogen-free water for reconstitution of media used for aspiration, 
incubation, transfer or storage of gametes or embryos for in vitro 
fertilization (IVF) or other assisted reproduction procedures. These 
devices may also be intended as the final rinse for labware or other 
assisted reproduction devices that will contact the gametes or embryos. 
These devices also include bottled water ready for reconstitution 
available from a vendor that is specifically intended for reconstitution 
of media used for aspiration, incubation, transfer, or storage of 
gametes or embryos for IVF or other assisted reproduction procedures.
    (b) Classification. Class II (special controls) (mouse embryo assay 
information, endotoxin testing, sterilization validation, water quality 
testing, design specifications, labeling requirements, biocompatibility 
testing, and clinical testing).



Sec. 884.6180  Reproductive media and supplements.

    (a) Identification. Reproductive media and supplement are products 
that are used for assisted reproduction procedures. Media include liquid 
and powder versions of various substances that come in direct physical 
contact with human gametes or embryos (including water, acid solutions 
used to treat gametes or embryos, rinsing solutions, sperm separation 
media, supplements, or oil used to cover the media) for the purposes of 
preparation, maintenance, transfer or storage. Supplements are specific 
reagents added to media to enhance specific properties of the media 
(e.g., proteins, sera, antibiotics, etc.).
    (b) Classification. Class II (special controls) (mouse embryo assay 
information, endotoxin testing, sterilization validation, design 
specifications, labeling requirements, biocompatibility

[[Page 704]]

testing, and clinical testing). The device, when it is phosphate-
buffered saline used for washing, and short-term handling and 
manipulation of gametes and embryos; culture oil used as an overlay for 
culture media containing gametes and embryos; and water for assisted 
reproduction applications, is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec. 884.9.

[63 FR 48436, Sept. 10, 1998, as amended at 85 FR 44188, July 22, 2020]



Sec. 884.6190  Assisted reproductive microscopes and microscope accessories.

    (a) Identification. Assisted reproduction microscopes and microscope 
accessories (excluding microscope stage warmers, which are classified 
under assisted reproduction accessories) are optical instruments used to 
enlarge images of gametes or embryos. Variations of microscopes and 
accessories used for these purposes would include phase contrast 
microscopes, dissecting microscopes and inverted stage microscopes.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter, 
subject to the limitations in Sec. 884.9.

[63 FR 48436, Sept. 10, 1998, as amended at 64 FR 62977, Nov. 18, 1999; 
66 FR 38809, July 25, 2001]



Sec. 884.6195  Assisted Reproduction Embryo Image Assessment System.

    (a) Identification. An Assisted Reproduction Embryo Image Assessment 
System is a prescription device that is designed to obtain and analyze 
light microscopy images of developing embryos. This device provides 
information to aid in the selection of embryo(s) for transfer when there 
are multiple embryos deemed suitable for transfer or freezing.
    (b) Classification. Class II (special controls). The special 
control(s) for this device are:
    (1) Clinical performance testing must demonstrate a reasonable 
assurance of safety and effectiveness of the device to predict embryo 
development. Classification performance (sensitivity and specificity) 
and predictive accuracy (Positive Predictive Value and Negative 
Predictive Value) must be assessed at the subject and embryo levels.
    (2) Software validation, verification, and hazard analysis must be 
provided.
    (3) Non-clinical performance testing data must demonstrate the 
performance characteristics of the device. Testing must include the 
following:
    (i) Total light exposure and output testing;
    (ii) A safety analysis must be performed based on maximum (worst-
case) light exposure to embryos, which also includes the safety of the 
light wavelength(s) emitted by the device;
    (iii) Simulated-use testing;
    (iv) Mouse Embryo Assay testing to assess whether device operation 
impacts growth and development of mouse embryos to the blastocyst stage;
    (v) Cleaning and disinfection validation of reusable components;
    (vi) Package integrity and transit testing;
    (vii) Hardware fail-safe validation;
    (viii) Electrical equipment safety and electromagnetic compatibility 
testing; and
    (ix) Prediction algorithm reproducibility.
    (4) Labeling must include the following:
    (i) A detailed summary of clinical performance testing, including 
any adverse events;
    (ii) Specific instructions, warnings, precautions, and training 
needed for safe use of the device
    (iii) Appropriate electromagnetic compatibility information;
    (iv) Validated methods and instructions for cleaning and 
disinfection of reusable components; and
    (v) Information identifying compatible cultureware and explain how 
they are used with the device.

[80 FR 10332, Feb. 26, 2015]



Sec. 884.6200  Assisted reproduction laser system.

    (a) Identification. The assisted reproduction laser system is a 
device that images, targets, and controls the power and pulse duration 
of a laser beam used to ablate a small tangential hole in, or

[[Page 705]]

to thin, the zona pellucida of an embryo for assisted hatching or other 
assisted reproduction procedures.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance document entitled ``Class II Special Controls Guidance 
Document: Assisted Reproduction Laser Systems.'' See Sec. 884.1(e) for 
the availability of this guidance document.

[69 FR 77624, Dec. 28, 2004]



PART 886_OPHTHALMIC DEVICES--Table of Contents



                      Subpart A_General Provisions

Sec.
886.1 Scope.
886.3 Effective dates of requirement for premarket approval.
886.9 Limitations of exemptions from section 510(k) of the Federal Food, 
          Drug, and Cosmetic Act (the act).

                      Subpart B_Diagnostic Devices

886.1040 Ocular esthesiometer.
886.1050 Adaptometer (biophotometer).
886.1070 Anomaloscope.
886.1090 Haidinger brush.
886.1100 Retinal diagnostic software device.
886.1120 Ophthalmic camera.
886.1140 Ophthalmic chair.
886.1150 Visual acuity chart.
886.1160 Color vision plate illuminator.
886.1170 Color vision tester.
886.1190 Distometer.
886.1200 Optokinetic drum.
886.1220 Corneal electrode.
886.1250 Euthyscope.
886.1270 Exophthalmometer.
886.1290 Fixation device.
886.1300 Afterimage flasher.
886.1320 Fornixscope.
886.1330 Amsler grid.
886.1340 Haploscope.
886.1342 Strabismus detection device.
886.1350 Keratoscope.
886.1360 Visual field laser instrument.
886.1375 Bagolini lens.
886.1380 Diagnostic condensing lens.
886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.
886.1390 Flexible diagnostic Fresnel lens.
886.1395 Diagnostic Hruby fundus lens.
886.1400 Maddox lens.
886.1405 Ophthalmic trial lens set.
886.1410 Ophthalmic trial lens clip.
886.1415 Ophthalmic trial lens frame.
886.1420 Ophthalmic lens gauge.
886.1425 Lens measuring instrument.
886.1430 Ophthalmic contact lens radius measuring device.
886.1435 Maxwell spot.
886.1450 Corneal radius measuring device.
886.1460 Stereopsis measuring instrument.
886.1500 Headband mirror.
886.1510 Eye movement monitor.
886.1570 Ophthalmoscope.
886.1605 Perimeter.
886.1630 AC-powered photostimulator.
886.1640 Ophthalmic preamplifier.
886.1650 Ophthalmic bar prism.
886.1655 Ophthalmic Fresnel prism.
886.1660 Gonioscopic prism.
886.1665 Ophthalmic rotary prism.
886.1670 Ophthalmic isotope uptake probe.
886.1680 Ophthalmic projector.
886.1690 Pupillograph.
886.1700 Pupillometer.
886.1750 Skiascopic rack.
886.1760 Ophthalmic refractometer.
886.1770 Manual refractor.
886.1780 Retinoscope.
886.1790 Nearpoint ruler.
886.1800 Schirmer strip.
886.1810 Tangent screen (campimeter).
886.1840 Simulatan (including crossed cylinder).
886.1850 AC-powered slitlamp biomicroscope.
886.1860 Ophthalmic instrument stand.
886.1870 Stereoscope.
886.1880 Fusion and stereoscopic target.
886.1905 Nystagmus tape.
886.1910 Spectacle dissociation test system.
886.1925 Diurnal pattern recorder system.
886.1930 Tonometer and accessories.
886.1940 Tonometer sterilizer.
886.1945 Transilluminator.

Subpart C [Reserved]

                      Subpart D_Prosthetic Devices

886.3100 Ophthalmic tantalum clip.
886.3130 Ophthalmic conformer.
886.3200 Artificial eye.
886.3300 Absorbable implant (scleral buckling method).
886.3320 Eye sphere implant.
886.3340 Extraocular orbital implant.
886.3400 Keratoprosthesis.
886.3600 Intraocular lens.
886.3800 Scleral shell.
886.3920 Aqueous shunt.

                       Subpart E_Surgical Devices

886.4070 Powered corneal burr.
886.4100 Radiofrequency electrosurgical cautery apparatus.
886.4115 Thermal cautery unit.
886.4150 Vitreous aspiration and cutting instrument.
886.4155 Scleral plug.
886.4170 Cryophthalmic unit.
886.4230 Ophthalmic knife test drum.
886.4250 Ophthalmic electrolysis unit.
886.4270 Intraocular gas.
886.4275 Intraocular fluid.
886.4280 Intraocular pressure measuring device.

[[Page 706]]

886.4300 Intraocular lens guide.
886.4335 Operating headlamp.
886.4350 Manual ophthalmic surgical instrument.
886.4355 Corneal inlay inserter handle.
886.4360 Ocular surgery irrigation device.
886.4370 Keratome.
886.4390 Ophthalmic laser.
886.4392 Nd:YAG laser for posterior capsulotomy and peripheral 
          iridotomy.
886.4400 Electronic metal locator.
886.4440 AC-powered magnet.
886.4445 Permanent magnet.
886.4570 Ophthalmic surgical marker.
886.4610 Ocular pressure applicator.
886.4670 Phacofragmentation system.
886.4690 Ophthalmic photocoagulator.
886.4750 Ophthalmic eye shield.
886.4770 Ophthalmic operating spectacles (loupes).
886.4790 Ophthalmic sponge.
886.4855 Ophthalmic instrument table.

                      Subpart F_Therapeutic Devices

886.5100 Ophthalmic beta radiation source.
886.5120 Low-power binocular loupe.
886.5200 Eyelid thermal pulsation system.
886.5201 Intense pulsed light device for managing dry eye.
886.5300 Tear electrostimulation device.
886.5305 Electromechanical tear stimulator.
886.5310 Intranasal electrostimulation device for dry eye symptoms.
886.5420 Contact lens inserter/remover.
886.5540 Low-vision magnifier.
886.5600 Ptosis crutch.
886.5700 Eyelid weight.
886.5800 Ophthalmic bar reader.
886.5810 Ophthalmic prism reader.
886.5820 Closed-circuit television reading system.
886.5838 Nasolacrimal compression device.
886.5840 Magnifying spectacles.
886.5842 Spectacle frame.
886.5844 Prescription spectacle lens.
886.5850 Sunglasses (nonprescription).
886.5870 Low-vision telescope.
886.5900 Electronic vision aid.
886.5905 Oral electronic vision aid.
886.5910 Image intensification vision aid.
886.5915 Optical vision aid.
886.5916 Rigid gas permeable contact lens.
886.5918 Rigid gas permeable contact lens care products.
886.5925 Soft (hydrophilic) contact lens.
886.5928 Soft (hydrophilic) contact lens care products.
886.5933 [Reserved]

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    Source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 886 appear at 73 FR 
35341, June 23, 2008.



                      Subpart A_General Provisions



Sec. 886.1  Scope.

    (a) This part sets forth the classification of ophthalmic devices 
intended for human use that are in commercial distribution.
    (b) The identification of a device in a regulation in this part is 
not a precise description of every device that is, or will be, subject 
to the regulation. A manufacturer who submits a premarket notification 
submission for a device under part 807 cannot show merely that the 
device is accurately described by the section title and identification 
provision of a regulation in this part but shall state why the device is 
substantially equivalent to other devices, as required by Sec. 807.87.
    (c) To avoid duplicative listings, an ophthalmic device that has two 
or more types of uses (e.g., used both as a diagnostic device and as a 
therapeutic device) is listed in one subpart only.
    (d) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21 unless otherwise noted.
    (e) Guidance documents referenced in this part are available on the 
Internet at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/default.htm..

[52 FR 33355, Sept. 2, 1987, as amended at 73 FR 34860, June 19, 2008; 
78 FR 18233, Mar. 26, 2013]



Sec. 886.3  Effective dates of requirement for premarket approval.

    A device included in this part that is classified into class III 
(premarket approval) shall not be commercially distributed after the 
date shown in the regulation classifying the device unless the 
manufacturer has an approval under section 515 of the act (unless an 
exemption has been granted under section 520(g)(2) of the act). An 
approval under section 515 of the act consists of FDA's issuance of an 
order approving an application for premarket approval (PMA) for the 
device or declaring completed a product development protocol (PDP) for 
the device.
    (a) Before FDA requires that a device commercially distributed 
before the enactment date of the amendments, or

[[Page 707]]

a device that has been found substantially equivalent to such a device, 
has an approval under section 515 of the act, FDA must promulgate a 
regulation under section 515(b) of the act requiring such approval, 
except as provided in paragraphs (b) and (c) of this section. Such a 
regulation under section 515(b) of the act shall not be effective during 
the grace period ending on the 90th day after its promulgation or on the 
last day of the 30th full calendar month after the regulation that 
classifies the device into class III is effective, whichever is later. 
See section 501(f)(2)(B) of the act. Accordingly, unless an effective 
date of the requirement for premarket approval is shown in the 
regulation for a device classified into class III in this part, the 
device may be commercially distributed without FDA's issuance of an 
order approving a PMA or declaring completed a PDP for the device. If 
FDA promulgates a regulation under section 515(b) of the act requiring 
premarket approval for a device, section 501(f)(1)(A) of the act applies 
to the device.
    (b) Any new, not substantially equivalent, device introduced into 
commercial distribution on or after May 28, 1976, including a device 
formerly marketed that has been substantially altered, is classified by 
statute (section 513(f) of the act) into class III without any grace 
period and FDA must have issued an order approving a PMA or declaring 
completed a PDP for the device before the device is commercially 
distributed unless it is reclassified. If FDA knows that a device being 
commercially distributed may be a ``new'' device as defined in this 
section because of any new intended use or other reasons, FDA may codify 
the statutory classification of the device into class III for such new 
use. Accordingly, the regulation for such a class III device states that 
as of the enactment date of the amendments, May 28, 1976, the device 
must have an approval under section 515 of the act before commercial 
distribution.
    (c) A device identified in a regulation in this part that is 
classified into class III and that is subject to the transitional 
provisions of section 520(1) of the act is automatically classified by 
statute into class III and must have an approval under section 515 of 
the act before being commercially distributed. Accordingly, the 
regulation for such a class III transitional device states that as of 
the enactment date of the amendments, May 28, 1976, the device must have 
an approval under section 515 of the act before commercial distribution.



Sec. 886.9  Limitations of exemptions from section 510(k) of
the Federal Food, Drug, and Cosmetic Act (the act).

    The exemption from the requirement of premarket notification 
(section 510(k) of the act) for a generic type of class I or II device 
is only to the extent that the device has existing or reasonably 
foreseeable characteristics of commercially distributed devices within 
that generic type or, in the case of in vitro diagnostic devices, only 
to the extent that misdiagnosis as a result of using the device would 
not be associated with high morbidity or mortality. Accordingly, 
manufacturers of any commercially distributed class I or II device for 
which FDA has granted an exemption from the requirement of premarket 
notification must still submit a premarket notification to FDA before 
introducing or delivering for introduction into interstate commerce for 
commercial distribution the device when:
    (a) The device is intended for a use different from the intended use 
of a legally marketed device in that generic type of device; e.g., the 
device is intended for a different medical purpose, or the device is 
intended for lay use where the former intended use was by health care 
professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro diagnostic 
device detects or identifies infectious agents by using deoxyribonucleic 
acid (DNA) probe or nucleic acid hybridization technology rather than 
culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:

[[Page 708]]

    (1) For use in the diagnosis, monitoring, or screening of neoplastic 
diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial or acquired 
genetic disorders, including inborn errors of metabolism;
    (3) For measuring an analyte that serves as a surrogate marker for 
screening, diagnosis, or monitoring life-threatening diseases such as 
acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, 
tuberculosis, or myocardial infarction or to monitor therapy;
    (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) or IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is intended 
for use in matrices other than serum or plasma;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).

[65 FR 2320, Jan. 14, 2000]



                      Subpart B_Diagnostic Devices



Sec. 886.1040  Ocular esthesiometer.

    (a) Identification. An ocular esthesiometer is a device, such as a 
single-hair brush, intended to touch the cornea to assess corneal 
sensitivity.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988; 
59 FR 63012, Dec. 7, 1994; 66 FR 38809, July 25, 2001]



Sec. 886.1050  Adaptometer (biophotometer).

    (a) Identification. An adaptometer (biophotometer) is an AC-powered 
device that provides a stimulating light source which has various 
controlled intensities intended to measure the time required for retinal 
adaptation (regeneration of the visual purple) and the minimum light 
threshold.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 
FR 38809, July 25, 2001]



Sec. 886.1070  Anomaloscope.

    (a) Identification. An anomaloscope is an AC-powered device intended 
to test for anomalies of color vision by displaying mixed spectral lines 
to be matched by the patient.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 
FR 38810, July 25, 2001]



Sec. 886.1090  Haidinger brush.

    (a) Identification. A Haidinger brush is an AC-powered device that 
provides two conical brushlike images with apexes touching which are 
viewed by the patient through a Nicol prism and intended to evaluate 
visual function. It may include a component for measuring macular 
integrity.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 
FR 38810, July 25, 2001; 72 FR 17400, Apr. 9, 2007]



Sec. 886.1100  Retinal diagnostic software device.

    (a) Identification. A retinal diagnostic software device is a 
prescription software device that incorporates an adaptive algorithm to 
evaluate ophthalmic images for diagnostic screening to identify retinal 
diseases or conditions.
    (b) Classification. Class II (special controls). The special 
controls for this device are:

[[Page 709]]

    (1) Software verification and validation documentation, based on a 
comprehensive hazard analysis, must fulfill the following:
    (i) Software documentation must provide a full characterization of 
technical parameters of the software, including algorithm(s).
    (ii) Software documentation must describe the expected impact of 
applicable image acquisition hardware characteristics on performance and 
associated minimum specifications.
    (iii) Software documentation must include a cybersecurity 
vulnerability and management process to assure software functionality.
    (iv) Software documentation must include mitigation measures to 
manage failure of any subsystem components with respect to incorrect 
patient reports and operator failures.
    (2) Clinical performance data supporting the indications for use 
must be provided, including the following:
    (i) Clinical performance testing must evaluate sensitivity, 
specificity, positive predictive value, and negative predictive value 
for each endpoint reported for the indicated disease or condition across 
the range of available device outcomes.
    (ii) Clinical performance testing must evaluate performance under 
anticipated conditions of use.
    (iii) Statistical methods must include the following:
    (A) Where multiple samples from the same patient are used, 
statistical analysis must not assume statistical independence without 
adequate justification.
    (B) Statistical analysis must provide confidence intervals for each 
performance metric.
    (iv) Clinical data must evaluate the variability in output 
performance due to both the user and the image acquisition device used.
    (3) A training program with instructions on how to acquire and 
process quality images must be provided.
    (4) Human factors validation testing that evaluates the effect of 
the training program on user performance must be provided.
    (5) A protocol must be developed that describes the level of change 
in device technical specifications that could significantly affect the 
safety or effectiveness of the device.
    (6) Labeling must include:
    (i) Instructions for use, including a description of how to obtain 
quality images and how device performance is affected by user 
interaction and user training;
    (ii) The type of imaging data used, what the device outputs to the 
user, and whether the output is qualitative or quantitative;
    (iii) Warnings regarding image acquisition factors that affect image 
quality;
    (iv) Warnings regarding interpretation of the provided outcomes, 
including:
    (A) A warning that the device is not to be used to screen for the 
presence of diseases or conditions beyond its indicated uses;
    (B) A warning that the device provides a screening diagnosis only 
and that it is critical that the patient be advised to receive followup 
care; and
    (C) A warning that the device does not treat the screened disease;
    (v) A summary of the clinical performance of the device for each 
output, with confidence intervals; and
    (vi) A summary of the clinical performance testing conducted with 
the device, including a description of the patient population and 
clinical environment under which it was evaluated.

[87 FR 3205, Jan. 21, 2022]



Sec. 886.1120  Ophthalmic camera.

    (a) Identification. An ophthalmic camera is an AC-powered device 
intended to take photographs of the eye and the surrounding area.
    (b) Classification. Class II (special controls). The device, when it 
is a photorefractor or a general-use ophthalmic camera, is exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 886.9.

[55 FR 48441, Nov. 20, 1990, as amended at 84 FR 71817, Dec. 30, 2019]



Sec. 886.1140  Ophthalmic chair.

    (a) Identification. An ophthalmic chair is an AC-powered or manual 
device with adjustable positioning in

[[Page 710]]

which a patient is to sit or recline during ophthalmological examination 
or treatment.
    (b) Classification. Class I. The AC-powered device and the manual 
device are exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter, subject to the limitations in Sec. 
886.9. The manual device is also exempt from the current good 
manufacturing practice requirements of the quality system regulation in 
part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.

[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 
FR 38810, July 25, 2001]



Sec. 886.1150  Visual acuity chart.

    (a) Identification. A visual acuity chart is a device that is a 
chart, such as a Snellen chart with block letters or other symbols in 
graduated sizes, intended to test visual acuity.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988; 
53 FR 40825, Oct. 18, 1988; 66 FR 38810, July 25, 2001]



Sec. 886.1160  Color vision plate illuminator.

    (a) Identification. A color vision plate illuminator is an AC-
powered device that is a lamp intended to properly illuminate color 
vision testing plates. It may include a filter.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 
FR 38810, July 25, 2001]



Sec. 886.1170  Color vision tester.

    (a) Identification. A color vision tester is a device that consists 
of various colored materials, such as colored yarns or color vision 
plates (multicolored plates which patients with color vision deficiency 
would perceive as being of one color), intended to evaluate color 
vision.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988; 
66 FR 38810, July 25, 2001]



Sec. 886.1190  Distometer.

    (a) Identification. A distometer is a device intended to measure the 
distance between the cornea and a corrective lens during refraction to 
help measure the change of the visual image when a lens is in place.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988; 
66 FR 38810, July 25, 2001]

[[Page 711]]



Sec. 886.1200  Optokinetic drum.

    (a) Identification. An optokinetic drum is a drum-like device 
covered with alternating white and dark stripes or pictures that can be 
rotated on its handle. The device is intended to elicit and evaluate 
nystagmus (involuntary rapid movement of the eyeball) in patients.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 
66 FR 38810, July 25, 2001]



Sec. 886.1220  Corneal electrode.

    (a) Identification. A corneal electrode is an AC-powered device, 
usually part of a special contact lens, intended to be applied directly 
to the cornea to provide data showing the changes in electrical 
potential in the retina after electroretinography (stimulation by 
light).
    (b) Classification. Class II.



Sec. 886.1250  Euthyscope.

    (a) Identification. A euthyscope is a device that is a modified AC-
powered or battery-powered ophthalmoscope (a perforated mirror device 
intended to inspect the interior of the eye) that projects a bright 
light encompassing an arc of about 30 degrees onto the fundus of the 
eye. The center of the light bundle is blocked by a black disk covering 
the fovea (the central depression of the macular retinae where only 
cones are present and blood vessels are lacking). The device is intended 
for use in the treatment of amblyopia (dimness of vision without 
apparent disease of the eye).
    (b) Classification. (1) Class I (general controls) for the battery-
powered device. The battery-powered device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 886.9.
    (2) Class II (special controls) for the AC-powered device. The AC-
powered device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec. 886.9.

[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 
FR 38810, July 25, 2001; 84 FR 71817, Dec. 30, 2019]



Sec. 886.1270  Exophthalmometer.

    (a) Identification. An exophthalmometer is a device, such as a 
ruler, gauge, or caliper, intended to measure the degree of exophthalmos 
(abnormal protrusion of the eyeball).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 
66 FR 38810, July 25, 2001]



Sec. 886.1290  Fixation device.

    (a) Identification. A fixation device is an AC-powered device 
intended for use as a fixation target for the patient during 
ophthalmological examination. The patient directs his or her gaze so 
that the visual image of the object falls on the fovea centralis (the 
center of the macular retina of the eye.)
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 
FR 38810, July 25, 2001]



Sec. 886.1300  Afterimage flasher.

    (a) Identification. An afterimage flasher is an AC-powered light 
that automatically switches on and off to allow performance of an 
afterimage test in which the patient indicates the positions of 
afterimages after the light is off. The device is intended to determine 
harmonious/anomalous retinal correspondence (the condition in which 
corresponding points on the retina have the same directional value).

[[Page 712]]

    (b) Classification. Class II.

[55 FR 48441, Nov. 20, 1990]



Sec. 886.1320  Fornixscope.

    (a) Identification. A fornixscope is a device intended to pull back 
and hold open the eyelid to aid examination of the conjunctiva.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 
66 FR 38810, July 25, 2001]



Sec. 886.1330  Amsler grid.

    (a) Identification. An Amsler grid is a device that is a series of 
charts with grids of different sizes that are held at 30 centimeters 
distance from the patient and intended to rapidly detect central and 
paracentral irregularities in the visual field.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 
66 FR 38810, July 25, 2001]



Sec. 886.1340  Haploscope.

    (a) Identification. A haploscope is an AC-powered device that 
consists of two movable viewing tubes, each containing a slide carrier, 
a low-intensity light source for the illumination of the slides, and a 
high-intensity light source for creating afterimages. The device is 
intended to measure strabismus (eye muscle imbalance), to assess 
binocular vision (use of both eyes to see), and to treat suppression and 
amblyopia (dimness of vision without any apparent disease of the eye).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 
FR 38810, July 25, 2001]



Sec. 886.1342  Strabismus detection device.

    (a) Identification. A strabismus detection device is a prescription 
device designed to simultaneously illuminate both eyes with polarized 
light for automated detection of strabismus by analyzing foveal 
birefringence properties.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must demonstrate the device 
performs as intended under anticipated conditions of use. Testing must 
be conducted in a representative patient population and clinical setting 
for the indicated use. Demonstration of clinical performance must 
include assessment of sensitivity and specificity compared to a clearly 
defined reference standard (e.g., comprehensive ophthalmological 
examination comprises age-appropriate visual acuity testing, examination 
of the external ocular adnexae and orbit, anterior segment evaluation, 
extraocular motility evaluation, assessment of stereopsis, cycloplegic 
refraction, and dilated fundus examination).
    (2) Non-clinical performance testing must demonstrate the device 
performs as intended under anticipated conditions of use. The following 
technical characteristics must be evaluated:
    (i) Verification of lowest detectable amount of deviation; and
    (ii) Validation of the accuracy and precision at the lowest 
detectable amount of deviation.
    (3) Software verification, validation, and hazard analysis must be 
performed.
    (4) Optical radiation safety testing must demonstrate the device is 
safe per the directions for use.

[[Page 713]]

    (5) Performance testing must demonstrate the electromagnetic 
compatibility of the device.
    (6) Performance testing must demonstrate the electrical safety of 
the device.
    (7) Labeling must include the following:
    (i) Summaries of non-clinical and clinical performance testing;
    (ii) Instructions on how to correctly use and maintain the device;
    (iii) Instructions and explanation of all user-interface components; 
and
    (iv) Information related to electromagnetic compatibility and 
optical radiation classification.

[81 FR 65280, Sept. 22, 2016]



Sec. 886.1350  Keratoscope.

    (a) Identification. A keratoscope is an AC-powered or battery-
powered device intended to measure and evaluate the corneal curvature of 
the eye. Lines and circles within the keratoscope are used to observe 
the corneal reflex. This generic type of device includes the 
photokeratoscope which records corneal curvature by taking photographs 
of the cornea.
    (b) The device is exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter subject to Sec. 886.9. The 
battery-powered device is exempt from the current good manufacturing 
practice requirements of the quality system regulation in part 820 of 
this chapter, with the exception of Sec. 820.180 of this chapter, with 
respect to general requirements concerning records, and Sec. 820.198 of 
this chapter, with respect to complaint files

[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 65 
FR 2320, Jan. 14, 2000]



Sec. 886.1360  Visual field laser instrument.

    (a) Identification. A visual field laser instrument is an AC-powered 
device intended to provide visible laser radiation that produces an 
interference pattern on the retina to evaluate retinal function.
    (b) Classification. Class II.



Sec. 886.1375  Bagolini lens.

    (a) Identification. A Bagolini lens is a device that consists of a 
plane lens containing almost imperceptible striations that do not 
obscure visualization of objects. The device is placed in a trial frame 
and intended to determine harmonious/anomalous retinal correspondence (a 
condition in which corresponding points on the retina have the same 
directional values).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 
66 FR 38810, July 25, 2001]



Sec. 886.1380  Diagnostic condensing lens.

    (a) Identification. A diagnostic condensing lens is a device used in 
binocular indirect ophthalmoscopy (a procedure that produces an inverted 
or reversed direct magnified image of the eye) intended to focus 
reflected light from the fundus of the eye.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 
66 FR 38810, July 25, 2001]



Sec. 886.1385  Polymethylmethacrylate (PMMA) diagnostic contact lens.

    (a) Identification. A polymethylmethacrylate (PMMA) diagnostic 
contact lens is a device that is a

[[Page 714]]

curved shell of PMMA intended to be applied for a short period of time 
directly on the globe or cornea of the eye for diagnosis or therapy of 
intraocular abnormalities.
    (b) Classification. Class II.



Sec. 886.1390  Flexible diagnostic Fresnel lens.

    (a) Identification. A flexible diagnostic Fresnel lens is a device 
that is a very thin lens which has its surface a concentric series of 
increasingly refractive zones. The device is intended to be applied to 
the back of the spectacle lenses of patients with aphakia (absence of 
the lens of the eye).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 
66 FR 38811, July 25, 2001]



Sec. 886.1395  Diagnostic Hruby fundus lens.

    (a) Identification. A diagnostic Hruby fundus lens is a device that 
is a 55 diopter lens intended for use in the examination of the vitreous 
body and the fundus of the eye under slitlamp illumination and 
magnification.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 
66 FR 38811, July 25, 2001]



Sec. 886.1400  Maddox lens.

    (a) Identification. A Maddox lens is a device that is a series of 
red cylinders that change the size, shape, and color of an image. The 
device is intended to be handheld or placed in a trial frame to evaluate 
eye muscle dysfunction.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 
66 FR 38811, July 25, 2001]



Sec. 886.1405  Ophthalmic trial lens set.

    (a) Identification. An ophthalmic trial lens set is a device that is 
a set of lenses of various dioptric powers intended to be handheld or 
inserted in a trial frame for vision testing to determine refraction.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 61 FR 1124, Jan. 16, 1996; 66 
FR 38811, July 25, 2001]



Sec. 886.1410  Ophthalmic trial lens clip.

    (a) Identification. An ophthalmic trial lens clip is a device 
intended to hold prisms, spheres, cylinders, or occluders on a trial 
frame or spectacles for vision testing.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 
66 FR 38811, July 25, 2001]

[[Page 715]]



Sec. 886.1415  Ophthalmic trial lens frame.

    (a) Identification. An opthalmic trial lens frame is a mechanical 
device intended to hold trial lenses for vision testing.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 
66 FR 38811, July 25, 2001]



Sec. 886.1420  Ophthalmic lens gauge.

    (a) Identification. An ophthalmic lens gauge is a calibrated device 
intended to manually measure the curvature of a spectacle lens.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 
66 FR 38811, July 25, 2001]



Sec. 886.1425  Lens measuring instrument.

    (a) Identification. A lens measuring instrument is an AC-powered 
device intended to measure the power of lenses, prisms, and their 
centers (e.g., lensometer).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 
FR 38811, July 25, 2001]



Sec. 886.1430  Ophthalmic contact lens radius measuring device.

    (a) Identification. An ophthalmic contact lens radius measuring 
device is an AC-powered device that is a microscope and dial gauge 
intended to measure the radius of a contact lens.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 
FR 38811, July 25, 2001]



Sec. 886.1435  Maxwell spot.

    (a) Identification. A Maxwell spot is an AC-powered device that is a 
light source with a red and blue filter intended to test macular 
function.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 
FR 38811, July 25, 2001]



Sec. 886.1450  Corneal radius measuring device.

    (a) Identification. A corneal radius measuring device is an AC-
powered device intended to measure corneal size by superimposing the 
image of the cornea on a scale at the focal length of the lens of a 
small, hand held, single tube penscope or eye gauge magnifier.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9, only when the 
device does not include computer software in the unit or topographers.

[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 
FR 38811, July 25, 2001]



Sec. 886.1460  Stereopsis measuring instrument.

    (a) Identification. A stereopsis measuring instrument is a device 
intended to measure depth perception by illumination of objects placed 
on different planes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current

[[Page 716]]

good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180, with respect to general requirements concerning records, and 
Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 
66 FR 38811, July 25, 2001]



Sec. 886.1500  Headband mirror.

    (a) Identification. A headband mirror is a device intended to be 
strapped to the head of the user to reflect light for use in examination 
of the eye.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 
66 FR 38811, July 25, 2001]



Sec. 886.1510  Eye movement monitor.

    (a) Identification. An eye movement monitor is an AC-powered device 
with an electrode intended to measure and record ocular movements.
    (b) Classification. Class II.



Sec. 886.1570  Ophthalmoscope.

    (a) Identification. An ophthalmoscope is an AC-powered or battery-
powered device containing illumination and viewing optics intended to 
examine the media (cornea, aqueous, lens, and vitreous) and the retina 
of the eye.
    (b) Classification. Class II (special controls). The device, when it 
is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a 
hand-held ophthalmoscope replacement battery, is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019]



Sec. 886.1605  Perimeter.

    (a) Identification. A perimeter is an AC-powered or manual device 
intended to determine the extent of the peripheral visual field of a 
patient. The device projects light on various points of a curved 
surface, and the patient indicates whether he or she sees the light.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[55 FR 48442, Nov. 20, 1990, as amended at 66 FR 38811, July 25, 2001]



Sec. 886.1630  AC-powered photostimulator.

    (a) Identification. An AC-powered photostimulator is an AC-powered 
device intended to provide light stimulus which allows measurement of 
retinal or visual function by perceptual or electrical methods (e.g., 
stroboscope).
    (b) Classification. Class II.



Sec. 886.1640  Ophthalmic preamplifier.

    (a) Identification. An ophthalmic preamplifier is an AC-powered or 
battery-powered device intended to amplify electrical signals from the 
eye in electroretinography (recording retinal action currents from the 
surface of the eyeball after stimulation by light), electrooculography 
(testing for retinal dysfunction by comparing the standing potential in 
the front and the back of the eyeball), and electromyography (recording 
electrical currents generated in active muscle).
    (b) Classification. Class II.



Sec. 886.1650  Ophthalmic bar prism.

    (a) Identification. An ophthalmic bar prism is a device that is a 
bar composed of fused prisms of gradually increasing strengths intended 
to measure latent and manifest strabismus (eye muscle deviation) or the 
power of fusion of a patient's eyes.

[[Page 717]]

    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 
66 FR 38812, July 25, 2001]



Sec. 886.1655  Ophthalmic Fresnel prism.

    (a) Identification. An ophthalmic Fresnel prism is a device that is 
a thin plastic sheet with embossed rulings which provides the optical 
effect of a prism. The device is intended to be applied to spectacle 
lenses to give a prismatic effect.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 
66 FR 38812, July 25, 2001]



Sec. 886.1660  Gonioscopic prism.

    (a) Identification. A gonioscopic prism is a device that is a prism 
intended to be placed on the eye to study the anterior chamber. The 
device may have angled mirrors to facilitate visualization of anatomical 
features.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 
59 FR 63013, Dec. 7, 1994; 66 FR 38812, July 25, 2001]



Sec. 886.1665  Ophthalmic rotary prism.

    (a) Identification. An ophthalmic rotary prism is a device with 
various prismatic powers intended to be handheld and used to measure 
ocular deviation in patients with latent or manifest strabismus (eye 
muscle deviation).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 
66 FR 38812, July 25, 2001]



Sec. 886.1670  Ophthalmic isotope uptake probe.

    (a) Identification. An ophthalmic isotope uptake probe is an AC-
powered device intended to measure, by a probe which is placed in close 
proximity to the eye, the uptake of a radioisotope (phosphorus 32) by 
tumors to detect tumor masses on, around, or within the eye.
    (b) Classification. Class II.



Sec. 886.1680  Ophthalmic projector.

    (a) Identification. An ophthalmic projector is an AC-powered device 
intended to project an image on a screen for vision testing.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 
FR 38812, July 25, 2001]



Sec. 886.1690  Pupillograph.

    (a) Identification. A pupillograph is an AC-powered device intended 
to measure the pupil of the eye by reflected light and record the 
responses of the pupil.

[[Page 718]]

    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 
FR 38812, July 25, 2001]



Sec. 886.1700  Pupillometer.

    (a) Identification. A pupillometer is an AC-powered or manual device 
intended to measure by reflected light the width or diameter of the 
pupil of the eye.
    (b) Classification. Class I (general controls). The AC-powered 
device and the manual device are exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter, subject to the 
limitations in Sec. 886.9. The manual device is also exempt from the 
current good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180, with respect to general requirements concerning records, and 
Sec. 820.198, with respect to complaint files.

[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 
FR 38812, July 25, 2001]



Sec. 886.1750  Skiascopic rack.

    (a) Identification. A skiascopic rack is a device that is a rack and 
a set of attached ophthalmic lenses of various dioptric strengths 
intended as an aid in refraction.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 61 FR 1124, Jan. 16, 1996; 66 
FR 38812, July 25, 2001]



Sec. 886.1760  Ophthalmic refractometer.

    (a) Identification. An ophthalmic refractometer is an automatic AC-
powered device that consists of a fixation system, a measurement and 
recording system, and an alignment system intended to measure the 
refractive power of the eye by measuring light reflexes from the retina.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 61 FR 1124, Jan. 16, 1996; 66 
FR 38812, July 25, 2001]



Sec. 886.1770  Manual refractor.

    (a) Identification. A manual refractor is a device that is a set of 
lenses of varous dioptric powers intended to measure the refractive 
error of the eye.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 
66 FR 38812, July 25, 2001]



Sec. 886.1780  Retinoscope.

    (a) Identification. A retinoscope is an AC-powered or battery-
powered device intended to measure the refraction of the eye by 
illuminating the retina and noting the direction of movement of the 
light on the retinal surface and of the refraction by the eye of the 
emergent rays.
    (b) Classification. (1) Class II (special controls) for the AC-
powered device. The device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec. 886.9.
    (2) Class I (general controls) for the battery-powered device. The 
class I battery-powered device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to Sec. 
886.9. The battery-powered device is exempt from the current good 
manufacturing practice requirements of the quality system regulation in 
part 820 of this chapter, with the exception of Sec. 820.180 of this 
chapter, with respect to general requirements concerning records, and 
Sec. 820.198 of this

[[Page 719]]

chapter, with respect to complaint files.

[55 FR 48442, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990, as amended at 
65 FR 2320, Jan. 14, 2000; 84 FR 71817, Dec. 30, 2019]



Sec. 886.1790  Nearpoint ruler.

    (a) Identification. A nearpoint ruler is a device calibrated in 
centimeters intended to measure the nearpoint of convergence (the point 
to which the visual lines are directed when convergence is at its 
maximum).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 
53 FR 40825, Oct. 18, 1988; 66 FR 38812, July 25, 2001]



Sec. 886.1800  Schirmer strip.

    (a) Identification. A Schirmer strip is a device made of filter 
paper or similar material intended to be inserted under a patient's 
lower eyelid to stimulate and evaluate formation of tears.
    (b) Classification. Class I (general controls). If the device is 
made of the same materials that were used in the device before May 28, 
1976, the device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter, subject to the limitations in 
Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 
66 FR 38812, July 25, 2001]



Sec. 886.1810  Tangent screen (campimeter).

    (a) Identification. A tangent screen (campimeter) is an AC-powered 
or battery-powered device that is a large square cloth chart with a 
central mark of fixation intended to map on a flat surface the central 
30 degrees of a patient's visual field. This generic type of device 
includes projection tangent screens, target tangent screens and targets, 
felt tangent screens, and stereo campimeters.
    (b) Classification. Class I (general controls). The AC-powered 
device and the battery-powered device are exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter, 
subject to the limitations in Sec. 886.9. The battery-powered device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 
FR 38812, July 25, 2001]



Sec. 886.1840  Simulatan (including crossed cylinder).

    (a) Identification. A simulatan (including crossed cylinder) is a 
device that is a set of pairs of cylinder lenses that provides various 
equal plus and minus refractive strengths. The lenses are arranged so 
that the user can exchange the positions of plus and minus cylinder 
lenses of equal strengths. The device is intended for subjective 
refraction (refraction in which the patient judges whether a given 
object is clearly in focus, as the examiner uses different lenses).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 
66 FR 38812, July 25, 2001]

[[Page 720]]



Sec. 886.1850  AC-powered slitlamp biomicroscope.

    (a) Identification. An AC-powered slitlamp biomicroscope is an AC-
powered device that is a microscope intended for use in eye examination 
that projects into a patient's eye through a control diaphragm a thin, 
intense beam of light.
    (b) Classification. Class II (special controls). The device, when it 
is intended only for the visual examination of the anterior segment of 
the eye, is classified as Group 1 per FDA-recognized consensus standard 
ANSI Z80.36, does not provide any quantitative output, and is not 
intended for screening or automated diagnostic indications, is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019]



Sec. 886.1860  Ophthalmic instrument stand.

    (a) Identification. An ophthalmic instrument stand is an AC-powered 
or nonpowered device intended to store ophthalmic instruments in a 
readily accessible position.
    (b) Classification. Class I (general controls). The AC-powered 
device and the battery-powered device are exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter, 
subject to the limitations in Sec. 886.9. The battery-powered device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 
FR 38812, July 25, 2001]



Sec. 886.1870  Stereoscope.

    (a) Identification. A stereoscope is an AC-powered or battery-
powered device that combines the images of two similar objects to 
produce a three-dimensional appearance of solidity and relief. It is 
intended to measure the angle of strabismus (eye muscle deviation), 
evaluate binocular vision (usage of both eyes to see), and guide a 
patient's corrective exercises of eye muscles.
    (b) Classification. Class I (general controls). The AC-powered 
device and the battery-powered device are exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter, 
subject to the limitations in Sec. 886.9. The battery-powered device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 
FR 38813, July 25, 2001]



Sec. 886.1880  Fusion and stereoscopic target.

    (a) Identification. A fusion and stereoscopic target is a device 
intended for use as a viewing object with a stereoscope (Sec. 
886.1870).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 
66 FR 38813, July 25, 2001]



Sec. 886.1905  Nystagmus tape.

    (a) Identification. Nystagmus tape is a device that is a long, 
narrow strip of fabric or other flexible material on which a series of 
objects are printed. The device is intended to be moved across a 
patient's field of vision to elicit optokinetic nystagmus (abnormal and 
irregular eye movements) and to test for blindness.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 721]]

subpart E of part 807 of this chapter, subject to the limitations in 
Sec. 886.9. The device is also exempt from the current good 
manufacturing practice requirements of the quality system regulation in 
part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 
66 FR 38813, July 25, 2001]



Sec. 886.1910  Spectacle dissociation test system.

    (a) Identification. A spectacle dissociation test system is an AC-
powered or battery-powered device, such as a Lancaster test system, that 
consists of a light source and various filters, usually red or green 
filters, intended to subjectively measure imbalance of ocular muscles.
    (b) Classification. Class I (general controls). The AC-powered 
device and the battery-powered device are exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter, 
subject to the limitations in Sec. 886.9. The battery-powered device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[55 FR 48442, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990, as amended at 
59 FR 63013, Dec. 7, 1994; 66 FR 38813, July 25, 2001]



Sec. 886.1925  Diurnal pattern recorder system.

    (a) Identification. A diurnal pattern recorder system is a 
nonimplantable, prescription device incorporating a telemetric sensor to 
detect changes in ocular dimension for monitoring diurnal patterns of 
intraocular pressure (IOP) fluctuations.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance data must demonstrate that the device and 
all of its components perform as intended under anticipated conditions 
of use. The following performance characteristics must be demonstrated:
    (i) Ability of the device to detect diurnal changes.
    (ii) Tolerability of the system at the corneoscleral interface in 
the intended use population.
    (2) Nonclinical testing must validate measurements in an appropriate 
nonclinical testing model to ensure ability to detect changes in 
intraocular pressure.
    (3) Patient-contacting components must be demonstrated to be 
biocompatible.
    (4) Any component that is intended to contact the eye must be 
demonstrated to be sterile throughout its intended shelf life.
    (5) Software verification, validation, and hazard analysis must be 
performed.
    (6) Performance testing must demonstrate the electromagnetic 
compatibility and electromagnetic interference of the device.
    (7) Performance testing must demonstrate electrical safety of the 
device.
    (8) Labeling must include the following:
    (i) Warning against activities and environments that may put the 
user at greater risk.
    (ii) Specific instructions for the safe use of the device, which 
includes:
    (A) Description of all device components and instructions for 
assembling the device;
    (B) Explanations of all available programs and instructions for 
their use;
    (C) Instructions and explanation of all user-interface components;
    (D) Instructions on all safety features of the device; and
    (E) Instructions for properly maintaining the device.
    (iii) A summary of nonclinical testing information to describe EMC 
safety considerations.
    (iv) A summary of safety information obtained from clinical testing.
    (v) Patient labeling to convey information regarding appropriate use 
of device.

[81 FR 34270, May 31, 2016]



Sec. 886.1930  Tonometer and accessories.

    (a) Identification. A tonometer and accessories is a manual device 
intended

[[Page 722]]

to measure intraocular pressure by applying a known force on the globe 
of the eye and measuring the amount of indentation produced (Schiotz 
type) or to measure intraocular tension by applanation (applying a small 
flat disk to the cornea). Accessories for the device may include a 
tonometer calibrator or a tonograph recording system. The device is 
intended for use in the diagnosis of glaucoma.
    (b) Classification. Class II.



Sec. 886.1940  Tonometer sterilizer.

    (a) Identification. A tonometer sterilizer is an AC-powered device 
intended to heat sterilize a tonometer (a device used to measure 
intraocular pressure).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 886.9.

[55 FR 48443, Nov. 20, 1990, as amended at 65 FR 2321, Jan. 14, 2000]



Sec. 886.1945  Transilluminator.

    (a) Identification. A transilluminator is an AC-powered or battery-
powered device that is a light source intended to transmit light through 
tissues to aid examination of patients.
    (b) Classification. (1) Class I (general controls) for the battery-
powered device. The battery-powered device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 886.9.
    (2) Class II (special controls) for the AC-powered device. The AC-
powered device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec. 886.9.

[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 
FR 38813, July 25, 2001; 84 FR 71817, Dec. 30, 2019]

Subpart C [Reserved]



                      Subpart D_Prosthetic Devices



Sec. 886.3100  Ophthalmic tantalum clip.

    (a) Identification. An ophthalmic tantalum clip is a malleable 
metallic device intended to be implanted permanently or temporarily to 
bring together the edges of a wound to aid healing or prevent bleeding 
from small blood vessels in the eye.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 63 FR 59230, Nov. 3, 1998]



Sec. 886.3130  Ophthalmic conformer.

    (a) Identification. An ophthalmic conformer is a device usually made 
of molded plastic intended to be inserted temporarily between the 
eyeball and eyelid to maintain space in the orbital cavity and prevent 
closure or adhesions during the healing process following surgery. ]
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 63 FR 59230, Nov. 3, 1998]



Sec. 886.3200  Artificial eye.

    (a) Identification. An artificial eye is a device resembling the 
anterior portion of the eye, usually made of glass or plastic, intended 
to be inserted in a patient's eye socket anterior to an orbital implant, 
or the eviscerated eyeball, for cosmetic purposes. The device is not 
intended to be implanted.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9, if the device 
is made from the same materials, has the same chemical composition, and 
uses the same manufacturing processes as currently legally marketed 
devices.

[61 FR 1124, Jan. 16, 1996, as amended at 66 FR 38813, July 25, 2001]



Sec. 886.3300  Absorbable implant (scleral buckling method).

    (a) Identification. An absorbable implant (scleral buckling method) 
is a device intended to be implanted on the sclera to aid retinal 
reattachment.
    (b) Classification. Class II.

[[Page 723]]



Sec. 886.3320  Eye sphere implant.

    (a) Identification. An eye sphere implant is a device intended to be 
implanted in the eyeball to occupy space following the removal of the 
contents of the eyeball with the sclera left intact.
    (b) Classification. Class II (special controls). The device, when it 
is an ocular peg which is supplied sterile only, is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019]



Sec. 886.3340  Extraocular orbital implant.

    (a) Identification. An extraocular orbital implant is a 
nonabsorbable device intended to be implanted during scleral surgery for 
buckling or building up the floor of the eye, usually in conjunction 
with retinal reattachment. Injectable substances are excluded.
    (b) Classification. Class II.



Sec. 886.3400  Keratoprosthesis.

    (a) Identification. A keratoprosthesis is a device intended to 
provide a transparent optical pathway through an opacified cornea, 
either intraoperatively or permanently, in an eye that is not a 
reasonable candidate for a corneal transplant.
    (b) Classification. Class II. The special controls for this device 
are FDA's:
    (1) ``Use of International Standard ISO 10993 `Biological Evaluation 
of Medical Devices--Part I: Evaluation and Testing,' ''
    (2) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),'' and
    (3) ``Guidance on 510(k) Submissions for Keratoprostheses.''

[65 FR 17147, Mar. 31, 2000]



Sec. 886.3600  Intraocular lens.

    (a) Identification. An intraocular lens is a device made of 
materials such as glass or plastic intended to be implanted to replace 
the natural lens of an eye.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. As of May 
28, 1976, an approval under section 515 of the act is required before 
this device may be commercially distributed. See Sec. 886.3.



Sec. 886.3800  Scleral shell.

    (a) Identification. A scleral shell is a device made of glass or 
plastic that is intended to be inserted for short time periods over the 
cornea and proximal-cornea sclera for cosmetic or reconstructive 
purposes. An artificial eye is usually painted on the device. The device 
is not intended to be implanted.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 63 FR 59230, Nov. 3, 1998]



Sec. 886.3920  Aqueous shunt.

    (a) Identification. An aqueous shunt is an implantable device 
intended to reduce intraocular pressure in the anterior chamber of the 
eye in patients with neovascular glaucoma or with glaucoma when medical 
and conventional surgical treatments have failed.
    (b) Classification. Class II. The special controls for this device 
are FDA's:
    (1) ``Use of International Standard ISO 10993 `Biological Evaluation 
of Medical Devices--Part I: Evaluation and Testing,' ''
    (2) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),'' and
    (3) ``Aqueous Shunts--510(k) Submissions.''

[65 FR 17147, Mar. 31, 2000, as amended at 66 FR 18542, Apr. 10, 2001]



                       Subpart E_Surgical Devices



Sec. 886.4070  Powered corneal burr.

    (a) Identification. A powered corneal burr is an AC-powered or 
battery-powered device that is a motor and drilling tool intended to 
remove rust rings from the cornea of the eye.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 886.9.

[55 FR 48443, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990, as amended at 
65 FR 2321, Jan. 14, 2000; 84 FR 71817, Dec. 30, 2019]

[[Page 724]]



Sec. 886.4100  Radiofrequency electrosurgical cautery apparatus.

    (a) Identification. A radiofrequency electrosurgical cautery 
apparatus is an AC-powered or battery-powered device intended for use 
during ocular surgery to coagulate tissue or arrest bleeding by a high 
frequency electric current.
    (b) Classification. Class II.



Sec. 886.4115  Thermal cautery unit.

    (a) Identification. A thermal cautery unit is an AC-powered or 
battery-powered device intended for use during ocular surgery to 
coagulate tissue or arrest bleeding by heat conducted through a wire 
tip.
    (b) Classification. Class II.



Sec. 886.4150  Vitreous aspiration and cutting instrument.

    (a) Identification. A vitreous aspiration and cutting instrument is 
an electrically powered device, which may use ultrasound, intended to 
remove vitreous matter from the vitreous cavity or remove a crystalline 
lens.
    (b) Classification. Class II (special controls). The device, when it 
is phacofragmentation unit replacement tubing, is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019]



Sec. 886.4155  Scleral plug.

    (a) Identification. A scleral plug is a prescription device intended 
to provide temporary closure of a scleral incision during an ophthalmic 
surgical procedure. These plugs prevent intraocular fluid and pressure 
loss when instruments are withdrawn from the eye. Scleral plugs include 
a head portion remaining above the sclera, which can be gripped for 
insertion and removal, and a shaft that fits inside the scleral 
incision. Scleral plugs are removed before completing the surgery.
    (b) Classification. Class II (special controls). The special 
controls for the scleral plug are as follows:
    (1) The device is exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter subject to the limitations in 
Sec. 886.9 if the material is a surgical grade stainless steel with or 
without a gold, silver, or titanium coating. The special controls for 
the surgical grade stainless steel scleral plug (with or without a gold, 
silver, or titanium coating) are:
    (i) The device must be demonstrated to be sterile during the labeled 
shelf life;
    (ii) The device must be demonstrated to be biocompatible; and
    (iii) Labeling must include all information required for the safe 
and effective use of the device, including specific instructions 
regarding the proper sizing, placement, and removal of the device.
    (2) The device is not exempt from premarket notification procedures 
if it is composed of a material other than surgical grade stainless 
steel (with or without a gold, silver, or titanium coating). The special 
controls for scleral plugs made of other materials are:
    (i) The device must be demonstrated to be sterile during the labeled 
shelf life;
    (ii) The device must be demonstrated to be biocompatible;
    (iii) Characterization of the device materials must be performed;
    (iv) Performance data must demonstrate acceptable mechanical 
properties under simulated clinical use conditions including insertion 
and removal of the device;
    (v) Performance data must demonstrate adequately low levels of the 
extractables or residues from manufacturing (or processing) of the 
device; and
    (vi) Labeling must include all information required for the safe and 
effective use of the device, including specific instructions regarding 
the proper sizing, placement, and removal of the device.

[78 FR 68715, Nov. 15, 2013]



Sec. 886.4170  Cryophthalmic unit.

    (a) Identification. A cryophthalmic unit is a device that is a probe 
with a small tip that becomes extremely cold through the controlled use 
of a refrigerant or gas. The device may be AC-powered. The device is 
intended to remove cataracts by the formation of an adherent ice ball in 
the lens, to freeze

[[Page 725]]

the eye and adjunct parts for surgical removal of scars, and to freeze 
tumors.
    (b) Classification. Class II.



Sec. 886.4230  Ophthalmic knife test drum.

    (a) Identification. An ophthalmic knife test drum is a device 
intended to test the keenness of ophthalmic surgical knives to determine 
whether resharpening is needed.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 
66 FR 38813, July 25, 2001]



Sec. 886.4250  Ophthalmic electrolysis unit.

    (a) Identification. An ophthalmic electrolysis unit is an AC-powered 
or battery-powered device intended to destroy ocular hair follicles by 
applying a galvanic electrical current.
    (b) Classification. (1) Class I (general controls) for the battery-
powered device. The battery-powered device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 886.9.
    (2) Class II (special controls) for the AC-powered device. The AC-
powered device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec. 886.9.

[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 
FR 38813, July 25, 2001; 84 FR 71817, Dec. 30, 2019]



Sec. 886.4270  Intraocular gas.

    (a) Identification. An intraocular gas is a device consisting of a 
gaseous fluid intended to be introduced into the eye to place pressure 
on a detached retina.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. As of May 
28, 1976, an approval under section 515 of the act is required before 
this device may be commercially distributed. See Sec. 886.3.



Sec. 886.4275  Intraocular fluid.

    (a) Identification. An intraocular fluid is a device consisting of a 
nongaseous fluid intended to be introduced into the eye to aid 
performance of surgery, such as to maintain anterior chamber depth, 
preserve tissue integrity, protect tissue from surgical trauma, or 
function as a tamponade during retinal reattachment.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. As of May 
28, 1976, an approval under section 515 of the act is required before 
this device may be commercially distributed. See Sec. 886.3.



Sec. 886.4280  Intraocular pressure measuring device.

    (a) Identification. An intraocular pressure measuring device is a 
manual or AC-powered device intended to measure intraocular pressure. 
Also included are any devices found by FDA to be substantially 
equivalent to such devices. Accessories for the device may include 
calibrators or recorders. The device is intended for use in the 
diagnosis of glaucoma.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of PDP is required. As of May 
28, 1976, an approval under section 515 of the act is required before 
this device may be commercially distributed. See Sec. 886.3.



Sec. 886.4300  Intraocular lens guide.

    (a) Identification. An intraocular lens guide is a device intended 
to be inserted into the eye during surgery to direct the insertion of an 
intraocular lens and be removed after insertion is completed.
    (b) Classification. Class I (general controls). Except when used as 
folders or injectors for soft or foldable intraocular lenses, the device 
is exempt from the premarket notification procedures in subpart E of 
part 807 of this chapter subject to Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 65 FR 2321, 2000]

[[Page 726]]



Sec. 886.4335  Operating headlamp.

    (a) Identification. An operating headlamp is an AC-powered or 
battery-powered device intended to be worn on the user's head to provide 
a light source to aid visualization during surgical, diagnostic, or 
therapeutic procedures.
    (b) Classification. (1) Class I (general controls) for the battery-
powered device. The battery-powered device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 886.9.
    (2) Class II (special controls) for the AC-powered device. The AC-
powered device is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec. 886.9.

[55 FR 48443, Nov. 20, 1990, as amended at 66 FR 38813, July 25, 2001; 
84 FR 71817, Dec. 30, 2019]



Sec. 886.4350  Manual ophthalmic surgical instrument.

    (a) Identification. A manual ophthalmic surgical instrument is a 
nonpowered, handheld device intended to aid or perform ophthalmic 
surgical procedures. This generic type of device includes the manual 
corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, 
ophthalmic muscle clamp, iris retractor clip, orbital compressor, 
ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, 
erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere 
introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal 
probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, 
ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, 
enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic 
spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 
59 FR 63013, Dec. 7, 1994; 60 FR 15872, Mar. 28, 1995; 66 FR 38813, July 
25, 2001]



Sec. 886.4355  Corneal inlay inserter handle.

    (a) Identification. The corneal inlay inserter handle is a hand-held 
device intended to be used as an accessory to a corneal inlay inserter. 
The device extends the length of the inlay inserter to aid in delivering 
the inlay implant.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 886.9.

[84 FR 14870, Apr. 12, 2019]



Sec. 886.4360  Ocular surgery irrigation device.

    (a) Identification. An ocular surgery irrigation device is a device 
intended to be suspended over the ocular area during ophthalmic surgery 
to deliver continuous, controlled irrigation to the surgical field.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 
59 FR 63013, Dec. 7, 1994; 66 FR 38813, July 25, 2001]



Sec. 886.4370  Keratome.

    (a) Identification. A keratome is an AC-powered or battery-powered 
device intended to shave tissue from sections of the cornea for a 
lamellar (partial thickness) transplant.
    (b) Classification. Class I.

[55 FR 48443, Nov. 20, 1990]



Sec. 886.4390  Ophthalmic laser.

    (a) Identification. An ophthalmic laser is an AC-powered device 
intended to coagulate or cut tissue of the eye, orbit, or surrounding 
skin by a laser beam.
    (b) Classification. Class II.

[[Page 727]]



Sec. 886.4392  Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.

    (a) Identification. The Nd:YAG laser for posterior capsulotomy and 
peripheral iridotomy consists of a mode-locked or Q-switched solid state 
Nd:YAG laser intended for disruption of the posterior capsule or the 
iris via optical breakdown. The Nd:YAG laser generates short pulse, low 
energy, high power, coherent optical radiation. When the laser output is 
combined with focusing optics, the high irradiance at the target causes 
tissue disruption via optical breakdown. A visible aiming system is 
utilized to target the invisible Nd:YAG laser radiation on or in close 
proximity to the target tissue.
    (b) Classification. Class II (special controls). Design Parameters: 
Device must emit a laser beam with the following parameters: wavelength 
= 1064 nanometers; spot size = 50 to 100 micros; pulse width = 3 to 30 
nanoseconds; output energy per pulse = 0.5 to 15 millijoules (mJ); 
repetition rate = 1 to 10 pulses; and total energy = 20 to 120 mJ.

[65 FR 6894, Feb. 11, 2000]



Sec. 886.4400  Electronic metal locator.

    (a) Identification. An electronic metal locator is an AC-powered 
device with probes intended to locate metallic foreign bodies in the eye 
or eye socket.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019]



Sec. 886.4440  AC-powered magnet.

    (a) Identification. An AC-powered magnet is an AC-powered device 
that generates a magnetic field intended to find and remove metallic 
foreign bodies from eye tissue.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019]



Sec. 886.4445  Permanent magnet.

    (a) Identification. A permanent magnet is a nonelectric device that 
generates a magnetic field intended to find and remove metallic foreign 
bodies from eye tissue.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 
66 FR 38813, July 25, 2001]



Sec. 886.4570  Ophthalmic surgical marker.

    (a) Identification. An ophthalmic surgical marker is a device 
intended to mark by use of ink, dye, or indentation the location of 
ocular or scleral surgical manipulation.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 
59 FR 63013, Dec. 7, 1994; 66 FR 38813, July 25, 2001]



Sec. 886.4610  Ocular pressure applicator.

    (a) Identification. An ocular pressure applicator is a manual device 
that consists of a sphygmomanometer-type squeeze bulb, a dial indicator, 
a band, and bellows, intended to apply pressure on the eye in 
preparation for ophthalmic surgery.
    (b) Classification. Class II.



Sec. 886.4670  Phacofragmentation system.

    (a) Identification. A phacofragmentation system is an AC-powered 
device with a fragmenting needle intended for use in cataract surgery to 
disrupt a cataract with ultrasound and extract the cataract.
    (b) Classification. Class II.

[[Page 728]]



Sec. 886.4690  Ophthalmic photocoagulator.

    (a) Identification. An ophthalmic photocoagulator is an AC-powered 
device intended to use the energy from an extended noncoherent light 
source to occlude blood vessels of the retina, choroid, or iris.
    (b) Classification. Class II.



Sec. 886.4750  Ophthalmic eye shield.

    (a) Identification. An ophthalmic eye shield is a device that 
consists of a plastic or aluminum eye covering intended to protect the 
eye or retain dressing materials in place.
    (b) Classification. Class I (general controls). When made only of 
plastic or aluminum, the device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to Sec. 886.9. When made only of plastic or aluminum, the devices are 
exempt from the current good manufacturing practice requirements of the 
quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180 of this chapter, with respect to general 
requirements concerning records, and Sec. 820.198 of this chapter, with 
respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 63014, Dec. 7, 1994; 65 
FR 2321, Jan. 14, 2000]



Sec. 886.4770  Ophthalmic operating spectacles (loupes).

    (a) Identification. Ophthalmic operating spectacles (loupes) are 
devices that consist of convex lenses or lens systems intended to be 
worn by a surgeon to magnify the surgical site during ophthalmic 
surgery.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 
66 FR 38813, July 25, 2001]



Sec. 886.4790  Ophthalmic sponge.

    (a) Identification. An ophthalmic sponge is a device that is an 
absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, 
or other material intended to absorb fluids from the operative field in 
ophthalmic surgery.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019]



Sec. 886.4855  Ophthalmic instrument table.

    (a) Identification. An ophthalmic instrument table is an AC-powered 
or manual device on which ophthalmic instruments are intended to be 
placed.
    (b) Classification. Class I (general controls). The AC-powered 
device and the manual device are exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter, subject to the 
limitations in Sec. 886.9. The manual device is also exempt from the 
current good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180, with respect to general requirements concerning records, and 
Sec. 820.198, with respect to complaint files.

[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994; 66 
FR 38814, July 25, 2001]



                      Subpart F_Therapeutic Devices



Sec. 886.5100  Ophthalmic beta radiation source.

    (a) Identification. An ophthalmic beta radiation source is a device 
intended to apply superficial radiation to benign and malignant ocular 
growths.
    (b) Classification. Class II.



Sec. 886.5120  Low-power binocular loupe.

    (a) Identification. A low-power binocular loupe is a device that 
consists of

[[Page 729]]

two eyepieces, each with a lens or lens system, intended for medical 
purposes to magnify the appearance of objects.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 
66 FR 38814, July 25, 2001]



Sec. 886.5200  Eyelid thermal pulsation system.

    (a) Identification. An eyelid thermal pulsation system is an 
electrically-powered device intended for use in the application of 
localized heat and pressure therapy to the eyelids. The device is used 
in adult patients with chronic cystic conditions of the eyelids, 
including meibomian gland dysfunction (MGD), also known as evaporative 
dry eye or lipid deficiency dry eye. The system consists of a component 
that is inserted around the eyelids and a component to control the 
application of heat and pressure to the eyelids.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Appropriate analysis/testing should validate electromagnetic 
compatibility (EMC) and safety of exposure to non-ionizing radiation;
    (2) Design, description, and performance data should validate 
safeguards related to the temperature and pressure aspects of the 
device, including during fault conditions;
    (3) Performance data should demonstrate the sterility of patient-
contacting components and the shelf-life of these components;
    (4) The device should be demonstrated to be biocompatible; and
    (5) Performance data should demonstrate that any technological 
changes do not adversely effect safety and effectiveness.

[76 FR 51878, Aug. 19, 2011]



Sec. 886.5201  Intense pulsed light device for managing dry eye.

    (a) Identification. An intense pulsed light device for managing dry 
eye is a prescription device intended for use in the application of 
intense pulsed light therapy to the skin. The device is used in patients 
with dry eye disease due to meibomian gland dysfunction, also known as 
evaporative dry eye or lipid deficiency dry eye.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must evaluate adverse events and 
improvement of dry eye signs and symptoms under anticipated conditions 
of use.
    (2) Thermal safety assessment in a worst-case scenario must be 
performed to validate temperature safeguards.
    (3) Performance testing must demonstrate electrical safety and 
electromagnetic compatibility (EMC) of the device in the intended use 
environment.
    (4) Software verification, validation, and hazard analysis must be 
performed.
    (5) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (6) Physician and patient labeling must include:
    (i) Device technical parameters;
    (ii) A summary of the clinical performance testing conducted with 
the device;
    (iii) A description of the intended treatment area location;
    (iv) Warnings and instructions regarding the use of safety-
protective eyewear for patient and device operator;
    (v) A description of intense pulse light (IPL) radiation hazards and 
protection for patient and operator;
    (vi) Instructions for use, including an explanation of all user 
interface components; and
    (vii) Instructions on how to clean and maintain the device and its 
components.

[88 FR 3638, Jan. 20, 2023]



Sec. 886.5300  Tear electrostimulation device.

    (a) Identification. A tear electrostimulation device is a non-

[[Page 730]]

implantable, electrostimulation device intended to increase tear 
production.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance testing must assess the following 
electrical output specifications: waveforms, output modes, maximum 
output voltage, maximum output current, pulse duration, frequency, net 
charge per pulse, maximum phase charge at 500 ohms, maximum current 
density, maximum average current, and maximum average power density.
    (2) Patient-contacting components of the device must be demonstrated 
to be biocompatible.
    (3) Performance testing must demonstrate the electrical, thermal, 
and mechanical safety along with electromagnetic compatibility (EMC) of 
the device in the intended use environment.
    (4) Software verification, validation, and hazard analysis must be 
performed.
    (5) Physician and patient labeling must include:
    (i) Summaries of electrical stimulation parameters;
    (ii) Instructions on how to correctly use and maintain the device;
    (iii) Instructions and explanations of all user-interface 
components;
    (iv) Information related to electromagnetic compatibility 
classification; and
    (v) Instructions on how to clean the device.

[82 FR 60116, Dec. 19, 2017]



Sec. 886.5305  Electromechanical tear stimulator.

    (a) Identification. An electromechanical tear stimulator is a non-
implantable device intended to increase tear production via mechanical 
stimulation.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing under anticipated conditions of use 
must evaluate tear production and all adverse events, including tissue 
damage, pain, headache, and discomfort.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following must be conducted:
    (i) An assessment of mechanical output specifications, including 
vibration amplitude and frequency, pressure and force, and acoustic 
(noise level) properties;
    (ii) Mechanical safety testing to validate safeguards related to the 
pressure aspects of the device; and
    (iii) Use life testing.
    (3) Performance data must demonstrate the electrical safety, thermal 
safety, and electromagnetic compatibility (EMC) of all electrical 
components of the device.
    (4) All patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (5) Software verification, validation, and hazard analysis must be 
performed.
    (6) Physician and patient labeling must include:
    (i) A detailed summary of the device's technical parameters;
    (ii) Instructions for use, including an explanation of all user-
interface components and information regarding proper device placement;
    (iii) Information related to electromagnetic compatibility 
classification;
    (iv) Instructions on how to clean and maintain the device;
    (v) A summary of the clinical performance testing conducted with the 
device;
    (vi) Language to direct end users to contact the device manufacturer 
and MedWatch if they experience any adverse events with this device; and
    (vii) Information on how the device operates and the typical 
sensations experienced during treatment.

[87 FR 9243, Feb. 18, 2022]



Sec. 886.5310  Intranasal electrostimulation device for dry eye symptoms.

    (a) Identification. An intranasal electrostimulation device for dry 
eye symptoms is a prescription non-implantable, electrostimulation 
device intended to increase tear production for improvement in dry eye 
symptoms.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must evaluate improvement of dry 
eye

[[Page 731]]

symptoms under anticipated conditions of use.
    (2) Non-clinical performance testing must assess the following 
electrical output specifications: waveforms, output modes, maximum 
output voltage, maximum output current, pulse duration, frequency, net 
charge per pulse, maximum phase charge at 500 ohms, maximum current 
density, maximum average current, and maximum average power density.
    (3) Patient-contacting components of the device must be demonstrated 
to be biocompatible.
    (4) Performance testing must demonstrate the electrical, thermal, 
and mechanical safety along with electromagnetic compatibility (EMC) of 
the device in the intended use environment.
    (5) Software verification, validation, and hazard analysis must be 
performed.
    (6) Training for the proper use of the device must be provided.
    (7) Physician and patient labeling must include:
    (i) Summaries of electrical stimulation parameters;
    (ii) Instructions on how to correctly use and maintain the device;
    (iii) Instructions and explanations of all user-interface 
components;
    (iv) Information related to electromagnetic compatibility 
classification;
    (v) Instructions on how to clean the device; and
    (vi) Summaries of clinical performance testing demonstrating safety 
and effectiveness.

[83 FR 52975, Oct. 19, 2018]



Sec. 886.5420  Contact lens inserter/remover.

    (a) Identification. A contact lens inserter/remover is a handheld 
device intended to insert or remove contact lenses by surface adhesion 
or suction.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 
66 FR 38814, July 25, 2001]



Sec. 886.5540  Low-vision magnifier.

    (a) Identification. A low-vision magnifier is a device that consists 
of a magnifying lens intended for use by a patient who has impaired 
vision. The device may be held in the hand or attached to spectacles.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 
66 FR 38814, July 25, 2001]



Sec. 886.5600  Ptosis crutch.

    (a) Identification. A ptosis crutch is a device intended to be 
mounted on the spectacles of a patient who has ptosis (drooping of the 
upper eyelid as a result of faulty development or paralysis) to hold the 
upper eyelid open.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 
66 FR 38814, July 25, 2001]



Sec. 886.5700  Eyelid weight.

    (a) Identification. An eyelid weight is a prescription device made 
of gold, tantalum, platinum, iridium, or surgical grade stainless steel 
that is rectangular in shape and contoured to the shape of the eye. The 
device is intended for the gravity assisted treatment of lagophthalmos 
(incomplete eyelid closure).

[[Page 732]]

    (1) The external eyelid weight is adhered to the outer skin of the 
upper eyelid.
    (2) The implantable eyelid weight is implanted into the upper 
eyelid.
    (b) Classification. (1) Class II (special controls) for the external 
eyelid weight. The external eyelid weight is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 886.9. The special controls for the external 
eyelid weight are:
    (i) Testing demonstrating the biocompatibility of the device; and
    (ii) Labeling must include the following information:
    (A) Specific instructions regarding the proper placement, sizing, 
and removal of the device; and
    (B) A warning stating that the patient should be instructed to 
remove the device prior to entering a magnetic resonance environment.
    (2) Class II (special controls) for the implantable eyelid weight. 
The special controls for the implantable eyelid weight are:
    (i) Testing demonstrating the biocompatibility of the device;
    (ii) Testing demonstrating the sterility and shelf life of the 
device;
    (iii) Nonclinical testing evaluating the compatibility of the device 
in a magnetic resonance environment.
    (iv) Patient labeling to convey information regarding the safety and 
compatibility of the device in a magnetic resonance environment, the 
conditions under which a patient with the device can be safely scanned, 
and a mechanism for a healthcare provider to obtain detailed information 
about magnetic resonance safety and compatibility if needed.

[79 FR 22015, Apr. 21, 2014]



Sec. 886.5800  Ophthalmic bar reader.

    (a) Identification. An ophthalmic bar reader is a device that 
consists of a magnifying lens intended for use by a patient who has 
impaired vision. The device is placed directly onto reading material to 
magnify print.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 
66 FR 38814, July 25, 2001]



Sec. 886.5810  Ophthalmic prism reader.

    (a) Identification. An ophthalmic prism reader is a device intended 
for use by a patient who is in a supine position to change the angle of 
print to aid reading.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 
66 FR 38814, July 25, 2001]



Sec. 886.5820  Closed-circuit television reading system.

    (a) Identification. A closed-circuit television reading system is a 
device that consists of a lens, video camera, and video monitor that is 
intended for use by a patient who has subnormal vision to magnify 
reading material.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994; 66 
FR 38814, July 25, 2001]



Sec. 886.5838  Nasolacrimal compression device.

    (a) Identification. A nasolacrimal compression device is a 
prescription device that is fitted to apply mechanical pressure to the 
nasal aspect of the

[[Page 733]]

orbital rim to reduce outflow through the nasolacrimal ducts.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[81 FR 37500, June 10, 2016]



Sec. 886.5840  Magnifying spectacles.

    (a) Identification. Magnifying spectacles are devices that consist 
of spectacle frames with convex lenses intended to be worn by a patient 
who has impaired vision to enlarge images.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 866.9.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 
59 FR 63014, Dec. 7, 1994; 66 FR 38814, July 25, 2001]



Sec. 886.5842  Spectacle frame.

    (a) Identification. A spectacle frame is a device made of metal or 
plastic intended to hold prescription spectacle lenses worn by a patient 
to correct refractive errors.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 63014, Dec. 7, 1994; 66 
FR 38814, July 25, 2001]



Sec. 886.5844  Prescription spectacle lens.

    (a) Identification. A prescription spectacle lens is a glass or 
plastic device that is a lens intended to be worn by a patient in a 
spectacle frame to provide refractive corrections in accordance with a 
prescription for the patient. The device may be modified to protect the 
eyes from bright sunlight (i.e., prescription sunglasses). Prescription 
sunglass lenses may be reflective, tinted, polarizing, or 
photosensitized.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 
59 FR 63014, Dec. 7, 1994; 66 FR 38814, July 25, 2001]



Sec. 886.5850  Sunglasses (nonprescription).

    (a) Identification. Sunglasses (nonprescription) are devices that 
consist of spectacle frames or clips with absorbing, reflective, tinted, 
polarizing, or photosensitized lenses intended to be worn by a person to 
protect the eyes from bright sunlight but not to provide refractive 
corrections. This device is usually available over-the-counter.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 65 FR 2321, 2000]



Sec. 886.5870  Low-vision telescope.

    (a) Identification. A low-vision telescope is a device that consists 
of an arrangement of lenses or mirrors intended for use by a patient who 
has impaired vision to increase the apparent size of objects. This 
generic type of device includes handheld or spectacle telescopes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 
66 FR 38814, July 25, 2001]



Sec. 886.5900  Electronic vision aid.

    (a) Identification. An electronic vision aid is an AC-powered or 
battery-powered device that consists of an electronic sensor/transducer 
intended for use by a patient who has impaired vision or blindness to 
translate visual

[[Page 734]]

images of objects into tactile or auditory signals.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9.

[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994; 66 
FR 38814, July 25, 2001]



Sec. 886.5905  Oral electronic vision aid.

    (a) Identification. An oral electronic vision aid is a battery-
powered prescription device that contains an electrode stimulation array 
to generate electrotactile stimulation patterns that are derived from 
digital object images captured by a camera. It is intended to aid 
profoundly blind patients in orientation, mobility, and object 
recognition as an adjunctive device to other assistive methods such as a 
white cane or a guide dog.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must demonstrate an acceptable 
adverse event profile, including adverse events involving the mouth, 
tongue, and gums and demonstrate the effect of the stimulation to 
provide clinically meaningful outcomes. The clinical performance testing 
must also investigate the anticipated conditions of use, including 
potential use error, intended environment of use, and duration of use.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use, 
including simulated moisture ingress, device durability, and battery 
reliability.
    (3) Software verification, validation, and hazard analysis must be 
performed.
    (4) Analysis/testing must validate electromagnetic compatibility.
    (5) Analysis/testing must validate electrical safety.
    (6) Analysis/testing must assess and validate wireless coexistence 
concerns.
    (7) Any elements of the device that contact the patient must be 
demonstrated to be biocompatible.
    (8) Training must include elements to ensure that the healthcare 
provider and user can identify the safe environments for device use, use 
all safety features of the device, and operate the device in the 
intended environment of use.
    (9) Labeling for the trainer and user must include a summary of the 
clinical testing including adverse events encountered under use 
conditions, summary of study outcomes and endpoints, and information 
pertinent to use of the device including the conditions under which the 
device was studied (e.g., level of supervision or assistance, and 
environment of use).

[80 FR 57092, Sept. 22, 2015]



Sec. 886.5910  Image intensification vision aid.

    (a) Identification. An image intensification vision aid is a 
battery-powered device intended for use by a patient who has limited 
dark adaptation or impaired vision to amplify ambient light.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 886.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 
66 FR 38814, July 25, 2001]



Sec. 886.5915  Optical vision aid.

    (a) Identification. An optical vision aid is a device that consists 
of a magnifying lens with an accompanying AC-powered or battery-powered 
light source intended for use by a patient who has impaired vision to 
increase the apparent size of object detail.
    (b) Classification. Class I (general controls). The AC-powered 
device and the battery-powered device are exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter, 
subject to the limitations in Sec. 886.9. The battery-powered device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in

[[Page 735]]

part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.

[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994; 66 
FR 38815, July 25, 2001]



Sec. 886.5916  Rigid gas permeable contact lens.

    (a) Identification. A rigid gas permeable contact lens is a device 
intended to be worn directly against the cornea of the eye to correct 
vision conditions. The device is made of various materials, such as 
cellulose acetate butyrate, polyacrylate-silicone, or silicone 
elastomers, whose main polymer molecules generally do not absorb or 
attract water.
    (b) Classification. (1) Class II if the device is intended for daily 
wear only.
    (2) Class III if the device is intended for extended wear.
    (c) Date PMA or notice of completion of a PDP is required. As of May 
28, 1976, an approval under section 515 of the act is required before a 
device described in paragraph (b)(2) of this section may be commercially 
distributed. See Sec. 886.3.

[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 10284, Mar. 4, 1994]



Sec. 886.5918  Rigid gas permeable contact lens care products.

    (a) Identification. A rigid gas permeable contact lens care product 
is a device intended for use in the cleaning, conditioning, rinsing, 
lubricating/rewetting, or storing of a rigid gas permeable contact lens. 
This includes all solutions and tablets used together with rigid gas 
permeable contact lenses.
    (b) Classification. Class II (Special Controls) Guidance Document: 
``Guidance for Industry Premarket Notification (510(k)) Guidance 
Document for Contact Lens Care Products.''

[62 FR 30987, June 6, 1997]



Sec. 886.5925  Soft (hydrophilic) contact lens.

    (a) Identification. A soft (hydrophilic) contact lens is a device 
intended to be worn directly against the cornea and adjacent limbal and 
scleral areas of the eye to correct vision conditions or act as a 
therapeutic bandage. The device is made of various polymer materials the 
main polymer molecules of which absorb or attract a certain volume 
(percentage) of water.
    (b) Classification. (1) Class II if the device is intended for daily 
wear only.
    (2) Class III if the device is intended for extended wear.
    (c) Date PMA or notice of completion of a PDP is required. As of May 
28, 1976, an approval under section 515 of the act is required before a 
device described in paragraph (b)(2) of this section may be commercially 
distributed. See Sec. 886.3.

[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 10284, Mar. 4, 1994]



Sec. 886.5928  Soft (hydrophilic) contact lens care products.

    (a) Identification. A soft (hydrophilic) contact lens care product 
is a device intended for use in the cleaning, rinsing, disinfecting, 
lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. 
This includes all solutions and tablets used together with soft 
(hydrophilic) contact lenses and heat disinfecting units intended to 
disinfect a soft (hydrophilic) contact lens by means of heat.
    (b) Classification. Class II (Special Controls) Guidance Document: 
``Guidance for Industry Premarket Notification (510(k)) Guidance 
Document for Contact Lens Care Products.''

[62 FR 30988, June 6, 1997]



Sec. 886.5933  [Reserved]



PART 888_ORTHOPEDIC DEVICES--Table of Contents



                      Subpart A_General Provisions

Sec.
888.1 Scope.
888.3 Effective dates of requirement for premarket approval.
888.5 Resurfacing technique.
888.6 Degree of constraint.
888.9 Limitations of exemptions from section 510(k) of the Federal Food, 
          Drug, and Cosmetic Act (the act).

                      Subpart B_Diagnostic Devices

888.1100 Arthroscope.
888.1240 AC-powered dynamometer.
888.1250 Nonpowered dynamometer.
888.1500 Goniometer.

[[Page 736]]

888.1520 Nonpowered goniometer.
888.1600 Bone indentation device.

Subpart C [Reserved]

                      Subpart D_Prosthetic Devices

888.3000 Bone cap.
888.3010 Bone fixation cerclage.
888.3015 Bone heterograft.
888.3020 Intramedullary fixation rod.
888.3023 In vivo cured intramedullary fixation rod.
888.3025 Passive tendon prosthesis.
888.3027 Polymethylmethacrylate (PMMA) bone cement.
888.3030 Single/multiple component metallic bone fixation appliances and 
          accessories.
888.3040 Smooth or threaded metallic bone fixation fastener.
888.3043 Screw sleeve bone fixation device.
888.3044 Resorbable implant for anterior cruciate ligament (ACL) repair.
888.3045 Resorbable calcium salt bone void filler device.
888.3050 Spinal interlaminal fixation orthosis.
888.3060 Spinal intervertebral body fixation orthosis.
888.3075 Posterior cervical screw system.
888.3070 Thoracolumbosacral pedicle screw system.
888.3080 Intervertebral body fusion device.
888.3083 Spinal spheres for use in intervertebral fusion procedures.
888.3090 Intraoperative orthopedic strain sensor.
888.3100 Ankle joint metal/composite semi-constrained cemented 
          prosthesis.
888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
888.3120 Ankle joint metal/polymer non-constrained cemented prosthesis.
888.3150 Elbow joint metal/polymer constrained cemented prosthesis.
888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.
888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
888.3180 Elbow joint humeral (hemi-elbow) metallic uncemented 
          prosthesis.
888.3200 Finger joint metal/metal constrained uncemented prosthesis.
888.3210 Finger joint metal/metal constrained cemented prosthesis.
888.3220 Finger joint metal/polymer constrained cemented prosthesis.
888.3230 Finger joint polymer constrained prosthesis.
888.3300 Hip joint metal constrained cemented or uncemented prosthesis.
888.3310 Hip joint metal/polymer constrained cemented or uncemented 
          prosthesis.
888.3320 Hip joint metal/metal semi-constrained, with a cemented 
          acetabular component, prosthesis.
888.3330 Hip joint metal/metal semi-constrained, with an uncemented 
          acetabular component, prosthesis.
888.3340 Hip joint metal/composite semi-constrained cemented prosthesis.
888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or 
          nonporous uncemented prosthesis.
888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated 
          uncemented prosthesis.
888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented 
          prosthesis.
888.3370 Hip joint (hemi-hip) acetabular metal cemented prosthesis.
888.3380 Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal 
          cemented prosthesis.
888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or 
          uncemented prosthesis.
888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
888.3410 Hip joint metal/polymer or ceramic/polymer semiconstrained 
          resurfacing
888.3480 Knee joint femorotibial metallic constrained cemented 
          prosthesis.
888.3490 Knee joint femorotibial metal/composite non-constrained 
          cemented prosthesis.
888.3500 Knee joint femorotibial metal/composite semi-constrained 
          cemented prosthesis.
888.3510 Knee joint femorotibial metal/polymer constrained cemented 
          prosthesis.
888.3520 Knee joint femorotibial metal/polymer non-constrained cemented 
          prosthesis.
888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented 
          prosthesis.
888.3535 Knee joint femorotibial (uni-compartmental) metal/polymer 
          porous-coated uncemented prosthesis.
888.3540 Knee joint patellofemoral polymer/metal semi-constrained 
          cemented prosthesis.
888.3550 Knee joint patellofemorotibial polymer/metal/metal constrained 
          cemented prosthesis.
888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-
          constrained cemented prosthesis.
888.3565 Knee joint patellofemorotibial metal/polymer porous-coated 
          uncemented prosthesis.
888.3570 Knee joint femoral (hemi-knee) metallic uncemented prosthesis.
888.3580 Knee joint patellar (hemi-knee) metallic resurfacing uncemented 
          prosthesis.
888.3590 Knee joint tibial (hemi-knee) metallic resurfacing uncemented 
          prosthesis.
888.3600 Implantable post-surgical kinematic measurement knee device.
888.3630 Resorbable shoulder spacer.

[[Page 737]]

888.3640 Shoulder joint metal/metal or metal/polymer constrained 
          cemented prosthesis.
888.3650 Shoulder joint metal/polymer non-constrained cemented 
          prosthesis.
888.3660 Shoulder joint metal/polymer semi-constrained cemented 
          prosthesis.
888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-
          constrained porous-coated uncemented prosthesis.
888.3680 Shoulder joint glenoid (hemi-shoulder) metallic cemented 
          prosthesis.
888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented 
          prosthesis.
888.3720 Toe joint polymer constrained prosthesis.
888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
888.3750 Wrist joint carpal lunate polymer prosthesis.
888.3760 Wrist joint carpal scaphoid polymer prosthesis.
888.3770 Wrist joint carpal trapezium polymer prosthesis.
888.3780 Wrist joint polymer constrained prosthesis.
888.3790 Wrist joint metal constrained cemented prosthesis.
888.3800 Wrist joint metal/polymer semi-constrained cemented prosthesis.
888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.

                       Subpart E_Surgical Devices

888.4150 Calipers for clinical use.
888.4200 Cement dispenser.
888.4210 Cement mixer for clinical use.
888.4220 Cement monomer vapor evacuator.
888.4230 Cement ventilation tube.
888.4300 Depth gauge for clinical use.
888.4505 Orthopedic surgical instrumentation designed for osteochondral 
          implants with press-fit fixation.
888.4540 Orthopedic manual surgical instrument.
888.4580 Sonic surgical instrument and accessories/attachments.
888.4600 Protractor for clinical use.
888.4800 Template for clinical use.
888.5850 Nonpowered orthopedic traction apparatus and accessories.
888.5890 Noninvasive traction component.
888.5940 Cast component.
888.5960 Cast removal instrument.
888.5980 Manual cast application and removal instrument.

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    Source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 888 appear at 73 FR 
35341, June 23, 2008.



                      Subpart A_General Provisions



Sec. 888.1  Scope.

    (a) This part sets forth the classification of orthopedic devices 
intended for human use that are in commercial distribution.
    (b) The identification of a device in a regulation in this part is 
not a precise description of every device that is, or will be, subject 
to the regulation. A manufacturer who submits a premarket notification 
submission for a device under part 807 cannot show merely that the 
device is accurately described by the section title and identification 
provision of a regulation in this part, but shall state why the device 
is substantially equivalent to other devices, as required by Sec. 
807.87.
    (c) To avoid duplicative listings, an orthopedic device that has two 
or more types of uses (e.g., used both as a diagnostic device and as a 
surgical device) is listed in one subpart only.
    (d) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21 unless otherwise noted.
    (e) Guidance documents referenced in this part are available on the 
Internet at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/default.htm.

[52 FR 33702, Sept. 4, 1987, as amended at 68 FR 14137, Mar. 24, 2003; 
78 FR 18233, Mar. 26, 2013]



Sec. 888.3  Effective dates of requirement for premarket approval.

    A device included in this part that is classified into class III 
(premarket approval) shall not be commercially distributed after the 
date shown in the regulation classifying the device unless the 
manufacturer has an approval under section 515 of the act (unless an 
exemption has been granted under section 520(g)(2) of the act). An 
approval under section 515 of the act consists of FDA's issuance of an 
order approving an application for premarket approval (PMA) for the 
device or declaring completed a product development protocol (PDP) for 
the device.
    (a) Before FDA requires that a device commercially distributed 
before the enactment date of the amendments, or

[[Page 738]]

a device that has been found substantially equivalent to such a device, 
has an approval under section 515 of the act, FDA must promulgate a 
regulation under section 515(b) of the act requiring such approval, 
except as provided in paragraphs (b) and (c) of this section. Such a 
regulation under section 515(b) of the act shall not be effective during 
the grace period ending on the 90th day after its promulgation or on the 
last day of the 30th full calendar month after the regulation that 
classifies the device into class III is effective, whichever is later. 
See section 501(f)(2)(B) of the act. Accordingly, unless an effective 
date of the requirement for premarket approval is shown in the 
regulation for a device classified into class III in this part, the 
device may be commercially distributed without FDA's issuance of an 
order approving a PMA or declaring completed a PDP for the device. If 
FDA promulgates a regulation under section 515(b) of the act requiring 
premarket approval for a device, section 501(f)(1)(A) of the act applies 
to the device.
    (b) Any new, not substantially equivalent, device introduced into 
commercial distribution on or after May 28, 1976, including a device 
formerly marketed that has been substantially altered, is classified by 
statute (section 513(f) of the act) into class III without any grace 
period and FDA must have issued an order approving a PMA or declaring 
completed a PDP for the device before the device is commercially 
distributed unless it is reclassified. If FDA knows that a device being 
commercially distributed may be a ``new'' device as defined in this 
section because of any new intended use or other reasons, FDA may codify 
the statutory classification of the device into class III for such new 
use. Accordingly, the regulation for such a class III device states that 
as of the enactment date of the amendments, May 28, 1976, the device 
must have an approval under section 515 of the act before commercial 
distribution.
    (c) A device identified in a regulation in this part that is 
classified into class III and that is subject to the transitional 
provisions of section 520(1) of the act is automatically classified by 
statute into class III and must have an approval under section 515 of 
the act before being commercially distributed. Accordingly, the 
regulation for such a class III transitional device states that as of 
the enactment date of the amendments, May 28, 1976, the device must have 
an approval under section 515 of the act before commercial distribution.



Sec. 888.5  Resurfacing technique.

    Because of resurfacing techniques, certain joint prostheses require 
far less bone resection than other devices intended to repair or replace 
the same joint. The amount of bone resection may or may not affect the 
safety and effectiveness of the implantation of the prosthesis. When a 
resurfacing technique is used, the name of the prosthesis includes this 
information.



Sec. 888.6  Degree of constraint.

    Certain joint prostheses provide more constraint of joint movement 
than others. FDA believes that the degree of constraint is an important 
factor affecting the safety and effectiveness of orthopedic prostheses. 
FDA is defining the following standard terms for categorizing the degree 
of constraint.
    (a) A ``constrained'' joint prosthesis is used for joint replacement 
and prevents dislocation of the prosthesis in more than one anatomic 
plane and consists of either a single, flexible, across-the-joint 
component or more than one component linked together or affined.
    (b) A ``semi-constrained'' joint prosthesis is used for partial or 
total joint replacement and limits translation and rotation of the 
prosthesis in one or more planes via the geometry of its articulating 
surfaces. It has no across-the-joint linkage.
    (c) A ``non-constrained'' joint prosthesis is used for partial or 
total joint replacement and restricts minimally prosthesis movement in 
one or more planes. Its components have no across-the-joint linkage.



Sec. 888.9  Limitations of exemptions from section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act).

    The exemption from the requirement of premarket notification 
(section 510(k) of the act) for a generic type of class I or II device 
is only to the extent

[[Page 739]]

that the device has existing or reasonably foreseeable characteristics 
of commercially distributed devices within that generic type or, in the 
case of in vitro diagnostic devices, only to the extent that 
misdiagnosis as a result of using the device would not be associated 
with high morbidity or mortality. Accordingly, manufacturers of any 
commercially distributed class I or II device for which FDA has granted 
an exemption from the requirement of premarket notification must still 
submit a premarket notification to FDA before introducing or delivering 
for introduction into interstate commerce for commercial distribution 
the device when:
    (a) The device is intended for a use different from the intended use 
of a legally marketed device in that generic type of device; e.g., the 
device is intended for a different medical purpose, or the device is 
intended for lay use where the former intended use was by health care 
professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro diagnostic 
device detects or identifies infectious agents by using deoxyribonucleic 
acid (DNA) probe or nucleic acid hybridization technology rather than 
culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of neoplastic 
diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial or acquired 
genetic disorders, including inborn errors of metabolism;
    (3) For measuring an analyte that serves as a surrogate marker for 
screening, diagnosis, or monitoring life-threatening diseases such as 
acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, 
tuberculosis, or myocardial infarction or to monitor therapy;
    (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) or IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is intended 
for use in matrices other than serum or plasma;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).

[65 FR 2321, Jan. 14, 2000]



                      Subpart B_Diagnostic Devices



Sec. 888.1100  Arthroscope.

    (a) Identification. An arthroscope is an electrically powered 
endoscope intended to make visible the interior of a joint. The 
arthroscope and accessories also is intended to perform surgery within a 
joint.
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for the following manual arthroscopic instruments: 
cannulas, currettes, drill guides, forceps, gouges, graspers, knives, 
obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, 
suture passers, suture knotpushers, suture punches, switching rods, and 
trocars. The devices subject to this paragraph (b)(2) are exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter, subject to the limitations in Sec. 888.9.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 1124, Jan. 16, 1996; 66 
FR 38815, July 25, 2001]



Sec. 888.1240  AC-powered dynamometer.

    (a) Identification. An AC-powered dynamometer is an AC-powered 
device intended for medical purposes to assess neuromuscular function or 
degree of neuromuscular blockage by measuring, with a force transducer 
(a device that translates force into electrical impulses), the grip-
strength of a patient's hand.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures

[[Page 740]]

in subpart E of part 807 of this chapter subject to the limitations in 
Sec. 886.9.

[52 FR 33702, Sept. 4, 1987, as amended at 84 FR 71818, Dec. 30, 2019]



Sec. 888.1250  Nonpowered dynamometer.

    (a) Identification. A nonpowered dynamometer is a mechanical device 
intended for medical purposes to measure the pinch and grip muscle 
strength of a patient's hand.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.



Sec. 888.1500  Goniometer.

    (a) Identification. A goniometer is an AC-powered or battery powered 
device intended to evaluate joint function by measuring and recording 
ranges of motion, acceleration, or forces exerted by a joint.
    (b) Classification. (1) Class I (general controls) for a goniometer 
that does not use electrode lead wires and patient cables. This device 
is exempt from the premarket notification procedures of subpart E of 
part 807 of this chapter subject to Sec. 888.9.
    (2) Class II (special controls) for a goniometer that uses electrode 
lead wires and patient cables. The special controls consist of:
    (i) The performance standard under part 898 of this chapter, and
    (ii) The guidance entitled ``Guidance on the Performance Standard 
for Electrode Lead Wires and Patient Cables.'' This device is exempt 
from the premarket notification procedures of subpart E of part 807 of 
this chapter subject to Sec. 888.9.

[65 FR 19319, Apr. 11, 2000]



Sec. 888.1520  Nonpowered goniometer.

    (a) Identification. A nonpowered goniometer is a mechanical device 
intended for medical purposes to measure the range of motion of joints.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 888.9.

[52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]



Sec. 888.1600  Bone indentation device.

    (a) Identification. A bone indentation device is a device that 
measures resistance to indentation in bone.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) In vivo performance testing must demonstrate that the device 
performs as intended under anticipated conditions of use. Testing must 
evaluate the risk of bone fracture, soft tissue damage, pain, 
discomfort, bruising, or bleeding.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use, 
including an evaluation of the accuracy and precision of the device with 
respect to resistance to bone indentation.
    (3) Human factors testing must demonstrate that the intended user(s) 
can correctly use the device, based on the instructions for use.
    (4) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (5) Performance testing must demonstrate:
    (i) The sterility of the patient-contacting components of the 
device; and
    (ii) Validation of reprocessing instructions for any reusable 
components of the device.
    (6) Performance data must support the shelf life of the device by 
demonstrating continued sterility and device functionality over the 
identified shelf life.
    (7) Software verification, validation, and hazard analysis must be 
performed.
    (8) Performance data must be provided to demonstrate the 
electromagnetic compatibility (EMC) and electrical safety of the device.
    (9) Labeling must include:
    (i) Instructions for use;
    (ii) Validated methods and instructions for reprocessing of any 
reusable components;
    (iii) A shelf life for any sterile components;
    (iv) Information regarding limitations of the clinical significance 
of the device output; and

[[Page 741]]

    (v) A detailed summary of the accuracy and precision of the device.

[88 FR 755, Jan. 5, 2023]

Subpart C [Reserved]



                      Subpart D_Prosthetic Devices



Sec. 888.3000  Bone cap.

    (a) Identification. A bone cap is a mushroom-shaped device intended 
to be implanted made of either silicone elastomer or ultra-high 
molecular weight polyethylene. It is used to cover the severed end of a 
long bone, such as the humerus or tibia, to control bone overgrowth in 
juvenile amputees.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 888.9.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 1124, Jan. 16, 1996; 66 
FR 38815, July 25, 2001]



Sec. 888.3010  Bone fixation cerclage.

    (a) Identification. A bone fixation cerclage is a device intended to 
be implanted that is made of alloys, such as cobalt-chromium-molybdenum, 
and that consists of a metallic ribbon or flat sheet or a wire. The 
device is wrapped around the shaft of a long bone, anchored to the bone 
with wire or screws, and used in the fixation of fractures.
    (b) Classification. Class II.



Sec. 888.3015  Bone heterograft.

    (a) Identification. Bone heterograft is a device intended to be 
implanted that is made from mature (adult) bovine bones and used to 
replace human bone following surgery in the cervical region of the 
spinal column.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. As of May 
28, 1976, an approval under section 515 of the act is required before 
this device may be commercially distributed. See Sec. 888.3.



Sec. 888.3020  Intramedullary fixation rod.

    (a) Identification. An intramedullary fixation rod is a device 
intended to be implanted that consists of a rod made of alloys such as 
cobalt-chromium-molybdenum and stainless steel. It is inserted into the 
medullary (bone marrow) canal of long bones for the fixation of 
fractures.
    (b) Classification. Class II.



Sec. 888.3023  In vivo cured intramedullary fixation rod.

    (a) Identification. An in vivo cured intramedullary fixation rod is 
a prescription implanted device consisting of a balloon that is inserted 
into the medullary canal of long bones for the fixation of fractures. 
The balloon is infused with, and completely encapsulates, a liquid 
monomer that is exposed to a curing agent which polymerizes the monomer 
within the balloon creating a hardened rigid structure.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be tested:
    (i) Mechanical testing must be conducted on the final device to 
assess burst, abrasion, bending, and torsion in static and dynamic 
conditions.
    (ii) Mechanical testing must demonstrate the integrity of the 
balloon including testing for leaks, ruptures, and release of cured/
uncured material.
    (iii) Performance testing must demonstrate that the device can be 
inserted and removed.
    (iv) Performance testing must demonstrate the ability, in the event 
of a leak, to remove the uncured material from its in vivo location.
    (v) Performance testing must demonstrate the reliability and 
accuracy of the curing method used.
    (vi) Thermal safety testing must be conducted to evaluate the 
temperature rise during curing.
    (2) Electrical safety, electromagnetic compatibility (EMC) testing, 
and electromagnetic interference (EMI) testing must be conducted for all 
electrical components.
    (3) All patient-contacting components must be demonstrated to be 
biocompatible.
    (4) Performance data must demonstrate the sterility and pyrogenicity

[[Page 742]]

of patient contacting components of the device that are provided 
sterile.
    (5) Performance data must validate the reprocessing instructions for 
any reusable components or instruments.
    (6) Performance data must support the shelf life of the system by 
demonstrating continued sterility, package integrity, and system 
functionality over the established shelf life.
    (7) Technological characterization of the device must include 
materials, curing agents, and a description of the operating principles 
of the device, including the delivery system and devices which initiate 
the curing process.
    (8) Labeling must include the following:
    (i) A detailed summary of the device technical parameters.
    (ii) Information describing all materials of the device.
    (iii) Information describing how to perform the procedure and use 
the device, including the delivery system and devices which initiate the 
curing process, as well as how to remove the device and any uncured 
materials.
    (iv) A shelf life.
    (v) Validated methods and instructions for reprocessing any reusable 
components or instruments.

[83 FR 26759, June 8, 2018]



Sec. 888.3025  Passive tendon prosthesis.

    (a) Identification. A passive tendon prosthesis is a device intended 
to be implanted made of silicon elastomer or a polyester reinforced 
medical grade silicone elastomer intended for use in the surgical 
reconstruction of a flexor tendon of the hand. The device is implanted 
for a period of 2 to 6 months to aid growth of a new tendon sheath. The 
device is not intended as a permanent implant nor to function as a 
replacement for the ligament or tendon nor to function as a scaffold for 
soft tissue ingrowth.
    (b) Classification. Class II.



Sec. 888.3027  Polymethylmethacrylate (PMMA) bone cement.

    (a) Identification. Polymethylmethacrylate (PMMA) bone cement is a 
device intended to be implanted that is made from methylmethacrylate, 
polymethylmethacrylate, esters of methacrylic acid, or copolymers 
containing polymethylmethacrylate and polystyrene. The device is 
intended for use in arthroplastic procedures of the hip, knee, and other 
joints for the fixation of polymer or metallic prosthetic implants to 
living bone.
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA guidance document entitled ``Class II Special 
Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.''

[67 FR 46855, July 17, 2002]



Sec. 888.3030  Single/multiple component metallic bone 
fixation appliances and accessories.

    (a) Identification. Single/multiple component metallic bone fixation 
appliances and accessories are devices intended to be implanted 
consisting of one or more metallic components and their metallic 
fasteners. The devices contain a plate, a nail/plate combination, or a 
blade/plate combination that are made of alloys, such as cobalt-
chromium-molybdenum, stainless steel, and titanium, that are intended to 
be held in position with fasteners, such as screws and nails, or bolts, 
nuts, and washers. These devices are used for fixation of fractures of 
the proximal or distal end of long bones, such as intracapsular, 
intertrochanteric, intercervical, supracondylar, or condylar fractures 
of the femur; for fusion of a joint; or for surgical procedures that 
involve cutting a bone. The devices may be implanted or attached through 
the skin so that a pulling force (traction) may be applied to the 
skeletal system.
    (b) Classification. Class II.



Sec. 888.3040  Smooth or threaded metallic bone fixation fastener.

    (a) Identification. A smooth or threaded metallic bone fixation 
fastener is a device intended to be implanted that consists of a stiff 
wire segment or rod made of alloys, such as cobalt-chromium-molybdenum 
and stainless steel, and that may be smooth on the outside, fully or 
partially threaded, straight or U-shaped; and may be either blunt 
pointed, sharp pointed, or have a formed, slotted head on the end.

[[Page 743]]

It may be used for fixation of bone fractures, for bone reconstructions, 
as a guide pin for insertion of other implants, or it may be implanted 
through the skin so that a pulling force (traction) may be applied to 
the skeletal system.
    (b) Classification. Class II.



Sec. 888.3043  Screw sleeve bone fixation device.

    (a) Identification. A screw sleeve bone fixation device is intended 
to be implanted in conjunction with a non-resorbable, metallic bone 
screw where the screw has lost purchase due to loosening, backout, or 
breakage. The device fits between the screw threads and surrounding bone 
and provides increased surface area to create an interference fit to 
restore stability of the implant construct.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) In vivo performance testing under anticipated conditions of use 
must demonstrate:
    (i) The device provides sufficient stability to allow for fracture 
healing; and
    (ii) A lack of adverse biologic response to the implant through 
histopathological and histomorphometric assessment.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. Testing 
must:
    (i) Assess the stability of the device in a rescue screw scenario;
    (ii) Demonstrate that the device can be inserted and removed without 
damage to the implant or associated hardware;
    (iii) Demonstrate the device can withstand dynamic loading without 
device failure; and
    (iv) Characterize wear particle generation.
    (3) The device must be demonstrated to be biocompatible.
    (4) The device must be demonstrated to be non-pyrogenic.
    (5) Performance data must demonstrate the sterility of the device.
    (6) Performance data must support the labeled shelf life of the 
device by demonstrating continued sterility, package integrity, and 
device functionality over the established shelf life.
    (7) Labeling must include:
    (i) A detailed summary of the device technical parameters;
    (ii) Information describing all materials of the device;
    (iii) Instructions for use, including device removal; and
    (iv) A shelf life.

[87 FR 11294, Mar. 1, 2022]



Sec. 888.3044  Resorbable implant for anterior cruciate ligament (ACL) repair.

    (a) Identification. A resorbable implant for anterior cruciate 
ligament (ACL) repair is a degradable material that allows for healing 
of a torn ACL that is biomechanically stabilized by traditional suturing 
procedures. The device is intended to protect the biological healing 
process from the surrounding intraarticular environment and not intended 
to replace biomechanical fixation via suturing. This classification 
includes devices that bridge or surround the torn ends of a ruptured 
ACL.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must demonstrate that the device 
performs as intended under anticipated conditions of use and include the 
following:
    (i) Post-operative evaluation of knee pain and function; and
    (ii) Durability as assessed by re-tear or re-operation rate.
    (2) Animal performance testing must demonstrate that the device 
performs as intended under anticipated conditions of use and include the 
following:
    (i) Device performance characteristics, including resorption and 
ligament healing at repair site; and
    (ii) Adverse effects as assessed by gross necropsy and 
histopathology.
    (3) Non-clinical testing must demonstrate that the device performs 
as intended under anticipated conditions of use and include the 
following:
    (i) Characterization of materials, including chemical composition, 
resorption profile, and mechanical properties; and
    (ii) Simulated use testing, including device preparation, device 
handling,

[[Page 744]]

compatibility with other ACL repair instrumentation, and user interface.
    (4) The device must be demonstrated to be biocompatible.
    (5) Performance data must demonstrate the device to be sterile and 
non-pyrogenic.
    (6) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the identified shelf life.
    (7) Labeling must include the following:
    (i) Identification of device materials and specifications;
    (ii) A summary of the clinical performance testing conducted with 
the device;
    (iii) Instructions for use, including compatibility with other ACL 
repair instrumentation or devices;
    (iv) Warnings regarding post-operative rehabilitation requirements; 
and
    (v) A shelf life.

[87 FR 80041, Dec. 29, 2022]



Sec. 888.3045  Resorbable calcium salt bone void filler device.

    (a) Identification. A resorbable calcium salt bone void filler 
device is a resorbable implant intended to fill bony voids or gaps of 
the extremities, spine, and pelvis that are caused by trauma or surgery 
and are not intrinsic to the stability of the bony structure.
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA guidance document entitled ``Class II Special 
Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; 
Guidance for Industry and FDA.'' See Sec. 888.1(e) of this chapter for 
the availability of this guidance.

[68 FR 32636, June 2, 2003]



Sec. 888.3050  Spinal interlaminal fixation orthosis.

    (a) Identification. A spinal interlaminal fixation orthosis is a 
device intended to be implanted made of an alloy, such as stainless 
steel, that consists of various hooks and a posteriorly placed 
compression or distraction rod. The device is implanted, usually across 
three adjacent vertebrae, to straighten and immobilize the spine to 
allow bone grafts to unite and fuse the vertebrae together. The device 
is used primarily in the treatment of scoliosis (a lateral curvature of 
the spine), but it also may be used in the treatment of fracture or 
dislocation of the spine, grades 3 and 4 of spondylolisthesis (a 
dislocation of the spinal column), and lower back syndrome.
    (b) Classification. Class II.



Sec. 888.3060  Spinal intervertebral body fixation orthosis.

    (a) Identification. A spinal intervertebral body fixation orthosis 
is a device intended to be implanted made of titanium. It consists of 
various vertebral plates that are punched into each of a series of 
vertebral bodies. An eye-type screw is inserted in a hole in the center 
of each of the plates. A braided cable is threaded through each eye-type 
screw. The cable is tightened with a tension device and it is fastened 
or crimped at each eye-type screw. The device is used to apply force to 
a series of vertebrae to correct ``sway back,'' scoliosis (lateral 
curvature of the spine), or other conditions.
    (b) Classification. Class II.



Sec. 888.3070  Thoracolumbosacral pedicle screw system.

    (a) Identification. (1) Rigid pedicle screw systems are comprised of 
multiple components, made from a variety of materials that allow the 
surgeon to build an implant system to fit the patient's anatomical and 
physiological requirements. Such a spinal implant assembly consists of a 
combination of screws, longitudinal members (e.g., plates, rods 
including dual diameter rods, plate/rod combinations), transverse or 
cross connectors, and interconnection mechanisms (e.g., rod-to-rod 
connectors, offset connectors).
    (2) Semi-rigid systems are defined as systems that contain one or 
more of the following features (including but not limited to): Non-
uniform longitudinal elements, or features that allow more motion or 
flexibility compared to rigid systems.
    (b) Classification. (1) Class II (special controls), when intended 
to provide immobilization and stabilization of spinal segments in 
skeletally mature patients

[[Page 745]]

as an adjunct to fusion in the treatment of the following acute and 
chronic instabilities or deformities of the thoracic, lumbar, and sacral 
spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; 
degenerative spondylolisthesis with objective evidence of neurologic 
impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; 
and failed previous fusion (pseudarthrosis). These pedicle screw spinal 
systems must comply with the following special controls:
    (i) Compliance with material standards;
    (ii) Compliance with mechanical testing standards;
    (iii) Compliance with biocompatibility standards; and
    (iv) Labeling that contains these two statements in addition to 
other appropriate labeling information:

    ``Warning: The safety and effectiveness of pedicle screw spinal 
systems have been established only for spinal conditions with 
significant mechanical instability or deformity requiring fusion with 
instrumentation. These conditions are significant mechanical instability 
or deformity of the thoracic, lumbar, and sacral spine secondary to 
severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, 
degenerative spondylolisthesis with objective evidence of neurologic 
impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, 
and failed previous fusion (pseudarthrosis). The safety and 
effectiveness of these devices for any other conditions are unknown.''
    ``Precaution: The implantation of pedicle screw spinal systems 
should be performed only by experienced spinal surgeons with specific 
training in the use of this pedicle screw spinal system because this is 
a technically demanding procedure presenting a risk of serious injury to 
the patient.''

    (2) Class II (special controls), when a rigid pedicle screw system 
is intended to provide immobilization and stabilization of spinal 
segments in the thoracic, lumbar, and sacral spine as an adjunct to 
fusion in the treatment of degenerative disc disease and 
spondylolisthesis other than either severe spondylolisthesis (grades 3 
and 4) at L5-S1 or degenerative spondylolisthesis with objective 
evidence of neurologic impairment. These pedicle screw systems must 
comply with the following special controls:
    (i) The design characteristics of the device, including engineering 
schematics, must ensure that the geometry and material composition are 
consistent with the intended use.
    (ii) Non-clinical performance testing must demonstrate the 
mechanical function and durability of the implant.
    (iii) Device components must be demonstrated to be biocompatible.
    (iv) Validation testing must demonstrate the cleanliness and 
sterility of, or the ability to clean and sterilize, the device 
components and device-specific instruments.
    (v) Labeling must include the following:
    (A) A clear description of the technological features of the device 
including identification of device materials and the principles of 
device operation;
    (B) Intended use and indications for use, including levels of 
fixation;
    (C) Identification of magnetic resonance (MR) compatibility status;
    (D) Cleaning and sterilization instructions for devices and 
instruments that are provided non-sterile to the end user; and
    (E) Detailed instructions of each surgical step, including device 
removal.
    (3) Class II (special controls), when a semi-rigid system is 
intended to provide immobilization and stabilization of spinal segments 
in the thoracic, lumbar, and sacral spine as an adjunct to fusion for 
any indication. In addition to complying with the special controls in 
paragraphs (b)(2)(i) through (v) of this section, these pedicle screw 
systems must comply with the following special controls:
    (i) Demonstration that clinical performance characteristics of the 
device support the intended use of the product, including assessment of 
fusion compared to a clinically acceptable fusion rate.
    (ii) Semi-rigid systems marketed prior to the effective date of this 
reclassification must submit an amendment to their previously cleared 
premarket notification (510(k)) demonstrating compliance with the 
special controls in paragraphs (b)(2)(i) through (v) and paragraph 
(b)(3)(i) of this section.

[66 FR 28053, May 22, 2001, as amended at 81 FR 96373, Dec. 30, 2016]

[[Page 746]]



Sec. 888.3075  Posterior cervical screw system.

    (a) Identification. Posterior cervical screw systems are comprised 
of multiple, interconnecting components, made from a variety of 
materials that allow an implant system to be built from the occiput to 
the upper thoracic spine to fit the patient's anatomical and 
physiological requirements, as determined by preoperative cross-
sectional imaging. Such a spinal assembly consists of a combination of 
bone anchors via screws (i.e., occipital screws, cervical lateral mass 
screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, 
C2 transarticular screws), longitudinal members (e.g., plates, rods, 
including dual diameter rods, plate/rod combinations), transverse or 
cross connectors, interconnection mechanisms (e.g., rod-to-rod 
connectors, offset connectors), and closure mechanisms (e.g., set 
screws, nuts). Posterior cervical screw systems are rigidly fixed 
devices that do not contain dynamic features, including but not limited 
to: non-uniform longitudinal elements or features that allow more motion 
or flexibility compared to rigid systems.
    Posterior cervical screw systems are intended to provide 
immobilization and stabilization of spinal segments in patients as an 
adjunct to fusion for acute and chronic instabilities of the cervical 
spine and/or craniocervical junction and/or cervicothoracic junction 
such as: (1) Traumatic spinal fractures and/or traumatic dislocations; 
(2) deformities; (3) instabilities; (4) failed previous fusions (e.g., 
pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal 
degeneration, including neck and/or arm pain of discogenic origin as 
confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of 
the facets with instability; and (9) reconstruction following 
decompression to treat radiculopathy and/or myelopathy. These systems 
are also intended to restore the integrity of the spinal column even in 
the absence of fusion for a limited time period in patients with 
advanced stage tumors involving the cervical spine in whom life 
expectancy is of insufficient duration to permit achievement of fusion.
    (b) Classification. Class II (special controls). The special 
controls for posterior cervical screw systems are:
    (1) The design characteristics of the device, including engineering 
schematics, must ensure that the geometry and material composition are 
consistent with the intended use.
    (2) Nonclinical performance testing must demonstrate the mechanical 
function and durability of the implant.
    (3) Device components must be demonstrated to be biocompatible.
    (4) Validation testing must demonstrate the cleanliness and 
sterility of, or the ability to clean and sterilize, the device 
components and device-specific instruments.
    (5) Labeling must include the following:
    (i) A clear description of the technological features of the device 
including identification of device materials and the principles of 
device operation;
    (ii) Intended use and indications for use including levels of 
fixation;
    (iii) Device specific warnings, precautions, and contraindications 
that include the following statements:
    (A) ``Precaution: Preoperative planning prior to implantation of 
posterior cervical screw systems should include review of cross-
sectional imaging studies (e.g., CT and/or MRI) to evaluate the 
patient's cervical anatomy including the transverse foramen, neurologic 
structures, and the course of the vertebral arteries. If any findings 
would compromise the placement of these screws, other surgical methods 
should be considered. In addition, use of intraoperative imaging should 
be considered to guide and/or verify device placement, as necessary.''
    (B) ``Precaution: Use of posterior cervical pedicle screw fixation 
at the C3 through C6 spinal levels requires careful consideration and 
planning beyond that required for lateral mass screws placed at these 
spinal levels, given the proximity of the vertebral arteries and 
neurologic structures in relation to the cervical pedicles at these 
levels.''
    (iv) Identification of magnetic resonance (MR) compatibility status;
    (v) Cleaning and sterilization instructions for devices and 
instruments that are provided non-sterile to the end user, and;

[[Page 747]]

    (vi) Detailed instructions of each surgical step, including device 
removal.

[84 FR 12092, Apr. 1, 2019]



Sec. 888.3080  Intervertebral body fusion device.

    (a) Identification. An intervertebral body fusion device is an 
implanted single or multiple component spinal device made from a variety 
of materials, including titanium and polymers. The device is inserted 
into the intervertebral body space of the cervical or lumbosacral spine, 
and is intended for intervertebral body fusion.
    (b) Classification. (1) Class II (special controls) for 
intervertebral body fusion devices that contain bone grafting material. 
The special control is the FDA guidance document entitled ``Class II 
Special Controls Guidance Document: Intervertebral Body Fusion Device.'' 
See Sec. 888.1(e) for the availability of this guidance document.
    (2) Class III (premarket approval) for intervertebral body fusion 
devices that include any therapeutic biologic (e.g., bone morphogenic 
protein). Intervertebral body fusion devices that contain any 
therapeutic biologic require premarket approval.
    (c) Date premarket approval application (PMA) or notice of product 
development protocol (PDP) is required. Devices described in paragraph 
(b)(2) of this section shall have an approved PMA or a declared 
completed PDP in effect before being placed in commercial distribution.

[72 FR 32172, June 12, 2007]



Sec. 888.3083  Spinal spheres for use in intervertebral fusion procedures.

    (a) Identification. A spinal sphere device is an implanted, solid, 
spherical, prescription device manufactured from metallic or polymeric 
materials. The device is inserted into the intervertebral body space of 
the lumbar spine to provide stabilization and to help promote 
intervertebral body fusion. The device is to be used with bone graft 
material.
    (b) Classification. Class III.
    (c) Date premarket approval application (PMA) or notice of 
completion of product development protocol (PDP) is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before October 30, 2025, for any spinal sphere 
for use in intervertebral fusion procedures as identified in paragraph 
(a) of this section that was in commercial distribution before May 28, 
1976, or that has, on or before October 30, 2025, been found to be 
substantially equivalent to any spinal sphere device for use in 
intervertebral fusion procedures identified in pa]ragraph (a) of this 
section, that was in commercial distribution before May 28, 1976. Any 
other spinal sphere device for use in intervertebral fusion procedures 
identified in paragraph (a) of this section shall have an approved PMA 
or declared completed PDP in effect before being placed in commercial 
distribution.

[88 FR 18993, 18995, Mar. 30, 2023]

    Effective Date Note: At 88 FR 18993, Mar. 30, 2023, Sec. 888.3083 
was added and at 88 FR 18995, Mar. 30, 2023, pargraph (c) was added, 
effective May 1, 2023.



Sec. 888.3090  Intraoperative orthopedic strain sensor.

    (a) Identification. A strain sensor device is an adjunct tool 
intended to measure strain on an orthopedic implant in the 
intraoperative setting only. The device is not intended to provide 
diagnostic information or influence clinical decision making.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance testing must be conducted:
    (i) Mechanical testing to evaluate the effect of the device on the 
mechanical performance of the implant and to characterize the mechanical 
limits of the components used with the implant; and
    (ii) Accuracy and repeatability testing of strain measurements.
    (2) Usability testing must evaluate the effect of the device on the 
performance of the surgical procedure.
    (3) The patient-contacting components of the device must be 
demonstrated to be biocompatible.

[[Page 748]]

    (4) Performance testing must support the sterility and shelf life of 
the patient-contacting components of the device.
    (5) Software verification, validation, and hazard analysis must be 
performed.
    (6) Performance data must validate the reprocessing instructions for 
reusable components of the device.
    (7) Performance data must be provided to demonstrate the 
electromagnetic compatibility (EMC) and electrical safety of the device.
    (8) Labeling must include the following:
    (i) A shelf life;
    (ii) Instructions for use;
    (iii) Reprocessing instructions for any reusable components; and
    (iv) A statement that the device is not intended to provide 
diagnostic information or influence clinical decision making.

[86 FR 68405, Dec. 2, 2021]



Sec. 888.3100  Ankle joint metal/composite semi-constrained cemented
prosthesis.

    (a) Identification. An ankle joint metal/composite semi-constrained 
cemented prosthesis is a device intended to be implanted to replace an 
ankle joint. The device limits translation and rotation: in one or more 
planes via the geometry of its articulating surfaces. It has no linkage 
across-the-joint. This generic type of device includes prostheses that 
consist of a talar resurfacing component made of alloys, such as cobalt-
chromium-molybdenum, and a tibial resurfacing component fabricated from 
ultra-high molecular weight polyethylene with carbon fibers composite, 
and is limited to those prostheses intended for use with bone cement 
(Sec. 888.3027).
    (b) Classification. Class II.



Sec. 888.3110  Ankle joint metal/polymer semi-constrained cemented
prosthesis.

    (a) Identification. An ankle joint metal/polymer semi-constrained 
cemented prosthesis is a device intended to be implanted to replace an 
ankle joint. The device limits translation and rotation in one or more 
planes via the geometry of its articulating surfaces and has no linkage 
across-the-joint. This generic type of device includes prostheses that 
have a talar resurfacing component made of alloys, such as cobalt-
chromium-molybdenum, and a tibial resurfacing component made of ultra-
high molecular weight polyethylene and is limited to those prostheses 
intended for use with bone cement (Sec. 888.3027).
    (b) Classification. Class II.



Sec. 888.3120  Ankle joint metal/polymer non-constrained cemented prosthesis.

    (a) Identification. An ankle joint metal/polymer non-constrained 
cemented prosthesis is a device intended to be implanted to replace an 
ankle joint. The device limits minimally (less than normal anatomic 
constraints) translation in one or more planes. It has no linkage 
across-the-joint. This generic type of device includes prostheses that 
have a tibial component made of alloys, such as cobalt-chromium-
molybdenum, and a talar component made of ultra-high molecular weight 
polyethylene, and is limited to those prostheses intended for use with 
bone cement (Sec. 888.3027).
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any ankle 
joint metal/polymer non-constrained cemented prosthesis that was in 
commercial distribution before May 28, 1976, or that has, on or before 
December 26, 1996, been found to be substantially equivalent to an ankle 
joint metal/polymer non-constrained cemented prosthesis that was in 
commercial distribution before May 28, 1976. Any other ankle joint 
metal/polymer non-constrained cemented prosthesis shall have an approved 
PMA or a declared completed PDP in effect before being placed in 
commercial distribution.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996]



Sec. 888.3150  Elbow joint metal/polymer constrained cemented prosthesis.

    (a) Identification. An elbow joint metal/polymer constrained 
cemented prosthesis is a device intended to be

[[Page 749]]

implanted to replace an elbow joint. It is made of alloys, such as 
cobalt-chromium-molybdenum, or of these alloys and of an ultra-high 
molecular weight polyethylene bushing. The device prevents dislocation 
in more than one anatomic plane and consists of two components that are 
linked together. This generic type of device is limited to those 
prostheses intended for use with bone cement (Sec. 888.3027).
    (b) Classification. Class II. The special controls for this device 
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological Evaluation 
of Medical Devices--Part I: Evaluation and Testing,' ''
    (ii) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),''
    (iii) ``Guidance Document for Testing Orthopedic Implants with 
Modified Metallic Surfaces Apposing Bone or Bone Cement,''
    (iv) ``Guidance Document for the Preparation of Premarket 
Notification (510(k)) Application for Orthopedic Devices,''
    (v) ``Guidance Document for Testing Non-articulating, `Mechanically 
Locked' Modular Implant Components,''
    (2) International Organization for Standardization's (ISO):
    (i) ISO 5832-3:1996 ``Implants for Surgery--Metallic Materials--Part 
3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,''
    (ii) ISO 5832-4:1996 ``Implants for Surgery--Metallic Materials--
Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,''
    (iii) ISO 5832-12:1996 ``Implants for Surgery--Metallic Materials--
Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,''
    (iv) ISO 5833:1992 ``Implants for Surgery--Acrylic Resin Cements,''
    (v) ISO 5834-2:1998 ``Implants for Surgery--Ultra High Molecular 
Weight Polyethylene--Part 2: Moulded Forms,''
    (vi) ISO 6018:1987 ``Orthopaedic Implants--General Requirements for 
Marking, Packaging, and Labeling,''
    (vii) ISO 9001:1994 ``Quality Systems--Model for Quality Assurance 
in Design/Development, Production, Installation, and Servicing,'' and
    (viii) ISO 14630:1997 ``Non-active Surgical Implants--General 
Requirements,''
    (3) American Society for Testing and Materials':
    (i) F 75-92 ``Specification for Cast Cobalt-28 Chromium-6 Molybdenum 
Alloy for Surgical Implant Material,''
    (ii) F 648-98 ``Specification for Ultra-High-Molecular-Weight 
Polyethylene Powder and Fabricated Form for Surgical Implants,''
    (iii) F 799-96 ``Specification for Cobalt-28 Chromium-6 Molybdenum 
Alloy Forgings for Surgical Implants,''
    (iv) F 981-93 ``Practice for Assessment of Compatibility of 
Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of 
Material on Muscle and Bone,''
    (v) F 1044-95 ``Test Method for Shear Testing of Porous Metal 
Coatings,''
    (vi) F 1108-97 ``Specification for Titanium-6 Aluminum-4 Vanadium 
Alloy Castings for Surgical Implants,''
    (vii) F 1147-95 ``Test Method for Tension Testing of Porous Metal 
Coatings, '' and
    (viii) F 1537-94 ``Specification for Wrought Cobalt-28 Chromium-6 
Molybdenum Alloy for Surgical Implants.''

[65 FR 17147, Mar. 31, 2000]



Sec. 888.3160  Elbow joint metal/polymer semi-constrained cemented
prosthesis.

    (a) Identification. An elbow joint metal/polymer semi-constrained 
cemented prosthesis is a device intended to be implanted to replace an 
elbow joint. The device limits translation and rotation in one or more 
planes via the geometry of its articulating surfaces. It has no linkage 
across-the-joint. This generic type of device includes prostheses that 
consist of a humeral resurfacing component made of alloys, such as 
cobalt-chromium-molybdenum, and a radial resurfacing component made of 
ultra-high molecular weight polyethylene. This generic type of device is 
limited to those prostheses intended for use with bone cement (Sec. 
888.3027).
    (b) Classification. Class II.



Sec. 888.3170  Elbow joint radial (hemi-elbow) polymer prosthesis.

    (a) Identification. An elbow joint radial (hemi-elbow) polymer 
prosthesis is

[[Page 750]]

a device intended to be implanted made of medical grade silicone 
elastomer used to replace the proximal end of the radius.
    (b) Classification. Class II.



Sec. 888.3180  Elbow joint humeral (hemi-elbow) metallic uncemented
prosthesis.

    (a) Identification. An elbow joint humeral (hemi-elbow) metallic 
uncemented prosthesis is a device intended to be implanted made of 
alloys, such as cobalt-chromium-molybdenum, that is used to replace the 
distal end of the humerus formed by the trochlea humeri and the 
capitulum humeri. The generic type of device is limited to prostheses 
intended for use without bone cement (Sec. 888.3027).
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any elbow 
joint humeral (hemi-elbow) metallic uncemented prosthesis that was in 
commercial distribution before May 28, 1976, or that has, on or before 
December 26, 1996 been found to be substantially equivalent to an elbow 
joint humeral (hemi-elbow) metallic uncemented prosthesis that was in 
commercial distribution before May 28, 1976. Any other elbow joint 
humeral (hemi-elbow) metallic uncemented prosthesis shall have an 
approved PMA or a declared completed PDP in effect before being placed 
in commercial distribution.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996]



Sec. 888.3200  Finger joint metal/metal constrained uncemented prosthesis.

    (a) Identification. A finger joint metal/metal constrained 
uncemented prosthesis is a device intended to be implanted to replace a 
metacarpophalangeal or proximal interphalangeal (finger) joint. The 
device prevents dislocation in more than one anatomic plane and consists 
of two components which are linked together. This generic type of device 
includes prostheses made of alloys, such as cobalt-chromium-molybdenum, 
or protheses made from alloys and ultra-high molecular weight 
polyethylene. This generic type of device is limited to prostheses 
intended for use without bone cement (Sec. 888.3027).
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any finger 
joint metal/metal constrained uncemented prosthesis that was in 
commercial distribution before May 28, 1976, or that has, on or before 
December 26, 1996 been found to be substantially equivalent to a finger 
joint metal/metal constrained uncemented prosthesis that was in 
commercial distribution before May 28, 1976. Any other finger joint 
metal/metal constrained uncemented prosthesis shall have an approved PMA 
or a declared completed PDP in effect before being placed in commercial 
distribution.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996]



Sec. 888.3210  Finger joint metal/metal constrained cemented prosthesis.

    (a) Identification. A finger joint metal/metal constrained cemented 
prosthesis is a device intended to be implanted to replace a 
metacarpophalangeal (finger) joint. This device prevents dislocation in 
more than one anatomic plane and has components which are linked 
together. This generic type of device includes prostheses that are made 
of alloys, such as cobalt-chromium-molybdenum, and is limited to those 
prostheses intended for use with bone cement (Sec. 888.3027).
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any finger 
joint metal/metal constrained cemented prosthesis that was in commercial 
distribution before May 28, 1976, or that has, on or before December 26, 
1996 been found to be substantially equivalent to a finger joint metal/
metal constrained cemented prosthesis that was in commercial 
distribution before May 28, 1976. Any

[[Page 751]]

other finger joint metal/metal constrained cemented prosthesis shall 
have an approved PMA or a declared completed PDP in effect before being 
placed in commercial distribution.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996]



Sec. 888.3220  Finger joint metal/polymer constrained cemented prosthesis.

    (a) Identification. A finger joint metal/polymer constrained 
cemented prosthesis is a device intended to be implanted to replace a 
metacarpophalangeal or proximal interphalangeal (finger) joint. The 
device prevents dislocation in more than one anatomic plane, and 
consists of two components which are linked together. This generic type 
of device includes prostheses that are made of alloys, such as cobalt-
chromium-molybdenum, and ultra-high molecular weight polyethylene, and 
is limited to those prostheses intended for use with bone cement (Sec. 
888.3027).
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any finger 
joint metal/polymer constrained cemented prosthesis that was in 
commercial distribution before May 28, 1976, or that has, on or before 
December 26, 1996 been found to be substantially equivalent to a finger 
joint metal/polymer constrained cemented prosthesis that was in 
commercial distribution before May 28, 1976. Any other finger joint 
metal/polymer constrained cemented prosthesis shall have an approved PMA 
or a declared completed PDP in effect before being placed in commercial 
distribution.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996]



Sec. 888.3230  Finger joint polymer constrained prosthesis.

    (a) Identification. A finger joint polymer constrained prosthesis is 
a device intended to be implanted to replace a metacarpophalangeal or 
proximal interphalangeal (finger) joint. This generic type of device 
includes prostheses that consist of a single flexible across-the-joint 
component made from either a silicone elastomer or a combination pf 
polypropylene and polyester material. The flexible across-the-joint 
component may be covered with a silicone rubber sleeve.
    (b) Classification. Class II.



Sec. 888.3300  Hip joint metal constrained cemented or uncemented
prosthesis.

    (a) Identification. A hip joint metal constrained cemented or 
uncemented prosthesis is a device intended to be implanted to replace a 
hip joint. The device prevents dislocation in more than one anatomic 
plane and has components that are linked together. This generic type of 
device includes prostheses that have components made of alloys, such as 
cobalt-chromium-molybdenum, and is intended for use with or without bone 
cement (Sec. 888.3027). This device is not intended for biological 
fixation.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any hip joint 
metal constrained cemented or uncemented prosthesis that was in 
commercial distribution before May 28, 1976, or that has, on or before 
December 26, 1996 been found to be substantially equivalent to a hip 
joint metal constrained cemented or uncemented prosthesis that was in 
commercial distribution before May 28, 1976. Any other hip joint metal 
constrained cemented or uncemented prosthesis shall have an approved PMA 
or a declared completed PDP in effect before being placed in commercial 
distribution.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996]



Sec. 888.3310  Hip joint metal/polymer constrained cemented or uncemented
prosthesis.

    (a) Identification. A hip joint metal/polymer constrained cemented 
or uncemented prosthesis is a device intended to be implanted to replace 
a hip joint. The device prevents dislocation in more than one anatomic 
plane and

[[Page 752]]

has components that are linked together. This generic type of device 
includes prostheses that have a femoral component made of alloys, such 
as cobalt-chromium-molybdenum, and an acetabular component made of 
ultra-high-molecular-weight polyethylene with or without a metal shell, 
made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. 
This generic type of device is intended for use with or without bone 
cement (Sec. 888.3027).
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA guidance document entitled ``Class II Special 
Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or 
Uncemented Prosthesis.''

[67 FR 21173, Apr. 30, 2002]



Sec. 888.3320  Hip joint metal/metal semi-constrained, with a cemented
acetabular component, prosthesis.

    (a) Identification. A hip joint metal/metal semi-constrained, with a 
cemented acetabular component, prosthesis is a two-part device intended 
to be implanted to replace a hip joint. The device limits translation 
and rotation in one or more planes via the geometry of its articulating 
surfaces. It has no linkage across-the-joint. This generic type of 
device includes prostheses that consist of a femoral and an acetabular 
component, both made of alloys, such as cobalt-chromium-molybdenum. This 
generic type of device is limited to those prostheses intended for use 
with bone cement (Sec. 888.3027).
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of PDP is required. A PMA or a 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before May 18, 2016, for any hip joint metal/
metal semi-constrained prosthesis with a cemented acetabular component 
that was in commercial distribution before May 28, 1976, or that has, on 
or before May 18, 2016, been found to be substantially equivalent to a 
hip joint metal/metal semi-constrained prosthesis with a cemented 
acetabular component that was in commercial distribution before May 28, 
1976. Any other hip joint metal/metal semi-constrained prosthesis with a 
cemented acetabular component shall have an approved PMA or a declared 
completed PDP in effect before being placed in commercial distribution.

[52 FR 33702, Sept. 4, 1987, as amended at 81 FR 8149, Feb. 18, 2016]



Sec. 888.3330  Hip joint metal/metal semi-constrained, with an 
uncemented acetabular component, prosthesis.

    (a) Identification. A hip joint metal/metal semi-constrained, with 
an uncemented acetabular component, prosthesis is a two-part device 
intended to be implanted to replace a hip joint. The device limits 
translation and rotation in one or more planes via the geometry of its 
articulating surfaces. It has no linkage across-the-joint. This generic 
type of device includes prostheses that consist of a femoral and an 
acetabular component, both made of alloys, such as cobalt-chromium-
molybdenum. The femoral component is intended to be fixed with bone 
cement. The acetabular component is intended for use without bone cement 
(Sec. 888.3027).
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of PDP is required. A PMA or a 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before May 18, 2016, for any hip joint metal/
metal semi-constrained prosthesis with an uncemented acetabular 
component that was in commercial distribution before May 28, 1976, or 
that has, on or before May 18, 2016, been found to be substantially 
equivalent to a hip joint metal/metal semi-constrained prosthesis with 
an uncemented acetabular component that was in commercial distribution 
before May 28, 1976. Any other hip joint metal/metal semi-constrained 
prosthesis with an uncemented acetabular component shall have an 
approved PMA or a declared completed PDP in effect before being placed 
in commercial distribution.

[52 FR 33702, Sept. 4, 1987, as amended at 81 FR 8149, Feb. 18, 2016]

[[Page 753]]



Sec. 888.3340  Hip joint metal/composite semi-constrained
cemented prosthesis.

    (a) Identification. A hip joint metal/composite semi-constrained 
cemented prosthesis is a two-part device intended to be implanted to 
replace a hip joint. The device limits translation and rotation in one 
or more planes via the geometry of its articulating surfaces. It has no 
linkage across-the-joint. This generic type of device includes 
prostheses that consist of a femoral component made of alloys, such as 
cobalt-chromium-molybdenum, and an acetabular component made of ultra-
high molecular weight polyethylene with carbon fibers composite. Both 
components are intended for use with bone cement (Sec. 888.3027).
    (b) Classification. Class II.



Sec. 888.3350  Hip joint metal/polymer semi-constrained cemented prosthesis.

    (a) Identification. A hip joint metal/polymer semi-constrained 
cemented prosthesis is a device intended to be implanted to replace a 
hip joint. The device limits translation and rotation in one or more 
planes via the geometry of its articulating surfaces. It has no linkage 
across-the-joint. This generic type of device includes prostheses that 
have a femoral component made of alloys, such as cobalt-chromium-
molybdenum, and an acetabular resurfacing component made of ultra-high 
molecular weight polyethylene and is limited to those prostheses 
intended for use with bone cement (Sec. 888.3027).
    (b) Classification. Class II.



Sec. 888.3353  Hip joint metal/ceramic/polymer semi-constrained
cemented or nonporous uncemented prosthesis.

    (a) Identification. A hip joint metal/ceramic/polymer semi-
constrained cemented or nonporous uncemented prosthesis is a device 
intended to be implanted to replace a hip joint. This device limits 
translation and rotation in one or more planes via the geometry of its 
articulating surfaces. It has no linkage across-the-joint. The two-part 
femoral component consists of a femoral stem made of alloys to be fixed 
in the intramedullary canal of the femur by impaction with or without 
use of bone cement. The proximal end of the femoral stem is tapered with 
a surface that ensures positive locking with the spherical ceramic 
(aluminium oxide, A1203) head of the femoral 
component. The acetabular component is made of ultra-high molecular 
weight polyethylene or ultra-high molecular weight polyethylene 
reinforced with nonporous metal alloys, and used with or without bone 
cement.
    (b) Classification. Class II.

[54 FR 48239, Nov. 22, 1989; 54 FR 51342, Dec. 14, 1989]



Sec. 888.3358  Hip joint metal/polymer/metal semi-constrained
porous-coated uncemented prosthesis.

    (a) Identification. A hip joint metal/polymer/metal semi-constrained 
porous-coated uncemented prosthesis is a device intended to be implanted 
to replace a hip joint. The device limits translation and rotation in 
one or more planes via the geometry of its articulating surfaces. It has 
no linkage across the joint. This generic type of device has a femoral 
component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a 
titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component 
composed of an ultra-high molecular weight polyethylene articulating 
bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. 
The femoral stem and acetabular shell have a porous coating made of, in 
the case of Co-Cr-Mo substrates, beads of the same alloy, and in the 
case of Ti-6Al-4V substrates, fibers of commercially pure titanium or 
Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 
70 percent, an average pore size between 100 and 1,000 microns, 
interconnecting porosity, and a porous coating thickness between 500 and 
1,500 microns. The generic type of device has a design to achieve 
biological fixation to bone without the use of bone cement.
    (b) Classification. Class II.

[58 FR 3228, Jan. 8, 1993]



Sec. 888.3360  Hip joint femoral (hemi-hip) metallic cemented
or uncemented prosthesis.

    (a) Identification. A hip joint femoral (hemi-hip) metallic cemented 
or

[[Page 754]]

uncemented prosthesis is a device intended to be implanted to replace a 
portion of the hip joint. This generic type of device includes 
prostheses that have a femoral component made of alloys, such as cobalt-
chromium-molybdenum. This generic type of device includes designs which 
are intended to be fixed to the bone with bone cement (Sec. 888.3027) 
as well as designs which have large window-like holes in the stem of the 
device and which are intended for use without bone cement. However, in 
these latter designs, fixation of the device is not achieved by means of 
bone ingrowth.
    (b) Classification. Class II.



Sec. 888.3370  Hip joint (hemi-hip) acetabular metal cemented prosthesis.

    (a) Identification. A hip joint (hemi-hip) acetabular metal cemented 
prosthesis is a device intended to be implanted to replace a portion of 
the hip joint. This generic type of device includes prostheses that have 
an acetabular component made of alloys, such as cobalt-chromium-
molybdenum. This generic type of device is limited to those prostheses 
intended for use with bone cement (Sec. 888.3027).
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any hip joint 
(hemi-hip) acetabular metal cemented prosthesis that was in commercial 
distribution before May 28, 1976, or that has, on or before December 26, 
1996 been found to be substantially equivalent to a hip joint (hemi-hip) 
acetabular metal cemented prosthesis that was in commercial distribution 
before May 28, 1976. Any other hip joint metal (hemi-hip) acetabular 
metal cemented prosthesis shall have an approved PMA or a declared 
completed PDP in effect before being placed in commercial distribution.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50710, Sept. 27, 1996]



Sec. 888.3380  Hip joint femoral (hemi-hip) trunnion-bearing
metal/polyacetal cemented prosthesis.

    (a) Identification. A hip joint femoral (hemi-hip) trunnion-bearing 
metal/polyacetal cemented prosthesis is a two-part device intended to be 
implanted to replace the head and neck of the femur. This generic type 
of device includes prostheses that consist of a metallic stem made of 
alloys, such as cobalt-chromium-molybdenum, with an integrated 
cylindrical trunnion bearing at the upper end of the stem that fits into 
a recess in the head of the device. The head of the device is made of 
polyacetal (polyoxymethylene) and it is covered by a metallic alloy, 
such as cobalt-chromium-molybdenum. The trunnion bearing allows the head 
of the device to rotate on its stem. The prosthesis is intended for use 
with bone cement (Sec. 888.3027).
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any hip joint 
femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis 
that was in commercial distribution before May 28, 1976, or that has, on 
or before December 26, 1996 been found to be substantially equivalent to 
a hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal 
cemented prosthesis that was in commercial distribution before May 28, 
1976. Any other hip joint femoral (hemi-hip) trunnion-bearing metal/
polyacetal cemented prosthesis shall have an approved PMA or a declared 
completed PDP in effect before being placed in commercial distribution.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50710, Sept. 27, 1996]



Sec. 888.3390  Hip joint femoral (hemi-hip) metal/polymer
cemented or uncemented prosthesis.

    (a) Identification. A hip joint femoral (hemi-hip) metal/polymer 
cemented or uncemented prosthesis is a two-part device intended to be 
implanted to replace the head and neck of the femur. This generic type 
of device includes prostheses that have a femoral component made of 
alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular 
component made of an alloy, such as cobalt-chromium-molybdenum, and 
ultra-high molecular weight polyethylene. This generic type

[[Page 755]]

of device may be fixed to the bone with bone cement (Sec. 888.3027) or 
implanted by impaction.
    (b) Classification. Class II.



Sec. 888.3400  Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.

    (a) Identification. A hip joint femoral (hemi-hip) metallic 
resurfacing prosthesis is a device intended to be implanted to replace a 
portion of the hip joint. This generic type of device includes 
prostheses that have a femoral resurfacing component made of alloys, 
such as cobalt-chromium-molybdenum.
    (b) Classification. Class II.



Sec. 888.3410  Hip joint metal/polymer or ceramic/polymer 
semiconstrained resurfacing cemented prosthesis.

    (a) Identification. A hip joint metal/polymer or ceramic/polymer 
semi-constrained resurfacing cemented prosthesis is a two-part device 
intended to be implanted to replace the articulating surfaces of the hip 
while preserving the femoral head and neck. The device limits 
translation and rotation in one or more planes via the geometry of its 
articulating surfaces. It has no linkage across the joint. This generic 
type of device includes prostheses that consist of a femoral cap 
component made of a metal alloy, such as cobalt-chromium-molybdenum, or 
a ceramic material, that is placed over a surgically prepared femoral 
head, and an acetabular resurfacing polymer component. Both components 
are intended for use with bone cement (Sec. 888.3027).
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before January 3, 2005, for any hip joint 
metal/polymer or ceramic/polymer semiconstrained resurfacing cemented 
prosthesis that was in commercial distribution before May 28, 1976, or 
that has, on or before January 3, 2005, been found to be substantially 
equivalent to a hip joint metal/polymer or ceramic/polymer 
semiconstrained resurfacing cemented prosthesis that was in commercial 
distribution before May 28, 1976. Any other hip joint metal/polymer or 
ceramic/polymer semiconstrained resurfacing cemented prosthesis must 
have an approved PMA or a declared completed PDP in effect before being 
placed in commercial distribution.

[69 FR 59134, Oct. 4, 2004]



Sec. 888.3480  Knee joint femorotibial metallic constrained 
cemented prosthesis.

    (a) Identification. A knee joint femorotibial metallic constrained 
cemented prosthesis is a device intended to be implanted to replace part 
of a knee joint. The device prevents dislocation in more than one 
anatomic plane and has components that are linked together. The only 
knee joint movement allowed by the device is in the sagittal plane. This 
generic type of device includes prostheses that have an intramedullary 
stem at both the proximal and distal locations. The upper and lower 
components may be joined either by a solid bolt or pin, an internally 
threaded bolt with locking screw, or a bolt retained by circlip. The 
components of the device are made of alloys, such as cobalt-chromium-
molybdenum. The stems of the device may be perforated, but are intended 
for use with bone cement (Sec. 888.3027).
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any knee 
joint femorotibial metallic constrained cemented prosthesis that was in 
commercial distribution before May 28, 1976, or that has, on or before 
December 26, 1996 been found to be substantially equivalent to a knee 
joint femorotibial metallic constrained cemented prosthesis that was in 
commercial distribution before May 28, 1976. Any other knee joint 
femorotibial metallic constrained cemented prosthesis shall have an 
approved PMA or a declared completed PDP in effect before being placed 
in commercial distribution.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50710, Sept. 27, 1996]

[[Page 756]]



Sec. 888.3490  Knee joint femorotibial metal/composite non-constrained 
cemented prosthesis.

    (a) Identification. A knee joint femorotibial metal/composite non-
constrained cemented prosthesis is a device intended to be implanted to 
replace part of a knee joint. The device limits minimally (less than 
normal anatomic constraints) translation in one or more planes. It has 
no linkage across-the-joint. This generic type of device includes 
prostheses that have a femoral condylar resurfacing component or 
components made of alloys, such as cobalt-chromium-molybdenum, and a 
tibial condylar component or components made of ultra-high molecular 
weight polyethylene with carbon fibers composite and are intended for 
use with bone cement (Sec. 888.3027).
    (b) Classification. Class II.



Sec. 888.3500  Knee joint femorotibial metal/composite semi-constrained 
cemented prosthesis.

    (a) Identification. A knee joint femorotibial metal/composite semi-
constrained cemented prosthesis is a two-part device intended to be 
implanted to replace part of a knee joint. The device limits translation 
and rotation in one or more planes via the geometry of its articulating 
surfaces. It has no linkage across-the-joint. This generic type of 
device includes prostheses that have a femoral component made of alloys, 
such as cobalt-chromium-molybdenum, and a tibial component with the 
articulating surfaces made of ultra-high molecular weight polyethylene 
with carbon-fibers composite and is limited to those prostheses intended 
for use with bone cement (Sec. 888.3027).
    (b) Classification. Class II.



Sec. 888.3510  Knee joint femorotibial metal/polymer constrained
cemented prosthesis.

    (a) Identification. A knee joint femorotibial metal/polymer 
constrained cemented prosthesis is a device intended to be implanted to 
replace part of a knee joint. The device limits translation or rotation 
in one or more planes and has components that are linked together or 
affined. This generic type of device includes prostheses composed of a 
ball-and-socket joint located between a stemmed femoral and a stemmed 
tibial component and a runner and track joint between each pair of 
femoral and tibial condyles. The ball-and-socket joint is composed of a 
ball at the head of a column rising from the stemmed tibial component. 
The ball, the column, the tibial plateau, and the stem for fixation of 
the tibial component are made of an alloy, such as cobalt-chromium-
molybdenum. The ball of the tibial component is held within the socket 
of the femoral component by the femoral component's flat outer surface. 
The flat outer surface of the tibial component abuts both a reciprocal 
flat surface within the cavity of the femoral component and flanges on 
the femoral component designed to prevent distal displacement. The stem 
of the femoral component is made of an alloy, such as cobalt-chromium-
molybdenum, but the socket of the component is made of ultra-high 
molecular weight polyethylene. The femoral component has metallic 
runners which align with the ultra-high molecular weight polyethylene 
tracks that press-fit into the metallic tibial component. The generic 
class also includes devices whose upper and lower components are linked 
with a solid bolt passing through a journal bearing of greater radius, 
permitting some rotation in the transverse plane, a minimal arc of 
abduction/adduction. This generic type of device is limited to those 
prostheses intended for use with bone cement (Sec. 888.3027).
    (b) Classification. Class II.



Sec. 888.3520  Knee joint femorotibial metal/polymer non-constrained
cemented prosthesis.

    (a) Identification. A knee joint femorotibial metal/polymer non-
constrained cemented prosthesis is a device intended to be implanted to 
replace part of a knee joint. The device limits minimally (less than 
normal anatomic constraints) translation in one or more planes. It has 
no linkage across-the-joint. This generic type of device includes 
prostheses that have a femoral condylar resurfacing component or 
components made of alloys, such as cobalt-chromium-molybdenum, and a 
tibial component or components

[[Page 757]]

made of ultra-high molecular weight polyethylene and are intended for 
use with bone cement (Sec. 888.3027).
    (b) Classification. Class II.



Sec. 888.3530  Knee joint femorotibial metal/polymer semi-constrained
cemented prosthesis.

    (a) Identification. A knee joint femorotibial metal/polymer semi-
constrained cemented prosthesis is a device intended to be implanted to 
replace part of a knee joint. The device limits translation and rotation 
in one or more planes via the geometry of its articulating surfaces. It 
has no linkage across-the-joint. This generic type of device includes 
prostheses that consist of a femoral component made of alloys, such as 
cobalt-chromium-molybdenum, and a tibial component made of ultra-high 
molecular weight polyethylene and is limited to those prostheses 
intended for use with bone cement (Sec. 888.3027).
    (b) Classification. Class II.



Sec. 888.3535  Knee joint femorotibial (uni-compartmental) metal/polymer
porous-coated uncemented prosthesis.

    (a) Identification. A knee joint femorotibial (uni-compartmental) 
metal/polymer porous-coated uncemented prosthesis is a device intended 
to be implanted to replace part of a knee joint. The device limits 
translation and rotation in one or more planes via the geometry of its 
articulating surface. It has no linkage across-the-joint. This generic 
type of device is designed to achieve biological fixation to bone 
without the use of bone cement. This identification includes fixed-
bearing knee prostheses where the ultra-high molecular weight 
polyethylene tibial bearing is rigidly secured to the metal tibial 
baseplate.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance: ``Class II Special Controls Guidance Document: Knee 
Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated 
Uncemented Prostheses; Guidance for Industry and FDA.'' See Sec. 888.1 
for the availability of this guidance.

[68 FR 14137, Mar. 24, 2003]



Sec. 888.3540  Knee joint patellofemoral polymer/metal semi-constrained
cemented prosthesis.

    (a) Identification. A knee joint patellofemoral polymer/metal semi-
constrained cemented prosthesis is a two-part device intended to be 
implanted to replace part of a knee joint in the treatment of primary 
patellofemoral arthritis or chondromalacia. The device limits 
translation and rotation in one or more planes via the geometry of its 
articulating surfaces. It has no linkage across-the-joint. This generic 
type of device includes a component made of alloys, such as cobalt-
chromium-molybdenum or austenitic steel, for resurfacing the 
intercondylar groove (femoral sulcus) on the anterior aspect of the 
distal femur, and a patellar component made of ultra-high molecular 
weight polyethylene. This generic type of device is limited to those 
devices intended for use with bone cement (Sec. 888.3027). The patellar 
component is designed to be implanted only with its femoral component.
    (b) Classification. Class II. The special controls for this device 
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological Evaluation 
of Medical Devices--Part I: Evaluation and Testing,' ''
    (ii) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),''
    (iii) ``Guidance Document for Testing Orthopedic Implants with 
Modified Metallic Surfaces Apposing Bone or Bone Cement,''
    (iv) ``Guidance Document for the Preparation of Premarket 
Notification (510(k)) Applications for Orthopedic Devices,'' and
    (v) ``Guidance Document for Testing Non-articulating, `Mechanically 
Locked' Modular Implant Components,'' and
    (2) International Organization for Standardization's (ISO):
    (i) ISO 5832-3:1996 ``Implants for Surgery--Metallic Materials--Part 
3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,''
    (ii) ISO 5832-4:1996 ``Implants for Surgery--Metallic Materials--
Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,''

[[Page 758]]

    (iii) ISO 5832-12:1996 ``Implants for Surgery--Metallic Materials--
Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,''
    (iv) ISO 5833:1992 ``Implants for Surgery--Acrylic Resin Cements,''
    (v) ISO 5834-2:1998 ``Implants for Surgery--Ultra-high Molecular 
Weight Polyethylene--Part 2: Moulded Forms,''
    (vi) ISO 6018:1987 ``Orthopaedic Implants--General Requirements for 
Marking, Packaging, and Labeling,''
    (vii) ISO 7207-2:1998 ``Implants for Surgery--Components for Partial 
and Total Knee Joint Prostheses--Part 2: Articulating Surfaces Made of 
Metal, Ceramic and Plastic Materials,'' and
    (viii) ISO 9001:1994 ``Quality Systems--Model for Quality Assurance 
in Design/Development, Production, Installation, and Servicing,'' and
    (3) American Society for Testing and Materials':
    (i) F 75-92 ``Specification for Cast Cobalt-28 Chromium-6 Molybdenum 
Alloy for Surgical Implant Material,''
    (ii) F 648-98 ``Specification for Ultra-High-Molecular-Weight 
Polyethylene Powder and Fabricated Form for Surgical Implants,''
    (iii) F 799-96 ``Specification for Cobalt-28 Chromium-6 Molybdenum 
Alloy Forgings for Surgical Implants,''
    (iv) F 1044-95 ``Test Method for Shear Testing of Porous Metal 
Coatings,''
    (v) F 1108-97 ``Titanium-6 Aluminum-4 Vanadium Alloy Castings for 
Surgical Implants,''
    (vi) F 1147-95 ``Test Method for Tension Testing of Porous Metal 
Coatings,''
    (vii) F 1537-94 ``Specification for Wrought Cobalt-28 Chromium-6 
Molybdenum Alloy for Surgical Implants,'' and
    (viii) F 1672-95 ``Specification for Resurfacing Patellar 
Prosthesis.''

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50710, Sept. 27, 1996; 
65 FR 17147, Mar. 31, 2000]



Sec. 888.3550  Knee joint patellofemorotibial polymer/metal/metal
constrained cemented prosthesis.

    (a) Identification. A knee joint patellofemorotibial polymer/metal/
metal constrained cemented prosthesis is a device intended to be 
implanted to replace a knee joint. The device prevents dislocation in 
more than one anatomic plane and has components that are linked 
together. This generic type of device includes prostheses that have a 
femoral component, a tibial component, a cylindrical bolt and 
accompanying locking hardware that are all made of alloys, such as 
cobalt-chromium-molybdenum, and a retropatellar resurfacing component 
made of ultra-high molecular weight polyethylene. The retropatellar 
surfacing component may be attached to the resected patella either with 
a metallic screw or bone cement. All stemmed metallic components within 
this generic type are intended for use with bone cement (Sec. 
888.3027).
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any knee 
joint patellofemorotibial polymer/metal/metal constrained cemented 
prosthesis that was in commercial distribution before May 28, 1976, or 
that has, on or before December 26, 1996 been found to be substantially 
equivalent to a knee joint patellofemorotibial polymer/metal/metal 
constrained cemented prosthesis that was in commercial distribution 
before May 28, 1976. Any other knee joint patellofemorotibial polymer/
metal/metal constrained cemented prosthesis shall have an approved PMA 
or a declared completed PDP in effect before being placed in commercial 
distribution.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50710, Sept. 27, 1996]



Sec. 888.3560  Knee joint patellofemorotibial polymer/metal/polymer semi
-constrained cemented prosthesis.

    (a) Identification. A knee joint patellofemorotibial polymer/metal/
polymer semi-constrained cemented prosthesis is a device intended to be 
implanted to replace a knee joint. The device limits translation and 
rotation in one or more planes via the geometry of its articulating 
surfaces. It has no linkage across-the-joint. This generic

[[Page 759]]

type of device includes prostheses that have a femoral component made of 
alloys, such as cobalt-chromium-molybdenum, and a tibial component or 
components and a retropatellar resurfacing component made of ultra-high 
molecular weight polyethylene. This generic type of device is limited to 
those prostheses intended for use with bone cement (Sec. 888.3027).
    (b) Classification. Class II.



Sec. 888.3565  Knee joint patellofemorotibial metal/polymer porous-coated
uncemented prosthesis.

    (a) Identification. A knee joint patellofemorotibial metal/polymer 
porous-coated uncemented prosthesis is a device intended to be implanted 
to replace a knee joint. The device limits translation and rotation in 
one or more planes via the geometry of its articulating surfaces. It has 
no linkage across-the-joint. This generic type of device is designed to 
achieve biological fixation to bone without the use of bone cement. This 
identification includes fixed-bearing knee prostheses where the ultra 
high molecular weight polyethylene tibial bearing is rigidly secured to 
the metal tibial base plate.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance: ``Class II Special Controls Guidance Document: Knee 
Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated 
Uncemented Prostheses; Guidance for Industry and FDA.'' See Sec. 888.1 
for the availability of this guidance.

[68 FR 14137, Mar. 24, 2003]



Sec. 888.3570  Knee joint femoral (hemi-knee) metallic uncemented
prosthesis.

    (a) Identification. A knee joint femoral (hemi-knee) metallic 
uncemented prosthesis is a device made of alloys, such as cobalt-
chromium-molybdenum, intended to be implanted to replace part of a knee 
joint. The device limits translation and rotation in one or more planes 
via the geometry of its articulating surfaces. It has no linkage across-
the-joint. This generic type of device includes prostheses that consist 
of a femoral component with or without protuberance(s) for the 
enhancement of fixation and is limited to those prostheses intended for 
use without bone cement (Sec. 888.3027).
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any knee 
joint femoral (hemi-knee) metallic uncemented prosthesis that was in 
commercial distribution before May 28, 1976, or that has, on or before 
December 26, 1996 been found to be substantially equivalent to a knee 
joint femoral (hemi-knee) metallic uncemented prosthesis that was in 
commercial distribution before May 28, 1976. Any other knee joint 
femoral (hemi-knee) metallic uncemented prosthesis shall have an 
approved PMA or a declared completed PDP in effect before being placed 
in commercial distribution.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50710, Sept. 27, 1996]



Sec. 888.3580  Knee joint patellar (hemi-knee) metallic resurfacing
uncemented prosthesis.

    (a) Identification. A knee joint patellar (hemi-knee) metallic 
resurfacing uncemented prosthesis is a device made of alloys, such as 
cobalt-chromium-molybdenum, intended to be implanted to replace the 
retropatellar articular surface of the patellofemoral joint. The device 
limits minimally (less than normal anatomic constraints) translation in 
one or more planes. It has no linkage across-the-joint. This generic 
type of device includes prostheses that have a retropatellar resurfacing 
component and an orthopedic screw to transfix the patellar remnant. This 
generic type of device is limited to those prostheses intended for use 
without bone cement (Sec. 888.3027).
    (b) Classification. (1) Class II when intended for treatment of 
degenerative and posttraumatic patellar arthritis.
    (2) Class III when intended for uses other than treatment of 
degenerative and posttraumatic patellar arthritis.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996

[[Page 760]]

for any knee joint patellar (hemi-knee) metallic resurfacing uncemented 
prosthesis described in paragraph (b)(2) of this section that was in 
commercial distribution before May 28, 1976, or that has, on or before 
December 26, 1996 been found to be substantially equivalent to a knee 
joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis 
that was in commercial distribution before May 28, 1976. Any other knee 
joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis 
shall have an approved PMA or a declared completed PDP in effect before 
being placed in commercial distribution.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50711, Sept. 27, 1996]



Sec. 888.3590  Knee joint tibial (hemi-knee) metallic resurfacing
uncemented prosthesis.

    (a) Identification. A knee joint tibial (hemi-knee) metallic 
resurfacing uncemented prosthesis is a device intended to be implanted 
to replace part of a knee joint. The device limits minimally (less than 
normal anatomic constraints) translation in one or more planes. It has 
no linkage across-the-joint. This prosthesis is made of alloys, such as 
cobalt-chromium-molybdenum, and is intended to resurface one tibial 
condyle. The generic type of device is limited to those prostheses 
intended for use without bone cement (Sec. 888.3027).
    (b) Classification. Class II.



Sec. 888.3600  Implantable post-surgical kinematic measurement
knee device.

    (a) Identification. An implantable post-surgical kinematic 
measurement knee device is a device that provides objective kinematic 
data after total knee arthroplasty surgery. The kinematic data provided 
by the device are used as an adjunct to other physiological parameter 
measurement tools utilized during the course of patient monitoring and 
treatment post surgery.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following tests must be conducted:
    (i) Mechanical testing must evaluate the mechanical function 
(mechanical fatigue, static mechanical strength) and durability of the 
implant.
    (ii) Simulated use testing must evaluate the ability of the device 
to be sized, inserted, and sufficiently secured to any compatible 
components.
    (iii) Testing must demonstrate the accuracy, reliability, and 
reproducibility of kinematic measurements.
    (iv) Testing must demonstrate diagnostic and therapeutic ultrasound 
conditions for safe use.
    (v) Testing must demonstrate that the device performs as intended 
under anticipated conditions of use demonstrating the following 
performance characteristics, if applicable:
    (A) Magnetic pulse output testing;
    (B) Magnetic and electrical field testing; and
    (C) Testing of the safety features built into the device.
    (vi) Testing must demonstrate hermeticity of any electronic 
component enclosures.
    (2) Performance testing must evaluate the compatibility of the 
device in a magnetic resonance (MR) environment.
    (3) Human factors testing must demonstrate that the intended user(s) 
can correctly use the device for its intended use, including for 
implantation and post-procedure data access.
    (4) Performance data must demonstrate the sterility of the device 
implant and patient-contacting components.
    (5) Performance data must validate the reprocessing instructions for 
the reusable components of the device.
    (6) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (7) Design characteristics of the device, including engineering 
schematics, must ensure that the geometry and material composition are 
consistent with the intended use.
    (8) Performance testing must demonstrate the electromagnetic 
compatibility/interference, (EMC/EMI), electrical safety, thermal 
safety, battery safety, and wireless performance of the device.

[[Page 761]]

    (9) Software verification, validation, and hazard analysis must be 
performed.
    (10) The labeling must include the following:
    (i) A shelf life;
    (ii) Physician and patient instructions for use, including images 
that demonstrate how to interact with the device;
    (iii) Detailed instruction of the surgical technique;
    (iv) Hardware and software requirements for interacting with the 
device;
    (v) A clear description of the technological features of the device 
including identification of the device materials, compatible components, 
and the principles of operation;
    (vi) Identification of magnetic resonance (MR) compatibility status;
    (vii) Validated methods and instructions for reprocessing of any 
reusable components; and
    (viii) A statement regarding the limitations of the clinical 
significance of the kinematic data.

[88 FR 753, Jan. 5, 2023]



Sec. 888.3630  Resorbable shoulder spacer.

    (a) Identification. A resorbable shoulder spacer is intended to act 
as a temporary spacer, creating a physical barrier between tissues in 
the shoulder, for the treatment of massive irreparable rotator cuff 
tears.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must demonstrate that the device 
performs as intended under anticipated conditions of use and include the 
following:
    (i) Evaluation of improvement of shoulder function and reduction of 
symptoms (e.g., pain and function) for the indications for use; and
    (ii) Evaluation of relevant adverse events.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use and 
include the following:
    (i) Integrity testing of the device, including mechanical and 
chemical stability; and
    (ii) Characterization of the device degradation profile.
    (3) Animal performance testing must include evaluation of the 
following:
    (i) Adverse effects, including gross necropsy and histopathology; 
and
    (ii) Device degradation to verify in vitro versus in vivo 
degradation correlation.
    (4) All patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (5) Performance data must support the sterility and pyrogenicity of 
the device components intended to be sterile.
    (6) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the identified shelf life.
    (7) Labeling must include the following:
    (i) Instruction for use, including specific instructions regarding 
device selection and placement;
    (ii) A detailed summary of the clinical performance testing with the 
device, including procedure- and device-related complications or adverse 
events; and
    (iii) A shelf life.

[87 FR 981, Jan. 6, 2023]



Sec. 888.3640  Shoulder joint metal/metal or metal/polymer 
constrained cemented prosthesis.

    (a) Identification. A shoulder joint metal/metal or metal/polymer 
constrained cemented prosthesis is a device intended to be implanted to 
replace a shoulder joint. The device prevents dislocation in more than 
one anatomic plane and has components that are linked together. This 
generic type of device includes prostheses that have a humeral component 
made of alloys, such as cobalt-chromium-molybdenum, and a glenoid 
component made of this alloy or a combination of this alloy and ultra-
high molecular weight polyethylene. This generic type of device is 
limited to those prostheses intended for use with bone cement (Sec. 
888.3027).
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996

[[Page 762]]

for any shoulder joint metal/metal or metal/polymer constrained cemented 
prosthesis that was in commercial distribution before May 28, 1976, or 
that has, on or before December 26, 1996 been found to be substantially 
equivalent to a shoulder joint metal/metal or metal/polymer constrained 
cemented prosthesis that was in commercial distribution before May 28, 
1976. Any other shoulder joint metal/metal or metal/polymer constrained 
cemented prosthesis shall have an approved PMA or a declared completed 
PDP in effect before being placed in commercial distribution.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50711, Sept. 27, 1996]



Sec. 888.3650  Shoulder joint metal/polymer non-constrained cemented
prosthesis.

    (a) Identification. A shoulder joint metal/polymer non-constrained 
cemented prosthesis is a device intended to be implanted to replace a 
shoulder joint. The device limits minimally (less than normal anatomic 
constraints) translation in one or more planes. It has no linkage 
across-the-joint. This generic type of device includes prostheses that 
have a humeral component made of alloys, such as cobalt-chromium-
molybdenum, and a glenoid resurfacing component made of ultra-high 
molecular weight polyethylene, and is limited to those prostheses 
intended for use with bone cement (Sec. 888.3027).
    (b) Classification. Class II. The special controls for this device 
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological Evaluation 
of Medical Devices--Part I: Evaluation and Testing,' ''
    (ii) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),''
    (iii) ``Guidance Document for Testing Orthopedic Implants with 
Modified Metallic Surfaces Apposing Bone or Bone Cement,''
    (iv) ``Guidance Document for the Preparation of Premarket 
Notification (510(k)) Application for Orthopedic Devices,'' and
    (v) ``Guidance Document for Testing Non-articulating, `Mechanically 
Locked' Modular Implant Components,''
    (2) International Organization for Standardization's (ISO):
    (i) ISO 5832-3:1996 ``Implants for Surgery--Metallic Materials--Part 
3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,''
    (ii) ISO 5832-4:1996 ``Implants for Surgery--Metallic Materials--
Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,''
    (iii) ISO 5832-12:1996 ``Implants for Surgery--Metallic Materials--
Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,''
    (iv) ISO 5833:1992 ``Implants for Surgery--Acrylic Resin Cements,''
    (v) ISO 5834-2:1998 ``Implants for Surgery--Ultra-high Molecular 
Weight Polyethylene--Part 2: Moulded Forms,''
    (vi) ISO 6018:1987 ``Orthopaedic Implants--General Requirements for 
Marking, Packaging, and Labeling,'' and
    (vii) ISO 9001:1994 ``Quality Systems--Model for Quality Assurance 
in Design/Development, Production, Installation, and Servicing,'' and
    (3) American Society for Testing and Materials':
    (i) F 75-92 ``Specification for Cast Cobalt-28 Chromium-6 Molybdenum 
Alloy for Surgical Implant Material,''
    (ii) F 648-98 ``Specification for Ultra-High-Molecular-Weight 
Polyethylene Powder and Fabricated Form for Surgical Implants,''
    (iii) F 799-96 ``Specification for Cobalt-28 Chromium-6 Molybdenum 
Alloy Forgings for Surgical Implants,''
    (iv) F 1044-95 ``Test Method for Shear Testing of Porous Metal 
Coatings,''
    (v) F 1108-97 ``Titanium-6 Aluminum-4 Vanadium Alloy Castings for 
Surgical Implants,''
    (vi) F 1147-95 ``Test Method for Tension Testing of Porous Metal 
Coatings,''
    (vii) F 1378-97 ``Specification for Shoulder Prosthesis,'' and
    (viii) F 1537-94 ``Specification for Wrought Cobalt-28 Chromium-6 
Molybdenum Alloy for Surgical Implants.''

[52 FR 33702, Sept. 4, 1987, as amended at 65 FR 17148, Mar. 31, 2000]

[[Page 763]]



Sec. 888.3660  Shoulder joint metal/polymer semi-constrained
cemented prosthesis.

    (a) Identification. A shoulder joint metal/polymer semi-constrained 
cemented prosthesis is a device intended to be implanted to replace a 
shoulder joint. The device limits translation and rotation in one or 
more planes via the geometry of its articulating surfaces. It has no 
linkage across-the-joint. This generic type of device includes 
prostheses that have a humeral resurfacing component made of alloys, 
such as cobalt-chromium-molybdenum, and a glenoid resurfacing component 
made of ultra-high molecular weight polyethylene, and is limited to 
those prostheses intended for use with bone cement (Sec. 888.3027).
    (b) Classification. Class II. The special controls for this device 
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological Evaluation 
of Medical Devices--Part I: Evaluation and Testing,' ''
    (ii) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),''
    (iii) ``Guidance Document for Testing Orthopedic Implants with 
Modified Metallic Surfaces Apposing Bone or Bone Cement,''
    (iv) ``Guidance Document for the Preparation of Premarket 
Notification (510(k)) Application for Orthopedic Devices,'' and
    (v) ``Guidance Document for Testing Non-articulating, `Mechanically 
Locked' Modular Implant Components,''
    (2) International Organization for Standardization's (ISO):
    (i) ISO 5832-3:1996 ``Implants for Surgery--Metallic Materials--Part 
3: Wrought Titanium 6-aluminum 4-vandium Alloy,''
    (ii) ISO 5832-4:1996 ``Implants for Surgery--Metallic Materials--
Part 4: Cobalt-chromium-molybdenum casting alloy,''
    (iii) ISO 5832-12:1996 ``Implants for Surgery--Metallic Materials--
Part 12: Wrought Cobalt-chromium-molybdenum alloy,''
    (iv) ISO 5833:1992 ``Implants for Surgery--Acrylic Resin Cements,''
    (v) ISO 5834-2:1998 ``Implants for Surgery--Ultra-high Molecular 
Weight Polyethylene--Part 2: Moulded Forms,''
    (vi) ISO 6018:1987 ``Orthopaedic Implants--General Requirements for 
Marking, Packaging, and Labeling,'' and
    (vii) ISO 9001:1994 ``Quality Systems--Model for Quality Assurance 
in Design/Development, Production, Installation, and Servicing,'' and
    (3) American Society for Testing and Materials':
    (i) F 75-92 ``Specification for Cast Cobalt-28 Chromium-6 Molybdenum 
Alloy for Surgical Implant Material,''
    (ii) F 648-98 ``Specification for Ultra-High-Molecular-Weight 
Polyethylene Powder and Fabricated Form for Surgical Implants,''
    (iii) F 799-96 ``Specification for Cobalt-28 Chromium-6 Molybdenum 
Alloy Forgings for Surgical Implants,''
    (iv) F 1044-95 ``Test Method for Shear Testing of Porous Metal 
Coatings,''
    (v) F 1108-97 ``Specification for Titanium-6 Aluminum-4 Vanadium 
Alloy Castings for Surgical Implants,''
    (vi) F 1147-95 ``Test Method for Tension Testing of Porous Metal,''
    (vii) F 1378-97 ``Standard Specification for Shoulder Prosthesis,'' 
and
    (viii) F 1537-94 ``Specification for Wrought Cobalt-28 Chromium-6 
Molybdenum Alloy for Surgical Implants.''

[52 FR 33702, Sept. 4, 1987, as amended at 65 FR 17148, Mar. 31, 2000]



Sec. 888.3670  Shoulder joint metal/polymer/metal nonconstrained
or semi-constrained porous-coated uncemented prosthesis.

    (a) Identification. A shoulder joint metal/polymer/metal 
nonconstrained or semi-constrained porous-coated uncemented prosthesis 
is a device intended to be implanted to replace a shoulder joint. The 
device limits movement in one or more planes. It has no linkage across-
the-joint. This generic type of device includes prostheses that have a 
humeral component made of alloys such as cobalt-chromium-molybdenum (Co-
Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid 
resurfacing component made of ultra-high molecular weight polyethylene, 
or a combination of an articulating ultra-high molecular weight bearing 
surface fixed in a metal

[[Page 764]]

shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral 
component and glenoid backing have a porous coating made of, in the case 
of Co-Cr-Mo components, beads of the same alloy or commercially pure 
titanium powder, and in the case of Ti-6Al-4V components, beads or 
fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially 
pure titanium powder. The porous coating has a volume porosity between 
30 and 70 percent, an average pore size between 100 and 1,000 microns, 
interconnecting porosity, and a porous coating thickness between 500 and 
1,500 microns. This generic type of device is designed to achieve 
biological fixation to bone without the use of bone cement.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's ``Class II Special Controls Guidance: Shoulder 
Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-
Coated Uncemented Prosthesis.''

[66 FR 12737, Feb. 28, 2001]



Sec. 888.3680  Shoulder joint glenoid (hemi-shoulder) metallic 
cemented prosthesis.

    (a) Identification. A shoulder joint glenoid (hemi-shoulder) 
metallic cemented prosthesis is a device that has a glenoid (socket) 
component made of alloys, such as cobalt-chromium-molybdenum, or alloys 
with ultra-high molecular weight polyethylene and intended to be 
implanted to replace part of a shoulder joint. This generic type of 
device is limited to those prostheses intended for use with bone cement 
(Sec. 888.3027).
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any shoulder 
joint glenoid (hemi-shoulder) metallic cemented prosthesis that was in 
commercial distribution before May 28, 1976, or that has, on or before 
December 26, 1996 been found to be substantially equivalent to a 
shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis that 
was in commercial distribution before May 28, 1976. Any other shoulder 
joint glenoid (hemi-shoulder) metallic cemented prosthesis shall have an 
approved PMA or a declared completed PDP in effect before being placed 
in commercial distribution.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50711, Sept. 27, 1996]



Sec. 888.3690  Shoulder joint humeral (hemi-shoulder) metallic 
uncemented prosthesis.

    (a) Identification. A shoulder joint humeral (hemi-shoulder) 
metallic uncemented prosthesis is a device made of alloys, such as 
cobalt-chromium-molybdenum. It has an intramedullary stem and is 
intended to be implanted to replace the articular surface of the 
proximal end of the humerus and to be fixed without bone cement (Sec. 
888.3027). This device is not intended for biological fixation.
    (b) Classification. Class II.



Sec. 888.3720  Toe joint polymer constrained prosthesis.

    (a) Identification. A toe joint polymer constrained prosthesis is a 
device made of silicone elastomer or polyester reinforced silicone 
elastomer intended to be implanted to replace the first 
metatarsophalangeal (big toe) joint. This generic type of device 
consists of a single flexible across-the-joint component that prevents 
dislocation in more than one anatomic plane.
    (b) Classification. Class II.



Sec. 888.3730  Toe joint phalangeal (hemi-toe) polymer prosthesis.

    (a) Identification. A toe joint phalangeal (hemi-toe) polymer 
prosthesis is a device made of silicone elastomer intended to be 
implanted to replace the base of the proximal phalanx of the toe.
    (b) Classification. Class II.



Sec. 888.3750  Wrist joint carpal lunate polymer prosthesis.

    (a) Identification. A wrist joint carpal lunate prosthesis is a one-
piece device made of silicone elastomer intended to be implanted to 
replace the carpal lunate bone of the wrist.
    (b) Classification. Class II.

[[Page 765]]



Sec. 888.3760  Wrist joint carpal scaphoid polymer prosthesis.

    (a) Identification. A wrist joint carpal scaphoid polymer prosthesis 
is a one-piece device made of silicone elastomer intended to be 
implanted to replace the carpal scaphoid bone of the wrist.
    (b) Classification. Class II.



Sec. 888.3770  Wrist joint carpal trapezium polymer prosthesis.

    (a) Identification. A wrist joint carpal trapezium polymer 
prosthesis is a one-piece device made of silicone elastomer or silicone 
elastomer/polyester material intended to be implanted to replace the 
carpal trapezium bone of the wrist.
    (b) Classification. Class II.



Sec. 888.3780  Wrist joint polymer constrained prosthesis.

    (a) Identification. A wrist joint polymer constrained prosthesis is 
a device made of polyester-reinforced silicone elastomer intended to be 
implanted to replace a wrist joint. This generic type of device consists 
of a single flexible across-the-joint component that prevents 
dislocation in more than one anatomic plane.
    (b) Classification. Class II.



Sec. 888.3790  Wrist joint metal constrained cemented prosthesis.

    (a) Identification. A wrist joint metal constrained cemented 
prosthesis is a device intended to be implanted to replace a wrist 
joint. The device prevents dislocation in more than one anatomic plane 
and consists of either a single flexible across-the-joint component or 
two components linked together. This generic type of device is limited 
to a device which is made of alloys, such as cobalt-chromium-molybdenum, 
and is limited to those prostheses intended for use with bone cement 
(Sec. 888.3027).
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any wrist 
joint metal constrained cemented prosthesis that was in commercial 
distribution before May 28, 1976, or that has, on or before December 26, 
1996 been found to be substantially equivalent to a wrist joint metal 
constrained cemented prosthesis that was in commercial distribution 
before May 28, 1976. Any other wrist joint metal constrained cemented 
prosthesis shall have an approved PMA or a declared completed PDP in 
effect before being placed in commercial distribution.

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50711, Sept. 27, 1996]



Sec. 888.3800  Wrist joint metal/polymer semi-constrained cemented prosthesis.

    (a) Identification. A wrist joint metal/polymer semi-constrained 
cemented prosthesis is a device intended to be implanted to replace a 
wrist joint. The device limits translation and rotation in one or more 
planes via the geometry of its articulating surfaces. It has no linkage 
across-the-joint. This generic type of device includes prostheses that 
have either a one-part radial component made of alloys, such as cobalt-
chromium-molybdenum, with an ultra-high molecular weight polyethylene 
bearing surface, or a two-part radial component made of alloys and an 
ultra-high molecular weight polyethylene ball that is mounted on the 
radial component with a trunnion bearing. The metallic portion of the 
two-part radial component is inserted into the radius. These devices 
have a metacarpal component(s) made of alloys, such as cobalt-chromium-
molybdenum. This generic type of device is limited to those prostheses 
intended for use with bone cement (Sec. 888.3027).
    (b) Classification. Class II.



Sec. 888.3810  Wrist joint ulnar (hemi-wrist) polymer prosthesis.

    (a) Identification. A wrist joint ulnar (hemi-wrist) polymer 
prosthesis is a mushroom-shaped device made of a medical grade silicone 
elastomer or ultra-high molecular weight polyethylene intended to be 
implanted into the intramedullary canal of the bone and held in place by 
a suture. Its purpose is to cover the resected end of the distal ulna to 
control bone overgrowth and to provide an articular surface for the 
radius and carpus.
    (b) Classification. Class II.

[[Page 766]]



                       Subpart E_Surgical Devices



Sec. 888.4150  Calipers for clinical use.

    (a) Identification. A caliper for clinical use is a compass-like 
device intended for use in measuring the thickness or diameter of a part 
of the body or the distance between two body surfaces, such as for 
measuring an excised skeletal specimen to determine the proper 
replacement size of a prosthesis.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 888.9.

[52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]



Sec. 888.4200  Cement dispenser.

    (a) Identification. A cement dispenser is a nonpowered syringe-like 
device intended for use in placing bone cement (Sec. 888.3027) into 
surgical sites.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 888.9.

[52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52953, Dec. 29, 1988; 
59 FR 63014, Dec. 7, 1994; 66 FR 38815, July 25, 2001]



Sec. 888.4210  Cement mixer for clinical use.

    (a) Identification. A cement mixer for clinical use is a device 
consisting of a container intended for use in mixing bone cement (Sec. 
888.3027).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 888.9.

[52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52953, Dec. 29, 1988; 
59 FR 63014, Dec. 7, 1994; 66 FR 38815, July 25, 2001]



Sec. 888.4220  Cement monomer vapor evacuator.

    (a) Identification. A cement monomer vapor evacuator is a device 
intended for use during surgery to contain or remove undesirable fumes, 
such as monomer vapor from bone cement (Sec. 888.3027).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 888.9.

[52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988; 
66 FR 38815, July 25, 2001]



Sec. 888.4230  Cement ventilation tube.

    (a) Identification. A cement ventilation tube is a tube-like device 
usually made of plastic intended to be inserted into a surgical cavity 
to allow the release of air or fluid from the cavity as it is being 
filled with bone cement (Sec. 888.3027).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 888.9.

[52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988; 
59 FR 63014, Dec. 7, 1994; 66 FR 38815, July 25, 2001]



Sec. 888.4300  Depth gauge for clinical use.

    (a) Identification. A depth gauge for clinical use is a measuring 
device intended for various medical purposes, such as to determine the 
proper length of screws for fastening the ends of a fractured bone.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 888.9.

[52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]



Sec. 888.4505  Orthopedic surgical instrumentation designed for 
osteochondral implants with press-fit fixation.

    (a) Identification. Orthopedic surgical instruments designed for 
osteochondral implants with press-fit fixation are hand-held devices 
intended to manipulate bone and cartilage tissue or the implant for the 
positioning, alignment, defect creation, and placement of press-fit 
osteochondral implants that utilize no additional means of fixation 
(e.g., suture fixation, adhesives). This type of device includes 
instruments specific to the geometry of the implant.
    (b) Classification. Class II (special controls). The device is 
exempt from

[[Page 767]]

the premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 888.9. The special controls 
for this device are:
    (1) Technical specifications regarding geometry of the instruments 
must be specified and validated to demonstrate that the instruments can 
safely position and place the implant.
    (2) The patient contacting components of the device must be 
demonstrated to be biocompatible.
    (3) Labeling must include:
    (i) Identification of implant(s) and instruments which have been 
validated for use together; and
    (ii) Validated methods and instructions for reprocessing any 
reusable parts.

[84 FR 57321, Oct. 25, 2019, as amended at 85 FR 44188, July 22, 2020]



Sec. 888.4540  Orthopedic manual surgical instrument.

    (a) Identification. An orthopedic manual surgical instrument is a 
nonpowered hand-held device intended for medical purposes to manipulate 
tissue, or for use with other devices in orthopedic surgery. This 
generic type of device includes the cerclage applier, awl, bender, drill 
brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, 
prosthesis driver, extractor, file, fork, needle holder, impactor, 
bending or contouring instrument, compression instrument, passer, socket 
positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, 
scissors, screwdriver, bone skid, staple driver, bone screw starter, 
surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 888.9.

[52 FR 33702, Sept. 4, 1987, as amended at 59 FR 63014, Dec. 7, 1994; 66 
FR 38815, July 25, 2001]



Sec. 888.4580  Sonic surgical instrument and accessories/attachments.

    (a) Identification. A sonic surgical instrument is a hand-held 
device with various accessories or attachments, such as a cutting tip 
that vibrates at high frequencies, and is intended for medical purposes 
to cut bone or other materials, such as acrylic.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 888.9.

[52 FR 33702, Sept. 4, 1987, as amended at 84 FR 71818, Dec. 30, 2019]



Sec. 888.4600  Protractor for clinical use.

    (a) Identification. A protractor for clinical use is a device 
intended for use in measuring the angles of bones, such as on x-rays or 
in surgery.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 888.9.

[52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]



Sec. 888.4800  Template for clinical use.

    (a) Identification. A template for clinical use is a device that 
consists of a pattern or guide intended for medical purposes, such as 
selecting or positioning orthopedic implants or guiding the marking of 
tissue before cutting.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 888.9.

[52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]



Sec. 888.5850  Nonpowered orthopedic traction apparatus and accessories.

    (a) Identification. A nonpowered orthopedic traction apparatus is a 
device that consists of a rigid frame with nonpowered traction 
accessories, such as cords, pulleys, or weights, and that is intended to 
apply a therapeutic pulling force to the skeletal system.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 888.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general

[[Page 768]]

requirements concerning records, and Sec. 820.198, regarding complaint 
files.

[52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]



Sec. 888.5890  Noninvasive traction component.

    (a) Identification. A noninvasive traction component is a device, 
such as a head halter, pelvic belt, or a traction splint, that does not 
penetrate the skin and is intended to assist in connecting a patient to 
a traction apparatus so that a therapeutic pulling force may be applied 
to the patient's body.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 888.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general requirements concerning 
records, and Sec. 820.198, regarding complaint files.

[52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988; 
66 FR 38815, July 25, 2001]



Sec. 888.5940  Cast component.

    (a) Identification. A cast component is a device intended for 
medical purposes to protect or support a cast. This generic type of 
device includes the cast heel, toe cap, cast support, and walking iron.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 888.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general requirements concerning 
records, and Sec. 820.198, regarding complaint files.

[52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988; 
59 FR 63014, Dec. 7, 1994; 66 FR 38815, July 25, 2001]



Sec. 888.5960  Cast removal instrument.

    (a) Identification. A cast removal instrument is an AC-powered, 
hand-held device intended to remove a cast from a patient. This generic 
type of device includes the electric cast cutter and cast vacuum.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 888.9.

[55 FR 48443, Nov. 20, 1990, as amended at 61 FR 1125, Jan. 16, 1996; 66 
FR 38816, July 25, 2001]



Sec. 888.5980  Manual cast application and removal instrument.

    (a) Identification. A manual cast application and removal instrument 
is a nonpowered hand-held device intended to be used in applying or 
removing a cast. This generic type of device includes the cast knife, 
cast spreader, plaster saw, plaster dispenser, and casting stand.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 888.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general requirements concerning 
records, and Sec. 820.198, regarding complaint files.

[52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988; 
66 FR 38816, July 25, 2001]



PART 890_PHYSICAL MEDICINE DEVICES--Table of Contents



                      Subpart A_General Provisions

Sec.
890.1 Scope.
890.3 Effective dates of requirement for premarket approval.
890.9 Limitations of exemptions from section 510(k) of the Federal Food, 
          Drug, and Cosmetic Act (the act).

             Subpart B_Physical Medicine Diagnostic Devices

890.1175 Electrode cable.
890.1225 Chronaximeter.
890.1375 Diagnostic electromyograph.
890.1385 Diagnostic electromyograph needle electrode.
890.1450 Powered reflex hammer.
890.1575 Force-measuring platform.

[[Page 769]]

890.1600 Intermittent pressure measurement system.
890.1615 Miniature pressure transducer.
890.1850 Diagnostic muscle stimulator.
890.1925 Isokinetic testing and evaluation system.

Subpart C [Reserved]

             Subpart D_Physical Medicine Prosthetic Devices

890.3025 Prosthetic and orthotic accessory.
890.3075 Cane.
890.3100 Mechanical chair.
890.3110 Electric positioning chair.
890.3150 Crutch.
890.3175 Flotation cushion.
890.3410 External limb orthotic component.
890.3420 External limb prosthetic component.
890.3450 Upper extremity prosthesis including a simultaneously powered 
          elbow and/or shoulder with greater than two simultaneous 
          powered degrees of freedom and controlled by non-implanted 
          electrical components.
890.3475 Limb orthosis.
890.3480 Powered lower extremity exoskeleton.
890.3490 Truncal orthosis.
890.3500 External assembled lower limb prosthesis.
890.3520 Plinth.
890.3610 Rigid pneumatic structure orthosis.
890.3640 Arm sling.
890.3665 Congenital hip dislocation abduction splint.
890.3675 Denis Brown splint.
890.3690 Powered wheeled stretcher.
890.3700 Nonpowered communication system.
890.3710 Powered communication system.
890.3725 Powered environmental control system.
890.3750 Mechanical table.
890.3760 Powered table.
890.3790 Cane, crutch, and walker tips and pads.
890.3800 Motorized three-wheeled vehicle.
890.3825 Mechanical walker.
890.3850 Mechanical wheelchair.
890.3860 Powered wheelchair.
890.3880 Special grade wheelchair.
890.3890 Stair-climbing wheelchair.
890.3900 Standup wheelchair.
890.3910 Wheelchair accessory.
890.3920 Wheelchair component.
890.3930 Wheelchair elevator.
890.3940 Wheelchair platform scale.

Subpart E [Reserved]

             Subpart F_Physical Medicine Therapeutic Devices

890.5050 Daily activity assist device.
890.5100 Immersion hydrobath.
890.5110 Paraffin bath.
890.5125 Nonpowered sitz bath.
890.5150 Powered patient transport.
890.5160 Air-fluidized bed.
890.5170 Powered flotation therapy bed.
890.5180 Manual patient rotation bed.
890.5225 Powered patient rotation bed.
890.5250 Moist steam cabinet.
890.5275 Microwave diathermy.
890.5290 Shortwave diathermy.
890.5300 Ultrasonic diathermy.
890.5350 Exercise component.
890.5360 Measuring exercise equipment.
890.5370 Nonmeasuring exercise equipment.
890.5380 Powered exercise equipment.
890.5410 Powered finger exerciser.
890.5420 Electroencephalography (EEG)-driven upper extremity powered 
          exerciser.
890.5500 Infrared lamp.
890.5525 Iontophoresis device.
890.5575 Powered external limb overload warning device.
890.5650 Powered inflatable tube massager.
890.5660 Therapeutic massager.
890.5670 Internal therapeutic massager.
890.5700 Cold pack.
890.5710 Hot or cold disposable pack.
890.5720 Water circulating hot or cold pack.
890.5730 Moist heat pack.
890.5740 Powered heating pad.
890.5760 Nonpowered lower extremity pressure wrap.
890.5765 Pressure-applying device.
890.5800 Virtual reality behavioral therapy device for pain relief.
890.5850 Powered muscle stimulator.
890.5860 Ultrasound and muscle stimulator.
890.5880 Multi-function physical therapy table.
890.5900 Powered traction equipment.
890.5925 Traction accessory.
890.5940 Chilling unit.
890.5950 Powered heating unit.
890.5975 Therapeutic vibrator.

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    Source: 48 FR 53047, Nov. 23, 1983, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 890 appear at 73 FR 
35341, June 23, 2008.



                      Subpart A_General Provisions



Sec. 890.1  Scope.

    (a) This part sets forth the classification of physical medicine 
devices intended for human use that are in commercial distribution.
    (b) The identification of a device in a regulation in this part is 
not a precise description of every device that is, or will be, subject 
to the regulation. A

[[Page 770]]

manufacturer who submits a premarket notification submission for a 
device under part 807 may not show merely that the device is accurately 
described by the section title and identification provisions of a 
regulation in this part, but shall state why the device is substantially 
equivalent to other devices, as required by Sec. 807.87.
    (c) To avoid duplicative listings, a physical medicine device that 
has two or more types of uses (e.g., used both as a diagnostic device 
and as a therapeutic device) is listed only in one subpart.
    (d) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.
    (e) Guidance documents referenced in this part are available on the 
Internet at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/default.htm..

[52 FR 17741, May 11, 1987, as amended at 73 FR 34860, June 19, 2008; 78 
FR 18233, Mar. 26, 2013]



Sec. 890.3  Effective dates of requirement for premarket approval.

    A device included in this part that is classified into class III 
(premarket approval) shall not be commercially distributed after the 
date shown in the regulation classifying the device unless the 
manufacturer has an approval under section 515 of the act (unless an 
exemption has been granted under section 520(g)(2) of the act). An 
approval under section 515 of the act consists of FDA's issuance of an 
order approving an application of premarket approval (PMA) for the 
device or declaring completed a product development protocol (PDP) for 
the device.
    (a) Before FDA requires that a device commercially distributed 
before the enactment date of the amendments, or a device that has been 
found substantially equivalent to such a device, has an approval under 
section 515 of the act FDA must promulgate a regulation under section 
515(b) of the act requiring such approval, except as provided in 
paragraph (b) of this section. Such a regulation under section 515(b) of 
the act shall not be effective during the grace period ending on the 
90th day after its promulgation or on the last day of the 30th full 
calendar month after the regulation that classifies the device into 
class III is effective, whichever is later. See section 501(f)(2)(B) of 
the act. Accordingly, unless an effective date of the requirement for 
premarket approval is shown in the regulation for a device classified 
into class III in this part, the device may be commercially distributed 
without FDA's issuance of an order approving a PMA or declaring 
completed a PDP for the device. If FDA promulgates a regulation under 
section 515(b) of the act requiring premarket approval for a device, 
section 501(f)(1)(A) of the act applies to the device.
    (b) Any new, not substantially equivalent, device introduced into 
commercial distribution on or after May 28, 1976, includiing a device 
formerly marketed that has been substantially altered, is classified by 
statute (section 513(f) of the act) into class III without any grace 
period and FDA must have issued an order approving a PMA or declaring 
completed a PDP for the device before the device is commercially 
distributed unless it is reclassified. If FDA knows that a device being 
commercially distributed may be a ``new'' device as defined in this 
section because of any new intended use or other reasons, FDA may codify 
the statutory classification of the device into class III for such new 
use. Accordingly, the regulation for such a class III device states that 
as of the enactment date of the amendments, May 28, 1976, the device 
must have an approval under section 515 of the act before commercial 
distribution.

[52 FR 17741, May 11, 1987]



Sec. 890.9  Limitations of exemptions from section 510(k) of 
the Federal Food, Drug, and Cosmetic Act (the act).

    The exemption from the requirement of premarket notification 
(section 510(k) of the act) for a generic type of class I or II device 
is only to the extent that the device has existing or reasonably 
foreseeable characteristics of commercially distributed devices within 
that generic type or, in the case of in vitro diagnostic devices, only 
to the extent that misdiagnosis as a result of using the device would 
not be associated with high morbidity or mortality.

[[Page 771]]

Accordingly, manufacturers of any commercially distributed class I or II 
device for which FDA has granted an exemption from the requirement of 
premarket notification must still submit a premarket notification to FDA 
before introducing or delivering for introduction into interstate 
commerce for commercial distribution the device when:
    (a) The device is intended for a use different from the intended use 
of a legally marketed device in that generic type of device; e.g., the 
device is intended for a different medical purpose, or the device is 
intended for lay use where the former intended use was by health care 
professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro diagnostic 
device detects or identifies infectious agents by using deoxyribonucleic 
acid (DNA) probe or nucleic acid hybridization technology rather than 
culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of neoplastic 
diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial or acquired 
genetic disorders, including inborn errors of metabolism;
    (3) For measuring an analyte that serves as a surrogate marker for 
screening, diagnosis, or monitoring life-threatening diseases such as 
acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, 
tuberculosis, or myocardial infarction or to monitor therapy;
    (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) or IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is intended 
for use in matrices other than serum or plasma;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).

[65 FR 2321, Jan. 14, 2000]



             Subpart B_Physical Medicine Diagnostic Devices



Sec. 890.1175  Electrode cable.

    (a) Identification. An electrode cable is a device composed of 
strands of insulated electrical conductors laid together around a 
central core and intended for medical purposes to connect an electrode 
from a patient to a diagnostic machine.
    (b) Classification. Class II (special controls). The special 
controls consist of:
    (1) The performance standard under part 898 of this chapter, and
    (2) The guidance document entitled ``Guidance on the Performance 
Standard for Electrode Lead Wires and Patient Cables.'' This device is 
exempt from the premarket notification procedures of subpart E of part 
807 of this chapter subject to Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994; 65 
FR 19319, Apr. 11, 2000]



Sec. 890.1225  Chronaximeter.

    (a) Identification. A chronaximeter is a device intended for medical 
purposes to measure neuromuscular excitability by means of a strength-
duration curve that provides a basis for diagnosis and prognosis of 
neurological dysfunction.
    (b) Classification. Class II (performance standards).



Sec. 890.1375  Diagnostic electromyograph.

    (a) Identification. A diagnostic electromyograph is a device 
intended for medical purposes, such as to monitor and display the 
bioelectric signals produced by muscles, to stimulate peripheral nerves, 
and to monitor and display the electrical activity produced by nerves, 
for the diagnosis and prognosis of neuromuscular disease.

[[Page 772]]

    (b) Classification. Class II (performance standards).



Sec. 890.1385  Diagnostic electromyograph needle electrode.

    (a) Identification. A diagnostic electromyograph needle electrode is 
a monopolar or bipolar needle intended to be inserted into muscle or 
nerve tissue to sense bioelectrical signals. The device is intended for 
medical purposes for use in connection with electromyography (recording 
the intrinsic electrical properties of skeletal muscle).
    (b) Classification. Class II (performance standards).



Sec. 890.1450  Powered reflex hammer.

    (a) Identification. A powered reflex hammer is a motorized device 
intended for medical purposes to elicit and determine controlled deep 
tendon reflexes.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]



Sec. 890.1575  Force-measuring platform.

    (a) Identification. A force-measuring platform is a device intended 
for medical purposes that converts pressure applied upon a planar 
surface into analog mechanical or electrical signals. This device is 
used to determine ground reaction force, centers of percussion, centers 
of torque, and their variations in both magnitude and direction with 
time.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 
FR 38816, July 25, 2001]



Sec. 890.1600  Intermittent pressure measurement system.

    (a) Identification. An intermittent pressure measurement system is 
an evaluative device intended for medical purposes, such as to measure 
the actual pressure between the body surface and the supporting media.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 
FR 38816, July 25, 2001]



Sec. 890.1615  Miniature pressure transducer.

    (a) Identification. A miniature pressure transducer is a device 
intended for medical purposes to measure the pressure between a device 
and soft tissue by converting mechanical inputs to analog electrical 
signals.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 
FR 38816, July 25, 2001]



Sec. 890.1850  Diagnostic muscle stimulator.

    (a) Identification. A diagnostic muscle stimulator is a device used 
mainly with an electromyograph machine to initiate muscle activity. It 
is intended for medical purposes, such as to diagnose motor nerve or 
sensory neuromuscular disorders and neuromuscular function.
    (b) Classification. Class II (performance standards).



Sec. 890.1925  Isokinetic testing and evaluation system.

    (a) Identification. An isokinetic testing and evaluation system is a 
rehabilitative exercise device intended for medical purposes, such as to 
measure, evaluate, and increase the strength of muscles and the range of 
motion of joints.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59230, Nov. 3, 1998]

Subpart C [Reserved]

[[Page 773]]



             Subpart D_Physical Medicine Prosthetic Devices



Sec. 890.3025  Prosthetic and orthotic accessory.

    (a) Identification. A prosthetic and orthotic accessory is a device 
intended for medical purposes to support, protect, or aid in the use of 
a cast, orthosis (brace), or prosthesis. Examples of prosthetic and 
orthotic accessories include the following: A pelvic support band and 
belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment 
device, a postsurgical pylon, a transverse rotator, and a temporary 
training splint.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general requirements concerning 
records and Sec. 820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001]



Sec. 890.3075  Cane.

    (a) Identification. A cane is a device intended for medical purposes 
that is used to provide minimal weight support while walking. Examples 
of canes include the following: A standard cane, a forearm cane, and a 
cane with a tripod, quad, or retractable stud on the ground end.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general requirements concerning 
records and Sec. 820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001]



Sec. 890.3100  Mechanical chair.

    (a) Identification. A mechanical chair is a manually operated device 
intended for medical purposes that is used to assist a disabled person 
in performing an activity that the person would otherwise find difficult 
to do or be unable to do. Examples of mechanical chairs include the 
following: A chair with an elevating seat used to raise a person from a 
sitting position to a standing position and a chair with casters used by 
a person to move from one place to another while sitting.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994; 66 
FR 38816, July 25, 2001]



Sec. 890.3110  Electric positioning chair.

    (a) Identification. An electric positioning chair is a device with a 
motorized positioning control that is intended for medical purposes and 
that can be adjusted to various positions. The device is used to provide 
stability for patients with athetosis (involuntary spasms) and to alter 
postural positions.
    (b) Classification. Class II. The electric positioning chair is 
exempt from premarket notification procedures in subpart E of part 807 
of this chapter, subject to Sec. 890.9 and the following conditions for 
exemption:
    (1) Appropriate analysis and non-clinical testing must demonstrate 
that the safety controls are adequate to ensure safe use of the device 
and prevent user falls from the device in the event of a device failure;
    (2) Appropriate analysis and non-clinical testing must demonstrate 
the ability of the device to withstand the rated user weight load with 
an appropriate factor of safety;
    (3) Appropriate analysis and non-clinical testing must demonstrate 
the longevity of the device to withstand external forces applied to the 
device and provide the user with an expected service life of the device;
    (4) Appropriate analysis and non-clinical testing must demonstrate 
proper

[[Page 774]]

environments of use and storage of the device to maximize the longevity 
of the device;
    (5) Appropriate analysis and non-clinical testing (such as that 
outlined in the currently FDA-recognized editions of ANSI/AAMI/ES60601-
1, ``Medical Electrical Equipment--Part 1: General Requirements for 
Basic Safety and Essential Performance,'' and ANSI/AAMI/IEC 60601-1-2, 
``Medical Electrical Equipment--Part 1-2: General Requirements for Basic 
Safety and Essential Performance--Collateral Standard: Electromagnetic 
Disturbances--Requirements and Tests'') must validate electromagnetic 
compatibility and electrical safety;
    (6) Appropriate analysis and non-clinical testing (such as that 
outlined in the currently FDA-recognized editions of ANSI/AAMI/ISO 
10993-1, ``Biological Evaluation of Medical Devices--Part 1: Evaluation 
and Testing Within a Risk Management Process,'' ANSI/AAMI/ISO 10993-5, 
``Biological Evaluation of Medical Devices--Part 5: Tests for In Vitro 
Cytotoxicity,'' and ANSI/AAMI/ISO 10993-10, ``Biological Evaluation of 
Medical Devices--Part 10: Tests for Irritation and Skin Sensitization'') 
must validate that the skin-contacting components of the device are 
biocompatible;
    (7) Appropriate analysis and non-clinical testing (such as that 
outlined in the currently FDA-recognized editions of IEC 62304, 
``Medical Device Software--Software Life Cycle Processes'') must 
validate the software life cycle and that all processes, activities, and 
tasks are implemented and documented;
    (8) Appropriate analysis and non-clinical testing must validate that 
the device components are found to be non-flammable;
    (9) Appropriate analysis and non-clinical testing must validate that 
the battery in the device (if applicable) performs as intended over the 
anticipated service life of the device; and
    (10) Adequate patient labeling is provided to the user to document 
proper use and maintenance of the device to ensure safe use of the 
device by the patient in the intended use environment.

[48 FR 53047, Nov. 23, 1983, as amended at 80 FR 72950, Nov. 20, 2015]



Sec. 890.3150  Crutch.

    (a) Identification. A crutch is a device intended for medical 
purposes for use by disabled persons to provide minimal to moderate 
weight support while walking.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general requirements concerning 
records and Sec. 820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001]



Sec. 890.3175  Flotation cushion.

    (a) Identification. A flotation cushion is a device intended for 
medical purposes that is made of plastic, rubber, or other type of 
covering, that is filled with water, air, gel, mud, or any other 
substance allowing a flotation media, used on a seat to lessen the 
likelihood of skin ulcers.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 
FR 38816, July 25, 2001]



Sec. 890.3410  External limb orthotic component.

    (a) Identification. An external limb orthotic component is a device 
intended for medical purposes for use in conjunction with an orthosis 
(brace) to increase the function of the orthosis for a patient's 
particular needs. Examples of external limb orthotic components include 
the following: A brace-setting twister and an external brace stirrup.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9. The device is 
also exempt from the current

[[Page 775]]

good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180, regarding general requirements concerning records and Sec. 
820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001]



Sec. 890.3420  External limb prosthetic component.

    (a) Identification. An external limb prosthetic component is a 
device intended for medical purposes that, when put together with other 
appropriate components, constitutes a total prosthesis. Examples of 
external limb prosthetic components include the following: Ankle, foot, 
hip, knee, and socket components; mechanical or powered hand, hook, 
wrist unit, elbow joint, and shoulder joint components; and cable and 
prosthesis suction valves.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general requirements concerning 
records and Sec. 820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001]



Sec. 890.3450  Upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of 
          freedom and controlled by non-implanted electrical components.

    (a) Identification. A upper extremity prosthesis including a 
simultaneously powered elbow and/or shoulder with greater than two 
simultaneous powered degrees of freedom and controlled by non-implanted 
electrical components, is a prescription device intended for medical 
purposes, and is intended to replace a partially or fully amputated or 
congenitally absent upper extremity. It uses electronic inputs (other 
than simple, manually controlled electrical components such as switches) 
to provide greater than two independent and simultaneously powered 
degrees of freedom and includes a simultaneously powered elbow and/or 
shoulder. Prosthetic arm components that are intended to be used as a 
system with other arm components must include all degrees of freedom of 
the total upper extremity prosthesis system.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Appropriate analysis/testing must validate electronic 
compatibility, electrical safety, thermal safety, mechanical safety, 
battery performance and safety, and wireless performance, if applicable.
    (2) Appropriate software verification, validation, and hazard 
analysis must be performed.
    (3) Non-clinical performance data must demonstrate that the device 
performs as intended under anticipated conditions of use. Performance 
testing must include:
    (i) Mechanical bench data, including durability testing, to 
demonstrate that the device will withstand forces, conditions, and 
environments encountered during use.
    (ii) Simulated use testing to demonstrate performance of arm 
commands and available safeguard(s) under worst case conditions and 
after durability testing.
    (iii) Verification and validation of force sensors and hand release 
button, if applicable, are necessary.
    (iv) Device functionality in terms of flame retardant materials, 
liquid/particle ingress prevention, sensor and actuator performance, and 
motor and brake performance.
    (v) The accuracy of the device features and safeguards.
    (4) Non-clinical and clinical performance testing must demonstrate 
the accuracy of device features and safeguards.
    (5) Elements of the device that may contact the patient must be 
demonstrated to be biocompatible.
    (6) Documented clinical experience and human factors testing must 
demonstrate safe and effective use, capture any adverse events observed 
during clinical use and demonstrate the accuracy of device features and 
safeguards.

[[Page 776]]

    (7) Labeling for the Prosthetist and User Guide must include:
    (i) Appropriate instructions, warning, cautions, limitations, and 
information related to the necessary safeguards of the device, including 
warning against activities that may put the user at greater risk (e.g., 
driving).
    (ii) Specific instructions and the clinical training needed for the 
safe use of the device, which includes:
    (A) Instructions on assembling the device in all available 
configurations,
    (B) Instructions on fitting the patient,
    (C) Instructions and explanations of all available programs and how 
to program the device,
    (D) Instructions and explanation of all controls, input, and 
outputs,
    (E) Instructions on all available modes or states of the device,
    (F) Instructions on all safety features of the device, and
    (G) Instructions for maintaining the device.
    (iii) Information on the patient population for which the device has 
been demonstrated to be effective.
    (iv) A detailed summary of the non-clinical and clinical testing 
pertinent to use of the device.

[81 FR 71612, Oct. 18, 2016]



Sec. 890.3475  Limb orthosis.

    (a) Identification. A limb orthosis (brace) is a device intended for 
medical purposes that is worn on the upper or lower extremities to 
support, to correct, or to prevent deformities or to align body 
structures for functional improvement. Examples of limb orthoses include 
the following: A whole limb and joint brace, a hand splint, an elastic 
stocking, a knee cage, and a corrective shoe.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general requirements concerning 
records and Sec. 820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001]



Sec. 890.3480  Powered lower extremity exoskeleton.

    (a) Identification. A powered lower extremity exoskeleton is a 
prescription device that is composed of an external, powered, motorized 
orthosis that is placed over a person's paralyzed or weakened limbs for 
medical purposes.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Elements of the device materials that may contact the patient 
must be demonstrated to be biocompatible.
    (2) Appropriate analysis/testing must validate electromagnetic 
compatibility/interference (EMC/EMI), electrical safety, thermal safety, 
mechanical safety, battery performance and safety, and wireless 
performance, if applicable.
    (3) Appropriate software verification, validation, and hazard 
analysis must be performed.
    (4) Design characteristics must ensure geometry and materials 
composition are consistent with intended use.
    (5) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. 
Performance testing must include:
    (i) Mechanical bench testing (including durability testing) to 
demonstrate that the device will withstand forces, conditions, and 
environments encountered during use;
    (ii) Simulated use testing (i.e., cyclic loading testing) to 
demonstrate performance of device commands and safeguard under worst 
case conditions and after durability testing;
    (iii) Verification and validation of manual override controls are 
necessary, if present;
    (iv) The accuracy of device features and safeguards; and
    (v) Device functionality in terms of flame retardant materials, 
liquid/particle ingress prevention, sensor and actuator performance, and 
motor performance.

[[Page 777]]

    (6) Clinical testing must demonstrate a reasonable assurance of safe 
and effective use and capture any adverse events observed during 
clinical use when used under the proposed conditions of use, which must 
include considerations for:
    (i) Level of supervision necessary, and
    (ii) Environment of use (e.g., indoors and/or outdoors) including 
obstacles and terrain representative of the intended use environment.
    (7) A training program must be included with sufficient educational 
elements so that upon completion of training program, the clinician, 
user, and companion can:
    (i) Identify the safe environments for device use,
    (ii) Use all safety features of device, and
    (iii) Operate the device in simulated or actual use environments 
representative of indicated environments and use.
    (8) Labeling for the Physician and User must include the following:
    (i) Appropriate instructions, warning, cautions, limitations, and 
information related to the necessary safeguards of the device, including 
warning against activities and environments that may put the user at 
greater risk.
    (ii) Specific instructions and the clinical training needed for the 
safe use of the device, which includes:
    (A) Instructions on assembling the device in all available 
configurations;
    (B) Instructions on fitting the patient;
    (C) Instructions and explanations of all available programs and how 
to program the device;
    (D) Instructions and explanation of all controls, input, and 
outputs;
    (E) Instructions on all available modes or states of the device;
    (F) Instructions on all safety features of the device; and
    (G) Instructions for properly maintaining the device.
    (iii) Information on the patient population for which the device has 
been demonstrated to have a reasonable assurance of safety and 
effectiveness.
    (iv) Pertinent non-clinical testing information (e.g., EMC, battery 
longevity).
    (v) A detailed summary of the clinical testing including:
    (A) Adverse events encountered under use conditions,
    (B) Summary of study outcomes and endpoints, and
    (C) Information pertinent to use of the device including the 
conditions under which the device was studied (e.g., level of 
supervision or assistance, and environment of use (e.g., indoors and/or 
outdoors) including obstacles and terrain).

[80 FR 25529, May 4, 2015]



Sec. 890.3490  Truncal orthosis.

    (a) Identification. A truncal orthosis is a device intended for 
medical purposes to support or to immobilize fractures, strains, or 
sprains of the neck or trunk of the body. Examples of truncal orthoses 
are the following: Abdominal, cervical, cervical-thoracic, lumbar, 
lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and 
clavicle splints.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general requirements concerning 
records and Sec. 820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001]



Sec. 890.3500  External assembled lower limb prosthesis.

    (a) Identification. An external assembled lower limb prosthesis is a 
device that is intended for medical purposes and is a preassembled 
external artificial limb for the lower extremity. Examples of external 
assembled lower limb prostheses are the following: Knee/shank/ankle/foot 
assembly and thigh/knee/shank/ankle/foot assembly.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures

[[Page 778]]

in subpart E of part 807 of this chapter subject to Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]



Sec. 890.3520  Plinth.

    (a) Identification. A plinth is a flat, padded board with legs that 
is intended for medical purposes. A patient is placed on the device for 
treatment or examination.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general requirements concerning 
records and Sec. 820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001]



Sec. 890.3610  Rigid pneumatic structure orthosis.

    (a) Identification. A rigid pneumatic structure orthosis is a device 
intended for medical purposes to provide whole body support by means of 
a pressurized suit to help thoracic paraplegics walk.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any rigid 
pneumatic structure orthosis that was in commercial distribution before 
May 28, 1976, or that has, on or before December 26, 1996 been found to 
be substantially equivalent to a rigid pneumatic structure orthosis that 
was in commercial distribution before May 28, 1976. Any other rigid 
pneumatic structure orthosis shall have an approved PMA or a declared 
completed PDP in effect before being placed in commercial distribution.

[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987; 61 
FR 50711, Sept. 27, 1996]



Sec. 890.3640  Arm sling.

    (a) Identification. An arm sling is a device intended for medical 
purposes to immobilize the arm, by means of a fabric band suspended from 
around the neck.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general requirements concerning 
records and Sec. 820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001]



Sec. 890.3665  Congenital hip dislocation abduction splint.

    (a) Identification. A congenital hip dislocation abduction splint is 
a device intended for medical purposes to stabilize the hips of a young 
child with dislocated hips in an abducted position (away from the 
midline).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general requirements concerning 
records and Sec. 820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001]



Sec. 890.3675  Denis Brown splint.

    (a) Identification. A Denis Brown splint is a device intended for 
medical purposes to immobilize the foot. It is used on young children 
with tibial torsion (excessive rotation of the lower leg) or club foot.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9. The device is 
also exempt from the current

[[Page 779]]

good manufacturing practice requirements of the quality system 
regulation in part 820 of this chapter, with the exception of Sec. 
820.180, regarding general requirements concerning records and Sec. 
820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001]



Sec. 890.3690  Powered wheeled stretcher.

    (a) Identification. A powered wheeled stretcher is a battery-powered 
table with wheels that is intended for medical purposes for use by 
patients who are unable to propel themselves independently and who must 
maintain a prone or supine position for prolonged periods because of 
skin ulcers or contractures (muscle contractions).
    (b) Classification. Class II (performance standards). The powered 
wheeled stretcher is exempt from premarket notification procedures in 
subpart E of part 807 of this chapter, subject to Sec. 890.9, and the 
following conditions for exemption:
    (1) Appropriate analysis and nonclinical testing must demonstrate 
that the safety controls are adequate to ensure safe use of the device 
and prevent user falls from the device in the event of a device failure;
    (2) Appropriate analysis and nonclinical testing must demonstrate 
the ability of the device to withstand the rated user weight load with 
an appropriate factor of safety;
    (3) Appropriate analysis and nonclinical testing must demonstrate 
the longevity of the device to withstand external forces applied to the 
device and provide the user with an expected service life of the device;
    (4) Appropriate analysis and nonclinical testing must demonstrate 
proper environments of use and storage of the device to maximize the 
longevity of the device;
    (5) Appropriate analysis and nonclinical testing (such as outlined 
in appropriate FDA-recognized consensus standards) must validate 
electromagnetic compatibility and electrical safety;
    (6) Appropriate analysis and nonclinical testing (such as outlined 
in appropriate FDA-recognized consensus standards) must validate that 
the skin-contacting components of the device are biocompatible;
    (7) Appropriate analysis and nonclinical testing (such as outlined 
in appropriate FDA-recognized consensus standards) must validate the 
software life cycle and that all processes, activities, and tasks are 
implemented and documented;
    (8) Appropriate analysis and nonclinical testing must validate that 
the device components are found to be nonflammable;
    (9) Appropriate analysis and nonclinical testing (such as outlined 
in appropriate FDA-recognized consensus standards) must validate that 
the battery in the device performs as intended over the anticipated 
service life of the device;
    (10) Adequate labeling is provided to the user to document proper 
use and maintenance of the device to ensure safe use of the device in 
the intended use environment; and
    (11) Appropriate risk assessment including, but not limited to, 
evaluating the dimensional limits of the gaps in hospital beds, and 
mitigation strategy to reduce entrapment.

[48 FR 53047, Nov. 23, 1983, as amended at 85 FR 2020, Jan. 14, 2020]



Sec. 890.3700  Nonpowered communication system.

    (a) Identification. A nonpowered communication system is a 
mechanical device intended for medical purposes that is used to assist a 
patient in communicating when physical impairment prevents writing, 
telephone use, reading, or talking. Examples of nonpowered 
communications systems include an alphabet board and a page turner.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general requirements concerning 
records and Sec. 820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 54 FR 25052, June 12, 1989; 
66 FR 38817, July 25, 2001]

[[Page 780]]



Sec. 890.3710  Powered communication system.

    (a) Identification. A powered communication system is an AC- or 
battery-powered device intended for medical purposes that is used to 
transmit or receive information. It is used by persons unable to use 
normal communication methods because of physical impairment. Examples of 
powered communication systems include the following: a specialized 
typewriter, a reading machine, and a video picture and word screen.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]



Sec. 890.3725  Powered environmental control system.

    (a) Identification. A powered environmental control system is an AC- 
or battery-powered device intended for medical purposes that is used by 
a patient to operate an environmental control function. Examples of 
environmental control functions include the following: to control room 
temperature, to answer a doorbell or telephone, or to sound an alarm for 
assistance.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]



Sec. 890.3750  Mechanical table.

    (a) Identification. A mechanical table is a device intended for 
medical purposes that has a flat surface that can be inclined or 
adjusted to various positions. It is used by patients with circulatory, 
neurological, or musculoskeletal conditions to increase tolerance to an 
upright or standing position.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994; 66 
FR 38817, July 25, 2001]



Sec. 890.3760  Powered table.

    (a) Identification. A powered table is a device intended for medical 
purposes that is an electrically operated flat surface table that can be 
adjusted to various positions. It is used by patients with circulatory, 
neurological, or musculoskeletal conditions to increase tolerance to an 
upright or standing position.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 
FR 38817, July 25, 2001]



Sec. 890.3790  Cane, crutch, and walker tips and pads.

    (a) Identification. Cane, crutch, and walker tips and pads are 
rubber (or rubber substitute) device accessories intended for medical 
purposes that are applied to the ground end of mobility aids to prevent 
skidding or that are applied to the body contact area of the device for 
comfort or as an aid in using an ambulatory assist device.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general requirements concerning 
records and Sec. 820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001]



Sec. 890.3800  Motorized three-wheeled vehicle.

    (a) Identification. A motorized three-wheeled vehicle is a gasoline-
fueled or battery-powered device intended for

[[Page 781]]

medical purposes that is used for outside transportation by disabled 
persons.
    (b) Classification. Class II (performance standards).



Sec. 890.3825  Mechanical walker.

    (a) Identification. A mechanical walker is a four-legged device with 
a metal frame intended for medical purposes to provide moderate weight 
support while walking. It is used by disabled persons who lack strength, 
good balance, or endurance.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general requirements concerning 
records and Sec. 820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001]



Sec. 890.3850  Mechanical wheelchair.

    (a) Identification. A mechanical wheelchair is a manually operated 
device with wheels that is intended for medical purposes to provide 
mobility to persons restricted to a sitting position.
    (b) Classification. Class I (general controls).



Sec. 890.3860  Powered wheelchair.

    (a) Identification. A powered wheelchair is a battery-operated 
device with wheels that is intended for medical purposes to provide 
mobility to persons restricted to a sitting position.
    (b) Classification. Class II (performance standards).



Sec. 890.3880  Special grade wheelchair.

    (a) Identification. A special grade wheelchair is a device with 
wheels that is intended for medical purposes to provide mobility to 
persons restricted to a sitting position. It is intended to be used in 
all environments for long-term use, e.g., for paraplegics, 
quadraplegics, and amputees.
    (b) Classification. Class II (performance standards).



Sec. 890.3890  Stair-climbing wheelchair.

    (a) Identification. A stair-climbing wheelchair is a device with 
wheels that is intended for medical purposes to provide mobility to 
persons restricted to a sitting position. The device is intended to 
climb stairs.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The design characteristics of the device must ensure that the 
geometry and material composition are consistent with the intended use.
    (2) Performance testing must demonstrate adequate mechanical 
performance under simulated use conditions and environments. Performance 
testing must include the following:
    (i) Fatigue testing;
    (ii) Resistance to dynamic loads (impact testing);
    (iii) Effective use of the braking mechanism and how the device 
stops in case of an electrical brake failure;
    (iv) Demonstration of adequate stability of the device on inclined 
planes (forward, backward, and lateral);
    (v) Demonstration of the ability of the device to safely ascend and 
descend obstacles (i.e., stairs, curb); and
    (vi) Demonstration of ability to effectively use the device during 
adverse temperatures and following storage in adverse temperatures and 
humidity conditions.
    (3) The skin-contacting components of the device must be 
demonstrated to be biocompatible.
    (4) Software design, verification, and validation must demonstrate 
that the device controls, alarms, and user interfaces function as 
intended.
    (5) Appropriate analysis and performance testing must be conducted 
to verify electrical safety and electromagnetic compatibility of the 
device.
    (6) Performance testing must demonstrate battery safety and evaluate 
longevity.
    (7) Performance testing must evaluate the flammability of device 
components.

[[Page 782]]

    (8) Patient labeling must bear all information required for the safe 
and effective use of the device, specifically including the following:
    (i) A clear description of the technological features of the device 
and the principles of how the device works;
    (ii) A clear description of the appropriate use environments/
conditions, including prohibited environments;
    (iii) Preventive maintenance recommendations;
    (iv) Operating specifications for proper use of the device such as 
patient weight limitations, device width, and clearance for 
maneuverability; and
    (v) A detailed summary of the device-related adverse events and how 
to report any complications.
    (9) Clinician labeling must include all the information in the 
Patient labeling noted in paragraph (b)(8) of this section but must also 
include the following:
    (i) Identification of patients who can effectively operate the 
device; and
    (ii) Instructions on how to fit, modify, or calibrate the device.
    (10) Usability studies of the device must demonstrate that the 
device can be used by the patient in the intended use environment with 
the instructions for use and user training.

[79 FR 20782, Apr. 14, 2014]



Sec. 890.3900  Standup wheelchair.

    (a) Identification. A standup wheelchair is a device with wheels 
that is intended for medical purposes to provide mobility to persons 
restricted to a sitting position. The device incorporates an external 
manually controlled mechanical system that is intended to raise a 
paraplegic to an upright position by means of an elevating seat.
    (b) Classification. Class II (performance standards).



Sec. 890.3910  Wheelchair accessory.

    (a) Identification. A wheelchair accessory is a device intended for 
medical purposes that is sold separately from a wheelchair and is 
intended to meet the specific needs of a patient who uses a wheelchair. 
Examples of wheelchair accessories include but are not limited to the 
following: armboard, lapboard, pusher cuff, crutch and cane holder, 
overhead suspension sling, head and trunk support, and blanket and leg 
rest strap.
    (b) Classification. Class I (general controls). If the device is not 
intended for use as a protective restraint as defined in Sec. 880.6760 
of this chapter, it is exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter, subject to the limitations in 
Sec. 890.9. The device is also exempt from the current good 
manufacturing practice requirements of the quality system regulation in 
part 820 of this chapter, with the exception of Sec. 820.180, regarding 
general requirements concerning records, and Sec. 820.198, regarding 
complaint files.

[61 FR 8439, Mar. 4, 1996, as amended at 66 FR 38817, July 25, 2001]



Sec. 890.3920  Wheelchair component.

    (a) Identification. A wheelchair component is a device intended for 
medical purposes that is generally sold as an integral part of a 
wheelchair, but may also be sold separately as a replacement part. 
Examples of wheelchair components are the following: Armrest, narrowing 
attachment, belt, extension brake, curb climber, cushion, antitip 
device, footrest, handrim, hill holder, leg rest, heel loops, and toe 
loops.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994; 66 
FR 38817, July 25, 2001]



Sec. 890.3930  Wheelchair elevator.

    (a) Permanently mounted wheelchair platform lift--(1) 
Identification. A permanently mounted wheelchair platform lift is a 
motorized vertical or inclined platform lift device permanently 
installed in one location that is intended for use in mitigating 
mobility impairment caused by injury or other disease by providing a 
guided platform to move a person from one level to another, with or 
without a wheelchair.
    (2) Classification. Class II. The permanently mounted wheelchair 
platform lift is exempt from premarket notification procedures in 
subpart E of part 807

[[Page 783]]

of this chapter, subject to Sec. 890.9 and the following conditions for 
exemption:
    (i) Appropriate analysis and nonclinical testing (such as that 
outlined in the currently FDA-recognized edition of ASME A18.1 ``Safety 
Standard for Platform Lifts and Stairway Chair Lifts'') must demonstrate 
that the safety controls are adequate to prevent a free fall of the 
platform in the event of a device failure;
    (ii) Appropriate analysis and nonclinical testing (such as that 
outlined in the currently FDA-recognized edition of ASME A18.1 ``Safety 
Standard for Platform Lifts and Stairway Chair Lifts'') must demonstrate 
the ability of the device to withstand the rated load with an 
appropriate factor of safety;
    (iii) Appropriate analysis and nonclinical testing (such as that 
outlined in the currently FDA-recognized edition of ASME A18.1 ``Safety 
Standard for Platform Lifts and Stairway Chair Lifts'') must demonstrate 
the ability of the enclosures to prevent the user from falling from the 
device; and
    (iv) Appropriate analysis and nonclinical testing (such as that 
outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 
60601-1-2, ``Medical Electrical Equipment--Part 1-2: General 
Requirements for Safety--Collateral Standard: Electromagnetic 
Compatibility--Requirements and Tests,'' and ASME A18.1 ``Safety 
Standard for Platform Lifts and Stairway Chair Lifts'') must validate 
electromagnetic compatibility and electrical safety.
    (b) Portable wheelchair elevators--(1) Identification. A portable 
wheelchair elevator is a motorized lift device that is not permanently 
mounted in one location and that is intended for use in mitigating 
mobility impairment caused by injury or other disease by providing a 
means to move a person, with or without a wheelchair, from one level to 
another (e.g., portable platform lifts, attendant-operated stair 
climbing devices for wheelchairs).
    (2) Classification. Class II.

[78 FR 14015, Mar. 4, 2013]



Sec. 890.3940  Wheelchair platform scale.

    (a) Identification. A wheelchair platform scale is a device with a 
base designed to accommodate a wheelchair. It is intended for medical 
purposes to weigh a person who is confined to a wheelchair.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general requirements concerning 
records and Sec. 820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63015, Dec. 7, 1994; 66 
FR 38817, July 25, 2001]

Subpart E [Reserved]



             Subpart F_Physical Medicine Therapeutic Devices



Sec. 890.5050  Daily activity assist device.

    (a) Identification. A daily activity assist device is a modified 
adaptor or utensil (e.g., a dressing, grooming, recreational activity, 
transfer, eating, or homemaking aid) that is intended for medical 
purposes to assist a patient to perform a specific function.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9. If the device 
is not labeled or otherwise represented as sterile, the device is also 
exempt from the current good manufacturing practice requirements of the 
quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general requirements concerning 
records and Sec. 820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001]



Sec. 890.5100  Immersion hydrobath.

    (a) Identification. An immersion hydrobath is a device intended for 
medical purposes that consists of water agitators and that may include a 
tub to be filled with water. The water temperature may be measured by a 
gauge. It is used in hydrotherapy to relieve pain and itching and as an 
aid in the

[[Page 784]]

healing process of inflamed and traumatized tissue, and it serves as a 
setting for removal of contaminated tissue.
    (b) Classification. Class II (special controls). The device, when it 
is a hydromassage bath or a powered sitz bath, is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]



Sec. 890.5110  Paraffin bath.

    (a) Identification. A paraffin bath is a device intended for medical 
purposes that consists of a tub to be filled with liquid paraffin (wax) 
and maintained at an elevated temperature in which the patient's 
appendages (e.g., hands or fingers) are placed to relieve pain and 
stiffness.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]



Sec. 890.5125  Nonpowered sitz bath.

    (a) Identification. A nonpowered sitz bath is a device intended for 
medical purposes that consists of a tub to be filled with water for use 
in external hydrotherapy to relieve pain or pruritis and to accelerate 
the healing of inflamed or traumatized tissues of the perianal and 
perineal areas.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general requirements concerning 
records and Sec. 820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 54 FR 25052, June 12, 1989; 
66 FR 38818, July 25, 2001]



Sec. 890.5150  Powered patient transport.

    (a) Powered patient stairway chair lifts--(1) Identification. A 
powered patient stairway chair lift is a motorized lift equipped with a 
seat and permanently mounted in one location that is intended for use in 
mitigating mobility impairment caused by injury or other disease by 
moving a person up and down a stairway.
    (2) Classification. Class II. The stairway chair lift is exempt from 
premarket notification procedures in subpart E of part 807 of this 
chapter, subject to Sec. 890.9 and the following conditions for 
exemption:
    (i) Appropriate analysis and nonclinical testing (such as that 
outlined in the currently FDA-recognized edition of American Society of 
Mechanical Engineers (ASME) A18.1 ``Safety Standard for Platform Lifts 
and Stairway Chair Lifts'') must demonstrate that the safety controls 
are adequate to prevent a free fall of the chair in the event of a 
device failure;
    (ii) Appropriate analysis and nonclinical testing must demonstrate 
the ability of the device, including armrests, to withstand the rated 
load with an appropriate factor of safety;
    (iii) Appropriate restraints must be provided to prevent the user 
from falling from the device (such as that outlined in the currently 
FDA-recognized edition of ASME A18.1 ``Safety Standard for Platform 
Lifts and Stairway Chair Lifts'');
    (iv) Appropriate analysis and nonclinical testing (such as that 
outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 
60601-1-2, ``Medical Electrical Equipment--Part 1-2: General 
Requirements for Safety--Collateral Standard: Electromagnetic 
Compatibility--Requirements and Tests,'' and ASME A18.1 ``Safety 
Standard for Platform Lifts and Stairway Chair Lifts'') must validate 
electromagnetic compatibility and electrical safety; and
    (v) Appropriate analysis and nonclinical testing must demonstrate 
the resistance of the device upholstery to ignition.
    (b) All other powered patient transport--(1) Identification. A 
powered patient transport is a motorized device intended for use in 
mitigating mobility

[[Page 785]]

impairment caused by injury or other disease by moving a person from one 
location or level to another, such as up and down flights of stairs 
(e.g., attendant-operated portable stair-climbing chairs). This generic 
type of device does not include motorized three-wheeled vehicles or 
wheelchairs.
    (2) Classification. Class II.

[78 FR 14017, Mar. 4, 2013]



Sec. 890.5160  Air-fluidized bed.

    (a) Identification. An air-fluidized bed is a device employing the 
circulation of filtered air through ceramic spherules (small, round 
ceramic objects) that is intended for medical purposes to treat or 
prevent bedsores, to treat severe or extensive burns, or to aid 
circulation.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]



Sec. 890.5170  Powered flotation therapy bed.

    (a) Identification. A powered flotation therapy bed is a device that 
is equipped with a mattress that contains a large volume of constantly 
moving water, air, mud, or sand. It is intended for medical purposes to 
treat or prevent a patient's bedsores, to treat severe or extensive 
burns, or to aid circulation. The mattress may be electrically heated.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]



Sec. 890.5180  Manual patient rotation bed.

    (a) Identification. A manual patient rotation bed is a device that 
turns a patient who is restricted to a reclining position. It is 
intended for medical purposes to treat or prevent bedsores, to treat 
severe and extensive burns, or to aid circulation.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 890.9.

[48 FR 53047, Nov. 23, 1963, as amended at 65 FR 2322, Jan. 14, 2000]



Sec. 890.5225  Powered patient rotation bed.

    (a) Identification. A powered patient rotation bed is a device that 
turns a patient who is restricted to a reclining position. It is 
intended for medical purposes to treat or prevent bedsores, to treat 
severe and extensive burns, urinary tract blockage, and to aid 
circulation.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]



Sec. 890.5250  Moist steam cabinet.

    (a) Identification. A moist steam cabinet is a device intended for 
medical purposes that delivers a flow of heated, moisturized air to a 
patient in an enclosed unit. It is used to treat arthritis and fibrosis 
(a formation of fibrosis tissue) and to increase local blood flow.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]



Sec. 890.5275  Microwave diathermy.

    (a) Microwave diathermy for use in applying therapeutic deep heat 
for selected medical conditions--(1) Identification. A microwave 
diathermy for use in applying therapeutic deep heat for selected medical 
conditions is a device that applies to specific areas of the body 
electromagnetic energy in the microwave frequency bands of 915 megahertz 
to 2,450 megahertz and that is intended to generate deep heat within 
body tissues for the treatment of selected medical conditions such as 
relief of pain, muscle spasms, and joint contractures, but not for the 
treatment of malignancies.
    (2) Classification. Class II (performance standards).

[[Page 786]]

    (b) Microwave diathermy for all other uses--(1) Identification. A 
microwave diathermy for all other uses except for the treatment of 
malignancies is a device that applies to the body electromagnetic energy 
in the microwave frequency bands of 915 megahertz to 2,450 megahertz and 
that is intended for the treatment of medical conditions by means other 
than the generation of deep heat within body tissues as described in 
paragraph (a) of this section.
    (2) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of PDP is required. A PMA or a 
notice of completion of a PDP for a device described in paragraph (b) of 
this section is required to be filed with the Food and Drug 
Administration on or before July 13, 1999, for any microwave diathermy 
described in paragraph (b) of this section that was in commercial 
distribution before May 28, 1976, or that has, on or before July 13, 
1999, been found to be substantially equivalent to a microwave diathermy 
described in paragraph (b) of this section that was in commercial 
distribution before May 28, 1976. Any other microwave diathermy 
described in paragraph (b) of this section shall have an approved PMA or 
declared completed PDP in effect before being placed in commercial 
distribution.

[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987; 64 
FR 18331, Apr. 14, 1999]



Sec. 890.5290  Shortwave diathermy.

    (a) Shortwave diathermy for use in applying therapeutic deep heat 
for selected medical conditions--(1) Identification. A shortwave 
diathermy for use in applying therapeutic deep heat for selected medical 
conditions is a device that applies to specific areas of the body 
electromagnetic energy in the radiofrequency (RF) bands of 13.56 
megahertz (MHz) or 27.12 MHz and that is intended to generate deep heat 
within body tissues for the treatment of selected medical conditions 
such as relief of pain, muscle spasms, and joint contractures, but not 
for the treatment of malignancies.
    (2) Classification. Class II (performance standards).
    (b) Nonthermal shortwave therapy--(1) Identification. A nonthermal 
shortwave therapy is a prescription device that applies to the body 
pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz 
and that is intended for adjunctive use in the palliative treatment of 
postoperative pain and edema of soft tissue by means other than the 
generation of deep heat within body tissues as described in paragraph 
(a) of this section.
    (2) Classification: Class II (special controls). The device is 
classified as class II. The special controls for this device are:
    (i) Components of the device that come into human contact must be 
demonstrated to be biocompatible.
    (ii) Appropriate analysis/testing must demonstrate that the device 
is electrically safe and electromagnetically compatible in its intended 
use environment.
    (iii) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. Non-
clinical performance testing must characterize the output waveform of 
the device and demonstrate that the device meets appropriate output 
performance specifications. The output characteristics and the methods 
used to determine these characteristics, including the following, must 
be determined:
    (A) Peak output power;
    (B) Pulse width;
    (C) Pulse frequency;
    (D) Duty cycle;
    (E) Characteristics of other types of modulation that may be used;
    (F) Average measured output powered into the RF antenna/applicator;
    (G) Specific absorption rates in saline gel test load or other 
appropriate model;
    (H) Characterization of the electrical and magnetic fields in saline 
gel test load or other appropriate model for each RF antenna and 
prescribed RF antenna orientation/position; and
    (I) Characterization of the deposited energy density in saline gel 
test load or other appropriate model.
    (iv) A detailed summary of the clinical testing pertinent to use of 
the device to demonstrate the effectiveness of the device in its 
intended use.

[[Page 787]]

    (v) Labeling must include the following:
    (A) Output characteristics of the device;
    (B) Recommended treatment regimes, including duration of use; and
    (C) A detailed summary of the clinical testing pertinent to the use 
of the device and a summary of the adverse events and complications.
    (vi) Nonthermal shortwave therapy devices marketed prior to the 
effective date of this reclassification must submit an amendment to 
their previously cleared premarket notification (510(k)) demonstrating 
compliance with these special controls.

[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987; 80 
FR 61302, Oct. 13, 2015]



Sec. 890.5300  Ultrasonic diathermy.

    (a) Ultrasonic diathermy for use in applying therapeutic deep heat 
for selected medical conditions--(1) Identification. An ultrasonic 
diathermy for use in applying therapeutic deep heat for selected medical 
conditions is a device that applies to specific areas of the body 
ultrasonic energy at a frequency beyond 20 kilohertz and that is 
intended to generate deep heat within body tissues for the treatment of 
selected medical conditions such as relief of pain, muscle spasms, and 
joint contractures, but not for the treatment of malignancies.
    (2) Classification. Class II (performance standards).
    (b) Ultrasonic diathermy for all other uses--(1) Identification. An 
ultrasonic diathermy for all other uses except for the treatment of 
malignancies is a device that applies to the body ultrasonic energy at a 
frequency beyond 20 kilohertz and that is intended for the treatment of 
medical conditions by means other than the generation of deep heat 
within body tissues as described in paragraph (a) of this section.
    (2) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of PDP is required. A PMA or 
notice of completion of a PDP for a device described in paragraph (b) of 
this section is required to be filed with the Food and Drug 
Administration on or before July 13, 1999, for any ultrasonic diathermy 
described in paragraph (b) of this section that was in commercial 
distribution before May 28, 1976, or that has, on or before July 13, 
1999, been found to be substantially equivalent to an ultrasonic 
diathermy described in paragraph (b) of this section that was in 
commercial distribution before May 28, 1976. Any other ultrasonic 
diathermy described in paragraph (b) of this section shall have an 
approved PMA or declared completed PDP in effect before being placed in 
commercial distribution.

[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987; 64 
FR 18331, Apr. 14, 1999]



Sec. 890.5350  Exercise component.

    (a) Identification. An exercise component is a device that is used 
in conjunction with other forms of exercise and that is intended for 
medical purposes, such as to redevelope muscles or restore motion to 
joints or for use as an adjunct treatment for obesity. Examples include 
weights, dumbbells, straps, and adaptive hand mitts.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general requirements concerning 
records and Sec. 820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38818, July 25, 2001]



Sec. 890.5360  Measuring exercise equipment.

    (a) Identification. Measuring exercise equipment consist of manual 
devices intended for medical purposes, such as to redevelop muscles or 
restore motion to joints or for use as an adjunct treatment for obesity. 
These devices also include instrumentation, such as the pulse rate 
monitor, that provide information used for physical evaluation and 
physical planning purposes., Examples include a therapeutic exercise 
bicycle with measuring instrumentation, a manually propelled treadmill 
with

[[Page 788]]

measuring instrumentation, and a rowing machine with measuring 
instrumentation.
    (b) Classification. Class II (special controls). The device, when it 
is a measuring exerciser or an interactive rehabilitation exercise 
device for prescription use only, is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019; 
85 FR 44188, July 22, 2020]



Sec. 890.5370  Nonmeasuring exercise equipment.

    (a) Identification. Nonmeasuring exercise equipment consist of 
devices intended for medical purposes, such as to redevelop muscles or 
restore motion to joints or for use as an adjunct treatment for obesity. 
Examples include a prone scooter board, parallel bars, a mechanical 
treadmill, an exercise table, and a manually propelled exercise bicycle.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general requirements concerning 
records and Sec. 820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38818, July 25, 2001]



Sec. 890.5380  Powered exercise equipment.

    (a) Identification. Powered exercise equipment consist of powered 
devices intended for medical purposes, such as to redevelop muscles or 
restore motion to joints or for use as an adjunct treatment for obesity. 
Examples include a powered treadmill, a powered bicycle, and powered 
parallel bars.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 
FR 38818, July 25, 2001]



Sec. 890.5410  Powered finger exerciser.

    (a) Identification. A powered finger exerciser is a device intended 
for medical purposes to increase flexion and the extension range of 
motion of the joints of the second to the fifth fingers of the hand.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 
FR 38818, July 25, 2001]



Sec. 890.5420  Electroencephalography (EEG)-driven upper extremity 
powered exerciser.

    (a) Identification. An EEG-driven upper extremity powered exerciser 
is a non-invasive prescription device intended for rehabilitation by 
driving movement or exercise of an impaired upper extremity in response 
to the detection of purpose oriented electrical activity produced by the 
patient's brain.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must demonstrate that the device 
performs as intended under anticipated conditions of use. Testing must 
capture any adverse events observed during clinical use and must 
demonstrate that the EEG signal can be translated into intended motion.
    (2) Software verification, validation, and hazard analysis must be 
performed.
    (3) Performance data must demonstrate the electromagnetic 
compatibility, electrical safety, battery safety, and wireless 
compatibility of the device.
    (4) The device components that contact the patient must be 
demonstrated to be biocompatible.
    (5) Performance data must validate the reprocessing instructions for 
the reusable components of the device.
    (6) Labeling must include:

[[Page 789]]

    (i) Instructions on fitting the device to the patient;
    (ii) Information on how the device operates and the typical 
sensations experienced during treatment; and
    (iii) Reprocessing instructions.

[88 FR 983, Jan. 6, 2023]



Sec. 890.5500  Infrared lamp.

    (a) Identification. An infrared lamp is a device intended for 
medical purposes that emits energy at infrared frequencies 
(approximately 700 nanometers to 50,000 nanometers) to provide topical 
heating.
    (b) Classification. Class II (special controls). The device, when it 
is an infrared therapeutic heating lamp, is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]



Sec. 890.5525  Iontophoresis device.

    (a) Iontophoresis device intended for certain specified uses--(1) 
Identification. An iontophoresis device is a device that is intended to 
use a direct current to introduce ions of soluble salts or other drugs 
into the body and induce sweating for use in the diagnosis of cystic 
fibrosis or for other uses if the labeling of the drug intended for use 
with the device bears adequate directions for the device's use with that 
drug. When used in the diagnosis of cystic fibrosis, the sweat is 
collected and its composition and weight are determined.
    (2) Classification. Class II (performance standards).
    (b) Iontophoresis device intended for any other purposes--(1) 
Identification. An iontophoresis device intended for any other purposes 
is a prescription device that is intended to use a current to introduce 
ions of drugs or non-drug solutions into the body for medical purposes 
other than those specified in paragraph (a) of this section, meaning 
that the device is not intended for use in diagnosis of cystic fibrosis, 
or a specific drug is not specified in the labeling of the iontophoresis 
device.
    (2) Classification. Class II (special controls). The device is 
classified as class II. The special controls for this device are:
    (i) The following performance testing must be conducted:
    (A) Testing using a drug approved for iontophoretic delivery, or a 
solution if identified in the labeling, to demonstrate safe use of the 
device as intended;
    (B) Testing of the ability of the device to maintain a safe pH 
level; and
    (C) If used in the ear, testing of the device to demonstrate 
mechanical safety.
    (ii) Labeling must include adequate instructions for use, including 
sufficient information for the health care provider to determine the 
device characteristics that affect delivery of the drug or solution and 
to select appropriate drug or solution dosing information for 
administration by iontophoresis. This includes the following:
    (A) A description and/or graphical representation of the electrical 
output;
    (B) A description of the electrode materials and pH buffer;
    (C) When intended for general drug delivery, language referring the 
user to drug labeling approved for iontophoretic delivery to determine 
if the drug they intend to deliver is specifically approved for use with 
that type of device and to obtain relevant dosing information; and
    (D) A detailed summary of the device-related and procedure-related 
complications pertinent to use of the device, and appropriate warnings 
and contraindications, including the following warning:
    Warning: Potential systemic adverse effects may result from use of 
this device. Drugs or solutions delivered with this device have the 
potential to reach the blood stream and cause systemic effects. 
Carefully read all labeling of the drug or solution used with this 
device to understand all potential adverse effects and to ensure 
appropriate dosing information. If systemic manifestations occur, refer 
to the drug or solution labeling for appropriate action.
    (iii) Appropriate analysis/testing must demonstrate electromagnetic 
compatibility, electrical safety, thermal safety, and mechanical safety.

[[Page 790]]

    (iv) Appropriate software verification, validation, and hazard 
analysis must be performed.
    (v) The elements of the device that may contact the patient must be 
demonstrated to be biocompatible.
    (vi) The elements of the device that may contact the patient must be 
assessed for sterility, for devices labeled as sterile.
    (vii) Performance data must support the shelf life of the elements 
of the device that may be affected by aging by demonstrating continued 
package integrity and device functionality over the stated shelf life.

[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987; 81 
FR 48706, July 26, 2016; 83 FR 13864, Apr. 2, 2018]



Sec. 890.5575  Powered external limb overload warning device.

    (a) Identification. A powered external limb overload warning device 
is a device intended for medical purposes to warn a patient of an 
overload or an underload in the amount of pressure placed on a leg.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]



Sec. 890.5650  Powered inflatable tube massager.

    (a) Identification. A powered inflatable tube massager is a powered 
device intended for medical purposes, such as to relieve minor muscle 
aches and pains and to increase circulation. It simulates kneading and 
stroking of tissues with the hands by use of an inflatable pressure 
cuff.
    (b) Classification. Class II (performance standards).



Sec. 890.5660  Therapeutic massager.

    (a) Identification. A therapeutic massager is an electrically 
powered device intended for medical purposes, such as to relieve minor 
muscle aches and pains.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 
FR 38818, July 25, 2001]



Sec. 890.5670  Internal therapeutic massager.

    (a) Identification. A hand-held internal therapeutic massager device 
is a prescription device intended for medical purposes to manually 
provide direct pressure applied to localized areas of pain or tenderness 
in the myofascial tissue associated with chronic pelvic pain syndromes. 
The device is inserted rectally or vaginally and provides quantitative 
feedback to the user of the applied force to the target tissue.
    (b) Classification. Class II (special controls). The device, when it 
is for prescription use only with a quantitative feedback mechanism and 
a disposable covering, is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec. 890.9. The special controls for this device are:
    (1) Labeling must include adequate directions for use.
    (2) Non-clinical performance testing must demonstrate 
electromagnetic compatibility (EMC), electrical safety and mechanical 
safety.
    (3) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be tested:
    (i) Mechanical durability; and
    (ii) Accuracy of the feedback mechanism.
    (4) Software verification, validation, and hazard analysis must be 
performed.
    (5) The patient-contacting components of the device must be 
demonstrated to be biocompatible.

[84 FR 57323, Oct. 25, 2019, as amended at 85 FR 44188, July 22, 2020]



Sec. 890.5700  Cold pack.

    (a) Identification. A cold pack is a device intended for medical 
purposes that consists of a compact fabric envelope containing a 
specially hydrated pliable silicate gel capable of forming to the 
contour of the body and that provides cold therapy for body surfaces.

[[Page 791]]

    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807. The 
device also is exempt from the current good manufacturing practice 
requirements of the quality system regulation in part 820, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.



Sec. 890.5710  Hot or cold disposable pack.

    (a) Identification. A hot or cold disposable pack is a device 
intended for medical purposes that consists of a sealed plastic bag 
incorporating chemicals that, upon activation, provides hot or cold 
therapy for body surfaces.
    (b) Classification. Class I (general controls). Except when intended 
for use on infants, the device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to Sec. 
890.9.

[48 FR 53047, Nov. 23, 1963, as amended at 65 FR 2322, Jan. 14, 2000]



Sec. 890.5720  Water circulating hot or cold pack.

    (a) Identification. A water circulating hot or cold pack is a device 
intended for medical purposes that operates by pumping heated or chilled 
water through a plastic bag and that provides hot or cold therapy for 
body surfaces.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]



Sec. 890.5730  Moist heat pack.

    (a) Identification. A moist heat pack is a device intended for 
medical purposes that consists of silica gel in a fabric container used 
to retain an elevated temperature and that provides moist heat therapy 
for body surfaces.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general requirements concerning 
records and Sec. 820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38818, July 25, 2001]



Sec. 890.5740  Powered heating pad.

    (a) Identification. A powered heating pad is an electrical device 
intended for medical purposes that provides dry heat therapy for body 
surfaces. It is capable of maintaining an elevated temperature during 
use.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E part 807 
of this chapter subject to Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]



Sec. 890.5760  Nonpowered lower extremity pressure wrap.

    (a) Identification. A nonpowered lower extremity pressure wrap is a 
prescription device that applies mechanical pressure by wrapping around 
the lower extremity, such as the leg or foot, and is intended for 
primary Restless Leg Syndrome.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9.

[79 FR 37950, July 3, 2014]



Sec. 890.5765  Pressure-applying device.

    (a) Identification. A pressure-applying device is a device intended 
for medical purposes to apply continuous pressure to the paravertebral 
tissues for muscular relaxation and neuro-inhibition. It consists of a 
table with an adjustable overhead weight that, in place of the 
therapist's hands, presses on the back of a prone patient.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63015, Dec. 7, 1994; 66 
FR 38818, July 25, 2001]

[[Page 792]]



Sec. 890.5800  Virtual reality behavioral therapy device for pain relief.

    (a) Identification. A virtual reality behavioral therapy device for 
pain relief is a device intended to provide behavioral therapy for 
patients with pain. Therapy is administered via a virtual reality 
display that utilizes a software program containing the behavioral 
therapy content.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing under the labeled conditions for 
use must validate the model of behavioral therapy as implemented by the 
device and evaluate all adverse events.
    (2) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (3) Software verification, validation, and hazard analysis must be 
performed.
    (4) Electromagnetic compatibility and electrical, mechanical, and 
thermal safety testing must be performed.
    (5) Labeling must include the following:
    (i) A warning regarding the risk of nausea and motion sickness;
    (ii) A warning regarding the risk of discomfort from the device; and
    (iii) A summary of the clinical testing with the device.

[88 FR 985, Jan. 6, 2023]



Sec. 890.5850  Powered muscle stimulator.

    (a) Identification. A powered muscle stimulator is an electrically 
powered device intended for medical purposes that repeatedly contracts 
muscles by passing electrical currents through electrodes contacting the 
affected body area.
    (b) Classification. Class II (performance standards).



Sec. 890.5860  Ultrasound and muscle stimulator.

    (a) Ultrasound and muscle stimulator for use in applying therapeutic 
deep heat for selected medical conditions--(1) Identification. An 
ultrasound and muscle stimulator for use in applying therapeutic deep 
heat for selected medical conditions is a device that applies to 
specific areas of the body ultrasonic energy at a frequency beyond 20 
kilohertz and that is intended to generate deep heat within body tissues 
for the treatment of selected medical conditions such as relief of pain, 
muscle spasms, and joint contractures, but not for the treatment of 
malignancies. The device also passes electrical currents through the 
body area to stimulate or relax muscles.
    (2) Classification. Class II (performance standards).
    (b) Ultrasound and muscle stimulator for all other uses--(1) 
Identification. An ultrasound and muscle stimulator for all other uses 
except for the treatment of malignancies is a device that applies to the 
body ultrasonic energy at a frequency beyond 20 kilohertz and applies to 
the body electrical currents and that is intended for the treatment of 
medical conditions by means other than the generation of deep heat 
within body tissues and the stimulation or relaxation of muscles as 
described in paragraph (a) of this section.
    (2) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of PDP is required. A PMA or 
notice of completion of a PDP for a device described in paragraph (b) of 
this section is required to be filed with the Food and Drug 
Administration on or before July 13, 1999 for any ultrasound and muscle 
stimulator described in paragraph (b) of this section that was in 
commercial distribution before May 28, 1976, or that has, on or before 
July 13, 1999, been found to be substantially equivalent to an 
ultrasound and muscle stimulator described in paragraph (b) of this 
section that was in commercial distribution before May 28, 1976. Any 
other ultrasound and muscle stimulator described in paragraph (b) of 
this section shall have an approved PMA or declared completed PDP in 
effect before being placed in commercial distribution.

[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987; 64 
FR 18331, Apr. 14, 1999]



Sec. 890.5880  Multi-function physical therapy table.

    (a) Identification. A multi-function physical therapy table is a 
device intended for medical purposes that consists of a motorized table 
equipped to

[[Page 793]]

provide patients with heat, traction, and muscle relaxation therapy.
    (b) Classification. Class II (performance standards).



Sec. 890.5900  Power traction equipment.

    (a) Identification. Powered traction equipment consists of powered 
devices intended for medical purposes for use in conjunction with 
traction accessories, such as belts and harnesses, to exert therapeutic 
pulling forces on the patient's body.
    (b) Classification. Class II (performance standards).



Sec. 890.5925  Traction accessory.

    (a) Identification. A traction accessory is a nonpowered accessory 
device intended for medical purposes to be used with powered traction 
equipment to aid in exerting therapeutic pulling forces on the patient's 
body. This generic type of device includes the pulley, strap, head 
halter, and pelvic belt.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general requirements concerning 
records and Sec. 820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 
FR 38818, July 25, 2001]



Sec. 890.5940  Chilling unit.

    (a) Identification. A chilling unit is a refrigerative device 
intended for medical purposes to chill and maintain cold packs at a 
reduced temperature.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9

[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 
FR 38818, July 25, 2001]



Sec. 890.5950  Powered heating unit.

    (a) Identification. A powered heating unit is a device intended for 
medical purposes that consists of an encased cabinet containing hot 
water and that is intended to heat and maintain hot packs at an elevated 
temperature.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 
FR 38818, July 25, 2001]



Sec. 890.5975  Therapeutic vibrator.

    (a) Identification. A therapeutic vibrator is an electrically 
powered device intended for medical purposes that incorporates various 
kinds of pads and that is held in the hand or attached to the hand or to 
a table. It is intended for various uses, such as relaxing muscles and 
relieving minor aches and pains.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 
FR 38818, July 25, 2001]



PART 892_RADIOLOGY DEVICES--Table of Contents



                      Subpart A_General Provisions

Sec.
892.1 Scope.
892.3 Effective dates of requirement for premarket approval.
892.9 Limitations of exemptions from section 510(k) of the Federal Food, 
          Drug, and Cosmetic Act (the act).

                      Subpart B_Diagnostic Devices

892.1000 Magnetic resonance diagnostic device.
892.1100 Scintillation (gamma) camera.
892.1110 Positron camera.
892.1130 Nuclear whole body counter.
892.1170 Bone densitometer.
892.1180 Bone sonometer.
892.1200 Emission computed tomography system.
892.1220 Fluorescent scanner.
892.1300 Nuclear rectilinear scanner.
892.1310 Nuclear tomography system.
892.1320 Nuclear uptake probe.
892.1330 Nuclear whole body scanner.
892.1350 Nuclear scanning bed.
892.1360 Radionuclide dose calibrator.
892.1370 Nuclear anthropomorphic phantom.

[[Page 794]]

892.1380 Nuclear flood source phantom.
892.1390 Radionuclide rebreathing system.
892.1400 Nuclear sealed calibration source.
892.1410 Nuclear electrocardiograph synchronizer.
892.1420 Radionuclide test pattern phantom.
892.1540 Nonfetal ultrasonic monitor.
892.1550 Ultrasonic pulsed doppler imaging system.
892.1560 Ultrasonic pulsed echo imaging system.
892.1570 Diagnostic ultrasonic transducer.
892.1600 Angiographic x-ray system.
892.1610 Diagnostic x-ray beam-limiting device.
892.1620 Cine or spot fluorographic x-ray camera.
892.1630 Electrostatic x-ray imaging system.
892.1640 Radiographic film marking system.
892.1650 Image-intensified fluoroscopic x-ray system.
892.1660 Non-image-intensified fluoroscopic x-ray system.
892.1670 Spot-film device.
892.1680 Stationary x-ray system.
892.1700 Diagnostic x-ray high voltage generator.
892.1710 Mammographic x-ray system.
892.1715 Full-field digital mammography system.
892.1720 Mobile x-ray system.
892.1730 Photofluorographic x-ray system.
892.1740 Tomographic x-ray system.
892.1750 Computed tomography x-ray system.
892.1760 Diagnostic x-ray tube housing assembly.
892.1770 Diagnostic x-ray tube mount.
892.1820 Pneumoencephalographic chair.
892.1830 Radiologic patient cradle.
892.1840 Radiographic film.
892.1850 Radiographic film cassette.
892.1860 Radiographic film/cassette changer.
892.1870 Radiographic film/cassette changer programmer.
892.1880 Wall-mounted radiographic cassette holder.
892.1890 Radiographic film illuminator.
892.1900 Automatic radiographic film processor.
892.1910 Radiographic grid.
892.1920 Radiographic head holder.
892.1940 Radiologic quality assurance instrument.
892.1950 Radiographic anthropomorphic phantom.
892.1960 Radiographic intensifying screen.
892.1970 Radiographic ECG/respirator synchronizer.
892.1980 Radiologic table.
892.1990 Transilluminator for breast evaluation.
892.2010 Medical image storage device.
892.2020 Medical image communications device.
892.2030 Medical image digitizer.
892.2040 Medical image hardcopy device.
892.2050 Medical image management and processing system.
892.2060 Radiological computer-assisted diagnostic software for lesions 
          suspicious of cancer.
892.2070 Medical image analyzer.
892.2080 Radiological computer aided triage and notification software.

Subparts C-E [Reserved]

                      Subpart F_Therapeutic Devices

892.5050 Medical charged-particle radiation therapy system.
892.5300 Medical neutron radiation therapy system.
892.5650 Manual radionuclide applicator system.
892.5700 Remote controlled radionuclide applicator system.
892.5710 Radiation therapy beam-shaping block.
892.5720 Rectal balloon for prostate immobilization.
892.5725 Absorbable perirectal spacer.
892.5730 Radionuclide brachytherapy source.
892.5740 Radionuclide teletherapy source.
892.5750 Radionuclide radiation therapy system.
892.5770 Powered radiation therapy patient support assembly.
892.5780 Light beam patient position indicator.
892.5840 Radiation therapy simulation system.
892.5900 X-ray radiation therapy system.
892.5930 Therapeutic x-ray tube housing assembly.

                     Subpart G_Miscellaneous Devices

892.6500 Personnel protective shield.

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    Source: 53 FR 1567, Jan. 20, 1988, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 892 appear at 73 FR 
35341, June 23, 2008.



                      Subpart A_General Provisions



Sec. 892.1  Scope.

    (a) This part sets forth the classification of radiology devices 
intended for human use that are in commercial distribution.
    (b) The identification of a device in a regulation in this part is 
not a precise description of every device that is, or will be, subject 
to the regulation. A manufacturer who submits a premarket notification 
submission for a device under part 807 cannot show

[[Page 795]]

merely that the device is accurately described by the section title and 
identification provision of a regulation in this part but shall state 
why the device is substantially equivalent to other devices, as required 
by Sec. 807.87.
    (c) To avoid duplicative listings, a radiology device that has two 
or more types of uses (e.g., use both as a diagnostic device and a 
therapeutic device) is listed in one subpart only.
    (d) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of this title 21, unless otherwise 
noted.
    (e) Guidance documents referenced in this part are available on the 
Internet at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/default.htm..

[53 FR 1567, Jan. 20, 1988, as amended at 73 FR 40969, July 17, 2008; 78 
FR 18233, Mar. 26, 2013]



Sec. 892.3  Effective dates of requirement for premarket approval.

    A device included in this part that is classified into class III 
(premarket approval) shall not be commercially distributed after the 
date shown in the regulation classifying the device unless the 
manufacturer has an approval under section 515 of the act (unless an 
exemption has been granted under section 520(g)(2) of the act). An 
approval under section 515 of the act consists of FDA's issuance of an 
order approving an application for premarket approval (PMA) for the 
device or declaring completed a product development protocol (PDP) for 
the device.
    (a) Before FDA requires that a device commercially distributed 
before the enactment date of the amendments, or a device that has been 
found substantially equivalent to such a device, has an approval under 
section 515 of the act, FDA must promulgate a regulation under section 
515(b) of the act requiring such approval, except as provided in 
paragraph (b) of this section. Such a regulation under section 515(b) of 
the act shall not be effective during the grace period ending on the 
90th day after its promulgation or on the last day of the 30th full 
calendar month after the regulation that classifies the device into 
class III is effective, whichever is later. See section 501(f)(2)(B) of 
the act. Accordingly, unless an effective date of the requirement for 
premarket approval is shown in the regulation for a device classified 
into class III in this part, the device may be commercially distributed 
without FDA's issuance of an order approving a PMA or declaring 
completed a PDP for the device. If FDA promulgates a regulation under 
section 515(b) of the act requiring premarket approval for a device, 
section 501(f)(1)(A) of the act applies to the device.
    (b) Any new, not substantially equivalent, device introduced into 
commercial distribution on or after May 28, 1976, including a device 
formerly marketed that has been substantially altered, is classified by 
statute (section 513(f) of the act) into class III without any grace 
period and FDA must have issued an order approving a PMA or declaring 
completed a PDP for the device before the device is commercially 
distributed unless it is reclassified. If FDA knows that a device being 
commercially distributed may be a ``new'' device as defined in this 
section because of any new intended use or other reasons, FDA may codify 
the statutory classification of the device into class III for such new 
use. Accordingly, the regulation for such a class III device states that 
as of the enactment date of the amendments, May 28, 1976, the device 
must have an approval under section 515 of the act before commercial 
distribution.



Sec. 892.9  Limitations of exemptions from section 510(k)
of the Federal Food, Drug, and Cosmetic Act (the act).

    The exemption from the requirement of premarket notification 
(section 510(k) of the act) for a generic type of class I or II device 
is only to the extent that the device has existing or reasonably 
foreseeable characteristics of commercially distributed devices within 
that generic type or, in the case of in vitro diagnostic devices, only 
to the extent that misdiagnosis as a result of using the device would 
not be associated with high morbidity or mortality. Accordingly, 
manufacturers of any commercially distributed class I or II device for 
which FDA has granted an exemption from the requirement of

[[Page 796]]

premarket notification must still submit a premarket notification to FDA 
before introducing or delivering for introduction into interstate 
commerce for commercial distribution the device when:
    (a) The device is intended for a use different from the intended use 
of a legally marketed device in that generic type of device; e.g., the 
device is intended for a different medical purpose, or the device is 
intended for lay use where the former intended use was by health care 
professionals only;
    (b) The modified device operates using a different fundamental 
scientific technology than a legally marketed device in that generic 
type of device; e.g., a surgical instrument cuts tissue with a laser 
beam rather than with a sharpened metal blade, or an in vitro diagnostic 
device detects or identifies infectious agents by using deoxyribonucleic 
acid (DNA) probe or nucleic acid hybridization technology rather than 
culture or immunoassay technology; or
    (c) The device is an in vitro device that is intended:
    (1) For use in the diagnosis, monitoring, or screening of neoplastic 
diseases with the exception of immunohistochemical devices;
    (2) For use in screening or diagnosis of familial or acquired 
genetic disorders, including inborn errors of metabolism;
    (3) For measuring an analyte that serves as a surrogate marker for 
screening, diagnosis, or monitoring life-threatening diseases such as 
acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, 
tuberculosis, or myocardial infarction or to monitor therapy;
    (4) For assessing the risk of cardiovascular diseases;
    (5) For use in diabetes management;
    (6) For identifying or inferring the identity of a microorganism 
directly from clinical material;
    (7) For detection of antibodies to microorganisms other than 
immunoglobulin G (IgG) or IgG assays when the results are not 
qualitative, or are used to determine immunity, or the assay is intended 
for use in matrices other than serum or plasma;
    (8) For noninvasive testing as defined in Sec. 812.3(k) of this 
chapter; and
    (9) For near patient testing (point of care).

[65 FR 2322, Jan. 14, 2000]



                      Subpart B_Diagnostic Devices



Sec. 892.1000  Magnetic resonance diagnostic device.

    (a) Identification. A magnetic resonance diagnostic device is 
intended for general diagnostic use to present images which reflect the 
spatial distribution and/or magnetic resonance spectra which reflect 
frequency and distribution of nuclei exhibiting nuclear magnetic 
resonance. Other physical parameters derived from the images and/or 
spectra may also be produced. The device includes hydrogen-1 (proton) 
imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 
spectroscopy, and chemical shift imaging (preserving simultaneous 
frequency and spatial information).
    (b) Classification. Class II (special controls). A magnetic 
resonance imaging disposable kit intended for use with a magnetic 
resonance diagnostic device only is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 892.9.

[53 FR 5078, Feb. 1, 1989, as amended at 84 FR 71818, Dec. 30, 2019]



Sec. 892.1100  Scintillation (gamma) camera.

    (a) Identification. A scintillation (gamma) camera is a device 
intended to image the distribution of radionuclides in the body by means 
of a photon radiation detector. This generic type of device may include 
signal analysis and display equipment, patient and equipment supports, 
radionuclide anatomical markers, component parts, and accessories.
    (b) Classification. Class I (general controls).

[55 FR 48443, Nov. 20, 1990, as amended at 66 FR 46953, Sept. 10, 2001]

[[Page 797]]



Sec. 892.1110  Positron camera.

    (a) Identification. A positron camera is a device intended to image 
the distribution of positron-emitting radionuclides in the body. This 
generic type of device may include signal analysis and display 
equipment, patient and equipment supports, radionuclide anatomical 
markers, component parts, and accessories.
    (b) Classification. Class I (general controls).

[55 FR 48444, Nov. 20, 1990, as amended at 66 FR 46953, Sept. 10, 2001]



Sec. 892.1130  Nuclear whole body counter.

    (a) Identification. A nuclear whole body counter is a device 
intended to measure the amount of radionuclides in the entire body. This 
generic type of device may include signal analysis and display 
equipment, patient and equipment supports, component parts, and 
accessories.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 59 FR 63015, Dec. 7, 1994; 66 
FR 38818, July 25, 2001]

[55 FR 48444, Nov. 20, 1990]



Sec. 892.1170  Bone densitometer.

    (a) Identification. A bone densitometer is a device intended for 
medical purposes to measure bone density and mineral content by x-ray or 
gamma ray transmission measurements through the bone and adjacent 
tissues. This generic type of device may include signal analysis and 
display equipment, patient and equipment supports, component parts, and 
accessories.
    (b) Classification. Class II.



Sec. 892.1180  Bone sonometer.

    (a) Identification. A bone sonometer is a device that transmits 
ultrasound energy into the human body to measure acoustic properties of 
bone that indicate overall bone health and fracture risk. The primary 
components of the device are a voltage generator, a transmitting 
transducer, a receiving transducer, and hardware and software for 
reception and processing of the received ultrasonic signal.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's ``Guidance for Industry and FDA Staff; Class II 
Special Controls Guidance Document: Bone Sonometers.'' See Sec. 
892.1(e) for the availability of this guidance document.

[73 FR 40969, July 17, 2008]



Sec. 892.1200  Emission computed tomography system.

    (a) Identification. An emission computed tomography system is a 
device intended to detect the location and distribution of gamma ray- 
and positron-emitting radionuclides in the body and produce cross-
sectional images through computer reconstruction of the data. This 
generic type of device may include signal analysis and display 
equipment, patient and equipment supports, radionuclide anatomical 
markers, component parts, and accessories.
    (b) Classification. Class II.



Sec. 892.1220  Fluorescent scanner.

    (a) Identification. A fluorescent scanner is a device intended to 
measure the induced fluorescent radiation in the body by exposing the 
body to certain x-rays or low-energy gamma rays. This generic type of 
device may include signal analysis and display equipment, patient and 
equipment supports, component parts and accessories.
    (b) Classification. Class II.



Sec. 892.1300  Nuclear rectilinear scanner.

    (a) Identification. A nuclear rectilinear scanner is a device 
intended to image the distribution of radionuclides in the body by means 
of a detector (or detectors) whose position moves in two directions with 
respect to the patient. This generic type of device may include signal 
analysis and display equipment, patient and equipment supports, 
radionuclide anatomical markers, component parts, and accessories.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 798]]

subpart E of part 807 of this chapter, subject to the limitations in 
Sec. 892.9.

[55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2322, Jan. 14, 2000; 66 
FR 38818, July 25, 2001]



Sec. 892.1310  Nuclear tomography system.

    (a) Identification. A nuclear tomography system is a device intended 
to detect nuclear radiation in the body and produce images of a specific 
cross-sectional plane of the body by blurring or eliminating detail from 
other planes. This generic type of devices may include signal analysis 
and display equipment, patient and equipment supports, radionuclide 
anatomical markers, component parts, and accessories.
    (b) Classification. Class II.



Sec. 892.1320  Nuclear uptake probe.

    (a) Identification. A nuclear uptake probe is a device intended to 
measure the amount of radionuclide taken up by a particular organ or 
body region. This generic type of device may include a single or 
multiple detector probe, signal analysis and display equipment, patient 
and equipment supports, component parts, and accessories.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 892.9.

[55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2322, Jan. 14, 2000]



Sec. 892.1330  Nuclear whole body scanner.

    (a) Identification. A nuclear whole body scanner is a device 
intended to measure and image the distribution of radionuclides in the 
body by means of a wide-aperture detector whose position moves in one 
direction with respect to the patient. This generic type of device may 
include signal analysis and display equipment, patient and equipment 
supports, radionuclide anatomical markers, component parts, and 
accessories.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 892.9.

[55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2322, Jan. 14, 2000]



Sec. 892.1350  Nuclear scanning bed.

    (a) Identification. A nuclear scanning bed is an adjustable bed 
intended to support a patient during a nuclear medicine procedure.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 892.9.

[55 FR 48444, Nov. 20, 1990, as amended at 59 FR 63015, Dec. 7, 1994; 65 
FR 2322, Jan. 14, 2000]



Sec. 892.1360  Radionuclide dose calibrator.

    (a) Identification. A radionuclide dose calibrator is a radiation 
detection device intended to assay radionuclides before their 
administration to patients.
    (b) Classification. Class II.



Sec. 892.1370  Nuclear anthropomorphic phantom.

    (a) Identification. A nuclear anthropomorphic phantom is a human 
tissue facsimile that contains a radioactive source or a cavity in which 
a radioactive sample can be inserted. It is intended to calibrate 
nuclear uptake probes or other medical instruments.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989; 66 
FR 38818, July 25, 2001]



Sec. 892.1380  Nuclear flood source phantom.

    (a) Identification. A nuclear flood source phantom is a device that 
consists of a radiolucent container filled with a uniformly distributed 
solution of a desired radionuclide. It is intended to calibrate a 
medical gamma camera-collimator system for uniformity of response.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 799]]

subpart E of part 807 of this chapter, subject to the limitations in 
Sec. 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989; 66 
FR 38819, July 25, 2001]



Sec. 892.1390  Radionuclide rebreathing system.

    (a) Identification. A radionuclide rebreathing system is a device 
intended to be used to contain a gaseous or volatile radionuclide or a 
radionuclide-labeled aerosol and permit it to be respired by the patient 
during nuclear medicine ventilatory tests (testing process of exchange 
between the lungs and the atmosphere). This generic type of device may 
include signal analysis and display equipment, patient and equipment 
supports, component parts, and accessories.
    (b) Classification. Class II.



Sec. 892.1400  Nuclear sealed calibration source.

    (a) Identification. A nuclear sealed calibration source is a device 
that consists of an encapsulated reference radionuclide intended for 
calibration of medical nuclear radiation detectors.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989; 66 
FR 38819, July 25, 2001]



Sec. 892.1410  Nuclear electrocardiograph synchronizer.

    (a) Identification. A nuclear electrocardiograph synchronizer is a 
device intended for use in nuclear radiology to relate the time of image 
formation to the cardiac cycle during the production of dynamic cardiac 
images.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 892.9.

[55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2322, Jan. 14, 2000]



Sec. 892.1420  Radionuclide test pattern phantom.

    (a) Identification. A radionuclide test pattern phantom is a device 
that consists of an arrangement of radiopaque or radioactive material 
sealed in a solid pattern intended to serve as a test for a performance 
characteristic of a nuclear medicine imaging device.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989; 66 
FR 38819, July 25, 2001]



Sec. 892.1540  Nonfetal ultrasonic monitor.

    (a) Identification. A nonfetal ultrasonic monitor is a device that 
projects a continuous high-frequency sound wave into body tissue other 
than a fetus to determine frequency changes (doppler shift) in the 
reflected wave and is intended for use in the investigation of nonfetal 
blood flow and other nonfetal body tissues in motion. This generic type 
of device may include signal analysis and display equipment, patient and 
equipment supports, component parts, and accessories.
    (b) Classification. Class II.



Sec. 892.1550  Ultrasonic pulsed doppler imaging system.

    (a) Identification. An ultrasonic pulsed doppler imaging system is a 
device that combines the features of continuous wave doppler-effect 
technology with pulsed-echo effect technology and is intended to 
determine stationary body tissue characteristics, such as depth or 
location of tissue interfaces or dynamic tissue characteristics such as 
velocity of blood or tissue motion. This generic type of device may 
include signal analysis and display equipment, patient and equipment 
supports, component parts, and accessories.
    (b) Classification. Class II.



Sec. 892.1560  Ultrasonic pulsed echo imaging system.

    (a) Identification. An ultrasonic pulsed echo imaging system is a 
device intended to project a pulsed sound beam into body tissue to 
determine the

[[Page 800]]

depth or location of the tissue interfaces and to measure the duration 
of an acoustic pulse from the transmitter to the tissue interface and 
back to the receiver. This generic type of device may include signal 
analysis and display equipment, patient and equipment supports, 
component parts, and accessories.
    (b) Classification. Class II (special controls). A biopsy needle 
guide kit intended for use with an ultrasonic pulsed echo imaging system 
only is exempt from the premarket notification procedures in subpart E 
of part 807 of this chapter subject to the limitations in Sec. 892.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]



Sec. 892.1570  Diagnostic ultrasonic transducer.

    (a) Identification. A diagnostic ultrasonic transducer is a device 
made of a piezoelectric material that converts electrical signals into 
acoustic signals and acoustic signals into electrical signals and 
intended for use in diagnostic ultrasonic medical devices. Accessories 
of this generic type of device may include transmission media for 
acoustically coupling the transducer to the body surface, such as 
acoustic gel, paste, or a flexible fluid container.
    (b) Classification. Class II.



Sec. 892.1600  Angiographic x-ray system.

    (a) Identification. An angiographic x-ray system is a device 
intended for radiologic visualization of the heart, blood vessels, or 
lymphatic system during or after injection of a contrast medium. This 
generic type of device may include signal analysis and display 
equipment, patient and equipment supports, component parts, and 
accessories.
    (b) Classification. Class II.



Sec. 892.1610  Diagnostic x-ray beam-limiting device.

    (a) Identification. A diagnostic x-ray beam-limiting device is a 
device such as a collimator, a cone, or an aperture intended to restrict 
the dimensions of a diagnostic x-ray field by limiting the size of the 
primary x-ray beam.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 892.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]



Sec. 892.1620  Cine or spot fluorographic x-ray camera.

    (a) Identification. A cine or spot fluorographic x-ray camera is a 
device intended to photograph diagnostic images produced by x-rays with 
an image intensifier.
    (b) Classification. Class II.



Sec. 892.1630  Electrostatic x-ray imaging system.

    (a) Identification. An electrostatic x-ray imaging system is a 
device intended for medical purposes that uses an electrostatic field 
across a semiconductive plate, a gas-filled chamber, or other similar 
device to convert a pattern of x-radiation into an electrostatic image 
and, subsequently, into a visible image. This generic type of device may 
include signal analysis and display equipment, patient and equipment 
supports, component parts, and accessories.
    (b) Classification. Class II.



Sec. 892.1640  Radiographic film marking system.

    (a) Identification. A radiographic film marking system is a device 
intended for medical purposes to add identification and other 
information onto radiographic film by means of exposure to visible 
light.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 892.9.

[55 FR 48444, Nov. 20, 1990, as amended at 59 FR 63015, Dec. 7, 1994; 66 
FR 38819, July 25, 2001]



Sec. 892.1650  Image-intensified fluoroscopic x-ray system.

    (a) Identification. An image-intensified fluoroscopic x-ray system 
is a device intended to visualize anatomical structures by converting a 
pattern of x-radiation into a visible image through electronic 
amplification. This

[[Page 801]]

generic type of device may include signal analysis and display 
equipment, patient and equipment supports, component parts, and 
accessories.
    (b) Classification. Class II (special controls). An anthrogram tray 
or radiology dental tray intended for use with an image-intensified 
fluoroscopic x-ray system only is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec. 892.9. In addition, when intended as an accessory 
to the device described in paragraph (a) of this section, the 
fluoroscopic compression device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 66 FR 57369, Nov. 15, 2001; 84 
FR 71818, Dec. 30, 2019]



Sec. 892.1660  Non-image-intensified fluoroscopic x-ray system.

    (a) Identification. A non-image-intensified fluoroscopic x-ray 
system is a device intended to be used to visualize anatomical 
structures by using a fluorescent screen to convert a pattern of x-
radiation into a visible image. This generic type of device may include 
signal analysis and display equipment, patient and equipment supports, 
component parts, and accessories.
    (b) Classification. Class II.



Sec. 892.1670  Spot-film device.

    (a) Identification. A spot-film device is an electromechanical 
component of a fluoroscopic x-ray system that is intended to be used for 
medical purposes to position a radiographic film cassette to obtain 
radiographs during fluoroscopy.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 892.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]



Sec. 892.1680  Stationary x-ray system.

    (a) Identification. A stationary x-ray system is a permanently 
installed diagnostic system intended to generate and control x-rays for 
examination of various anatomical regions. This generic type of device 
may include signal analysis and display equipment, patient and equipment 
supports, component parts, and accessories.
    (b) Classification. Class II (special controls). A radiographic 
contrast tray or radiology diagnostic kit intended for use with a 
stationary x-ray system only is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec. 892.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]



Sec. 892.1700  Diagnostic x-ray high voltage generator.

    (a) Identification. A diagnostic x-ray high voltage generator is a 
device that is intended to supply and control the electrical energy 
applied to a diagnostic x-ray tube for medical purposes. This generic 
type of device may include a converter that changes alternating current 
to direct current, filament transformers for the x-ray tube, high 
voltage switches, electrical protective devices, or other appropriate 
elements.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 
FR 38819, July 25, 2001]



Sec. 892.1710  Mammographic x-ray system.

    (a) Identification. A mammographic x-ray system is a device intended 
to be used to produce radiographs of the breast. This generic type of 
device may include signal analysis and display equipment, patient and 
equipment supports, component parts, and accessories.
    (b) Classification. Class II.



Sec. 892.1715  Full-field digital mammography system.

    (a) Identification. A full-field digital mammography system is a 
device intended to produce planar digital x-ray

[[Page 802]]

images of the entire breast. This generic type of device may include 
digital mammography acquisition software, full-field digital image 
receptor, acquisition workstation, automatic exposure control, image 
processing and reconstruction programs, patient and equipment supports, 
component parts, and accessories.
    (b) Classification. Class II (special controls). The special control 
for the device is FDA's guidance document entitled ``Class II Special 
Controls Guidance Document: Full-Field Digital Mammography System.'' See 
Sec. 892.1(e) for the availability of this guidance document.

[75 FR 68203, Nov. 5, 2010]



Sec. 892.1720  Mobile x-ray system.

    (a) Identification. A mobile x-ray system is a transportable device 
system intended to be used to generate and control x-ray for diagnostic 
procedures. This generic type of device may include signal analysis and 
display equipment, patient and equipment supports, component parts, and 
accessories.
    (b) Classification. Class II.



Sec. 892.1730  Photofluorographic x-ray system.

    (a) Identification. A photofluorographic x-ray system is a device 
that includes a fluoroscopic x-ray unit and a camera intended to be used 
to produce, then photograph, a fluoroscopic image of the body. This 
generic type of device may include signal analysis and display 
equipment, patient and equipment supports, component parts, and 
accessories.
    (b) Classification. Class II (special controls). A discography kit 
intended for use with a photofluorographic x-ray system only is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 892.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019]



Sec. 892.1740  Tomographic x-ray system.

    (a) Identification. A tomographic x-ray system is an x-ray device 
intended to be used to produce radiologic images of a specific cross-
sectional plane of the body by blurring or eliminating detail from other 
planes. This generic type of device may include signal analysis and 
display equipment, patient and equipment supports, component parts, and 
accessories.
    (b) Classification. Class II.



Sec. 892.1750  Computed tomography x-ray system.

    (a) Identification. A computed tomography x-ray system is a 
diagnostic x-ray system intended to produce cross-sectional images of 
the body by computer reconstruction of x-ray transmission data from the 
same axial plane taken at different angles. This generic type of device 
may include signal analysis and display equipment, patient and equipment 
supports, component parts, and accessories.
    (b) Classification. Class II.



Sec. 892.1760  Diagnostic x-ray tube housing assembly.

    (a) Identification. A diagnostic x-ray tube housing assembly is an 
x-ray generating tube encased in a radiation-shielded housing that is 
intended for diagnostic purposes. This generic type of device may 
include high voltage and filament transformers or other appropriate 
components.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 
FR 38819, July 25, 2001]



Sec. 892.1770  Diagnostic x-ray tube mount.

    (a) Identification. A diagnostic x-ray tube mount is a device 
intended to support and to position the diagnostic x-ray tube housing 
assembly for a medical radiographic procedure.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 
FR 38819, July 25, 2001]

[[Page 803]]



Sec. 892.1820  Pneumoencephalographic chair.

    (a) Identification. A pneumoencephalographic chair is a chair 
intended to support and position a patient during pneumoencephalography 
(x-ray imaging of the brain).
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 892.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019]



Sec. 892.1830  Radiologic patient cradle.

    (a) Identification. A radiologic patient cradle is a support device 
intended to be used for rotational positioning about the longitudinal 
axis of a patient during radiologic procedures.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 
FR 38819, July 25, 2001]



Sec. 892.1840  Radiographic film.

    (a) Identification. Radiographic film is a device that consists of a 
thin sheet of radiotransparent material coated on one or both sides with 
a photographic emulsion intended to record images during diagnostic 
radiologic procedures.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 66 FR 38819, July 25, 2001]



Sec. 892.1850  Radiographic film cassette.

    (a) Identification. A radiographic film cassette is a device 
intended for use during diagnostic x-ray procedures to hold a 
radiographic film in close contact with an x-ray intensifying screen and 
to provide a light-proof enclosure for direct exposure of radiographic 
film.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 892.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019]



Sec. 892.1860  Radiographic film/cassette changer.

    (a) Identification. A radiographic film/cassette changer is a device 
intended to be used during a radiologic procedure to move a radiographic 
film or cassette between x-ray exposures and to position it during the 
exposure.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 892.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019]



Sec. 892.1870  Radiographic film/cassette changer programmer.

    (a) Identification. A radiographic film/cassette changer programmer 
is a device intended to be used to control the operations of a film or 
cassette changer during serial medical radiography.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 892.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019]



Sec. 892.1880  Wall-mounted radiographic cassette holder.

    (a) Identification. A wall-mounted radiographic cassette holder is a 
device that is a support intended to hold and position radiographic 
cassettes for a radiographic exposure for medical use.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 
FR 38819, July 25, 2001]



Sec. 892.1890  Radiographic film illuminator.

    (a) Identification. A radiographic film illuminator is a device 
containing a visible light source covered with a

[[Page 804]]

translucent front that is intended to be used to view medical 
radiographs.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 892.9.

[55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2323, Jan. 14, 2000]



Sec. 892.1900  Automatic radiographic film processor.

    (a) Identification. An automatic radiographic film processor is a 
device intended to be used to develop, fix, wash, and dry automatically 
and continuously film exposed for medical purposes.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 892.9.

[55 FR 48444, Nov. 20, 1990, as amended at 84 FR 71819, Dec. 30, 2019]



Sec. 892.1910  Radiographic grid.

    (a) Identification. A radiographic grid is a device that consists of 
alternating radiolucent and radiopaque strips intended to be placed 
between the patient and the image receptor to reduce the amount of 
scattered radiation reaching the image receptor.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 65 FR 2323, Jan. 14, 2000]



Sec. 892.1920  Radiographic head holder.

    (a) Identification. A radiographic head holder is a device intended 
to position the patient's head during a radiographic procedure.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 892.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[53 FR 1567, Jan. 20, 1988, as amended at 66 FR 38819, July 25, 2001]



Sec. 892.1940  Radiologic quality assurance instrument.

    (a) Identification. A radiologic quality assurance instrument is a 
device intended for medical purposes to measure a physical 
characteristic associated with another radiologic device.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 892.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[53 FR 1567, Jan. 20, 1988, as amended at 66 FR 38819, July 25, 2001]



Sec. 892.1950  Radiographic anthropomorphic phantom.

    (a) Identification. A radiographic anthropomorphic phantom is a 
device intended for medical purposes to simulate a human body for 
positioning radiographic equipment.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 892.9. The device is 
also exempt from the current good manufacturing practice requirements of 
the quality system regulation in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.

[53 FR 1567, Jan. 20, 1988, as amended at 66 FR 38819, July 25, 2001]



Sec. 892.1960  Radiographic intensifying screen.

    (a) Identification. A radiographic intensifying screen is a device 
that is a thin radiolucent sheet coated with a luminescent material that 
transforms incident x-ray photons into visible

[[Page 805]]

light and intended for medical purposes to expose radiographic film.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 65 FR 2323, Jan. 14, 2000]



Sec. 892.1970  Radiographic ECG/respirator synchronizer.

    (a) Identification. A radiographic ECG/respirator synchronizer is a 
device intended to be used to coordinate an x-ray film exposure with the 
signal from an electrocardiograph (ECG) or respirator at a predetermined 
phase of the cardiac or respiratory cycle.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 892.9.

[55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2323, Jan. 14, 2000]



Sec. 892.1980  Radiologic table.

    (a) Identification. A radiologic table is a device intended for 
medical purposes to support a patient during radiologic procedures. The 
table may be fixed or tilting and may be electrically powered.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 63 FR 59231, Nov. 3, 1998]



Sec. 892.1990  Transilluminator for breast evaluation.

    (a) Identification. A transilluminator, also known as a 
diaphanoscope or lightscanner, is an electrically powered device that 
uses low intensity emissions of visible light and near-infrared 
radiation (approximately 700-1050 nanometers (nm)), transmitted through 
the breast, to visualize translucent tissue for the diagnosis of cancer, 
other conditions, diseases, or abnormalities.
    (b) Classification. Class III (premarket approval).
    (c) Date premarket approval (PMA) or notice of completion of product 
development protocol (PDP) is required. A PMA or notice of completion of 
a PDP is required to be filed with FDA by April 17, 2014, for any 
transilluminator for breast evaluation that was in commercial 
distribution before May 28, 1976, or that has, by April 17, 2014, been 
found to be substantially equivalent to any transilluminator for breast 
evaluation that was in commercial distribution before May 28, 1976. Any 
other transilluminator for breast evaluation shall have an approved PMA 
or declared completed PDP in effect before being placed in commercial 
distribution.

[60 FR 36639, July 18, 1995, as amended at 79 FR 3094, Jan. 17, 2014]



Sec. 892.2010  Medical image storage device.

    (a) Identification: A medical image storage device is a hardware 
device that provides electronic storage and retrieval functions for 
medical images. Examples include electronic hardware devices employing 
magnetic and optical discs, magnetic tapes, and digital memory.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 892.9.

[63 FR 23387, Apr. 29, 1998; 63 FR 44998, Aug. 24, 1998, as amended at 
65 FR 2323, Jan. 14, 2000; 86 FR 20284, Apr. 19, 2021]



Sec. 892.2020  Medical image communications device.

    (a) Identification. A medical image communications device provides 
electronic transfer of medical image data between medical devices. It 
may include a physical communications medium, modems, and interfaces. It 
may provide simple image review software functionality for medical image 
processing and manipulation, such as grayscale window and level, zoom 
and pan, user delineated geometric measurements, compression, or user 
added image annotations. The device does not perform advanced image 
processing or complex quantitative functions. This does not include 
electronic transfer of medical image software functions.
    (b) Classification. Class I (general controls). The device is exempt 
from the

[[Page 806]]

premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 892.9.

[63 FR 23387, Apr. 29, 1998; 63 FR 44998, Aug. 24, 1998, as amended at 
65 FR 2323, Jan. 14, 2000;86 FR 20283, Apr. 19, 2021]



Sec. 892.2030  Medical image digitizer.

    (a) Identification. A medical image digitizer is a device intended 
to convert an analog medical image into a digital format. Examples 
include Iystems employing video frame grabbers, and scanners which use 
lasers or charge-coupled devices.
    (b) Classification. Class II (special controls; voluntary 
standards--Digital Imaging and Communications in Medicine (DICOM) Std., 
Joint Photographic Experts Group (JPEG) Std.). The device is exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec. 892.9.

[63 FR 23387, Apr. 29, 1998, as amended at 84 FR 71819, Dec. 30, 2019]



Sec. 892.2040  Medical image hardcopy device.

    (a) Identification. A medical image hardcopy device is a device that 
produces a visible printed record of a medical image and associated 
identification information. Examples include multiformat cameras and 
laser printers.
    (b) Classification. Class II (special controls; voluntary 
standards--Digital Imaging and Communications in Medicine (DICOM) Std., 
Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture 
and Television Engineers (SMPTE) Test Pattern). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 892.9.

[63 FR 23387, Apr. 29, 1998, as amended at 84 FR 71819, Dec. 30, 2019]



Sec. 892.2050  Medical image management and processing system.

    (a) Identification. A medical image management and processing system 
is a device that provides one or more capabilities relating to the 
review and digital processing of medical images for the purposes of 
interpretation by a trained practitioner of disease detection, 
diagnosis, or patient management. The software components may provide 
advanced or complex image processing functions for image manipulation, 
enhancement, or quantification that are intended for use in the 
interpretation and analysis of medical images. Advanced image 
manipulation functions may include image segmentation, multimodality 
image registration, or 3D visualization. Complex quantitative functions 
may include semi-automated measurements or time-series measurements.
    (b) Classification. Class II (special controls; voluntary 
standards--Digital Imaging and Communications in Medicine (DICOM) Std., 
Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture 
and Television Engineers (SMPTE) Test Pattern).

[63 FR 23387, Apr. 29, 1998, as amended at 86 FR 20284, Apr. 19, 2021]



Sec. 892.2060  Radiological computer-assisted diagnostic software
for lesions suspicious of cancer.

    (a) Identification. A radiological computer-assisted diagnostic 
software for lesions suspicious of cancer is an image processing 
prescription device intended to aid in the characterization of lesions 
as suspicious for cancer identified on acquired medical images such as 
magnetic resonance, mammography, radiography, or computed tomography. 
The device characterizes lesions based on features or information 
extracted from the images and provides information about the lesion(s) 
to the user. Diagnostic and patient management decisions are made by the 
clinical user.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Design verification and validation must include:
    (i) A detailed description of the image analysis algorithms 
including, but not limited to, a detailed description of the algorithm 
inputs and outputs, each major component or block, and algorithm 
limitations.
    (ii) A detailed description of pre-specified performance testing 
protocols and dataset(s) used to assess whether the device will improve 
reader performance as intended.

[[Page 807]]

    (iii) Results from performance testing protocols that demonstrate 
that the device improves reader performance in the intended use 
population when used in accordance with the instructions for use. The 
performance assessment must be based on appropriate diagnostic accuracy 
measures (e.g., receiver operator characteristic plot, sensitivity, 
specificity, predictive value, and diagnostic likelihood ratio). The 
test dataset must contain sufficient numbers of cases from important 
cohorts (e.g., subsets defined by clinically relevant confounders, 
effect modifiers, concomitant diseases, and subsets defined by image 
acquisition characteristics) such that the performance estimates and 
confidence intervals of the device for these individual subsets can be 
characterized for the intended use population and imaging equipment.
    (iv) Standalone performance testing protocols and results of the 
device.
    (v) Appropriate software documentation (e.g., device hazard 
analysis; software requirements specification document; software design 
specification document; traceability analysis; and description of 
verification and validation activities including system level test 
protocol, pass/fail criteria, results, and cybersecurity).
    (2) Labeling must include:
    (i) A detailed description of the patient population for which the 
device is indicated for use.
    (ii) A detailed description of the intended reading protocol.
    (iii) A detailed description of the intended user and recommended 
user training.
    (iv) A detailed description of the device inputs and outputs.
    (v) A detailed description of compatible imaging hardware and 
imaging protocols.
    (vi) Warnings, precautions, and limitations, including situations in 
which the device may fail or may not operate at its expected performance 
level (e.g., poor image quality or for certain subpopulations), as 
applicable.
    (vii) Detailed instructions for use.
    (viii) A detailed summary of the performance testing, including: 
Test methods, dataset characteristics, results, and a summary of sub-
analyses on case distributions stratified by relevant confounders (e.g., 
lesion and organ characteristics, disease stages, and imaging 
equipment).

[85 FR 3542, Jan. 22, 2020]



Sec. 892.2070  Medical image analyzer.

    (a) Identification. Medical image analyzers, including computer-
assisted/aided detection (CADe) devices for mammography breast cancer, 
ultrasound breast lesions, radiograph lung nodules, and radiograph 
dental caries detection, is a prescription device that is intended to 
identify, mark, highlight, or in any other manner direct the clinicians' 
attention to portions of a radiology image that may reveal abnormalities 
during interpretation of patient radiology images by the clinicians. 
This device incorporates pattern recognition and data analysis 
capabilities and operates on previously acquired medical images. This 
device is not intended to replace the review by a qualified radiologist, 
and is not intended to be used for triage, or to recommend diagnosis.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Design verification and validation must include:
    (i) A detailed description of the image analysis algorithms 
including a description of the algorithm inputs and outputs, each major 
component or block, and algorithm limitations.
    (ii) A detailed description of pre-specified performance testing 
methods and dataset(s) used to assess whether the device will improve 
reader performance as intended and to characterize the standalone device 
performance. Performance testing includes one or more standalone tests, 
side-by-side comparisons, or a reader study, as applicable.
    (iii) Results from performance testing that demonstrate that the 
device improves reader performance in the intended use population when 
used in accordance with the instructions for use. The performance 
assessment must be based on appropriate diagnostic accuracy measures 
(e.g., receiver operator characteristic plot, sensitivity, specificity, 
predictive value, and diagnostic likelihood ratio). The test dataset 
must contain a sufficient number of

[[Page 808]]

cases from important cohorts (e.g., subsets defined by clinically 
relevant confounders, effect modifiers, concomitant diseases, and 
subsets defined by image acquisition characteristics) such that the 
performance estimates and confidence intervals of the device for these 
individual subsets can be characterized for the intended use population 
and imaging equipment.
    (iv) Appropriate software documentation (e.g., device hazard 
analysis; software requirements specification document; software design 
specification document; traceability analysis; description of 
verification and validation activities including system level test 
protocol, pass/fail criteria, and results; and cybersecurity).
    (2) Labeling must include the following:
    (i) A detailed description of the patient population for which the 
device is indicated for use.
    (ii) A detailed description of the intended reading protocol.
    (iii) A detailed description of the intended user and user training 
that addresses appropriate reading protocols for the device.
    (iv) A detailed description of the device inputs and outputs.
    (v) A detailed description of compatible imaging hardware and 
imaging protocols.
    (vi) Discussion of warnings, precautions, and limitations must 
include situations in which the device may fail or may not operate at 
its expected performance level (e.g., poor image quality or for certain 
subpopulations), as applicable.
    (vii) Device operating instructions.
    (viii) A detailed summary of the performance testing, including: 
test methods, dataset characteristics, results, and a summary of sub-
analyses on case distributions stratified by relevant confounders, such 
as lesion and organ characteristics, disease stages, and imaging 
equipment.

[85 FR 3548, Jan. 22, 2020]



Sec. 892.2080  Radiological computer aided triage and
notification software.

    (a) Identification. Radiological computer aided triage and 
notification software is an image processing prescription device 
intended to aid in prioritization and triage of radiological medical 
images. The device notifies a designated list of clinicians of the 
availability of time sensitive radiological medical images for review 
based on computer aided image analysis of those images performed by the 
device. The device does not mark, highlight, or direct users' attention 
to a specific location in the original image. The device does not remove 
cases from a reading queue. The device operates in parallel with the 
standard of care, which remains the default option for all cases.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Design verification and validation must include:
    (i) A detailed description of the notification and triage algorithms 
and all underlying image analysis algorithms including, but not limited 
to, a detailed description of the algorithm inputs and outputs, each 
major component or block, how the algorithm affects or relates to 
clinical practice or patient care, and any algorithm limitations.
    (ii) A detailed description of pre-specified performance testing 
protocols and dataset(s) used to assess whether the device will provide 
effective triage (e.g., improved time to review of prioritized images 
for pre-specified clinicians).
    (iii) Results from performance testing that demonstrate that the 
device will provide effective triage. The performance assessment must be 
based on an appropriate measure to estimate the clinical effectiveness. 
The test dataset must contain sufficient numbers of cases from important 
cohorts (e.g., subsets defined by clinically relevant confounders, 
effect modifiers, associated diseases, and subsets defined by image 
acquisition characteristics) such that the performance estimates and 
confidence intervals for these individual subsets can be characterized 
with the device for the intended use population and imaging equipment.
    (iv) Stand-alone performance testing protocols and results of the 
device.

[[Page 809]]

    (v) Appropriate software documentation (e.g., device hazard 
analysis; software requirements specification document; software design 
specification document; traceability analysis; description of 
verification and validation activities including system level test 
protocol, pass/fail criteria, and results).
    (2) Labeling must include the following:
    (i) A detailed description of the patient population for which the 
device is indicated for use;
    (ii) A detailed description of the intended user and user training 
that addresses appropriate use protocols for the device;
    (iii) Discussion of warnings, precautions, and limitations must 
include situations in which the device may fail or may not operate at 
its expected performance level (e.g., poor image quality for certain 
subpopulations), as applicable;
    (iv) A detailed description of compatible imaging hardware, imaging 
protocols, and requirements for input images;
    (v) Device operating instructions; and
    (vi) A detailed summary of the performance testing, including: test 
methods, dataset characteristics, triage effectiveness (e.g., improved 
time to review of prioritized images for pre-specified clinicians), 
diagnostic accuracy of algorithms informing triage decision, and results 
with associated statistical uncertainty (e.g., confidence intervals), 
including a summary of subanalyses on case distributions stratified by 
relevant confounders, such as lesion and organ characteristics, disease 
stages, and imaging equipment.

[85 FR 3544, Jan. 22, 2020]

Subparts C-E [Reserved]



                      Subpart F_Therapeutic Devices



Sec. 892.5050  Medical charged-particle radiation therapy system.

    (a) Identification. A medical charged-particle radiation therapy 
system is a device that produces by acceleration high energy charged 
particles (e.g., electrons and protons) intended for use in radiation 
therapy. This generic type of device may include signal analysis and 
display equipment, patient and equipment supports, treatment planning 
computer programs, component parts, and accessories.
    (b) Classification. Class II. When intended for use as a quality 
control system, the film dosimetry system (film scanning system) 
included as an accessory to the device described in paragraph (a) of 
this section, is exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec. 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 64 FR 1125, Jan. 8, 1999]



Sec. 892.5300  Medical neutron radiation therapy system.

    (a) Identification. A medical neutron radiation therapy system is a 
device intended to generate high-energy neutrons for radiation therapy. 
This generic type of device may include signal analysis and display 
equipment, patient and equipment support, treatment planning computer 
programs, component parts, and accessories.
    (b) Classification. Class II.



Sec. 892.5650  Manual radionuclide applicator system.

    (a) Identification. A manual radionuclide applicator system is a 
manually operated device intended to apply a radionuclide source into 
the body or to the surface of the body for radiation therapy. This 
generic type of device may include patient and equipment supports, 
component parts, treatment planning computer programs, and accessories.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 65 FR 2323, Jan. 14, 2000]



Sec. 892.5700  Remote controlled radionuclide applicator system.

    (a) Identification. A remote controlled radionuclide applicator 
system is an electromechanical or pneumatic device intended to enable an 
operator to apply, by remote control, a radionuclide source into the 
body or to the

[[Page 810]]

surface of the body for radiation therapy. This generic type of device 
may include patient and equipment supports, component parts, treatment 
planning computer programs, and accessories.
    (b) Classification. Class II.



Sec. 892.5710  Radiation therapy beam-shaping block.

    (a) Identification. A radiation therapy beam-shaping block is a 
device made of a highly attenuating material (such as lead) intended for 
medical purposes to modify the shape of a beam from a radiation therapy 
source.
    (b) Classification. Class II.



Sec. 892.5720  Rectal balloon for prostate immobilization.

    (a) Identification. A rectal balloon for prostate immobilization is 
a single use, inflatable, non-powered positioning device placed in the 
rectum to immobilize the prostate in patients undergoing radiation 
therapy. The device is intended to be used during all the phases of 
radiation therapy, including treatment planning, image verification, and 
radiotherapy delivery.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The premarket notification submission must include methodology 
and results of the following non-clinical and clinical performance 
testing:
    (i) Biocompatibility testing of the final finished device;
    (ii) If provided sterile, sterilization validation;
    (iii) If not provided sterile, bioburden testing of the final 
finished device;
    (iv) Shelf life and expiration date validation; and
    (v) Performance testing including but not limited to:
    (A) Venting mechanism (if device has a vent mechanism);
    (B) Safety mechanism(s) to prevent advancement beyond its intended 
safe placement; and
    (C) Structural integrity testing (e.g., tensile strength, balloon 
leakage and burst strength).
    (2) Labeling that includes:
    (i) Appropriate warnings and contraindications, including, but not 
limited to the following statements:
    (A) ``Do not transport the patient with the rectal balloon inserted. 
The balloon should be removed prior to transport.'';
    (B) ``Failure to perform the standard imaging position verification 
protocol may cause the device to not perform as intended.'';
    (C) ``Reduce the rectal balloon fill volume if the patient 
experiences discomfort due to the rectal balloon inflation.''; and
    (D) ``Do not apply excessive pressure/force on the shaft or tubing 
of the rectal balloon.''
    (ii) Adequate instructions for use on the proper insertion 
procedure, positioning, and inflation of the rectal balloon;
    (iii) Whether the device is sterile or non-sterile; and
    (iv) An expiration date.

[82 FR 61171, Dec. 27, 2017]



Sec. 892.5725  Absorbable perirectal spacer.

    (a) Identification. An absorbable perirectal spacer is composed of 
biodegradable material that temporarily positions the anterior rectal 
wall away from the prostate during radiotherapy for prostate cancer with 
the intent to reduce the radiation dose delivered to the anterior 
rectum. The absorbable spacer maintains space for the entire course of 
prostate radiotherapy treatment and is completely absorbed by the 
patient's body over time.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The premarket notification submission must include methodology 
and results of the following non-clinical and clinical performance 
testing. For all clinical investigations used to support premarket 
notification submissions for this type of device, line listings of the 
study data must be provided.
    (i) Performance bench testing must demonstrate appropriate 
perirectal space creation and maintenance for the duration of prostate 
radiotherapy.
    (ii) Performance bench testing must demonstrate that therapeutic 
radiation levels do not alter the performance of the device.

[[Page 811]]

    (iii) Performance in vivo testing must demonstrate appropriate 
deployment of spacer as indicated in the accompanying labeling, and 
demonstrate appropriate expansion and absorption characteristics in a 
clinically relevant environment.
    (iv) Clinical study must demonstrate appropriate spacer stability 
and lack of migration for the entire course of radiotherapy, complete 
absorption, and lack of long term toxicity.
    (v) Sterility testing must demonstrate the sterility of the device 
and the effects of the sterilization process on the physical 
characteristics of the spacer.
    (vi) Shelf-life testing must demonstrate the stability of the 
physical characteristics of the spacer throughout the shelf-life as 
indicated in the accompanying labeling.
    (vii) The device must be demonstrated to be biocompatible.
    (2) The risk management activities performed as part of the 
manufacturer's Sec. 820.30 design controls must document an appropriate 
end user initial training program which will be offered as part of 
efforts to mitigate the risk of failure to correctly operate the device, 
including, but not limited to, documentation of an appropriate end user 
initial training program on the proper spacer deployment technique.
    (3) The device labeling must include the following:
    (i) A detailed summary of reported or observed complications related 
to the use of the device;
    (ii) Appropriate warnings;
    (iii) Detailed instructions for system preparations and detailed 
implant procedure instructions; and
    (iv) An expiration date that is supported by performance data as 
specified in paragraph (b)(1)(vi) of this section.

[83 FR 601, Jan. 5, 2018]



Sec. 892.5730  Radionuclide brachytherapy source.

    (a) Identification. A radionuclide brachytherapy source is a device 
that consists of a radionuclide which may be enclosed in a sealed 
container made of gold, titanium, stainless steel, or platinum and 
intended for medical purposes to be placed onto a body surface or into a 
body cavity or tissue as a source of nuclear radiation for therapy.
    (b) Classification. Class II (special controls). A prostate seeding 
kit intended for use with a radionuclide brachytherapy source only is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 892.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019]



Sec. 892.5740  Radionuclide teletherapy source.

    (a) Identification. A radionuclide teletherapy source is a device 
consisting of a radionuclide enclosed in a sealed container. The device 
is intended for radiation therapy, with the radiation source located at 
a distance from the patient's body.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 59 FR 63015, Dec. 7, 1994; 66 
FR 38819, July 25, 2001]



Sec. 892.5750  Radionuclide radiation therapy system.

    (a) Identification. A radionuclide radiation therapy system is a 
device intended to permit an operator to administer gamma radiation 
therapy, with the radiation source located at a distance from the 
patient's body. This generic type of device may include signal analysis 
and display equipment, patient and equipment supports, treatment 
planning computer programs, component parts (including beam-limiting 
devices), and accessories.
    (b) Classification. Class II.



Sec. 892.5770  Powered radiation therapy patient support assembly.

    (a) Identification. A powered radiation therapy patient support 
assembly is an electrically powered adjustable couch intended to support 
a patient during radiation therapy.
    (b) Classification. Class II.

[[Page 812]]



Sec. 892.5780  Light beam patient position indicator.

    (a) Identification. A light beam patient position indicator is a 
device that projects a beam of light (incoherent light or laser) to 
determine the alignment of the patient with a radiation beam. The beam 
of light is intended to be used during radiologic procedures to ensure 
proper positioning of the patient and to monitor alignment of the 
radiation beam with the patient's anatomy.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 
FR 38819, July 25, 2001]



Sec. 892.5840  Radiation therapy simulation system.

    (a) Identification. A radiation therapy simulation system is a 
fluoroscopic or radiographic x-ray system intended for use in localizing 
the volume to be exposed during radiation therapy and confirming the 
position and size of the therapeutic irradiation field produced. This 
generic type of device may include signal analysis and display 
equipment, patient and equipment supports, treatment planning computer 
programs, component parts, and accessories.
    (b) Classification. Class II.



Sec. 892.5900  X-ray radiation therapy system.

    (a) Identification. An x-ray radiation therapy system is a device 
intended to produce and control x-rays used for radiation therapy. This 
generic type of device may include signal analysis and display 
equipment, patient and equipment supports, treatment planning computer 
programs, component parts, and accessories.
    (b) Classification. Class II.



Sec. 892.5930  Therapeutic x-ray tube housing assembly.

    (a) Identification. A therapeutic x-ray tube housing assembly is an 
x-ray generating tube encased in a radiation-shielded housing intended 
for use in radiation therapy. This generic type of device may include 
high-voltage and filament transformers or other appropriate components 
when contained in radiation-shielded housing.
    (b) Classification. Class II.



                     Subpart G_Miscellaneous Devices



Sec. 892.6500  Personnel protective shield.

    (a) Identification. A personnel protective shield is a device 
intended for medical purposes to protect the patient, the operator, or 
other persons from unnecessary exposure to radiation during radiologic 
procedures by providing an attenuating barrier to radiation. This 
generic type of device may include articles of clothing, furniture, and 
movable or stationary structures.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 65 
FR 2323, Jan. 14, 2000]



PART 895_BANNED DEVICES--Table of Contents



                      Subpart A_General Provisions

Sec.
895.1 Scope.
895.20 General.
895.21 Procedures for banning a device.
895.22 Submission of data and information by the manufacturer, 
          distributor, or importer.
895.25 Labeling.
895.30 Special effective date.

                   Subpart B_Listing of Banned Devices

895.101 Prosthetic hair fibers.
895.102 Powdered surgeon's glove.
895.103 Powdered patient examination glove.
895.104 Absorbable powder for lubricating a surgeon's glove.
895.105 Electrical stimulation devices for self-injurious or aggressive 
          behavior.

    Authority: 21 U.S.C. 352, 360f, 360h, 360i, 371.

    Source: 44 FR 29221, May 18, 1979, unless otherwise noted.

[[Page 813]]



                      Subpart A_General Provisions



Sec. 895.1  Scope.

    (a) This part describes the procedures by which the Commissioner may 
institute proceedings to make a device intended for human use that 
presents substantial deception or an unreasonable and substantial risk 
of illness or injury a banned device.
    (b) This part applies to any ``device'', as defined in section 
201(h) of the Federal Food, Drug, and Cosmetic Act (act) that is 
intended for human use.
    (c) A device that is made a banned device in accordance with this 
part is adulterated under section 501(g) of the act. A restricted device 
that is banned may also be misbranded under section 502(q) of the act.
    (d) Although this part does not cover devices intended for animal 
use, the manufacturer, distributor, importer, or any other person(s) 
responsible for the labeling of the device that is banned cannot avoid 
the ban by relabeling the device for veterinary use. A device that has 
been banned from human use but that also has a valid veterinary use may 
be marketed for use as a veterinary device only under the following 
conditions: The device shall comply with all requirements applicable to 
veterinary devices under the Federal Food, Drug, and Cosmetic Act and 
this chapter, and the label for the device shall bear the following 
statement: ``For Veterinary Use Only. Caution: Federal law prohibits the 
distribution of this device for human use.'' A device so labeled, 
however, that is determined by the Food and Drug Administration to be 
intended for human use, will be considered to be a banned device. In 
determining whether such a device is intended for human use, the Food 
and Drug Administration will consider, among other things, the ultimate 
destination of the device.



Sec. 895.20  General.

    The Commissioner may initiate a proceeding to make a device a banned 
device whenever the Commissioner finds, on the basis of all available 
data and information, that the device presents substantial deception or 
an unreasonable and substantial risk of illness or injury that the 
Commissioner determines cannot be, or has not been, corrected or 
eliminated by labeling or by a change in labeling, or by a change in 
advertising if the device is a restricted device.

[44 FR 29221, May 18, 1979, as amended at 57 FR 58405, Dec. 10, 1992]



Sec. 895.21  Procedures for banning a device.

    (a) Before initiating a proceeding to make a device a banned device, 
the Commissioner shall find that the continued marketing of the device 
presents a substantial deception or an unreasonable and substantial risk 
of illness or injury.
    (1) In determining whether the deception or risk of illness or 
injury is substantial, the Commissioner will consider whether the 
deception or risk posed by continued marketing of the device, or 
continued marketing of the device as presently labeled, is important, 
material, or significant in relation to the benefit to the public health 
from its continued marketing.
    (2) In determining whether a device is deceptive, the Commissioner 
will consider whether users of the device may be deceived or otherwise 
harmed by the device. The Commissioner is not required to determine that 
there was an intent on the part of the manufacturer, distributor, 
importer, or any other responsible person(s) to mislead or otherwise 
harm users of the device or that there exists any actual proof of 
deception of, or injury to, an individual.
    (3) In determining whether a device presents deception or risk of 
illness or injury, the Commissioner will consider all available data and 
information, including data and information that the Commissioner may 
obtain under other provisions of the act, data and information that may 
be supplied by the manufacturer, distributor, or importer of the device 
under Sec. 895.22, and data and information voluntarily submitted by 
any other interested persons.
    (b) Before initiating a proceeding to make a device a banned device, 
the Commissioner of Food and Drugs (the Commissioner) may consult with 
the panel established under section 513 of the act that has expertise 
with respect to the type of device under consideration. The consultation 
with the panel

[[Page 814]]

may occur at a regular or specially scheduled panel meeting or may be 
accomplished by correspondence or telephone conversation with panel 
members. The Commissioner may request that the panel submit in writing 
any advice on the device under consideration. The Commissioner will 
record in written memoranda any oral communications with a panel or its 
members.
    (c) If the Commissioner determines that any substantial deception or 
unreasonable and substantial risk of illness or injury or any 
unreasonable, direct, and substantial danger to the health of 
individuals presented by a device can be corrected or eliminated by 
labeling or change in labeling, or change in advertising if the device 
is a restricted device, the Commissioner will notify the responsible 
person of the required labeling or change in labeling or change in 
advertising in accordance with Sec. 895.25. If such required relabeling 
or change in advertising is not accomplished in accordance with Sec. 
895.25, the Commissioner may initiate a proceeding to ban the device in 
accordance with Sec. 895.21(d) and, when appropriate, may establish a 
special effective date in accordance with Sec. 895.30.
    (d) If the Commissioner decides to initiate a proceeding to make a 
device a banned device, a notice of proposed rulemaking will be 
published in the Federal Register to this effect. The notice will 
briefly summarize--
    (1) The Commissioner's finding under paragraph (a) of this section 
that the device presents substantial deception or an unreasonable and 
substantial risk of illness or injury, and, when appropriate, the 
Commissioner's determination under Sec. 895.30 that the deception or 
risk of illness or injury presents an unreasonable, direct, and 
substantial danger to the health of individuals;
    (2) The reasons why the Commissioner initiated the proceeding;
    (3) The evaluation of data and information obtained under other 
provisions of the act, submitted by the manufacturer, distributer, or 
importer of the device, or voluntarily submitted by any other interested 
persons under paragraph (a)(3) of this section, if any;
    (4) The consultation with the panel, if any, under paragraph (b) of 
this section;
    (5) The determination as to whether the deception or risk of illness 
or injury or the danger to the health of individuals could be corrected 
by labeling or change in labeling, or change in advertising if the 
device is a restricted device;
    (6) The determination of whether the required labeling or change of 
labeling, or change in advertising if the device is a restricted device, 
if any, has been made in accordance with paragraph (c) of this section;
    (7) The determination as to whether, and the reasons why, the 
banning should apply to devices already in commercial distribution or 
those already sold to the ultimate user, or both; and
    (8) Any other data and information that the Commissioner believes 
are pertinent to the proceeding. The notice will afford all interested 
persons an opportunity to submit written comments within 30 days after 
the date of publication of the proposed regulation. All nonconfidential 
information upon which the proposed finding is based, including the 
recommendations of the panel, will be available for public review in the 
Division of Dockets Management, Food and Drug Administration.
    (e)(1) If, after reviewing the administrative record of the 
regulatory hearing before the Food and Drug Administration, if any, the 
written comments received on the proposed regulation, and any additional 
available data and information, the Commissioner determines to ban a 
device, a final regulation to this effect will be published in the 
Federal Register. The final regulation will amend subpart B by adding 
the name or description of the device, or both, to the list of banned 
devices.
    (2) If the Commissioner determines not to ban the device, a notice 
of withdrawal and termination of rulemaking proceedings and reasons 
therefor will be published in the Federal Register.
    (f) The effective date of a final regulation to make a device a 
banned device, promulgated under paragraph (e) of this section, will be 
the date of publication of the final regulation in the Federal Register 
unless the Commissioner, for reasons stated, determines that the 
effective date should be later than the date of the publication and

[[Page 815]]

specifies that date in the notice. Each such regulation will specify 
whether devices already in commercial distribution or sold to the 
ultimate user or both are banned.
    (g) A regulation promulgated under paragraph (e) of this section is 
final agency action, subject to judicial review under section 517 of the 
act.
    (h) Upon petition of any interested person submitted in accordance 
with Sec. 10.30 of this chapter, or as a matter of discretion, the 
Commissioner may institute proceedings to amend or revoke a regulation 
that made a device a banned device if the Commissioner finds that the 
conditions that constituted the basis for the regulation banning the 
device are no longer applicable. When appropriate, the procedures in 
this section will be employed in such proceedings.

[44 FR 29221, May 18, 1979, as amended at 53 FR 11254, Apr. 6, 1988; 57 
FR 58405, Dec. 10, 1992; 65 FR 43690, July 14, 2000]



Sec. 895.22  Submission of data and information by the manufacturer
, distributor, or importer.

    (a) A manufacturer, distributor, or importer of a device may be 
required to submit to the Food and Drug Administration all relevant and 
available data and information to enable the Commissioner to determine 
whether the device presents substantial deception, unreasonable and 
substantial risk of illness or injury, or unreasonable, direct, and 
substantial danger to the health of individuals. The data and 
information required by the Commissioner may include scientific or test 
data, reports, records, or other information, including data and 
information on whether the device is safe and effective for its intended 
use or when used as directed, whether the device performs according to 
the claims made for the device, and information on adulteration or 
misbranding. Any relevant information that is voluntarily submitted will 
also be reviewed.
    (b) A manufacturer, distributor, or importer of a device required to 
submit data and information as provided in paragraph (a) of this section 
will be notified in writing by the Food and Drug Administration that 
such data and information shall be submitted. The written notification 
will advise the manufacturer, distributor, or importer of the device 
that the purpose for the request is to enable the Commissioner to 
determine whether any of the conditions listed in paragraph (a) of this 
section or Sec. 895.30(a)(1) exists with respect to the device such 
that a proceeding should be initiated to make the device a banned 
device. When the required data and information can be identified by the 
Food and Drug Administration at the time of the notification, the agency 
will provide such identification to the manufacturer, distributor, or 
importer of the device.
    (c) The required data and information shall be submitted to the Food 
and Drug Administration no more than 30 days after the date of receipt 
of the request, unless the Commissioner determines that the data and 
information shall be submitted by some other date and so informs the 
manufacturer, distributor, or importer, in which case the data and 
information shall be submitted on the date specified by the 
Commissioner.
    (d) If the data or information submitted to the Food and Drug 
Administration is sufficient to persuade the Commissioner that the 
deception or risk of illness or injury or the danger to the health of 
individuals presented by a device could be corrected or eliminated by 
labeling or change in labeling, or change in advertising if the device 
is a restricted device, the Commissioner will proceed in accordance with 
Sec. 895.25.
    (e) If the data or information submitted to the Food and Drug 
Administration is insufficient to show that the device does not present 
a substantial deception or an unreasonable and substantial risk of 
illness or injury, or an unreasonable, direct, and substantial danger to 
the health of individuals, or if the manufacturer, distributor, or 
importer fails to submit the required information, the Commissioner may 
rely upon this insufficiency or failure to submit the required 
information in considering whether to initiate a proceeding to make the 
device a banned device under Sec. 895.21(d) and, when appropriate, to 
establish a special effective date in accordance with Sec. 895.30. The 
Commissioner may also initiate

[[Page 816]]

other regulatory action as provided in the act or this chapter.



Sec. 895.25  Labeling.

    (a) If the Commissioner determines that the substantial deception or 
unreasonable and substantial risk of illness or injury or the 
unreasonable, direct, and substantial danger to the health of 
individuals presented by a device can be corrected or eliminated by 
labeling or a change in labeling, or change in advertising if the device 
is a restricted device, the Commissioner will provide written notice to 
the manufacturer, distributor, importer, or any other person(s) 
responsible for the labeling or advertising of the device specifying:
    (1) The deception or risk of illness or injury or the danger to the 
health of individuals,
    (2) The labeling or change in labeling, or change in advertising if 
the device is a restricted device, necessary to correct the deception or 
eliminate or reduce such risk or danger, and
    (3) The period of time within which the labeling, change in 
labeling, or change in advertising must be accomplished.
    (b) In specifying the labeling or change in labeling or change in 
advertising to correct the deception or to eliminate or reduce the risk 
of illness or injury or the danger to the health of individuals, the 
Commissioner may require the manufacturer, distributor, importer, or any 
other person(s) responsible for the labeling or advertising of the 
device to include in labeling for the device, and in advertising if the 
device is a restricted device, a statement, notice, or warning. Such 
statement, notice, or warning shall be in the manner and form prescribed 
by the Commissioner and shall identify the deception or risk of illness 
or injury or the unreasonable, direct, and substantial danger to the 
health of individuals associated with the device as previously labeled. 
Such statement, notice, or warning shall be used in the labeling and 
advertising of the device for a time period specified by the 
Commissioner on the basis of the degree of deception, risk of illness or 
injury, or danger to health; the frequency of sale of the device; the 
length of time the device has been on the market; the intended uses of 
the device; the method of its use; and any other factors that the 
Commissioner considers pertinent.
    (c) The Commissioner will allow a manufacturer, distributor, 
importer, or any other person(s) responsible for the labeling or 
advertising of the device a reasonable time, considering the deception 
or risk of illness or injury or the danger to the health of individuals 
presented by the device, within which to accomplish the required 
labeling, change in labeling, and, if the device is a restricted device, 
any change in advertising. The Commissioner may, however, request that 
no additional devices be introduced into commerce until the labeling or 
change in labeling, or change in advertising is accomplished by the 
manufacturer, distributor, importer, or other person(s) responsible for 
the labeling or advertising of the device.
    (d) If such voluntary action is not taken, the Commissioner may take 
action under other sections of the act to prevent the introduction of 
the devices into commerce. The Commissioner may consider the failure of 
a manufacturer, distributor, importer, or any other person(s) 
responsible for the labeling or advertising of the device to accomplish 
the required labeling or change in labeling, or change in advertising in 
accordance with this section as a basis for initiating a proceeding to 
make a device a banned device in accordance with Sec. 895.21(d) and 
when appropriate to establish a special effective date in accordance 
with Sec. 895.30.



Sec. 895.30  Special effective date.

    (a) The Commissioner may declare a proposed regulation under Sec. 
895.21(d) to be effective upon its publication in the Federal Register 
and until the effective date of any final action taken respecting the 
regulation if:
    (1) The Commissioner determines, on the basis of all available data 
and information, that the deception or risk of illness or injury 
associated with use of the device that is subject to the regulation 
presents an unreasonable, direct, and substantial danger to the health 
of individuals, and
    (2) Before the date of the publication of such regulation, the 
Commissioner

[[Page 817]]

notifies the domestic manufacturer and importer, if any, of the device 
that the regulation is to be made so effective. If necessary, the 
Commissioner may also notify the distributor or any other responsible 
person(s). In addition, the Commissioner will attempt to notify any 
foreign manufacturer when the name and address of the foreign 
manufacturer are readily available.
    (b) This procedure may be used when the Commissioner determines that 
the potential or actual injury involved is a serious one that the 
Commissioner believes will endanger the health of individuals who have 
been, or will be, exposed to the device. In assessing the degree of 
danger, the Commissioner need not find that the danger is immediate, and 
it shall be sufficient for the Commissioner to determine that the danger 
may involve a serious long-term risk.
    (c) If the Commissioner makes a proposed regulation effective in 
accordance with this section, the Commissioner will, as expeditiously as 
possible, give interested persons prompt notice of this action in the 
Federal Register and will provide an opportunity for an informal hearing 
in accordance with part 16 of this chapter.
    (d) After the hearing, if any, and after considering any written 
comments submitted on the proposal and any additional available 
information and data, the Commissioner will as expeditiously as possible 
either affirm, modify, or revoke the proposed regulation making the 
device a banned device. If the Commissioner decides to affirm or modify 
the proposed regulation to make a device a banned device, the 
Commissioner will amend subpart B by adding the name or description of 
the device, or both, to the list of banned devices. If the Commissioner 
decides to revoke a proposed regulation making a device a banned device, 
a notice of termination of rulemaking proceedings and reasons therefor 
will be published in the Federal Register.
    (e) The Commissioner may declare the special effective date provided 
by this section to be in effect after the publication of a proposed 
regulation under Sec. 895.21(d), if, based on new information, or upon 
reconsideration of previously available information, the Commissioner 
makes the determination and provides the appropriate notices and an 
opportunity for a hearing in accordance with paragraphs (a) and (c) of 
this section.
    (f) Those devices that have been named banned devices under Sec. 
895.30 and that have already been sold to the public may be subject to 
relabeling by the manufacturer, distributor, importer, or any other 
person(s) responsible for the labeling of the device or may be subject 
to the provisions of section 518(a) or (b) of the act.

[44 FR 29221, May 18, 1979, as amended at 57 FR 58405, Dec. 10, 1992; 80 
FR 31300, June 2, 2015]



                   Subpart B_Listing of Banned Devices



Sec. 895.101  Prosthetic hair fibers.

    Prosthetic hair fibers are devices intended for implantation into 
the human scalp to simulate natural hair or conceal baldness. Prosthetic 
hair fibers may consist of various materials; for example, synthetic 
fibers, such as modacrylic, polyacrylic, and polyester; and natural 
fibers, such as processed human hair. Excluded from the banned device 
are natural hair transplants, in which a person's hair and its 
surrounding tissue are surgically removed from one location on the 
person's scalp and then grafted onto another area of the person's scalp.

[48 FR 25136, June 3, 1983]



Sec. 895.102  Powdered surgeon's glove.

    (a) Identification. A powdered surgeon's glove is a device intended 
to be worn on the hands of operating room personnel to protect a 
surgical wound from contamination. A powdered surgeon's glove 
incorporates powder for purposes other than manufacturing.
    (b) [Reserved]

[81 FR 91731, Dec. 19, 2016]



Sec. 895.103  Powdered patient examination glove.

    (a) Identification. A powdered patient examination glove is a 
disposable device intended for medical purposes that is worn on the 
examiner's hand or finger to prevent contamination between patient and 
examiner. A powdered patient examination glove incorporates

[[Page 818]]

powder for purposes other than manufacturing.
    (b) [Reserved]

[81 FR 91731, Dec. 19, 2016]



Sec. 895.104  Absorbable powder for lubricating a surgeon's glove.

    Absorbable powder for lubricating a surgeon's glove is a powder made 
from cornstarch that meets the specifications for absorbable powder in 
the United States Pharmacopeia (U.S.P.) and that is intended to be used 
to lubricate the surgeon's hand before putting on a surgeon's glove. The 
device is absorbable through biological degradation.

[81 FR 91731, Dec. 19, 2016]



Sec. 895.105  Electrical stimulation devices for self-injurious or
aggressive behavior.

    Electrical stimulation devices for self-injurious or aggressive 
behavior are aversive conditioning devices that apply a noxious 
electrical stimulus to a person's skin to reduce or cease self-injurious 
or aggressive behavior.

[85 FR 13354, Mar. 6, 2020]



PART 898_PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES
--Table of Contents



Sec.
898.11 Applicability.
898.12 Performance standard.
898.13 Compliance dates.
898.14 Exemptions and variances.

    Authority: 21 U.S.C. 351, 352, 360c, 360d, 360gg-360ss, 371, 374; 42 
U.S.C. 262, 264.

    Source: 62 FR 25497, May 9, 1997, unless otherwise noted.



Sec. 898.11  Applicability.

    Electrode lead wires and patient cables intended for use with a 
medical device shall be subject to the performance standard set forth in 
Sec. 898.12.



Sec. 898.12  Performance standard.

    (a) Any connector in a cable or electrode lead wire having a 
conductive connection to a patient shall be constructed in such a manner 
as to comply with subclause 56.3(c) of the following standard:

    International Electrotechnical Commission (IEC)
    601-1: Medical Electrical Equipment
    601-1 (1988) Part 1: General requirements for safety
    Amendment No. 1 (1991)
    Amendment No. 2 (1995).

    (b) Compliance with the standard shall be determined by inspection 
and by applying the test requirements and test methods of subclause 
56.3(c) of the standard set forth in paragraph (a) of this section.



Sec. 898.13  Compliance dates.

    The dates for compliance with the standard set forth in Sec. 
898.12(a) shall be as follows:
    (a) For electrode lead wires and patient cables used with, or 
intended for use with, the following devices, the date for which 
compliance is required is May 11, 1998:

                          Listing of Devices for Which Compliance is Required Effective
                                                  May 11, 1998
----------------------------------------------------------------------------------------------------------------
                                                             21 CFR
                Phase                    Product code       section          Class             Device name
----------------------------------------------------------------------------------------------------------------
1....................................  73 BZQ                868.2375   II              Monitor, Breathing
                                                                                         Frequency.
1....................................  73 FLS                868.2375   II              Monitor (Apnea
                                                                                         Detector), Ventilatory
                                                                                         Effort.
1....................................  74 DPS                870.2340   II              Electrocardiograph.
1....................................  74 DRG                870.2910   II              Transmitters and
                                                                                         Receivers,
                                                                                         Physiological Signal,
                                                                                         Radio Frequency.
1....................................  74 DRT                870.2300   II              Monitor, Cardiac
                                                                                         (including
                                                                                         Cardiotachometer and
                                                                                         Rate Alarm).
1....................................  74 DRX                870.2360   II              Electrode,
                                                                                         Electrocardiograph.
1....................................  74 DSA                870.2900   II              Cable, Transducer and
                                                                                         Electrode, Patient
                                                                                         (including Connector).
1....................................  74 DSH                870.2800   II              Recorder, Magnetic Tape,
                                                                                         Medical.
1....................................  74 DSI                870.1025   III             Detector and Alarm,
                                                                                         Arrhythmia.
1....................................  74 DXH                870.2920   II              Transmitters and
                                                                                         Receivers,
                                                                                         Electrocardiograph,
                                                                                         Telephone.
----------------------------------------------------------------------------------------------------------------


[[Page 819]]

    (b) For electrode lead wires and patient cables used with, or 
intended for use with, any other device, the date for which compliance 
is required is May 9, 2000.



Sec. 898.14  Exemptions and variances.

    (a) A request for an exemption or variance shall be submitted in the 
form of a petition under Sec. 10.30 of this chapter and shall comply 
with the requirements set out therein. The petition shall also contain 
the following:
    (1) The name of the device, the class in which the device has been 
classified, and representative labeling showing the intended uses(s) of 
the device;
    (2) The reasons why compliance with the performance standard is 
unnecessary or unfeasible;
    (3) A complete description of alternative steps that are available, 
or that the petitioner has already taken, to ensure that a patient will 
not be inadvertently connected to hazardous voltages via an unprotected 
patient cable or electrode lead wire for intended use with the device; 
and
    (4) Other information justifying the exemption or variance.
    (b) An exemption or variance is not effective until the agency 
approves the request under Sec. 10.30(e)(2)(i) of this chapter.

    Effective Date Note: At 62 FR 25477, May 9, 1997, Sec. 898.14 was 
stayed pending Office of Management and Budget approval of information 
collection and recordkeeping requirements.

[[Page 820]]



             SUBCHAPTER I_MAMMOGRAPHY QUALITY STANDARDS ACT





PART 900_MAMMOGRAPHY--Table of Contents



                         Subpart A_Accreditation

Sec.
900.1 Scope.
900.2 Definitions.
900.3 Application for approval as an accreditation body.
900.4 Standards for accreditation bodies.
900.5 Evaluation.
900.6 Withdrawal of approval.
900.7 Hearings.
900.8-900.9 [Reserved]

              Subpart B_Quality Standards and Certification

900.10 Applicability.
900.11 Requirements for certification.
900.12 Quality standards.
900.13 Revocation of accreditation and revocation of accreditation body 
          approval.
900.14 Suspension or revocation of certificates.
900.15 Appeals of adverse accreditation or reaccreditation decisions 
          that preclude certification or recertification.
900.16 Appeals of denials of certification.
900.17 [Reserved]
900.18 Alternative requirements for Sec. 900.12 quality standards.

                     Subpart C_States as Certifiers

900.20 Scope.
900.21 Application for approval as a certification agency.
900.22 Standards for certification agencies.
900.23 Evaluation.
900.24 Withdrawal of approval.
900.25 Hearings and appeals.

    Authority: 21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b.

    Source: 62 FR 55976, Oct. 28, 1997, unless otherwise noted. 
Republished and corrected at 62 FR 60614, Nov. 10, 1997.



                         Subpart A_Accreditation



Sec. 900.1  Scope.

    The regulations set forth in this part implement the Mammography 
Quality Standards Act (MQSA) (42 U.S.C. 263b). Subpart A of this part 
establishes procedures whereby an entity can apply to become a Food and 
Drug Administration (FDA)-approved accreditation body to accredit 
facilities to be eligible to perform screening or diagnostic mammography 
services. Subpart A further establishes requirements and standards for 
accreditation bodies to ensure that all mammography facilities under the 
jurisdiction of the United States are adequately and consistently 
evaluated for compliance with national quality standards for 
mammography. Subpart B of this part establishes minimum national quality 
standards for mammography facilities to ensure safe, reliable, and 
accurate mammography. The regulations set forth in this part do not 
apply to facilities of the Department of Veterans Affairs.



Sec. 900.2  Definitions.

    The following definitions apply to subparts A, B, and C of this 
part:
    (a) Accreditation body or body means an entity that has been 
approved by FDA under Sec. 900.3(d) to accredit mammography facilities.
    (b) Action limits or action levels means the minimum and maximum 
values of a quality assurance measurement that can be interpreted as 
representing acceptable performance with respect to the parameter being 
tested. Values less than the minimum or greater than the maximum action 
limit or level indicate that corrective action must be taken by the 
facility. Action limits or levels are also sometimes called control 
limits or levels.
    (c) Adverse event means an undesirable experience associated with 
mammography activities within the scope of 42 U.S.C. 263b. Adverse 
events include but are not limited to:
    (1) Poor image quality;
    (2) Failure to send mammography reports within 30 days to the 
referring physician or in a timely manner to the self-referred patient; 
and
    (3) Use of personnel that do not meet the applicable requirements of 
Sec. 900.12(a).
    (d) Air kerma means kerma in a given mass of air. The unit used to 
measure the quantity of air kerma is the Gray (Gy). For X-rays with 
energies less

[[Page 821]]

than 300 kiloelectron volts (keV), 1 Gy = 100 rad. In air, 1 Gy of 
absorbed dose is delivered by 114 roentgens (R) of exposure.
    (e) Breast implant means a prosthetic device implanted in the 
breast.
    (f) Calendar quarter means any one of the following time periods 
during a given year: January 1 through March 31, April 1 through June 
30, July 1 through September 30, or October 1 through December 31.
    (g) Category I means medical educational activities that have been 
designated as Category I by the Accreditation Council for Continuing 
Medical Education (ACCME), the American Osteopathic Association (AOA), a 
state medical society, or an equivalent organization.
    (h) Certificate means the certificate described in Sec. 900.11(a).
    (i) Certification means the process of approval of a facility by FDA 
or a certification agency to provide mammography services.
    (j) Clinical image means a mammogram.
    (k) Consumer means an individual who chooses to comment or complain 
in reference to a mammography examination, including the patient or 
representative of the patient (e.g., family member or referring 
physician).
    (l) Continuing education unit or continuing education credit means 
one contact hour of training.
    (m) Contact hour means an hour of training received through direct 
instruction.
    (n) Direct instruction means:
    (1) Face-to-face interaction between instructor(s) and student(s), 
as when the instructor provides a lecture, conducts demonstrations, or 
reviews student performance; or
    (2) The administration and correction of student examinations by an 
instructor(s) with subsequent feedback to the student(s).
    (o) Direct supervision means that:
    (1) During joint interpretation of mammograms, the supervising 
interpreting physician reviews, discusses, and confirms the diagnosis of 
the physician being supervised and signs the resulting report before it 
is entered into the patient's records; or
    (2) During the performance of a mammography examination or survey of 
the facility's equipment and quality assurance program, the supervisor 
is present to observe and correct, as needed, the performance of the 
individual being supervised who is performing the examination or 
conducting the survey.
    (p) Established operating level means the value of a particular 
quality assurance parameter that has been established as an acceptable 
normal level by the facility's quality assurance program.
    (q) Facility means a hospital, outpatient department, clinic, 
radiology practice, mobile unit, office of a physician, or other 
facility that conducts mammography activities, including the following: 
Operation of equipment to produce a mammogram, processing of the 
mammogram, initial interpretation of the mammogram, and maintaining 
viewing conditions for that interpretation. This term does not include a 
facility of the Department of Veterans Affairs.
    (r) First allowable time means the earliest time a resident 
physician is eligible to take the diagnostic radiology boards from an 
FDA-designated certifying body. The ``first allowable time'' may vary 
with the certifying body.
    (s) FDA means the Food and Drug Administration.
    (t) Interim regulations means the regulations entitled 
``Requirements for Accrediting Bodies of Mammography Facilities'' (58 FR 
67558-67565) and ``Quality Standards and Certification Requirements for 
Mammography Facilities'' (58 FR 67565-67572), published by FDA on 
December 21, 1993, and amended on September 30, 1994 (59 FR 49808-
49813). These regulations established the standards that had to be met 
by mammography facilities in order to lawfully operate between October 
1, 1994, and April 28, 1999.
    (u) Interpreting physician means a licensed physician who interprets 
mammograms and who meets the requirements set forth in Sec. 
900.12(a)(1).
    (v) Kerma means the sum of the initial energies of all the charged 
particles liberated by uncharged ionizing particles in a material of 
given mass.
    (w) Laterality means the designation of either the right or left 
breast.

[[Page 822]]

    (x) Lead interpreting physician means the interpreting physician 
assigned the general responsibility for ensuring that a facility's 
quality assurance program meets all of the requirements of Sec. 
900.12(d) through (f). The administrative title and other supervisory 
responsibilities of the individual, if any, are left to the discretion 
of the facility.
    (y) Mammogram means a radiographic image produced through 
mammography.
    (z) Mammographic modality means a technology, within the scope of 42 
U.S.C. 263b, for radiography of the breast. Examples are screen-film 
mammography and xeromammography.
    (aa) Mammography means radiography of the breast, but, for the 
purposes of this part, does not include:
    (1) Radiography of the breast performed during invasive 
interventions for localization or biopsy procedures; or
    (2) Radiography of the breast performed with an investigational 
mammography device as part of a scientific study conducted in accordance 
with FDA's investigational device exemption regulations in part 812 of 
this chapter.
    (bb) Mammography equipment evaluation means an onsite assessment of 
mammography unit or image processor performance by a medical physicist 
for the purpose of making a preliminary determination as to whether the 
equipment meets all of the applicable standards in Sec. 900.12(b) and 
(e).
    (cc) Mammography medical outcomes audit means a systematic 
collection of mammography results and the comparison of those results 
with outcomes data.
    (dd) Mammography unit or units means an assemblage of components for 
the production of X-rays for use during mammography, including, at a 
minimum: An X-ray generator, an X-ray control, a tube housing assembly, 
a beam limiting device, and the supporting structures for these 
components.
    (ee) Mean optical density means the average of the optical densities 
measured using phantom thicknesses of 2, 4, and 6 centimeters with 
values of kilovolt peak (kVp) clinically appropriate for those 
thicknesses.
    (ff) Medical physicist means a person trained in evaluating the 
performance of mammography equipment and facility quality assurance 
programs and who meets the qualifications for a medical physicist set 
forth in Sec. 900.12(a)(3).
    (gg) MQSA means the Mammography Quality Standards Act.
    (hh) Multi-reading means two or more physicians, at least one of 
whom is an interpreting physician, interpreting the same mammogram.
    (ii) Patient means any individual who undergoes a mammography 
evaluation in a facility, regardless of whether the person is referred 
by a physician or is self-referred.
    (jj) Phantom means a test object used to simulate radiographic 
characteristics of compressed breast tissue and containing components 
that radiographically model aspects of breast disease and cancer.
    (kk) Phantom image means a radiographic image of a phantom.
    (ll) Physical science means physics, chemistry, radiation science 
(including medical physics and health physics), and engineering.
    (mm) Positive mammogram means a mammogram that has an overall 
assessment of findings that are either ``suspicious'' or ``highly 
suggestive of malignancy.''
    (nn) Provisional certificate means the provisional certificate 
described in Sec. 900.11(b)(2).
    (oo) Qualified instructor means an individual whose training and 
experience adequately prepares him or her to carry out specified 
training assignments. Interpreting physicians, radiologic technologists, 
or medical physicists who meet the requirements of Sec. 900.12(a) would 
be considered qualified instructors in their respective areas of 
mammography. Other examples of individuals who may be qualified 
instructors for the purpose of providing training to meet the 
regulations of this part include, but are not limited to, instructors in 
a post-high school training institution and manufacturer's 
representatives.
    (pp) Quality control technologist means an individual meeting the 
requirements of Sec. 900.12(a)(2) who is responsible

[[Page 823]]

for those quality assurance responsibilities not assigned to the lead 
interpreting physician or to the medical physicist.
    (qq) Radiographic equipment means X-ray equipment used for the 
production of static X-ray images.
    (rr) Radiologic technologist means an individual specifically 
trained in the use of radiographic equipment and the positioning of 
patients for radiographic examinations and who meets the requirements 
set forth in Sec. 900.12(a)(2).
    (ss) Serious adverse event means an adverse advent that may 
significantly compromise clinical outcomes, or an adverse event for 
which a facility fails to take appropriate corrective action in a timely 
manner.
    (tt) Serious complaint means a report of a serious adverse event.
    (uu) Standard breast means a 4.2 centimeter (cm) thick compressed 
breast consisting of 50 percent glandular and 50 percent adipose tissue.
    (vv) Survey means an onsite physics consultation and evaluation of a 
facility quality assurance program performed by a medical physicist.
    (ww) Time cycle means the film development time.
    (xx) Traceable to a national standard means an instrument is 
calibrated at either the National Institute of Standards and Technology 
(NIST) or at a calibration laboratory that participates in a proficiency 
program with NIST at least once every 2 years and the results of the 
proficiency test conducted within 24 months of calibration show 
agreement within 3 percent of the national 
standard in the mammography energy range.
    (yy) Review physician means a physician who, by meeting the 
requirements set out in Sec. 900.4(c)(5), is qualified to review 
clinical images on behalf of the accreditation body.
    (zz) Certification agency means a State that has been approved by 
FDA under Sec. 900.21 to certify mammography facilities.
    (aaa) Performance indicators mean the measures used to evaluate the 
certification agency's ability to conduct certification, inspection, and 
compliance activities.
    (bbb) Authorization means obtaining approval from FDA to utilize new 
or changed State regulations or procedures during the issuance, 
maintenance, and withdrawal of certificates by the certification agency.

[62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 
63 FR 56558, Oct. 22, 1998; 64 FR 32407, June 17, 1999; 67 FR 5467, Feb. 
6, 2002]

    Effective Date Note: At 88 FR 15168, Mar. 10, 2023, Sec. 900.2 was 
amended by revising paragraphs (c)(2), (k), (z), and (aa)(1) (2), and 
(ii), and adding paragraph (aa)(3), eff. Sept. 10, 2024. For the 
convenience of the user, the added and revised text is set forth as 
follows:



Sec. 900.2  Definitions.

                                * * * * *

    (c) * * *
    (2) Failure to send mammography reports within 30 days to the 
referring healthcare provider or in a timely manner to the self-referred 
patient; and

                                * * * * *

    (k) Consumer means an individual who chooses to comment or complain 
in reference to a mammography examination, including the patient or 
representative of the patient (e.g., family member or referring 
healthcare provider).

                                * * * * *

    (z) Mammographic modality means a technology, within the scope of 42 
U.S.C. 263b, for radiography of the breast. Examples are screen-film 
mammography, full field digital mammography, and digital breast 
tomosynthesis.
    (aa) * * *
    (1) Radiography of the breast performed during invasive 
interventions for localization or biopsy procedures;
    (2) Radiography of the breast performed with an investigational 
mammography device as part of a scientific study conducted in accordance 
with FDA's investigational device exemption regulations in part 812 of 
this chapter; or
    (3) Computed tomography of the breast.

                                * * * * *

    (ii) Patient means any individual who undergoes a mammography 
evaluation in a facility, regardless of whether the person is referred 
by a healthcare provider or is self-referred.

                                * * * * *

[[Page 824]]



Sec. 900.3  Application for approval as an accreditation body.

    (a) Eligibility. Private nonprofit organizations or State agencies 
capable of meeting the requirements of this subpart A may apply for 
approval as accreditation bodies.
    (b) Application for initial approval. (1) An applicant seeking 
initial FDA approval as an accreditation body shall inform the Division 
of Mammography Quality Standards, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 3621, Silver Spring, MD 20993, Attn: Program Management Branch, 
of its desire to be approved as an accreditation body and of its 
requested scope of authority.
    (2) Following receipt of the request, FDA will provide the applicant 
with additional information to aid in submission of an application for 
approval as an accreditation body.
    (3) The applicant shall furnish to FDA, at the address in Sec. 
900.3(b)(1), three copies of an application containing the following 
information, materials, and supporting documentation:
    (i) Name, address, and phone number of the applicant and, if the 
applicant is not a State agency, evidence of nonprofit status (i.e., of 
fulfilling Internal Revenue Service requirements as a nonprofit 
organization);
    (ii) Detailed description of the accreditation standards the 
applicant will require facilities to meet and a discussion 
substantiating their equivalence to FDA standards required under Sec. 
900.12;
    (iii) Detailed description of the applicant's accreditation review 
and decisionmaking process, including:
    (A) Procedures for performing accreditation and reaccreditation 
clinical image review in accordance with Sec. 900.4(c), random clinical 
image reviews in accordance with Sec. 900.4(f), and additional 
mammography review in accordance with Sec. 900.12(j);
    (B) Procedures for performing phantom image review;
    (C) Procedures for assessing mammography equipment evaluations and 
surveys;
    (D) Procedures for initiating and performing onsite visits to 
facilities;
    (E) Procedures for assessing facility personnel qualifications;
    (F) Copies of the accreditation application forms, guidelines, 
instructions, and other materials the applicant will send to facilities 
during the accreditation process, including an accreditation history 
form that requires each facility to provide a complete history of prior 
accreditation activities and a statement that all information and data 
submitted in the application is true and accurate, and that no material 
fact has been omitted;
    (G) Policies and procedures for notifying facilities of 
deficiencies;
    (H) Procedures for monitoring corrections of deficiencies by 
facilities;
    (I) Policies and procedures for suspending or revoking a facility's 
accreditation;
    (J) Policies and procedures that will ensure processing of 
accreditation applications and renewals within a timeframe approved by 
FDA and assurances that the body will adhere to such policies and 
procedures; and
    (K) A description of the applicant's appeals process for facilities 
contesting adverse accreditation status decisions.
    (iv) Education, experience, and training requirements for the 
applicant's professional staff, including reviewers of clinical or 
phantom images;
    (v) Description of the applicant's electronic data management and 
analysis system with respect to accreditation review and decision 
processes and the applicant's ability to provide electronic data in a 
format compatible with FDA data systems;
    (vi) Resource analysis that demonstrates that the applicant's 
staffing, funding, and other resources are adequate to perform the 
required accreditation activities;
    (vii) Fee schedules with supporting cost data;
    (viii) Statement of policies and procedures established to avoid 
conflicts of interest or the appearance of conflicts of interest by the 
applicant's board members, commissioners, professional personnel 
(including reviewers of clinical and phantom images), consultants, 
administrative personnel, and other representatives of the applicant;

[[Page 825]]

    (ix) Statement of policies and procedures established to protect 
confidential information the applicant will collect or receive in its 
role as an accreditation body;
    (x) Disclosure of any specific brand of imaging system or component, 
measuring device, software package, or other commercial product used in 
mammography that the applicant develops, sells, or distributes;
    (xi) Description of the applicant's consumer complaint mechanism;
    (xii) Satisfactory assurances that the applicant shall comply with 
the requirements of Sec. 900.4; and
    (xiii) Any other information as may be required by FDA.
    (c) Application for renewal of approval. An approved accreditation 
body that intends to continue to serve as an accreditation body beyond 
its current term shall apply to FDA for renewal or notify FDA of its 
plans not to apply for renewal in accordance with the following 
procedures and schedule:
    (1) At least 9 months before the date of expiration of a body's 
approval, the body shall inform FDA, at the address given in Sec. 
900.3(b)(1), of its intent to seek renewal.
    (2) FDA will notify the applicant of the relevant information, 
materials, and supporting documentation required under Sec. 900.3(b)(3) 
that the applicant shall submit as part of the renewal procedure.
    (3) At least 6 months before the date of expiration of a body's 
approval, the applicant shall furnish to FDA, at the address in Sec. 
900.3(b)(1), three copies of a renewal application containing the 
information, materials, and supporting documentation requested by FDA in 
accordance with Sec. 900.3(c)(2).
    (4) No later than July 28, 1998, any accreditation body approved 
under the interim regulations published in the Federal Register of 
December 21, 1993 (58 FR 67558), that desires to continue to serve as an 
accreditation body under the final regulations shall apply for renewal 
of approval in accordance with the procedures set forth in paragraphs 
(c)(1) through (c)(3) of this section.
    (5) Any accreditation body that does not plan to renew its approval 
shall so notify FDA at the address given in paragraph (b)(1) of this 
section at least 9 months before the expiration of the body's term of 
approval.
    (d) Rulings on applications for initial and renewed approval. (1) 
FDA will conduct a review and evaluation to determine whether the 
applicant substantially meets the applicable requirements of this 
subpart and whether the accreditation standards the applicant will 
require facilities to meet are substantially the same as the quality 
standards published under subpart B of this part.
    (2) FDA will notify the applicant of any deficiencies in the 
application and request that those deficiencies be rectified within a 
specified time period. If the deficiencies are not rectified to FDA's 
satisfaction within the specified time period, the application for 
approval as an accreditation body may be rejected.
    (3) FDA shall notify the applicant whether the application has been 
approved or denied. That notification shall list any conditions 
associated with approval or state the bases for any denial.
    (4) The review of any application may include a meeting between FDA 
and representatives of the applicant at a time and location mutually 
acceptable to FDA and the applicant.
    (5) FDA will advise the applicant of the circumstances under which a 
denied application may be resubmitted.
    (6) If FDA does not reach a final decision on a renewal application 
in accordance with this paragraph before the expiration of an 
accreditation body's current term of approval, the approval will be 
deemed extended until the agency reaches a final decision on the 
application, unless an accreditation body does not rectify deficiencies 
in the application within the specified time period, as required in 
paragraph (d)(2) of this section.
    (e) Relinquishment of authority. An accreditation body that decides 
to relinquish its accreditation authority before expiration of the 
body's term of approval shall submit a letter of such intent to FDA, at 
the address in Sec. 900.3(b)(1), at least 9 months before relinquishing 
such authority.
    (f) Transfer of records. An accreditation body that does not apply 
for renewal of accreditation body approval,

[[Page 826]]

is denied such approval by FDA, or relinquishes its accreditation 
authority and duties before expiration of its term of approval, shall:
    (1) Transfer facility records and other related information as 
required by FDA to a location and according to a schedule approved by 
FDA.
    (2) Notify, in a manner and time period approved by FDA, all 
facilities accredited or seeking accreditation by the body that the body 
will no longer have accreditation authority.
    (g) Scope of authority. An accreditation body's term of approval is 
for a period not to exceed 7 years. FDA may limit the scope of 
accreditation authority.

[62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 
83 FR 13864, Apr. 2, 2018; 85 FR 18443, Apr. 2, 2020]



Sec. 900.4  Standards for accreditation bodies.

    (a) Code of conduct and general responsibilities. The accreditation 
body shall accept the following responsibilities in order to ensure safe 
and accurate mammography at the facilities it accredits and shall 
perform these responsibilities in a manner that ensures the integrity 
and impartiality of accreditation body actions.
    (1)(i) When an accreditation body receives or discovers information 
that suggests inadequate image quality, or upon request by FDA, the 
accreditation body shall review a facility's clinical images or other 
aspects of a facility's practice to assist FDA in determining whether or 
not the facility's practice poses a serious risk to human health. Such 
reviews are in addition to the evaluation an accreditation body performs 
as part of the initial accreditation or renewal process for facilities.
    (ii) If review by the accreditation body demonstrates that a problem 
does exist with respect to image quality or other aspects of a 
facility's compliance with quality standards, or upon request by FDA, 
the accreditation body shall require or monitor corrective actions, or 
suspend or revoke accreditation of the facility.
    (2) The accreditation body shall inform FDA as soon as possible but 
in no case longer than 2 business days after becoming aware of equipment 
or practices that pose a serious risk to human health.
    (3) The accreditation body shall establish and administer a quality 
assurance (QA) program that has been approved by FDA in accordance with 
Sec. 900.3(d) or paragraph (a)(8) of this section. Such quality 
assurance program shall:
    (i) Include requirements for clinical image review and phantom image 
review;
    (ii) Ensure that clinical and phantom images are evaluated 
consistently and accurately; and
    (iii) Specify the methods and frequency of training and evaluation 
for clinical and phantom image reviewers, and the bases and procedures 
for removal of such reviewers.
    (4) The accreditation body shall establish measures that FDA has 
approved in accordance with Sec. 900.3(d) or paragraph (a)(8) of this 
section to reduce the possibility of conflict of interest or facility 
bias on the part of individuals acting on the body's behalf. Such 
individuals who review clinical or phantom images under the provisions 
of paragraphs (c) and (d) of this section or who visit facilities under 
the provisions of paragraph (f) of this section shall not review 
clinical or phantom images from or visit a facility with which such 
individuals maintain a relationship, or when it would otherwise be a 
conflict of interest for them to do so, or when they have a bias in 
favor of or against the facility.
    (5) The accreditation body may require specific equipment 
performance or design characteristics that FDA has approved. However, no 
accreditation body shall require, either explicitly or implicitly, the 
use of any specific brand of imaging system or component, measuring 
device, software package, or other commercial product as a condition for 
accreditation by the body, unless FDA determines that it is in the best 
interest of public health to do so.
    (i) Any representation, actual or implied, either orally, in sales 
literature, or in any other form of representation, that the purchase or 
use of a particular product brand is required in order for any facility 
to be accredited or certified under Sec. 900.11(b), is prohibited,

[[Page 827]]

unless FDA approves such representation.
    (ii) Unless FDA has approved the exclusive use and promotion of a 
particular commercial product in accordance with this section, all 
products produced, distributed, or sold by an accreditation body or an 
organization that has a financial or other relationship with the 
accreditation body that may be a conflict of interest or have the 
appearance of a conflict of interest with the body's accreditation 
functions, shall bear a disclaimer stating that the purchase or use of 
such products is not required for accreditation or certification of any 
facility under Sec. 900.11(b). Any representations about such products 
shall include a similar disclaimer.
    (6) When an accreditation body denies accreditation to a facility, 
the accreditation body shall notify the facility in writing and explain 
the bases for its decision. The notification shall also describe the 
appeals process available from the accreditation body for the facility 
to contest the decision.
    (7) No accreditation body may establish requirements that preclude 
facilities from being accredited under Sec. 900.11(b) by any other 
accreditation body, or require accreditation by itself under MQSA if 
another accreditation body is available to a facility.
    (8) The accreditation body shall obtain FDA authorization for any 
changes it proposes to make in any standards that FDA has previously 
accepted under Sec. 900.3(d).
    (9) An accreditation body shall establish procedures to protect 
confidential information it collects or receives in its role as an 
accreditation body.
    (i) Nonpublic information collected from facilities for the purpose 
of carrying out accreditation body responsibilities shall not be used 
for any other purpose or disclosed, other than to FDA or its duly 
designated representatives, including State agencies, without the 
consent of the facility;
    (ii) Nonpublic information that FDA or its duly designated 
representatives, including State agencies, share with the accreditation 
body concerning a facility that is accredited or undergoing 
accreditation by that body shall not be further disclosed except with 
the written permission of FDA.
    (b) Monitoring facility compliance with quality standards. (1) The 
accreditation body shall require that each facility it accredits meet 
standards for the performance of quality mammography that are 
substantially the same as those in this subpart and in subpart B of this 
part.
    (2) The accreditation body shall notify a facility regarding 
equipment, personnel, and other aspects of the facility's practice that 
do not meet such standards and advise the facility that such equipment, 
personnel, or other aspects of the practice should not be used by the 
facility for activities within the scope of part 900.
    (3) The accreditation body shall specify the actions that facilities 
shall take to correct deficiencies in equipment, personnel, and other 
aspects of the practice to ensure facility compliance with applicable 
standards.
    (4) If deficiencies cannot be corrected to ensure compliance with 
standards or if a facility is unwilling to take corrective actions, the 
accreditation body shall immediately so notify FDA, and shall suspend or 
revoke the facility's accreditation in accordance with the policies and 
procedures described under Sec. 900.3(b)(3)(iii)(I).
    (c) Clinical image review for accreditation and reaccreditation--(1) 
Frequency of review. The accreditation body shall review clinical images 
from each facility accredited by the body at least once every 3 years.
    (2) Requirements for clinical image attributes. The accreditation 
body shall use the following attributes for all clinical image reviews, 
unless FDA has approved other attributes:
    (i) Positioning. Sufficient breast tissue shall be imaged to ensure 
that cancers are not likely to be missed because of inadequate 
positioning.
    (ii) Compression. Compression shall be applied in a manner that 
minimizes the potential obscuring effect of overlying breast tissue and 
motion artifact.
    (iii) Exposure level. Exposure level shall be adequate to visualize 
breast structures. Images shall be neither underexposed nor overexposed.

[[Page 828]]

    (iv) Contrast. Image contrast shall permit differentiation of subtle 
tissue density differences.
    (v) Sharpness. Margins of normal breast structures shall be distinct 
and not blurred.
    (vi) Noise. Noise in the image shall not obscure breast structures 
or suggest the appearance of structures not actually present.
    (vii) Artifacts. Artifacts due to lint, processing, scratches, and 
other factors external to the breast shall not obscure breast structures 
or suggest the appearance of structures not actually present.
    (viii) Examination identification. Each image shall have the 
following information indicated on it in a permanent, legible, and 
unambiguous manner and placed so as not to obscure anatomic structures:
    (A) Name of the patient and an additional patient identifier.
    (B) Date of examination.
    (C) View and laterality. This information shall be placed on the 
image in a position near the axilla. Standardized codes specified by the 
accreditation body and approved by FDA in accordance with Sec. 900.3(d) 
or paragraph (a)(8) of this section shall be used to identify view and 
laterality.
    (D) Facility name and location. At a minimum, the location shall 
include the city, State, and zip code of the facility.
    (E) Technologist identification.
    (F) Cassette/screen identification.
    (G) Mammography unit identification, if there is more than one unit 
in the facility.
    (3) Scoring of clinical images. Accreditation bodies shall establish 
and administer a system for scoring clinical images using all attributes 
specified in paragraphs (c)(2)(i) through (c)(2)(viii) of this section 
or an alternative system that FDA has approved in accordance with Sec. 
900.3(d) or paragraph (a)(8) of this section. The scoring system shall 
include an evaluation for each attribute.
    (i) The accreditation body shall establish and employ criteria for 
acceptable and nonacceptable results for each of the 8 attributes as 
well as an overall pass-fail system for clinical image review that has 
been approved by FDA in accordance with Sec. 900.3(d) or paragraph 
(a)(8) of this section.
    (ii) All clinical images submitted by a facility to the 
accreditation body shall be reviewed independently by two or more review 
physicians.
    (4) Selection of clinical images for review. Unless otherwise 
specified by FDA, the accreditation body shall require that for each 
mammography unit in the facility:
    (i) The facility shall submit craniocaudal (CC) and mediolateral 
oblique (MLO) views from two mammographic examinations that the facility 
produced during a time period specified by the accreditation body;
    (ii) Clinical images submitted from one such mammographic 
examination for each unit shall be of dense breasts (predominance of 
glandular tissue) and the other shall be of fat-replaced breasts 
(predominance of adipose tissue);
    (iii) All clinical images submitted shall be images that the 
facility's interpreting physician(s) interpreted as negative or benign.
    (iv) If the facility has no clinical images meeting the requirements 
in paragraphs (c)(4)(i) through (c)(4)(iii) of this section, it shall so 
notify the accreditation body, which shall specify alternative clinical 
image selection methods that do not compromise care of the patient.
    (5) Review physicians. Accreditation bodies shall ensure that all of 
their review physicians:
    (i) Meet the interpreting physician requirements specified in Sec. 
900.12(a)(1) and meet such additional requirements as have been 
established by the accreditation body and approved by FDA;
    (ii) Are trained and evaluated in the clinical image review process, 
for the types of clinical images to be evaluated by a review physician, 
by the accreditation body before designation as review physicians and 
periodically thereafter; and
    (iii) Clearly document their findings and reasons for assigning a 
particular score to any clinical image and provide information to the 
facility for use in improving the attributes for which significant 
deficiencies were identified.
    (6) Image management. The accreditation body's QA program shall 
include a

[[Page 829]]

tracking system to ensure the security and return to the facility of all 
clinical images received and to ensure completion of all clinical image 
reviews by the body in a timely manner. The accreditation body shall 
return all clinical images to the facility within 60 days of their 
receipt by the body, with the following exceptions:
    (i) If the clinical images are needed earlier by the facility for 
clinical purposes, the accreditation body shall cooperate with the 
facility to accommodate such needs.
    (ii) If a review physician identifies a suspicious abnormality on an 
image submitted for clinical image review, the accreditation body shall 
ensure that this information is provided to the facility and that the 
clinical images are returned to the facility. Both shall occur no later 
than 10-business days after identification of the suspected abnormality.
    (7) Notification of unsatisfactory image quality. If the 
accreditation body determines that the clinical images received from a 
facility are of unsatisfactory quality, the body shall notify the 
facility of the nature of the problem and its possible causes.
    (d) Phantom image review for accreditation and reaccreditation--(1) 
Frequency of review. The accreditation body shall review phantom images 
from each facility accredited by the body at least once every 3 years.
    (2) Requirements for the phantom used. The accreditation body shall 
require that each facility submit for review phantom images that the 
facility produced using a phantom and methods of use specified by the 
body and approved by FDA in accordance with Sec. 900.3(d) or paragraph 
(a)(8) of this section.
    (3) Scoring phantom images. The accreditation body shall use a 
system for scoring phantom images that has been approved by FDA in 
accordance with Sec. 900.3(b) and (d) or paragraph (a)(8) of this 
section.
    (4) Phantom images selected for review. For each mammography unit in 
the facility, the accreditation body shall require the facility to 
submit phantom images that the facility produced during a time period 
specified by the body.
    (5) Phantom image reviewers. Accreditation bodies shall ensure that 
all of their phantom image reviewers:
    (i) Meet the requirements specified in Sec. 900.12(a)(3) or 
alternative requirements established by the accreditation body and 
approved by FDA in accordance with Sec. 900.3 or paragraph (a)(8) of 
this section;
    (ii) Are trained and evaluated in the phantom image review process, 
for the types of phantom images to be evaluated by a phantom image 
reviewer, by the accreditation body before designation as phantom image 
reviewers and periodically thereafter; and
    (iii) Clearly document their findings and reasons for assigning a 
particular score to any phantom image and provide information to the 
facility for use in improving its phantom image quality with regard to 
the significant deficiencies identified.
    (6) Image management. The accreditation body's QA program shall 
include a tracking system to ensure the security of all phantom images 
received and to ensure completion of all phantom image reviews by the 
body in a timely manner. All phantom images that result in a failure of 
accreditation shall be returned to the facility.
    (7) Notification measures for unsatisfactory image quality. If the 
accreditation body determines that the phantom images received from a 
facility are of unsatisfactory quality, the body shall notify the 
facility of the nature of the problem and its possible causes.
    (e) Reports of mammography equipment evaluation, surveys, and 
quality control. The following requirements apply to all facility 
equipment covered by the provisions of subparts A and B:
    (1) The accreditation body shall require every facility applying for 
accreditation to submit:
    (i) With its initial accreditation application, a mammography 
equipment evaluation that was performed by a medical physicist no 
earlier than 6 months before the date of application for accreditation 
by the facility. Such evaluation shall demonstrate compliance of the 
facility's equipment with the requirements in Sec. 900.12(e).
    (ii) Prior to accreditation, a survey that was performed no earlier 
than 6 months before the date of application

[[Page 830]]

for accreditation by the facility. Such survey shall assess the 
facility's compliance with the facility standards referenced in 
paragraph (b) of this section.
    (2) The accreditation body shall require that all facilities undergo 
an annual survey to ensure continued compliance with the standards 
referenced in paragraph (b) of this section and to provide continued 
oversight of facilities' quality control programs as they relate to such 
standards. The accreditation body shall require for all facilities that:
    (i) Such surveys be conducted annually;
    (ii) Facilities take reasonable steps to ensure that they receive 
reports of such surveys within 30 days of survey completion; and
    (iii) Facilities submit the results of such surveys and any other 
information that the body may require to the body at least annually.
    (3) The accreditation body shall review and analyze the information 
required in this section and use it to identify necessary corrective 
measures for facilities and to determine whether facilities should 
remain accredited by the body.
    (f) Accreditation body onsite visits and random clinical image 
reviews. The accreditation body shall conduct onsite visits and random 
clinical image reviews of a sample of facilities to monitor and assess 
their compliance with standards established by the body for 
accreditation. The accreditation body shall submit annually to FDA, at 
the address given in Sec. 900.3(b)(1), 3 copies of a summary report 
describing all facility assessments the body conducted under the 
provisions of this section for the year being reported.
    (1) Onsite visits--(i) Sample size. Annually, each accreditation 
body shall visit at least 5 percent of the facilities it accredits. 
However, a minimum of 5 facilities shall be visited, and visits to no 
more than 50 facilities are required, unless problems identified in 
paragraph (f)(1)(i)(B) of this section indicate a need to visit more 
than 50 facilities.
    (A) At least 50 percent of the facilities visited shall be selected 
randomly.
    (B) Other facilities visited shall be selected based on problems 
identified through State or FDA inspections, serious complaints received 
from consumers or others, a previous history of noncompliance, or any 
other information in the possession of the accreditation body, 
inspectors, or FDA.
    (C) Before, during, or after any facility visit, the accreditation 
body may require that the facility submit to the body for review 
clinical images, phantom images, or any other information relevant to 
applicable standards in this subpart and in subpart B of this part.
    (ii) Visit plan. The accreditation body shall conduct facility 
onsite visits according to a visit plan that has been approved by FDA in 
accordance with Sec. 900.3(d) or paragraph (a)(8) of this section, 
unless otherwise directed by FDA in particular circumstances. At a 
minimum, such a plan shall provide for:
    (A) Assessment of overall clinical image QA activities of the 
facility;
    (B) Review of facility documentation to determine if appropriate 
mammography reports are sent to patients and physicians as required;
    (C) Selection of a sample of clinical images for clinical image 
review by the accreditation body. Clinical images shall be selected in a 
manner specified by the accreditation body and approved by FDA that does 
not compromise care of the patient as a result of the absence of the 
selected images from the facility;
    (D) Verification that the facility has a medical audit system in 
place and is correlating films and pathology reports for positive cases;
    (E) Verification that personnel specified by the facility are the 
ones actually performing designated personnel functions;
    (F) Verification that equipment specified by the facility is the 
equipment that is actually being used to perform designated equipment 
functions;
    (G) Verification that a consumer complaint mechanism is in place and 
that the facility is following its procedures; and
    (H) Review of all factors related to previously identified concerns 
or concerns identified during that visit.
    (2) Clinical image review for random sample of facilities--(i) 
Sample size. In addition to conducting clinical image

[[Page 831]]

reviews for accreditation and reaccreditation for all facilities, the 
accreditation body shall conduct clinical image reviews annually for a 
randomly selected sample as specified by FDA, but to include at least 3 
percent of the facilities the body accredits. Accreditation bodies may 
count toward this random sample requirement all facilities selected 
randomly for the onsite visits described in paragraph (f)(1)(i)(A) of 
this section. Accreditation bodies shall not count toward the random 
sample requirement any facilities described in paragraph (f)(1)(i)(B) of 
this section that were selected for a visit because of previously 
identified concerns.
    (ii) Random clinical image review. In performing clinical image 
reviews of the random sample of facilities, accreditation bodies shall 
evaluate the same attributes as those in paragraph (c) of this section 
for review of clinical images for accreditation and reaccreditation.
    (iii) Accreditation bodies should not schedule random clinical image 
reviews at facilities that have received notification of the need to 
begin the accreditation renewal process or that have completed the 
accreditation renewal process within the previous 6 months.
    (iv) Selection of the random sample of clinical images for clinical 
image review by the accreditation body. Clinical images shall be 
selected in a manner, specified by the accreditation body and approved 
by FDA under Sec. 900.3(d) or paragraph (a)(8) of this section, that 
does not compromise care of the patient as a result of the absence of 
the selected images from the facility.
    (g) Consumer complaint mechanism. The accreditation body shall 
develop and administer a written and documented system, including 
timeframes, for collecting and resolving serious consumer complaints 
that could not be resolved at a facility. Such system shall have been 
approved by FDA in accordance withSec. 900.3(d) or paragraph (a)(8) of 
this section. Accordingly, all accreditation bodies shall:
    (1) Provide a mechanism for all facilities it accredits to file 
serious unresolved complaints with the accreditation body;
    (2) Maintain a record of every serious unresolved complaint received 
by the body on all facilities it accredits for a period of at least 3 
years from the date of receipt of each such complaint;
    (h) Reporting and recordkeeping. All reports to FDA specified in 
paragraphs (h)(1) through (h)(4) of this section shall be prepared and 
submitted in a format and medium prescribed by FDA and shall be 
submitted to a location and according to a schedule specified by FDA. 
The accreditation body shall:
    (1) Collect and submit to FDA the information required by 42 U.S.C. 
263b(d) for each facility when the facility is initially accredited and 
at least annually when updated, in a manner and at a time specified by 
FDA.
    (2) Accept applications containing the information required in 42 
U.S.C. 263b(c)(2) for provisional certificates and in Sec. 900.11(b)(3) 
for extension of provisional certificates, on behalf of FDA, and notify 
FDA of the receipt of such information;
    (3) Submit to FDA the name, identifying information, and other 
information relevant to 42 U.S.C. 263b and specified by FDA for any 
facility for which the accreditation body denies, suspends, or revokes 
accreditation, and the reason(s) for such action;
    (4) Submit to FDA an annual report summarizing all serious 
complaints received during the previous calendar year, their resolution 
status, and any actions taken in response to them;
    (5) Provide to FDA other information relevant to 42 U.S.C. 263b and 
required by FDA about any facility accredited or undergoing 
accreditation by the body.
    (i) Fees. Fees charged to facilities for accreditation shall be 
reasonable. Costs of accreditation body activities that are not related 
to accreditation functions under 42 U.S.C. 263b are not recoverable 
through fees established for accreditation.
    (1) The accreditation body shall make public its fee structure, 
including those factors, if any, contributing to variations in fees for 
different facilities.
    (2) At FDA's request, accreditation bodies shall provide financial 
records

[[Page 832]]

or other material to assist FDA in assessing the reasonableness of 
accreditation body fees. Such material shall be provided to FDA in a 
manner and time period specified by the agency.

[62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 
64 FR 32407, June 17, 1999]

    Effective Date Note: At 88 FR 15168, Mar. 10, 2023, Sec. 900.4 was 
ameded by revising paragraphs (a)(6) and (f)(1)(ii)(B), eff. Sept. 10, 
2024. For the convenience of the user, the revised text is set forth as 
follows:



Sec. 900.4  Standards for accreditation bodies.

    (a) * * *
    (6)(i) When an accreditation body denies accreditation to a 
facility, the accreditation body shall notify the facility in writing 
and explain the bases for its decision. The notification shall also 
describe the appeals process available from the accreditation body for 
the facility to contest the decision.
    (ii) If a facility has failed to become accredited after three 
consecutive attempts, no accreditation body shall accept an application 
for accreditation from the facility for a period of 1 year from the date 
of the most recent accreditation failure.

                                * * * * *

    (f) * * *
    (1) * * *
    (ii) * * *
    (B) Review of facility documentation to determine if appropriate 
mammography reports are sent to patients and providers as required;

                                * * * * *



Sec. 900.5  Evaluation.

    FDA shall evaluate annually the performance of each accreditation 
body. Such evaluation shall include an assessment of the reports of FDA 
or State inspections of facilities accredited by the body as well as any 
additional information deemed relevant by FDA that has been provided by 
the accreditation body or other sources or has been required by FDA as 
part of its oversight initiatives. The evaluation shall include a 
determination of whether there are major deficiencies in the 
accreditation body's performance that, if not corrected, would warrant 
withdrawal of the approval of the accreditation body under the 
provisions of Sec. 900.6.



Sec. 900.6  Withdrawal of approval.

    If FDA determines, through the evaluation activities of Sec. 900.5, 
or through other means, that an accreditation body is not in substantial 
compliance with this subpart, FDA may initiate the following actions:
    (a) Major deficiencies. If FDA determines that an accreditation body 
has failed to perform a major accreditation function satisfactorily, has 
demonstrated willful disregard for public health, has violated the code 
of conduct, has committed fraud, or has submitted material false 
statements to the agency, FDA may withdraw its approval of that 
accreditation body.
    (1) FDA shall notify the accreditation body of the agency's action 
and the grounds on which the approval was withdrawn.
    (2) An accreditation body that has lost its approval shall notify 
facilities accredited or seeking accreditation by it that its approval 
has been withdrawn. Such notification shall be made within a time period 
and in a manner approved by FDA.
    (b) Minor deficiencies. If FDA determines that an accreditation body 
has demonstrated deficiencies in performing accreditation functions and 
responsibilities that are less serious or more limited than the 
deficiencies in paragraph (a) of this section, FDA shall notify the body 
that it has a specified period of time to take particular corrective 
measures directed by FDA or to submit to FDA for approval the body's own 
plan of corrective action addressing the minor deficiencies. FDA may 
place the body on probationary status for a period of time determined by 
FDA, or may withdraw approval of the body as an accreditation body if 
corrective action is not taken.
    (1) If FDA places an accreditation body on probationary status, the 
body shall notify all facilities accredited or seeking accreditation by 
it of its probationary status within a time period and in a manner 
approved by FDA.
    (2) Probationary status shall remain in effect until such time as 
the body can demonstrate to the satisfaction of FDA that it has 
successfully implemented or is implementing the corrective action plan 
within the established

[[Page 833]]

schedule, and that the corrective actions have substantially eliminated 
all identified problems.
    (3) If FDA determines that an accreditation body that has been 
placed on probationary status is not implementing corrective actions 
satisfactorily or within the established schedule, FDA may withdraw 
approval of the accreditation body. The accreditation body shall notify 
all facilities accredited or seeking accreditation by it of its loss of 
FDA approval, within a time period and in a manner approved by FDA.
    (c) Reapplication by accreditation bodies that have had their 
approval withdrawn. (1) A former accreditation body that has had its 
approval withdrawn may submit a new application for approval if the body 
can provide information to FDA to establish that the problems that were 
grounds for withdrawal of approval have been resolved.
    (2) If FDA determines that the new application demonstrates that the 
body satisfactorily has addressed the causes of its previous 
unacceptable performance, FDA may reinstate approval of the 
accreditation body.
    (3) FDA may request additional information or establish additional 
conditions that must be met by a former accreditation body before FDA 
approves the reapplication.
    (4) FDA may refuse to accept an application from a former 
accreditation body whose approval was withdrawn because of fraud or 
willful disregard of public health.



Sec. 900.7  Hearings.

    (a) Opportunities to challenge final adverse actions taken by FDA 
regarding approval or reapproval of accreditation bodies, withdrawal of 
approval of accreditation bodies, or rejection of a proposed fee for 
accreditation shall be communicated through notices of opportunity for 
informal hearings in accordance with part 16 of this chapter.
    (b) A facility that has been denied accreditation is entitled to an 
appeals process from the accreditation body. The appeals process shall 
be specified in writing by the accreditation body and shall have been 
approved by FDA in accordance with Sec. 900.3(d) or Sec. 900.4(a)(8).
    (c) A facility that cannot achieve satisfactory resolution of an 
adverse accreditation decision through the accreditation body's appeals 
process may appeal to FDA for reconsideration in accordance with Sec. 
900.15.



Sec. Sec. 900.8-900.9  [Reserved]



              Subpart B_Quality Standards and Certification



Sec. 900.10  Applicability.

    The provisions of subpart B are applicable to all facilities under 
the regulatory jurisdiction of the United States that provide 
mammography services, with the exception of the Department of Veterans 
Affairs.



Sec. 900.11  Requirements for certification.

    (a) General. After October 1, 1994, a certificate issued by FDA is 
required for lawful operation of all mammography facilities subject to 
the provisions of this subpart. To obtain a certificate from FDA, 
facilities are required to meet the quality standards in Sec. 900.12 
and to be accredited by an approved accreditation body or other entity 
as designated by FDA.
    (b) Application--(1) Certificates. (i) In order to qualify for a 
certificate, a facility must apply to an FDA-approved accreditation 
body, or to another entity designated by FDA. The facility shall submit 
to such body or entity the information required in 42 U.S.C. 263b(d)(1).
    (ii) Following the agency's receipt of the accreditation body's 
decision to accredit a facility, or an equivalent decision by another 
entity designated by FDA, the agency may issue a certificate to the 
facility, or renew an existing certificate, if the agency determines 
that the facility has satisfied the requirements for certification or 
recertification.
    (2) Provisional certificates. (i) A new facility beginning operation 
after October 1, 1994, is eligible to apply for a provisional 
certificate. The provisional certificate will enable the facility to 
perform mammography and to obtain the clinical images needed to complete 
the accreditation process. To apply for and receive a provisional 
certificate, a

[[Page 834]]

facility must meet the requirements of 42 U.S.C. 263b(c)(4) and submit 
the necessary information to an approved accreditation body or other 
entity designated by FDA.
    (ii) Following the agency's receipt of the accreditation body's 
decision that a facility has submitted the required information, FDA may 
issue a provisional certificate to a facility upon determination that 
the facility has satisfied the requirements of Sec. 900.11(b)(2)(i). A 
provisional certificate shall be effective for up to 6 months from the 
date of issuance. A provisional certificate cannot be renewed, but a 
facility may apply for a 90-day extension of the provisional 
certificate.
    (3) Extension of provisional certificate. (i) To apply for a 90-day 
extension to a provisional certificate, a facility shall submit to its 
accreditation body, or other entity designated by FDA, a statement of 
what the facility is doing to obtain certification and evidence that 
there would be a significant adverse impact on access to mammography in 
the geographic area served if such facility did not obtain an extension.
    (ii) The accreditation body shall forward the request, with its 
recommendation, to FDA within 2 business days after receipt.
    (iii) FDA may issue a 90-day extension for a provisional certificate 
upon determination that the extension meets the criteria set forth in 42 
U.S.C. 263b(c)(2).
    (iv) There can be no renewal of a provisional certificate beyond the 
90-day extension.
    (c) Reinstatement policy. A previously certified facility that has 
allowed its certificate to expire, that has been refused a renewal of 
its certificate by FDA, or that has had its certificate suspended or 
revoked by FDA, may apply to have the certificate reinstated so that the 
facility may be considered to be a new facility and thereby be eligible 
for a provisional certificate.
    (1) Unless prohibited from reinstatement under Sec. 900.11(c)(4), a 
facility applying for reinstatement shall:
    (i) Contact an FDA-approved accreditation body or other entity 
designated by FDA to determine the requirements for reapplication for 
accreditation;
    (ii) Fully document its history as a previously provisionally 
certified or certified mammography facility, including the following 
information:
    (A) Name and address of the facility under which it was previously 
provisionally certified or certified;
    (B) Name of previous owner/lessor;
    (C) FDA facility identification number assigned to the facility 
under its previous certification; and
    (D) Expiration date of the most recent FDA provisional certificate 
or certificate; and
    (iii) Justify application for reinstatement of accreditation by 
submitting to the accreditation body or other entity designated by FDA, 
a corrective action plan that details how the facility has corrected 
deficiencies that contributed to the lapse of, denial of renewal, or 
revocation of its certificate.
    (2) FDA may issue a provisional certificate to the facility if:
    (i) The accreditation body or other entity designated by FDA 
notifies the agency that the facility has adequately corrected, or is in 
the process of correcting, pertinent deficiencies; and
    (ii) FDA determines that the facility has taken sufficient 
corrective action since the lapse of, denial of renewal, or revocation 
of its previous certificate.
    (3) After receiving the provisional certificate, the facility may 
lawfully resume performing mammography services while completing the 
requirements for certification.
    (4) If a facility's certificate was revoked on the basis of an act 
described in 41 U.S.C. 263b(i)(1), no person who owned or operated that 
facility at the time the act occurred may own or operate a mammography 
facility within 2 years of the date of revocation.

[62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 
83 FR 13864, Apr. 2, 2018]

    Effective Date Note: At 88 FR 15168, Mar. 10, 2023, Sec. 900.11 was 
amended by revising paragraph (c)(4), eff. Sept. 10, 2024. For the 
convenience of the user, the revised text is set forth as follows:



Sec. 900.11  Requirements for certification.

                                * * * * *

    (c) * * *

[[Page 835]]

    (4) If a facility's certificate was revoked on the basis of an act 
described in 42 U.S.C. 263b(i)(1), as implemented by Sec. 900.14(a), no 
person who owned or operated that facility at the time the act occurred 
may own or operate a mammography facility within 2 years of the date of 
revocation.



Sec. 900.12  Quality standards.

    (a) Personnel. The following requirements apply to all personnel 
involved in any aspect of mammography, including the production, 
processing, and interpretation of mammograms and related quality 
assurance activities:
    (1) Interpreting physicians. All physicians interpreting mammograms 
shall meet the following qualifications:
    (i) Initial qualifications. Unless the exemption in paragraph 
(a)(1)(iii)(A) of this section applies, before beginning to interpret 
mammograms independently, the interpreting physician shall:
    (A) Be licensed to practice medicine in a State;
    (B)(1) Be certified in an appropriate specialty area by a body 
determined by FDA to have procedures and requirements adequate to ensure 
that physicians certified by the body are competent to interpret 
radiological procedures, including mammography; or
    (2) Have had at least 3 months of documented formal training in the 
interpretation of mammograms and in topics related to mammography. The 
training shall include instruction in radiation physics, including 
radiation physics specific to mammography, radiation effects, and 
radiation protection. The mammographic interpretation component shall be 
under the direct supervision of a physician who meets the requirements 
of paragraph (a)(1) of this section;
    (C) Have a minimum of 60 hours of documented medical education in 
mammography, which shall include: Instruction in the interpretation of 
mammograms and education in basic breast anatomy, pathology, physiology, 
technical aspects of mammography, and quality assurance and quality 
control in mammography. All 60 of these hours shall be category I and at 
least 15 of the category I hours shall have been acquired within the 3 
years immediately prior to the date that the physician qualifies as an 
interpreting physician. Hours spent in residency specifically devoted to 
mammography will be considered as equivalent to Category I continuing 
medical education credits and will be accepted if documented in writing 
by the appropriate representative of the training institution; and
    (D) Unless the exemption in paragraph (a)(1)(iii)(B) of this section 
applies, have interpreted or multi-read at least 240 mammographic 
examinations within the 6-month period immediately prior to the date 
that the physician qualifies as an interpreting physician. This 
interpretation or multi-reading shall be under the direct supervision of 
an interpreting physician.
    (ii) Continuing experience and education. All interpreting 
physicians shall maintain their qualifications by meeting the following 
requirements:
    (A) Following the second anniversary date of the end of the calendar 
quarter in which the requirements of paragraph (a)(1)(i) of this section 
were completed, the interpreting physician shall have interpreted or 
multi-read at least 960 mammographic examinations during the 24 months 
immediately preceding the date of the facility's annual MQSA inspection 
or the last day of the calendar quarter preceding the inspection or any 
date in-between the two. The facility will choose one of these dates to 
determine the 24-month period.
    (B) Following the third anniversary date of the end of the calendar 
quarter in which the requirements of paragraph (a)(1)(i) of this section 
were completed, the interpreting physician shall have taught or 
completed at least 15 category I continuing medical education units in 
mammography during the 36 months immediately preceding the date of the 
facility's annual MQSA inspection or the last day of the calendar 
quarter preceding the inspection or any date in between the two. The 
facility will choose one of these dates to determine the 36-month 
period. This training shall include at least six category I continuing 
medical education credits in each mammographic modality used by the 
interpreting physician in his or her practice; and
    (C) Before an interpreting physician may begin independently 
interpreting

[[Page 836]]

mammograms produced by a new mammographic modality, that is, a 
mammographic modality in which the physician has not previously been 
trained, the interpreting physician shall have at least 8 hours of 
training in the new mammographic modality.
    (D) Units earned through teaching a specific course can be counted 
only once towards the 15 required by paragraph (a)(1)(ii)(B) of this 
section, even if the course is taught multiple times during the previous 
36 months.
    (iii) Exemptions. (A) Those physicians who qualified as interpreting 
physicians under paragraph (a)(1) of this section of FDA's interim 
regulations prior to April 28, 1999, are considered to have met the 
initial requirements of paragraph (a)(1)(i) of this section. They may 
continue to interpret mammograms provided they continue to meet the 
licensure requirement of paragraph (a)(1)(i)(A) of this section and the 
continuing experience and education requirements of paragraph (a)(1)(ii) 
of this section.
    (B) Physicians who have interpreted or multi-read at least 240 
mammographic examinations under the direct supervision of an 
interpreting physician in any 6-month period during the last 2 years of 
a diagnostic radiology residency and who become appropriately board 
certified at the first allowable time, as defined by an eligible 
certifying body, are otherwise exempt from paragraph (a)(1)(i)(D) of 
this section.
    (iv) Reestablishing qualifications. Interpreting physicians who fail 
to maintain the required continuing experience or continuing education 
requirements shall reestablish their qualifications before resuming the 
independent interpretation of mammograms, as follows:
    (A) Interpreting physicians who fail to meet the continuing 
experience requirements of paragraph (a)(1)(ii)(A) of this section 
shall:
    (1) Interpret or multi-read at least 240 mammographic examinations 
under the direct supervision of an interpreting physician, or
    (2) Interpret or multi-read a sufficient number of mammographic 
examinations, under the direct supervision of an interpreting physician, 
to bring the physician's total up to 960 examinations for the prior 24 
months, whichever is less.
    (3) The interpretations required under paragraph (a)(1)(iv)(A)(1) or 
(a)(1)(iv)(A)(2) of this section shall be done within the 6 months 
immediately prior to resuming independent interpretation.
    (B) Interpreting physicians who fail to meet the continuing 
education requirements of paragraph (a)(1)(ii)(B) of this section shall 
obtain a sufficient number of additional category I continuing medical 
education credits in mammography to bring their total up to the required 
15 credits in the previous 36 months before resuming independent 
interpretation.
    (2) Radiologic technologists. All mammographic examinations shall be 
performed by radiologic technologists who meet the following general 
requirements, mammography requirements, and continuing education and 
experience requirements:
    (i) General requirements. (A) Be licensed to perform general 
radiographic procedures in a State; or
    (B) Have general certification from one of the bodies determined by 
FDA to have procedures and requirements adequate to ensure that 
radiologic technologists certified by the body are competent to perform 
radiologic examinations; and
    (ii) Mammography requirements. Have, prior to April 28, 1999, 
qualified as a radiologic technologist under paragraph (a)(2) of this 
section of FDA's interim regulations of December 21, 1993, or completed 
at least 40 contact hours of documented training specific to mammography 
under the supervision of a qualified instructor. The hours of documented 
training shall include, but not necessarily be limited to:
    (A) Training in breast anatomy and physiology, positioning and 
compression, quality assurance/quality control techniques, imaging of 
patients with breast implants;
    (B) The performance of a minimum of 25 examinations under the direct 
supervision of an individual qualified under paragraph (a)(2) of this 
section; and
    (C) At least 8 hours of training in each mammography modality to be

[[Page 837]]

used by the technologist in performing mammography exams; and
    (iii) Continuing education requirements. (A) Following the third 
anniversary date of the end of the calendar quarter in which the 
requirements of paragraphs (a)(2)(i) and (a)(2)(ii) of this section were 
completed, the radiologic technologist shall have taught or completed at 
least 15 continuing education units in mammography during the 36 months 
immediately preceding the date of the facility's annual MQSA inspection 
or the last day of the calendar quarter preceding the inspection or any 
date in between the two. The facility will choose one of these dates to 
determine the 36-month period.
    (B) Units earned through teaching a specific course can be counted 
only once towards the 15 required in paragraph (a)(2)(iii)(A) of this 
section, even if the course is taught multiple times during the previous 
36 months.
    (C) At least six of the continuing education units required in 
paragraph (a)(2)(iii)(A) of this section shall be related to each 
mammographic modality used by the technologist.
    (D) Requalification. Radiologic technologists who fail to meet the 
continuing education requirements of paragraph (a)(2)(iii)(A) of this 
section shall obtain a sufficient number of continuing education units 
in mammography to bring their total up to at least 15 in the previous 3 
years, at least 6 of which shall be related to each modality used by the 
technologist in mammography. The technologist may not resume performing 
unsupervised mammography examinations until the continuing education 
requirements are completed.
    (E) Before a radiologic technologist may begin independently 
performing mammographic examinations using a mammographic modality other 
than one of those for which the technologist received training under 
paragraph (a)(2)(ii)(C) of this section, the technologist shall have at 
least 8 hours of continuing education units in the new modality.
    (iv) Continuing experience requirements. (A) Following the second 
anniversary date of the end of the calendar quarter in which the 
requirements of paragraphs (a)(2)(i) and (a)(2)(ii) of this section were 
completed or of April 28, 1999, whichever is later, the radiologic 
technologist shall have performed a minimum of 200 mammography 
examinations during the 24 months immediately preceding the date of the 
facility's annual inspection or the last day of the calendar quarter 
preceding the inspection or any date in between the two. The facility 
will choose one of these dates to determine the 24-month period.
    (B) Requalification. Radiologic technologists who fail to meet the 
continuing experience requirements of paragraph (a)(2)(iv)(A) of this 
section shall perform a minimum of 25 mammography examinations under the 
direct supervision of a qualified radiologic technologist, before 
resuming the performance of unsupervised mammography examinations.
    (3) Medical physicists. All medical physicists conducting surveys of 
mammography facilities and providing oversight of the facility quality 
assurance program under paragraph (e) of this section shall meet the 
following:
    (i) Initial qualifications. (A) Be State licensed or approved or 
have certification in an appropriate specialty area by one of the bodies 
determined by FDA to have procedures and requirements to ensure that 
medical physicists certified by the body are competent to perform 
physics survey; and
    (B)(1) Have a masters degree or higher in a physical science from an 
accredited institution, with no less than 20 semester hours or 
equivalent (e.g., 30 quarter hours) of college undergraduate or graduate 
level physics;
    (2) Have 20 contact hours of documented specialized training in 
conducting surveys of mammography facilities; and
    (3) Have the experience of conducting surveys of at least 1 
mammography facility and a total of at least 10 mammography units. No 
more than one survey of a specific unit within a period of 60 days can 
be counted towards the total mammography unit survey requirement. After 
April 28, 1999, experience conducting surveys must be acquired under the 
direct supervision of a medical physicist who meets all the requirements 
of paragraphs (a)(3)(i) and (a)(3)(iii) of this section; or

[[Page 838]]

    (ii) Alternative initial qualifications. (A) Have qualified as a 
medical physicist under paragraph (a)(3) of this section of FDA's 
interim regulations and retained that qualification by maintenance of 
the active status of any licensure, approval, or certification required 
under the interim regulations; and
    (B) Prior to the April 28, 1999, have:
    (1) A bachelor's degree or higher in a physical science from an 
accredited institution with no less than 10 semester hours or equivalent 
of college undergraduate or graduate level physics,
    (2) Forty contact hours of documented specialized training in 
conducting surveys of mammography facilities and,
    (3) Have the experience of conducting surveys of at least 1 
mammography facility and a total of at least 20 mammography units. No 
more than one survey of a specific unit within a period of 60 days can 
be counted towards the total mammography unit survey requirement. The 
training and experience requirements must be met after fulfilling the 
degree requirement.
    (iii) Continuing qualifications. (A) Continuing education. Following 
the third anniversary date of the end of the calendar quarter in which 
the requirements of paragraph (a)(3)(i) or (a)(3)(ii) of this section 
were completed, the medical physicist shall have taught or completed at 
least 15 continuing education units in mammography during the 36 months 
immediately preceding the date of the facility's annual inspection or 
the last day of the calendar quarter preceding the inspection or any 
date in between the two. The facility shall choose one of these dates to 
determine the 36-month period. This continuing education shall include 
hours of training appropriate to each mammographic modality evaluated by 
the medical physicist during his or her surveys or oversight of quality 
assurance programs. Units earned through teaching a specific course can 
be counted only once towards the required 15 units in a 36-month period, 
even if the course is taught multiple times during the 36 months.
    (B) Continuing experience. Following the second anniversary date of 
the end of the calendar quarter in which the requirements of paragraphs 
(a)(3)(i) and (a)(3)(ii) of this section were completed or of April 28, 
1999, whichever is later, the medical physicist shall have surveyed at 
least two mammography facilities and a total of at least six mammography 
units during the 24 months immediately preceding the date of the 
facility's annual MQSA inspection or the last day of the calendar 
quarter preceding the inspection or any date in between the two. The 
facility shall choose one of these dates to determine the 24-month 
period. No more than one survey of a specific facility within a 10-month 
period or a specific unit within a period of 60 days can be counted 
towards this requirement.
    (C) Before a medical physicist may begin independently performing 
mammographic surveys of a new mammographic modality, that is, a 
mammographic modality other than one for which the physicist received 
training to qualify under paragraph (a)(3)(i) or (a)(3)(ii) of this 
section, the physicist must receive at least 8 hours of training in 
surveying units of the new mammographic modality.
    (iv) Reestablishing qualifications. Medical physicists who fail to 
maintain the required continuing qualifications of paragraph (a)(3)(iii) 
of this section may not perform the MQSA surveys without the supervision 
of a qualified medical physicist. Before independently surveying another 
facility, medical physicists must reestablish their qualifications, as 
follows:
    (A) Medical physicists who fail to meet the continuing educational 
requirements of paragraph (a)(3)(iii)(A) of this section shall obtain a 
sufficient number of continuing education units to bring their total 
units up to the required 15 in the previous 3 years.
    (B) Medical physicists who fail to meet the continuing experience 
requirement of paragraph (a)(3)(iii)(B) of this section shall complete a 
sufficient number of surveys under the direct supervision of a medical 
physicist who meets the qualifications of paragraphs (a)(3)(i) and 
(a)(3)(iii) of this section to bring their total surveys up to the 
required two facilities and six units in the previous 24 months. No more 
than one survey of a specific unit within a

[[Page 839]]

period of 60 days can be counted towards the total mammography unit 
survey requirement.
    (4) Retention of personnel records. Facilities shall maintain 
records to document the qualifications of all personnel who worked at 
the facility as interpreting physicians, radiologic technologists, or 
medical physicists. These records must be available for review by the 
MQSA inspectors. Records of personnel no longer employed by the facility 
should not be discarded until the next annual inspection has been 
completed and FDA has determined that the facility is in compliance with 
the MQSA personnel requirements.
    (b) Equipment. Regulations published under Sec. Sec. 1020.30, 
1020.31, and 900.12(e) of this chapter that are relevant to equipment 
performance should also be consulted for a more complete understanding 
of the equipment performance requirements.
    (1) Prohibited equipment. Radiographic equipment designed for 
general purpose or special nonmammography procedures shall not be used 
for mammography. This prohibition includes systems that have been 
modified or equipped with special attachments for mammography. This 
requirement supersedes the implied acceptance of such systems in Sec. 
1020.31(f)(3) of this chapter.
    (2) General. All radiographic equipment used for mammography shall 
be specifically designed for mammography and shall be certified pursuant 
to Sec. 1010.2 of this chapter as meeting the applicable requirements 
of Sec. Sec. 1020.30 and 1020.31 of this chapter in effect at the date 
of manufacture.
    (3) Motion of tube-image receptor assembly. (i) The assembly shall 
be capable of being fixed in any position where it is designed to 
operate. Once fixed in any such position, it shall not undergo 
unintended motion.
    (ii) The mechanism ensuring compliance with paragraph (b)(3)(i) of 
this section shall not fail in the event of power interruption.
    (4) Image receptor sizes. (i) Systems using screen-film image 
receptors shall provide, at a minimum, for operation with image 
receptors of 18 x 24 centimeters (cm) and 24 x 30 cm.
    (ii) Systems using screen-film image receptors shall be equipped 
with moving grids matched to all image receptor sizes provided.
    (iii) Systems used for magnification procedures shall be capable of 
operation with the grid removed from between the source and image 
receptor.
    (5) Light fields. For any mammography system with a light beam that 
passes through the x-ray beam-limiting device, the light shall provide 
an average illumination of not less than 160 lux (15 foot candles) at 
100 cm or the maximum source-image receptor distance (SID), whichever is 
less.
    (6) Magnification. (i) Systems used to perform noninterventional 
problem solving procedures shall have radiographic magnification 
capability available for use by the operator.
    (ii) Systems used for magnification procedures shall provide, at a 
minimum, at least one magnification value within the range of 1.4 to 
2.0.
    (7) Focal spot selection. (i) When more than one focal spot is 
provided, the system shall indicate, prior to exposure, which focal spot 
is selected.
    (ii) When more than one target material is provided, the system 
shall indicate, prior to exposure, the preselected target material.
    (iii) When the target material and/or focal spot is selected by a 
system algorithm that is based on the exposure or on a test exposure, 
the system shall display, after the exposure, the target material and/or 
focal spot actually used during the exposure.
    (8) Compression. All mammography systems shall incorporate a 
compression device.
    (i) Application of compression. Effective October 28, 2002, each 
system shall provide:
    (A) An initial power-driven compression activated by hands-free 
controls operable from both sides of the patient; and
    (B) Fine adjustment compression controls operable from both sides of 
the patient.
    (ii) Compression paddle. (A) Systems shall be equipped with 
different sized compression paddles that match the sizes of all full-
field image receptors provided for the system. Compression paddles for 
special purposes, including

[[Page 840]]

those smaller than the full size of the image receptor (for ``spot 
compression'') may be provided. Such compression paddles for special 
purposes are not subject to the requirements of paragraphs (b)(8)(ii)(D) 
and (b)(8)(ii)(E) of this section.
    (B) Except as provided in paragraph (b)(8)(ii)(C) of this section, 
the compression paddle shall be flat and parallel to the breast support 
table and shall not deflect from parallel by more than 1.0 cm at any 
point on the surface of the compression paddle when compression is 
applied.
    (C) Equipment intended by the manufacturer's design to not be flat 
and parallel to the breast support table during compression shall meet 
the manufacturer's design specifications and maintenance requirements.
    (D) The chest wall edge of the compression paddle shall be straight 
and parallel to the edge of the image receptor.
    (E) The chest wall edge may be bent upward to allow for patient 
comfort but shall not appear on the image.
    (9) Technique factor selection and display. (i) Manual selection of 
milliampere seconds (mAs) or at least one of its component parts 
(milliapere (mA) and/or time) shall be available.
    (ii) The technique factors (peak tube potential in kilovolt (kV) and 
either tube current in mA and exposure time in seconds or the product of 
tube current and exposure time in mAs) to be used during an exposure 
shall be indicated before the exposure begins, except when automatic 
exposure controls (AEC) are used, in which case the technique factors 
that are set prior to the exposure shall be indicated.
    (iii) Following AEC mode use, the system shall indicate the actual 
kilovoltage peak (kVp) and mAs used during the exposure. The mAs may be 
displayed as mA and time.
    (10) Automatic exposure control. (i) Each screen-film system shall 
provide an AEC mode that is operable in all combinations of equipment 
configuration provided, e.g., grid, nongrid; magnification, 
nonmagnification; and various target-filter combinations.
    (ii) The positioning or selection of the detector shall permit 
flexibility in the placement of the detector under the target tissue.
    (A) The size and available positions of the detector shall be 
clearly indicated at the X-ray input surface of the breast compression 
paddle.
    (B) The selected position of the detector shall be clearly 
indicated.
    (iii) The system shall provide means for the operator to vary the 
selected optical density from the normal (zero) setting.
    (11) X-ray film. The facility shall use X-ray film for mammography 
that has been designated by the film manufacturer as appropriate for 
mammography.
    (12) Intensifying screens. The facility shall use intensifying 
screens for mammography that have been designated by the screen 
manufacturer as appropriate for mammography and shall use film that is 
matched to the screen's spectral output as specified by the 
manufacturer.
    (13) Film processing solutions. For processing mammography films, 
the facility shall use chemical solutions that are capable of developing 
the films used by the facility in a manner equivalent to the minimum 
requirements specified by the film manufacturer.
    (14) Lighting. The facility shall make special lights for film 
illumination, i.e., hot-lights, capable of producing light levels 
greater than that provided by the view box, available to the 
interpreting physicians.
    (15) Film masking devices. Facilities shall ensure that film masking 
devices that can limit the illuminated area to a region equal to or 
smaller than the exposed portion of the film are available to all 
interpreting physicians interpreting for the facility.
    (c) Medical records and mammography reports--(1) Contents and 
terminology. Each facility shall prepare a written report of the results 
of each mammography examination performed under its certificate. The 
mammography report shall include the following information:
    (i) The name of the patient and an additional patient identifier;
    (ii) Date of examination;
    (iii) The name of the interpreting physician who interpreted the 
mammogram;

[[Page 841]]

    (iv) Overall final assessment of findings, classified in one of the 
following categories:
    (A) ``Negative:'' Nothing to comment upon (if the interpreting 
physician is aware of clinical findings or symptoms, despite the 
negative assessment, these shall be explained);
    (B) ``Benign:'' Also a negative assessment;
    (C) ``Probably Benign:'' Finding(s) has a high probability of being 
benign;
    (D) ``Suspicious:'' Finding(s) without all the characteristic 
morphology of breast cancer but indicating a definite probability of 
being malignant;
    (E) ``Highly suggestive of malignancy:'' Finding(s) has a high 
probability of being malignant;
    (v) In cases where no final assessment category can be assigned due 
to incomplete work-up, ``Incomplete: Need additional imaging 
evaluation'' shall be assigned as an assessment and reasons why no 
assessment can be made shall be stated by the interpreting physician; 
and
    (vi) Recommendations made to the health care provider about what 
additional actions, if any, should be taken. All clinical questions 
raised by the referring health care provider shall be addressed in the 
report to the extent possible, even if the assessment is negative or 
benign.
    (2) Communication of mammography results to the patients. Each 
facility shall send each patient a summary of the mammography report 
written in lay terms within 30 days of the mammographic examination. If 
assessments are ``Suspicious'' or ``Highly suggestive of malignancy,'' 
the facility shall make reasonable attempts to ensure that the results 
are communicated to the patient as soon as possible.
    (i) Patients who do not name a health care provider to receive the 
mammography report shall be sent the report described in paragraph 
(c)(1) of this section within 30 days, in addition to the written 
notification of results in lay terms.
    (ii) Each facility that accepts patients who do not have a health 
care provider shall maintain a system for referring such patients to a 
health care provider when clinically indicated.
    (3) Communication of mammography results to health care providers. 
When the patient has a referring health care provider or the patient has 
named a health care provider, the facility shall:
    (i) Provide a written report of the mammography examination, 
including the items listed in paragraph (c)(1) of this section, to that 
health care provider as soon as possible, but no later than 30 days from 
the date of the mammography examination; and
    (ii) If the assessment is ``Suspicious'' or ``Highly suggestive of 
malignancy,'' make reasonable attempts to communicate with the health 
care provider as soon as possible, or if the health care provider is 
unavailable, to a responsible designee of the health care provider.
    (4) Recordkeeping. Each facility that performs mammograms:
    (i) Shall (except as provided in paragraph (c)(4)(ii) of this 
section) maintain mammography films and reports in a permanent medical 
record of the patient for a period of not less than 5 years, or not less 
than 10 years if no additional mammograms of the patient are performed 
at the facility, or a longer period if mandated by State or local law; 
and
    (ii) Shall upon request by, or on behalf of, the patient, 
permanently or temporarily transfer the original mammograms and copies 
of the patient's reports to a medical institution, or to a physician or 
health care provider of the patient, or to the patient directly;
    (iii) Any fee charged to the patients for providing the services in 
paragraph (c)(4)(ii) of this section shall not exceed the documented 
costs associated with this service.
    (5) Mammographic image identification. Each mammographic image shall 
have the following information indicated on it in a permanent, legible, 
and unambiguous manner and placed so as not to obscure anatomic 
structures:
    (i) Name of patient and an additional patient identifier.
    (ii) Date of examination.
    (iii) View and laterality. This information shall be placed on the 
image in a position near the axilla. Standardized codes specified by the 
accreditation

[[Page 842]]

body and approved by FDA in accordance with Sec. 900.3(b) or Sec. 
900.4(a)(8) shall be used to identify view and laterality.
    (iv) Facility name and location. At a minimum, the location shall 
include the city, State, and zip code of the facility.
    (v) Technologist identification.
    (vi) Cassette/screen identification.
    (vii) Mammography unit identification, if there is more than one 
unit in the facility.
    (d) Quality assurance--general. Each facility shall establish and 
maintain a quality assurance program to ensure the safety, reliability, 
clarity, and accuracy of mammography services performed at the facility.
    (1) Responsible individuals. Responsibility for the quality 
assurance program and for each of its elements shall be assigned to 
individuals who are qualified for their assignments and who shall be 
allowed adequate time to perform these duties.
    (i) Lead interpreting physician. The facility shall identify a lead 
interpreting physician who shall have the general responsibility of 
ensuring that the quality assurance program meets all requirements of 
paragraphs (d) through (f) of this section. No other individual shall be 
assigned or shall retain responsibility for quality assurance tasks 
unless the lead interpreting physician has determined that the 
individual's qualifications for, and performance of, the assignment are 
adequate.
    (ii) Interpreting physicians. All interpreting physicians 
interpreting mammograms for the facility shall:
    (A) Follow the facility procedures for corrective action when the 
images they are asked to interpret are of poor quality, and
    (B) Participate in the facility's medical outcomes audit program.
    (iii) Medical physicist. Each facility shall have the services of a 
medical physicist available to survey mammography equipment and oversee 
the equipment-related quality assurance practices of the facility. At a 
minimum, the medical physicist(s) shall be responsible for performing 
the surveys and mammography equipment evaluations and providing the 
facility with the reports described in paragraphs (e)(9) and (e)(10) of 
this section.
    (iv) Quality control technologist. Responsibility for all individual 
tasks within the quality assurance program not assigned to the lead 
interpreting physician or the medical physicist shall be assigned to a 
quality control technologist(s). The tasks are to be performed by the 
quality control technologist or by other personnel qualified to perform 
the tasks. When other personnel are utilized for these tasks, the 
quality control technologist shall ensure that the tasks are completed 
in such a way as to meet the requirements of paragraph (e) of this 
section.
    (2) Quality assurance records. The lead interpreting physician, 
quality control technologist, and medical physicist shall ensure that 
records concerning mammography technique and procedures, quality control 
(including monitoring data, problems detected by analysis of that data, 
corrective actions, and the effectiveness of the correction actions), 
safety, protection, and employee qualifications to meet assigned quality 
assurance tasks are properly maintained and updated. These quality 
control records shall be kept for each test specified in paragraphs (e) 
and (f) of this section until the next annual inspection has been 
completed and FDA has determined that the facility is in compliance with 
the quality assurance requirements or until the test has been performed 
two additional times at the required frequency, whichever is longer.
    (e) Quality assurance--equipment--(1) Daily quality control tests. 
Film processors used to develop mammograms shall be adjusted and 
maintained to meet the technical development specifications for the 
mammography film in use. A processor performance test shall be performed 
on each day that clinical films are processed before any clinical films 
are processed that day. The test shall include an assessment of base 
plus fog density, mid-density, and density difference, using the 
mammography film used clinically at the facility.
    (i) The base plus fog density shall be within + 0.03 of the 
established operating level.
    (ii) The mid-density shall be within 0.15 of 
the established operating level.

[[Page 843]]

    (iii) The density difference shall be within 0.15 of the established operating level.
    (2) Weekly quality control tests. Facilities with screen-film 
systems shall perform an image quality evaluation test, using an FDA-
approved phantom, at least weekly.
    (i) The optical density of the film at the center of an image of a 
standard FDA-accepted phantom shall be at least 1.20 when exposed under 
a typical clinical condition.
    (ii) The optical density of the film at the center of the phantom 
image shall not change by more than 0.20 from the 
established operating level.
    (iii) The phantom image shall achieve at least the minimum score 
established by the accreditation body and accepted by FDA in accordance 
with Sec. 900.3(d) or Sec. 900.4(a)(8).
    (iv) The density difference between the background of the phantom 
and an added test object, used to assess image contrast, shall be 
measured and shall not vary by more than 0.05 from 
the established operating level.
    (3) Quarterly quality control tests. Facilities with screen-film 
systems shall perform the following quality control tests at least 
quarterly:
    (i) Fixer retention in film. The residual fixer shall be no more 
than 5 micrograms per square cm.
    (ii) Repeat analysis. If the total repeat or reject rate changes 
from the previously determined rate by more than 2.0 percent of the 
total films included in the analysis, the reason(s) for the change shall 
be determined. Any corrective actions shall be recorded and the results 
of these corrective actions shall be assessed.
    (4) Semiannual quality control tests. Facilities with screen-film 
systems shall perform the following quality control tests at least 
semiannually:
    (i) Darkroom fog. The optical density attributable to darkroom fog 
shall not exceed 0.05 when a mammography film of the type used in the 
facility, which has a mid-density of no less than 1.2 OD, is exposed to 
typical darkroom conditions for 2 minutes while such film is placed on 
the counter top emulsion side up. If the darkroom has a safelight used 
for mammography film, it shall be on during this test.
    (ii) Screen-film contact. Testing for screen-film contact shall be 
conducted using 40 mesh copper screen. All cassettes used in the 
facility for mammography shall be tested.
    (iii) Compression device performance. (A) A compression force of at 
least 111 newtons (25 pounds) shall be provided.
    (B) Effective October 28, 2002, the maximum compression force for 
the initial power drive shall be between 111 newtons (25 pounds) and 200 
newtons (45 pounds).
    (5) Annual quality control tests. Facilities with screen-film 
systems shall perform the following quality control tests at least 
annually:
    (i) Automatic exposure control performance. (A) The AEC shall be 
capable of maintaining film optical density within 0.30 of the mean optical density when thickness of a 
homogeneous material is varied over a range of 2 to 6 cm and the kVp is 
varied appropriately for such thicknesses over the kVp range used 
clinically in the facility. If this requirement cannot be met, a 
technique chart shall be developed showing appropriate techniques (kVp 
and density control settings) for different breast thicknesses and 
compositions that must be used so that optical densities within 0.30 of the average under phototimed conditions can be 
produced.
    (B) After October 28, 2002, the AEC shall be capable of maintaining 
film optical density (OD) within 0.15 of the mean 
optical density when thickness of a homogeneous material is varied over 
a range of 2 to 6 cm and the kVp is varied appropriately for such 
thicknesses over the kVp range used clinically in the facility.
    (C) The optical density of the film in the center of the phantom 
image shall not be less than 1.20.
    (ii) Kilovoltage peak (kVp) accuracy and reproducibility. (A) The 
kVp shall be accurate within 5 percent of the 
indicated or selected kVp at:
    (1) The lowest clinical kVp that can be measured by a kVp test 
device;
    (2) The most commonly used clinical kVp;
    (3) The highest available clinical kVp, and
    (B) At the most commonly used clinical settings of kVp, the 
coefficient of

[[Page 844]]

variation of reproducibility of the kVp shall be equal to or less than 
0.02.
    (iii) Focal spot condition. Until October 28, 2002, focal spot 
condition shall be evaluated either by determining system resolution or 
by measuring focal spot dimensions. After October 28, 2002, facilities 
shall evaluate focal spot condition only by determining the system 
resolution.
    (A) System resolution. (1) Each X-ray system used for mammography, 
in combination with the mammography screen-film combination used in the 
facility, shall provide a minimum resolution of 11 Cycles/millimeter 
(mm) (line-pairs/mm) when a high contrast resolution bar test pattern is 
oriented with the bars perpendicular to the anode-cathode axis, and a 
minimum resolution of 13 line-pairs/mm when the bars are parallel to 
that axis.
    (2) The bar pattern shall be placed 4.5 cm above the breast support 
surface, centered with respect to the chest wall edge of the image 
receptor, and with the edge of the pattern within 1 cm of the chest wall 
edge of the image receptor.
    (3) When more than one target material is provided, the measurement 
in paragraph (e)(5)(iii)(A) of this section shall be made using the 
appropriate focal spot for each target material.
    (4) When more than one SID is provided, the test shall be performed 
at SID most commonly used clinically.
    (5) Test kVp shall be set at the value used clinically by the 
facility for a standard breast and shall be performed in the AEC mode, 
if available. If necessary, a suitable absorber may be placed in the 
beam to increase exposure times. The screen-film cassette combination 
used by the facility shall be used to test for this requirement and 
shall be placed in the normal location used for clinical procedures.
    (B) Focal spot dimensions. Measured values of the focal spot length 
(dimension parallel to the anode cathode axis) and width (dimension 
perpendicular to the anode cathode axis) shall be within the tolerance 
limits specified in table 1.

                                 Table 1
------------------------------------------------------------------------
                       Focal Spot Tolerance Limit
-------------------------------------------------------------------------
                                        Maximum Measured Dimensions
  Nominal Focal Spot Size (mm)   ---------------------------------------
                                       Width(mm)          Length(mm)
------------------------------------------------------------------------
0.10                                        0.15                0.15
0.15                                        0.23                0.23
0.20                                        0.30                0.30
0.30                                        0.45                0.65
0.40                                        0.60                0.85
0.60                                        0.90                1.30
------------------------------------------------------------------------

    (iv) Beam quality and half-value layer (HVL). The HVL shall meet the 
specifications of Sec. 1020.30(m)(1) of this chapter for the minimum 
HVL. These values, extrapolated to the mammographic range, are shown in 
table 2. Values not shown in table 2 may be determined by linear 
interpolation or extrapolation.

                                 Table 2
------------------------------------------------------------------------
           X-ray Tube Voltage (kilovolt peak) and Minimum HVL
-------------------------------------------------------------------------
                                                          Minimum HVL
  Designed Operating Range (kV)   Measured Operating    (millimeters of
                                     Voltage (kV)          aluminum)
------------------------------------------------------------------------
Below 50                                   20                   0.20
                                           25                   0.25
                                           30                   0.30
------------------------------------------------------------------------

    (v) Breast entrance air kerma and AEC reproducibility. The 
coefficient of variation for both air kerma and mAs shall not exceed 
0.05.
    (vi) Dosimetry. The average glandular dose delivered during a single 
cranio-caudal view of an FDA-accepted phantom simulating a standard 
breast shall not exceed 3.0 milligray (mGy) (0.3 rad) per exposure. The 
dose shall be determined with technique factors and conditions used 
clinically for a standard breast.
    (vii) X-ray field/light field/image receptor/compression paddle 
alignment. (A) All systems shall have beam-limiting devices that allow 
the entire chest wall edge of the x-ray field to extend to the chest 
wall edge of the image receptor and provide means to assure that the x-
ray field does not extend beyond any edge of the image receptor by more 
than 2 percent of the SID.
    (B) If a light field that passes through the X-ray beam limitation 
device is provided, it shall be aligned with the X-ray field so that the 
total of any misalignment of the edges of the

[[Page 845]]

light field and the X-ray field along either the length or the width of 
the visually defined field at the plane of the breast support surface 
shall not exceed 2 percent of the SID.
    (C) The chest wall edge of the compression paddle shall not extend 
beyond the chest wall edge of the image receptor by more than one 
percent of the SID when tested with the compression paddle placed above 
the breast support surface at a distance equivalent to standard breast 
thickness. The shadow of the vertical edge of the compression paddle 
shall not be visible on the image.
    (viii) Uniformity of screen speed. Uniformity of screen speed of all 
the cassettes in the facility shall be tested and the difference between 
the maximum and minimum optical densities shall not exceed 0.30. Screen 
artifacts shall also be evaluated during this test.
    (ix) System artifacts. System artifacts shall be evaluated with a 
high-grade, defect-free sheet of homogeneous material large enough to 
cover the mammography cassette and shall be performed for all cassette 
sizes used in the facility using a grid appropriate for the cassette 
size being tested. System artifacts shall also be evaluated for all 
available focal spot sizes and target filter combinations used 
clinically.
    (x) Radiation output. (A) The system shall be capable of producing a 
minimum output of 4.5 mGy air kerma per second (513 milli Roentgen (mR) 
per second) when operating at 28 kVp in the standard mammography (moly/
moly) mode at any SID where the system is designed to operate and when 
measured by a detector with its center located 4.5 cm above the breast 
support surface with the compression paddle in place between the source 
and the detector. After October 28, 2002, the system, under the same 
measuring conditions shall be capable of producing a minimum output of 
7.0 mGy air kerma per second (800 mR per second) when operating at 28 
kVp in the standard (moly/moly) mammography mode at any SID where the 
system is designed to operate.
    (B) The system shall be capable of maintaining the required minimum 
radiation output averaged over a 3.0 second period.
    (xi) Decompression. If the system is equipped with a provision for 
automatic decompression after completion of an exposure or interruption 
of power to the system, the system shall be tested to confirm that it 
provides:
    (A) An override capability to allow maintenance of compression;
    (B) A continuous display of the override status; and
    (C) A manual emergency compression release that can be activated in 
the event of power or automatic release failure.
    (6) Quality control tests--other modalities. For systems with image 
receptor modalities other than screen-film, the quality assurance 
program shall be substantially the same as the quality assurance program 
recommended by the image receptor manufacturer, except that the maximum 
allowable dose shall not exceed the maximum allowable dose for screen-
film systems in paragraph (e)(5)(vi) of this section.
    (7) Mobile units. The facility shall verify that mammography units 
used to produce mammograms at more than one location meet the 
requirements in paragraphs (e)(1) through (e)(6) of this section. In 
addition, at each examination location, before any examinations are 
conducted, the facility shall verify satisfactory performance of such 
units using a test method that establishes the adequacy of the image 
quality produced by the unit.
    (8) Use of test results. (i) After completion of the tests specified 
in paragraphs (e)(1) through (e)(7) of this section, the facility shall 
compare the test results to the corresponding specified action limits; 
or, for nonscreen-film modalities, to the manufacturer's recommended 
action limits; or, for post-move, preexamination testing of mobile 
units, to the limits established in the test method used by the 
facility.
    (ii) If the test results fall outside of the action limits, the 
source of the problem shall be identified and corrective actions shall 
be taken:
    (A) Before any further examinations are performed or any films are 
processed using a component of the mammography system that failed any of 
the tests described in paragraphs (e)(1), (e)(2), (e)(4)(i), (e)(4)(ii), 
(e)(4)(iii), (e)(5)(vi), (e)(6), or (e)(7) of this section;

[[Page 846]]

    (B) Within 30 days of the test date for all other tests described in 
paragraph (e) of this section.
    (9) Surveys. (i) At least once a year, each facility shall undergo a 
survey by a medical physicist or by an individual under the direct 
supervision of a medical physicist. At a minimum, this survey shall 
include the performance of tests to ensure that the facility meets the 
quality assurance requirements of the annual tests described in 
paragraphs (e)(5) and (e)(6) of this section and the weekly phantom 
image quality test described in paragraph (e)(2) of this section.
    (ii) The results of all tests conducted by the facility in 
accordance with paragraphs (e)(1) through (e)(7) of this section, as 
well as written documentation of any corrective actions taken and their 
results, shall be evaluated for adequacy by the medical physicist 
performing the survey.
    (iii) The medical physicist shall prepare a survey report that 
includes a summary of this review and recommendations for necessary 
improvements.
    (iv) The survey report shall be sent to the facility within 30 days 
of the date of the survey.
    (v) The survey report shall be dated and signed by the medical 
physicist performing or supervising the survey. If the survey was 
performed entirely or in part by another individual under the direct 
supervision of the medical physicist, that individual and the part of 
the survey that individual performed shall also be identified in the 
survey report.
    (10) Mammography equipment evaluations. Additional evaluations of 
mammography units or image processors shall be conducted whenever a new 
unit or processor is installed, a unit or processor is disassembled and 
reassembled at the same or a new location, or major components of a 
mammography unit or processor equipment are changed or repaired. These 
evaluations shall be used to determine whether the new or changed 
equipment meets the requirements of applicable standards in paragraphs 
(b) and (e) of this section. All problems shall be corrected before the 
new or changed equipment is put into service for examinations or film 
processing. The mammography equipment evaluation shall be performed by a 
medical physicist or by an individual under the direct supervision of a 
medical physicist.
    (11) Facility cleanliness. (i) The facility shall establish and 
implement adequate protocols for maintaining darkroom, screen, and view 
box cleanliness.
    (ii) The facility shall document that all cleaning procedures are 
performed at the frequencies specified in the protocols.
    (12) Calibration of air kerma measuring instruments. Instruments 
used by medical physicists in their annual survey to measure the air 
kerma or air kerma rate from a mammography unit shall be calibrated at 
least once every 2 years and each time the instrument is repaired. The 
instrument calibration must be traceable to a national standard and 
calibrated with an accuracy of 6 percent (95 
percent confidence level) in the mammography energy range.
    (13) Infection control. Facilities shall establish and comply with a 
system specifying procedures to be followed by the facility for cleaning 
and disinfecting mammography equipment after contact with blood or other 
potentially infectious materials. This system shall specify the methods 
for documenting facility compliance with the infection control 
procedures established and shall:
    (i) Comply with all applicable Federal, State, and local regulations 
pertaining to infection control; and
    (ii) Comply with the manufacturer's recommended procedures for the 
cleaning and disinfection of the mammography equipment used in the 
facility; or
    (iii) If adequate manufacturer's recommendations are not available, 
comply with generally accepted guidance on infection control, until such 
recommendations become available.
    (f) Quality assurance-mammography medical outcomes audit. Each 
facility shall establish and maintain a mammography medical outcomes 
audit program to followup positive mammographic assessments and to 
correlate pathology results with the interpreting physician's findings. 
This program shall be designed to ensure the reliability, clarity, and 
accuracy of the interpretation of mammograms.

[[Page 847]]

    (1) General requirements. Each facility shall establish a system to 
collect and review outcome data for all mammograms performed, including 
followup on the disposition of all positive mammograms and correlation 
of pathology results with the interpreting physician's mammography 
report. Analysis of these outcome data shall be made individually and 
collectively for all interpreting physicians at the facility. In 
addition, any cases of breast cancer among women imaged at the facility 
that subsequently become known to the facility shall prompt the facility 
to initiate followup on surgical and/or pathology results and review of 
the mammograms taken prior to the diagnosis of a malignancy.
    (2) Frequency of audit analysis. The facility's first audit analysis 
shall be initiated no later than 12 months after the date the facility 
becomes certified, or 12 months after April 28, 1999, whichever date is 
the latest. This audit analysis shall be completed within an additional 
12 months to permit completion of diagnostic procedures and data 
collection. Subsequent audit analyses will be conducted at least once 
every 12 months.
    (3) Audit interpreting physician. Each facility shall designate at 
least one interpreting physician to review the medical outcomes audit 
data at least once every 12 months. This individual shall record the 
dates of the audit period(s) and shall be responsible for analyzing 
results based on this audit. This individual shall also be responsible 
for documenting the results and for notifying other interpreting 
physicians of their results and the facility aggregate results. If 
followup actions are taken, the audit interpreting physician shall also 
be responsible for documenting the nature of the followup.
    (g) Mammographic procedure and techniques for mammography of 
patients with breast implants. (1) Each facility shall have a procedure 
to inquire whether or not the patient has breast implants prior to the 
actual mammographic exam.
    (2) Except where contraindicated, or unless modified by a 
physician's directions, patients with breast implants undergoing 
mammography shall have mammographic views to maximize the visualization 
of breast tissue.
    (h) Consumer complaint mechanism. Each facility shall:
    (1) Establish a written and documented system for collecting and 
resolving consumer complaints;
    (2) Maintain a record of each serious complaint received by the 
facility for at least 3 years from the date the complaint was received;
    (3) Provide the consumer with adequate directions for filing serious 
complaints with the facility's accreditation body if the facility is 
unable to resolve a serious complaint to the consumer's satisfaction;
    (4) Report unresolved serious complaints to the accreditation body 
in a manner and timeframe specified by the accreditation body.
    (i) Clinical image quality. Clinical images produced by any 
certified facility must continue to comply with the standards for 
clinical image quality established by that facility's accreditation 
body.
    (j) Additional mammography review and patient notification. (1) If 
FDA believes that mammography quality at a facility has been compromised 
and may present a serious risk to human health, the facility shall 
provide clinical images and other relevant information, as specified by 
FDA, for review by the accreditation body or other entity designated by 
FDA. This additional mammography review will help the agency to 
determine whether the facility is in compliance with this section and, 
if not, whether there is a need to notify affected patients, their 
physicians, or the public that the reliability, clarity, and accuracy of 
interpretation of mammograms has been compromised.
    (2) If FDA determines that the quality of mammography performed by a 
facility, whether or not certified under Sec. 900.11, was so 
inconsistent with the quality standards established in this section as 
to present a significant risk to individual or public health, FDA may 
require such facility to notify patients who received mammograms at such 
facility, and their referring physicians, of the deficiencies presenting 
such risk, the potential harm resulting, appropriate remedial measures, 
and such other relevant information as

[[Page 848]]

FDA may require. Such notification shall occur within a timeframe and in 
a manner specified by FDA.

[62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 
63 FR 56558, Oct. 22, 1998; 64 FR 18333, Apr. 14, 1999; 64 FR 32408, 
June 17, 1999; 65 FR 43690, July 14, 2000]

    Effective Date Note: At 88 FR 15168, Mar. 10, 2023, Sec. 900.12 was 
amended by revising paragraphs (a)(4), (b)(11), (c)(1) and (2), 
(c)(3)(ii), (c)(4), (f)(1) and (j) and by adding paragraphs (b)(2)(i), 
(ii), (16), and (f)(4), eff. Sept. 10, 2024. For the convenience of the 
user, the revised text is set forth as follows:



Sec. 900.12  Quality standards.

    (a) * * *
    (4) Retention of personnel records. Facilities shall maintain 
records of training and experience relevant to their qualification under 
MQSA for personnel who work or have worked at the facility as 
interpreting physicians, radiologic technologists, or medical 
physicists. These records must be available for review by the MQSA 
inspectors. Records of personnel no longer employed by the facility must 
be maintained for no less than 24 months from the date of the departure 
of an employee, and these records must be available for review at the 
time of any annual inspection occurring during those 24 months. The 
facility shall provide copies of these personnel records to current 
interpreting physicians, radiologic technologists, and medical 
physicists upon their request. Facilities must provide personnel records 
to former employees if the former employees communicate their request 
within 24 months of the date of their departure. If it has been greater 
than 24 months and the facility has maintained those records, the 
facility must provide those records to former employees upon request. 
Before a facility closes or ceases to provide mammography services, it 
must make arrangements for access by current and former personnel to 
their MQSA personnel records. This access may be provided by the 
permanent transfer of these records to the personnel or the transfer of 
the records to a facility or other entity that will provide access to 
these records for no less than 24 months from the date of facility 
closure or cessation of mammography services.
    (b) * * *
    (2) * * *
    (i) All devices used in mammography must have met the applicable FDA 
premarket authorization requirements for medical devices of that type 
with that intended use.
    (ii) A mammography unit that is converted from one mammographic 
modality to another is considered a new unit at the facility under this 
part and must, prior to clinical use, undergo a mammography equipment 
evaluation demonstrating compliance with applicable requirements. The 
facility must also follow its accreditation body's procedures for 
applying for accreditation of that unit.

                                * * * * *

    (11) Film. For facilities using screen-film units, the facility 
shall use x-ray film for mammography that has been designated by the 
film manufacturer as appropriate for mammography. For facilities using 
hardcopy prints of digital images for transfer, retention, or final 
interpretation purposes, the facility shall use a type of film 
designated by the film manufacturer as appropriate for these purposes 
and compatible with the printer being used.

                                * * * * *

    (16) Equipment--other modalities. Systems with image receptor 
modalities other than screen-film shall demonstrate compliance with 
quality standards by successful results of quality assurance testing as 
specified under paragraph (e)(6) of this section.
    (c) Medical records and mammography reports--(1) Contents and 
terminology. Each facility shall prepare a written report of the results 
of each mammographic examination performed under its certificate. The 
mammographic examination presented for interpretation must be in the 
original mammographic modality in which it was performed, and must not 
consist of digital images produced through copying or digitizing 
hardcopy original images. The mammography report shall include the 
following information:
    (i) The name of the patient and an additional patient identifier;
    (ii) Date of examination, facility name, and location. At a minimum, 
the location shall include the city, State, ZIP code, and telephone 
number of the facility;
    (iii) The name of the interpreting physician who interpreted the 
mammogram;
    (iv) Overall final assessment of findings, classified in one of the 
following categories (the assessment statement is only the word or 
phrase within the quotation marks):
    (A) ``Negative.'' Nothing to comment upon (if the interpreting 
physician is aware of clinical findings or symptoms, despite the 
negative assessment, these shall be documented and addressed);
    (B) ``Benign.'' Also a normal result, with benign findings present, 
but no evidence of malignancy (if the interpreting physician is aware of 
clinical findings or symptoms, despite the benign assessment, these 
shall be documented and addressed);
    (C) ``Probably Benign.'' Finding(s) has a high probability of being 
benign;

[[Page 849]]

    (D) ``Suspicious.'' Finding(s) without all the characteristic 
morphology of breast cancer but indicating a definite probability of 
being malignant;
    (E) ``Highly Suggestive of Malignancy.'' Finding(s) has a high 
probability of being malignant;
    (F) ``Known Biopsy-Proven Malignancy.'' Reserved for known 
malignancies being mammographically evaluated for definitive therapy; 
and
    (G) ``Post-Procedure Mammogram for Marker Placement.'' Reserved for 
a post-procedure mammogram used to confirm the deployment and position 
of a breast tissue marker.
    (v) In cases where no final assessment category can be assigned due 
to incomplete work-up, one of the following classification statements 
shall be assigned as an assessment and reasons why no final assessment 
can be made shall be stated by the interpreting physician.
    (A) ``Incomplete: Need additional imaging evaluation.'' Reserved for 
examinations where additional imaging needs to be performed before an 
assessment category identified in paragraphs (c)(1)(iv)(A) through (G) 
of this section can be given; or
    (B) ``Incomplete: Need prior mammograms for comparison.'' Reserved 
for examinations where comparison with prior mammograms should be 
performed before an assessment category identified in paragraphs 
(c)(1)(iv)(A) through (G) of this section can be given. If this 
assessment category is used, a followup report with an assessment 
category identified in paragraphs (c)(1)(iv)(A) through (E) of this 
section must be issued within 30 calendar days of the initial report 
whether or not comparison views can be obtained.
    (vi) Overall assessment of breast density, classified in one of the 
following categories:
    (A) ``The breasts are almost entirely fatty.''
    (B) ``There are scattered areas of fibroglandular density.''
    (C) ``The breasts are heterogeneously dense, which may obscure small 
masses.''
    (D) ``The breasts are extremely dense, which lowers the sensitivity 
of mammography.''
    (vii) Recommendations made to the healthcare provider about what 
additional actions, if any, should be taken. All clinical questions 
raised by the referring healthcare provider shall be addressed in the 
report to the extent possible, even if the assessment is negative or 
benign.
    (2) Communication of mammography results to the patients. Each 
facility shall provide each patient a summary of the mammography report 
written in lay terms within 30 calendar days of the mammographic 
examination which shall, at a minimum, include the name of the patient; 
the name, address, and telephone number of the facility performing the 
mammographic examination; and an assessment of breast density as 
described in paragraphs (c)(2)(iii) and (iv) of this section. If the 
assessment of the mammography report is ``Suspicious'' or ``Highly 
Suggestive of Malignancy,'' the facility shall provide the patient a 
summary of the mammography report written in lay language within 7 
calendar days of the final interpretation of the mammograms.
    (i) Patients who do not name a healthcare provider to receive the 
mammography report shall be sent the report described in paragraph 
(c)(1) of this section within 30 days, in addition to the written 
notification of results in lay terms. If the assessment of the 
mammography report is ``Suspicious'' or ``Highly Suggestive of 
Malignancy,'' the facility shall send this report to the patient within 
7 calendar days of the final interpretation of the mammograms.
    (ii) Each facility that accepts patients who do not have a 
healthcare provider shall maintain a system for referring such patients 
to a healthcare provider when clinically indicated, which shall include 
when such patients' mammogram assessment is either probably benign, 
suspicious, or highly suggestive of malignancy.
    (iii) If the mammography report identifies the patient's breast 
density as ``The breasts are almost entirely fatty'' or ``There are 
scattered areas of fibroglandular density,'' the lay summary shall 
include the statement ``Breast tissue can be either dense or not dense. 
Dense tissue makes it harder to find breast cancer on a mammogram and 
also raises the risk of developing breast cancer. Your breast tissue is 
not dense. Talk to your healthcare provider about breast density, risks 
for breast cancer, and your individual situation.''
    (iv) If the mammography report identifies the breast density as 
``The breasts are heterogeneously dense, which may obscure small 
masses'' or ``The breasts are extremely dense, which lowers the 
sensitivity of mammography,'' the lay summary shall include the 
statement ``Breast tissue can be either dense or not dense. Dense tissue 
makes it harder to find breast cancer on a mammogram and also raises the 
risk of developing breast cancer. Your breast tissue is dense. In some 
people with dense tissue, other imaging tests in addition to a mammogram 
may help find cancers. Talk to your healthcare provider about breast 
density, risks for breast cancer, and your individual situation.''
    (3) * * *
    (ii) If the assessment is ``Suspicious'' or ``Highly Suggestive of 
Malignancy,'' the facility shall provide a written report of the 
mammographic examination, including the items listed in paragraph (c)(1) 
of this section, to the referring healthcare provider, or

[[Page 850]]

if the referring healthcare provider is unavailable, to a responsible 
designee of the referring healthcare provider within 7 calendar days of 
the final interpretation of the mammograms.
    (4) Recordkeeping. Each facility that performs mammograms:
    (i) Shall (except as provided in paragraph (c)(4)(ii) of this 
section) maintain the original mammograms and mammography reports in a 
permanent medical record of the patient for the longest of the 
following: a period of not less than 5 years, a period of not less than 
10 years if no additional mammograms of the patient are performed at the 
facility, or a period, if any, mandated by State or local law. 
Facilities shall implement policies and procedures to minimize the 
possibility of loss of these records. The original mammograms must be 
retained in retrievable form in the mammographic modality in which they 
were produced. They cannot be produced by copying or digitizing hardcopy 
originals.
    (ii) Shall upon request by, or on behalf of, the patient, 
permanently or temporarily transfer the original mammograms and copies 
of the patient's reports to a medical institution, a physician or 
healthcare provider of the patient, or to the patient directly during 
the time specified in paragraph (c)(4)(i) of this section. Transfer of 
the mammograms and mammography reports must take place within 15 
calendar days of the facility receiving such request. The transferred 
mammograms must be in the mammographic modality in which they were 
produced, and cannot be produced by copying or digitizing hardcopy 
originals. For digital mammograms or digital breast tomosynthesis, if 
the examination is being transferred for final interpretation purposes, 
the facility must be able to provide the recipient with original digital 
images electronically;
    (iii) Shall upon request by, or on behalf of, the patient, provide 
copies of mammograms and copies of mammogram reports to a medical 
institution, a physician or healthcare provider of the patient, or to 
the patient directly during the time specified in paragraph (c)(4)(i) of 
this section. Release of the copies must take place within 15 calendar 
days of the facility receiving such request. For digital mammograms or 
digital breast tomosynthesis, if the copies are being released for final 
interpretation purposes, the facility must be able to provide the 
recipient with digital images electronically;
    (iv) Any fee charged to the patients for providing the services in 
paragraphs (c)(4)(ii) or (iii) of this section shall not exceed the 
documented costs associated with this service; and
    (v) Before a facility closes or ceases to provide mammography 
services, it must make arrangements for access by patients and 
healthcare providers to their mammographic records. This access may be 
provided by the permanent transfer of mammographic records to the 
patient or the patient's healthcare provider or the transfer of the 
mammographic records to a facility or other entity that will provide 
access to patients and healthcare providers. Access to the records must 
be provided by such other facility or entity for the remainder of the 
time periods specified in paragraph (c)(4)(i) of this section. If a 
facility ceases to perform mammography but continues to operate as a 
medical entity, and is able to satisfy the recordkeeping requirements of 
paragraphs (c)(4)(i) through (iv) of this section, it may choose to 
continue to retain the medical records rather than transfer them to 
another facility, unless such a transfer is requested by, or on behalf 
of, the patient. The facility must notify its accreditation body and 
certification agency in writing of the arrangements it has made and must 
make reasonable efforts to notify all affected patients.

                                * * * * *

    (f) * * *
    (1) General requirements. For the purposes of these audit 
requirements, a mammographic examination consisting of routine views of 
an asymptomatic patient shall be termed a screening mammogram, while a 
mammographic examination consisting of individualized views of a patient 
with breast symptoms, physical signs of breast disease, or abnormal 
findings on a screening mammogram shall be termed a diagnostic 
mammogram. Each facility shall establish a system to collect and review 
outcome data for all mammographic examinations performed, including 
followup on the disposition of all positive mammograms and correlation 
of pathology results with the interpreting physician's mammography 
report. In addition, for cases of breast cancer among patients imaged at 
the facility that subsequently become known to the facility, the 
facility shall promptly initiate followup on surgical and/or pathology 
results and review of the mammographic examinations taken prior to the 
diagnosis of a malignancy. Analysis of these outcome data shall be made 
individually and collectively for all interpreting physicians and, at a 
minimum, shall consist of a determination of the following:
    (i) Positive predictive value--percent of patients with positive 
mammograms who are diagnosed with breast cancer within 1 year of the 
date of the mammographic examination.
    (ii) Cancer detection rate--of the patients initially examined with 
screening mammograms who receive an assessment of ``Incomplete: Need 
additional imaging evaluation,'' ``Suspicious,'' or ``Highly Suggestive 
of Malignancy'' on the screening mammogram or on a subsequent diagnostic 
mammogram, the number of patients who are diagnosed with

[[Page 851]]

breast cancer within 1 year of the date of the initial screening 
mammogram, expressed arithmetically as a ratio per 1,000 patients.
    (iii) Recall rate--percentage of screening mammograms given an 
assessment of ``Incomplete: Need additional imaging evaluation.''

                                * * * * *

    (4) The records and data required to demonstrate compliance with the 
requirements in paragraphs (f)(1) through (3) of this section must be 
retained until the annual inspection that follows the facility's 
analysis of that information.

                                * * * * *

    (j) Additional mammography review and patient and referring provider 
notification. (1) If FDA or the State certification agency believes that 
mammographic quality at a facility has been compromised and may present 
a significant risk to human health, the facility shall provide clinical 
images and other relevant information, as specified by FDA or the State 
certification agency, for review by the accreditation body or the State 
certification agency. This additional mammography review will help FDA 
or the State certification agency determine whether the facility is in 
compliance with this section and whether there is a need to notify 
affected patients, their referring physicians or other healthcare 
providers, and/or the public that there is a significant risk to human 
health.
    (2) Based on the results of the additional mammography review, the 
facility's failure to comply with the terms of the additional 
mammography review, or other information, FDA or the State certification 
agency may determine that the quality of mammography performed by a 
facility, whether or not certified under Sec. 900.11, was so 
inconsistent with the quality standards established in this part as to 
present a significant risk to human health. FDA or the State 
certification agency may require such a facility to notify all patients 
who received mammograms at the facility or those patients who are 
determined to be at risk due to the quality of their mammography, and 
their referring physicians or other healthcare providers, of the 
deficiencies and resulting potential harm, appropriate remedial 
measures, and such other relevant information as FDA or the State 
certification agency may require. Such notification shall occur within a 
timeframe and in a manner specified by FDA or the State certification 
agency. If the facility is unable or unwilling to perform such 
notification, FDA or the State certification agency may notify patients 
and their referring physicians or other healthcare providers 
individually or through the mass media.



Sec. 900.13  Revocation of accreditation and revocation of
accreditation body approval.

    (a) FDA action following revocation of accreditation. If a 
facility's accreditation is revoked by an accreditation body, the agency 
may conduct an investigation into the reasons for the revocation. 
Following such investigation, the agency may determine that the 
facility's certificate shall no longer be in effect or the agency may 
take whatever other action or combination of actions will best protect 
the public health, including the establishment and implementation of a 
corrective plan of action that will permit the certificate to continue 
in effect while the facility seeks reaccreditation. A facility whose 
certificate is no longer in effect because it has lost its accreditation 
may not practice mammography.
    (b) Withdrawal of FDA approval of an accreditation body. (1) If FDA 
withdraws approval of an accreditation body under Sec. 900.6, the 
certificates of facilities previously accredited by such body shall 
remain in effect for up to 1 year from the date of the withdrawal of 
approval, unless FDA determines, in order to protect human health or 
because the accreditation body fraudulently accredited facilities, that 
the certificates of some or all of the facilities should be revoked or 
suspended or that a shorter time period should be established for the 
certificates to remain in effect.
    (2) After 1 year from the date of withdrawal of approval of an 
accreditation body, or within any shorter period of time established by 
the agency, the affected facilities must obtain accreditation from 
another accreditation body, or from another entity designated by FDA.



Sec. 900.14  Suspension or revocation of certificates.

    (a) Except as provided in paragraph (b) of this section, FDA may 
suspend or revoke a certificate if FDA finds, after providing the owner 
or operator of the facility with notice and opportunity for an informal 
hearing in accordance with part 16 of this chapter, that the owner, 
operator, or any employee of the facility:

[[Page 852]]

    (1) Has been guilty of misrepresentation in obtaining the 
certificate;
    (2) Has failed to comply with the standards of Sec. 900.12;
    (3) Has failed to comply with reasonable requests of the agency or 
the accreditation body for records, information, reports, or materials 
that FDA believes are necessary to determine the continued eligibility 
of the facility for a certificate or continued compliance with the 
standards of Sec. 900.12;
    (4) Has refused a reasonable request of a duly designated FDA 
inspector, State inspector, or accreditation body representative for 
permission to inspect the facility or the operations and pertinent 
records of the facility;
    (5) Has violated or aided and abetted in the violation of any 
provision of or regulation promulgated pursuant to 42 U.S.C. 263b; or
    (6) Has failed to comply with prior sanctions imposed by the agency 
under 42 U.S.C. 263b(h).
    (b) FDA may suspend the certificate of a facility before holding a 
hearing if FDA makes a finding described in paragraph (a) of this 
section and also determines that;
    (1) The failure to comply with required standards presents a serious 
risk to human health;
    (2) The refusal to permit inspection makes immediate suspension 
necessary; or
    (3) There is reason to believe that the violation or aiding and 
abetting of the violation was intentional or associated with fraud.
    (c) If FDA suspends a certificate in accordance with paragraph (b) 
of this section:
    (1) The agency shall provide the facility with an opportunity for an 
informal hearing under part 16 of this chapter not later than 60 days 
from the effective date of this suspension;
    (2) The suspension shall remain in effect until the agency 
determines that:
    (i) Allegations of violations or misconduct were not substantiated;
    (ii) Violations of required standards have been corrected to the 
agency's satisfaction; or
    (iii) The facility's certificate is revoked in accordance with 
paragraph (d) of this section;
    (d) After providing a hearing in accordance with paragraph (c)(1) of 
this section, the agency may revoke the facility's certificate if the 
agency determines that the facility:
    (1) Is unwilling or unable to correct violations that were the basis 
for suspension; or
    (2) Has engaged in fraudulent activity to obtain or continue 
certification.

    Effective Date Note: At 88 FR 15171, Mar. 10, 2023, Sec. 900.14 was 
amended by revising paragraphs (a) introductory text, (3), (5), and (6) 
and adding paragraph (a)(7), eff. Sept. 10, 2024. For the convenience of 
the user, the revised and added text is set forth as follows:



Sec. 900.14  Suspension or revocation of certificates.

    (a) Except as provided in paragraph (b) of this section, FDA may 
suspend or revoke a certificate if FDA finds, after providing the owner 
or operator of the facility with notice and opportunity for a hearing in 
accordance with part 16 of this chapter, that the facility, owner, 
operator, or any employee of the facility:

                                * * * * *

    (3) Has failed to comply with reasonable requests of FDA, the State 
certification agency, or the accreditation body for records, 
information, reports, or materials, including clinical images for an 
additional mammography review under Sec. 900.12(j), that FDA or the 
State certification agency believes are necessary to determine the 
continued eligibility of the facility for a certificate or continued 
compliance with the standards of Sec. 900.12;

                                * * * * *

    (5) Has violated or aided and abetted in the violation of any 
provision of or regulation issued pursuant to 42 U.S.C. 263b;
    (6) Has failed to comply with prior sanctions imposed by FDA or the 
State certification agency under 42 U.S.C. 263b(h), including a directed 
plan of correction or a patient and referring physician notification; or
    (7) Has failed to comply with requests of current or former facility 
personnel for records of their training or experience relevant to their 
qualification under MQSA, in violation of Sec. 900.12(a)(4).

                                * * * * *

[[Page 853]]



Sec. 900.15  Appeals of adverse accreditation or reaccreditation decisions that preclude certification or recertification.

    (a) The appeals procedures described in this section are available 
only for adverse accreditation or reaccreditation decisions that 
preclude certification or recertification by FDA. Agency decisions to 
suspend or revoke certificates that are already in effect will be 
handled in accordance with Sec. 900.14.
    (b) Upon learning that a facility has failed to become accredited or 
reaccredited, FDA will notify the facility that the agency is unable to 
certify that facility without proof of accreditation.
    (c) A facility that has been denied accreditation or reaccreditation 
is entitled to an appeals process from the accreditation body, in 
accordance with Sec. 900.7. A facility must avail itself of the 
accreditation body's appeal process before requesting reconsideration 
from FDA.
    (d) A facility that cannot achieve satisfactory resolution of an 
adverse accreditation decision through the accreditation body's appeal 
process is entitled to further appeal in accordance with procedures set 
forth in this section and in regulations published in 42 CFR part 498.
    (1) References to the Health Care Financing Administration (HCFA) in 
42 CFR part 498 should be read as the Division of Mammography Quality 
and Radiation Programs (DMQRP), Center for Devices and Radiological 
Health, Food and Drug Administration.
    (2) References to the Appeals Council of the Social Security 
Administration in 42 CFR part 498 should be read as references to the 
Departmental Appeals Board.
    (3) In accordance with the procedures set forth in subpart B of 42 
CFR part 498, a facility that has been denied accreditation following 
appeal to the accreditation body may request reconsideration of that 
adverse decision from DMQRP.
    (i) A facility must request reconsideration by DMQS within 60 days 
of the accreditation body's adverse appeals decision, at the following 
address: Food and Drug Administration, Center for Devices and 
Radiological Health, Division of Mammography Quality Standards, Attn: 
Facility Accreditation Review Committee, 10903 New Hampshire Ave., Bldg. 
66, Rm. 3621, Silver Spring, MD 20993-0002.
    (ii) The request for reconsideration shall include three copies of 
the following records:
    (A) The accreditation body's original denial of accreditation.
    (B) All information the facility submitted to the accreditation body 
as part of the appeals process;
    (C) A copy of the accreditation body's adverse appeals decision; and
    (D) A statement of the basis for the facility's disagreement with 
the accreditation body's decision.
    (iii) DMQRP will conduct its reconsideration in accordance with the 
procedures set forth in subpart B of 42 CFR part 498.
    (4) A facility that is dissatisfied with DMQRP's decision following 
reconsideration is entitled to a formal hearing in accordance with 
procedures set forth in subpart D of 42 CFR part 498.
    (5) Either the facility or FDA may request review of the hearing 
officer's decision. Such review will be conducted by the Departmental 
Appeals Board in accordance with subpart E of 42 CFR part 498.
    (6) A facility cannot perform mammography services while an adverse 
accreditation decision is being appealed.

[62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 
75 FR 20916, Apr. 22, 2010; 85 FR 18443, Apr. 2, 2020]

    Effective Date Note: At 88 FR 15171, Mar. 10, 2023, Sec. 900.15 was 
amended by revising paragraph (d)(1), eff. Sept. 10, 2024. For the 
convenience of the user, the revised text is set forth as follows:



Sec. 900.15  Appeals of adverse accreditation or reaccreditation 
          decisions that preclude certification or recertification.

                                * * * * *

    (d) * * *
    (1) References to the Centers for Medicare and Medicaid Services in 
42 CFR part 498 should be read as the Division of Mammography Quality 
Standards (DMQS), Center for Devices and Radiological Health, Food and 
Drug Administration.

                                * * * * *

[[Page 854]]



Sec. 900.16  Appeals of denials of certification.

    (a) The appeals procedures described in this section are available 
only to facilities that are denied certification by FDA after they have 
been accredited by an approved accreditation body. Appeals for 
facilities that have failed to become accredited are governed by the 
procedures set forth in Sec. 900.15.
    (b) FDA may deny the application if the agency has reason to believe 
that:
    (1) The facility will not be operated in accordance with standards 
established under Sec. 900.12;
    (2) The facility will not permit inspections or provide access to 
records or information in a timely fashion; or
    (3) The facility has been guilty of misrepresentation in obtaining 
the accreditation.
    (c)(1) If FDA denies an application for certification by a faciity 
that has received accreditation from an approved accreditation body, FDA 
shall provide the facility with a statement of the grounds on which the 
denial is based.
    (2) A facility that has been denied accreditation may request 
reconsideration and appeal of FDA's determination in accordance with the 
applicable provisions of Sec. 900.15(d).



Sec. 900.17  [Reserved]



Sec. 900.18  Alternative requirements for Sec. 900.12 quality standards.

    (a) Criteria for approval of alternative standards. Upon application 
by a qualified party as defined in paragraph (b) of this section, FDA 
may approve an alternative to a quality standard under Sec. 900.12, 
when the agency determines that:
    (1) The proposed alternative standard will be at least as effective 
in assuring quality mammography as the standard it proposes to replace, 
and
    (2) The proposed alternative:
    (i) Is too limited in its applicability to justify an amendment to 
the standard; or
    (ii) Offers an expected benefit to human health that is so great 
that the time required for amending the standard would present an 
unjustifiable risk to the human health; and
    (3) The granting of the alternative is in keeping with the purposes 
of 42 U.S.C. 263b.
    (b) Applicants for alternatives. (1) Mammography facilities and 
accreditation bodies may apply for alternatives to the quality standards 
of Sec. 900.12.
    (2) Federal agencies and State governments that are not 
accreditation bodies may apply for alternatives to the standards of 
Sec. 900.12(a).
    (3) Manufacturers and assemblers of equipment used for mammography 
may apply for alternatives to the standards of Sec. 900.12(b) and (e).
    (c) Applications for approval of an alternative standard. An 
application for approval of an alternative standard or for an amendment 
or extension of the alternative standard shall be submitted in an 
original and two copies to the Food and Drug Administration, Center for 
Devices and Radiological Health, Director, Division of Mammography 
Quality Standards, 10903 New Hampshire Ave., Bldg. 66, Rm. 3621, Silver 
Spring, MD 20993-0002. The application for approval of an alternative 
standard shall include the following information:
    (1) Identification of the original standard for which the 
alternative standard is being proposed and an explanation of why the 
applicant is proposing the alternative;
    (2) A description of the manner in which the alternative is proposed 
to deviate from the original standard;
    (3) A description, supported by data, of the advantages to be 
derived from such deviation;
    (4) An explanation, supported by data, of how such a deviation would 
ensure equal or greater quality of production, processing, or 
interpretation of mammograms than the original standard;
    (5) The suggested period of time that the proposed alternative 
standard would be in effect; and
    (6) Such other information required by the Director to evaluate and 
act on the application.
    (d) Ruling on applications. (1) FDA may approve or deny, in whole or 
in part, a request for approval of an alternative standard or any 
amendment or extension thereof, and shall inform the applicant in 
writing of this action. The

[[Page 855]]

written notice shall state the manner in which the requested alternative 
standard differs from the agency standard and a summary of the reasons 
for approval or denial of the request. If the request is approved, the 
written notice shall also include the effective date and the termination 
date of the approval and a summary of the limitations and conditions 
attached to the approval and any other information that may be relevant 
to the approved request. Each approved alternative standard shall be 
assigned an identifying number.
    (2) Notice of an approved request for an alternative standard or any 
amendment or extension thereof shall be placed in the public docket file 
in the Division of Dockets Management and may also be in the form of a 
notice published in the Federal Register. The notice shall state the 
name of the applicant, a description of the published agency standard, 
and a description of the approved alternative standard, including 
limitations and conditions attached to the approval of the alternative 
standard.
    (3) Summaries of the approval of alternative standards, including 
information on their nature and number, shall be provided to the 
National Mammography Quality Assurance Advisory Committee.
    (4) All applications for approval of alternative standards and for 
amendments and extensions thereof and all correspondence (including 
written notices of approval) on these applications shall be available 
for public disclosure in the Division of Dockets Management, excluding 
patient identifiers and confidential commercial information.
    (e) Amendment or extension of an alternative standard. An 
application for amending or extending approval of an alternative 
standard shall include the following information:
    (1) The approval number and the expiration date of the alternative 
standard;
    (2) The amendment or extension requested and the basis for the 
amendment or extension; and
    (3) An explanation, supported by data, of how such an amendment or 
extension would ensure equal or greater quality of production, 
processing, or interpretation of mammograms than the original standard.
    (f) Applicability of the alternative standards. (1) Except as 
provided in paragraphs (f)(2) and (f)(3) of this section, any approval 
of an alternative standard, amendment, or extension may be implemented 
only by the entity to which it was granted and under the terms under 
which it was granted. Other entities interested in similar or identical 
approvals must file their own application following the procedures of 
paragraph (c) of this section.
    (2) When an alternative standard is approved for a manufacturer of 
equipment, any facility using that equipment will also be covered by the 
alternative standard.
    (3) The agency may extend the alternative standard to other entities 
when FDA determines that expansion of the approval of the alternative 
standard would be an effective means of promoting the acceptance of 
measures to improve the quality of mammography. All such determinations 
will be publicized by appropriate means.
    (g) Withdrawal of approval of alternative requirements. FDA shall 
amend or withdraw approval of an alternative standard whenever the 
agency determines that this action is necessary to protect the human 
health or otherwise is justified by Sec. 900.12. Such action will 
become effective on the date specified in the written notice of the 
action sent to the applicant, except that it will become effective 
immediately upon notification of the applicant when FDA determines that 
such action is necessary to prevent an imminent health hazard.

[62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 
75 FR 20916, Apr. 22, 2010; 85 FR 18444, Apr. 2, 2020]



                     Subpart C_States as Certifiers

    Source: 67 FR 5467, Feb. 6, 2002, unless otherwise noted.



Sec. 900.20  Scope.

    The regulations set forth in this part implement the Mammography 
Quality Standards Act (MQSA) (42 U.S.C. 263b). Subpart C of this part 
establishes procedures whereby a State can apply to become a FDA-
approved certification agency to certify facilities within the

[[Page 856]]

State to perform mammography services. Subpart C of this part further 
establishes requirements and standards for State certification agencies 
to ensure that all mammography facilities under their jurisdiction are 
adequately and consistently evaluated for compliance with quality 
standards at least as stringent as the national quality standards 
established by FDA.



Sec. 900.21  Application for approval as a certification agency.

    (a) Eligibility. State agencies may apply for approval as a 
certification agency if they have standards at least as stringent as 
those of Sec. 900.12, qualified personnel, adequate resources to carry 
out the States as Certifiers' responsibilities, and the authority to 
enter into a legal agreement with FDA to accept these responsibilities.
    (b) Application for approval. (1) An applicant seeking FDA approval 
as a certification agency shall inform the Food and Drug Administration, 
Center for Devices and Radiological Health, Director, Division of 
Mammography Quality Standards, Attn: Program Management Branch, 10903 
New Hampshire Ave., Bldg. 66, Rm. 3621, Silver Spring, MD 20993-0002, in 
writing, of its desire to be approved as a certification agency.
    (2) Following receipt of the written request, FDA will provide the 
applicant with additional information to aid in the submission of an 
application for approval as a certification agency.
    (3) The applicant shall furnish to FDA, at the address in paragraph 
(b)(1) of this section, three copies of an application containing the 
following information, materials, and supporting documentation:
    (i) Name, address, and phone number of the applicant;
    (ii) Detailed description of the mammography quality standards the 
applicant will require facilities to meet and, for those standards 
different from FDA's quality standards, information substantiating that 
they are at least as stringent as FDA standards under Sec. 900.12;
    (iii) Detailed description of the applicant's review and 
decisionmaking process for facility certification, including:
    (A) Policies and procedures for notifying facilities of certificate 
denials and expirations;
    (B) Procedures for monitoring and enforcement of the correction of 
deficiencies by facilities;
    (C) Policies and procedures for suspending or revoking a facility's 
certification;
    (D) Policies and procedures that will ensure processing certificates 
within a timeframe approved by FDA;
    (E) A description of the appeals process for facilities contesting 
adverse certification status decisions;
    (F) Education, experience, and training requirements of the 
applicant's professional and supervisory staff;
    (G) Description of the applicant's electronic data management and 
analysis system;
    (H) Fee schedules;
    (I) Statement of policies and procedures established to avoid 
conflict of interest;
    (J) Description of the applicant's mechanism for handling facility 
inquiries and complaints;
    (K) Description of a plan to ensure that certified mammography 
facilities will be inspected according to MQSA (42 U.S.C. 263b) and 
procedures and policies for notifying facilities of inspection 
deficiencies;
    (L) Policies and procedures for monitoring and enforcing the 
correction of facility deficiencies discovered during inspections or by 
other means;
    (M) Policies and procedures for additional mammography review and 
for requesting such reviews from accreditation bodies;
    (N) Policies and procedures for patient notification;
    (O) If a State has regulations that are more stringent than those of 
Sec. 900.12, an explanation of how adverse actions taken against a 
facility under the more stringent regulations will be distinguished from 
those taken under the requirements of Sec. 900.12; and
    (P) Any other information that FDA identifies as necessary to make a 
determination on the approval of the State as a certification agency.
    (c) Rulings on applications for approval. (1) FDA will conduct a 
review and evaluation to determine whether the applicant substantially 
meets the

[[Page 857]]

applicable requirements of this subpart and whether the certification 
standards the applicant will require facilities to meet are the quality 
standards published under subpart B of this part or at least as 
stringent as those of subpart B.
    (2) FDA will notify the applicant of any deficiencies in the 
application and request that those deficiencies be corrected within a 
specified time period. If the deficiencies are not corrected to FDA's 
satisfaction within the specified time period, FDA may deny the 
application for approval as a certification agency.
    (3) FDA shall notify the applicant whether the application has been 
approved or denied. The notification shall list any conditions 
associated with approval or state the bases for any denial.
    (4) The review of any application may include a meeting between FDA 
and representatives of the applicant at a time and location mutually 
acceptable to FDA and the applicant.
    (5) FDA will advise the applicant of the circumstances under which a 
denied application may be resubmitted.
    (d) Scope of authority. FDA may limit the scope of certification 
authority delegated to the State in accordance with MQSA.

[62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 
75 FR 20916, Apr. 22, 2010; 85 FR 18444, Apr. 2, 2020]



Sec. 900.22  Standards for certification agencies.

    The certification agency shall accept the following responsibilities 
in order to ensure quality mammography at the facilities it certifies 
and shall perform these responsibilities in a manner that ensures the 
integrity and impartiality of the certification agency's actions:
    (a) Conflict of interest. The certification agency shall establish 
and implement measures that FDA has approved in accordance with Sec. 
900.21(b) to reduce the possibility of conflict of interest or facility 
bias on the part of individuals acting on the certification agency's 
behalf.
    (b) Certification and inspection responsibilities. Mammography 
facilities shall be certified and inspected in accordance with statutory 
and regulatory requirements that are at least as stringent as those of 
MQSA and this part.
    (c) Compliance with quality standards. The scope, timeliness, 
disposition, and technical accuracy of completed inspections and related 
enforcement activities shall ensure compliance with facility quality 
standards required under Sec. 900.12.
    (d) Enforcement actions. (1) There shall be appropriate criteria and 
processes for the suspension and revocation of certificates.
    (2) There shall be prompt investigation of and appropriate 
enforcement action for facilities performing mammography without 
certificates.
    (e) Appeals. There shall be processes for facilities to appeal 
inspection findings, enforcement actions, and adverse certification 
decision or adverse accreditation decisions after exhausting appeals to 
the accreditation body.
    (f) Additional mammography review. There shall be a process for the 
certification agency to request additional mammography review from 
accreditation bodies for issues related to mammography image quality and 
clinical practice. The certification agency should request additional 
mammography review only when it believes that mammography quality at a 
facility has been compromised and may present a serious risk to human 
health.
    (g) Patient notification. There shall be processes for the 
certification agency to conduct, or cause to be conducted, patient 
notifications should the certification agency determine that mammography 
quality has been compromised to such an extent that it may present a 
serious risk to human health.
    (h) Electronic data transmission. There shall be processes to ensure 
the timeliness and accuracy of electronic transmission of inspection 
data and facility certification status information in a format and 
timeframe determined by FDA.
    (i) Changes to standards. A certification agency shall obtain FDA 
authorization for any changes it proposes to make in any standard that 
FDA has previously accepted under Sec. 900.21 before requiring 
facilities to comply with the changes as a condition of obtaining or 
maintaining certification.

[[Page 858]]



Sec. 900.23  Evaluation.

    FDA shall evaluate annually the performance of each certification 
agency. The evaluation shall include the use of performance indicators 
that address the adequacy of program performance in certification, 
inspection, and enforcement activities. FDA will also consider any 
additional information deemed relevant by FDA that has been provided by 
the certification body or other sources or has been required by FDA as 
part of its oversight mandate. The evaluation also shall include a 
review of any changes in the standards or procedures in the areas listed 
in Sec. Sec. 900.21(b) and 900.22 that have taken place since the 
original application or the last evaluation, whichever is most recent. 
The evaluation shall include a determination of whether there are major 
deficiencies in the certification agency's regulations or performance 
that, if not corrected, would warrant withdrawal of the approval of the 
certification agency under the provisions of Sec. 900.24, or minor 
deficiencies that would require corrective action.



Sec. 900.24  Withdrawal of approval.

    If FDA determines, through the evaluation activities of Sec. 
900.23, or through other means, that a certification agency is not in 
substantial compliance with this subpart, FDA may initiate the following 
actions:
    (a) Major deficiencies. If, after providing notice and opportunity 
for corrective action, FDA determines that a certification agency has 
demonstrated willful disregard for public health, has committed fraud, 
has failed to provide adequate resources for the program, has submitted 
material false statements to the agency, has failed to achieve the MQSA 
goals of quality mammography and access, or has performed or failed to 
perform a delegated function in a manner that may cause serious risk to 
human health, FDA may withdraw its approval of that certification 
agency. The certification agency shall notify, within a time period and 
in a manner approved by FDA, all facilities certified or seeking 
certification by it that it has been required to correct major 
deficiencies.
    (1) FDA shall notify the certification agency of FDA's action and 
the grounds on which the approval was withdrawn.
    (2) A certification agency that has lost its approval shall notify 
facilities certified or seeking certification by it, as well as the 
appropriate accreditation bodies with jurisdiction in the State, that 
its approval has been withdrawn. Such notification shall be made within 
a timeframe and in a manner approved by FDA.
    (b) Minor deficiencies. If FDA determines that a certification 
agency has demonstrated deficiencies in performing certification 
functions and responsibilities that are less serious or more limited 
than the deficiencies in paragraph (a) of this section, including 
failure to follow the certification agency's own procedures and policies 
as approved by FDA, FDA shall notify the certification agency that it 
has a specified period of time to take particular corrective measures as 
directed by FDA or to submit to FDA for approval the certification 
agency's own plan of corrective action addressing the minor 
deficiencies. If the approved corrective actions are not being 
implemented satisfactorily or within the established schedule, FDA may 
place the agency on probationary status for a period of time determined 
by FDA, or may withdraw approval of the certification agency.
    (1) If FDA places a certification agency on probationary status, the 
certification agency shall notify all facilities certified or seeking 
certification by it of its probationary status within a time period and 
in a manner approved by FDA.
    (2) Probationary status shall remain in effect until such time as 
the certification agency can demonstrate to the satisfaction of FDA that 
it has successfully implemented or is implementing the corrective action 
plan within the established schedule, and that the corrective actions 
have substantially eliminated all identified problems, or
    (3) If FDA determines that a certification agency that has been 
placed on probationary status is not implementing corrective actions 
satisfactorily or within the established schedule, FDA may withdraw 
approval of the certification agency. The certification

[[Page 859]]

agency shall notify all facilities certified or seeking certification by 
it, as well as the appropriate accreditation bodies with jurisdiction in 
the State, of its loss of FDA approval, within a timeframe and in a 
manner approved by FDA.
    (c) Transfer of records. A certification agency that has its 
approval withdrawn shall transfer facility records and other related 
information as required by FDA to a location and according to a schedule 
approved by FDA.



Sec. 900.25  Hearings and appeals.

    (a) Opportunities to challenge final adverse actions taken by FDA 
regarding approval of certification agencies or withdrawal of approval 
of certification agencies shall be communicated through notices of 
opportunity for informal hearings in accordance with part 16 of this 
chapter.
    (b) A facility that has been denied certification is entitled to an 
appeals process from the certification agency. The appeals process shall 
be specified in writing by the certification agency and shall have been 
approved by FDA in accordance with Sec. Sec. 900.21 and 900.22.

[[Page 860]]



                    SUBCHAPTER J_RADIOLOGICAL HEALTH





PART 1000_GENERAL--Table of Contents



                      Subpart A_General Provisions

Sec.
1000.1 General.
1000.3 Definitions.

            Subpart B_Statements of Policy and Interpretation

1000.15 Examples of electronic products subject to the Radiation Control 
          for Health and Safety Act of 1968.

    Authority: 21 U.S.C. 360hh-360ss.

    Source: 38 FR 28624, Oct. 15, 1973, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 1000.1  General.

    References in this subchapter J to regulatory sections of the Code 
of Federal Regulations are to chapter I of title 21 unless otherwise 
noted.

[50 FR 33688, Aug. 20, 1985]



Sec. 1000.3  Definitions.

    As used in this subchapter J:
    (a) Accidental radiation occurrence means a single accidental event 
or series of accidental events that has/have resulted in injurious or 
potentially injurious exposure of any person to electronic product 
radiation as a result of the manufacturing, testing, or use of an 
electronic product.
    (b) Act means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360hh-360ss).
    (c) Chassis family means a group of one or more models with all of 
the following common characteristics:
    (1) The same circuitry in the high voltage, horizontal oscillator, 
and power supply sections;
    (2) The same worst component failures;
    (3) The same type of high voltage hold-down or safety circuits; and
    (4) The same design and installation.
    (d) Commerce means:
    (1) Commerce between any place in any State and any place outside 
thereof, and
    (2) Commerce wholly within the District of Columbia.
    (e) Component, for the purposes of this part, means an essential 
functional part of a subassembly or of an assembled electronic product, 
and which may affect the quantity, quality, direction, or radiation 
emission of the finished product.
    (f) Dealer means a person engaged in the business of offering 
electronic products for sale to purchasers, without regard to whether 
such person is or has been primarily engaged in such business, and 
includes persons who offer such products for lease or as prizes or 
awards.
    (g) Director means the Director of the Center for Devices and 
Radiological Health.
    (h) Distributor means a person engaged in the business of offering 
electronic products for sale to dealers, without regard to whether such 
person is or has been primarily or customarily engaged in such business.
    (i) Electromagnetic radiation includes the entire electromagnetic 
spectrum of radiation of any wavelength. The electromagnetic spectrum 
illustrated in figure 1 includes, but is not limited to, gamma rays, x-
rays, ultra-violet, visible, infrared, microwave, radiowave, and low 
frequency radiation.

[[Page 861]]

[GRAPHIC] [TIFF OMITTED] TR01FE93.029

    (j) Electronic product means:
    (1) Any manufactured or assembled product which, when in operation:
    (i) Contains or acts as part of an electronic circuit and
    (ii) Emits (or in the absence of effective shielding or other 
controls would emit) electronic product radiation, or
    (2) Any manufactured or assembled article that is intended for use 
as a component, part, or accessory of a product described in paragraph 
(j)(1) of this section and which, when in operation, emits (or in the 
absence of effective shielding or other controls would emit) such 
radiation.
    (k) Electronic product radiation means:
    (1) Any ionizing or nonionizing electromagnetic or particulate 
radiation, or
    (2) Any sonic, infrasonic, or ultrasonic wave that is emitted from 
an electronic product as the result of the operation of an electronic 
circuit in such product.
    (l) Federal standard means a performance standard issued pursuant to 
section 534 of the Federal Food, Drug, and Cosmetic Act.
    (m) Infrasonic, sonic (or audible) and ultrasonic waves refer to 
energy transmitted as an alteration (pressure, particle displacement or 
density) in a property of an elastic medium (gas, liquid or solid) that 
can be detected by an instrument or listener.
    (n) Manufacturer means any person engaged in the business of 
manufacturing, assembling, or importing electronic products.
    (o) Model means any identifiable, unique electronic product design, 
and refers to products having the same structural and electrical design 
characteristics and to which the manufacturer has assigned a specific 
designation to differentiate between it and other products produced by 
that manufacturer.
    (p) Model family means products having similar design and radiation 
characteristics but different manufacturer model numbers.

[[Page 862]]

    (q) Modified model means a product that is redesigned so that actual 
or potential radiation emission, the manner of compliance with a 
standard, or the manner of radiation safety testing is affected.
    (r) Particulate radiation is defined as:
    (1) Charged particles, such as protons, electrons, alpha particles, 
or heavy particles, which have sufficient kinetic energy to produce 
ionization or atomic or electron excitation by collision, electrical 
attractions or electrical repulsion; or
    (2) Uncharged particles, such as neutrons, which can initiate a 
nuclear transformation or liberate charged particles having sufficient 
kinetic energy to produce ionization or atomic or electron excitation.
    (s) Purchaser means the first person who, for value, or as an award 
or prize, acquires an electronic product for purposes other than resale, 
and includes a person who leases an electronic product for purposes 
other than subleasing.
    (t) State means a State, the District of Columbia, the Commonwealth 
of Puerto Rico, the Virgin Islands, Guam, and American Samoa.

[60 FR 48380, Sept. 19, 1995; 61 FR 13422, Mar. 27, 1996, as amended at 
88 FR 3652, Jan. 20, 2023]



            Subpart B_Statements of Policy and Interpretation



Sec. 1000.15  Examples of electronic products subject to the 
Radiation Control for Health and Safety Act of 1968.

    The following listed electronic products are intended to serve as 
illustrative examples of sources of electronic product radiation to 
which the regulations of this part apply.
    (a) Examples of electronic products which may emit x-rays and other 
ionizing electromagnetic radiation, electrons, neutrons, and other 
particulate radiation include:

Ionizing electromagnetic radiation:
    Television receivers.
    Accelerators.
    X-ray machines (industrial, medical, research, educational).
Particulate radiation and ionizing electromagnetic radiation:
    Electron microscopes.
    Neutron generators.

    (b) Examples of electronic products which may emit ultraviolet, 
visible, infrared, microwaves, radio and low frequency electromagnetic 
radiation include:

Ultraviolet:
    Biochemical and medical analyzers.
    Tanning and therapeutic lamps.
    Sanitizing and sterilizing devices.
    Black light sources.
    Welding equipment.
Visible:
    White light devices.
Infrared:
    Alarm systems.
    Diathermy units.
    Dryers, ovens, and heaters.
Microwave:
    Alarm systems.
    Diathermy units.
    Dryers, ovens, and heaters.
    Medico-biological heaters.
    Microwave power generating devices.
    Radar devices.
    Remote control devices.
    Signal generators.
Radio and low frequency:
    Cauterizers.
    Diathermy units.
    Power generation and transmission equipment.
    Signal generators.
    Electromedical equipment.

    (c) Examples of electronic products which may emit coherent 
electromagnetic radiation produced by stimulated emission include:

Laser:
    Art-form, experimental and educational devices.
    Biomedical analyzers.
    Cauterizing, burning and welding devices.
    Cutting and drilling devices.
    Communications transmitters.
    Rangefinding devices.
Maser:
    Communications transmitters.

    (d) Examples of electronic products which may emit infrasonic, 
sonic, and ultrasonic vibrations resulting from operation of an 
electronic circuit include:

Infrasonic:
    Vibrators.
Sonic:
    Electronic oscillators.
    Sound amplification equipment.
Ultrasonic:
    Cauterizers.
    Cell and tissue disintegrators.
    Cleaners.

[[Page 863]]

    Diagnostic and nondestructive testing equipment.
    Ranging and detection equipment.



PART 1002_RECORDS AND REPORTS--Table of Contents



                      Subpart A_General Provisions

Sec.
1002.1 Applicability.
1002.2 [Reserved]
1002.3 Notification to user of performance and technical data.
1002.4 Confidentiality of information.
1002.7 Submission of data and reports.

Subpart B_Required Manufacturers' Reports for Listed Electronic Products

1002.10 Product reports.
1002.11 Supplemental reports.
1002.12 Abbreviated reports.
1002.13 Annual reports.

  Subpart C_Manufacturers' Reports on Accidental Radiation Occurrences

1002.20 Reporting of accidental radiation occurrences.

                    Subpart D_Manufacturers' Records

1002.30 Records to be maintained by manufacturers.
1002.31 Preservation and inspection of records.

                Subpart E_Dealer and Distributor Records

1002.40 Records to be obtained by dealers and distributors.
1002.41 Disposition of records obtained by dealers and distributors.
1002.42 Confidentiality of records furnished by dealers and 
          distributors.

       Subpart F_Exemptions From Records and Reports Requirements

1002.50 Special exemptions.
1002.51 Exemptions for manufacturers of products intended for the U.S. 
          Government.

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 360hh-360ss, 371, 374.

    Source: 38 FR 28625, Oct. 15, 1973, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 1002.1  Applicability.

    The provisions of this part are applicable as follows:
    (a) All manufacturers of electronic products are subject to Sec. 
1002.20.
    (b) Manufacturers, dealers, and distributors of electronic products 
are subject to the provisions of part 1002 as set forth in table 1 of 
this section, unless excluded by paragraph (c) of this section, or 
unless an exemption has been granted under Sec. 1002.50 or Sec. 
1002.51.
    (c) The requirements of part 1002 as specified in table 1 of this 
section are not applicable to:
    (1) Manufacturers of electronic products intended solely for export 
if such product is labeled or tagged to show that the product meets all 
the applicable requirements of the country to which such product is 
intended for export.
    (2) Manufacturers of electronic products listed in table 1 of this 
section if such product is sold exclusively to other manufacturers for 
use as components of electronic products to be sold to purchasers, with 
the exception that the provisions are applicable to those manufacturers 
certifying components of diagnostic x-ray systems pursuant to provisions 
of Sec. 1020.30(c) of this chapter.
    (3) Manufacturers of electronic products that are intended for use 
by the U.S. Government and whose function or design cannot be divulged 
by the manufacturer for reasons of national security, as evidenced by 
government security classification.
    (4) Assemblers of diagnostic x-ray equipment subject to the 
provisions of Sec. 1020.30(d) of this chapter, provided the assembler 
has submitted the report required by Sec. 1020.30(d)(1) or (d)(2) of 
this chapter and retains a copy of such report for a period of 5 years 
from its date.

[[Page 864]]



                                         Table 1 to Sec. 1002.1--Record and Reporting Requirements by Product
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Manufacturer                                                                   Dealer &
----------------------------------------------------------------------------------------------------------------------------------------   distributor
                                                                                                                                        ----------------
                                                     Product   Supplemental    Abbreviated                        Test     Distribution    Distribution
                     Products                        reports      reports        reports      Annual  reports    records      records        records
                                                     1002.10      1002.11        1002.12           1002.13     1002.30(a)   1002.30(b)     1002.40 and
                                                                                                                   \1\          \2\          1002.41
--------------------------------------------------------------------------------------------------------------------------------------------------------
DIAGNOSTIC X-RAY \3\ (1020.30, 1020.31, 1020.32,
 1020.33):
  Computed tomography............................  ..........  ............  ...............  ...............          X             X                X
  X-ray system \4\...............................  ..........  ............  ...............  ...............          X             X                X
  Tube housing assembly..........................  ..........  ............  ...............  ...............          X             X
  X-ray control..................................  ..........  ............  ...............  ...............          X             X                X
  X-ray high voltage generator...................  ..........  ............  ...............  ...............          X             X                X
  X-ray table or cradle..........................  ..........  ............  ...............  ...............          X             X                X
  X-ray film changer.............................  ..........  ............  ...............  ...............          X             X
  Vertical cassette holders mounted in a fixed     ..........  ............  ...............  ...............          X             X                X
   location and cassette holders with front
   panels........................................
  Beam-limiting devices..........................  ..........  ............  ...............  ...............          X             X                X
  Spot-film devices and image intensifiers         ..........  ............  ...............  ...............          X             X                X
   manufactured after April 26, 1977.............
  Cephalometric devices manufactured after         ..........  ............  ...............  ...............          X             X
   February 25, 1978.............................
  Image receptor support devices for mammographic  ..........  ............  ...............  ...............          X             X                X
   X-ray systems manufactured after September 5,
   1978..........................................
CABINET X RAY (1020.40):
  Baggage inspection.............................          X            X    ...............               X           X             X                X
  Other..........................................          X            X    ...............               X           X             X
PRODUCTS INTENDED TO PRODUCE PARTICULATE
 RADIATION OR X-RAYS OTHER THAN DIAGNOSTIC OR
 CABINET X-RAY:
  Medical........................................  ..........  ............  ...............  ...............          X             X
  Analytical.....................................  ..........  ............               X                X           X             X
  Industrial.....................................  ..........  ............               X                X           X             X
TELEVISION PRODUCTS (1020.10):
  <0.1 milliroentgen per hour (mR/hr) IRLC \5\...  ..........  ............           X \8\            X \6\   ..........
  =0.1mR/hr IRLC \5\..................      X \8\   ............  ...............               X           X             X
MICROWAVE/RF:
  MW ovens (1030.10).............................      X \8\   ............  ...............               X           X             X
  MW diathermy...................................  ..........  ............               X   ...............  ..........

[[Page 865]]

 
  MW heating, drying, security systems...........  ..........  ............               X   ...............  ..........
  RF sealers, electromagnetic induction and        ..........  ............               X   ...............  ..........
   heating equipment, dielectric heaters (2-500
   megahertz)....................................
OPTICAL:
  Laser products (1040.10, 1040.11)..............  ..........  ............  ...............  ...............  ..........
  Class I lasers and products containing such          X \8\   ............  ...............               X           X
   lasers \7 9\..................................
  Class I laser products containing class IIa,             X   ............  ...............               X           X             X
   II, IIIa, lasers \7 9\........................
  Class IIa, II, IIIa lasers and products other            X   ............  ...............               X           X             X                X
   than class I products containing such lasers
   \7 9\.........................................
  Class IIIb and IV lasers and products                    X            X    ...............               X           X             X                X
   containing such lasers \7\....................
SUNLAMP PRODUCTS (1040.20):
  Lamps only.....................................          X   ............  ...............  ...............  ..........
  Sunlamp products...............................          X            X    ...............               X           X             X                X
  Mercury vapor lamps (1040.30)..................  ..........  ............  ...............  ...............  ..........
  R lamps and T lamps............................  ..........  ............               X   ...............  ..........  ............
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ However, authority to inspect all appropriate documents supporting the adequacy of a manufacturer's compliance testing program is retained.
\2\ The requirement includes Sec. Sec. 1002.31 and 1002.42, if applicable.
\3\ Report of Assembly (Form FDA 2579) is required for diagnostic x-ray components; see Sec. 1020.30(d)(1)-(3) of this chapter.
\4\ Systems records and reports are required if a manufacturer exercises the option and certifies the system as permitted in Sec. 1020.30(c) of this
  chapter.
\5\ Determined using the isoexposure rate limit curve (IRLC) under phase III test conditions (Sec. 1020.10(c)(3)(iii)) of this chapter.
\6\ Annual report is for production status information only.
\7\ Determination of the applicable reporting category for a laser product shall be based on the worst-case hazard present within the laser product.
\8\ Manufacturers are exempt from product reports (Sec. 1002.10) and abbreviated reports (Sec. 1002.12), except the first product or abbreviated
  report for each category of: television products; microwave ovens; and products that are Class I laser under any condition of operation, maintenance,
  service, or failure (e.g., Class I optical disc products, laser printers).
\9\ Manufacturers that incorporate a certified laser system meeting the conditions of 21 CFR 1010.2(e) are considered distributors of the certified
  laser and only subject to the applicable distribution recordkeeping requirements under Sec. Sec. 1002.40 and 1002.41 for the certified products.


[[Page 866]]


[60 FR 48382, Sept. 19, 1995; 61 FR 13423, Mar. 27, 1996, as amended at 
88 FR 3652, Jan. 20, 2023]



Sec. 1002.2  [Reserved]



Sec. 1002.3  Notification to user of performance and technical data.

    The Director and Deputy Director of the Center for Devices and 
Radiological Health, as authorized under delegated authority, may 
require a manufacturer of a radiation emitting electronic product to 
provide to the ultimate purchaser, at the time of original purchase, 
such performance data and other technical data related to safety of the 
product as the Director or Deputy Director finds necessary.

[69 FR 17292, Apr. 2, 2004]



Sec. 1002.4  Confidentiality of information.

    The Secretary or his representative shall not disclose any 
information reported to or otherwise obtained by him, pursuant to this 
part, which concerns or relates to a trade secret or other matter 
referred to in section 1905 of title 18 of the United States Code, 
except that such information may be disclosed to other officers or 
employees of the Department and of the other agencies concerned with 
carrying out the requirements of the Act. Nothing in this section shall 
authorize the withholding of information by the Secretary, or by any 
officers or employees under his control, from the duly authorized 
committees of the Congress.



Sec. 1002.7  Submission of data and reports.

    All submissions such as reports, test data, product descriptions, 
and other information required by this part, or voluntarily submitted to 
the Director, Center for Devices and Radiological Health, shall be filed 
with the number of copies as prescribed by the Director, Center for 
Devices and Radiological Health, and shall be signed by the person 
making the submission. The submissions required by this part shall be 
addressed to the Food and Drug Administration, Center for Devices and 
Radiological Health, ATTN: Electronic Product Reports, Document Mail 
Center, 10903 New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 
20993-0002.
    (a) In addition to the requirements of this part, all material 
submitted to the Director, Center for Devices and Radiological Health, 
shall be submitted pursuant to the provisions of part 20--Public 
Information, of this chapter.
    (b) Where guides or instructions have been issued by the Director 
for the submission of material required by this part, such as test data, 
product reports, abbreviated reports, supplemental reports, and annual 
reports, the material submitted shall conform to the applicable 
reporting guides or instructions. Where it is not feasible or where it 
would not be appropriate to conform to any portion of a prescribed 
reporting guide or instruction, an alternate format for providing the 
information requested by that portion of the guide or instruction may be 
used provided the submitter of such information submits adequate 
explanation and justification for use of an alternate format. If the 
Director, Center for Devices and Radiological Health, determines that 
such justification is inadequate and that it is feasible or appropriate 
to conform to the prescribed reporting guide or instruction, he may 
require resubmission of the information in conformance with the 
reporting guide or instruction.
    (c) Where the submission of quality control and testing information 
is common to more than one model, or model family of the same product 
category, a ``common aspects report'' consolidating similar information 
may be provided, if applicable.

[42 FR 18062, Apr. 5, 1977, as amended at 53 FR 11254, Apr. 6, 1988; 60 
FR 48385, Sept. 19, 1995; 72 FR 17400, Apr. 9, 2007; 75 FR 20916, Apr. 
22, 2010]



Subpart B_Required Manufacturers' Reports for Listed Electronic Products

    Source: 60 FR 48386, Sept. 19, 1995, unless otherwise noted.



Sec. 1002.10  Product reports.

    Every manufacturer of a product or component requiring a product 
report as set forth in table 1 of Sec. 1002.1 shall submit a product 
report to the Food

[[Page 867]]

and Drug Administration, Center for Devices and Radiological Health, 
ATTN: Electronic Product Reports, Document Mail Center, 10903 New 
Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993-0002, prior 
to the introduction of such product into commerce. The report shall be 
distinctly marked ``Radiation Safety Product Report of (name of 
manufacturer)'' and shall:
    (a) Identify which listed product is being reported.
    (b) Identify each model of the listed product together with 
sufficient information concerning the manufacturer's code or other 
system of labeling to enable the Director to determine the place of 
manufacture.
    (c) Include information on all components and accessories provided 
in, on, or with the listed product that may affect the quantity, 
quality, or direction of the radiation emissions.
    (d) Describe the function, operational characteristics affecting 
radiation emissions, and intended and known uses of each model of the 
listed product.
    (e) State the standard or design specifications, if any, for each 
model with respect to electronic product radiation safety. Reference may 
be made to a Federal standard, if applicable.
    (f) For each model, describe the physical or electrical 
characteristics, such as shielding or electronic circuitry, incorporated 
into the product in order to meet the standards or specifications 
reported pursuant to paragraph (e) of this section.
    (g) Describe the methods and procedures employed, if any, in testing 
and measuring each model with respect to electronic product radiation 
safety, including the control of unnecessary, secondary, or leakage 
electronic product radiation, the applicable quality control procedures 
used for each model, and the basis for selecting such testing and 
quality control procedures.
    (h) For those products which may produce increased radiation with 
aging, describe the methods and procedures used, and frequency of 
testing of each model for durability and stability with respect to 
electronic product radiation safety. Include the basis for selecting 
such methods and procedures, or for determining that such testing and 
quality control procedures are not necessary.
    (i) Provide sufficient results of the testing, measuring, and 
quality control procedures described in accordance with paragraphs (g) 
and (h) of this section to enable the Director to determine the 
effectiveness of those test methods and procedures.
    (j) Report for each model all warning signs, labels, and 
instructions for installation, operation, and use that relate to 
electronic product radiation safety.
    (k) Provide, upon request, such other information as the Director 
may reasonably require to enable him/her to determine whether the 
manufacturer has acted or is acting in compliance with the Act and any 
standards prescribed thereunder, and to enable the Director to carry out 
the purposes of the Act.

[60 FR 48386, Sept. 19, 1995, as amended at 72 FR 17400, Apr. 9, 2007; 
75 FR 20916, Apr. 22, 2010]



Sec. 1002.11  Supplemental reports.

    Prior to the introduction into commerce of a new or modified model 
within a model or chassis family of a product listed in table 1 of Sec. 
1002.1 for which a report under Sec. 1002.10 is required, each 
manufacturer shall submit a report with respect to such new or modified 
model describing any changes in the information previously submitted in 
the product report. Reports will be required for changes that:
    (a) Affect actual or potential radiation emission.
    (b) Affect the manner of compliance with a standard or manner of 
testing for radiation safety.



Sec. 1002.12  Abbreviated reports.

    Manufacturers of products requiring abbreviated reports as specified 
in table 1 of Sec. 1002.1 shall submit, prior to the introduction of 
such product, a report distinctly marked ``Radiation Safety Abbreviated 
Report'' which shall include:
    (a) Firm and model identification.
    (b) A brief description of operational characteristics that affect 
radiation emissions, transmission, or leakage or that control exposure.

[[Page 868]]

    (c) A list of applications or uses.
    (d) Radiation emission, transmission, or leakage levels.
    (e) If necessary, additional information as may be requested to 
determine compliance with the Act and this part.



Sec. 1002.13  Annual reports.

    (a) Every manufacturer of products requiring an annual report as 
specified in table 1 of Sec. 1002.1 shall submit an annual report 
summarizing the contents of the records required to be maintained by 
Sec. 1002.30(a) and providing the volume of products produced, sold, or 
installed.
    (b) Reports are due annually by September 1. Such reports shall 
cover the 12-month period ending on June 30 preceding the due date of 
the report.

[60 FR 48386, Sept. 19, 1995, as amended at 88 FR 3653, Jan. 20, 2023]



  Subpart C_Manufacturers' Reports on Accidental Radiation Occurrences



Sec. 1002.20  Reporting of accidental radiation occurrences.

    (a) Manufacturers of electronic products shall, where reasonable 
grounds for suspecting that such an incident has occurred, report to the 
Director, Center for Devices and Radiological Health, all accidental 
radiation occurrences reported to or otherwise known to the manufacturer 
and arising from the manufacturing, testing, or use of any product 
introduced or intended to be introduced into commerce by such 
manufacturer. Reasonable grounds include, but are not necessarily 
limited to, professional, scientific, or medical facts or opinions 
documented or otherwise, that conclude or lead to the conclusion that 
such an incident has occurred.
    (b) Such reports shall be submitted either electronically through 
Center for Devices and Radiological Health eSubmitter or addressed to 
the Food and Drug Administration, Center for Devices and Radiological 
Health, ATTN: Accidental Radiation Occurrence Reports, Document Mail 
Center, 10903 New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 
20993-0002, and the reports and their envelopes shall be distinctly 
marked ``Report on 1002.20'' and shall contain all of the following 
information where known to the manufacturer:
    (1) The nature of the accidental radiation occurrence;
    (2) The location at which the accidental radiation occurrence 
occurred;
    (3) The manufacturer, type, and model number of the electronic 
product or products involved;
    (4) The circumstances surrounding the accidental radiation 
occurrence, including causes;
    (5) The number of persons involved, adversely affected, or exposed 
during the accidental radiation occurrence, the nature and magnitude of 
their exposure and/or injuries and, if requested by the Director, Center 
for Devices and Radiological Health, the names of the persons involved;
    (6) The actions, if any, which may have been taken by the 
manufacturer, to control, correct, or eliminate the causes and to 
prevent reoccurrence; and
    (7) Any other pertinent information with respect to the accidental 
radiation occurrence.
    (c) If a manufacturer:
    (1) Is required to report to the Director under paragraph (a) of 
this section and also is required to report under part 803 of this 
chapter, the manufacturer shall report in accordance with part 803; or
    (2) Is required to report to the Director under paragraph (a) of 
this section and is not required to report under part 803 of this 
chapter, the manufacturer shall:
    (i) Immediately report incidents associated with a death or serious 
injury in accordance with paragraphs (a) and (b) of this section; and
    (ii) Either immediately report incidents not associated with a death 
or serious injury individually or compile such incidents for submission 
in a quarterly summary report with tracking and trending analysis of 
that data in accordance with paragraphs (a) and (b) of this section. The 
quarterly report must cover information required under paragraphs (b)(1) 
through (7) of this section for each occurrence were known to the 
manufacturer. Occurrences may be grouped to identify the

[[Page 869]]

most common circumstances and potential cause(s), including but not 
limited to, design changes, manufacturing, or user. Planned 
mitigation(s) with an assessment of effectiveness, or a justification 
for why mitigation is not necessary, must be associated with each 
occurrence or grouping of similar occurrences. A manufacturer need not 
file a separate report under this section if an incident involving an 
accidental radiation occurrence is associated with a defect or 
noncompliance and is reported pursuant to Sec. 1003.10 of this chapter.

[88 FR 3653, Jan. 20, 2023]



                    Subpart D_Manufacturers' Records



Sec. 1002.30  Records to be maintained by manufacturers.

    (a) Manufacturers of products listed under table 1 of Sec. 1002.1 
shall establish and maintain the following records with respect to such 
products:
    (1) Description of the quality control procedures with respect to 
electronic product radiation safety.
    (2) Records of the results of tests for electronic product radiation 
safety, including the control of unnecessary, secondary or leakage 
electronic product radiation, the methods, devices, and procedures used 
in such tests, and the basis for selecting such methods, devices, and 
procedures.
    (3) For those products displaying aging effects which may increase 
electronic product radiation emission, records of the results of tests 
for durability and stability of the product, and the basis for selecting 
these tests.
    (4) Copies of all written communications between the manufacturer 
and dealers, distributors, and purchasers concerning radiation safety 
including complaints, investigations, instructions, or explanations 
affecting the use, repair, adjustment, maintenance, or testing of the 
listed product.
    (5) Data on production and sales volume levels if available.
    (b) In addition to the records required by paragraph (a) of this 
section, manufacturers of products listed in table 1 of Sec. 1002.1 
shall establish and maintain the following records with respect to such 
products:
    (1) A record of the manufacturer's distribution of products in a 
form which will enable the tracing of specific products or production 
lots to distributors or to dealers in those instances in which the 
manufacturer distributes directly to dealers.
    (2) Records received from dealers or distributors pursuant to Sec. 
1002.41.

[38 FR 28625, Oct. 15, 1973, as amended at 60 FR 48386, Sept. 19, 1995; 
75 FR 16352, Apr. 1, 2010]



Sec. 1002.31  Preservation and inspection of records.

    (a) Every manufacturer required to maintain records pursuant to this 
part, including records received pursuant to Sec. 1002.41, shall 
preserve such records for a period of 5 years from the date of the 
record.
    (b) Upon reasonable notice by an officer or employee duly designated 
by the Department, manufacturers shall permit such officer or employee 
to inspect appropriate books, records, papers, and documents as are 
relevant to determining whether the manufacturer has acted or is acting 
in compliance with Federal standards.
    (c) Upon request of the Director, Center for Devices and 
Radiological Health, a manufacturer of products listed in table 1 of 
Sec. 1002.1 shall submit to the Director, copies of the records 
required to be maintained by paragraph (b) of Sec. 1002.30.

[38 FR 28625, Oct. 15, 1973, as amended at 53 FR 11254, Apr. 6, 1988; 60 
FR 48386, Sept. 19, 1995]



                Subpart E_Dealer and Distributor Records



Sec. 1002.40  Records to be obtained by dealers and distributors.

    (a) Dealers and distributors of electronic products for which there 
are performance standards and for which the retail price is $50 or more 
shall obtain such information as is necessary to identify and locate 
first purchasers if the product is subject to this section by virtue of 
table 1 of Sec. 1002.1.
    (b) Such information shall include:

[[Page 870]]

    (1) The name and mailing address of the distributor, dealer, or 
purchaser to whom the product was transferred.
    (2) Identification and brand name of the product.
    (3) Model number and serial or other identification number of the 
product.
    (4) Date of sale, award, or lease.
    (c) The information obtained pursuant to this section shall be 
forwarded immediately to the appropriate manufacturer of the electronic 
product, or preserved as prescribed in Sec. 1002.41.

[38 FR 28625, Oct. 15, 1973, as amended at 42 FR 18063, Apr. 5, 1977; 60 
FR 48386, Sept. 19, 1995]



Sec. 1002.41  Disposition of records obtained by dealers and distributors.

    (a) Information obtained by dealers and distributors pursuant to 
Sec. 1002.40 shall immediately be forwarded to the appropriate 
manufacturer unless:
    (1) The dealer or distributor elects to hold and preserve such 
information and to immediately furnish it to the manufacturer when 
advised by the manufacturer or the Director, Center for Devices and 
Radiological Health, that such information is required for purposes of 
section 535 of the Act; and
    (2) The dealer or distributor, upon making the election under 
paragraph (a)(1) of this section, promptly notifies the manufacturer of 
such election; such notification shall be in writing and shall identify 
the dealer or distributor and the electronic product or products for 
which the information is being accumulated and preserved.
    (b) Every dealer or distributor who elects to hold and preserve 
information required pursuant to Sec. 1002.40 shall preserve the 
information for a period of 5 years from the date of the sale, award, or 
lease of the product, or until the dealer or distributor discontinues 
dealing in, or distributing the product, whichever is sooner. If the 
dealer or distributor discontinues dealing in, or distributing the 
product, such information as obtained pursuant to Sec. 1002.40 shall be 
furnished at that time, or before, to the manufacturer of the product.

[38 FR 28625, Oct. 15, 1973, as amended at 42 FR 18063, Apr. 5, 1977; 53 
FR 11254, Apr. 6, 1988; 75 FR 16352, Apr. 1, 2010]



Sec. 1002.42  Confidentiality of records furnished by dealers and distributors.

    All information furnished to manufacturers by dealers and 
distributors pursuant to this part shall be treated by such 
manufacturers as confidential information which may be used only as 
necessary to notify persons pursuant to section 535 of the Act.

[75 FR 16353, Apr. 1, 2010]



       Subpart F_Exemptions From Records and Reports Requirements



Sec. 1002.50  Special exemptions.

    (a) Manufacturers of electronic products may submit to the Director 
a request, together with accompanying justification, for exemption from 
any requirements listed in table 1 of Sec. 1002.1. The request must 
specify each requirement from which an exemption is requested. In 
addition to other information that is required, the justification must 
contain documented evidence showing that the product or product type for 
which the exemption is requested does not pose a public health risk and 
meets at least one of the following criteria:
    (1) The products cannot emit electronic product radiation in 
sufficient intensity or of such quality, under any conditions of 
operation, maintenance, service, or product failure, to be hazardous;
    (2) The products are produced in small quantities;
    (3) The products are used by trained individuals and are to be used 
by the same manufacturing corporation or for research, investigation, or 
training.
    (4) The products are custom designed and used by trained individuals 
knowledgeable of the hazards; or
    (5) The products are produced in such a way that the requirements 
are inappropriate or unnecessary.
    (b) The Director may, subject to any conditions that the Director 
deems necessary to protect the public health, exempt manufacturers from 
all or part of the record and reporting requirements of this part on the 
basis of information submitted in accordance with paragraph (a) of this 
section or such

[[Page 871]]

other information which the Director may possess if the Director 
determines that such exemption is in keeping with the purposes of the 
Act.
    (c) The Director will provide written notification of the reason for 
any denial. If the exemption is granted, the Director will provide 
written notification of:
    (1) The electronic product or products for which the exemption has 
been granted;
    (2) The requirements from which the product is exempted; and
    (3) Such conditions as are deemed necessary to protect the public 
health and safety. Copies of exemptions shall be available upon request 
from the Food and Drug Administration, Center for Devices and 
Radiological Health, Division of Mammography Quality Standards, 10903 
New Hampshire Ave., Bldg. 66, Rm. 3621, Silver Spring, MD 20993-0002.
    (d) The Director may, on the Director's own motion, exempt certain 
classes of products from the reporting requirements listed in table 1 of 
Sec. 1002.1, provided that the Director finds that such exemption is in 
keeping with the purposes of the act.
    (e) Manufacturers of products for which there is no applicable 
performance standard under parts 1020 through 1050 of this chapter and 
for which an investigational device exemption has been approved under 
Sec. 812.30 of this chapter or for which a premarket approval 
application has been approved in accordance with Sec. 814.44(d) of this 
chapter are exempt from submitting all reports listed in table 1 of 
Sec. 1002.1.

[60 FR 48387, Sept. 19, 1995, as amended at 72 FR 17401, Apr. 9, 2007; 
75 FR 20916, Apr. 22, 2010; 85 FR 18444, Apr. 2, 2020]



Sec. 1002.51  Exemptions for manufacturers of products intended 
for the U.S. Government.

    Upon application therefor by the manufacturer, the Director, Center 
for Devices and Radiological Health, may exempt from the provisions of 
this part a manufacturer of any electronic product intended for use by 
departments or agencies of the United States provided such department or 
agency has prescribed procurement specifications governing emissions of 
electronic product radiation and provided further that such product is 
of a type used solely or predominantly by departments or agencies of the 
United States.

[38 FR 28625, Oct. 15, 1973, as amended at 53 FR 11254, Apr. 6, 1988]



PART 1003_NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY--Table of Contents



                      Subpart A_General Provisions

Sec.
1003.1 Applicability.
1003.2 Defect in an electronic product.
1003.5 Effect of regulations on other laws.

           Subpart B_Discovery of Defect or Failure To Comply

1003.10 Discovery of defect or failure of compliance by manufacturer; 
          notice requirements.
1003.11 Determination by Secretary that product fails to comply or has a 
          defect.

                         Subpart C_Notification

1003.20 Notification by the manufacturer to the Secretary.
1003.21 Notification by the manufacturer to affected persons.
1003.22 Copies of communications sent to purchasers, dealers, or 
          distributors.

           Subpart D_Exemptions from Notification Requirements

1003.30 Application for exemption from notification requirements.
1003.31 Granting the exemption.

    Authority: 21 U.S.C. 360hh-360ss.

    Source: 38 FR 28628, Oct. 15, 1973, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 1003.1  Applicability.

    The provisions of this part are applicable to electronic products 
which were manufactured after October 18, 1968.



Sec. 1003.2  Defect in an electronic product.

    For the purpose of this part, an electronic product shall be 
considered to have a defect which relates to the safety of use by reason 
of the emission of electronic product radiation if:
    (a) It is a product which does not utilize the emission of 
electronic product radiation in order to accomplish its

[[Page 872]]

purpose, and from which such emissions are unintended, and as a result 
of its design, production or assembly;
    (1) It emits electronic product radiation which creates a risk of 
injury, including genetic injury, to any person, or
    (2) It fails to conform to its design specifications relating to 
electronic radiation emissions; or
    (b) It is a product which utilizes electronic product radiation to 
accomplish its primary purpose and from which such emissions are 
intended, and as a result of its design, production or assembly it;
    (1) Fails to conform to its design specifications relating to the 
emission of electronic product radiation; or
    (2) Without regard to the design specifications of the product, 
emits electronic product radiation unnecessary to the accomplishment of 
its primary purpose which creates a risk of injury, including genetic 
injury to any person; or
    (3) Fails to accomplish the intended purpose.



Sec. 1003.5  Effect of regulations on other laws.

    The remedies provided for in this subchapter shall be in addition to 
and not in substitution for any other remedies provided by law and shall 
not relieve any person from liability at common law or under statutory 
law.



           Subpart B_Discovery of Defect or Failure To Comply



Sec. 1003.10  Discovery of defect or failure of compliance by
manufacturer; notice requirements.

    Any manufacturer who discovers that any electronic product produced, 
assembled, or imported by him, which product has left its place of 
manufacture, has a defect or fails to comply with an applicable Federal 
standard shall:
    (a) Immediately notify the Secretary in accordance with Sec. 
1003.20, and
    (b) Except as authorized by Sec. 1003.30, furnish notification with 
reasonable promptness to the following persons:
    (1) The dealers or distributors to whom such product was delivered 
by the manufacturer; and
    (2) The purchaser of such product and any subsequent transferee of 
such product (where known to the manufacturer or where the manufacturer 
upon reasonable inquiry to dealers, distributors, or purchasers can 
identify the present user).
    (c) If a manufacturer is required to notify the Secretary under 
paragraph (a) of this section and also is required to report to the Food 
and Drug Administration under part 803 of this chapter, the manufacturer 
shall report in accordance with part 803. If a manufacturer is required 
to notify the Secretary under paragraph (a) of this section and is not 
required to report to the Food and Drug Administration under part 803, 
the manufacturer shall notify the Secretary in accordance with paragraph 
(a) of this section.

[38 FR 28628, Oct. 15, 1973 and 49 FR 36351, Sept. 14, 1984]



Sec. 1003.11  Determination by Secretary that product fails to comply or has a defect.

    (a) If, the Secretary, through testing, inspection, research, or 
examination of reports or other data, determines that any electronic 
product does not comply with an applicable Federal standard issued 
pursuant to the Act or has a defect, he shall immediately notify the 
manufacturer of the product in writing specifying:
    (1) The defect in the product or the manner in which the product 
fails to comply with the applicable Federal standard;
    (2) The Secretary's findings, with references to the tests, 
inspections, studies, or reports upon which such findings are based;
    (3) A reasonable period of time during which the manufacturer may 
present his views and evidence to establish that there is no failure of 
compliance or that the alleged defect does not exist or does not relate 
to safety of use of the product by reason of the emission of electronic 
product radiation.

The manufacturer shall have an opportunity for a regulatory hearing 
before the Food and Drug Administration pursuant to part 16 of this 
chapter.
    (b) Every manufacturer who receives a notice under paragraph (a) of 
this section shall immediately advise the

[[Page 873]]

Secretary in writing of the total number of such product units produced 
and the approximate number of such product units which have left the 
place of manufacture.
    (c) If, after the expiration of the period of time specified in the 
notice, the Secretary determines that the product has a defect or does 
not comply with an applicable Federal standard and the manufacturer has 
not applied for an exemption, he shall direct the manufacturer to 
furnish the notification to the persons specified in Sec. 1003.10(b) in 
the manner specified in Sec. 1003.21. The manufacturer shall within 14 
days from the date of receipt of such directive furnish the required 
notification.

[38 FR 28628, Oct. 15, 1973, as amended at 41 FR 48269, Nov. 2, 1976; 42 
FR 15676, Mar. 22, 1977]



                         Subpart C_Notification



Sec. 1003.20  Notification by the manufacturer to the Secretary.

    The notification to the Secretary required by Sec. 1003.10(a) shall 
be confirmed in writing and, in addition to other relevant information 
which the Secretary may require, shall include the following:
    (a) Identification of the product or products involved;
    (b) The total number of such product units so produced, and the 
approximate number of such product units which have left the place of 
manufacture;
    (c) The expected usage for the product if known to the manufacturer;
    (d) A description of the defect in the product or the manner in 
which the product fails to comply with an applicable Federal standard;
    (e) An evaluation of the hazards reasonably related to defect or the 
failure to comply with the Federal standard;
    (f) A statement of the measures to be taken to repair such defect or 
to bring the product into compliance with the Federal standard;
    (g) The date and circumstances under which the defect was 
discovered; and
    (h) The identification of any trade secret information which the 
manufacturer desires kept confidential.



Sec. 1003.21  Notification by the manufacturer to affected persons.

    (a) The notification to the persons specified in Sec. 1003.10(b) 
shall be in writing and, in addition to other relevant information which 
the Secretary may require, shall include:
    (1) The information prescribed by Sec. 1003.20 (a), (d), and 
instructions with respect to the use of the product pending the 
correction of the defect;
    (2) A clear evaluation in nontechnical terms of the hazards 
reasonably related to any defect or failure to comply; and
    (3) The following statement:

    The manufacturer will, without charge, remedy the defect or bring 
the product into compliance with each applicable Federal standard in 
accordance with a plan to be approved by the Secretary of Health and 
Human Services, the details of which will be included in a subsequent 
communication to you.


Provided, That if at the time the notification is sent, the Secretary 
has approved a plan for the repair, replacement or refund of the 
product, the notification may include the details of the approved plan 
in lieu of the above statement.
    (b) The envelope containing the notice shall not contain advertising 
or other extraneous material, and such mailings will be made in 
accordance with this section.
    (1) No. 10 white envelopes shall be used, and the name and address 
of the manufacturer shall appear in the upper left corner of the 
envelope.
    (2) The following statement is to appear in the far left third of 
the envelope in the type and size indicated and in reverse printing, 
centered in a red rectangle 3\3/4\ inches wide and 2\1/4\ inches high:

             Important--Electronic Product Radiation Warning

The statement shall be in three lines, all capitals, and centered. 
``Important'' shall be in 36-point Gothic Bold type. ``Electronic 
Product'' and ``Radiation Warning'' shall be in 36-point Gothic 
Condensed type.

    (3) Envelopes with markings similar to those prescribed in this 
section shall not be used by manufacturers for mailings other than those 
required by this part.
    (c) The notification shall be sent:

[[Page 874]]

    (1) By certified mail to purchasers of the product and to subsequent 
transferees.
    (2) By certified mail or other more expeditious means to dealers and 
distributors.
    (d) Where products were sold under a name other than that of the 
manufacturer of the product, the name of the individual or company under 
whose name the product was sold may be used in the notification required 
by this section.



Sec. 1003.22  Copies of communications sent to purchasers, dealers or distributors.

    (a) Every manufacturer of electronic products shall furnish to the 
Secretary a copy of all notices, bulletins, or other communications sent 
to the dealers or distributors of such manufacturers or to purchasers 
(or subsequent transferees) of electronic products of such manufacturer 
regarding any defect in such product or any failure of such product to 
comply with an applicable Federal standard.
    (b) In the event the Secretary deems the content of such notices to 
be insufficient to protect the public health and safety, the Secretary 
may require additional notice to such recipients, or may elect to make 
or cause to be made such notification by whatever means he deems 
appropriate.



           Subpart D_Exemptions From Notification Requirements



Sec. 1003.30  Application for exemption from notification requirements.

    (a) A manufacturer may at the time of giving the written 
confirmation required by Sec. 1003.20 or within 15 days of the receipt 
of any notice from the Secretary pursuant to Sec. 1003.11(a), apply for 
an exemption from the requirement of notice to the persons specified in 
Sec. 1003.10(b).
    (b) The application for exemption shall contain the information 
required by Sec. 1003.20 and in addition shall set forth in detail the 
grounds upon which the exemption is sought.



Sec. 1003.31  Granting the exemption.

    (a) If, in the judgment of the Secretary, the application filed 
pursuant to Sec. 1003.30 states reasonable grounds for an exemption 
from the requirement of notice, the Secretary shall give the 
manufacturer written notice specifying a reasonable period of time 
during which he may present his views and evidence in support of the 
application.
    (b) Such views and evidence shall be confined to matters relevant to 
whether the defect in the product or its failure to comply with an 
applicable Federal standard is such as to create a significant risk of 
injury, including genetic injury, to any person and shall be presented 
in writing unless the Secretary determines that an oral presentation is 
desirable. Where such evidence includes nonclinical laboratory studies, 
the data submitted shall include, with respect to each such study, 
either a statement that the study was conducted in compliance with the 
requirements set forth in part 58 of this chapter, or, if the study was 
not conducted in compliance with such regulations, a brief statement of 
the reason for the noncompliance. When such evidence includes clinical 
investigations involving human subjects, the data submitted shall 
include, with respect to each clinical investigation either a statement 
that each investigation was conducted in compliance with the 
requirements set forth in part 56 of this chapter, or a statement that 
the investigation is not subject to such requirements in accordance with 
Sec. 56.104 or Sec. 56.105, and a statement that each investigation 
was conducted in compliance with the requirements set forth in part 50 
of this chapter.
    (c) If, during the period of time afforded the manufacturer to 
present his views and evidence, the manufacturer proves to the 
Secretary's satisfaction that the defect or failure to comply does not 
create a significant risk of injury, including genetic injury, to any 
person, the Secretary shall issue an exemption from the requirement of 
notification to the manufacturer and shall notify the manufacturer in 
writing specifying:
    (1) The electronic product or products for which the exemption has 
been issued; and
    (2) Such conditions as the Secretary deems necessary to protect the 
public health and safety.

[[Page 875]]

    (d) Any person who contests denial of an exemption shall have an 
opportunity for a regulatory hearing before the Food and Drug 
Administration pursuant to part 16 of this chapter.

[38 FR 28628, Oct. 15, 1973, as amended at 41 FR 48269, Nov. 2, 1976; 42 
FR 15676, Mar. 22, 1977; 50 FR 7518, Feb. 22, 1985]



PART 1004_REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS
--Table of Contents



Sec.
1004.1 Manufacturer's obligation to repair, replace, or refund cost of 
          electronic products.
1004.2 Plans for the repair of electronic products.
1004.3 Plans for the replacement of electronic products.
1004.4 Plans for refunding the cost of electronic products.
1004.6 Approval of plans.

    Authority: 21 U.S.C. 360hh-360ss.

    Source: 38 FR 28629, Oct. 15, 1973, unless otherwise noted.



Sec. 1004.1  Manufacturer's obligation to repair, replace, or refund
cost of electronic products.

    (a) If any electronic product fails to comply with an applicable 
Federal standard or has a defect and the notification specified in Sec. 
1003.10(b) of this chapter is required to be furnished, the manufacturer 
of such product shall;
    (1) Without charge, bring such product into conformity with such 
standard or remedy such defect and provide reimbursement for any 
expenses for transportation of such product incurred in connection with 
having such product brought into conformity or having such defect 
remedied; or
    (2) Replace such product with a like or equivalent product which 
complies with each applicable Federal standard and which has no defect 
relating to the safety of its use; or
    (3) Make a refund of the cost of the product to the purchaser.
    (b) The manufacturer shall take the action required by this section 
in accordance with a plan approved by the Secretary pursuant to Sec. 
1004.6.



Sec. 1004.2  Plans for the repair of electronic products.

    Every plan for bringing an electronic product into conformity with 
applicable Federal standards or for remedying any defect in such product 
shall be submitted to the Secretary in writing, and in addition to other 
relevant information which the Secretary may require, shall include:
    (a) Identification of the product involved.
    (b) The approximate number of defective product units which have 
left the place of manufacture.
    (c) The specific modifications, alterations, changes, repairs, 
corrections, or adjustments to be made to bring the product into 
conformity or remedy any defect.
    (d) The manner in which the operations described in paragraph (c) 
will be accomplished, including the procedure for obtaining access to, 
or possession of, the products and the location where such operations 
will be performed.
    (e) The technical data, test results or studies demonstrating the 
effectiveness of the proposed remedial action.
    (f) A time limit, reasonable in light of the circumstances, for 
completion of the operations.
    (g) The system by which the manufacturer will provide reimbursement 
for any transportation expenses incurred in connection with having such 
product brought into conformity or having any defect remedied.
    (h) The text of the statement which the manufacturer will send to 
the persons specified in Sec. 1003.10(b) of this chapter informing such 
persons;
    (1) That the manufacturer, at his expense, will repair the 
electronic product involved,
    (2) Of the method by which the manufacturer will obtain access to or 
possession of the product to make such repairs,
    (3) That the manufacturer will reimburse such persons for any 
transportation expenses incurred in connection with making such repairs, 
and
    (4) Of the manner in which such reimbursement will be effected.
    (i) An assurance that the manufacturer will provide the Secretary 
with progress reports on the effectiveness of

[[Page 876]]

the plan, including the number of electronic products repaired.



Sec. 1004.3  Plans for the replacement of electronic products.

    Every plan for replacing an electronic product with a like or 
equivalent product shall be submitted to the Secretary in writing, and 
in addition to other relevant information which the Secretary may 
require, shall include:
    (a) Identification of the product to be replaced.
    (b) A description of the replacement product in sufficient detail to 
support the manufacturer's contention that the replacement product is 
like or equivalent to the product being replaced.
    (c) The approximate number of defective product units which have 
left the place of manufacture.
    (d) The manner in which the replacement operation will be effected 
including the procedure for obtaining possession of the product to be 
replaced.
    (e) A time limit, reasonable, in light of the circumstances for 
completion of the replacement.
    (f) The steps which the manufacturer will take to insure that the 
defective product will not be reintroduced into commerce, until it 
complies with each applicable Federal standard and has no defect 
relating to the safety of its use.
    (g) The system by which the manufacturer will provide reimbursement 
for any expenses for transportation of such product incurred in 
connection with effecting the replacement.
    (h) The text of the statement which the manufacturer will send to 
the persons specified in Sec. 1003.10(b) of this chapter informing such 
persons;
    (1) That the manufacturer, at its expense, will replace the 
electronic product involved,
    (2) Of the method by which the manufacturer will obtain possession 
of the product and effect the replacement,
    (3) That the manufacturer will reimburse such persons for any 
transportation expenses incurred in connection with effecting such 
replacement, and
    (4) Of the manner in which such reimbursement will be made.
    (i) An assurance that the manufacturer will provide the Secretary 
with progress reports on the effectiveness of the plan, including the 
number of electronic products replaced.



Sec. 1004.4  Plans for refunding the cost of electronic products.

    Every plan for refunding the cost of an electronic product shall be 
submitted to the Secretary in writing, and in addition to other relevant 
information which the Secretary may require, shall include:
    (a) Identification of the product involved.
    (b) The approximate number of defective product units which have 
left the place of manufacture.
    (c) The manner in which the refund operation will be effected 
including the procedure for obtaining possession of the product for 
which the refund is to be made.
    (d) The steps which the manufacturer will take to insure that the 
defective products will not be reintroduced into commerce, until it 
complies with each applicable Federal standard and has no defect 
relating to the safety of its use.
    (e) A time limit, reasonable in light of the circumstances, for 
obtaining the product and making the refund.
    (f) A statement that the manufacturer will refund the cost of such 
product together with the information the manufacturer has used to 
determine the amount of the refund.
    (g) The text of the statement which the manufacturer will send to 
the persons specified in Sec. 1003.10(b) of this chapter informing such 
persons;
    (1) That the manufacturer, at his expense, will refund the cost of 
the electronic product plus any transportation costs,
    (2) Of the amount to be refunded exclusive of transportation costs,
    (3) Of the method by which the manufacturer will obtain possession 
of the product and make the refund.
    (h) An assurance that the manufacturer will provide the Secretary 
with progress reports on the effectiveness of the plan, including the 
number of refunds made.



Sec. 1004.6  Approval of plans.

    If, after review of any plan submitted pursuant to this subchapter, 
the Secretary determines that the action to be

[[Page 877]]

taken by the manufacturer will expeditiously and effectively fulfill the 
manufacturer's obligation under Sec. 1004.1 in a manner designed to 
encourage the public to respond to the proposal, the Secretary will send 
written notice of his approval of such plan to the manufacturer. Such 
approval may be conditioned upon such additional terms as the Secretary 
deems necessary to protect the public health and safety. Any person who 
contests denial of a plan shall have an opportunity for a regulatory 
hearing before the Food and Drug Administration pursuant to part 16 of 
this chapter.

[38 FR 28629, Oct. 15, 1973, as amended at 41 FR 48269, Nov. 2, 1976; 42 
FR 15676, Mar. 22, 1977]



PART 1005_IMPORTATION OF ELECTRONIC PRODUCTS--Table of Contents



                      Subpart A_General Provisions

Sec.
1005.1 Applicability.
1005.2 Definitions.
1005.3 Importation of noncomplying goods prohibited.

                    Subpart B_Inspection and Testing

1005.10 Notice of sampling.
1005.11 Payment for samples.

               Subpart C_Bonding and Compliance Procedures

1005.20 Hearing.
1005.21 Application for permission to bring product into compliance.
1005.22 Granting permission to bring product into compliance.
1005.23 Bonds.
1005.24 Costs of bringing product into compliance.
1005.25 Service of process on manufacturers.

    Authority: 21 U.S.C. 360ii, 360mm.

    Source: 38 FR 28630, Oct. 15, 1973, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 1005.1  Applicability.

    (a) The provisions of Sec. Sec. 1005.1 through 1005.24 are 
applicable to electronic products which are subject to the standards 
prescribed under this subchapter and are offered for importation into 
the United States.
    (b) Section 1005.25 is applicable to every manufacturer of 
electronic products offering an electronic product for importation into 
the United States.

[38 FR 28630, Oct. 15, 1973, as amended at 45 FR 81739, Dec. 12, 1980]



Sec. 1005.2  Definitions.

    As used in this part:
    The term owner or consignee means the person who makes entry under 
the provisions of section 484 of the Tariff Act of 1930, as amended (19 
U.S.C. 1484), namely, the ``importer of record.''

[81 FR 85973, Nov. 29, 2016]



Sec. 1005.3  Importation of noncomplying goods prohibited.

    The importation of any electronic product for which standards have 
been prescribed under section 534 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360kk) shall be refused admission into 
the United States unless there is affixed to such product a 
certification in the form of a label or tag in conformity with section 
534(h) of the act (21 U.S.C. 360kk(h)). Merchandise refused admission 
shall be destroyed or exported under regulations prescribed by the 
Secretary of the Treasury unless a timely and adequate petition for 
permission to bring the product into compliance is filed and granted 
under Sec. Sec. 1005.21 and 1005.22.

[69 FR 11314, Mar. 10, 2004]



                    Subpart B_Inspection and Testing



Sec. 1005.10  Notice of sampling.

    When a sample of a product to be offered for importation has been 
requested by the Secretary, the District Director of Customs having 
jurisdiction over the shipment shall, upon the arrival of the shipment, 
procure the sample and shall give to its owner or consignee prompt 
notice of the delivery or of the intention to deliver such sample to the 
Secretary. If the notice so requires, the owner or consignee will hold 
the shipment of which the sample is typical and not release such 
shipment until he receives notice of the results of the tests of the 
sample from the Secretary, stating that the product is in compliance 
with the requirements of the Act. The District Director of

[[Page 878]]

Customs will be given the results of the tests. If the Secretary 
notifies the District Director of Customs that the product does not meet 
the requirements of the Act, the District Director of Customs shall 
require the exportation or destruction of the shipment in accordance 
with customs laws.



Sec. 1005.11  Payment for samples.

    The Department of Health and Human Services will pay for all import 
samples of electronic products rendered unsalable as a result of 
testing, or will pay the reasonable costs of repackaging such samples 
for sale, if the samples are found to be in compliance with the 
requirements of Subchapter C--Electronic Product Radiation Control of 
the Federal Food, Drug, and Cosmetic Act (formerly the Radiation Control 
for Health and Safety Act of 1968). Billing for reimbursement should be 
made by the owner or consignee to the Food and Drug Administration 
division where the shipment was offered for import. Payment for samples 
will not be made if the sample is found to be in violation of the Act, 
even though subsequently brought into compliance pursuant to terms 
specified in a notice of permission issued under Sec. 1005.22.

[73 FR 34860, June 19, 2008, as amended at 85 FR 50783, Aug. 18, 2020]



               Subpart C_Bonding and Compliance Procedures



Sec. 1005.20  Hearing.

    (a) If, from an examination of the sample or otherwise, it appears 
that the product may be subject to a refusal of admission, the Secretary 
shall give the owner or consignee a written notice to that effect, 
stating the reasons therefor. The notice shall specify a place and a 
period of time during which the owner or consignee shall have an 
opportunity to introduce testimony unless the owner or consignee 
indicates his intention to bring the product into compliance. Upon 
timely request, such time and place may be changed. Such testimony shall 
be confined to matters relevant to the admissibility of the article and 
may be introduced orally or in writing.
    (b) If the owner or consignee submits or indicates his intention to 
submit an application for permission to perform such action as is 
necessary to bring the product into compliance with the Act, such 
application shall include the information required by Sec. 1005.21.
    (c) If the application is not submitted at or prior to the hearing, 
the Secretary may allow a reasonable time for filing such application.



Sec. 1005.21  Application for permission to bring product into compliance.

    Application for permission to perform such action as is necessary to 
bring the product into compliance with the Act may be filed only by the 
owner, consignee, or manufacturer and, in addition to any other 
information which the Secretary may reasonably require, shall:
    (a) Contain a detailed proposal for bringing the product into 
compliance with the Act;
    (b) Specify the time and place where such operations will be 
effected and the approximate time for their completion; and
    (c) Identify the bond required to be filed pursuant to Sec. 
1005.23.



Sec. 1005.22  Granting permission to bring product into compliance.

    (a) When permission contemplated by Sec. 1005.21 is granted, the 
Secretary shall notify the applicant in writing, specifying:
    (1) The procedure to be followed;
    (2) The disposition of the rejected articles or portions thereof;
    (3) That the operations are to be carried out under the supervision 
of a representative of the Department of Health and Human Services;
    (4) A reasonable time limit for completing the operations; and
    (5) Such other conditions as he finds necessary to maintain adequate 
supervision and control over the product.
    (b) Upon receipt of a written request for an extension of time to 
complete the operations necessary to bring the product into compliance, 
the Secretary may grant such additional time as he deems necessary.
    (c) The notice of permission may be amended upon a showing of 
reasonable grounds thereof and the filing of an

[[Page 879]]

amended application for permission with the Secretary.
    (d) If ownership of a product included in a notice of permission 
changes before the operations specified in the notice have been 
completed, the original owner will remain responsible under its bond, 
unless the new owner has executed a superseding bond on customs Form 
7601 and obtained a new notice.
    (e) The Secretary will notify the District Director of Customs 
having jurisdiction over the shipment involved, of the determination as 
to whether or not the product has in fact been brought into compliance 
with the Act.



Sec. 1005.23  Bonds.

    The bond required under section 360(b) of the Act shall be executed 
by the owner or consignee on the appropriate form of a customs single-
entry bond, customs Form 7551 or term bond, customs Form 7553 or 7595, 
containing a condition for the redelivery of the shipment or any part 
thereof not complying with the laws and regulations governing its 
admission into the commerce of the United States upon demand of the 
District Director of Customs and containing a provision for the 
performance of any action necessary to bring the product into compliance 
with all applicable laws and regulations. The bond shall be filed with 
the District Director of Customs.



Sec. 1005.24  Costs of bringing product into compliance.

    The costs of supervising the operations necessary to bring a product 
into compliance with the Act shall be paid by the owner or consignee who 
files an application pursuant to Sec. 1005.21 and executes a bond under 
section 360(b) of the Act. Such costs shall include:
    (a) Travel expenses of the supervising officer;
    (b) Per diem in lieu of subsistence of the supervising officer when 
away from his or her home station, as provided by law;
    (c)(1) The charge for the services of the supervising officer, which 
shall include administrative support, shall be computed at a rate per 
hour equal to 267 percent of the hourly rate of regular pay of a grade 
GS-11/4 employee, except that such services performed by a customs 
officer and subject to the provisions of the act of February 13, 1911, 
as amended (section 5, 36 Stat. 901, as amended (19 U.S.C. 267)), shall 
be calculated as provided in that act.
    (2) The charge for the services of the analyst, which shall include 
administrative and laboratory support, shall be computed at a rate per 
hour equal to 267 percent of the hourly rate of regular pay of a grade 
GS-12/4 employee.
    (3) The rate per hour equal to 267 percent of the equivalent hourly 
rate of regular pay of the supervising officer (GS-11/4) and the analyst 
(GS-12/4) is computed as follows:

                       Table 1 to Paragraph (c)(3)
------------------------------------------------------------------------
                                                                  Hours
------------------------------------------------------------------------
Gross number of working hours in 52 40-hour weeks..............    2,080
Less:
    10 legal public holidays--New Year's Day, Birthday of             80
     Martin Luther King, Jr., Washington's Birthday, Memorial
     Day, Independence Day, Labor Day, Columbus Day, Veterans
     Day, Thanksgiving Day, and Christmas Day..................
    Annual Leave--26 days......................................      208
    Sick Leave--13 days........................................      104
                                                                --------
        Total..................................................      392
                                                                --------
        Net number of working hours............................    1,688
------------------------------------------------------------------------
Gross number of working hours in 52 40-hour weeks..............    2,080
Working hour equivalent of Government contributions for              176
 employee retirement, life insurance, and health benefits
 computed at 8\1/2\% of annual rate of pay of employee.........
Equivalent annual working hours................................    2,256
Support required to equal to 1 person-year.....................    2,256
Equivalent gross annual working hours charged to Food and Drug     4,512
 appropriation.................................................
------------------------------------------------------------------------
Note: Ratio of equivalent gross annual number of working hours charged
  to Food and Drug appropriation to net number of annual working hours
  (4,512/1,688) = 267 pct.


[[Page 880]]

    (d) The minimum charge for services of supervising officers shall be 
not less than the charge for 1 hour and time after the first hour shall 
be computed in multiples of 1 hour, disregarding fractional parts less 
than one-half hour.

[38 FR 28630, Oct. 15, 1973, as amended at 42 FR 55207, Oct. 14, 1977; 
42 FR 62130, Dec. 9, 1977; 85 FR 50783, Aug. 18, 2020]



Sec. 1005.25  Service of process on manufacturers.

    (a) Every manufacturer of electronic products, prior to offering 
such product for importation into the United States, shall designate a 
permanent resident of the United States as the manufacturer's agent upon 
whom service of all processes, notices, orders, decisions, and 
requirements may be made for and on behalf of the manufacturer as 
provided in section 536(d) of Subchapter C--Electronic Product Radiation 
Control of the Federal Food, Drug, and Cosmetic Act (formerly the 
Radiation Control for Health and Safety Act of 1968) (21 U.S.C. 
360mm(d)) and this section. The agent may be an individual, a firm, or a 
domestic corporation. For purposes of this section, any number of 
manufacturers may designate the same agent.
    (b) A manufacturer designating an agent must address the designation 
to the Center for Devices and Radiological Health, 10903 New Hampshire 
Ave., Document Mail Center--WO66-G609, Silver Spring, MD 20993-0002. It 
must be in writing and dated; all signatures must be in ink. The 
designation must be made in the legal form required to make it valid and 
binding on the manufacturer under the laws, corporate bylaws, or other 
requirements governing the making of the designation by the manufacturer 
at the place and time where it is made, and the persons or person 
signing the designation shall certify that it is so made. The 
designation must disclose the manufacturer's full legal name and the 
name(s) under which the manufacturer conducts the business, if 
applicable, the principal place of business, and mailing address. If any 
of the products of the manufacturer do not bear his legal name, the 
designation must identify the marks, trade names, or other designations 
of origin which these products bear. The designation must provide that 
it will remain in effect until withdrawn or replaced by the manufacturer 
and shall bear a declaration of acceptance duly signed by the designated 
agent. The full legal name and mailing address of the agent must be 
stated. Until rejected by the Secretary, designations are binding on the 
manufacturer even when not in compliance with all the requirements of 
this section. The designated agent may not assign performance of his 
function under the designation to another.
    (c) Service of any process, notice, order, requirement, or decision 
specified in section 536(d) of Subchapter C--Electronic Product 
Radiation Control of the Federal Food, Drug, and Cosmetic Act (formerly 
the Radiation Control for Health and Safety Act of 1968) (21 U.S.C. 
360mm(d)) may be made by registered or certified mail addressed to the 
agent with return receipt requested, or in any other manner authorized 
by law. In the absence of such a designation or if for any reason 
service on the designated agent cannot be effected, service may be made 
as provided in section 536(d) by posting such process, notice, order, 
requirement, or decision in the Office of the Director, Center for 
Devices and Radiological Health and publishing a notice that such 
service was made in the Federal Register.

[38 FR 28630, Oct. 15, 1973, as amended at 53 FR 11254, Apr. 6, 1988; 65 
FR 17137, Mar. 31, 2000; 72 FR 17401, Apr. 9, 2007; 73 FR 34860, June 
19, 2008; 75 FR 16353, Apr. 1, 2010; 78 FR 18234, Mar. 26, 2013]



PART 1010_PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: 
GENERAL--Table of Contents



                      Subpart A_General Provisions

Sec.
1010.1 Scope.
1010.2 Certification.
1010.3 Identification.
1010.4 Variances.
1010.5 Exemptions for products intended for United States Government 
          use.

                   Subpart B_Alternate Test Procedures

1010.13 Special test procedures.

[[Page 881]]

              Subpart C_Exportation of Electronic Products

1010.20 Electronic products intended for export.

    Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss, 371, 
381.

    Source: 38 FR 28631, Oct. 15, 1973, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 1010.1  Scope.

    The standards listed in this subchapter are prescribed pursuant to 
section 534 of Subchapter C--Electronic Product Radiation Control of the 
Federal Food, Drug, and Cosmetic Act (formerly the Radiation Control for 
Health and Safety Act of 1968) (21 U.S.C. 360kk) and are applicable to 
electronic products as specified herein, to control electronic product 
radiation from such products. Standards so prescribed are subject to 
amendment or revocation and additional standards may be prescribed as 
are determined necessary for the protection of the public health and 
safety.

[73 FR 34861, June 19, 2008]



Sec. 1010.2  Certification.

    (a) Every manufacturer of an electronic product for which an 
applicable standard is in effect under this subchapter shall furnish to 
the dealer or distributor, at the time of delivery of such product, the 
certification that such product conforms to all applicable standards 
under this subchapter.
    (b) The certification shall be in the form of a label or tag 
permanently affixed to or inscribed on such product so as to be legible 
and readily accessible to view when the product is fully assembled for 
use, unless the applicable standard prescribes some other manner of 
certification. All such labels or tags shall be in the English language.
    (c) Such certification shall be based upon a test, in accordance 
with the standard, of the individual article to which it is attached or 
upon a testing program which is in accordance with good manufacturing 
practices. The Director, Center for Devices and Radiological Health may 
disapprove such a testing program on the grounds that it does not assure 
the adequacy of safeguards against hazardous electronic product 
radiation or that it does not assure that electronic products comply 
with the standards prescribed under this subchapter.
    (d) In the case of products for which it is not feasible to certify 
in accordance with paragraph (b) of this section, upon application by 
the manufacturer, the Director, Center for Devices and Radiological 
Health may approve an alternate means by which such certification may be 
provided.
    (e) Laser products under Sec. 1040.10 of this chapter that 
incorporate a certified laser system (laser product) will be considered 
to have met the certification requirements in this section if all of the 
following conditions are met:
    (1) The incorporated laser system is not a laser product intended 
for use as a component or replacement as described in Sec. 
1040.10(a)(1) and (2) of this chapter;
    (2) The manufacturer of the incorporated laser system has certified 
such laser system under this section and meets the reporting 
requirements under part 1002 of this chapter;
    (3) The product incorporating the certified laser system is not 
independently subject to additional reporting or performance standards 
requirements;
    (4) The incorporated laser system is not modified as defined in 
Sec. 1040.10(i) of this chapter, and all performance features that 
apply to the incorporated laser system under Sec. 1040.10(f) are 
available on the product incorporating the certified laser system;
    (5) All labeling requirements that apply to the incorporated laser 
system under Sec. Sec. 1010.2, 1010.3, 1040.10(g), and 1040.11(a)(3) of 
this chapter are visible on the outside of the product incorporating the 
certified laser system, with the exception that the certification or 
identification labels need not be visible on the outside of products 
incorporating a certified Class I laser;
    (6) The incorporated laser system is installed in accordance with 
the instructions provided by the manufacturer of the incorporated laser 
system, including instructions for placing additional externally facing 
labels found in paragraph (e)(5) of this section, and

[[Page 882]]

meeting the other conditions in paragraphs (e)(1) through (8) of this 
section;
    (7) The manufacturer of the product that incorporates the laser 
system provides the end user with information required under Sec. 
1040.10(h)(1) of this chapter as provided to them by the manufacturer of 
the incorporated laser system; and
    (8) The labeling requirements under part 1010 and Sec. 1040.10(g) 
of this chapter for the incorporated laser system would be met in any 
service configuration of the product incorporating the laser system or 
when the incorporated laser system is removed from the product into 
which it had been incorporated, and reproductions of such labels are 
found in the user information.

[38 FR 28631, Oct. 15, 1973, as amended at 40 FR 32257, July 31, 1975; 
42 FR 18063, Apr. 5, 1977; 53 FR 11254, Apr. 6, 1988; 88 FR 3653, Jan. 
20, 2023]



Sec. 1010.3  Identification.

    (a) Every manufacturer of an electronic product to which a standard 
under this subchapter is applicable shall set forth the information 
specified in paragraphs (a)(1) and (2) of this section. This information 
shall be provided in the form of a tag or label permanently affixed or 
inscribed on such product so as to be legible and readily accessible to 
view when the product is fully assembled for use or in such other manner 
as may be prescribed in the applicable standard. Except for foreign 
equivalent abbreviations as authorized in paragraph (a)(1) of this 
section all such labels or tags shall be in the English language.
    (1) The full name and address of the manufacturer of the product; 
abbreviations such as ``Co.,'' ``Inc.,'' or their foreign equivalents 
and the first and middle initials of individuals may be used. Where 
products are sold under a name other than that of the manufacturer of 
the product, the full name and address of the individual or company 
under whose name the product was sold may be set forth, provided such 
individual or company has previously suppled the Director, Center for 
Devices and Radiological Health with sufficient information to identify 
the manufacturer of the product.
    (2) The place and month and year of manufacture:
    (i) The place of manufacture may be expressed in code provided the 
manufacturer has previously supplied the Director, Center for Devices 
and Radiological Health with the key to such code.
    (ii) The month and year of manufacture shall be provided clearly and 
legibly, without abbreviation, and with the year shown as a four-digit 
number as follows in this paragraph. Alternatively, a manufacturer may 
utilize a manufacturing symbol and date format that conforms with an 
applicable FDA recognized consensus standard.

          Manufactured: (Insert Month and Year of Manufacture.)

    (b) In the case of products for which it is not feasible to affix 
identification labeling in accordance with paragraph (a) of this 
section, upon application by the manufacturer, the Director, Center for 
Devices and Radiological Health may approve an alternate means by which 
such identification may be provided.
    (c) Every manufacturer of an electronic product to which a standard 
under this subchapter is applicable shall provide to the Director, 
Center for Devices and Radiological Health a list identifying each brand 
name which is applied to the product together with the full name and 
address of the individual or company for whom each product so branded is 
manufactured.

[40 FR 32257, July 31, 1975, as amended at 42 FR 18063, Apr. 5, 1977; 53 
FR 11254, Apr. 6, 1988; 88 FR 3653, Jan. 20, 2023]



Sec. 1010.4  Variances.

    (a) Criteria for variances. (1) Upon application by a manufacturer 
(including an assembler), the Director, Center for Devices and 
Radiological Health, Food and Drug Administration, may grant a variance 
from one or more provisions of any performance standard under subchapter 
J of this chapter for an electronic product subject to such standard 
when the Director determines that granting such a variance is in keeping 
with the purposes of Subchapter C--Electronic Product Radiation Control 
of the Federal Food, Drug, and Cosmetic Act (formerly the

[[Page 883]]

Radiation Control for Health and Safety Act of 1968), and:
    (i) The scope of the requested variance is so limited in its 
applicability as not to justify an amendment to the standard, or
    (ii) There is not sufficient time for the promulgation of an 
amendment to the standard.
    (2) The issuance of the variance shall be based upon a determination 
that:
    (i) The product utilizes an alternate means for providing radiation 
safety or protection equal to or greater than that provided by products 
meeting all requirements of the applicable standard, or
    (ii) The product performs a function or is intended for a purpose 
which could not be performed or accomplished if required to meet the 
applicable standards, and suitable means for assuring radiation safety 
or protection are provided, or
    (iii) One or more requirements of the applicable standard are not 
appropriate, and suitable means for assuring radiation safety or 
protection are provided.
    (b) Applications for variances. If you are submitting an application 
for variances or for amendments or extensions thereof:
    (1) You must either:
    (i) Submit the variance application and supporting materials to CDRH 
by email using the [email protected] mailbox; or
    (ii) Submit an original copy of the variance application by mail to: 
U.S. Food and Drug Administration, Center for Devices and Radiological 
Health, Document Mail Center, Bldg. 66, Rm. G609, 10903 New Hampshire 
Ave., Silver Spring, MD 20993-0002.
    (2) The application for variance shall include the following 
information:
    (i) The variance number and expiration date.
    (ii) The amendment or extension requested and basis for the 
amendment or extension.
    (iii) A description of the effect of the amendment or extension on 
protection from radiation produced by the product.
    (iv) An explanation of how alternate or suitable means of protection 
will be provided.
    (c) Ruling on applications. (1) The Director, Center for Devices and 
Radiological Health, may approve or deny, in whole or in part, a 
requested variance or any amendment or extension thereof, and the 
director shall inform the applicant in writing of this action on a 
requested variance or amendment or extension. The written notice will 
state the manner in which the variance differs from the standard, the 
effective date and the termination date of the variance, a summary of 
the requirements and conditions attached to the variance, any other 
information that may be relevant to the application or variance, and, if 
appropriate, the number of units or other similar limitations for which 
the variance is approved. Each variance will be assigned an identifying 
number.
    (2) The Director, Center for Devices and Radiological Health, shall 
amend or withdraw a variance whenever the Director determines that this 
action is necessary to protect the public health or otherwise is 
justified by this subchapter. Such action will become effective on the 
date specified in the written notice of the action sent to the 
applicant, except that it will become effective immediately upon 
notification to the applicant when the Director determines that such 
action is necessary to prevent an imminent health hazard.
    (3) All applications for variances and for amendments and extensions 
thereof and all correspondence (including written notices of approval) 
on these applications will be available for public disclosure in the 
office of the Division of Dockets Management, except for information 
regarded as confidential under section 537(e) of the act.
    (d) Certification of equipment covered by variance. The manufacturer 
of any product for which a variance is granted shall modify the tag, 
label, or other certification required by Sec. 1010.2 to state:
    (1) That the product is in conformity with the applicable standard, 
except with respect to those characteristics covered by the variance;

[[Page 884]]

    (2) That the product is in conformity with the provisions of the 
variance; and
    (3) The assigned number and effective date of the variance.

[39 FR 13879, Apr. 18, 1974, as amended at 44 FR 48191, Aug. 17, 1979; 
50 FR 7518, Feb. 22, 1985; 50 FR 13565, Apr. 5, 1985; 53 FR 11254, Apr. 
6, 1988; 53 FR 52683, Dec. 29, 1988; 59 FR 14365, Mar. 28, 1994; 65 FR 
17137, Mar. 31, 2000; 73 FR 34861, June 19, 2008; 75 FR 16353, Apr. 1, 
2010; 88 FR 3654, Jan. 20, 2023]



Sec. 1010.5  Exemptions for products intended for United States Government use.

    (a) Criteria for exemption. Upon application by a manufacturer 
(including assembler) or by a U.S. department or agency, the Director, 
Center for Devices and Radiological Health, Food and Drug 
Administration, may grant an exemption from any performance standard 
under subchapter J of this chapter for an electronic product, or class 
of products, otherwise subject to such standard when he determines that 
such electronic product or class is intended for use by departments or 
agencies of the United States and meets the criteria set forth in 
paragraph (a) (1) or (2) of this section.
    (1) The procuring agency shall prescribe procurement specifications 
for the product or class of products governing emissions of electronic 
product radiation, and the product or class shall be of a type used 
solely or predominantly by a department or agency of the United States.
    (2) The product or class of products is intended for research, 
investigations, studies, demonstration, or training, or for reasons of 
national security.
    (b) Consultation between the procuring agency and the Food and Drug 
Administration. The United States department or agency that intends to 
procure or manufacture a product or class of products subject to 
electronic product radiation safety standards contained in this 
subchapter should consult with the Center for Devices and Radiological 
Health, Food and Drug Administration, whenever it is anticipated that 
the specifications for the product or class must deviate from, or be in 
conflict with, such applicable standards. Such consultation should occur 
as early as possible during development of such specifications. The 
department or agency should include in the specifications all 
requirements of such standards that are not in conflict with, or are not 
inappropriate for, the special or unique uses for which the product is 
intended. The procuring agency should indicate to the Center for Devices 
and Radiological Health if it desires to be notified of the approval, 
amendment, or withdrawal of the exemption.
    (c) Application for exemption. If you are submitting an application 
for exemption, or for amendment or extension thereof, you must submit an 
original and two copies to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. For an exemption under the criteria prescribed in paragraph 
(a)(1) of this section, the application shall include the information 
prescribed in paragraphs (c)(1) through (c)(13) of this section. For an 
exemption under the criteria prescribed in paragraph (a)(2) of this 
section, the application shall include the information prescribed in 
paragraphs (c)(3) through (c)(13) of this section. An application for 
exemption, or for amendment or extension thereof, and correspondence 
relating to such application shall be made available for public 
disclosure in the Division of Dockets Management, except for 
confidential or proprietary information submitted in accordance with 
part 20 of this chapter. Information classified for reasons of national 
security shall not be included in the application. Except as indicated 
in this paragraph, the application for exemption shall include the 
following:
    (1) The procurement specifications for the product or class of 
products that govern emissions of electronic product radiation.
    (2) Evidence that the product or class of products is of a type used 
solely or predominantly by departments or agencies of the United States.
    (3) Evidence that such product or class of products is intended for 
use by a department or agency of the United States.
    (4) A description of the product or class of products and its 
intended use.

[[Page 885]]

    (5) An explanation of how compliance with the applicable standard 
would restrict or be inappropriate for this intended use.
    (6) A description of the manner in which it is proposed that the 
product or class of products shall deviate from the requirements of the 
applicable standard.
    (7) An explanation of the advantages to be derived from such 
deviation.
    (8) An explanation of how means of radiation protection will be 
provided where the product or class of products deviates from the 
requirements of the applicable standard.
    (9) The period of time it is desired that the exemption be in 
effect, and, if appropriate, the number of units to be manufactured 
under the exemption.
    (10) The name, address, and telephone number of the manufacturer or 
his agent.
    (11) The name, address, and telephone number of the appropriate 
office of the United States department or agency purchasing the product 
or class of products.
    (12) Such other information required by regulation or by the 
Director, Center for Devices and Radiological Health, to evaluate and 
act on the application. Where such information includes nonclinical 
laboratory studies, the information shall include, with respect to each 
nonclinical study, either a statement that each study was conducted in 
compliance with the requirements set forth in part 58 of this chapter, 
or, if the study was not conducted in compliance with such regulations, 
a statement that describes in detail all differences between the 
practices used in the study and those required in the regulations. When 
such information includes clinical investigations involving human 
subjects, the information shall include, with respect to each clinical 
investigation, either a statement that each investigation was conducted 
in compliance with the requirements set forth in part 56 of this 
chapter, or a statement that the investigation is not subject to such 
requirements in accordance with Sec. 56.104 or Sec. 56.105 and a 
statement that each investigation was conducted in compliance with the 
requirements set forth in part 50 of this chapter.
    (13) With respect to each nonclinical laboratory study contained in 
the application, either a statement that the study was conducted in 
compliance with the requirements set forth in part 58 of this chapter, 
or, if the study was not conducted in compliance with such regulations, 
a brief statement of the reason for the noncompliance.
    (d) Amendment or extension of an exemption. An exemption is granted 
on the basis of the information contained in the orginal applicaion. 
Therefore, if changes are needed in the radiation safety specifications 
for the product, or its use, or related radiation control procedures 
such that the information in the original application would no longer be 
correct with respect to radiation safety, the applicant shall submit in 
advance of such changes a request for an amendment to the exemption. He 
also shall submit a request for extension of the exemption, if needed, 
at least 60 days before the expiration date. The application for 
amendment or extension of an exemption shall include the following 
information:
    (1) The exemption number and expiration date.
    (2) The amendment or extension requested and basis for the amendment 
or extension.
    (3) If the radiation safety specifications for the product or class 
of products or the product's or class of products' use or related 
radiation control procedures differ from the description provided in the 
original application, a description of such changes.
    (e) Ruling on an application. (1) The Director, Center for Devices 
and Radiological Health, may grant an exemption including in the written 
notice of exemption such conditions or terms as may be necessary to 
protect the public health and safety and shall notify the applicant in 
writing of his action. The conditions or terms of the exemption may 
include specifications concerning the manufacture, use, control, and 
disposal of the excess or surplus exempted product of class of products 
as provided in the Code of Federal Regulations, title 41, subtitle C. 
Each exemption will be assigned an identifying number.
    (2) The Director, Center for Devices and Radiological Health, shall 
amend or withdraw an exemption whenever he

[[Page 886]]

determines that such action is necessary to protect the public health or 
otherwise is justified by provisions of the act or this subchapter. Such 
action shall become effective on the date specified in the written 
notice of the action sent to the applicant, except that it shall become 
effective immediately when the Director determines that it is necessary 
to prevent an imminent health hazard.
    (f) Identification of equipment covered by exemption. The 
manufacturer of any product for which an exemption is granted shall 
provide the following identification in the form of a tag or label 
permanently affixed or inscribed on such product so as to be legible and 
readily accessible to view when the product is fully assembled for use 
or in such other manner as may be prescribed in the exemption:

                                 Caution

    This electronic product has been exempted from Food and Drug 
Administration radiation safety performance standards prescribed in the 
Code of Federal Regulations, title 21, chapter I, subchapter J, pursuant 
to Exemption No. ___, granted on _______

[42 FR 44229, Sept. 2, 1977; 42 FR 61257, Dec. 2, 1977, as amended at 44 
FR 17657, Mar. 23, 1979; 46 FR 8460, 8958, Jan. 27, 1981; 50 FR 7518, 
Feb. 22, 1985; 50 FR 13564, Apr. 5, 1985; 53 FR 11254, Apr. 6, 1988; 59 
FR 14365, Mar. 28, 1994; 65 FR 17138, Mar. 31, 2000]



                   Subpart B_Alternate Test Procedures



Sec. 1010.13  Special test procedures.

    The Director, Center for Devices and Radiological Health, may, on 
the basis of a written application by a manufacturer, authorize test 
programs other than those set forth in the standards under this 
subchapter for an electronic product if he determines that such products 
are not susceptible to satisfactory testing by the procedures set forth 
in the standard and that the alternative test procedures assure 
compliance with the standard.

[40 FR 32257, July 31, 1975, as amended at 53 FR 11254, Apr. 6, 1988]



              Subpart C_Exportation of Electronic Products



Sec. 1010.20  Electronic products intended for export.

    The performance standards prescribed in this subchapter shall not 
apply to any electronic product which is intended solely for export if:
    (a) Such product and the outside of any shipping container used in 
the export of such product are labeled or tagged to show that such 
product is intended for export, and
    (b) Such product meets all the applicable requirements of the 
country to which such product is intended for export.

[40 FR 32257, July 31, 1975]



PART 1020_PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING
PRODUCTS--Table of Contents



Sec.
1020.10 Television receivers.
1020.20 Cold-cathode gas discharge tubes.
1020.30 Diagnostic x-ray systems and their major components.
1020.31 Radiographic equipment.
1020.32 Fluoroscopic equipment.
1020.33 Computed tomography (CT) equipment.
1020.40 Cabinet x-ray systems.

    Authority: 21 U.S.C. 351, 352, 360e-360j, 360hh-360ss, 371, 381.

    Source: 38 FR 28632, Oct. 15, 1973, unless otherwise noted.



Sec. 1020.10  Television receivers.

    (a) Applicability. The provisions of this section are applicable to 
television receivers with cathode ray tubes manufactured subsequent to 
January 15, 1970.
    (b) Definitions. (1) External surface means the cabinet or enclosure 
provided by the manufacturer as part of the receiver. If a cabinet or 
enclosure is not provided as part of the receiver, the external surface 
shall be considered to be a hypothetical cabinet, the plane surfaces of 
which are located at those minimum distances from the chassis sufficient 
to enclose all components of the receiver except that portion of the 
neck and socket of the cathode-ray tube which normally extends beyond 
the plane surfaces of the enclosure.

[[Page 887]]

    (2) Maximum test voltage means 130 root mean square volts if the 
receiver is designed to operate from nominal 110 to 120 root mean square 
volt power sources. If the receiver is designed to operate from a power 
source having some voltage other than from nominal 110 to 120 root mean 
square volts, maximum test voltage means 110 percent of the nominal root 
mean square voltage specified by the manufacturer for the power source.
    (3) Service controls means all of those controls on a television 
receiver provided by the manufacturer for purposes of adjustment which, 
under normal usage, are not accessible to the user.
    (4) Television receiver means an electronic product designed to 
receive and display a television picture through broadcast, cable, or 
closed circuit television.
    (5) Usable picture means a picture in synchronization and 
transmitting viewable intelligence.
    (6) User controls means all of those controls on a television 
receiver, provided by the manufacturer for purposes of adjustment, which 
on a fully assembled receiver under normal usage, are accessible to the 
user.
    (c) Requirements--(1) Exposure rate limit. Radiation exposure rates 
produced by a television receiver shall not exceed 0.5 milliroentgens 
per hour at a distance of five (5) centimeters from any point on the 
external surface of the receiver, as measured in accordance with this 
section.
    (2) Measurements. Compliance with the exposure rate limit defined in 
paragraph (c)(1) of this section shall be determined by measurements 
made with an instrument, the radiation sensitive volume of which shall 
have a cross section parallel to the external surface of the receiver 
with an area of ten (10) square centimeters and no dimension larger than 
five (5) centimeters. Measurements made with instruments having other 
areas must be corrected for spatial nonuniformity of the radiation field 
to obtain the exposure rate average over a ten (10) square centimeter 
area.
    (3) Test conditions. All measurements shall be made with the 
receiver displaying a usable picture and with the power source operated 
at supply voltages up to the maximum test voltage of the receiver and, 
as applicable, under the following specific conditions:
    (i) On television receivers manufactured subsequent to January 15, 
1970, measurements shall be made with all user controls adjusted so as 
to produce maximum x-radiation emissions from the receiver.
    (ii) On television receivers manufactured subsequent to June 1, 
1970, measurements shall be made with all user controls and all service 
controls adjusted to combinations which result in the production of 
maximum x-radiation emissions.
    (iii) On television receivers manufactured subsequent to June 1, 
1971, measurements shall be made under the conditions described in 
paragraph (c)(3) (ii) of this section, together with conditions 
identical to those which result from that component or circuit failure 
which maximizes x-radiation emissions.
    (4) Critical component warning. The manufacturer shall permanently 
affix or inscribe a warning label, clearly legible under conditions of 
service, on all television receivers which could produce radiation 
exposure rates in excess of the requirements of this section as a result 
of failure or improper adjustment or improper replacement of a circuit 
or shield component. The warning label shall include the specification 
of operating high voltage and an instruction for adjusting the high 
voltage to the specified value.

[38 FR 28632, Oct. 15, 1973, as amended at 88 FR 3654, Jan. 20, 2023]



Sec. 1020.20  Cold-cathode gas discharge tubes.

    (a) Applicability. The provisions of this section are applicable to 
cold-cathode gas discharge tubes designed to demonstrate the effects of 
a flow of electrons or the production of x-radiation as specified 
herein.
    (b) Definitions. Beam blocking device means a movable or removable 
portion of any enclosure around a cold-cathode gas discharge tube, which 
may be opened or closed to permit or prevent the emergence of an exit 
beam.
    Cold-cathode gas discharge tube means an electronic device in which 
electron

[[Page 888]]

flow is produced and sustained by ionization of contained gas atoms and 
ion bombardment of the cathode.
    Exit beam means that portion of the radiation which passes through 
the aperture resulting from the opening of the beam blocking device.
    Exposure means the sum of the electrical charges on all of the ions 
of one sign produced in air when all electrons liberated by photons in a 
volume element of air are completely stopped in air divided by the mass 
of the air in the volume element. The special unit of exposure is the 
roentgen. One (1) roentgen equals 2.58 x 10-4 coulombs/
kilogram.
    (c) Requirements--(1) Exposure rate limit. (i) Radiation exposure 
rates produced by cold-cathode gas discharge tubes shall not exceed 10 
mR./hr. at a distance of thirty (30) centimeters from any point on the 
external surface of the tube, as measured in accordance with this 
section.
    (ii) The divergence of the exit beam from tubes designed primarily 
to demonstrate the effects of x radiation, with the beam blocking device 
in the open position, shall not exceed (Pi) steradians.
    (2) Measurements. (i) Compliance with the exposure rate limit 
defined in paragraph (c)(1)(i) of this section shall be determined by 
measurements averaged over an area of one hundred (100) square 
centimeters with no linear dimension greater than twenty (20) 
centimeters.
    (ii) Measurements of exposure rates from tubes in enclosures from 
which the tubes cannot be removed without destroying the function of the 
tube may be made at a distance of thirty (30) centimeters from any point 
on the external surface of the enclosure, provided:
    (a) In the case of enclosures containing tubes designed primarily to 
demonstrate the production of x radiation, measurements shall be made 
with any beam blocking device in the beam blocking position, or
    (b) In the case of enclosures containing tubes designed primarily to 
demonstrate the effects of a flow of electrons, measurements shall be 
made with all movable or removable parts of such enclosure in the 
position which would maximize external exposure levels.
    (3) Test conditions. (i) Measurements shall be made under the 
conditions of use specified in instructions provided by the 
manufacturer.
    (ii) Measurements shall be made with the tube operated under forward 
and reverse polarity.
    (4) Instructions, labels, and warnings. (i) Manufacturers shall 
provide, or cause to be provided, with each tube to which this section 
is applicable, appropriate safety instructions, together with 
instructions for the use of such tube, including the specification of a 
power source for use with the tube.
    (ii) Each enclosure or tube shall have inscribed on or permanently 
affixed to it, tags or labels, which identify the intended polarity of 
the terminals and:
    (a) In the case of tubes designed primarily to demonstrate the heat 
effect, fluorescence effect, or magnetic effect, a warning that 
application of power in excess of that specified may result in the 
production of x-rays in excess of allowable limits; and (b) in the case 
of tubes designed primarily to demonstrate the production of x-
radiation, a warning that this device produces x-rays when energized.
    (iii) The tag or label required by this paragraph shall be located 
on the tube or enclosure so as to be readily visible and legible when 
the product is fully assembled for use.



Sec. 1020.30  Diagnostic x-ray systems and their major components.

    (a) Applicability. (1) The provisions of this section are applicable 
to:
    (i) The following components of diagnostic x-ray systems:
    (A) Tube housing assemblies, x-ray controls, x-ray high-voltage 
generators, x-ray tables, cradles, film changers, vertical cassette 
holders mounted in a fixed location and cassette holders with front 
panels, and beam-limiting devices manufactured after August 1, 1974.
    (B) Fluoroscopic imaging assemblies manufactured after August 1, 
1974, and before April 26, 1977, or after June 10, 2006.
    (C) Spot-film devices and image intensifiers manufactured after 
April 26, 1977.

[[Page 889]]

    (D) Cephalometric devices manufactured after February 25, 1978.
    (E) Image receptor support devices for mammographic x-ray systems 
manufactured after September 5, 1978.
    (F) Image receptors that are electrically powered or connected with 
the x-ray system manufactured on or after June 10, 2006.
    (G) Fluoroscopic air kerma display devices manufactured on or after 
June 10, 2006.
    (ii) Diagnostic x-ray systems, except computed tomography x-ray 
systems, incorporating one or more of such components; however, such x-
ray systems shall be required to comply only with those provisions of 
this section and Sec. Sec. 1020.31 and 1020.32, which relate to the 
components certified in accordance with paragraph (c) of this section 
and installed into the systems.
    (iii) Computed tomography (CT) x-ray systems manufactured before 
November 29, 1984.
    (iv) CT gantries manufactured after September 3, 1985.
    (2) The following provisions of this section and Sec. 1020.33 are 
applicable to CT x-ray systems manufactured or remanufactured on or 
after November 29, 1984:
    (i) Section 1020.30(a);
    (ii) Section 1020.30(b) ``Technique factors'';
    (iii) Section 1020.30(b) ``CT,'' ``Dose,'' ``Scan,'' ``Scan time,'' 
and ``Tomogram'';
    (iv) Section 1020.30(h)(3)(vi) through (h)(3)(viii);
    (v) Section 1020.30(n);
    (vi) Section 1020.33(a) and (b);
    (vii) Section 1020.33(c)(1) as it affects Sec. 1020.33(c)(2); and
    (viii) Section 1020.33(c)(2).
    (3) The provisions of this section and Sec. 1020.33 in its 
entirety, including those provisions in paragraph (a)(2) of this 
section, are applicable to CT x-ray systems manufactured or 
remanufactured on or after September 3, 1985. The date of manufacture of 
the CT system is the date of manufacture of the CT gantry.
    (b) Definitions. As used in this section and Sec. Sec. 1020.31, 
1020.32, and 1020.33, the following definitions apply:
    Accessible surface means the external surface of the enclosure or 
housing provided by the manufacturer.
    Accessory component means:
    (1) A component used with diagnostic x-ray systems, such as a cradle 
or film changer, that is not necessary for the compliance of the system 
with applicable provisions of this subchapter but which requires an 
initial determination of compatibility with the system; or
    (2) A component necessary for compliance of the system with 
applicable provisions of this subchapter but which may be interchanged 
with similar compatible components without affecting the system's 
compliance, such as one of a set of interchangeable beam-limiting 
devices; or
    (3) A component compatible with all x-ray systems with which it may 
be used and that does not require compatibility or installation 
instructions, such as a tabletop cassette holder.
    Air kerma means kerma in air (see definition of Kerma).
    Air kerma rate (AKR) means the air kerma per unit time.
    Aluminum equivalent means the thickness of aluminum (type 1100 
alloy) \1\ affording the same attenuation, under specified conditions, 
as the material in question.
---------------------------------------------------------------------------

    \1\ The nominal chemical composition of type 1100 aluminum alloy is 
99.00 percent minimum aluminum, 0.12 percent copper, as given in 
``Aluminum Standards and Data'' (1969). Copies may be obtained from The 
Aluminum Association, New York, NY.
---------------------------------------------------------------------------

    Articulated joint means a joint between two separate sections of a 
tabletop which joint provides the capacity for one of the sections to 
pivot on the line segment along which the sections join.
    Assembler means any person engaged in the business of assembling, 
replacing, or installing one or more components into a diagnostic x-ray 
system or subsystem. The term includes the owner of an x-ray system or 
his or her employee or agent who assembles components into an x-ray 
system that is subsequently used to provide professional or commercial 
services.
    Attenuation block means a block or stack of type 1100 aluminum 
alloy, or aluminum alloy having equivalent attenuation, with dimensions 
20 centimeters (cm) or larger by 20 cm or larger by 3.8 cm, that is 
large enough to intercept the entire x-ray beam.

[[Page 890]]

    Automatic exposure control (AEC) means a device which automatically 
controls one or more technique factors in order to obtain at a 
preselected location(s) a required quantity of radiation.
    Automatic exposure rate control (AERC) means a device which 
automatically controls one or more technique factors in order to obtain 
at a preselected location(s) a required quantity of radiation per unit 
time.
    Beam axis means a line from the source through the centers of the x-
ray fields.
    Beam-limiting device means a device which provides a means to 
restrict the dimensions of the x-ray field.
    C-arm fluoroscope means a fluoroscopic x-ray system in which the 
image receptor and the x-ray tube housing assembly are connected or 
coordinated to maintain a spatial relationship. Such a system allows a 
change in the direction of the beam axis with respect to the patient 
without moving the patient.
    Cantilevered tabletop means a tabletop designed such that the 
unsupported portion can be extended at least 100 cm beyond the support.
    Cassette holder means a device, other than a spot-film device, that 
supports and/or fixes the position of an x-ray film cassette during an 
x-ray exposure.
    Cephalometric device means a device intended for the radiographic 
visualization and measurement of the dimensions of the human head.
    Coefficient of variation means the ratio of the standard deviation 
to the mean value of a population of observations. It is estimated using 
the following equation:
[GRAPHIC] [TIFF OMITTED] TR10JN05.001

where:

s = Estimated standard deviation of the population.
X = Mean value of observations in sample.
Xi = ith observation sampled.
n = Number of observations sampled.

    Computed tomography (CT) means the production of a tomogram by the 
acquisition and computer processing of x-ray transmission data.
    Control panel means that part of the x-ray control upon which are 
mounted the switches, knobs, pushbuttons, and other hardware necessary 
for manually setting the technique factors.
    Cooling curve means the graphical relationship between heat units 
stored and cooling time.
    Cradle means:
    (1) A removable device which supports and may restrain a patient 
above an x-ray table; or
    (2) A device;
    (i) Whose patient support structure is interposed between the 
patient and the image receptor during normal use;
    (ii) Which is equipped with means for patient restraint; and
    (iii) Which is capable of rotation about its long (longitudinal) 
axis.
    CT gantry means tube housing assemblies, beam-limiting devices, 
detectors, and the supporting structures, frames, and covers which hold 
and/or enclose these components.
    Cumulative air kerma means the total air kerma accrued from the 
beginning of an examination or procedure and includes all contributions 
from fluoroscopic and radiographic irradiation.
    Diagnostic source assembly means the tube housing assembly with a 
beam-limiting device attached.
    Diagnostic x-ray system means an x-ray system designed for 
irradiation of any part of the human body for the purpose of diagnosis 
or visualization.

[[Page 891]]

    Dose means the absorbed dose as defined by the International 
Commission on Radiation Units and Measurements. The absorbed dose, D, is 
the quotient of de by dm, where de is the mean energy imparted to matter 
of mass dm; thus D = de/dm, in units of J/kg, where the special name for 
the unit of absorbed dose is gray (Gy).
    Equipment means x-ray equipment.
    Exposure (X) means the quotient of dQ by dm where dQ is the absolute 
value of the total charge of the ions of one sign produced in air when 
all the electrons and positrons liberated or created by photons in air 
of mass dm are completely stopped in air; thus X = dQ/dm, in units of C/
kg. A second meaning of exposure is the process or condition during 
which the x-ray tube produces x-ray radiation.
    Field emission equipment means equipment which uses an x-ray tube in 
which electron emission from the cathode is due solely to action of an 
electric field.
    Fluoroscopic air kerma display device means a device, subsystem, or 
component that provides the display of AKR and cumulative air kerma 
required by Sec. 1020.32(k). It includes radiation detectors, if any, 
electronic and computer components, associated software, and data 
displays.
    Fluoroscopic imaging assembly means a subsystem in which x-ray 
photons produce a set of fluoroscopic images or radiographic images 
recorded from the fluoroscopic image receptor. It includes the image 
receptor(s), electrical interlocks, if any, and structural material 
providing linkage between the image receptor and diagnostic source 
assembly.
    Fluoroscopic irradiation time means the cumulative duration during 
an examination or procedure of operator-applied continuous pressure to 
the device, enabling x-ray tube activation in any fluoroscopic mode of 
operation.
    Fluoroscopy means a technique for generating x-ray images and 
presenting them simultaneously and continuously as visible images. This 
term has the same meaning as the term ``radioscopy'' in the standards of 
the International Electrotechnical Commission.
    General purpose radiographic x-ray system means any radiographic x-
ray system which, by design, is not limited to radiographic examination 
of specific anatomical regions.
    Half-value layer (HVL) means the thickness of specified material 
which attenuates the beam of radiation to an extent such that the AKR is 
reduced to one-half of its original value. In this definition the 
contribution of all scattered radiation, other than any which might be 
present initially in the beam concerned, is deemed to be excluded.
    Image intensifier means a device, installed in its housing, which 
instantaneously converts an x-ray pattern into a corresponding light 
image of higher energy density.
    Image receptor means any device, such as a fluorescent screen, 
radiographic film, x-ray image intensifier tube, solid-state detector, 
or gaseous detector, which transforms incident x-ray photons either into 
a visible image or into another form which can be made into a visible 
image by further transformations. In those cases where means are 
provided to preselect a portion of the image receptor, the term ``image 
receptor'' shall mean the preselected portion of the device.
    Image receptor support device means, for mammography x-ray systems, 
that part of the system designed to support the image receptor during a 
mammographic examination and to provide a primary protective barrier.
    Isocenter means the center of the smallest sphere through which the 
beam axis passes when the equipment moves through a full range of 
rotations about its common center.
    Kerma means the quantity as defined by the International Commission 
on Radiation Units and Measurements. The kerma, K, is the quotient of 
dEtr by dm, where dEtr is the sum of the initial 
kinetic energies of all the charged particles liberated by uncharged 
particles in a mass dm of material; thus K = dEtr/dm, in 
units of J/kg, where the special name for the unit of kerma is gray 
(Gy). When the material is air, the quantity is referred to as ``air 
kerma.''
    Last-image-hold (LIH) radiograph means an image obtained either by 
retaining one or more fluoroscopic images, which may be temporally 
integrated, at the end of a fluoroscopic exposure or by initiating a 
separate and

[[Page 892]]

distinct radiographic exposure automatically and immediately in 
conjunction with termination of the fluoroscopic exposure.
    Lateral fluoroscope means the x-ray tube and image receptor 
combination in a biplane system dedicated to the lateral projection. It 
consists of the lateral x-ray tube housing assembly and the lateral 
image receptor that are fixed in position relative to the table with the 
x-ray beam axis parallel to the plane of the table.
    Leakage radiation means radiation emanating from the diagnostic 
source assembly except for:
    (1) The useful beam; and
    (2) Radiation produced when the exposure switch or timer is not 
activated.
    Leakage technique factors means the technique factors associated 
with the diagnostic source assembly which are used in measuring leakage 
radiation. They are defined as follows:
    (1) For diagnostic source assemblies intended for capacitor energy 
storage equipment, the maximum-rated peak tube potential and the 
maximum-rated number of exposures in an hour for operation at the 
maximum-rated peak tube potential with the quantity of charge per 
exposure being 10 millicoulombs (or 10 mAs) or the minimum obtainable 
from the unit, whichever is larger;
    (2) For diagnostic source assemblies intended for field emission 
equipment rated for pulsed operation, the maximum-rated peak tube 
potential and the maximum-rated number of x-ray pulses in an hour for 
operation at the maximum-rated peak tube potential; and
    (3) For all other diagnostic source assemblies, the maximum-rated 
peak tube potential and the maximum-rated continuous tube current for 
the maximum-rated peak tube potential.
    Light field means that area of the intersection of the light beam 
from the beam-limiting device and one of the set of planes parallel to 
and including the plane of the image receptor, whose perimeter is the 
locus of points at which the illuminance is one-fourth of the maximum in 
the intersection.
    Line-voltage regulation means the difference between the no-load and 
the load line potentials expressed as a percent of the load line 
potential; that is,

Percent line-voltage regulation = 100(Vn - Vi)/
    Vi

where:

Vn = No-load line potential and
Vi = Load line potential.

    Maximum line current means the root mean square current in the 
supply line of an x-ray machine operating at its maximum rating.
    Mode of operation means, for fluoroscopic systems, a distinct method 
of fluoroscopy or radiography provided by the manufacturer and selected 
with a set of several technique factors or other control settings 
uniquely associated with the mode. The set of distinct technique factors 
and control settings for the mode may be selected by the operation of a 
single control. Examples of distinct modes of operation include normal 
fluoroscopy (analog or digital), high-level control fluoroscopy, 
cineradiography (analog or digital), digital subtraction angiography, 
electronic radiography using the fluoroscopic image receptor, and 
photospot recording. In a specific mode of operation, certain system 
variables affecting air kerma, AKR, or image quality, such as image 
magnification, x-ray field size, pulse rate, pulse duration, number of 
pulses, source-image receptor distance (SID), or optical aperture, may 
be adjustable or may vary; their variation per se does not comprise a 
mode of operation different from the one that has been selected.
    Movable tabletop means a tabletop which, when assembled for use, is 
capable of movement with respect to its supporting structure within the 
plane of the tabletop.
    Non-image-intensified fluoroscopy means fluoroscopy using only a 
fluorescent screen.
    Peak tube potential means the maximum value of the potential 
difference across the x-ray tube during an exposure.
    Primary protective barrier means the material, excluding filters, 
placed in the useful beam to reduce the radiation exposure for 
protection purposes.
    Pulsed mode means operation of the x-ray system such that the x-ray 
tube current is pulsed by the x-ray control

[[Page 893]]

to produce one or more exposure intervals of duration less than one-half 
second.
    Quick change x-ray tube means an x-ray tube designed for use in its 
associated tube housing such that:
    (1) The tube cannot be inserted in its housing in a manner that 
would result in noncompliance of the system with the requirements of 
paragraphs (k) and (m) of this section;
    (2) The focal spot position will not cause noncompliance with the 
provisions of this section or Sec. 1020.31 or 1020.32;
    (3) The shielding within the tube housing cannot be displaced; and
    (4) Any removal and subsequent replacement of a beam-limiting device 
during reloading of the tube in the tube housing will not result in 
noncompliance of the x-ray system with the applicable field limitation 
and alignment requirements of Sec. Sec. 1020.31 and 1020.32.
    Radiation therapy simulation system means a radiographic or 
fluoroscopic x-ray system intended for localizing the volume to be 
exposed during radiation therapy and confirming the position and size of 
the therapeutic irradiation field.
    Radiography means a technique for generating and recording an x-ray 
pattern for the purpose of providing the user with an image(s) after 
termination of the exposure.
    Rated line voltage means the range of potentials, in volts, of the 
supply line specified by the manufacturer at which the x-ray machine is 
designed to operate.
    Rated output current means the maximum allowable load current of the 
x-ray high-voltage generator.
    Rated output voltage means the allowable peak potential, in volts, 
at the output terminals of the x-ray high-voltage generator.
    Rating means the operating limits specified by the manufacturer.
    Recording means producing a retrievable form of an image resulting 
from x-ray photons.
    Scan means the complete process of collecting x-ray transmission 
data for the production of a tomogram. Data may be collected 
simultaneously during a single scan for the production of one or more 
tomograms.
    Scan time means the period of time between the beginning and end of 
x-ray transmission data accumulation for a single scan.
    Solid state x-ray imaging device means an assembly, typically in a 
rectangular panel configuration, that intercepts x-ray photons and 
converts the photon energy into a modulated electronic signal 
representative of the x-ray intensity over the area of the imaging 
device. The electronic signal is then used to create an image for 
display and/or storage.
    Source means the focal spot of the x-ray tube.
    Source-image receptor distance (SID) means the distance from the 
source to the center of the input surface of the image receptor.
    Source-skin distance (SSD) means the distance from the source to the 
center of the entrant x-ray field in the plane tangent to the patient 
skin surface.
    Spot-film device means a device intended to transport and/or 
position a radiographic image receptor between the x-ray source and 
fluoroscopic image receptor. It includes a device intended to hold a 
cassette over the input end of the fluoroscopic image receptor for the 
purpose of producing a radiograph.
    Stationary tabletop means a tabletop which, when assembled for use, 
is incapable of movement with respect to its supporting structure within 
the plane of the tabletop.
    Technique factors means the following conditions of operation:
    (1) For capacitor energy storage equipment, peak tube potential in 
kilovolts (kV) and quantity of charge in milliampere-seconds (mAs);
    (2) For field emission equipment rated for pulsed operation, peak 
tube potential in kV and number of x-ray pulses;
    (3) For CT equipment designed for pulsed operation, peak tube 
potential in kV, scan time in seconds, and either tube current in 
milliamperes (mA), x-ray pulse width in seconds, and the number of x-ray 
pulses per scan, or the product of the tube current, x-ray pulse width, 
and the number of x-ray pulses in mAs;

[[Page 894]]

    (4) For CT equipment not designed for pulsed operation, peak tube 
potential in kV, and either tube current in mA and scan time in seconds, 
or the product of tube current and exposure time in mAs and the scan 
time when the scan time and exposure time are equivalent; and
    (5) For all other equipment, peak tube potential in kV, and either 
tube current in mA and exposure time in seconds, or the product of tube 
current and exposure time in mAs.
    Tomogram means the depiction of the x-ray attenuation properties of 
a section through a body.
    Tube means an x-ray tube, unless otherwise specified.
    Tube housing assembly means the tube housing with tube installed. It 
includes high-voltage and/or filament transformers and other appropriate 
elements when they are contained within the tube housing.
    Tube rating chart means the set of curves which specify the rated 
limits of operation of the tube in terms of the technique factors.
    Useful beam means the radiation which passes through the tube 
housing port and the aperture of the beam-limiting device when the 
exposure switch or timer is activated.
    Variable-aperture beam-limiting device means a beam-limiting device 
which has the capacity for stepless adjustment of the x-ray field size 
at a given SID.
    Visible area means the portion of the input surface of the image 
receptor over which incident x-ray photons are producing a visible 
image.
    X-ray control means a device which controls input power to the x-ray 
high-voltage generator and/or the x-ray tube. It includes equipment such 
as timers, phototimers, automatic brightness stabilizers, and similar 
devices, which control the technique factors of an x-ray exposure.
    X-ray equipment means an x-ray system, subsystem, or component 
thereof. Types of x-ray equipment are as follows:
    (1) Mobile x-ray equipment means x-ray equipment mounted on a 
permanent base with wheels and/or casters for moving while completely 
assembled;
    (2) Portable x-ray equipment means x-ray equipment designed to be 
hand-carried; and
    (3) Stationary x-ray equipment means x-ray equipment which is 
installed in a fixed location.
    X-ray field means that area of the intersection of the useful beam 
and any one of the set of planes parallel to and including the plane of 
the image receptor, whose perimeter is the locus of points at which the 
AKR is one-fourth of the maximum in the intersection.
    X-ray high-voltage generator means a device which transforms 
electrical energy from the potential supplied by the x-ray control to 
the tube operating potential. The device may also include means for 
transforming alternating current to direct current, filament 
transformers for the x-ray tube(s), high-voltage switches, electrical 
protective devices, and other appropriate elements.
    X-ray subsystem means any combination of two or more components of 
an x-ray system for which there are requirements specified in this 
section and Sec. Sec. 1020.31 and 1020.32.
    X-ray system means an assemblage of components for the controlled 
production of x-rays. It includes minimally an x-ray high-voltage 
generator, an x-ray control, a tube housing assembly, a beam-limiting 
device, and the necessary supporting structures. Additional components 
which function with the system are considered integral parts of the 
system.
    X-ray table means a patient support device with its patient support 
structure (tabletop) interposed between the patient and the image 
receptor during radiography and/or fluoroscopy. This includes, but is 
not limited to, any stretcher equipped with a radiolucent panel and any 
table equipped with a cassette tray (or bucky), cassette tunnel, 
fluoroscopic image receptor, or spot-film device beneath the tabletop.
    X-ray tube means any electron tube which is designed for the 
conversion of electrical energy into x-ray energy.
    (c) Manufacturers' responsibility. Manufacturers of products subject 
to Sec. Sec. 1020.30 through 1020.33 shall certify that each of their 
products meets all applicable requirements when installed

[[Page 895]]

into a diagnostic x-ray system according to instructions. This 
certification shall be made under the format specified in Sec. 1010.2 
of this chapter. Manufacturers may certify a combination of two or more 
components if they obtain prior authorization in writing from the 
Director, Center for Devices and Radiological Health. Manufacturers 
shall not be held responsible for noncompliance of their products if 
that noncompliance is due solely to the improper installation or 
assembly of that product by another person; however, manufacturers are 
responsible for providing assembly instructions adequate to assure 
compliance of their components with the applicable provisions of 
Sec. Sec. 1020.30 through 1020.33.
    (d) Assemblers' responsibility. An assembler who installs one or 
more components certified as required by paragraph (c) of this section 
shall install certified components that are of the type required by 
Sec. 1020.31, Sec. 1020.32, or Sec. 1020.33 and shall assemble, 
install, adjust, and test the certified components according to the 
instructions of their respective manufacturers. Assemblers shall not be 
liable for noncompliance of a certified component if the assembly of 
that component was according to the component manufacturer's 
instruction.
    (1) Reports of assembly. All assemblers who install certified 
components shall file a report of assembly, except as specified in 
paragraph (d)(2) of this section. The report will be construed as the 
assembler's certification and identification under Sec. Sec. 1010.2 and 
1010.3 of this chapter. The assembler shall affirm in the report that 
the manufacturer's instructions were followed in the assembly or that 
the certified components as assembled into the system meet all 
applicable requirements of Sec. Sec. 1020.30 through 1020.33. All 
assembler reports must be on a form (Form FDA 2579 made available at 
https://www.fda.gov/about-fda/reports-manuals-forms/forms) prescribed by 
the Director, Center for Devices and Radiological Health. Completed 
reports must be submitted to the purchaser and, where applicable, to the 
State agency responsible for radiation protection within 15 days 
following completion of the assembly.
    (2) Exceptions to reporting requirements. Reports of assembly need 
not be submitted for any of the following:
    (i) Reloaded or replacement tube housing assemblies that are 
reinstalled in or newly assembled into an existing x-ray system;
    (ii) Certified accessory components;
    (iii) Repaired components, whether or not removed from the system 
and reinstalled during the course of repair, provided the original 
installation into the system was reported; or
    (iv)(A) Components installed temporarily in an x-ray system in place 
of components removed temporarily for repair, provided the temporarily 
installed component is identified by a tag or label bearing the 
following information:

Temporarily Installed Component
This certified component has been assembled, installed, adjusted, and 
tested by me according to the instructions provided by the manufacturer.
Signature
Company Name
Street Address, P.O. Box
City, State, Zip Code
Date of Installation

    (B) The replacement of the temporarily installed component by a 
component other than the component originally removed for repair shall 
be reported as specified in paragraph (d)(1) of this section.
    (e) Identification of x-ray components. In addition to the 
identification requirements specified in Sec. 1010.3 of this chapter, 
manufacturers of components subject to this section and Sec. Sec. 
1020.31, 1020.32, and 1020.33, except high-voltage generators contained 
within tube housings and beam-limiting devices that are integral parts 
of tube housings, shall permanently inscribe or affix thereon the model 
number and serial number of the product so that they are legible and 
accessible to view. The word ``model'' or ``type'' shall appear as part 
of the manufacturer's required identification of certified x-ray 
components. Where the certification of a system or subsystem, consisting 
of two or more components, has been authorized under paragraph (c) of 
this section, a single inscription, tag, or label bearing the model 
number and serial number may be used to identify the product.

[[Page 896]]

    (1) Tube housing assemblies. In a similar manner, manufacturers of 
tube housing assemblies shall also inscribe or affix thereon the name of 
the manufacturer, model number, and serial number of the x-ray tube 
which the tube housing assembly incorporates.
    (2) Replacement of tubes. Except as specified in paragraph (e)(3) of 
this section, the replacement of an x-ray tube in a previously 
manufactured tube housing assembly certified under paragraph (c) of this 
section constitutes manufacture of a new tube housing assembly, and the 
manufacturer is subject to the provisions of paragraph (e)(1) of this 
section. The manufacturer shall remove, cover, or deface any previously 
affixed inscriptions, tags, or labels that are no longer applicable.
    (3) Quick-change x-ray tubes. The requirements of paragraph (e)(2) 
of this section shall not apply to tube housing assemblies designed and 
designated by their original manufacturer to contain quick change x-ray 
tubes. The manufacturer of quick-change x-ray tubes shall include with 
each replacement tube a label with the tube manufacturer's name, the 
model, and serial number of the x-ray tube. The manufacturer of the tube 
shall instruct the assembler who installs the new tube to attach the 
label to the tube housing assembly and to remove, cover, or deface the 
previously affixed inscriptions, tags, or labels that are described by 
the tube manufacturer as no longer applicable.
    (f) [Reserved]
    (g) Information to be provided to assemblers. Manufacturers of 
components listed in paragraph (a)(1) of this section shall provide to 
assemblers subject to paragraph (d) of this section and, upon request, 
to others at a cost not to exceed the cost of publication and 
distribution, instructions for assembly, installation, adjustment, and 
testing of such components adequate to assure that the products will 
comply with applicable provisions of this section and Sec. Sec. 
1020.31, 1020.32, and 1020.33, when assembled, installed, adjusted, and 
tested as directed. Such instructions shall include specifications of 
other components compatible with that to be installed when compliance of 
the system or subsystem depends on their compatibility. Such 
specifications may describe pertinent physical characteristics of the 
components and/or may list by manufacturer model number the components 
which are compatible. For x-ray controls and generators manufactured 
after May 3, 1994, manufacturers shall provide:
    (1) A statement of the rated line voltage and the range of line-
voltage regulation for operation at maximum line current;
    (2) A statement of the maximum line current of the x-ray system 
based on the maximum input voltage and current characteristics of the 
tube housing assembly compatible with rated output voltage and rated 
output current characteristics of the x-ray control and associated high-
voltage generator. If the rated input voltage and current 
characteristics of the tube housing assembly are not known by the 
manufacturer of the x-ray control and associated high-voltage generator, 
the manufacturer shall provide information necessary to allow the 
assembler to determine the maximum line current for the particular tube 
housing assembly(ies);
    (3) A statement of the technique factors that constitute the maximum 
line current condition described in paragraph (g)(2) of this section.
    (h) Information to be provided to users. Manufacturers of x-ray 
equipment shall provide to purchasers and, upon request, to others at a 
cost not to exceed the cost of publication and distribution, manuals or 
instruction sheets which shall include the following technical and 
safety information:
    (1) All x-ray equipment. For x-ray equipment to which this section 
and Sec. Sec. 1020.31, 1020.32, and 1020.33 are applicable, there shall 
be provided:
    (i) Adequate instructions concerning any radiological safety 
procedures and precautions which may be necessary because of unique 
features of the equipment; and
    (ii) A schedule of the maintenance necessary to keep the equipment 
in compliance with this section and Sec. Sec. 1020.31, 1020.32, and 
1020.33.
    (2) Tube housing assemblies. For each tube housing assembly, there 
shall be provided:

[[Page 897]]

    (i) Statements of the leakage technique factors for all combinations 
of tube housing assemblies and beam-limiting devices for which the tube 
housing assembly manufacturer states compatibility, the minimum 
filtration permanently in the useful beam expressed as millimeters (mm) 
of aluminum equivalent, and the peak tube potential at which the 
aluminum equivalent was obtained;
    (ii) Cooling curves for the anode and tube housing; and
    (iii) Tube rating charts. If the tube is designed to operate from 
different types of x-ray high-voltage generators (such as single-phase 
self rectified, single-phase half-wave rectified, single-phase full-wave 
rectified, 3-phase 6-pulse, 3-phase 12-pulse, constant potential, 
capacitor energy storage) or under modes of operation such as alternate 
focal spot sizes or speeds of anode rotation which affect its rating, 
specific identification of the difference in ratings shall be noted.
    (3) X-ray controls and generators. For the x-ray control and 
associated x-ray high-voltage generator, there shall be provided:
    (i) A statement of the rated line voltage and the range of line-
voltage regulation for operation at maximum line current;
    (ii) A statement of the maximum line current of the x-ray system 
based on the maximum input voltage and output current characteristics of 
the tube housing assembly compatible with rated output voltage and rated 
current characteristics of the x-ray control and associated high-voltage 
generator. If the rated input voltage and current characteristics of the 
tube housing assembly are not known by the manufacturer of the x-ray 
control and associated high-voltage generator, the manufacturer shall 
provide necessary information to allow the purchaser to determine the 
maximum line current for his particular tube housing assembly(ies);
    (iii) A statement of the technique factors that constitute the 
maximum line current condition described in paragraph (h)(3)(ii) of this 
section;
    (iv) In the case of battery-powered generators, a specification of 
the minimum state of charge necessary for proper operation;
    (v) Generator rating and duty cycle;
    (vi) A statement of the maximum deviation from the preindication 
given by labeled technique factor control settings or indicators during 
any radiographic or CT exposure where the equipment is connected to a 
power supply as described in accordance with this paragraph. In the case 
of fixed technique factors, the maximum deviation from the nominal fixed 
value of each factor shall be stated;
    (vii) A statement of the maximum deviation from the continuous 
indication of x-ray tube potential and current during any fluoroscopic 
exposure when the equipment is connected to a power supply as described 
in accordance with this paragraph; and
    (viii) A statement describing the measurement criteria for all 
technique factors used in paragraphs (h)(3)(iii), (h)(3)(vi), and 
(h)(3)(vii) of this section; for example, the beginning and endpoints of 
exposure time measured with respect to a certain percentage of the 
voltage waveform.
    (4) Beam-limiting device. For each variable-aperture beam-limiting 
device, there shall be provided;
    (i) Leakage technique factors for all combinations of tube housing 
assemblies and beam-limiting devices for which the beam-limiting device 
manufacturer states compatibility; and
    (ii) A statement including the minimum aluminum equivalent of that 
part of the device through which the useful beam passes and including 
the x-ray tube potential at which the aluminum equivalent was obtained. 
When two or more filters are provided as part of the device, the 
statement shall include the aluminum equivalent of each filter.
    (5) Imaging system information. For x-ray systems manufactured on or 
after June 10, 2006, that produce images using the fluoroscopic image 
receptor, the following information shall be provided in a separate, 
single section of the user's instruction manual or in a separate manual 
devoted to this information:
    (i) For each mode of operation, a description of the mode and 
detailed instructions on how the mode is engaged and disengaged. The 
description of the mode shall identify those technique

[[Page 898]]

factors and system controls that are fixed or automatically adjusted by 
selection of the mode of operation, including the manner in which the 
automatic adjustment is controlled. This information shall include how 
the operator can recognize which mode of operation has been selected 
prior to initiation of x-ray production.
    (ii) For each mode of operation, a descriptive example(s) of any 
specific clinical procedure(s) or imaging task(s) for which the mode is 
recommended or designed and how each mode should be used. Such 
recommendations do not preclude other clinical uses.
    (6) Displays of values of AKR and cumulative air kerma. For 
fluoroscopic x-ray systems manufactured on or after June 10, 2006, the 
following shall be provided:
    (i) A schedule of maintenance for any system instrumentation 
associated with the display of air kerma information necessary to 
maintain the displays of AKR and cumulative air kerma within the limits 
of allowed uncertainty specified by Sec. 1020.32(k)(6) and, if the 
capability for user calibration of the display is provided, adequate 
instructions for such calibration;
    (ii) Identification of the distances along the beam axis:
    (A) From the focal spot to the isocenter, and
    (B) From the focal spot to the reference location to which displayed 
values of AKR and cumulative air kerma refer according to Sec. 
1020.32(k)(4);
    (iii) A rationale for specification of a reference irradiation 
location alternative to 15 cm from the isocenter toward the x-ray source 
along the beam axis when such alternative specification is made 
according to Sec. 1020.32(k)(4)(ii).
    (i) [Reserved]
    (j) Warning label. The control panel containing the main power 
switch shall bear the warning statement, legible and accessible to view:

    ``Warning: This x-ray unit may be dangerous to patient and operator 
unless safe exposure factors, operating instructions and maintenance 
schedules are observed.''

    (k) Leakage radiation from the diagnostic source assembly. The 
leakage radiation from the diagnostic source assembly measured at a 
distance of 1 meter in any direction from the source shall not exceed 
0.88 milligray (mGy) air kerma (vice 100 milliroentgen (mR) exposure) in 
1 hour when the x-ray tube is operated at the leakage technique factors. 
If the maximum rated peak tube potential of the tube housing assembly is 
greater than the maximum rated peak tube potential for the diagnostic 
source assembly, positive means shall be provided to limit the maximum 
x-ray tube potential to that of the diagnostic source assembly. 
Compliance shall be determined by measurements averaged over an area of 
100 square cm with no linear dimension greater than 20 cm.
    (l) Radiation from components other than the diagnostic source 
assembly. The radiation emitted by a component other than the diagnostic 
source assembly shall not exceed an air kerma of 18 microGy (vice 2 mR 
exposure) in 1 hour at 5 cm from any accessible surface of the component 
when it is operated in an assembled x-ray system under any conditions 
for which it was designed. Compliance shall be determined by 
measurements averaged over an area of 100 square cm with no linear 
dimension greater than 20 cm.
    (m) Beam quality--(1) Half-value layer (HVL). The HVL of the useful 
beam for a given x-ray tube potential shall not be less than the 
appropriate value shown in table 1 in paragraph (m)(1) of this section 
under the heading ``Specified Dental Systems,'' for any dental x-ray 
system designed for use with intraoral image receptors and manufactured 
after December 1, 1980; under the heading ``I--Other X-Ray Systems,'' 
for any dental x-ray system designed for use with intraoral image 
receptors and manufactured before December 1, 1980, and all other x-ray 
systems subject to this section and manufactured before June 10, 2006; 
and under the heading ``II--Other X-Ray Systems,'' for all x-ray 
systems, except dental x-ray systems designed for use with intraoral 
image receptors, subject to this section and manufactured on or after 
June 10, 2006. If it is necessary to determine such HVL at an x-ray tube 
potential which is not listed in table 1 in paragraph (m)(1) of this 
section, linear interpolation or extrapolation may

[[Page 899]]

be made. Positive means \2\ shall be provided to ensure that at least 
the minimum filtration needed to achieve the above beam quality 
requirements is in the useful beam during each exposure. Table 1 
follows:
---------------------------------------------------------------------------

    \2\ In the case of a system, which is to be operated with more than 
one thickness of filtration, this requirement can be met by a filter 
interlocked with the kilovoltage selector which will prevent x-ray 
emissions if the minimum required filtration is not in place.

                                                     Table 1
----------------------------------------------------------------------------------------------------------------
             X-Ray Tube Voltage (kilovolt peak)                    Minimum HVL (mm of aluminum)
----------------------------------------------------------------------------------------------------
                                                Measured       Specified   I--Other X-  II--Other X-
          Designed Operating Range              Operating       Dental     Ray Systems   Ray Systems
                                                Potential     Systems \1\      \2\           \3\
----------------------------------------------------------------------------------------------------
Below 51                                                 30           1.5          0.3           0.3
                                                         40           1.5          0.4           0.4
                                                         50           1.5          0.5           0.5
51 to 70                                                 51           1.5          1.2           1.3
                                                         60           1.5          1.3           1.5
                                                         70           1.5          1.5           1.8
Above 70                                                 71           2.1          2.1           2.5
                                                         80           2.3          2.3           2.9
                                                         90           2.5          2.5           3.2
                                                        100           2.7          2.7           3.6
                                                        110           3.0          3.0           3.9
                                                        120           3.2          3.2           4.3
                                                        130           3.5          3.5           4.7
                                                        140           3.8          3.8           5.0
                                                        150           4.1          4.1           5.4
----------------------------------------------------------------------------------------------------------------
\1\ Dental x-ray systems designed for use with intraoral image receptors and manufactured after December 1,
  1980.
\2\ Dental x-ray systems designed for use with intraoral image receptors and manufactured before or on December
  1, 1980, and all other x-ray systems subject to this section and manufactured before June 10, 2006.
\3\ All x-ray systems, except dental x-ray systems designed for use with intraoral image receptors, subject to
  this section and manufactured on or after June 10, 2006.

    (2) Optional filtration. Fluoroscopic systems manufactured on or 
after June 10, 2006, incorporating an x-ray tube(s) with a continuous 
output of 1 kilowatt or more and an anode heat storage capacity of 1 
million heat units or more shall provide the option of adding x-ray 
filtration to the diagnostic source assembly in addition to the amount 
needed to meet the HVL provisions of Sec. 1020.30(m)(1). The selection 
of this additional x-ray filtration shall be either at the option of the 
user or automatic as part of the selected mode of operation. A means of 
indicating which combination of additional filtration is in the x-ray 
beam shall be provided.
    (3) Measuring compliance. For capacitor energy storage equipment, 
compliance shall be determined with the maximum selectable quantity of 
charge per exposure.
    (n) Aluminum equivalent of material between patient and image 
receptor. Except when used in a CT x-ray system, the aluminum equivalent 
of each of the items listed in table 2 in paragraph (n) of this section, 
which are used between the patient and image receptor, may not exceed 
the indicated limits. Compliance shall be determined by x-ray 
measurements made at a potential of 100 kilovolts peak and with an x-ray 
beam that has an HVL specified in table 1 in paragraph (m)(1) of this 
section for the potential. This requirement applies to front panel(s) of 
cassette holders and film changers provided by the manufacturer for 
patient support or for prevention of foreign object intrusions. It does 
not apply to screens and their associated mechanical support panels or 
grids. Table 2 follows:

                                 Table 2
------------------------------------------------------------------------
                                                        Maximum Aluminum
                         Item                              Equivalent
                                                         (millimeters)
------------------------------------------------------------------------
1. Front panel(s) of cassette holders (total of all)                1.2

[[Page 900]]

 
2. Front panel(s) of film changer (total of all)                    1.2
3. Cradle                                                           2.3
4. Tabletop, stationary, without articulated joints                 1.2
5. Tabletop, movable, without articulated joint(s)                  1.7
 (including stationary subtop)
6. Tabletop, with radiolucent panel having one                      1.7
 articulated joint
7. Tabletop, with radiolucent panel having two or                   2.3
 more articulated joints
8. Tabletop, cantilevered                                           2.3
9. Tabletop, radiation therapy simulator                            5.0
------------------------------------------------------------------------

    (o) Battery charge indicator. On battery-powered generators, visual 
means shall be provided on the control panel to indicate whether the 
battery is in a state of charge adequate for proper operation.
    (p) [Reserved]
    (q) Modification of certified diagnostic x-ray components and 
systems. (1) Diagnostic x-ray components and systems certified in 
accordance with Sec. 1010.2 of this chapter shall not be modified such 
that the component or system fails to comply with any applicable 
provision of this chapter unless a variance in accordance with Sec. 
1010.4 of this chapter or an exemption under section 534(a)(5) or 538(b) 
of the Federal Food, Drug, and Cosmetic Act has been granted.
    (2) The owner of a diagnostic x-ray system who uses the system in a 
professional or commercial capacity may modify the system, provided the 
modification does not result in the failure of the system or component 
to comply with the applicable requirements of this section or of Sec. 
1020.31, 1020.32, or 1020.33. The owner who causes such modification 
need not submit the reports required by subpart B of part 1002 of this 
chapter, provided the owner records the date and the details of the 
modification in the system records and maintains this information, and 
provided the modification of the x-ray system does not result in a 
failure to comply with Sec. 1020.31, 1020.32, or 1020.33.

[71 FR 34028, June 10, 2006, as amended at 72 FR 17401, Apr. 9, 2007; 83 
FR 13864, Apr. 2, 2018; 88 FR 3654, Jan. 20, 202]



Sec. 1020.31  Radiographic equipment.

    The provisions of this section apply to equipment for radiography, 
except equipment for fluoroscopic imaging or for recording images from 
the fluoroscopic image receptor, or computed tomography x-ray systems 
manufactured on or after November 29, 1984.
    (a) Control and indication of technique factors--(1) Visual 
indication. The technique factors to be used during an exposure shall be 
indicated before the exposure begins, except when automatic exposure 
controls are used, in which case the technique factors which are set 
prior to the exposure shall be indicated. On equipment having fixed 
technique factors, this requirement may be met by permanent markings. 
Indication of technique factors shall be visible from the operator's 
position except in the case of spot films made by the fluoroscopist.
    (2) Timers. Means shall be provided to terminate the exposure at a 
preset time interval, a preset product of current and time, a preset 
number of pulses, or a preset radiation exposure to the image receptor.
    (i) Except during serial radiography, the operator shall be able to 
terminate the exposure at any time during an exposure of greater than 
one-half second. Except during panoramic dental radiography, termination 
of exposure shall cause automatic resetting of the timer to its initial 
setting or to zero. It shall not be possible to make an exposure when 
the timer is set to a zero or off position if either position is 
provided.
    (ii) During serial radiography, the operator shall be able to 
terminate the x-ray exposure(s) at any time, but means may be provided 
to permit completion of any single exposure of the series in process.
    (3) Automatic exposure controls. When an automatic exposure control 
is provided:

[[Page 901]]

    (i) Indication shall be made on the control panel when this mode of 
operation is selected;
    (ii) When the x-ray tube potential is equal to or greater than 51 
kilovolts peak (kVp), the minimum exposure time for field emission 
equipment rated for pulsed operation shall be equal to or less than a 
time interval equivalent to two pulses and the minimum exposure time for 
all other equipment shall be equal to or less than \1/60\ second or a 
time interval required to deliver 5 milliampere-seconds (mAs), whichever 
is greater;
    (iii) Either the product of peak x-ray tube potential, current, and 
exposure time shall be limited to not more than 60 kilowatt-seconds 
(kWs) per exposure or the product of x-ray tube current and exposure 
time shall be limited to not more than 600 mAs per exposure, except when 
the x-ray tube potential is less than 51 kVp, in which case the product 
of x-ray tube current and exposure time shall be limited to not more 
than 2,000 mAs per exposure; and
    (iv) A visible signal shall indicate when an exposure has been 
terminated at the limits described in paragraph (a)(3)(iii) of this 
section, and manual resetting shall be required before further 
automatically timed exposures can be made.
    (4) Accuracy. Deviation of technique factors from indicated values 
shall not exceed the limits given in the information provided in 
accordance with Sec. 1020.30(h)(3).
    (b) Reproducibility. The following requirements shall apply when the 
equipment is operated on an adequate power supply as specified by the 
manufacturer in accordance with the requirements of Sec. 1020.30(h)(3):
    (1) Coefficient of variation. For any specific combination of 
selected technique factors, the estimated coefficient of variation of 
the air kerma shall be no greater than 0.05.
    (2) Measuring compliance. Determination of compliance shall be based 
on 10 consecutive measurements taken within a time period of 1 hour. 
Equipment manufactured after September 5, 1978, shall be subject to the 
additional requirement that all variable controls for technique factors 
shall be adjusted to alternate settings and reset to the test setting 
after each measurement. The percent line-voltage regulation shall be 
determined for each measurement. All values for percent line-voltage 
regulation shall be within 1 of the mean value for 
all measurements. For equipment having automatic exposure controls, 
compliance shall be determined with a sufficient thickness of 
attenuating material in the useful beam such that the technique factors 
can be adjusted to provide individual exposures of a minimum of 12 
pulses on field emission equipment rated for pulsed operation or no less 
than one-tenth second per exposure on all other equipment.
    (c) Linearity. The following requirements apply when the equipment 
is operated on a power supply as specified by the manufacturer in 
accordance with the requirements of Sec. 1020.30(h)(3) for any fixed x-
ray tube potential within the range of 40 percent to 100 percent of the 
maximum rated.
    (1) Equipment having independent selection of x-ray tube current 
(mA). The average ratios of air kerma to the indicated milliampere-
seconds product (mGy/mAs) obtained at any two consecutive tube current 
settings shall not differ by more than 0.10 times their sum. This is: 
[bond]X1 - X2[bond] <=0.10(X1 + 
X2); where X1 and X2 are the average 
mGy/mAs values obtained at each of two consecutive mAs selector settings 
or at two settings differing by no more than a factor of 2 where the mAs 
selector provides continuous selection.
    (2) Equipment having selection of x-ray tube current-exposure time 
product (mAs). For equipment manufactured after May 3, 1994, the average 
ratios of air kerma to the indicated milliampere-seconds product (mGy/
mAs) obtained at any two consecutive mAs selector settings shall not 
differ by more than 0.10 times their sum. This is: [bond]X1 - 
X2[bond] <=0.10 (X1 + X2); where 
X1 and X2 are the average mGy/mAs values obtained 
at each of two consecutive mAs selector settings or at two settings 
differing by no more than a factor of 2 where the mAs selector provides 
continuous selection.
    (3) Measuring compliance. Determination of compliance will be based 
on 10 exposures, made within 1 hour, at each of the two settings. These 
two settings

[[Page 902]]

may include any two focal spot sizes except where one is equal to or 
less than 0.45 mm and the other is greater than 0.45 mm. For purposes of 
this requirement, focal spot size is the focal spot size specified by 
the x-ray tube manufacturer. The percent line-voltage regulation shall 
be determined for each measurement. All values for percent line-voltage 
regulation at any one combination of technique factors shall be within 
1 of the mean value for all measurements at these 
technique factors.
    (d) Field limitation and alignment for mobile, portable, and 
stationary general purpose x-ray systems. Except when spot-film devices 
are in service, mobile, portable, and stationary general purpose 
radiographic x-ray systems shall meet the following requirements:
    (1) Variable x-ray field limitation. A means for stepless adjustment 
of the size of the x-ray field shall be provided. Each dimension of the 
minimum field size at an SID of 100 centimeters (cm) shall be equal to 
or less than 5 cm.
    (2) Visual definition. (i) Means for visually defining the perimeter 
of the x-ray field shall be provided. The total misalignment of the 
edges of the visually defined field with the respective edges of the x-
ray field along either the length or width of the visually defined field 
shall not exceed 2 percent of the distance from the source to the center 
of the visually defined field when the surface upon which it appears is 
perpendicular to the axis of the x-ray beam.
    (ii) When a light localizer is used to define the x-ray field, it 
shall provide an average illuminance of not less than 160 lux (15 
footcandles) at 100 cm or at the maximum SID, whichever is less. The 
average illuminance shall be based on measurements made in the 
approximate center of each quadrant of the light field. Radiation 
therapy simulation systems are exempt from this requirement.
    (iii) The edge of the light field at 100 cm or at the maximum SID, 
whichever is less, shall have a contrast ratio, corrected for ambient 
lighting, of not less than 4 in the case of beam-limiting devices 
designed for use on stationary equipment, and a contrast ratio of not 
less than 3 in the case of beam-limiting devices designed for use on 
mobile and portable equipment. The contrast ratio is defined as 
I1/I2, where I1 is the illuminance 3 mm 
from the edge of the light field toward the center of the field; and 
I2 is the illuminance 3 mm from the edge of the light field 
away from the center of the field. Compliance shall be determined with a 
measuring aperture of 1 mm.
    (e) Field indication and alignment on stationary general purpose x-
ray equipment. Except when spot-film devices are in service, stationary 
general purpose x-ray systems shall meet the following requirements in 
addition to those prescribed in paragraph (d) of this section:
    (1) Means shall be provided to indicate when the axis of the x-ray 
beam is perpendicular to the plane of the image receptor, to align the 
center of the x-ray field with respect to the center of the image 
receptor to within 2 percent of the SID, and to indicate the SID to 
within 2 percent;
    (2) The beam-limiting device shall numerically indicate the field 
size in the plane of the image receptor to which it is adjusted;
    (3) Indication of field size dimensions and SIDs shall be specified 
in centimeters and/or inches and shall be such that aperture adjustments 
result in x-ray field dimensions in the plane of the image receptor 
which correspond to those indicated by the beam-limiting device to 
within 2 percent of the SID when the beam axis is indicated to be 
perpendicular to the plane of the image receptor; and
    (4) Compliance measurements will be made at discrete SIDs and image 
receptor dimensions in common clinical use (such as SIDs of 100, 150, 
and 200 cm and/or 36, 40, 48, and 72 inches and nominal image receptor 
dimensions of 13, 18, 24, 30, 35, 40, and 43 cm and/or 5, 7, 8, 9, 10, 
11, 12, 14, and 17 inches) or at any other specific dimensions at which 
the beam-limiting device or its associated diagnostic x-ray system is 
uniquely designed to operate.
    (f) Field limitation on radiographic x-ray equipment other than 
general purpose radiographic systems--(1) Equipment for use with 
intraoral image receptors. Radiographic equipment designed for use with 
an intraoral image receptor shall

[[Page 903]]

be provided with means to limit the x-ray beam such that:
    (i) If the minimum source-to-skin distance (SSD) is 18 cm or more, 
the x-ray field at the minimum SSD shall be containable in a circle 
having a diameter of no more than 7 cm; and
    (ii) If the minimum SSD is less than 18 cm, the x-ray field at the 
minimum SSD shall be containable in a circle having a diameter of no 
more than 6 cm.
    (2) X-ray systems designed for one image receptor size. Radiographic 
equipment designed for only one image receptor size at a fixed SID shall 
be provided with means to limit the field at the plane of the image 
receptor to dimensions no greater than those of the image receptor, and 
to align the center of the x-ray field with the center of the image 
receptor to within 2 percent of the SID, or shall be provided with means 
to both size and align the x-ray field such that the x-ray field at the 
plane of the image receptor does not extend beyond any edge of the image 
receptor.
    (3) Systems designed for mammography--(i) Radiographic systems 
designed only for mammography and general purpose radiography systems, 
when special attachments for mammography are in service, manufactured on 
or after November 1, 1977, and before September 30, 1999, shall be 
provided with means to limit the useful beam such that the x-ray field 
at the plane of the image receptor does not extend beyond any edge of 
the image receptor at any designated SID except the edge of the image 
receptor designed to be adjacent to the chest wall where the x-ray field 
may not extend beyond this edge by more than 2 percent of the SID. This 
requirement can be met with a system that performs as prescribed in 
paragraphs (f)(4)(i), (f)(4)(ii), and (f)(4)(iii) of this section. When 
the beam-limiting device and image receptor support device are designed 
to be used to immobilize the breast during a mammographic procedure and 
the SID may vary, the SID indication specified in paragraphs (f)(4)(ii) 
and (f)(4)(iii) of this section shall be the maximum SID for which the 
beam-limiting device or aperture is designed.
    (ii) Mammographic beam-limiting devices manufactured on or after 
September 30, 1999, shall be provided with a means to limit the useful 
beam such that the x-ray field at the plane of the image receptor does 
not extend beyond any edge of the image receptor by more than 2 percent 
of the SID. This requirement can be met with a system that performs as 
prescribed in paragraphs (f)(4)(i), (f)(4)(ii), and (f)(4)(iii) of this 
section. For systems that allow changes in the SID, the SID indication 
specified in paragraphs (f)(4)(ii) and (f)(4)(iii) of this section shall 
be the maximum SID for which the beam-limiting device or aperture is 
designed.
    (iii) Each image receptor support device manufactured on or after 
November 1, 1977, intended for installation on a system designed for 
mammography shall have clear and permanent markings to indicate the 
maximum image receptor size for which it is designed.
    (4) Other x-ray systems. Radiographic systems not specifically 
covered in paragraphs (d), (e), (f)(2), (f)(3), and (h) of this section 
and systems covered in paragraph (f)(1) of this section, which are also 
designed for use with extraoral image receptors and when used with an 
extraoral image receptor, shall be provided with means to limit the x-
ray field in the plane of the image receptor so that such field does not 
exceed each dimension of the image receptor by more than 2 percent of 
the SID, when the axis of the x-ray beam is perpendicular to the plane 
of the image receptor. In addition, means shall be provided to align the 
center of the x-ray field with the center of the image receptor to 
within 2 percent of the SID, or means shall be provided to both size and 
align the x-ray field such that the x-ray field at the plane of the 
image receptor does not extend beyond any edge of the image receptor. 
These requirements may be met with:
    (i) A system which performs in accordance with paragraphs (d) and 
(e) of this section; or when alignment means are also provided, may be 
met with either;
    (ii) An assortment of removable, fixed-aperture, beam-limiting 
devices sufficient to meet the requirement for each combination of image 
receptor

[[Page 904]]

size and SID for which the unit is designed. Each such device shall have 
clear and permanent markings to indicate the image receptor size and SID 
for which it is designed; or
    (iii) A beam-limiting device having multiple fixed apertures 
sufficient to meet the requirement for each combination of image 
receptor size and SID for which the unit is designed. Permanent, clearly 
legible markings shall indicate the image receptor size and SID for 
which each aperture is designed and shall indicate which aperture is in 
position for use.
    (g) Positive beam limitation (PBL). The requirements of this 
paragraph shall apply to radiographic systems which contain PBL.
    (1) Field size. When a PBL system is provided, it shall prevent x-
ray production when:
    (i) Either the length or width of the x-ray field in the plane of 
the image receptor differs from the corresponding image receptor 
dimension by more than 3 percent of the SID; or
    (ii) The sum of the length and width differences as stated in 
paragraph (g)(1)(i) of this section without regard to sign exceeds 4 
percent of the SID.
    (iii) The beam limiting device is at an SID for which PBL is not 
designed for sizing.
    (2) Conditions for PBL. When provided, the PBL system shall function 
as described in paragraph (g)(1) of this section whenever all the 
following conditions are met:
    (i) The image receptor is inserted into a permanently mounted 
cassette holder;
    (ii) The image receptor length and width are less than 50 cm;
    (iii) The x-ray beam axis is within 3 degrees 
of vertical and the SID is 90 cm to 130 cm inclusive; or the x-ray beam 
axis is within 3 degrees of horizontal and the SID 
is 90 cm to 205 cm inclusive;
    (iv) The x-ray beam axis is perpendicular to the plane of the image 
receptor to within 3 degrees; and
    (v) Neither tomographic nor stereoscopic radiography is being 
performed.
    (3) Measuring compliance. Compliance with the requirements of 
paragraph (g)(1) of this section shall be determined when the equipment 
indicates that the beam axis is perpendicular to the plane of the image 
receptor and the provisions of paragraph (g)(2) of this section are met. 
Compliance shall be determined no sooner than 5 seconds after insertion 
of the image receptor.
    (4) Operator initiated undersizing. The PBL system shall be capable 
of operation such that, at the discretion of the operator, the size of 
the field may be made smaller than the size of the image receptor 
through stepless adjustment of the field size. Each dimension of the 
minimum field size at an SID of 100 cm shall be equal to or less than 5 
cm. Return to PBL function as described in paragraph (g)(1) of this 
section shall occur automatically upon any change of image receptor size 
or SID.
    (5) Override of PBL. A capability may be provided for overriding PBL 
in case of system failure and for servicing the system. This override 
may be for all SIDs and image receptor sizes. A key shall be required 
for any override capability that is accessible to the operator. It shall 
not be possible to remove the key while PBL is overridden. Each such key 
switch or key shall be clearly and durably labeled as follows:

For X-ray Field Limitation System Failure
The override capability is considered accessible to the operator if it 
is referenced in the operator's manual or in other material intended for 
the operator or if its location is such that the operator would consider 
it part of the operational controls.

    (h) Field limitation and alignment for spot-film devices. The 
following requirements shall apply to spot-film devices, except when the 
spot-film device is provided for use with a radiation therapy simulation 
system:
    (1) Means shall be provided between the source and the patient for 
adjustment of the x-ray field size in the plane of the image receptor to 
the size of that portion of the image receptor which has been selected 
on the spot-film selector. Such adjustment shall be accomplished 
automatically when the x-ray field size in the plane of the image 
receptor is greater than the selected portion of the image receptor. If 
the x-ray field size is less than the size of the selected portion of 
the image receptor, the field size shall not open

[[Page 905]]

automatically to the size of the selected portion of the image receptor 
unless the operator has selected that mode of operation.
    (2) Neither the length nor the width of the x-ray field in the plane 
of the image receptor shall differ from the corresponding dimensions of 
the selected portion of the image receptor by more than 3 percent of the 
SID when adjusted for full coverage of the selected portion of the image 
receptor. The sum, without regard to sign, of the length and width 
differences shall not exceed 4 percent of the SID. On spot-film devices 
manufactured after February 25, 1978, if the angle between the plane of 
the image receptor and beam axis is variable, means shall be provided to 
indicate when the axis of the x-ray beam is perpendicular to the plane 
of the image receptor, and compliance shall be determined with the beam 
axis indicated to be perpendicular to the plane of the image receptor.
    (3) The center of the x-ray field in the plane of the image receptor 
shall be aligned with the center of the selected portion of the image 
receptor to within 2 percent of the SID.
    (4) Means shall be provided to reduce the x-ray field size in the 
plane of the image receptor to a size smaller than the selected portion 
of the image receptor such that:
    (i) For spot-film devices used on fixed-SID fluoroscopic systems 
which are not required to, and do not provide stepless adjustment of the 
x-ray field, the minimum field size, at the greatest SID, does not 
exceed 125 square cm; or
    (ii) For spot-film devices used on fluoroscopic systems that have a 
variable SID and/or stepless adjustment of the field size, the minimum 
field size, at the greatest SID, shall be containable in a square of 5 
cm by 5 cm.
    (5) A capability may be provided for overriding the automatic x-ray 
field size adjustment in case of system failure. If it is so provided, a 
signal visible at the fluoroscopist's position shall indicate whenever 
the automatic x-ray field size adjustment override is engaged. Each such 
system failure override switch shall be clearly labeled as follows:

For X-ray Field Limitation System Failure

    (i) Source-skin distance--(1) X-ray systems designed for use with an 
intraoral image receptor shall be provided with means to limit the 
source-skin distance to not less than:
    (i) Eighteen cm if operable above 50 kVp; or
    (ii) Ten cm if not operable above 50 kVp.
    (2) Mobile and portable x-ray systems other than dental shall be 
provided with means to limit the source-skin distance to not less than 
30 cm.
    (j) Beam-on indicators. The x-ray control shall provide visual 
indication whenever x-rays are produced. In addition, a signal audible 
to the operator shall indicate that the exposure has terminated.
    (k) Multiple tubes. Where two or more radiographic tubes are 
controlled by one exposure switch, the tube or tubes which have been 
selected shall be clearly indicated before initiation of the exposure. 
This indication shall be both on the x-ray control and at or near the 
tube housing assembly which has been selected.
    (l) Radiation from capacitor energy storage equipment. Radiation 
emitted from the x-ray tube shall not exceed:
    (1) An air kerma of 0.26 microGy (vice 0.03 mR exposure) in 1 minute 
at 5 cm from any accessible surface of the diagnostic source assembly, 
with the beam-limiting device fully open, the system fully charged, and 
the exposure switch, timer, or any discharge mechanism not activated. 
Compliance shall be determined by measurements averaged over an area of 
100 square cm, with no linear dimension greater than 20 cm; and
    (2) An air kerma of 0.88 mGy (vice 100 mR exposure) in 1 hour at 100 
cm from the x-ray source, with the beam-limiting device fully open, when 
the system is discharged through the x-ray tube either manually or 
automatically by use of a discharge switch or deactivation of the input 
power. Compliance shall be determined by measurements of the maximum air 
kerma per discharge multiplied by the total number of discharges in 1 
hour (duty cycle). The measurements shall be averaged over an area of 
100 square cm with no linear dimension greater than 20 cm.
    (m) Primary protective barrier for mammography x-ray systems--(1) 
For x-ray

[[Page 906]]

systems manufactured after September 5, 1978, and before September 30, 
1999, which are designed only for mammography, the transmission of the 
primary beam through any image receptor support provided with the system 
shall be limited such that the air kerma 5 cm from any accessible 
surface beyond the plane of the image receptor supporting device does 
not exceed 0.88 microGy (vice 0.1 mR exposure) for each activation of 
the tube.
    (2) For mammographic x-ray systems manufactured on or after 
September 30, 1999:
    (i) At any SID where exposures can be made, the image receptor 
support device shall provide a primary protective barrier that 
intercepts the cross section of the useful beam along every direction 
except at the chest wall edge.
    (ii) The x-ray system shall not permit exposure unless the 
appropriate barrier is in place to intercept the useful beam as required 
in paragraph (m)(2)(i) of this section.
    (iii) The transmission of the useful beam through the primary 
protective barrier shall be limited such that the air kerma 5 cm from 
any accessible surface beyond the plane of the primary protective 
barrier does not exceed 0.88 microGy (vice 0.1 mR exposure) for each 
activation of the tube.
    (3) Compliance with the requirements of paragraphs (m)(1) and 
(m)(2)(iii) of this section for transmission shall be determined with 
the x-ray system operated at the minimum SID for which it is designed, 
at the maximum rated peak tube potential, at the maximum rated product 
of x-ray tube current and exposure time (mAs) for the maximum rated peak 
tube potential, and by measurements averaged over an area of 100 square 
cm with no linear dimension greater than 20 cm. The sensitive volume of 
the radiation measuring instrument shall not be positioned beyond the 
edge of the primary protective barrier along the chest wall side.

[70 FR 34036, June 10, 2005]



Sec. 1020.32  Fluoroscopic equipment.

    The provisions of this section apply to equipment for fluoroscopic 
imaging or for recording images from the fluoroscopic image receptor, 
except computed tomography x-ray systems manufactured on or after 
November 29, 1984.
    (a) Primary protective barrier--(1) Limitation of useful beam. The 
fluoroscopic imaging assembly shall be provided with a primary 
protective barrier which intercepts the entire cross section of the 
useful beam at any SID. The x-ray tube used for fluoroscopy shall not 
produce x-rays unless the barrier is in position to intercept the entire 
useful beam. The AKR due to transmission through the barrier with the 
attenuation block in the useful beam combined with radiation from the 
fluoroscopic image receptor shall not exceed 3.34 x 10-3 
percent of the entrance AKR, at a distance of 10 cm from any accessible 
surface of the fluoroscopic imaging assembly beyond the plane of the 
image receptor. Radiation therapy simulation systems shall be exempt 
from this requirement provided the systems are intended only for remote 
control operation and the manufacturer sets forth instructions for 
assemblers with respect to control location as part of the information 
required in Sec. 1020.30(g). Additionally, the manufacturer shall 
provide to users, under Sec. 1020.30(h)(1)(i), precautions concerning 
the importance of remote control operation.
    (2) Measuring compliance. The AKR shall be measured in accordance 
with paragraph (d) of this section. The AKR due to transmission through 
the primary barrier combined with radiation from the fluoroscopic image 
receptor shall be determined by measurements averaged over an area of 
100 square cm with no linear dimension greater than 20 cm. If the source 
is below the tabletop, the measurement shall be made with the input 
surface of the fluoroscopic imaging assembly positioned 30 cm above the 
tabletop. If the source is above the tabletop and the SID is variable, 
the measurement shall be made with the end of the beam-limiting device 
or spacer as close to the tabletop as it can be placed, provided that it 
shall not be closer than 30 cm. Movable grids and compression devices 
shall be removed from the useful beam during the measurement. For all 
measurements, the attenuation block shall be positioned in the useful 
beam 10 cm

[[Page 907]]

from the point of measurement of entrance AKR and between this point and 
the input surface of the fluoroscopic imaging assembly.
    (b) Field limitation--(1) Angulation. For fluoroscopic equipment 
manufactured after February 25, 1978, when the angle between the image 
receptor and the beam axis of the x-ray beam is variable, means shall be 
provided to indicate when the axis of the x-ray beam is perpendicular to 
the plane of the image receptor. Compliance with paragraphs (b)(4) and 
(b)(5) of this section shall be determined with the beam axis indicated 
to be perpendicular to the plane of the image receptor.
    (2) Further means for limitation. Means shall be provided to permit 
further limitation of the x-ray field to sizes smaller than the limits 
of paragraphs (b)(4) and (b)(5). Beam-limiting devices manufactured 
after May 22, 1979, and incorporated in equipment with a variable SID 
and/or the capability of a visible area of greater than 300 square cm, 
shall be provided with means for stepless adjustment of the x-ray field. 
Equipment with a fixed SID and the capability of a visible area of no 
greater than 300 square cm shall be provided with either stepless 
adjustment of the x-ray field or with a means to further limit the x-ray 
field size at the plane of the image receptor to 125 square cm or less. 
Stepless adjustment shall, at the greatest SID, provide continuous field 
sizes from the maximum obtainable to a field size containable in a 
square of 5 cm by 5 cm. This paragraph does not apply to non-image-
intensified fluoroscopy.
    (3) Non-image-intensified fluoroscopy. The x-ray field produced by 
non-image-intensified fluoroscopic equipment shall not extend beyond the 
entire visible area of the image receptor. Means shall be provided for 
stepless adjustment of field size. The minimum field size, at the 
greatest SID, shall be containable in a square of 5 cm by 5 cm.
    (4) Fluoroscopy and radiography using the fluoroscopic imaging 
assembly with inherently circular image receptors. (i) For fluoroscopic 
equipment manufactured before June 10, 2006, other than radiation 
therapy simulation systems, the following applies:
    (A) Neither the length nor the width of the x-ray field in the plane 
of the image receptor shall exceed that of the visible area of the image 
receptor by more than 3 percent of the SID. The sum of the excess length 
and the excess width shall be no greater than 4 percent of the SID.
    (B) For rectangular x-ray fields used with circular image receptors, 
the error in alignment shall be determined along the length and width 
dimensions of the x-ray field which pass through the center of the 
visible area of the image receptor.
    (ii) For fluoroscopic equipment manufactured on or after June 10, 
2006, other than radiation therapy simulation systems, the maximum area 
of the x-ray field in the plane of the image receptor shall conform with 
one of the following requirements:
    (A) When every linear dimension of the visible area of the image 
receptor measured through the center of the visible area is less than or 
equal to 34 cm in any direction, at least 80 percent of the area of the 
x-ray field overlaps the visible area of the image.
    (B) When any linear dimension of the visible area of the image 
receptor measured through the center of the visible area is greater than 
34 cm in any direction, the x-ray field measured along the direction of 
greatest misalignment with the visible area of the image receptor does 
not extend beyond the edge of the visible area of the image receptor by 
more than 2 cm.
    (5) Fluoroscopy and radiography using the fluoroscopic imaging 
assembly with inherently rectangular image receptors. For x-ray systems 
manufactured on or after June 10, 2006, the following applies:
    (i) Neither the length nor the width of the x-ray field in the plane 
of the image receptor shall exceed that of the visible area of the image 
receptor by more than 3 percent of the SID. The sum of the excess length 
and the excess width shall be no greater than 4 percent of the SID.
    (ii) The error in alignment shall be determined along the length and 
width dimensions of the x-ray field which pass through the center of the 
visible area of the image receptor.

[[Page 908]]

    (6) Override capability. If the fluoroscopic x-ray field size is 
adjusted automatically as the SID or image receptor size is changed, a 
capability may be provided for overriding the automatic adjustment in 
case of system failure. If it is so provided, a signal visible at the 
fluoroscopist's position shall indicate whenever the automatic field 
adjustment is overridden. Each such system failure override switch shall 
be clearly labeled as follows:

For X-ray Field Limitation System Failure

    (c) Activation of tube. X-ray production in the fluoroscopic mode 
shall be controlled by a device which requires continuous pressure by 
the operator for the entire time of any exposure. When recording serial 
radiographic images from the fluoroscopic image receptor, the operator 
shall be able to terminate the x-ray exposure(s) at any time, but means 
may be provided to permit completion of any single exposure of the 
series in process.
    (d) Air kerma rates. For fluoroscopic equipment, the following 
requirements apply:
    (1) Fluoroscopic equipment manufactured before May 19, 1995--(i) 
Equipment provided with automatic exposure rate control (AERC) shall not 
be operable at any combination of tube potential and current that will 
result in an AKR in excess of 88 mGy per minute (vice 10 R/min exposure 
rate) at the measurement point specified in Sec. 1020.32(d)(3), except 
as specified in Sec. 1020.32(d)(1)(v).
    (ii) Equipment provided without AERC shall not be operable at any 
combination of tube potential and current that will result in an AKR in 
excess of 44 mGy per minute (vice 5 R/min exposure rate) at the 
measurement point specified in Sec. 1020.32(d)(3), except as specified 
in Sec. 1020.32(d)(1)(v).
    (iii) Equipment provided with both an AERC mode and a manual mode 
shall not be operable at any combination of tube potential and current 
that will result in an AKR in excess of 88 mGy per minute (vice 10 R/min 
exposure rate) in either mode at the measurement point specified in 
Sec. 1020.32(d)(3), except as specified in Sec. 1020.32(d)(1)(v).
    (iv) Equipment may be modified in accordance with Sec. 1020.30(q) 
to comply with Sec. 1020.32(d)(2). When the equipment is modified, it 
shall bear a label indicating the date of the modification and the 
statement:

Modified to comply with 21 CFR 1020.32(h)(2).

    (v) Exceptions:
    (A) During recording of fluoroscopic images, or
    (B) When a mode of operation has an optional high-level control, in 
which case that mode shall not be operable at any combination of tube 
potential and current that will result in an AKR in excess of the rates 
specified in Sec. 1020.32(d)(1)(i), (d)(1)(ii), or (d)(1)(iii) at the 
measurement point specified in Sec. 1020.32(d)(3), unless the high-
level control is activated. Special means of activation of high-level 
controls shall be required. The high-level control shall be operable 
only when continuous manual activation is provided by the operator. A 
continuous signal audible to the fluoroscopist shall indicate that the 
high-level control is being employed.
    (2) Fluoroscopic equipment manufactured on or after May 19, 1995--
(i) Shall be equipped with AERC if operable at any combination of tube 
potential and current that results in an AKR greater than 44 mGy per 
minute (vice 5 R/min exposure rate) at the measurement point specified 
in Sec. 1020.32(d)(3). Provision for manual selection of technique 
factors may be provided.
    (ii) Shall not be operable at any combination of tube potential and 
current that will result in an AKR in excess of 88 mGy per minute (vice 
10 R/min exposure rate) at the measurement point specified in Sec. 
1020.32(d)(3), except as specified in Sec. 1020.32(d)(2)(iii):
    (iii) Exceptions:
    (A) For equipment manufactured prior to June 10, 2006, during the 
recording of images from a fluoroscopic image receptor using 
photographic film or a video camera when the x-ray source is operated in 
a pulsed mode.
    (B) For equipment manufactured on or after June 10, 2006, during the 
recording of images from the fluoroscopic image receptor for the purpose 
of providing the user with a recorded image(s) after termination of the 
exposure. Such recording does not include images resulting from a last-

[[Page 909]]

image-hold feature that are not recorded.
    (C) When a mode of operation has an optional high-level control and 
the control is activated, in which case the equipment shall not be 
operable at any combination of tube potential and current that will 
result in an AKR in excess of 176 mGy per minute (vice 20 R/min exposure 
rate) at the measurement point specified in Sec. 1020.32(d)(3). Special 
means of activation of high-level controls shall be required. The high-
level control shall be operable only when continuous manual activation 
is provided by the operator. A continuous signal audible to the 
fluoroscopist shall indicate that the high-level control is being 
employed.
    (3) Measuring compliance. Compliance with paragraph (d) of this 
section shall be determined as follows:
    (i) If the source is below the x-ray table, the AKR shall be 
measured at 1 cm above the tabletop or cradle.
    (ii) If the source is above the x-ray table, the AKR shall be 
measured at 30 cm above the tabletop with the end of the beam-limiting 
device or spacer positioned as closely as possible to the point of 
measurement.
    (iii) In a C-arm type of fluoroscope, the AKR shall be measured at 
30 cm from the input surface of the fluoroscopic imaging assembly, with 
the source positioned at any available SID, provided that the end of the 
beam-limiting device or spacer is no closer than 30 cm from the input 
surface of the fluoroscopic imaging assembly.
    (iv) In a C-arm type of fluoroscope having an SID less than 45 cm, 
the AKR shall be measured at the minimum SSD.
    (v) In a lateral type of fluoroscope, the air kerma rate shall be 
measured at a point 15 cm from the centerline of the x-ray table and in 
the direction of the x-ray source with the end of the beam-limiting 
device or spacer positioned as closely as possible to the point of 
measurement. If the tabletop is movable, it shall be positioned as 
closely as possible to the lateral x-ray source, with the end of the 
beam-limiting device or spacer no closer than 15 cm to the centerline of 
the x-ray table.
    (4) Exemptions. Fluoroscopic radiation therapy simulation systems 
are exempt from the requirements set forth in paragraph (d) of this 
section.
    (e) [Reserved]
    (f) Indication of potential and current. During fluoroscopy and 
cinefluorography, x-ray tube potential and current shall be continuously 
indicated. Deviation of x-ray tube potential and current from the 
indicated values shall not exceed the maximum deviation as stated by the 
manufacturer in accordance with Sec. 1020.30(h)(3).
    (g) Source-skin distance. (1) Means shall be provided to limit the 
source-skin distance to not less than 38 cm on stationary fluoroscopes 
and to not less than 30 cm on mobile and portable fluoroscopes. In 
addition, for fluoroscopes intended for specific surgical application 
that would be prohibited at the source-skin distances specified in this 
paragraph, provisions may be made for operation at shorter source-skin 
distances but in no case less than 20 cm. When provided, the 
manufacturer must set forth precautions with respect to the optional 
means of spacing, in addition to other information as required in Sec. 
1020.30(h).
    (2) For stationary, mobile, or portable C-arm fluoroscopic systems 
manufactured on or after June 10, 2006, having a maximum source-image 
receptor distance of less than 45 cm, means shall be provided to limit 
the source-skin distance to not less than 19 cm. Such systems shall be 
labeled for extremity use only. In addition, for those systems intended 
for specific surgical application that would be prohibited at the 
source-skin distances specified in this paragraph, provisions may be 
made for operation at shorter source-skin distances but in no case less 
than 10 cm. When provided, the manufacturer must set forth precautions 
with respect to the optional means of spacing, in addition to other 
information as required in Sec. 1020.30(h).
    (h) Fluoroscopic irradiation time, display, and signal. (1)(i) 
Fluoroscopic equipment manufactured before June 10, 2006, shall be 
provided with means to preset the cumulative irradiation time of the 
fluoroscopic tube. The maximum cumulative time of the timing device 
shall not exceed 5 minutes without resetting. A signal audible to the

[[Page 910]]

fluoroscopist shall indicate the completion of any preset cumulative 
irradiation-time. Such signal shall continue to sound while x-rays are 
produced until the timing device is reset. Fluoroscopic equipment may be 
modified in accordance with Sec. 1020.30(q) to comply with the 
requirements of Sec. 1020.32(h)(2). When the equipment is modified, it 
shall bear a label indicating the statement:

Modified to comply with 21 CFR 1020.32(h)(2).

    (ii) As an alternative to the requirements of this paragraph, 
radiation therapy simulation systems may be provided with a means to 
indicate the total cumulative exposure time during which x-rays were 
produced, and which is capable of being reset between x-ray 
examinations.
    (2) For x-ray controls manufactured on or after June 10, 2006, there 
shall be provided for each fluoroscopic tube:
    (i) A display of the fluoroscopic irradiation time at the 
fluoroscopist's working position. This display shall function 
independently of the audible signal described in Sec. 
1020.32(h)(2)(ii). The following requirements apply:
    (A) When the x-ray tube is activated, the fluoroscopic irradiation 
time in minutes and tenths of minutes shall be continuously displayed 
and updated at least once every 6 seconds.
    (B) The fluoroscopic irradiation time shall also be displayed within 
6 seconds of termination of an exposure and remain displayed until 
reset.
    (C) Means shall be provided to reset the display to zero prior to 
the beginning of a new examination or procedure.
    (ii) A signal audible to the fluoroscopist shall sound for each 
passage of 5 minutes of fluoroscopic irradiation time during an 
examination or procedure. The signal shall sound until manually reset 
or, if automatically reset, for at least 2 second.
    (i) Mobile and portable fluoroscopes. In addition to the other 
requirements of this section, mobile and portable fluoroscopes shall 
provide an image receptor incorporating more than a simple fluorescent 
screen.
    (j) Display of last-image-hold (LIH). Fluoroscopic equipment 
manufactured on or after June 10, 2006, shall be equipped with means to 
display LIH image following termination of the fluoroscopic exposure.
    (1) For an LIH image obtained by retaining pretermination 
fluoroscopic images, if the number of images and method of combining 
images are selectable by the user, the selection shall be indicated 
prior to initiation of the fluoroscopic exposure.
    (2) For an LIH image obtained by initiating a separate radiographic-
like exposure at the termination of fluoroscopic imaging, the techniques 
factors for the LIH image shall be selectable prior to the fluoroscopic 
exposure, and the combination selected shall be indicated prior to 
initiation of the fluoroscopic exposure.
    (3) Means shall be provided to clearly indicate to the user whether 
a displayed image is the LIH radiograph or fluoroscopy. Display of the 
LIH radiograph shall be replaced by the fluoroscopic image concurrently 
with re-initiation of fluoroscopic exposure, unless separate displays 
are provided for the LIH radiograph and fluoroscopic images.
    (4) The predetermined or selectable options for producing the LIH 
radiograph shall be described in the information required by Sec. 
1020.30(h). The information shall include a description of any technique 
factors applicable for the selected option and the impact of the 
selectable options on image characteristics and the magnitude of 
radiation emissions.
    (k) Displays of values of AKR and cumulative air kerma. Fluoroscopic 
equipment manufactured on or after June 10, 2006, shall display at the 
fluoroscopist's working position the AKR and cumulative air kerma. The 
following requirements apply for each x-ray tube used during an 
examination or procedure:
    (1) When the x-ray tube is activated and the number of images 
produced per unit time is greater than six images per second, the AKR in 
mGy/min shall be continuously displayed and updated at least once every 
second.
    (2) The cumulative air kerma in units of mGy shall be displayed 
either within 5 seconds of termination of an exposure or displayed 
continuously and updated at least once every 5 seconds.

[[Page 911]]

    (3) The display of the AKR shall be clearly distinguishable from the 
display of the cumulative air kerma.
    (4) The AKR and cumulative air kerma shall represent the value for 
conditions of free-in-air irradiation at one of the following reference 
locations specified according to the type of fluoroscope. The reference 
location shall be identified and described specifically in the 
information provided to users according to Sec. 1020.30(h)(6)(iii).
    (i) For fluoroscopes with x-ray source below the x-ray table, x-ray 
source above the table, or of lateral type, the reference locations 
shall be the respective locations specified in Sec. 1020.32(d)(3)(i), 
(d)(3)(ii), or (d)(3)(v) for measuring compliance with air-kerma rate 
limits.
    (ii) For C-arm fluoroscopes, the reference location shall be 15 cm 
from the isocenter toward the x-ray source along the beam axis. 
Alternatively, the reference location shall be at a point specified by 
the manufacturer to represent the location of the intersection of the x-
ray beam with the patient's skin.
    (5) Means shall be provided to reset to zero the display of 
cumulative air kerma prior to the commencement of a new examination or 
procedure.
    (6) The displayed AKR and cumulative air kerma shall not deviate 
from the actual values by more than 35 percent 
over the range of 6 mGy/min and 100 mGy to the maximum indication of AKR 
and cumulative air kerma, respectively. Compliance shall be determined 
with an irradiation time greater than 3 seconds.

[70 FR 34039, June 10, 2005, as amended at 80 FR 19532, Apr. 13, 2015]



Sec. 1020.33  Computed tomography (CT) equipment.

    (a) Applicability. (1) The provisions of this section, except for 
paragraphs (b), (c)(1), and (c)(2) are applicable as specified herein to 
CT x-ray systems manufactured or remanufactured on or after September 3, 
1985.
    (2) The provisions of paragraphs (b), (c)(1), and (c)(2) are 
applicable to CT x-ray systems manufactured or remanufactured on or 
after November 29, 1984.
    (b) Definitions. As used in this section, the following definitions 
apply:
    (1) Computed tomography dose index (CTDI) means the integral of the 
dose profile along a line perpendicular to the tomographic plane divided 
by the product of the nominal tomographic section thickness and the 
number of tomograms produced in a single scan; that is:
[GRAPHIC] [TIFF OMITTED] TC01AP93.003

where:

z = position along a line perpendicular to the tomographic plane.
D(z) = Dose at position z.
T = Nominal tomographic section thickness.
n = Number of tomograms produced in a single scan.


This definition assumes that the dose profile is centered around z = 0 
and that, for a multiple tomogram system, the scan increment between 
adjacent scans is nT.
    (2) Contrast scale means the change in linear attenuation 
coefficient per CT number relative to water; that is:
[GRAPHIC] [TIFF OMITTED] TC01AP93.000

where:

[mu]w = Linear attenuation coefficient of water.
[mu]x = Linear attenuation coefficient of material of 
interest.
(CT)w = CT number of water.
(CT)x = CT number of material of interest.

    (3) CT conditions of operation means all selectable parameters 
governing the operation of a CT x-ray system including nominal 
tomographic section thickness, filtration, and the technique factors as 
defined in Sec. 1020.30(b)(36).
    (4) CT number means the number used to represent the x-ray 
attenuation associated with each elemental area of the CT image.
    (5) [Reserved]
    (6) CT dosimetry phantom means the phantom used for determination of 
the dose delivered by a CT x-ray system. The phantom shall be a right 
circular cylinder of polymethl-methacrylate of density 1.190.01 grams per cubic centimeter. The phantom shall be at 
least 14 centimeters in length and shall have diameters of 32.0 
centimeters for testing any CT system designed to image

[[Page 912]]

any section of the body (whole body scanners) and 16.0 centimeters for 
any system designed to image the head (head scanners) or for any whole 
body scanner operated in the head scanning mode. The phantom shall 
provide means for the placement of a dosimeter(s) along its axis of 
rotation and along a line parallel to the axis of rotation 1.0 
centimeter from the outer surface and within the phantom. Means for the 
placement of a dosimeter(s) or alignment device at other locations may 
be provided for convenience. The means used for placement of a 
dosimeter(s) (i.e., hole size) and the type of dosimeter(s) used is at 
the discretion of the manufacturer. Any effect on the doses measured due 
to the removal of phantom material to accommodate dosimeters shall be 
accounted for through appropriate corrections to the reported data or 
included in the statement of maximum deviation for the values obtained 
using the phantom.
    (7) Dose profile means the dose as a function of position along a 
line.
    (8) Modulation transfer function means the modulus of the Fourier 
transform of the impulse response of the system.
    (9) Multiple tomogram system means a CT x-ray system which obtains 
x-ray transmission data simultaneously during a single scan to produce 
more than one tomogram.
    (10) Noise means the standard deviation of the fluctuations in CT 
number expressed as a percent of the attenuation coefficient of water. 
Its estimate (Sn) is calculated using the following 
expression:
[GRAPHIC] [TIFF OMITTED] TC01AP93.001

where:

CS = Contrast scale.
[mu]w = Linear attenuation coefficient of water.
s = Estimated standard deviation of the CT numbers of picture elements 
in a specified area of the CT image.

    (11) Nominal tomographic section thickness means the full-width at 
half-maximum of the sensitivity profile taken at the center of the 
cross-sectional volume over which x-ray transmission data are collected.
    (12) Picture element means an elemental area of a tomogram.
    (13) Remanufacturing means modifying a CT system in such a way that 
the resulting dose and imaging performance become substantially 
equivalent to any CT x-ray system manufactured by the original 
manufacturer on or after November 29, 1984. Any reference in this 
section to ``manufacture'', ``manufacturer'', or ``manufacturing'' 
includes remanufacture, remanufacturer, or remanufacturing, 
respectively.
    (14) Scan increment means the amount of relative displacement of the 
patient with respect to the CT x-ray system between successive scans 
measured along the direction of such displacement.
    (15) Scan sequence means a preselected set of two or more scans 
performed consecutively under preselected CT conditions of operations.
    (16) Sensitivity profile means the relative response of the CT x-ray 
system as a function of position along a line perpendicular to the 
tomographic plane.
    (17) Single tomogram system means a CT x-ray system which obtains x-
ray transmission data during a scan to produce a single tomogram.
    (18) Tomographic plane means that geometric plane which the 
manufacturer identifies as corresponding to the output tomogram.
    (19) Tomographic section means the volume of an object whose x-ray 
attenuation properties are imaged in a tomogram.
    (c) Information to be provided for users. Each manufacturer of a CT 
x-ray system shall provide the following technical and safety 
information, in addition to that required under Sec. 1020.30(h), to 
purchasers and, upon request, to others at a cost not to exceed the cost 
of publication and distribution of such information. This information 
shall be identified and provided in a separate section of the user's 
instruction manual or in a separate manual devoted only to this 
information.
    (1) Conditions of operation. A statement of the CT conditions of 
operation used to provide the information required by paragraph (c) (2) 
and (3) of this section.
    (2) Dose information. The following dose information obtained by 
using the

[[Page 913]]

CT dosimetry phantom. For any CT x-ray system designed to image both the 
head and body, separate dose information shall be provided for each 
application. All dose measurements shall be performed with the CT 
dosimetry phantom placed on the patient couch or support device without 
additional attenuating materials present.
    (i) The CTDI at the following locations in the dosimetry phantom:
    (a) Along the axis of rotation of the phantom.
    (b) Along a line parallel to the axis of rotation and 1.0 centimeter 
interior to the surface of the phantom with the phantom positioned so 
that CTDI is the maximum obtainable at this depth.
    (c) Along lines parallel to the axis of rotation and 1.0 centimeter 
interior to the surface of the phantom at positions 90, 180, and 270 
degrees from the position in paragraph (c)(2)(i)(b) of this section. The 
CT conditions of operation shall be the typical values suggested by the 
manufacturer for CT of the head or body. The location of the position 
where the CTDI is maximum as specified in paragraph (c)(2)(i)(b) of this 
section shall be given by the manufacturer with respect to the housing 
of the scanning mechanism or other readily identifiable feature of the 
CT x-ray system in such a manner as to permit placement of the dosimetry 
phantom in this orientation.
    (ii) The CTDI in the center location of the dosimetry phantom for 
each selectable CT condition of operation that varies either the rate or 
duration of x-ray exposure. This CTDI shall be presented as a value that 
is normalized to the CTDI in the center location of the dosimetry 
phantom from paragraph (c)(2)(i) of this section, with the CTDI of 
paragraph (c)(2)(i) of this section having a value of one. As each 
individual CT condition of operation is changed, all other independent 
CT conditions of operation shall be maintained at the typical values 
described in paragraph (c)(2)(i) of this section. These data shall 
encompass the range of each CT condition of operation stated by the 
manufacturer as appropriate for CT of the head or body. When more than 
three selections of a CT condition of operation are available, the 
normalized CTDI shall be provided, at least, for the minimum, maximum, 
and mid-range value of the CT condition of operation.
    (iii) The CTDI at the location coincident with the maximum CTDI at 1 
centimeter interior to the surface of the dosimetry phantom for each 
selectable peak tube potential. When more than three selections of peak 
tube potential are available, the normalized CTDI shall be provided, at 
least, for the minimum, maximum, and a typical value of peak tube 
potential. The CTDI shall be presented as a value that is normalized to 
the maximum CTDI located at 1 centimeter interior to the surface of the 
dosimetry phantom from paragraph (c)(2)(i) of this section, with the 
CTDI of paragraph (c)(2)(i) of this section having a value of one.
    (iv) The dose profile in the center location of the dosimetry 
phantom for each selectable nominal tomographic section thickness. When 
more than three selections of nominal tomographic section thicknesses 
are available, the information shall be provided, at least, for the 
minimum, maximum, and midrange value of nominal tomographic section 
thickness. The dose profile shall be presented on the same graph and to 
the same scale as the corresponding sensitivity profile required by 
paragraph (c)(3)(iv) of this section.
    (v) A statement of the maximum deviation from the values given in 
the information provided according to paragraph (c)(2) (i), (ii), (iii), 
and (iv) of this section. Deviation of actual values may not exceed 
these limits.
    (3) Imaging performance information. The following performance data 
shall be provided for the CT conditions of operation used to provide the 
information required by paragraph (c)(2)(i) of this section. All other 
aspects of data collection, including the x-ray attenuation properties 
of the material in the tomographic section, shall be similar to those 
used to provide the dose information required by paragraph (c)(2)(i) of 
this section. For any CT x-ray system designed to image both the head 
and body, separate imaging performance information shall be provided for 
each application.
    (i) A statement of the noise.
    (ii) A graphical presentation of the modulation transfer function 
for the

[[Page 914]]

same image processing and display mode as that used in the statement of 
the noise.
    (iii) A statement of the nominal tomographic section thickness(es).
    (iv) A graphical presentation of the sensitivity profile, at the 
location corresponding to the center location of the dosimetry phantom, 
for each selectable nominal tomographic section thickness for which the 
dose profile is given according to paragraph (c)(2)(iv) of this section.
    (v) A description of the phantom or device and test protocol or 
procedure used to determine the specifications and a statement of the 
maximum deviation from the specifications provided in accordance with 
paragraphs (c)(3) (i), (ii), (iii), and (iv) of this section. Deviation 
of actual values may not exceed these limits.
    (d) Quality assurance. The manufacturer of any CT x-ray system shall 
provide the following with each system. All information required by this 
subsection shall be provided in a separate section of the user's 
instructional manual.
    (1) A phantom(s) capable of providing an indication of contrast 
scale, noise, nominal tomographic section thickness, the spatial 
resolution capability of the system for low and high contrast objects, 
and measuring the mean CT number of water or a reference material.
    (2) Instructions on the use of the phantom(s) including a schedule 
of testing appropriate for the system, allowable variations for the 
indicated parameters, and a method to store as records, quality 
assurance data.
    (3) Representative images obtained with the phantom(s) using the 
same processing mode and CT conditions of operation as in paragraph 
(c)(3) of this section for a properly functioning system of the same 
model. The representative images shall be of two forms as follows:
    (i) Photographic copies of the images obtained from the image 
display device.
    (ii) Images stored in digital form on a storage medium compatible 
with the CT x-ray system. The CT x-ray system shall be provided with the 
means to display these images on the image display device.
    (e) [Reserved]
    (f) Control and indication of conditions of operation--(1) Visual 
indication. The CT conditions of operation to be used during a scan or a 
scan sequence shall be indicated prior to initiation of a scan or a scan 
sequence. On equipment having all or some of these conditions of 
operation at fixed values, this requirement may be met by permanent 
markings. Indication of the CT conditions of operation shall be visible 
from any position from which scan initiation is possible.
    (2) Timers. (i) Means shall be provided to terminate the x-ray 
exposure automatically by either deenergizing the x-ray source or 
shuttering the x-ray beam in the event of equipment failure affecting 
data collection. Such termination shall occur within an interval that 
limits the total scan time to no more than 110 percent of its preset 
value through the use of either a backup timer or devices which monitor 
equipment function. A visible signal shall indicate when the x-ray 
exposure has been terminated through these means and manual resetting of 
the CT conditions of operation shall be required prior to the initiation 
of another scan.
    (ii) Means shall be provided so that the operator can terminate the 
x-ray exposure at any time during a scan, or series of scans under x-ray 
system control, of greater than one-half second duration. Termination of 
the x-ray exposure shall necessitate resetting of the CT conditions of 
operation prior to the initiation of another scan.
    (g) Tomographic plane indication and alignment. (1) For any single 
tomogram system, means shall be provided to permit visual determination 
of the tomographic plane or a reference plane offset from the 
tomographic plane.
    (2) For any multiple tomogram system, means shall be provided to 
permit visual determination of the location of a reference plane. The 
relationship of the reference plane to the planes of the tomograms shall 
be provided to the user in addition to other information provided 
according to Sec. 1020.30(h). This reference plane can be offset from 
the location of the tomographic planes.

[[Page 915]]

    (3) The distance between the indicated location of the tomographic 
plane or reference plane and its actual location may not exceed 5 
millimeters.
    (4) For any offset alignment system, the manufacturer shall provide 
specific instructions with respect to the use of this system for patient 
positioning, in addition to other information provided according to 
Sec. 1020.30(h).
    (5) If a mechanism using a light source is used to satisfy the 
requirements of paragraphs (g) (1) and (2) of this section, the light 
source shall allow visual determination of the location of the 
tomographic plane or reference plane under ambient light conditions of 
up to 500 lux.
    (h) Beam-on and shutter status indicators. (1) Means shall be 
provided on the control and on or near the housing of the scanning 
mechanism to provide visual indication when and only when x rays are 
produced and, if applicable, whether the shutter is open or closed. If 
the x-ray production period is less than one-half second, the indication 
of x-ray production shall be actuated for one-half second. Indicators at 
or near the housing of the scanning mechanism shall be discernible from 
any point external to the patient opening where insertion of any part of 
the human body into the primary beam is possible.
    (2) For systems that allow high voltage to be applied to the x-ray 
tube continuously and that control the emission of x-ray with a shutter, 
the radiation emitted may not exceed 0.88 milligray (vice 100 
milliroentgen exposure) in 1 hour at any point 5 cm outside the external 
surface of the housing of the scanning mechanism when the shutter is 
closed. Compliance shall be determined by measurements average over an 
area of 100 square cm with no linear dimension greater than 20 cm.
    (i) Scan increment accuracy. The deviation of indicated scan 
increment from actual scan increment may not exceed 1 millimeter. 
Compliance shall be measured as follows: The determination of the 
deviation of indicated versus actual scan increment shall be based on 
measurements taken with a mass 100 kilograms or less, on the patient 
support device. The patient support device shall be incremented from a 
typical starting position to the maximum incrementation distance or 30 
centimeters, whichever is less, and then returned to the starting 
position. Measurement of actual versus indicated scan increment may be 
taken anywhere along this travel.
    (j) CT number mean and standard deviation. (1) A method shall be 
provided to calculate the mean and standard deviation of CT numbers for 
an array of picture elements about any location in the image. The number 
of elements in this array shall be under user control.
    (2) The manufacturer shall provide specific instructions concerning 
the use of the method provided for calculation of CT number mean and 
standard deviation in addition to other information provided according 
to Sec. 1020.30(h).

[49 FR 34712, Aug. 31, 1984; 49 FR 37381, Sept. 24, 1984, as amended at 
49 FR 47388, Dec. 4, 1984; 56 FR 36098, Aug. 1, 1991; 67 FR 9587, Mar. 
4, 2002; 70 FR 34042, June 10, 2005]



Sec. 1020.40  Cabinet x-ray systems.

    (a) Applicability. The provisions of this section are applicable to 
cabinet x-ray systems manufactured or assembled on or after April 10, 
1975, except that the provisions as applied to x-ray systems designed 
primarily for the inspection of carry-on baggage are applicable to such 
systems manufactured or assembled on or after April 25, 1974. The 
provisions of this section are not applicable to systems which are 
designed exclusively for microscopic examination of material, e.g., x-
ray diffraction, spectroscopic, and electron microscope equipment or to 
systems for intentional exposure of humans to x-rays.
    (b) Definitions. As used in this section the following definitions 
apply:
    (1) Access panel means any barrier or panel which is designed to be 
removed or opened for maintenance or service purposes, requires tools to 
open, and permits access to the interior of the cabinet.
    (2) Aperture means any opening in the outside surface of the 
cabinet, other than a port, which remains open during generation of x 
radiation.
    (3) Cabinet x-ray system means an x-ray system with the x-ray tube 
installed in an enclosure (hereinafter termed cabinet) which, 
independently of

[[Page 916]]

existing architectural structures except the floor on which it may be 
placed, is intended to contain at least that portion of a material being 
irradiated, provide radiation attenuation, and exclude personnel from 
its interior during generation of x radiation. Included are all x-ray 
systems designed primarily for the inspection of carry-on baggage at 
airline, railroad, and bus terminals, and in similar facilities. An x-
ray tube used within a shielded part of a building, or x-ray equipment 
which may temporarily or occasionally incorporate portable shielding is 
not considered a cabinet x-ray system.
    (4) Door means any barrier which is designed to be movable or opened 
for routine operation purposes, does not generally require tools to 
open, and permits access to the interior of the cabinet. For the 
purposes of paragraph (c)(4)(i) of this section, inflexible hardware 
rigidly affixed to the door shall be considered part of the door.
    (5) Exposure means the quotient of dQ by dm where dQ is the absolute 
value of the total charge of the ions of one sign produced in air when 
all the electrons (negatrons and positrons) liberated by photons in a 
volume element of air having mass dm are completely stopped in air.
    (6) External surface means the outside surface of the cabinet x-ray 
system, including the high-voltage generator, doors, access panels, 
latches, control knobs, and other permanently mounted hardware and 
including the plane across any aperture or port.
    (7) Floor means the underside external surface of the cabinet.
    (8) Ground fault means an accidental electrical grounding of an 
electrical conductor.
    (9) Port means any opening in the outside surface of the cabinet 
which is designed to remain open, during generation of x-rays, for the 
purpose of conveying material to be irradiated into and out of the 
cabinet, or for partial insertion for irradiation of an object whose 
dimensions do not permit complete insertion into the cabinet.
    (10) Primary beam means the x radiation emitted directly from the 
from the target and passing through the window of the x-ray tube.
    (11) Safety interlock means a device which is intended to prevent 
the generation of x radiation when access by any part of the human body 
to the interior of the cabinet x-ray system through a door or access 
panel is possible.
    (12) X-ray system means an assemblage of components for the 
controlled generation of x-rays.
    (13) X-ray tube means any electron tube which is designed for the 
conversion of electrical energy into x-ray energy.
    (c) Requirements--(1) Emission limit. (i) Radiation emitted from the 
cabinet x-ray system shall not exceed an exposure of 0.5 milliroentgen 
in one hour at any point five centimeters outside the external surface.
    (ii) Compliance with the exposure limit in paragraph (c)(1)(i) of 
this section shall be determined by measurements averaged over a cross-
sectional area of ten square centimeters with no linear dimension 
greater than 5 centimeters, with the cabinet x-ray system operated at 
those combinations of x-ray tube potential, current, beam orientation, 
and conditions of scatter radiation which produce the maximum x-ray 
exposure at the external surface, and with the door(s) and access 
panel(s) fully closed as well as fixed at any other position(s) which 
will allow the generation of x radiation.
    (2) Floors. A cabinet x-ray system shall have a permanent floor. Any 
support surface to which a cabinet x-ray system is permanently affixed 
may be deemed the floor of the system.
    (3) Ports and apertures. (i) The insertion of any part of the human 
body through any port into the primary beam shall not be possible.
    (ii) The insertion of any part of the human body through any 
aperture shall not be possible.
    (4) Safety interlocks. (i) Each door of a cabinet x-ray system shall 
have a minimum of two safety interlocks. One, but not both of the 
required interlocks shall be such that door opening results in physical 
disconnection of the energy supply circuit to the high-voltage 
generator, and such disconnection shall not be dependent upon any moving 
part other than the door.

[[Page 917]]

    (ii) Each access panel shall have at least one safety interlock.
    (iii) Following interruption of x-ray generation by the functioning 
of any safety interlock, use of a control provided in accordance with 
paragraph (c)(6)(ii) of this section shall be necessary for resumption 
of x-ray generation.
    (iv) Failure of any single component of the cabinet x-ray system 
shall not cause failure of more than one required safety interlock.
    (5) Ground fault. A ground fault shall not result in the generation 
of x-rays.
    (6) Controls and indicators for all cabinet x-ray systems. For all 
systems to which this section is applicable there shall be provided:
    (i) A key-actuated control to insure that x-ray generation is not 
possible with the key removed.
    (ii) A control or controls to initiate and terminate the generation 
of x-rays other than by functioning of a safety interlock or the main 
power control.
    (iii) Two independent means which indicate when and only when x-rays 
are being generated, unless the x-ray generation period is less than 
one-half second, in which case the indicators shall be activated for 
one-half second, and which are discernible from any point at which 
initiation of x-ray generation is possible. Failure of a single 
component of the cabinet x-ray system shall not cause failure of both 
indicators to perform their intended function. One, but not both, of the 
indicators required by this subdivision may be a milliammeter labeled to 
indicate x-ray tube current. All other indicators shall be legibly 
labeled ``X-RAY ON''.
    (iv) Additional means other than milliammeters which indicate when 
and only when x-rays are being generated, unless the x-ray generation 
period is less than one-half second in which case the indicators shall 
be activated for one-half second, as needed to insure that at least one 
indicator is visible from each door, access panel, and port, and is 
legibly labeled ``X-RAY ON''.
    (7) Additional controls and indicators for cabinet x-ray systems 
designed to admit humans. For cabinet x-ray systems designed to admit 
humans there shall also be provided:
    (i) A control within the cabinet for preventing and terminating x-
ray generation, which cannot be reset, overridden or bypassed from the 
outside of the cabinet.
    (ii) No means by which x-ray generation can be initiated from within 
the cabinet.
    (iii) Audible and visible warning signals within the cabinet which 
are actuated for at least 10 seconds immediately prior to the first 
initiation of x-ray generation after closing any door designed to admit 
humans. Failure of any single component of the cabinet x-ray system 
shall not cause failure of both the audible and visible warning signals.
    (iv) A visible warning signal within the cabinet which remains 
actuated when and only when x-rays are being generated, unless the x-ray 
generation period is less than one-half second in which case the 
indicators shall be activated for one-half second.
    (v) Signs indicating the meaning of the warning signals provided 
pursuant to paragraphs (c)(7) (iii) and (iv) of this section and 
containing instructions for the use of the control provided pursuant to 
paragraph (c)(7)(i) of this section. These signs shall be legible, 
accessible to view, and illuminated when the main power control is in 
the ``on'' position.
    (8) Warning labels. (i) There shall be permanently affixed or 
inscribed on the cabinet x-ray system at the location of any controls 
which can be used to initiate x-ray generation, a clearly legible and 
visible label bearing the statement:

                 Caution: X-Rays Produced When Energized

    (ii) There shall be permanently affixed or inscribed on the cabinet 
x-ray system adjacent to each port a clearly legible and visible label 
bearing the statement:

caution: Do Not Insert Any Part of the Body When System is Energized--X-
                               ray Hazard

    (9) Instructions. (i) Manufacturers of cabinet x-ray systems shall 
provide for purchasers, and to others upon request at a cost not to 
exceed the cost of preparation and distribution, manuals and

[[Page 918]]

instructions which shall include at least the following technical and 
safety information: Potential, current, and duty cycle ratings of the x-
ray generation equipment; adequate instructions concerning any 
radiological safety procedures and precautions which may be necessary 
because of unique features of the system; and a schedule of maintenance 
necessary to keep the system in compliance with this section.
    (ii) Manufacturers of cabinet x-ray systems which are intended to be 
assembled or installed by the purchaser shall provide instructions for 
assembly, installation, adjustment and testing of the cabinet x-ray 
system adequate to assure that the system is in compliance with 
applicable provisions of this section when assembled, installed, 
adjusted and tested as directed.
    (10) Additional requirements for x-ray baggage inspection systems. 
X-ray systems designed primarily for the inspection of carry-on baggage 
at airline, railroad, and bus terminals, and at similar facilities, 
shall be provided with means, pursuant to paragraphs (c)(10) (i) and 
(ii) of this section, to insure operator presence at the control area in 
a position which permits surveillance of the ports and doors during 
generation of x-radiation.
    (i) During an exposure or preset succession of exposures of one-half 
second or greater duration, the means provided shall enable the operator 
to terminate the exposure or preset succession of exposures at any time.
    (ii) During an exposure or preset succession of exposures of less 
than one-half second duration, the means provided may allow completion 
of the exposure in progress but shall enable the operator to prevent 
additional exposures.
    (d) Modification of a certified system. The modification of a 
cabinet x-ray system, previously certified pursuant to Sec. 1010.2 by 
any person engaged in the business of manufacturing, assembling or 
modifying cabinet x-ray systems shall be construed as manufacturing 
under the act if the modification affects any aspect of the system's 
performance for which this section has an applicable requirement. The 
manufacturer who performs such modification shall recertify and 
reidentify the system in accordance with the provisions of Sec. Sec. 
1010.2 and 1010.3 of this chapter.

[39 FR 12986, Apr. 10, 1974]



PART 1030_PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY 
EMITTING PRODUCTS--Table of Contents



    Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss, 371, 
381.



Sec. 1030.10  Microwave ovens.

    (a) Applicability. The provisions of this standard are applicable to 
microwave ovens manufactured after October 6, 1971.
    (b) Definitions--(1) Microwave oven means a device designed to heat, 
cook, or dry food through the application of electromagnetic energy at 
frequencies assigned by the Federal Communications Commission in the 
normal ISM heating bands ranging from 890 megahertz to 6,000 megahertz. 
As defined in this standard, ``microwave ovens'' are limited to those 
manufactured for use in homes, restaurants, food vending, or service 
establishments, on interstate carriers, and in similar facilities.
    (2) Cavity means that portion of the microwave oven in which food 
may be heated, cooked, or dried.
    (3) Door means the movable barrier which prevents access to the 
cavity during operation and whose function is to prevent emission of 
microwave energy from the passage or opening which provides access to 
the cavity.
    (4) Safety interlock means a device or system of devices which is 
intended to prevent generation of microwave energy when access to the 
cavity is possible.
    (5) Service adjustments or service procedures means those servicing 
methods prescribed by the manufacturer for a specific product model.
    (6) Stirrer means that feature of a microwave oven which is intended 
to provide uniform heating of the load by constantly changing the 
standing wave pattern within the cavity or moving the load.
    (7) External surface means the outside surface of the cabinet or 
enclosure provided by the manufacturer as part of the microwave oven, 
including doors,

[[Page 919]]

door handles, latches, and control knobs.
    (8) Equivalent plane-wave power density means the square of the 
root-mean-square (rms) electric field strength divided by the impedance 
of free space (377 ohms).
    (c) Requirements--(1) Power density limit. The equivalent plane-wave 
power density existing in the proximity of the external oven surface 
shall not exceed 1 milliwatt per square centimeter at any point 5 
centimeters or more from the external surface of the oven, measured 
prior to acquisition by a purchaser, and, thereafter, 5 milliwatts per 
square centimeter at any such point.
    (2) Safety interlocks. (i) Microwave ovens shall have a minimum of 
two operative safety interlocks. At least one operative safety interlock 
on a fully assembled microwave oven shall not be operable by any part of 
the human body, or any object with a straight insertable length of 10 
centimeters. Such interlock must also be concealed, unless its actuation 
is prevented when access to the interlock is possible. Any visible 
actuator or device to prevent actuation of this safety interlock must 
not be removable without disassembly of the oven or its door. A 
magnetically operated interlock is considered to be concealed, or its 
actuation is considered to be prevented, only if a test magnet held in 
place on the oven by gravity or its own attraction cannot operate the 
safety interlock. The test magnet shall be capable of lifting vertically 
at zero air gap at least 4.5 kilograms, and at 1 centimeter air gap at 
least 450 grams when the face of the magnet, which is toward the 
interlock when the magnet is in the test position, is pulling against 
one of the large faces of a mild steel armature having dimensions of 80 
millimeters by 50 millimeters by 8 millimeters.
    (ii) Failure of any single mechanical or electrical component of the 
microwave oven shall not cause all safety interlocks to be inoperative.
    (iii) Service adjustments or service procedures on the microwave 
oven shall not cause the safety interlocks to become inoperative or the 
microwave radiation emission to exceed the power density limits of this 
section as a result of such service adjustments or procedures.
    (iv) Microwave radiation emission in excess of the limits specified 
in paragraph (c)(1) of this section shall not be caused by insertion of 
an insulated wire through any opening in the external surfaces of a 
fully assembled oven into the cavity, waveguide, or other microwave-
energy-containing spaces while the door is closed, provided the wire, 
when inserted, could consist of two straight segments forming an obtuse 
angle of not less than 170 degrees.
    (v) One (the primary) required safety interlock shall prevent 
microwave radiation emission in excess of the requirement of paragraph 
(c)(1) of this section; the other (secondary) required safety interlock 
shall prevent microwave radiation emission in excess of 5 milliwatts per 
square centimeter at any point 5 centimeters or more from the external 
surface of the oven. The two required safety interlocks shall be 
designated as primary or secondary in the service instructions for the 
oven.
    (vi) A means of monitoring one or both of the required safety 
interlocks shall be provided which shall cause the oven to become 
inoperable and remain so until repaired if the required safety 
interlock(s) should fail to perform required functions as specified in 
this section. Interlock failures shall not disrupt the monitoring 
function.
    (3) Measurement and test conditions. (i) Compliance with the power 
density limit in paragraph (c)(1) of this section shall be determined by 
measurement of the equivalent plane-wave power density made with an 
instrument which reaches 90 percent of its steady-state reading within 3 
seconds, when the system is subjected to a step-function input signal. 
Tests for compliance shall account for all measurement errors and 
uncertainties to ensure that the equivalent plane-wave power density 
does not exceed the limit prescribed by paragraph (c)(1) of this 
section.
    (ii) Microwave ovens shall be in compliance with the power density 
limits if the maximum reading obtained at the location of greatest 
microwave radiation emission, taking into account all measurement errors 
and uncertainties, does not exceed the limit specified in paragraph 
(c)(1) of this section, when

[[Page 920]]

the emission is measured through at least one stirrer cycle. As provided 
in Sec. 1010.13 of this chapter, a manufacturer may request alternative 
test procedures if, as a result of the stirrer characteristics of a 
microwave oven, such oven is not susceptible to testing by the 
procedures described in this paragraph.
    (iii) Measurements shall be made with the microwave oven operating 
at its maximum output and containing a load of 275 15 milliliters of tap water initially at 20 5 [deg]centigrade placed within the cavity at the center 
of the load-carrying surface provided by the manufacturer. The water 
container shall be a low form 600-milliliter beaker having an inside 
diameter of approximately 8.5 centimeters and made of an electrically 
nonconductive material such as glass or plastic.
    (iv) Measurements shall be made with the door fully closed as well 
as with the door fixed in any other position which allows the oven to 
operate.
    (4) User instructions. Manufacturers of microwave ovens to which 
this section is applicable shall provide, or cause to be provided, with 
each oven, radiation safety instructions which:
    (i) Occupy a separate section and are an integral part of the 
regularly supplied users' manual and cookbook, if supplied separately, 
and are located so as to elicit the attention of the reader.
    (ii) Are as legible and durable as other instructions with the title 
emphasized to elicit the attention of the reader by such means as bold-
faced type, contrasting color, a heavy-lined border, or by similar 
means.
    (iii) Contain the following wording:

  Precautions To Avoid Possible Exposure To Excessive Microwave Energy

    (a) Do not attempt to operate this oven with the door open since 
open-door operation can result in harmful exposure to microwave energy. 
It is important not to defeat or tamper with the safety interlocks.
    (b) Do not place any object between the oven front face and the door 
or allow soil or cleaner residue to accumulate on sealing surfaces.
    (c) Do not operate the oven if it is damaged. It is particularly 
important that the oven door close properly and that there is no damage 
to the: (1) Door (bent), (2) hinges and latches (broken or loosened), 
(3) door seals and sealing surfaces.
    (d) The oven should not be adjusted or repaired by anyone except 
properly qualified service personnel.

    (iv) Include additional radiation safety precautions or instructions 
which may be necessary for particular oven designs or models, as 
determined by the Director, Center for Devices and Radiological Health 
or the manufacturer.
    (5) Service instructions. Manufacturers of microwave ovens to which 
this section is applicable shall provide or cause to be provided to 
servicing dealers and distributors and to others upon request, for each 
oven model, adequate instructions for service adjustments and service 
procedures, and, in addition, radiation safety instructions which:
    (i) Occupy a separate section and are an integral part of the 
regularly supplied service manual and are located so as to elicit the 
attention of the reader.
    (ii) Are as legible and durable as other instructions with the title 
emphasized so as to elicit the attention of the reader by such means as 
bold-faced type, contrasting color, a heavy-lined border, or by similar 
means.
    (iii) Contain the following wording:

Precautions To Be Observed Before And During Servicing To Avoid Possible 
                 Exposure To Excessive Microwave Energy

    (a) Do not operate or allow the oven to be operated with the door 
open.
    (b) Make the following safety checks on all ovens to be serviced 
before activating the magnetron or other microwave source, and make 
repairs as necessary: (1) Interlock operation, (2) proper door closing, 
(3) seal and sealing surfaces (arcing, wear, and other damage), (4) 
damage to or loosening of hinges and latches, (5) evidence of dropping 
or abuse.
    (c) Before turning on microwave power for any service test or 
inspection within the microwave generating compartments, check the 
magnetron, wave guide or transmission line, and cavity for proper 
alignment, integrity, and connections.
    (d) Any defective or misadjusted components in the interlock, 
monitor, door seal, and microwave generation and transmission systems 
shall be repaired, replaced, or adjusted by procedures described in this 
manual before the oven is released to the owner.
    (e) A Microwave leakage check to verify compliance with the Federal 
performance standard should be performed on each oven prior to release 
to the owner.


[[Page 921]]


    (iv) Include additional radiation safety precautions or instructions 
which may be necessary for particular oven designs or models, as 
determined by the Director, Center for Devices and Radiological Health 
or the manufacturer.
    (6) Warning labels. Except as provided in paragraph (c)(6)(iv) of 
this section, microwave ovens shall have the following warning labels:
    (i) A label, permanently attached to or inscribed on the oven, which 
shall be legible and readily viewable during normal oven use, and which 
shall have the title emphasized and be so located as to elicit the 
attention of the user. The label shall bear the following warning 
statement:

    Precautions For Safe Use To Avoid Possible Exposure To Excessive 
                            Microwave Energy

    DO NOT Attempt to Operate This Oven With:
    (a) Object Caught in Door.
    (b) Door That Does Not Close Properly.
    (c) Damaged Door, Hinge, Latch, or Sealing Surface.

    (ii) A label, permanently attached to or inscribed on the external 
surface of the oven, which shall be legible and readily viewable during 
servicing, and which shall have the word ``CAUTION'' emphasized and be 
so located as to elicit the attention of service personnel. The label 
shall bear the following warning statement:

    Caution: This Device is to be Serviced Only by Properly Qualified 
Service Personnel. Consult the Service Manual for Proper Service 
Procedures to Assure Continued Compliance with the Federal Performance 
Standard for Microwave Ovens and for Precautions to be Taken to Avoid 
Possible Exposure to Excessive Microwave Energy.

    (iii) The labels provided in accordance with paragraphs (c)(6)(i) 
and (ii) of this section shall bear only the statements specified in 
that paragraph, except for additional radiation safety warnings or 
instructions which may be necessary for particular oven designs or 
models, as determined by the Director, Center for Devices and 
Radiological Health or the manufacturer.
    (iv) Upon application by a manufacturer, the Director, Center for 
Devices and radiological Health, Food and Drug Administration, may grant 
an exemption from one or more of the statements (radiation safety 
warnings) specified in paragraph (c)(6)(i) of this section. Such 
exemption shall be based upon a determination by the Director that the 
microwave oven model for which the exemption is sought should continue 
to comply with paragraphs (c)(1) through (3) of this section under the 
adverse condition of use addressed by such precautionary statement(s). 
An application shall be submitted to the Dockets Management Staff (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. Copies of the written portion of the application, 
including supporting data and information, and the Director's action on 
the application will be maintained by the Dockets Management Branch for 
public review. The application shall include:
    (a) The specific microwave oven model(s) for which the exemption is 
sought.
    (b) The specific radiation safety warning(s) from which exemption is 
sought.
    (c) Data and information which clearly establish that one or more of 
the radiation safety warnings in paragraph (c)(6)(i) of this section is 
not necessary for the specified microwave oven model(s).
    (d) Such other information and a sample of the applicable product if 
required by regulation or by the Director, Center for Devices and 
Radiological Health, to evaluate and act on the application.

[38 FR 28640, Oct. 15, 1973, as amended at 40 FR 14752, Apr. 4, 1975; 40 
FR 52007, Nov. 7, 1975; 46 FR 8461, Jan. 27, 1981; 48 FR 57482, Dec. 30, 
1983; 50 FR 13566, Apr. 5, 1985; 53 FR 11254, Apr. 6, 1988; 59 FR 14365, 
Mar. 28, 1994; 88 FR 3654, Jan. 20, 202]



PART 1040_PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS--Table of Contents



Sec.
1040.10 Laser products.
1040.11 Specific purpose laser products.
1040.20 Sunlamp products and ultraviolet lamps intended for use in 
          sunlamp products.
1040.30 High-intensity mercury vapor discharge lamps.


[[Page 922]]


    Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss, 371, 
381.



Sec. 1040.10  Laser products.

    (a) Applicability. The provisions of this section and Sec. 1040.11, 
as amended, are applicable as specified to all laser products 
manufactured or assembled after August 1, 1976, except when:
    (1) Such a laser product is either sold to a manufacturer of an 
electronic product for use as a component (or replacement) in such 
electronic product, or
    (2) Sold by or for a manufacturer of an electronic product for use 
as a component (or replacement) in such electronic product, provided 
that such laser product:
    (i) Is accompanied by a general warning notice that adequate 
instructions for the safe installation of the laser product are provided 
in servicing information available from the complete laser product 
manufacturer under paragraph (h)(2)(ii) of this section, and should be 
followed,
    (ii) Is labeled with a statement that it is designated for use 
solely as a component of such electronic product and therefore does not 
comply with the appropriate requirements of this section and Sec. 
1040.11 for complete laser products, and
    (iii) Is not a removable laser system as described in paragraph 
(c)(2) of this section; and
    (3) The manufacturer of such a laser product, if manufactured after 
August 20, 1986:
    (i) Registers, and provides a listing by type of such laser products 
manufactured that includes the product name, model number, and laser 
medium or emitted wavelength(s), and the name and address of the 
manufacturer. The manufacturer must submit the registration and listing 
to the Director, Center for Devices and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, 
MD 20993-0002.
    (ii) Maintains and allows access to any sales, shipping, or 
distribution records that identify the purchaser of such a laser product 
by name and address, the product by type, the number of units sold, and 
the date of sale (shipment). These records shall be maintained and made 
available as specified in Sec. 1002.31.
    (b) Definitions. As used in this section and Sec. 1040.11, the 
following definitions apply:
    (1) Accessible emission level means the magnitude of accessible 
laser or collateral radiation of a specific wavelength and emission 
duration at a particular point as measured according to paragraph (e) of 
this section. Accessible laser or collateral radiation is radiation to 
which human access is possible, as defined in paragraphs (b) (12), (15), 
and (22) of this section.
    (2) Accessible emission limit means the maximum accessible emission 
level permitted within a particular class as set forth in paragraphs 
(c), (d), and (e) of this section.
    (3) Aperture means any opening in the protective housing or other 
enclosure of a laser product through which laser or collateral radiation 
is emitted, thereby allowing human access to such radiation.
    (4) Aperture stop means an opening serving to limit the size and to 
define the shape of the area over which radiation is measured.
    (5) Class I laser product means any laser product that does not 
permit access during the operation to levels of laser radiation in 
excess of the accessible emission limits contained in table I of 
paragraph (d) of this section. \1\
---------------------------------------------------------------------------

    \1\ Class I levels of laser radiation are not considered to be 
hazardous.
---------------------------------------------------------------------------

    (6) Class IIa laser product means any laser product that permits 
human access during operation to levels of visible laser radiation in 
excess of the accessible emission limits contained in table I, but does 
not permit human access during operation to levels of laser radiation in 
excess of the accessible emission limits contained in table II-A of 
paragraph (d) of this section. \2\
---------------------------------------------------------------------------

    \2\ Class IIa levels of laser radiation are not considered to be 
hazardous if viewed for any period of time less than or equal to 1 x 
10\3\ seconds but are considered to be a chronic viewing hazard for any 
period of time greater than 1 x 10 \3\ seconds.
---------------------------------------------------------------------------

    (7) Class II laser product means any laser product that permits 
human access during operation to levels of visible laser radiation in 
excess of the accessible emission limits contained in

[[Page 923]]

table II-A, but does not permit human access during operation to levels 
of laser radiation in excess of the accessible emission limits contained 
in table II of paragraph (d) of this section. \3\
---------------------------------------------------------------------------

    \3\ Class II levels of laser radiation are considered to be a 
chronic viewing hazard.
---------------------------------------------------------------------------

    (8) Class IIIa laser product means any laser product that permits 
human access during operation to levels of visible laser radiation in 
excess of the accessible emission limits contained in table II, but does 
not permit human access during operation to levels of laser radiation in 
excess of the accessible emission limits contained in table III-A of 
paragraph (d) of this section. \4\
---------------------------------------------------------------------------

    \4\ Class IIIa levels of laser radiation are considered to be, 
depending upon the irradiance, either an acute intrabeam viewing hazard 
or chronic viewing hazard, and an acute viewing hazard if viewed 
directly with optical instruments.
---------------------------------------------------------------------------

    (9) Class IIIb laser product means any laser product that permits 
human access during operation to levels of laser radiation in excess of 
the accessible emission limits of table III-A, but does not permit human 
access during operation to levels of laser radiation in excess of the 
accessible emission limits contained in table III-B of paragraph (d) of 
this section. \5\
---------------------------------------------------------------------------

    \5\ Class IIIb levels of laser radiation are considered to be an 
acute hazard to the skin and eyes from direct radiation.
---------------------------------------------------------------------------

    (10) Class III laser product means any Class IIIa or Class IIIb 
laser product.
    (11) Class IV laser product means any laser that permits human 
access during operation to levels of laser radiation in excess of the 
accessible emission limits contained in table III-B of paragraph (d) of 
this section. \6\
---------------------------------------------------------------------------

    \6\ Class IV levels of laser radiation are considered to be an acute 
hazard to the skin and eyes from direct and scattered radiation.
---------------------------------------------------------------------------

    (12) Collateral radiation means any electronic product radiation, 
except laser radiation, emitted by a laser product as a result of the 
operation of the laser(s) or any component of the laser product that is 
physically necessary for the operation of the laser(s).
    (13) Demonstration laser product means any laser product 
manufactured, designed, intended, or promoted for purposes of 
demonstration, entertainment, advertising display, or artistic 
composition. The term ``demonstration laser product'' does not apply to 
laser products which are not manufactured, designed, intended, or 
promoted for such purposes, even though they may be used for those 
purposes or are intended to demonstrate other applications.
    (14) Emission duration means the temporal duration of a pulse, a 
series of pulses, or continuous operation, expressed in seconds, during 
which human access to laser or collateral radiation could be permitted 
as a result of operation, maintenance, or service of a laser product.
    (15) Human access means the capacity to intercept laser or 
collateral radiation by any part of the human body. For laser products 
that contain Class IIIb or IV levels of laser radiation, ``human 
access'' also means access to laser radiation that can be reflected 
directly by any single introduced flat surface from the interior of the 
product through any opening in the protective housing of the product.
    (16) Integrated radiance means radiant energy per unit area of a 
radiating surface per unit solid angle of emission, expressed in joules 
per square centimeter per steradian (Jcm-2 sr-1).
    (17) Invisible radiation means laser or collateral radiation having 
wavelengths of equal to or greater than 180 nm but less than or equal to 
400 nm or greater than 710 nm but less than or equal to 1.0 x 10\6\ nm 
(1 millimeter).
    (18) Irradiance means the time-averaged radiant power incident on an 
element of a surface divided by the area of that element, expressed in 
watts per square centimeter (W cm-2).
    (19) Laser means any device that can be made to produce or amplify 
electromagnetic radiation at wavelenghts greater than 250 nm but less 
than or equal to 13,000 nm or, after August 20, 1986, at wavelengths 
equal to or greater than 180 nm but less than or equal to 1.0 x 10\6\ nm 
primarily by the process of controlled stimulated emission.
    (20) Laser energy source means any device intended for use in 
conjunction with a laser to supply energy for the operation of the 
laser. General energy sources such as electrical supply mains or 
batteries shall not be considered to constitute laser energy sources.

[[Page 924]]

    (21) Laser product means any manufactured product or assemblage of 
components which constitutes, incorporates, or is intended to 
incorporate a laser or laser system. A laser or laser system that is 
intended for use as a component of an electronic product shall itself be 
considered a laser product.
    (22) Laser radiation means all electromagnetic radiation emitted by 
a laser product within the spectral range specified in paragraph (b)(19) 
of this section that is produced as a result of controlled stimulated 
emission or that is detectable with radiation so produced through the 
appropriate aperture stop and within the appropriate solid angle of 
acceptance, as specified in paragraph (e) of this section.
    (23) Laser system means a laser in combination with an appropriate 
laser energy source with or without additional incorporated components. 
See paragraph (c)(2) of this section for an explanation of the term 
``removable laser system.''
    (24) Maintenance means performance of those adjustments or 
procedures specified in user information provided by the manufacturer 
with the laser product which are to be performed by the user for the 
purpose of assuring the intended performance of the product. It does not 
include operation or service as defined in paragraph (b) (27) and (38) 
of this section.
    (25) Maximum output means the maximum radiant power and, where 
applicable, the maximum radiant energy per pulse of accessible laser 
radiation emitted by a laser product during operation, as determined 
under paragraph (e) of this section.
    (26) Medical laser product means any laser product which is a 
medical device as defined in 21 U.S.C. 321(h) and is manufactured, 
designed, intended or promoted for in vivo laser irradiation of any part 
of the human body for the purpose of: (i) Diagnosis, surgery, or 
therapy; or (ii) relative positioning of the human body.
    (27) Operation means the performance of the laser product over the 
full range of its functions. It does not include maintenance or service 
as defined in paragraphs (b) (24) and (38) of this section.
    (28) Protective housing means those portions of a laser product 
which are designed to prevent human access to laser or collateral 
radiation in excess of the prescribed accessible emission limits under 
conditions specified in this section and in Sec. 1040.11.
    (29) Pulse duration means the time increment measured between the 
half-peak-power points at the leading and trailing edges of a pulse.
    (30) Radiance means time-averaged radiant power per unit area of a 
radiating surface per unit solid angle of emission, expressed in watts 
per square centimeter per steradian (W cm-2 sr-1).
    (31) Radiant energy means energy emitted, transferred or received in 
the form of radiation, expressed in joules (J).
    (32) Radiant exposure means the radiant energy incident on an 
element of a surface divided by the area of the element, expressed in 
joules per square centimeter (Jcm-2)
    (33) Radiant power means time-averaged power emitted, transferred or 
received in the form of radiation, expressed in watts (W).
    (34) Remote interlock connector means an electrical connector which 
permits the connection of external remote interlocks.
    (35) Safety interlock means a device associated with the protective 
housing of a laser product to prevent human access to excessive 
radiation in accordance with paragraph (f)(2) of this section.
    (36) Sampling interval means the time interval during which the 
level of accessible laser or collateral radiation is sampled by a 
measurement process. The magnitude of the sampling interval in units of 
seconds is represented by the symbol (t).
    (37) Scanned laser radiation means laser radiation having a time-
varying direction, origin or pattern of propagation with respect to a 
stationary frame of reference.
    (38) Service means the performance of those procedures or 
adjustments described in the manufacturer's service instructions which 
may affect any aspect of the product's performance for

[[Page 925]]

which this section and Sec. 1040.11 have applicable requirements. It 
does not include maintenance or operation as defined in paragraphs (b) 
(24) and (27) of this section.
    (39) Surveying, leveling, or alignment laser product means a laser 
product manufactured, designed, intended or promoted for one or more of 
the following uses:
    (i) Determining and delineating the form, extent, or position of a 
point, body, or area by taking angular measurement.
    (ii) Positioning or adjusting parts in proper relation to one 
another.
    (iii) Defining a plane, level, elevation, or straight line.
    (40) Visible radiation means laser or collateral radiation having 
wavelengths of greater than 400 nm but less than or equal to 710 nm.
    (41) Warning logotype means a logotype as illustrated in either 
figure 1 or figure 2 of paragraph (g) of this section.
    (42) Wavelength means the propagation wavelength in air of 
electromagnetic radiation.
    (c) Classification of laser products--(1) All laser products. Each 
laser product shall be classified in Class I, IIa, II, IIIa, IIIb, or IV 
in accordance with definitions set forth in paragraphs (b) (5) through 
(11) of this section. The product classification shall be based on the 
highest accessible emission level(s) of laser radiation to which human 
access is possible during operation in accordance with paragraphs (d), 
(e), and (f)(1) of this section.
    (2) Removable laser systems. Any laser system that is incorporated 
into a laser product subject to the requirements of this section and 
that is capable, without modification, of producing laser radiation when 
removed from such laser product, shall itself be considered a laser 
product and shall be separately subject to the applicable requirements 
in this subchapter for laser products of its class. It shall be 
classified on the basis of accessible emission of laser radiation when 
so removed.
    (d) Accessible emission limits. Accessible emission limits for laser 
radiation in each class are specified in tables I, II-A, II, III-A, and 
III-B of this paragraph. The factors, k1 and k2 
vary with wavelength and emission duration. These factors are given in 
table IV of this paragraph, with selected numerical values in table V of 
this paragraph. Accessible emission limits for collateral radiation are 
specified in table VI of this paragraph.

    Notes applicable to tables I, II-A, II, III-A and III-B: (1) The 
factors k1 and k2 are wavelength-dependent 
correction factors determined from table IV.
    (2) The variable t in the expressions of emission limits is the 
magnitude of the sampling interval in units of seconds.

[[Page 926]]

[GRAPHIC] [TIFF OMITTED] TR01FE93.031


[[Page 927]]


[GRAPHIC] [TIFF OMITTED] TR01FE93.032


[[Page 928]]


[GRAPHIC] [TIFF OMITTED] TR01FE93.033


[[Page 929]]


[GRAPHIC] [TIFF OMITTED] TR01FE93.034


[[Page 930]]


[GRAPHIC] [TIFF OMITTED] TR01FE93.035


[[Page 931]]


[GRAPHIC] [TIFF OMITTED] TR01FE93.036

    (1) Beam of a single wavelength. Laser or collateral radiation of a 
single wavelength exceeds the accessible emission limits of a class if 
its accessible emission level is greater than the accessible emission 
limit of that class within any of the ranges of emission duration 
specified in tables I, II-A, II, III-A, and III-B of this paragraph.
    (2) Beam of multiple wavelengths in same range. Laser or collateral 
radiation having two or more wavelengths within any one of the 
wavelength ranges specified in tables I, II-A, II, III-A, and III-B of 
this paragraph exceeds the accessible emission limits of a class if the 
sum of the ratios of the accessible emission level to the corresponding 
accessible emission limit at each such wavelength is greater than unity 
for that combination of emission duration and wavelength distribution 
which results in the maximum sum.
    (3) Beam with multiple wavelengths in different ranges. Laser or 
collateral radiation having wavelengths within two or more of the 
wavelength ranges specified in tables I, II-A, II, III-A, and III-B of 
this paragraph exceeds the accessible emission limits of a class if it 
exceeds the applicable limits within any one of those wavelength ranges. 
This determination is made for each wavelength range in accordance with 
paragraph (d) (1) or (2) of this section.

[[Page 932]]

    (4) Class I dual limits. Laser or collateral radiation in the 
wavelength range of greater than 400 nm but less than or equal to 1.400 
nm exceeds the accessible emission limits of Class I if it exceeds both:
    (i) The Class I accessible emission limits for radiant energy within 
any range of emission duration specified in table I of this paragraph, 
and
    (ii) The Class I accessible emission limits for integrated radiance 
within any range of emission duration specified in table I of this 
paragraph.
    (e) Tests for determination of compliance--(1) Tests for 
certification. Tests on which certification under Sec. 1010.2 is based 
shall account for all errors and statistical uncertainties in the 
measurement process. Because compliance with the standard is required 
for the useful life of a product such tests shall also account for 
increases in emission and degradation in radiation safety with age.
    (2) Test conditions. Except as provided in Sec. 1010.13, tests for 
compliance with each of the applicable requirements of this section and 
Sec. 1040.11 shall be made during operation, maintenance, or service as 
appropriate:
    (i) Under those conditions and procedures which maximize the 
accessible emission levels, including start-up, stabilized emission, and 
shut-down of the laser product; and
    (ii) With all controls and adjustments listed in the operation, 
maintenance, and service instructions adjusted in combination to result 
in the maximum accessible emission level of radiation; and
    (iii) At points in space to which human access is possible in the 
product configuration which is necessary to determine compliance with 
each requirement, e.g., if operation may require removal of portions of 
the protective housing and defeat of safety interlocks, measurements 
shall be made at points accessible in that product configuration; and
    (iv) With the measuring instrument detector so positioned and so 
oriented with respect to the laser product as to result in the maximum 
detection of radiation by the instrument; and
    (v) For a laser product other than a laser system, with the laser 
coupled to that type of laser energy source which is specified as 
compatible by the laser product manufacturer and which produces the 
maximum emission level of accessible radiation from that product.
    (3) Measurement parameters. Accessible emission levels of laser and 
collateral radiation shall be based upon the following measurements as 
appropriate, or their equivalent:
    (i) For laser products intended to be used in a locale where the 
emitted laser radiation is unlikely to be viewed with optical 
instruments, the radiant power (W) or radiant energy (J) detectable 
through a circular aperture stop having a diameter of 7 millimeters and 
within a circular solid angle of acceptance of 1 x 10-3 
steradian with collimating optics of 5 diopters or less. For scanned 
laser radiation, the direction of the solid angle of acceptance shall 
change as needed to maximize detectable radiation, with an angular speed 
of up to 5 radians/second. A 50 millimeter diameter aperture stop with 
the same collimating optics and acceptance angle stated above shall be 
used for all other laser products (except that a 7 millimeter diameter 
aperture stop shall be used in the measurement of scanned laser 
radiation emitted by laser products manufactured on or before August 20, 
1986.
    (ii) The irradiance (W cm-2) or radiant exposure (J 
cm-2 equivalent to the radiant power (W) or radiant energy 
(J) detectable through a circular aperture stop having a diameter of 7 
millimeters and, for irradiance, within a circular solid angle of 
acceptance of 1 x x 10-3 steradian with collimating optics of 
5 diopters or less, divided by the area of the aperture stop 
(cm-2).
    (iii) The radiance (W cm-2 sr-1) or integrated 
radiance (J cm-2 sr-1) equivalent to the radiant 
power (W) or radiant energy (J) detectable through a circular aperture 
stop having a diameter of 7 millimeters and within a circular solid 
angle of acceptance of 1 x 10-5 steradian with collimating 
optics of 5 diopters or less, divided by that solid angle (sr) and by 
the area of the aperture stop (cm-2).
    (f) Performance requirements--(1) Protective housing. Each laser 
product shall have a protective housing that prevents human access 
during operation

[[Page 933]]

to laser and collateral radiation that exceed the limits of Class I and 
table VI, respectively, wherever and whenever such human access is not 
necessary for the product to perform its intended function. Wherever and 
whenever human access to laser radiation levels that exceed the limits 
of Class I is necessary, these levels shall not exceed the limits of the 
lowest class necessary to perform the intended function(s) of the 
product.
    (2) Safety interlocks. (i) Each laser product, regardless of its 
class, shall be provided with at least one safety interlock for each 
portion of the protective housing which is designed to be removed or 
displaced during operation or maintenance, if removal or displacement of 
the protective housing could permit, in the absence of such 
interlock(s), human access to laser or collateral radiation in excess of 
the accessible emission limit applicable under paragraph (f)(1) of this 
section.
    (ii) Each required safety interlock, unless defeated, shall prevent 
such human access to laser and collateral radiation upon removal or 
displacement of such portion of the protective housing
    (iii) Either multiple safety interlocks or a means to preclude 
removal or displacement of the interlocked portion of the protective 
housing shall be provided, if failure of a single interlock would allow;
    (a) Human access to a level of laser radiation in excess of the 
accessible emission limits of Class IIIa; or
    (b) Laser radiation in excess of the accessible emission limits of 
Class II to be emitted directly through the opening created by removal 
or displacement of the interlocked portion of the protective housing.
    (iv) Laser products that incorporate safety interlocks designed to 
allow safety interlock defeat shall incorporate a means of visual or 
aural indication of interlock defeat. During interlock defeat, such 
indication shall be visible or audible whenever the laser product is 
energized, with and without the associated portion of the protective 
housing removed or displaced.
    (v) Replacement of a removed or displaced portion of the protective 
housing shall not be possible while required safety interlocks are 
defeated.
    (3) Remote interlock connector. Each laser system classified as a 
Class IIIb or IV laser product shall incorporate a readily available 
remote interlock connector having an electrical potential difference of 
no greater than 130 root-mean-square volts between terminals. When the 
terminals of the connector are not electrically joined, human access to 
all laser and collateral radiation from the laser product in excess of 
the accessible emission limits of Class I and table VI shall be 
prevented.
    (4) Key control. Each laser system classified as a Class IIIb or IV 
laser product shall incorporate a key-actuated master control. The key 
shall be removable and the laser shall not be operable when the key is 
removed.
    (5) Laser radiation emission indicator. (i) Each laser system 
classified as a Class II or IIIa laser product shall incorporate an 
emission indicator that provides a visible or audible signal during 
emission of accessible laser radiation in excess of the accessible 
emission limits of Class I.
    (ii) Each laser system classified as a Class IIIb or IV laser 
product shall incorporate an emission indicator which provides a visible 
or audible signal during emission of accessible laser radiation in 
excess of the accessible emission limits of Class I, and sufficiently 
prior to emission of such radiation to allow appropriate action to avoid 
exposure to the laser radiation.
    (iii) For laser systems manufactured on or before August 20, 1986, 
if the laser and laser energy source are housed separately and can be 
operated at a separation distance of greater than 2 meters, both laser 
and laser energy source shall incorporate an emission indicator as 
required in accordance with paragraph (f)(5) (i) or (ii) of this 
section. For laser systems manufactured after August 20, 1986, each 
separately housed laser and operation control of a laser system that 
regulates the laser or collateral radiation emitted by a product during 
operation shall incorporate an emission indicator as required in 
accordance with paragraph (f)(5) (i) or (ii) of this section, if the 
laser or operation control can be operated at a separation distance 
greater than 2 meters from

[[Page 934]]

any other separately housed portion of the laser product incorporating 
an emission indicator.
    (iv) Any visible signal required by paragraph (f)(5) (i) or (ii) of 
this section shall be clearly visible through protective eyewear 
designed specifically for the wavelength(s) of the emitted laser 
radiation.
    (v) Emission indicators required by paragraph (f)(5) (i) or (ii) of 
this section shall be located so that viewing does not require human 
exposure to laser or collateral radiation in excess of the accessible 
emission limits of Class I and table VI.
    (6) Beam attenuator. (i) Each laser system classified as a Class II, 
III, or IV laser product shall be provided with one or more permanently 
attached means, other than laser energy source switch(es), electrical 
supply main connectors, or the key-actuated master control, capable of 
preventing access by any part of the human body to all laser and 
collateral radiation in excess of the accessible emission limits of 
Class I and table VI.
    (ii) If the configuration, design, or function of the laser product 
would make unnecessary compliance with the requirement in paragraph 
(f)(6)(i) of this section, the Director, Center for Devices and 
Radiological Health, may, upon written application by the manufacturer, 
approve alternate means to accomplish the radiation protection provided 
by the beam attenuator.
    (7) Location of controls. Each Class IIa, II, III, or IV laser 
product shall have operational and adjustment controls located so that 
human exposure to laser or collateral radiation in excess of the 
accessible emission limits of Class I and table VI is unnecessary for 
operation or adjustment of such controls.
    (8) Viewing optics. All viewing optics, viewports, and display 
screens incorporated into a laser product, regardless of its class, 
shall limit the levels of laser and collateral radiation accessible to 
the human eye by means of such viewing optics, viewports, or display 
screens during operation or maintenance to less than the accessible 
emission limits of Class I and table VI. For any shutter or variable 
attenuator incorporated into such viewing optics, viewports, or display 
screens, a means shall be provided:
    (i) To prevent access by the human eye to laser and collateral 
radiation in excess of the accessible emission limits of Class I and 
table VI whenever the shutter is opened or the attenuator varied.
    (ii) To preclude, upon failure of such means as required in 
paragraph (f)(8)(i) of this section, opening the shutter or varying the 
attenuator when access by the human eye is possible to laser or 
collateral radiation in excess of the accessible emission limits of 
Class I and table VI.
    (9) Scanning safeguard. Laser products that emit accessible scanned 
laser radiation shall not, as a result of any failure causing a change 
in either scan velocity or amplitude, permit human access to laser 
radiation in excess of:
    (i) The accessible emission limits of the class of the product, or
    (ii) The accessible emission limits of the class of the scanned 
laser radiation if the product is Class IIIb or IV and the accessible 
emission limits of Class IIIa would be exceeded solely as result of such 
failure.
    (10) Manual reset mechanism. Each laser system manufactured after 
August 20, 1986, and classified as a Class IV laser product shall be 
provided with a manual reset to enable resumption of laser radiation 
emission after interruption of emission caused by the use of a remote 
interlock or after an interruption of emission in excess of 5 seconds 
duration due to the unexpected loss of main electrical power.
    (g) Labeling requirements. In addition to the requirements of 
Sec. Sec. 1010.2 and 1010.3, each laser product shall be subject to the 
applicable labeling requirements of this paragraph.
    (1) Class IIa and II designations and warnings. (i) Each Class IIa 
laser product shall have affixed a label bearing the following wording: 
``Class IIa Laser Product--Avoid Long-Term Viewing of Direct Laser 
Radiation.''

[[Page 935]]

    (ii) Each Class II laser product shall have affixed a label bearing 
the warning logotype A (figure 1 in this paragraph) and including the 
following wording:

                      [Position I on the logotype]

            ``LASER RADIATION--DO NOT STARE INTO BEAM''; and

                      [Position 3 on the logotype]

                       ``CLASS II LASER PRODUCT''.
[GRAPHIC] [TIFF OMITTED] TR01FE93.037

    (2) Class IIIa and IIIb designations and warnings. (i) Each Class 
IIIa laser product with an irradiance less than or equal to 2.5 x 
10-3 W cm2- shall have affixed a label bearing the 
warning logotype A (figure 1 of paragraph (g)(1)(ii) of this section) 
and including the following wording:

                      [Position 1 on the logotype]

``LASER RADIATION--DO NOT STARE INTO BEAM OR VIEW DIRECTLY WITH OPTICAL 
                           INSTRUMENTS''; and,

                      [Position 3 on the logotype]

                      ``CLASS IIIa LASER PRODUCT''.

    (ii) Each Class IIIa laser product with an irradiance greater than 
2.5 x 10-3 W cm-2 shall have affixed a label 
bearing the warning logotype B (figure 2 in this paragraph) and 
including the following wording:

                      [Position 1 on the logotype]

          ``LASER RADIATION--AVOID DIRECT EYE EXPOSURE''; and,

                      [Position 3 on the logotype]

                      ``CLASS IIIa LASER PRODUCT''.

[[Page 936]]

[GRAPHIC] [TIFF OMITTED] TR01FE93.038

    (iii) Each Class IIIb laser product shall have affixed a label 
bearing the warning logotype B (figure 2 of paragraph (g)(2)(ii) of this 
section) and including the following wording:

                      [Position 1 on the logotype]

        ``LASER RADIATION--AVOID DIRECT EXPOSURE TO BEAM''; and,

                      [Position 3 on the logotype]

                      ``CLASS IIIb LASER PRODUCT''.

    (3) Class IV designation and warning. Each Class IV laser product 
shall have affixed a label bearing the warning logotype B (figure 2 of 
paragraph (g)(2)(ii) of this section), and including the following 
wording:

                      [Position 1 on the logotype]

  ``LASER RADIATION--AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED 
                            RADIATION''; and,

                      [Position 3 on the logotype]

                       ``CLASS IV LASER PRODUCT''.

    (4) Radiation output information on warning logotype. Each Class II, 
III, and IV laser product shall state in appropriate units, at position 
2 on the required warning logotype, the maximum output of laser 
radiation, the pulse duration when appropriate, and the laser medium or 
emitted wavelength(s).
    (5) Aperture label. Each laser product, except medical laser 
products and Class IIa laser products, shall have affixed, in close 
proximity to each aperture through which is emitted accessible laser or 
collateral radiation in excess of the accessible emission limits of 
Class I and table VI of paragraph (d) of this section, a label(s) 
bearing the following wording as applicable.

[[Page 937]]

    (i) ``AVOID EXPOSURE--Laser radiation is emitted from this 
aperture,'' if the radiation emitted through such aperture is laser 
radiation.
    (ii) ``AVOID EXPOSURE--Hazardous electromagnetic radiation is 
emitted from this aperture,'' if the radiation emitted through such 
aperture is collateral radiation described in table VI, item 1.
    (iii) ``AVOID EXPOSURE--Hazardous x-rays are emitted from this 
aperture,'' if the radiation emitted through such aperture is collateral 
radiation described in table VI, item 2.
    (6) Labels for noninterlocked protective housings. For each laser 
product, labels shall be provided for each portion of the protective 
housing which has no safety interlock and which is designed to be 
displaced or removed during operation, maintenance, or service, and 
thereby could permit human access to laser or collateral radiation in 
excess of the limits of Class I and table VI. Such labels shall be 
visible on the protective housing prior to displacement or removal of 
such portion of the protective housing and visible on the product in 
close proximity to the opening created by removal or displacement of 
such portion of the protective housing, and shall include the wording:
    (i) ``CAUTION--Laser radiation when open. DO NOT STARE INTO BEAM.'' 
for Class II accessible laser radiation.
    (ii) ``CAUTION--Laser radiation when open. DO NOT STARE INTO BEAM OR 
VIEW DIRECTLY WITH OPTICAL INSTRUMENTS.'' for Class IIIa accessible 
laser radiation with an irradiance less than or equal to 2.5 x 
10-3 W cm-2.
    (iii) ``DANGER--Laser radiation when open. AVOID DIRECT EYE 
EXPOSURE.'' for Class IIIa accessible laser radiation with an irradiance 
greater than 2.5 x 10-3 W cm-2.
    (iv) ``DANGER--Laser radiation when open. AVOID DIRECT EXPOSURE TO 
BEAM.'' for Class IIIb accessible laser radiation.
    (v) ``DANGER--Laser radiation when open. AVOID EYE OR SKIN EXPOSURE 
TO DIRECT OR SCATTERED RADIATION.'' for Class IV accessible laser 
radiation.
    (vi) ``CAUTION--Hazardous electromagnetic radiation when open.'' for 
collateral radiation in excess of the accessible emission limits in 
table VI, item 1 of paragraph (d) of this section.
    (vii) ``CAUTION--Hazardous x-rays when open.'' for collateral 
radiation in excess of the accessible emission limits in table VI, item 
2 of paragraph (d) of this section.
    (7) Labels for defeatably interlocked protective housings. For each 
laser product, labels shall be provided for each defeatably interlocked 
(as described in paragraph (f)(2)(iv) of this section) portion of the 
protective housing which is designed to be displaced or removed during 
operation, maintenance, or service, and which upon interlock defeat 
could permit human access to laser or collateral radiation in excess of 
the limits of Class I or table VI. Such labels shall be visible on the 
product prior to and during interlock defeat and in close proximity to 
the opening created by the removal or displacement of such portion of 
the protective housing, and shall include the wording:
    (i) ``CAUTION--Laser radiation when open and interlock defeated. DO 
NOT STARE INTO BEAM.'' for Class II accessible laser radiation.
    (ii) ``CAUTION--Laser radiation when open and interlock defeated. DO 
NOT STARE INTO BEAM OR VIEW DIRECTLY WITH OPTICAL INSTRUMENTS.'' for 
Class IIIa accessible laser radiation with an irradiance less than or 
equal to 2.5 x 10-3 W cm-2.
    (iii) ``DANGER--Laser radiation when open and interlock defeated. 
AVOID DIRECT EYE EXPOSURE.'' for Class IIIa accessible laser radiation 
when an irradiance greater than 2.5 x 10-3 W cm-2.
    (iv) ``DANGER--Laser radiation when open and interlock defeated. 
AVOID DIRECT EXPOSURE TO BEAM.'' for Class IIIb accessible laser 
radiation.
    (v) ``DANGER--Laser radiation when open and interlock defeated. 
AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION.'' for Clas 
IV accessible laser radiation.
    (vi) ``CAUTION--Hazardous electromagnetic radiation when open and 
interlock defeated.'' for collateral radiation in excess of the 
accessible emission limits in table VI. item 1 of paragraph (d) of this 
section.

[[Page 938]]

    (vii) ``CAUTION--Hazardous x-rays when open and interlock 
defeated.'' for collateral radiation in excess of the accesible emission 
limits in table VI. item 2 of paragraph (d) of this section.
    (8) Warning for visible and/or invisible radiation. On the labels 
specified in this paragraph, if the laser or collateral radiation 
referred to is:
    (i) Invisible radiation, the word ``invisible'' shall appropriately 
precede the word ``radiation''; or
    (ii) Visible and invisible radiation, the words ``visible and 
invisible'' or ``visible and/or invisible'' shall appropriately precede 
the word ``radiation.''
    (iii) Visible laser radiation only, the phrase ``laser light'' may 
replace the phrase ``laser radiation.''
    (9) Positioning of labels. All labels affixed to a laser product 
shall be positioned so as to make unnecessary, during reading, human 
exposure to laser radiation in excess of the accessible emission limits 
of Class I radiation or the limits of collateral radiation established 
to table VI of paragraph (d) of this section.
    (10) Label specifications. Labels required by this section and Sec. 
1040.11 shall be permanently affixed to, or inscribed on, the laser 
product, legible, and clearly visible during operation, maintenance, or 
service, as appropriate. If the size, configuration, design, or function 
of the laser product would preclude compliance with the requirements for 
any required label or would render the required wording of such label 
inappropriate or ineffective, the Director, Center for Devices and 
Radiological Health, on the Director's own initiative or upon written 
application by the manufacturer, may approve alternate means of 
providing such label(s) or alternate wording for such label(s) as 
applicable.
    (h) Informational requirements--(1) User information. Manufacturers 
of laser products shall provide as an integral part of any user 
instruction or operation manual which is regularly supplied with the 
product, or, if not so supplied, shall cause to be provided with each 
laser product:
    (i) Adequate instructions for assembly, operation, and maintenance, 
including clear warnings concerning precautions to avoid possible 
exposure to laser and collateral radiation in excess of the accessible 
emission limits in tables I, II-A, II, III-A, III-B, and VI of paragraph 
(d) of this section, and a schedule of maintenance necessary to keep the 
product in compliance with this section and Sec. 1040.11.
    (ii) A statement of the magnitude, in appropriate units, of the 
pulse durations(s), maximum radiant power and, where applicable, the 
maximum radiant energy per pulse of the accessible laser radiation 
detectable in each direction in excess of the accessible emission limits 
in table I of paragraph (d) of this section determined under paragraph 
(e) of this section.
    (iii) Legible reproductions (color optional) of all labels and 
hazard warnings required by paragraph (g) of this section and Sec. 
1040.11 to be affixed to the laser product or provided with the laser 
product, including the information required for positions 1, 2, and 3 of 
the applicable logotype (figure 1 of paragraph (g)(1)(ii) or figure 2 or 
paragraph (g)(2)(ii) of this section). The corresponding position of 
each label affixed to the product shall be indicated or, if provided 
with the product, a statement that such labels could not be affixed to 
the product but were supplied with the product and a statement of the 
form and manner in which they were supplied shall be provided.
    (iv) A listing of all controls, adjustments, and procedures for 
operation and maintenance, including the warning ``Caution--use of 
controls or adjustments or performance of procedures other than those 
specified herein may result in hazardous radiation exposure.''
    (v) In the case of laser products other than laser systems, a 
statment of the compatibility requirements for a laser energy source 
that will assure compliance of the laser product with this section and 
Sec. 1040.11.
    (vi) In the case of laser products classified with a 7 millimeter 
diameter aperture stop as provided in paragraph (e)(3)(i) of this 
section, if the use of a 50 millimeter diameter aperture stop would 
result in a higher classification of the product, the following warning

[[Page 939]]

shall be included in the user information: ``CAUTION--The use of optical 
instruments with this product will increase eye hazard.''
    (2) Purchasing and servicing information. Manufacturers of laser 
products shall provide or cause to be provided:
    (i) In all catalogs, specification sheets, and descriptive brochures 
pertaining to each laser product, a legible reproduction (color 
optional) of the class designation and warning required by paragraph (g) 
of this section to be affixed to that product, including the information 
required for positions 1, 2, and 3 of the applicable logotype (figure 1 
of paragraph (g)(1)(ii) or figure 2 of paragraph (g)(2)(ii) of this 
section).
    (ii) To servicing dealers and distributors and to others upon 
request at a cost not to exceed the cost of preparation and 
distribution, adequate instructions for service adjustments and service 
procedures for each laser product model, including clear warnings and 
precautions to be taken to avoid possible exposure to laser and 
collateral radiation in excess of the accessible emission limits in 
tables I, II-A, II, III-A, III-B, and VI of paragraph (d) of this 
section, and a schedule of maintenance necessary to keep the product in 
compliance with this section and Sec. 1040.11; and in all such service 
instructions, a listing of those controls and procedures that could be 
utilized by persons other than the manufacturers or the manufacturer's 
agents to increase accessible emission levels of radiation and a clear 
description of the location of displaceable portions of the protective 
housing that could allow human access to laser or collateral radiation 
in excess of the accessible emission limits in tables I, II-A, II, III-
A, III-B, and VI of paragraph (d) of this section. The instructions 
shall include protective procedures for service personnel to avoid 
exposure to levels of laser and collateral radiation known to be 
hazardous for each procedure or sequence of procedures to be 
accomplished, and legible reproductions (color optional) of required 
labels and hazard warnings.
    (i) Modification of a certified product. The modification of a laser 
product, previously certified under Sec. 1010.2, by any person engaged 
in the business of manufacturing, assembling, or modifying laser 
products shall be construed as manufacturing under the act if the 
modification affects any aspect of the product's performance or intended 
function(s) for which this section and Sec. 1040.11 have an applicable 
requirement. The manufacturer who performs such modification shall 
recertify and reidentify the product in accordance with the provisions 
of Sec. Sec. 1010.2. and 1010.3.

(The information collection requirements contained in paragraph 
(a)(3)(ii) were approved by the Office of Management and Budget under 
control number 0910-0176)

[50 FR 33688, Aug. 20, 1985; 50 FR 42156, Oct. 18, 1985; 65 FR 17138, 
Mar. 31, 2000, as amended at 75 FR 20917, Apr. 22, 2010; 83 FR 13864, 
Apr. 2, 2018]



Sec. 1040.11  Specific purpose laser products.

    (a) Medical laser products. Each medical laser product shall comply 
with all of the applicable requirements of Sec. 1040.10 for laser 
products of its class. In addition, the manufacturer shall:
    (1) Incorporate in each Class III or IV medical laser product a 
means for the measurement of the level of that laser radiation intended 
for irradiation of the human body. Such means may have an error in 
measurement of no more than 20 percent when calibrated in accordance 
with paragraph (a)(2) of this section. Indication of the measurement 
shall be in International System Units. The requirements of this 
paragraph do not apply to any laser radiation that is all of the 
following:
    (i) Of a level less than the accessible limits of Class IIIa; and
    (ii) Used for relative positioning of the human body; and
    (iii) Not used for irradiation of the human eye for ophthalmic 
purposes.
    (2) Supply with each Class III or IV medical laser product 
instructions specifying a procedure and schedule for calibration of the 
measurement system required by paragraph (a)(1) of this section.
    (3) Affix to each medical laser product, in close proximity to each 
aperture through which is emitted accessible laser radiation in excess 
of the accessible emission limits of Class I, a

[[Page 940]]

label bearing the wording: ``Laser aperture.''
    (b) Surveying, leveling, and alignment laser products. Each 
surveying, leveling. or alignment laser product shall comply with all of 
the applicable requirements of Sec. 1040.10 for a Class I, IIa, II or 
IIIa laser product and shall not permit human access to laser radiation 
in excess of the accessible emission limits of Class IIIa.
    (c) Demonstration laser products. Each demonstration laser product 
shall comply with all of the applicable requirements of Sec. 1040.10 
for a Class I, IIa, II, or IIIa laser product and shall not permit human 
access to laser radiation in excess of the accessible emission limits of 
Class I and, if applicable, Class IIa, Class II, or Class IIIa.

[50 FR 33702, Aug. 20, 1985]



Sec. 1040.20  Sunlamp products and ultraviolet lamps intended for use in sunlamp products.

    (a) Applicability. (1) The provisions of this section, as amended, 
are applicable as specified herein to the following products 
manufactured on or after September 8, 1986.
    (i) Any sunlamp product.
    (ii) Any ultraviolet lamp intended for use in any sunlamp product.
    (2) Sunlamp products and ultraviolet lamps manufactured on or after 
May 7, 1980, but before September 8, 1986, are subject to the provisions 
of this section as published in the Federal Register of November 9, 1979 
(44 FR 65357).
    (b) Definitions. As used in this section the following definitions 
apply:
    (1) Exposure position means any position, distance, orientation, or 
location relative to the radiating surfaces of the sunlamp product at 
which the user is intended to be exposed to ultraviolet radiation from 
the product, as recommended by the manufacturer.
    (2) Intended means the same as ``intended uses'' in Sec. 801.4.
    (3) Irradiance means the radiant power incident on a surface at a 
specified location and orientation relative to the radiating surface 
divided by the area of the surface, as the area becomes vanishingly 
small, expressed in units of watts per square centimeter (W/cm\2\).
    (4) Maximum exposure time means the greatest continuous exposure 
time interval recommended by the manufacturer of the product.
    (5) Maximum timer interval means the greatest time interval setting 
on the timer of a product.
    (6) Protective eyewear means any device designed to be worn by users 
of a product to reduce exposure of the eyes to radiation emitted by the 
product.
    (7) Spectral irradiance means the irradiance resulting from 
radiation within a wavelength range divided by the wavelength range as 
the range becomes vanishingly small, expressed in units of watts per 
square centimeter per nanometer (W/(cm\2\/nm)).
    (8) Spectral transmittance means the spectral irradiance transmitted 
through protective eyewear divided by the spectral irradiance incident 
on the protective eyewear.
    (9) Sunlamp product means any electronic product designed to 
incorporate one or more ultraviolet lamps and intended for irradiation 
of any part of the living human body, by ultraviolet radiation with 
wavelengths in air between 200 and 400 nanometers, to induce skin 
tanning.
    (10) Timer means any device incorporated into a product that 
terminates radiation emission after a preset time interval.
    (11) Ultraviolet lamp means any lamp that produces ultraviolet 
radiation in the wavelength interval of 200 to 400 nanometers in air and 
that is intended for use in any sunlamp product.
    (c) Performance requirements--(1) Irradiance ratio limits. For each 
sunlamp product and ultraviolet lamp, the ratio of the irradiance within 
the wavelength range of greater than 200 nanometers through 260 
nanometers to the irradiance within the wavelength range of greater than 
260 nanometers through 320 nanometers may not exceed 0.003 at any 
distance and direction from the product or lamp.
    (2) Timer system. (i) Each sunlamp product shall incorporate a timer 
system with multiple timer settings adequate for the recommended 
exposure time intervals for different exposure positions and expected 
results of the products as specified in the label required by paragraph 
(d) of this section.

[[Page 941]]

    (ii) The maximum timer interval(s) may not exceed the manufacturer's 
recommended maximum exposure time(s) that is indicated on the label 
required by paragraph (d)(1)(iv) of this section.
    (iii) No timer interval may have an error greater than 10 percent of 
the maximum timer interval of the product.
    (iv) The timer may not automatically reset and cause radiation 
emission to resume for a period greater than the unused portion of the 
timer cycle, when emission from the sunlamp product has been terminated.
    (v) The timer requirements do not preclude a product from allowing a 
user to reset the timer before the end of the preset time interval.
    (3) Control for termination of radiation emission. Each sunlamp 
product shall incorporate a control on the product to enable the person 
being exposed to terminate manually radiation emission from the product 
at any time without disconnecting the electrical plug or removing the 
ultraviolet lamp.
    (4) Protective eyewear. (i) Each sunlamp product shall be 
accompanied by the number of sets of protective eyewear that is equal to 
the maximum number of persons that the instructions provided under 
paragraph (e)(1)(ii) of this section recommend to be exposed 
simultaneously to radiation from such product.
    (ii) The spectral transmittance to the eye of the protective eyewear 
required by paragraph (c)(4)(i) of this section shall not exceed a value 
of 0.001 over the wavelength range of greater than 200 nanometers 320 
nanometers and a value of 0.01 over the wavelength range of greater than 
320 nanometers through 400 nanometers, and shall be sufficient over the 
wavelength greater than 400 nanometers to enable the user to see clearly 
enough to reset the timer.
    (5) Compatibility of lamps. An ultraviolet lamp may not be capable 
of insertion and operation in either the ``single-contact medium screw'' 
or the ``double-contact medium screw'' lampholders described in American 
National Standard C81.10-1976, Specifications for Electric Lamp Bases 
and Holders--Screw-Shell Types, which is incorporated by reference. 
Copies are available from the American National Standards Institute, 
1430 Broadway, New York, NY 10018, or available for inspection at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
    (d) Label requirements. In addition to the labeling requirements in 
part 801 and the certification and identification requirements of 
Sec. Sec. 1010.2 and 1010.3, each sunlamp product and ultraviolet lamp 
shall be subject to the labeling requirements prescribed in this 
paragraph and paragraph (e) of this section.
    (1) Labels for sunlamp products. Each sunlamp product shall have a 
label(s) which contains:
    (i) A warning statement with the words ``DANGER--Ultraviolet 
radiation. Follow instructions. Avoid overexposure. As with natural 
sunlight, overexposure can cause eye and skin injury and allergic 
reactions. Repeated exposure may cause premature aging of the skin and 
skin cancer. WEAR PROTECTIVE EYEWEAR; FAILURE TO MAY RESULT IN SEVERE 
BURNS OR LONG-TERM INJURY TO THE EYES. Medications or cosmetics may 
increase your sensitivity to the ultraviolet radiation. Consult 
physician before using sunlamp if you are using medications or have a 
history of skin problems or believe yourself especially sensitive to 
sunlight. If you do not tan in the sun, you are unlikely to tan from the 
use of this product.''
    (ii) Recommended exposure position(s). Any exposure position may be 
expressed either in terms of a distance specified both in meters and in 
feet (or in inches) or through the use of markings or other means to 
indicate clearly the recommended exposure position.
    (iii) Directions for achieving the recommended exposure position(s) 
and a warning that the use of other positions may result in 
overexposure.
    (iv) A recommended exposure schedule including duration and spacing 
of sequential exposures and maximum exposure time(s) in minutes.
    (v) A statement of the time it may take before the expected results 
appear.

[[Page 942]]

    (vi) Designation of the ultraviolet lamp type to be used in the 
product.
    (2) Labels for ultraviolet lamps. Each ultraviolet lamp shall have a 
label which contains:
    (i) The words ``Sunlamp--DANGER--Ultraviolet radiation. Follow 
instructions.''
    (ii) The model identification.
    (iii) The words ``Use ONLY in fixture equipped with a timer.''
    (3) Label specifications. (i) Any label prescribed in this paragraph 
for sunlamp products shall be permanently affixed or inscribed on an 
exterior surface of the product when fully assembled for use so as to be 
legible and readily accessible to view by the person being exposed 
immediately before the use of the product.
    (ii) Any label prescribed in this paragraph for ultraviolet lamps 
shall be permanently affixed or inscribed on the product so as to be 
legible and readily accessible to view.
    (iii) If the size, configuration, design, or function of the sunlamp 
product or ultraviolet lamp would preclude compliance with the 
requirements for any required label or would render the required wording 
of such label inappropriate or ineffective, or would render the required 
label unnecessary, the Director, Center for Devices and Radiological 
Health, on the center's own initiative or upon written application by 
the manufacturer, may approve alternate means of providing such 
label(s), alternate wording for such label(s), or deletion, as 
applicable.
    (iv) In lieu of permanently affixing or inscribing tags or labels on 
the ultraviolet lamp as required by Sec. Sec. 1010.2(b) and 1010.3(a), 
the manufacturer of the ultraviolet lamp may permanently affix or 
inscribe such required tags or labels on the lamp packaging uniquely 
associated with the lamp, if the name of the manufacturer and month and 
year of manufacture are permanently affixed or inscribed on the exterior 
surface of the ultraviolet lamp so as to be legible and readily 
accessible to view. The name of the manufacturer and month and year of 
manufacture affixed or inscribed on the exterior surface of the lamp may 
be expressed in code or symbols, if the manufacturer has previously 
supplied the Director, Center for Devices and Radiological Health, with 
the key to such code or symbols and the location of the coded 
information or symbols on the ultraviolet lamp. The label or tag affixed 
or inscribed on the lamp packaging may provide either the month and year 
of manufacture without abbreviation, or information to allow the date to 
be readily decoded.
    (v) A label may contain statements or illustrations in addition to 
those required by this paragraph if the additional statements are not 
false or misleading in any particular; e.g., if they do not diminish the 
impact of the required statements; and are not prohibited by this 
chapter.
    (e) Instructions to be provided to users. Each manufacturer of a 
sunlamp product and ultraviolet lamp shall provide or cause to be 
provided to purchasers and, upon request, to others at a cost not to 
exceed the cost of publication and distribution, adequate instructions 
for use to avoid or to minimize potential injury to the user, including 
the following technical and safety information as applicable:
    (1) Sunlamp products. The users' instructions for a sunlamp product 
shall contain:
    (i) A reproduction of the label(s) required in paragraph (d)(1) of 
this section prominently displayed at the beginning of the instructions.
    (ii) A statement of the maximum number of people who may be exposed 
to the product at the same time and a warning that only that number of 
protective eyewear has been provided.
    (iii) Instructions for the proper operation of the product including 
the function, use, and setting of the timer and other controls, and the 
use of protective eyewear.
    (iv) Instructions for determining the correct exposure time and 
schedule for persons according to skin type.
    (v) Instructions for obtaining repairs and recommended replacement 
components and accessories which are compatible with the product, 
including compatible protective eyewear, ultraviolet lamps, timers, 
reflectors, and filters, and which will, if installed or used as 
instructed, result in continued compliance with the standard.

[[Page 943]]

    (2) Ultraviolet lamps. The users' instructions for an ultraviolet 
lamp not accompanying a sunlamp product shall contain:
    (i) A reproduction of the label(s) required in paragraphs (d)(1)(i) 
and (2) of this section, prominently displayed at the beginning of the 
instructions.
    (ii) A warning that the instructions accompanying the sunlamp 
product should always be followed to avoid or to minimize potential 
injury.
    (iii) A clear identification by brand and model designation of all 
lamp models for which replacement lamps are promoted, if applicable.
    (f) Test for determination of compliance. Tests on which 
certification pursuant to Sec. 1010.2 is based shall account for all 
errors and statistical uncertainties in the process and, wherever 
applicable, for changes in radiation emission or degradation in 
radiation safety with age of the product. Measurements for certification 
purposes shall be made under those operational conditions, lamp voltage, 
current, and position as recommended by the manufacturer. For these 
measurements, the measuring instrument shall be positioned at the 
recommended exposure position and so oriented as to result in the 
maximum detection of the radiation by the instrument.

[50 FR 36550, Sept. 6, 1985, as amended at 67 FR 9587, Mar. 4, 2002; 69 
FR 18803, Apr. 9, 2004; 75 FR 20917, Apr. 22, 2010; 83 FR 13865, Apr. 2, 
2018]



Sec. 1040.30  High-intensity mercury vapor discharge lamps.

    (a) Applicability. The provisions of this section apply to any high-
intensity mercury vapor discharge lamp that is designed, intended, or 
promoted for illumination purposes and is manufactured or assembled 
after March 7, 1980, except as described in paragraph (d)(1)(ii) of this 
section.
    (b) Definitions. (1) High-intensity mercury vapor discharge lamp 
means any lamp including any ``mercury vapor'' and ``metal halide'' 
lamp, with the exception of the tungsten filament self-ballasted mercury 
vapor lamp, incorporating a high-pressure arc discharge tube that has a 
fill consisting primarily of mercury and that is contained within an 
outer envelope.
    (2) Advertisement means any catalog, specification sheet, price 
list, and any other descriptive or commercial brochure and literature, 
including videotape and film, pertaining to high-intensity mercury vapor 
discharge lamps.
    (3) Packaging means any lamp carton, outer wrapping, or other means 
of containment that is intended for the storage, shipment, or display of 
a high-intensity mercury vapor lamp and is intended to identify the 
contents or recommend its use.
    (4) Outer envelope means the lamp element, usually glass, 
surrounding a high-pressure arc discharge tube, that, when intact, 
attenuates the emission of shortwave ultraviolet radiation.
    (5) Shortwave ultraviolet radiation means ultraviolet radiation with 
wavelengths shorter than 320 nanometers.
    (6) Cumulative operating time means the sum of the times during 
which electric current passes through the high-pressure arc discharge.
    (7) Self-extinguishing lamp means a high-intensity mercury vapor 
discharge lamp that is intended to comply with the requirements of 
paragraph (d)(1) of this section as applicable.
    (8) Reference ballast is an inductive reactor designed to have the 
operating characteristics as listed in Section 7 in the American 
National Standard Specifications for High-Intensity Discharge Lamp 
Reference Ballasts (ANSI C82.5-1977) \1\ or its equivalent.
---------------------------------------------------------------------------

    \1\ Copies are available from American National Standards Institute, 
1430 Broadway, New York, NY 10018.
---------------------------------------------------------------------------

    (c) General requirements for all lamps. (1) Each high-intensity 
mercury vapor discharge lamp shall:
    (i) Meet the requirements of either paragraph (d) or paragraph (e) 
of this section; and
    (ii) Be permanently labeled or marked in such a manner that the name 
of the manufacturer and the month and year of manufacture of the lamp 
can be determined on an intact lamp and after the outer envelope of the 
lamp is broken or removed. The name of the manufacturer and month and 
year of manufacture may be expressed in code or symbols, provided the 
manufacturer has previously supplied the Director, Center for Devices

[[Page 944]]

and Radiological Health, with the key to the code or symbols and the 
location of the coded information or symbols on the lamp.
    (2) In lieu of permanently affixing or inscribing tags or labels on 
the product as required by Sec. Sec. 1010.2(b) and 1010.3(a) of this 
chapter, the manufacturer of any high-intensity mercury vapor discharge 
lamp may permanently affix or inscribe such required tags or labels on 
the lamp packaging uniquely associated with the applicable lamp.
    (d) Requirements for self-extinguishing lamps--(1) Maximum 
cumulative operating time. (i) Each self-extinguishing lamp manufactured 
after March 7, 1980 shall cease operation within a cumulative operating 
time not to exceed 15 minutes following complete breakage or removal of 
the outer envelope (with the exception of fragments extending 50 
millimeters or less from the base shell); and
    (ii) Each self-extinguishing lamp manufactured after September 7, 
1981, shall cease operation within a cumulative operating time not to 
exceed 15 minutes following breakage or removal of at least 3 square 
centimeters of contiguous surface of the outer envelope.
    (2) Lamp labeling. Each self-extinguishing lamp shall be clearly 
marked with the letter ``T'' on the outer envelope and on another part 
of the lamp in such a manner that it is visible after the outer envelope 
of the lamp is broken or removed.
    (3) Lamp packaging. Lamp packaging for each self-extinguishing lamp 
shall clearly and prominently display:
    (i) The letter ``T''; and
    (ii) The words ``This lamp should self-extinguish within 15 minutes 
after the outer envelope is broken or punctured. If such damage occurs, 
TURN OFF AND REMOVE LAMP to avoid possible injury from hazardous 
shortwave ultraviolet radiation.''
    (e) Requirements for lamps that are not self-extinguishing lamps--
(1) Lamp labeling. Any high-intensity mercury vapor discharge lamp that 
does not comply with paragraph (d)(1) of this section shall be clearly 
and legibly marked with the letter ``R'' on the outer envelope and on 
another part of the lamp in such a manner that it is visible after the 
outer envelope of the lamp is broken or removed.
    (2) Lamp packaging. Lamp packaging for each high-intensity mercury 
vapor discharge lamp that does not comply with paragraph (d)(1) of this 
section shall clearly and prominently display:
    (i) The letter ``R''; and
    (ii) The words ``WARNING: This lamp can cause serious skin burn and 
eye inflammation from shortwave ultraviolet radiation if outer envelope 
of the lamp is broken or punctured. Do not use where people will remain 
for more than a few minutes unless adequate shielding or other safety 
precautions are used. Lamps that will automatically extinguish when the 
outer envelope is broken or punctured are commercially available.''
    (3) Lamp advertisement. Advertising for any high-intensity mercury 
vapor discharge lamp that does not comply with paragraph (d)(1) of this 
section shall prominently display the following wording: ``WARNING: This 
lamp can cause serious skin burn and eye inflammation from shortwave 
ultraviolet radiation if outer envelope of the lamp is broken or 
punctured. Do not use where people will remain for more than a few 
minutes unless adequate shielding or other safety precautions are used. 
Lamps that will automatically extinguish when the outer envelope is 
broken or punctured are commercially available.''
    (f) Test conditions. Any high-intensity mercury vapor discharge lamp 
under test for compliance with the requirements set forth in paragraph 
(d)(1) of this section shall be started and operated under the following 
conditions as applicable:
    (1) Lamp voltage, current, and orientation shall be those indicated 
or recommended by the manufacturer for operation of the intact lamp.
    (2) The lamp shall be operated on a reference ballast.
    (3) The lamp shall be started in air that has a temperature of 25 
5 [deg]C. Heating and movement of the air 
surrounding the lamp shall be that produced by the lamp and ballast 
alone.
    (4) If any test is performed in an enclosure, the enclosure shall be 
not less than 0.227 cubic meter (8 cubic feet).

[[Page 945]]

    (5) Any lamp designed to be operated only in a specific fixture or 
luminaire that the lamp manufacturer supplies or specifies shall be 
tested in that fixture or luminaire. Any other lamp shall be tested with 
no reflector or other surrounding material.

[44 FR 52195, Sept. 7, 1979, as amended at 53 FR 11254, Apr. 6, 1988]

[[Page 946]]



                      SUBCHAPTER K_TOBACCO PRODUCTS





PART 1100_GENERAL--Table of Contents



           Subpart A_Tobacco Products Subject to FDA Authority

Sec.
1100.1 Scope.
1100.2 Requirements.
1100.3 Definitions.
1100.5 Exclusion from tobacco regulation.

Subpart B [Reserved]

 Subpart C_Maintenance of Records Demonstrating That a Tobacco Product 
 Was Commercially Marketed in the United States as of February 15, 2007

1100.200 Purpose and scope.
1100.202 Definitions.
1100.204 Recordkeeping requirements.

    Authority: 21 U.S.C. 371, 374, 387a(b), 387e, 387i; Pub. L. 117-103, 
136 Stat. 49.

    Source: 81 FR 29102, May 10, 2016, unless otherwise noted.



           Subpart A_Tobacco Products Subject to FDA Authority



Sec. 1100.1  Scope.

    In addition to FDA's authority over cigarettes, cigarette tobacco, 
roll-your-own tobacco, smokeless tobacco, and any tobacco product 
containing nicotine not made or derived from tobacco, FDA deems all 
other products meeting the definition of tobacco product under section 
201(rr) of the Federal Food, Drug, and Cosmetic Act, except accessories 
of such other tobacco products, to be subject to the Federal Food, Drug, 
and Cosmetic Act.

[88 FR 16552, Mar. 20, 2023]



Sec. 1100.2  Requirements.

    Cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless 
tobacco, and any tobacco product containing nicotine not made or derived 
from tobacco are subject to chapter IX of the Federal Food, Drug, and 
Cosmetic Act and its implementing regulations. FDA has deemed all other 
tobacco products, except accessories of such other tobacco products, 
subject to chapter IX of the Federal Food, Drug, and Cosmetic Act and 
its implementing regulations.

[81 FR 29102, May 10, 2016, as amended at 88 FR 16552, Mar. 20, 2023]



Sec. 1100.3  Definitions.

    For the purposes of this part:
    Accessory means any product that is intended or reasonably expected 
to be used with or for the human consumption of a tobacco product; does 
not contain tobacco and is not made or derived from tobacco; and meets 
either of the following:
    (1) Is not intended or reasonably expected to affect or alter the 
performance, composition, constituents, or characteristics of a tobacco 
product; or
    (2) Is intended or reasonably expected to affect or maintain the 
performance, composition, constituents, or characteristics of a tobacco 
product but
    (i) Solely controls moisture and/or temperature of a stored tobacco 
product; or
    (ii) Solely provides an external heat source to initiate but not 
maintain combustion of a tobacco product.
    Component or part means any software or assembly of materials 
intended or reasonably expected:
    (1) To alter or affect the tobacco product's performance, 
composition, constituents, or characteristics; or
    (2) To be used with or for the human consumption of a tobacco 
product. Component or part excludes anything that is an accessory of a 
tobacco product.
    Package or packaging means a pack, box, carton, or container of any 
kind or, if no other container, any wrapping (including cellophane), in 
which a tobacco product is offered for sale, sold, or otherwise 
distributed to consumers.
    Tobacco product, as stated in section 201(rr) of the Federal Food, 
Drug, and Cosmetic Act in relevant part:
    (1) Means any product made or derived from tobacco, or containing 
nicotine from any source, that is intended for human consumption, 
including any

[[Page 947]]

component, part, or accessory of a tobacco product (except for raw 
materials other than tobacco used in manufacturing a component, part, or 
accessory of a tobacco product); and
    (2) Does not mean an article that is a drug under section 201(g)(1) 
of the Federal Food, Drug, and Cosmetic Act; a device under section 
201(h) of the Federal Food, Drug, and Cosmetic Act; a combination 
product described in section 503(g) of the Federal Food, Drug, and 
Cosmetic Act; or a food under 201(f) of the Federal Food, Drug, and 
Cosmetic Act if such article contains no nicotine or no more than trace 
amounts of naturally occurring nicotine.

[81 FR 29102, May 10, 2016, as amended at 88 FR 16552, Mar. 20, 2023]



Sec. 1100.5  Exclusion from tobacco regulation.

    If a product made or derived from tobacco that is intended for human 
consumption is intended for use for any of the purposes described in 
paragraph (a) or (b) of this section, the product is not a tobacco 
product as defined in section 201(rr) of the Federal Food, Drug, and 
Cosmetic Act and will be subject to regulation as a drug, device, or 
combination product.
    (a) The product is intended for use in the diagnosis of disease or 
other conditions, or in the cure, mitigation, treatment or prevention of 
disease, including use in the cure or treatment of nicotine addiction 
(e.g., smoking cessation), relapse prevention, or relief of nicotine 
withdrawal symptoms;
    (b) The product is intended to affect the structure or any function 
of the body in any way that is different from effects related to 
nicotine that were commonly and legally claimed in the marketing of 
cigarettes and smokeless tobacco products prior to March 21, 2000.

[82 FR 2217, Jan. 9, 2017]

Subpart B [Reserved]



 Subpart C_Maintenance of Records Demonstrating That a Tobacco Product 
 Was Commercially Marketed in the United States as of February 15, 2007.

    Source: 86 FR 55411, Oct. 4, 2021, unless otherwise noted.



Sec. 1100.200  Purpose and scope.

    This subpart sets out requirements under the Federal Food, Drug, and 
Cosmetic Act for the maintenance of records by tobacco product 
manufacturers that introduce a Pre-Existing Tobacco Product, or deliver 
it for introduction, into interstate commerce.



Sec. 1100.202  Definitions.

    For the purposes of this subpart:
    Commercially marketed means selling or offering for sale a tobacco 
product in the United States to consumers or to any person for the 
eventual purchase by consumers in the United States.
    Pre-Existing Tobacco Product means a tobacco product (including 
those products in test markets) that was commercially marketed in the 
United States as of February 15, 2007. A Pre-Existing Tobacco Product is 
not subject to the premarket requirements of section 910 of the Federal 
Food, Drug, and Cosmetic Act.
    Tobacco product means any product made or derived from tobacco, or 
containing nicotine from any source, that is intended for human 
consumption, including any component, part, or accessory of a tobacco 
product (except for raw materials other than tobacco used in 
manufacturing a component, part, or accessory of a tobacco product). The 
term ``tobacco product'' does not mean an article that under the Federal 
Food, Drug, and Cosmetic Act is: a drug (section 201(g)(1)); a device 
(section 201(h)); a combination product (section 503(g)); or a food 
(section 201(f)) if such article contains no nicotine or no more than 
trace amounts of naturally occurring nicotine.
    Tobacco product manufacturer means any person, including any 
repacker or relabeler, who--

[[Page 948]]

    (1) Manufactures, fabricates, assembles, processes, or labels a 
tobacco product; or
    (2) Imports a finished tobacco product for sale or distribution in 
the United States.

[81 FR 29102, May 10, 2016, as amended at 88 FR 16552, Mar. 20, 2023]



Sec. 1100.204  Recordkeeping requirements.

    (i) Any tobacco product manufacturer that introduces a Pre-Existing 
Tobacco Product, or delivers it for introduction, into interstate 
commerce must maintain records that demonstrate that the tobacco product 
was commercially marketed in the United States as of February 15, 2007, 
as described in this subpart. These records may include items such as:
    (A) Dated copies of advertisements;
    (B) Dated catalog pages;
    (C) Dated promotional material;
    (D) Dated trade publications;
    (E) Dated bills of lading;
    (F) Dated freight bills;
    (G) Dated waybills;
    (H) Dated invoices;
    (I) Dated purchase orders;
    (J) Dated customer receipts;
    (K) Dated manufacturing documents;
    (L) Dated distributor or retailer inventory lists; or
    (M) Any other dated document that demonstrates that the tobacco 
product was commercially marketed in the United States as of February 
15, 2007.
    (ii) All records must be legible, in the English language, and 
available for inspection and copying by officers or employees duly 
designated by the Secretary. Documents that have been translated from 
another language into English (e.g., advertisements written in a 
language other than English) must be accompanied by the original 
language version of the document, a signed statement by an authorized 
representative of the manufacturer certifying that the English language 
translation is complete and accurate, and a brief statement of the 
qualifications of the person that made the translation.
    (iii) All records required by this subpart must be retained for a 
period of not less than 4 years after the date either FDA makes a 
determination that the product is a Pre-Existing Tobacco Product, or the 
tobacco product manufacturer permanently ceases the introduction or 
delivery for introduction into interstate commerce of the tobacco 
product, whichever occurs sooner.



PART 1105_GENERAL--Table of Contents



    Authority: 21 U.S.C. 371(a), 387e, 387j, and 387k.

    Source: 81 FR 95869, Dec. 29, 2016, unless otherwise noted.



                Subpart A_General Submission Requirements



Sec. 1105.10  Refusal to accept a premarket submission.

    (a) FDA will refuse to accept for review, as soon as practicable, a 
premarket tobacco product application, modified risk tobacco product 
application, substantial equivalence application, or exemption request 
or subsequent abbreviated report for the following reasons, if 
applicable:
    (1) The submission does not pertain to a tobacco product as defined 
in 21 U.S.C. 321(rr).
    (2) The submission is not in English or does not contain complete 
English translations of any information submitted within.
    (3) If submitted in an electronic format, the submission is in a 
format that FDA cannot process, read, review, and archive.
    (4) The submission does not contain contact information, including 
the applicant's name and address.
    (5) The submission is from a foreign applicant and does not identify 
an authorized U.S. agent, including the agent's name and address, for 
the submission.
    (6) The submission does not contain a required FDA form(s).
    (7) The submission does not contain the following product-
identifying information: The manufacturer of the tobacco product; the 
product name, including the brand and subbrand; the product category and 
subcategory; package type and package quantity; and characterizing 
flavor.
    (8) The type of submission is not specified.

[[Page 949]]

    (9) The submission does not contain a signature of a responsible 
official, authorized to represent the applicant, who either resides in 
or has a place of business in the United States.
    (10) For premarket tobacco applications, modified risk tobacco 
product applications, substantial equivalence applications, and 
exemption requests only: The submission does not include a valid claim 
of categorical exclusion in accordance with part 25 of this chapter, or 
an environmental assessment.
    (b) If FDA finds that none of the reasons in paragraph (a) of this 
section exists for refusing to accept a premarket submission, FDA may 
accept the submission for processing and further review. FDA will send 
to the submitter an acknowledgement letter stating the submission has 
been accepted for processing and further review and will provide the 
premarket submission tracking number.
    (c) If FDA finds that any of the reasons in paragraph (a) of this 
section exist for refusing to accept the submission, FDA will notify the 
submitter in writing of the reason(s) and that the submission has not 
been accepted, unless insufficient contact information was provided.



PART 1107_EXEMPTION REQUESTS AND SUBSTANTIAL EQUIVALENCE REPORTS
--Table of Contents



                          Subpart A_Exemptions

Sec.
1107.1 Exemptions.
1107.3 Recordkeeping.

                            Subpart B_General

1107.10 Scope.
1107.12 Definitions.

                Subpart C_Substantial Equivalence Reports

1107.16 Submission of a substantial equivalence report.
1107.18 Required content and format of an SE Report.
1107.19 Comparison information.
1107.20 Amendments.
1107.22 Withdrawal by applicant.
1107.24 Change in ownership of an SE Report.

                          Subpart D_FDA Review

1107.40 Communications between FDA and applicants.
1107.42 Review cycles.
1107.44 FDA action on an SE Report.
1107.46 Issuance of an order finding a new tobacco product substantially 
          equivalent.
1107.48 Issuance of an order denying marketing authorization.
1107.50 Rescission of order.

                         Subpart E_Miscellaneous

1107.58 Record retention.
1107.60 Confidentiality.
1107.62 Electronic submission.

    Authority: 21 U.S.C. 371, 374, 387e(j), 387i, 387j; Pub. L. 117-103, 
136 Stat. 49.

    Source: 76 FR 38974, July 5, 2011, unless otherwise noted.



                          Subpart A_Exemptions



Sec. 1107.1  Exemptions.

    (a) General requirements. Under section 905(j)(3) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 387e(j)(3)), FDA may exempt from 
the requirements relating to the demonstration that a tobacco product is 
substantially equivalent within the meaning of section 910 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j), tobacco products 
that are modified by adding or deleting a tobacco additive, or 
increasing or decreasing the quantity of an existing tobacco additive, 
if FDA determines that:
    (1) Such modification would be a minor modification of a tobacco 
product that can be sold under the Federal Food, Drug, and Cosmetic Act 
(a legally marketed tobacco product);
    (2) A report under section 905(j)(1) intended to demonstrate 
substantial equivalence is not necessary to ensure that permitting the 
tobacco product to be marketed would be appropriate for protection of 
the public health; and
    (3) An exemption is otherwise appropriate.
    (b) Request for an exemption under section 905(j)(3) of the Federal 
Food, Drug, and Cosmetic Act. A request for an exemption from the 
requirement of demonstrating substantial equivalence may be made only by 
the manufacturer of a legally marketed tobacco product

[[Page 950]]

for a minor modification to that tobacco product. To request an 
exemption, the manufacturer must submit the request and all information 
supporting the request in an electronic format that FDA can process, 
review, and archive. If the manufacturer is unable to submit an 
exemption request in an electronic format, the manufacturer may submit a 
written request to the Center for Tobacco Products explaining in detail 
why the manufacturer cannot submit the request in an electronic format 
and requesting an alternative format. Such request must include an 
explanation of why an alternative format is necessary. All submissions, 
including requests to submit the information in an alternative format, 
requests for exemptions, and all supporting information must be legible 
and in the English language. An exemption request must contain:
    (1) The manufacturer's address and contact information;
    (2) Identification of the tobacco product(s);
    (3) A detailed explanation of the purpose of the modification;
    (4) A detailed description of the modification, including a 
statement as to whether the modification involves adding or deleting a 
tobacco additive, or increasing or decreasing the quantity of an 
existing tobacco additive;
    (5) A detailed explanation of why the modification is a minor 
modification of a tobacco product that can be sold under the Federal 
Food, Drug, and Cosmetic Act;
    (6) A detailed explanation of why a report under section 905(j)(1) 
of the Federal Food, Drug, and Cosmetic Act intended to demonstrate 
substantial equivalence is not necessary to ensure that permitting the 
tobacco product to be marketed would be appropriate for protection of 
the public health;
    (7) A certification (i.e., a signed statement by a responsible 
official of the manufacturer) summarizing the supporting evidence and 
providing the rationale for the official's determination that the 
modification does not increase the tobacco product's appeal to or use by 
minors, toxicity, addictiveness, or abuse liability;
    (8) Other information justifying an exemption; and
    (9) An environmental assessment under part 25 of this chapter 
prepared in accordance with the requirements of Sec. 25.40 of this 
chapter.
    (c) Exemption determination. FDA will review the information 
submitted and determine whether to grant or deny an exemption request 
based on whether the criteria in section 905(j)(3) of the Federal Food, 
Drug, and Cosmetic Act are met. FDA may request additional information 
if necessary to make a determination. FDA will consider the exemption 
request withdrawn if the information is not provided within the 
requested timeframe.
    (d) Rescission of an exemption. FDA may rescind an exemption if it 
finds that the exemption is not appropriate for the protection of public 
health. In general, FDA will rescind an exemption only after notice and 
opportunity for a hearing under part 16 of this chapter is provided. 
However, FDA may rescind an exemption prior to notice and opportunity 
for a hearing under part 16 of this chapter if the continuance of the 
exemption presents a serious risk to public health. In that case, FDA 
will provide the manufacturer an opportunity for a hearing as soon as 
possible after the rescission.

[76 FR 38974, July 5, 2011]



Sec. 1107.3  Recordkeeping.

    (a) Definition. The term ``Pre-Existing Tobacco Product'' means a 
tobacco product (including those products in test markets) that was 
commercially marketed in the United States as of February 15, 2007. A 
Pre-Existing Tobacco Product is not subject to the premarket 
requirements of section 910 of the Federal Food, Drug, and Cosmetic Act.
    (b) Record maintenance. (1) Each applicant who submits an 
abbreviated report under section 905(j)(1)(A)(ii) of the Federal Food, 
Drug, and Cosmetic Act and receives a letter acknowledging the receipt 
of an abbreviated report from FDA must maintain all records (including 
those created by third parties on the applicant's behalf) that support 
the submission. Such records may include, but are not limited to:
    (i) A copy of the abbreviated report and, if applicable, the 
exemption request and all amendments thereto.

[[Page 951]]

    (ii) A copy of the acknowledgement letter issued in response to an 
abbreviated report and, if applicable, the exemption order issued by 
FDA.
    (iii) Documents related to formulation of product, design 
specifications, packaging, and related items.
    (iv) Documents showing design specifications are consistently met.
    (v) Documents related to product packing and storage conditions.
    (vi) Analytical test method records, including:
    (A) Performance criteria.
    (B) Validation or verification documentation; and
    (C) Reports/results from these test methods.
    (vii) Source data and related summaries.
    (2) An applicant that submits an abbreviated report for a 
modification to a Pre-Existing Tobacco Product must also maintain 
records demonstrating that the Pre-Existing Tobacco Product was 
commercially marketed in the United States as of February 15, 2007, such 
as the records described in Sec. 1100.204 of this chapter.
    (3) An applicant that submits an abbreviated report for a 
modification to a tobacco product that previously received premarket 
authorization (i.e., an exemption (and for which the applicant has 
submitted an abbreviated report under section 905(j)(1)(A)(ii) of the 
Federal Food, Drug, and Cosmetic Act, a substantially equivalent order 
under section 910(a), or a marketing granted order under section 910(c)) 
must maintain a copy of the exemption order, substantially equivalent 
order, or marketing granted order.
    (4) An applicant that submits an abbreviated report for a 
modification to a tobacco product that is the subject of a pending SE 
report and is marketed pursuant to section 910(a)(2)(B) of the Federal 
Food, Drug, and Cosmetic Act must maintain all communications to and 
from FDA relating to the pending SE Report (e.g., acknowledgement 
letter, deficiency letters), including the SE Report.
    (c) Record quality. All records must be legible, in the English 
language, and available for inspection and copying by officers or 
employees duly designated by the Secretary. Documents that have been 
translated from another language into English (e.g., advertisements 
written in a language other than English) must be accompanied by the 
original language version of the document, a signed statement by an 
authorized representative of the manufacturer certifying that the 
English language translation is complete and accurate, and a brief 
statement of the qualifications of the person that made the translation.
    (d) Record retention. All records required by this subpart must be 
retained for a period of 4 years from the date that an acknowledgement 
letter is issued by FDA.

[86 FR 55412, Oct. 5, 2021]



                            Subpart B_General

    Source: 86 FR 55275, Oct. 4, 2021, unless otherwise noted.



Sec. 1107.10  Scope.

    (a) Subparts B through E of this part apply to a substantial 
equivalence report (or an SE Report) for a new tobacco product, other 
than ``premium'' cigars as defined in Sec. 1107.12, that has:
    (1) Characteristics different from a predicate tobacco product and 
for which information is submitted to demonstrate it is not appropriate 
to regulate the product under section 910(b) and (c) of the Federal 
Food, Drug, and Cosmetic Act because the new tobacco product does not 
raise different questions of public health or
    (2) The same characteristics as a predicate tobacco product.
    (b) These subparts set forth procedures and requirements for the 
submission to FDA of an SE Report under sections 905 and 910 of the 
Federal, Food, Drug, and Cosmetic Act; the basic criteria for 
establishing substantial equivalence; and the general procedures FDA 
will follow when evaluating submissions.



Sec. 1107.12  Definitions.

    For purposes of this part:
    Accessory means any product that is intended or reasonably expected 
to be used with or for the human consumption of a tobacco product; does 
not contain tobacco and is not made or derived

[[Page 952]]

from tobacco; and meets either of the following:
    (1) Is not intended or reasonably expected to affect or alter the 
performance, composition, constituents, or characteristics of a tobacco 
product; or
    (2) Is intended or reasonably expected to affect or maintain the 
performance, composition, constituents, or characteristics of a tobacco 
product but
    (i) Solely controls moisture and/or temperature of a stored product; 
or
    (ii) Solely provides an external heat source to initiate but not 
maintain combustion of a tobacco product.
    Additive means any substance the intended use of which results or 
may reasonably be expected to result, directly or indirectly, in its 
becoming a component or otherwise affecting the characteristic of any 
tobacco product (including any substances intended for use as a 
flavoring or coloring or in producing, manufacturing, packing, 
processing, preparing, treating, packaging, transporting, or holding), 
except that the term does not include tobacco or a pesticide chemical 
residue in or on raw tobacco, or a pesticide chemical.
    Applicant means any manufacturer of tobacco products who is subject 
to chapter IX of the Federal Food, Drug, and Cosmetic Act that submits a 
premarket application to receive marketing authorization for a new 
tobacco product.
    Brand means a variety of tobacco product distinguished by the 
tobacco used, tar content, nicotine content, flavoring used, size, 
filtration, packaging, logo, registered trademark, brand name(s), 
identifiable pattern of colors, or any combination of such attributes.
    Characteristic means the materials, ingredients, design, 
composition, heating source, or other features of a tobacco product.
    Commercial distribution means any distribution of a tobacco product, 
whether domestic or imported, to consumers or to any person, but does 
not include interplant transfers of a tobacco product between 
establishments within the same parent, subsidiary, and/or affiliate 
company, nor does it include providing a tobacco product for product 
testing where such product is not made available for personal 
consumption or resale. ``Commercial distribution'' does not include the 
handing or transfer of a tobacco product from one consumer to another 
for personal consumption.
    Commercially marketed means selling or offering for sale a tobacco 
product in the United States to consumers or to any person for the 
eventual purchase by consumers in the United States.
    Component or part means any software or assembly of materials 
intended or reasonably expected:
    (1) To alter or affect the tobacco product's performance, 
composition, constituents, or characteristics; or
    (2) To be used with or for the human consumption of a tobacco 
product. Component or part excludes anything that is an accessory of a 
tobacco product.
    Composition means the materials in a tobacco product, including 
ingredients, additives, and biological organisms. The term includes the 
manner in which the materials, for example, ingredients, additives, and 
biological organisms, are arranged and integrated to produce a tobacco 
product.
    Constituent means any chemical or chemical compound in a tobacco 
product that is or potentially is inhaled, ingested, or absorbed into 
the body, any chemical or chemical compound in an emission (e.g., smoke, 
aerosol, droplets) from a tobacco product, that either transfers from 
any component or part of the tobacco product to the emission or that is 
formed by the combustion or heating of tobacco, additives, or other 
component of the tobacco product.
    Container closure system means any packaging materials that are a 
component or part of a tobacco product.
    Design means the form and structure concerning, and the manner in 
which, components or parts, ingredients, software, and materials are 
integrated to produce a tobacco product.
    Distributor means any person who furthers the distribution of a 
tobacco product, whether domestic or imported, at any point from the 
original place of manufacture to the person who sells or distributes the 
product to individuals for personal consumption. Common carriers are not 
considered distributors for the purposes of this part.

[[Page 953]]

    Finished tobacco product means a tobacco product, including all 
components and parts, sealed in final packaging (e.g., filters or filter 
tubes sold to consumers separately or as part of kits) or in the final 
form in which it is intended to be sold to consumers.
    Harmful or potentially harmful constituent (HPHC) means any chemical 
or chemical compound in a tobacco product or tobacco smoke or emission 
that:
    (1) Is or potentially is inhaled, ingested, or absorbed into the 
body, including as an aerosol or any other emission; and
    (2) Causes or has the potential to cause direct or indirect harm to 
users or nonusers of tobacco products.
    Health information statement means a statement, made under section 
910(a)(4) of the Federal Food, Drug, and Cosmetic Act, that the health 
information related to a new tobacco product will be made available upon 
request by any person.
    Health information summary means a summary, submitted under section 
910(a)(4) of the Federal Food, Drug, and Cosmetic Act, of any health 
information related to a new tobacco product.
    Heating source means the source of energy used to burn or heat the 
tobacco product.
    Ingredient means tobacco, substances, compounds, or additives 
contained within or added to the tobacco, paper, filter, or any other 
component or part of a tobacco product, including substances and 
compounds reasonably expected to be formed through a chemical reaction 
during tobacco product manufacturing.
    Material means an assembly of ingredients. Materials are assembled 
to form a tobacco product or components or parts of tobacco products.
    New tobacco product means:
    (1) Any tobacco product (including those products in test markets) 
that was not commercially marketed in the United States as of February 
15, 2007; or
    (2) Any modification (including a change in design, any component, 
any part, or any constituent, including a smoke constituent, or in the 
content, delivery or form of nicotine, or any other additive or 
ingredient) of a tobacco product where the modified product was 
commercially marketed in the United States after February 15, 2007.
    Other features means any distinguishing qualities of a tobacco 
product similar to those specifically enumerated in section 910(a)(3)(B) 
of the Federal Food, Drug, and Cosmetic Act. Such other features include 
harmful and potentially harmful constituents and any other product 
characteristics that relate to the chemical, biological, and physical 
properties of the tobacco product.
    Package or packaging means a pack, box, carton, or container of any 
kind or, if no other container, any wrapping (including cellophane), in 
which a tobacco product is offered for sale, sold, or otherwise 
distributed to consumers.
    Predicate tobacco product means a tobacco product that was 
commercially marketed (other than for test marketing) in the United 
States as of February 15, 2007, or a tobacco product that FDA has 
previously found substantially equivalent under section 910(a)(2)(A)(i) 
of the Federal Food, Drug, and Cosmetic Act.
    Premium cigars means a type of cigar that:
    (1) Is wrapped in whole tobacco leaf;
    (2) Contains a 100 percent leaf tobacco binder;
    (3) Contains at least 50 percent (of the filler by weight) long 
filler tobacco (i.e., whole tobacco leaves that run the length of the 
cigar);
    (4) Is handmade or hand rolled (i.e., no machinery was used apart 
from simple tools, such as scissors to cut the tobacco prior to 
rolling);
    (5) Has no filter, nontobacco tip, or nontobacco mouthpiece;
    (6) Does not have a characterizing flavor other than tobacco;
    (7) Contains only tobacco, water, and vegetable gum with no other 
ingredients or additives; and
    (8) Weighs more than 6 pounds per 1,000 units.
    Submission tracking number or STN means the number that FDA assigns 
to submissions that are received from a manufacturer of tobacco 
products, such as SE Reports and voluntary requests for determinations 
that a tobacco product was commercially marketed in the United States as 
of February 15, 2007.

[[Page 954]]

    Substantial equivalence or substantially equivalent means, with 
respect to a new tobacco product being compared to a predicate tobacco 
product, that FDA by order has found that the new tobacco product:
    (1) Has the same characteristics as the predicate tobacco product; 
or
    (2) Has different characteristics and the information submitted 
contains information, including clinical data if deemed necessary by 
FDA, that demonstrates that it is not appropriate to require premarket 
review under section 910(b) and (c) of the Federal Food, Drug, and 
Cosmetic Act because the new tobacco product does not raise different 
questions of public health.
    Substantial equivalence report or SE Report means a submission under 
section 905(j)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act that 
includes the basis for the applicant's determination that a new tobacco 
product is substantially equivalent to a predicate tobacco product. This 
term includes the initial substantial equivalence report and all 
subsequent amendments.
    Tobacco product means any product made or derived from tobacco, or 
containing nicotine from any source, that is intended for human 
consumption, including any component, part, or accessory of a tobacco 
product (except for raw materials other than tobacco used in 
manufacturing a component, part, or accessory of a tobacco product). The 
term ``tobacco product'' does not mean an article that under the Federal 
Food, Drug, and Cosmetic Act is: a drug (section 201(g)(1)); a device 
(section 201(h)); a combination product (section 503(g)); or a food 
(section 201(f)) if such article contains no nicotine or no more than 
trace amounts of naturally occurring nicotine.
    Tobacco product manufacturer means any person, including a repacker 
or relabeler, who:
    (1) Manufactures, fabricates, assembles, processes, or labels a 
tobacco product, or
    (2) Imports a finished tobacco product for sale or distribution in 
the United States.

[86 FR 55275, Oct. 4, 2021, as amended at 88 FR 16552, Mar. 20, 2023]



                Subpart C_Substantial Equivalence Reports

    Source: 86 FR 55275, Oct. 4, 2021, unless otherwise noted.



Sec. 1107.16  Submission of a substantial equivalence report.

    An applicant may submit an SE Report intended to demonstrate that a 
new tobacco product is substantially equivalent to a predicate tobacco 
product. The applicant must submit the SE Report at least 90 calendar 
days prior to the date the applicant intends to introduce or deliver for 
introduction a new tobacco product into interstate commerce for 
commercial distribution. The applicant cannot begin commercial 
distribution of the new tobacco product until FDA has provided the 
applicant an order stating that the Agency has determined that the new 
tobacco product is substantially equivalent to a predicate tobacco 
product, unless the new tobacco product has received authorization to be 
marketed through another premarket pathway.



Sec. 1107.18  Required content and format of an SE Report.

    (a) Overview. The SE Report must provide information uniquely 
identifying the new tobacco product and the predicate tobacco product, 
and compare the new tobacco product to either a tobacco product 
commercially marketed (other than for test marketing) in the United 
States as of February 15, 2007, or a tobacco product that FDA previously 
found to be substantially equivalent. The SE Report must provide 
sufficient information as described in this section to enable FDA to 
determine whether the new tobacco product is substantially equivalent to 
a tobacco product that was commercially marketed (other than for test 
marketing) in the United States as of February 15, 2007. If FDA cites 
deficiencies and requests information to support a statement in the SE 
Report, the applicant must provide that information for review to 
continue, or FDA may issue an order under Sec. 1107.48. FDA generally 
intends to refuse to accept an SE Report for review if it does not 
comply with

[[Page 955]]

Sec. 1105.10 and this section. The SE Report must contain the following 
information:
    (1) General information (as described in paragraph (c) of this 
section);
    (2) Summary (as described in paragraph (d) of this section);
    (3) New tobacco product description (as described in paragraph (e) 
of this section);
    (4) Predicate tobacco product description (as described in paragraph 
(f) of this section), including a statement that the predicate tobacco 
product has not been removed from the market at the initiative of FDA 
and has not been determined by judicial order to be adulterated or 
misbranded, and the submission tracking number of the SE order finding 
the predicate product SE, or the submission tracking number of, or 
information to support, that the predicate tobacco product was 
commercially marketed (other than for test marketing) in the United 
States as of February 15, 2007;
    (5) Comparison information (as described in paragraph (g) of this 
section);
    (6) Comparative testing information (as described in paragraph (h) 
of this section);
    (7) Statement of compliance with applicable tobacco product 
standards (as described in paragraph (i) of this section);
    (8) Health information summary or statement that such information 
will be made available upon request (as described in paragraph (j) of 
this section);
    (9) Compliance with part 25 of this chapter (as described in 
paragraph (k) of this section); and
    (10) Certification statement (as described in paragraph (l) of this 
section).
    (b) Format. The applicant must submit the SE Report using the 
form(s) that FDA provides. The SE Report must contain a comprehensive 
index and table of contents, be well-organized and legible, and be 
written in English. As described in Sec. 1107.62, the applicant must 
submit the SE Report and all information supporting the SE Report in an 
electronic format that FDA can process, read, review, and archive, 
unless FDA has provided a waiver under Sec. 1107.62(b).
    (c) General information. The SE Report must include the following 
information, using the form FDA provides:
    (1) The date the SE Report is submitted;
    (2) Type of submission (e.g., the SE Report or amendment to a 
report);
    (3) FDA STN, if previously assigned;
    (4) Any other relevant FDA STN, such as a voluntary request for a 
determination that a tobacco product was commercially marketed in the 
United States as of February 15, 2007, or SE Report previously found 
substantially equivalent (if applicable), and cross-references to 
meetings with FDA regarding the new tobacco product;
    (5) Applicant name, address, and contact information (including 
email address);
    (6) Authorized representative or U.S. agent (for a foreign 
applicant), including the name, address, and contact information 
(including email address);
    (7) For both the new and predicate tobacco products, the following 
information to uniquely identify the products:
    (i) Manufacturer;
    (ii) Product name, including the brand and sub brand (or other 
commercial name used in commercial distribution); and
    (iii) Product category, product subcategory, and product properties 
(if the product does not have a listed product property, e.g., 
ventilation or characterizing flavor, the report must state ``none'' for 
that property) as provided in the following table:

                  Table 1 to Sec. 1107.18(c)(7)(iii)
------------------------------------------------------------------------
                                 Tobacco product
   Tobacco product category        subcategory       Product properties
------------------------------------------------------------------------
(A) Cigarettes................  (1) Filtered.....  --Package type (e.g.,
                                                    hard pack, soft
                                                    pack, clam shell).
                                                   --Product quantity
                                                    (e.g., 20
                                                    cigarettes, 25
                                                    cigarettes).
                                                   --Length (e.g., 89.1
                                                    millimeters (mm),
                                                    100 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Ventilation (e.g.,
                                                    none, 10%, 25%).
                                                   --Characterizing
                                                    Flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).

[[Page 956]]

 
                                (2) Non-filtered.  --Package type (e.g.,
                                                    hard pack, soft
                                                    pack, clam shell).
                                                   --Product quantity
                                                    (e.g., 20
                                                    cigarettes, 25
                                                    cigarettes).
                                                   --Length (e.g., 89.1
                                                    mm, 100 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Characterizing
                                                    Flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (3) Other........  --Package type (e.g.,
                                                    hard pack, soft
                                                    pack, clam shell).
                                                   --Product quantity
                                                    (e.g., 20
                                                    cigarettes, 25
                                                    cigarettes).
                                                   --Length (e.g., 89.1
                                                    mm, 100 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Ventilation (e.g.,
                                                    none, 10%, 25%).
                                                   --Characterizing
                                                    Flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
(B) Roll-Your-Own Tobacco       (1) Roll-Your-Own  --Package type (e.g.,
 Products.                       Tobacco Filler.    bag, pouch).
                                                   --Product quantity
                                                    (e.g., 20.1 grams
                                                    (g), 16 ounces
                                                    (oz.)).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (2) Rolling Paper  --Package type (e.g.,
                                                    box, booklet).
                                                   --Product quantity
                                                    (e.g., 50 sheets,
                                                    200 papers).
                                                   --Length (e.g., 79.1
                                                    mm, 100 mm, 110.2
                                                    mm).
                                                   --Width (e.g., 28.1
                                                    mm, 33 mm, 45.2 mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    tobacco).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (3) Filtered       --Package type (e.g.,
                                 Cigarette Tube.    bag, box).
                                                   --Product quantity
                                                    (e.g., 100 tubes,
                                                    200 tubes).
                                                   --Length (e.g., 89.1
                                                    mm, 100 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Ventilation (e.g.,
                                                    none, 10%, 25%).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    tobacco).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (4) Non-Filtered   --Package type (e.g.,
                                 Cigarette Tube.    bag, box).
                                                   --Product quantity
                                                    (e.g., 100 tubes,
                                                    200 tubes).
                                                   --Length (e.g., 89.1
                                                    mm, 100 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    tobacco).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (5) Filter.......  --Package type (e.g.,
                                                    bag, box).
                                                   --Product quantity
                                                    (e.g., 100 filters,
                                                    200 filters).
                                                   --Length (e.g., 8 mm,
                                                    12.1 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    tobacco).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (6) Paper Tip....  --Package type (e.g.,
                                                    bag, box).
                                                   --Product quantity
                                                    (e.g., 200 tips, 275
                                                    tips).
                                                   --Length (e.g., 12
                                                    mm, 15.1 mm).
                                                   --Width (e.g., 27.1
                                                    mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    tobacco).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (7) Other........  --Package type (e.g.,
                                                    bag, box, booklet).
                                                   --Product quantity
                                                    (e.g., 200 tips, 100
                                                    filters, 200 tubes).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    tobacco).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product.
(C) Smokeless Tobacco Products  (1) Loose Moist    --Package type (e.g.,
                                 Snuff.             plastic can with
                                                    metal lid, plastic
                                                    can with plastic
                                                    lid).
                                                   --Product quantity
                                                    (e.g., 20 g, 2.1
                                                    oz.).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cherry,
                                                    wintergreen).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable,
                                                    e.g., fine cut, long
                                                    cut, straight cut).
                                (2) Portioned      --Package type (e.g.,
                                 Moist Snuff.       plastic can with
                                                    metal lid, plastic
                                                    can with plastic
                                                    lid).

[[Page 957]]

 
                                                   --Product quantity
                                                    (e.g., 22.5 g, 20
                                                    g).
                                                   --Portion count
                                                    (e.g., 15 pouches,
                                                    20 pieces).
                                                   --Portion mass (e.g.,
                                                    1.5 g/pouch, 1 g/
                                                    piece).
                                                   --Portion length
                                                    (e.g., 15 mm, 20.1
                                                    mm).
                                                   --Portion width
                                                    (e.g., 10 mm, 15.1
                                                    mm).
                                                   --Portion thickness
                                                    (e.g., 5 mm, 7.1
                                                    mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cherry,
                                                    wintergreen).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (3) Loose Snus...  --Package type (e.g.,
                                                    plastic can with
                                                    metal lid, plastic
                                                    can with plastic
                                                    lid).
                                                   --Product quantity
                                                    (e.g., 20 g, 2.1
                                                    oz.).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cherry,
                                                    wintergreen).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (4) Portioned      --Package type (e.g.,
                                 Snus.              plastic can with
                                                    metal lid, plastic
                                                    can with plastic
                                                    lid).
                                                   --Product quantity
                                                    (e.g., 22.5 g, 20
                                                    g).
                                                   --Portion count
                                                    (e.g., 15 pouches,
                                                    20 pieces).
                                                   --Portion mass (e.g.,
                                                    1.5 g/pouch, 1 g/
                                                    piece).
                                                   --Portion length
                                                    (e.g., 15 mm, 20.1
                                                    mm).
                                                   --Portion width
                                                    (e.g., 10 mm, 15.1
                                                    mm).
                                                   --Portion thickness
                                                    (e.g., 5 mm, 7.1
                                                    mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cherry,
                                                    wintergreen).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (5) Loose Dry      --Package type (e.g.,
                                 Snuff.             plastic can with
                                                    metal lid, plastic
                                                    can with plastic
                                                    lid).
                                                   --Product quantity
                                                    (e.g., 20 g, 2.1
                                                    oz.).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cherry,
                                                    wintergreen).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (6) Dissolvable..  --Package type (e.g.,
                                                    plastic can with
                                                    metal lid, plastic
                                                    can with plastic
                                                    lid).
                                                   --Product quantity
                                                    (e.g., 22.5 g, 20
                                                    g).
                                                   --Portion count
                                                    (e.g., 15 sticks, 20
                                                    pieces).
                                                   --Portion mass (e.g.,
                                                    1.5 g/strip, 1 g/
                                                    piece).
                                                   --Portion length
                                                    (e.g., 10 mm, 15.1
                                                    mm).
                                                   --Portion width
                                                    (e.g., 5 mm, 8.1
                                                    mm).
                                                   --Portion thickness
                                                    (e.g., 3 mm, 4.1
                                                    mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cherry,
                                                    wintergreen).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (7) Loose Chewing  --Package type (e.g.,
                                 Tobacco.           bag, pouch,
                                                    wrapped).
                                                   --Product quantity
                                                    (e.g., 20 g, 3.1
                                                    oz.).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cherry,
                                                    wintergreen).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (8) Portioned      --Package type (e.g.,
                                 Chewing Tobacco.   plastic can with
                                                    metal lid, plastic
                                                    can with plastic
                                                    lid).
                                                   --Product quantity
                                                    (e.g., 22.5 g, 20
                                                    g).
                                                   --Portion count
                                                    (e.g., 10 bits).
                                                   --Portion mass (e.g.,
                                                    2.1 g/bit).
                                                   --Portion length
                                                    (e.g., 8 mm, 10.1
                                                    mm).
                                                   --Portion width
                                                    (e.g., 6 mm, 8.1
                                                    mm).
                                                   --Portion thickness
                                                    (e.g., 5.1 mm, 7
                                                    mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cherry,
                                                    wintergreen).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (9) Other........  --Package type (e.g.,
                                                    box, bag, can).
                                                   --Product quantity
                                                    (e.g., 20.1 g, 22.5
                                                    g, 3 oz.).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cherry, wintergreen,
                                                    tobacco).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product.

[[Page 958]]

 
(D) Electronic Nicotine         (1) Open E-Liquid  --Package type (e.g.,
 Delivery Systems (ENDS)                            bottle, box, pod).
 (Vapes).
                                                   --Product quantity
                                                    (e.g., 1 bottle, 5
                                                    bottles).
                                                   --E-liquid volume
                                                    (e.g., 0.5
                                                    milliliters (ml)), 2
                                                    ml, 5.1 ml).
                                                   --Nicotine
                                                    concentration (e.g.,
                                                    0 mg/ml), 0.2 mg/ml,
                                                    0.4 mg/ml, 1%, 0.2
                                                    mg/bottle).
                                                   --Propylene Glycol
                                                    (PG)/Vegetable
                                                    Glycerin (VG) ratio
                                                    (e.g., not
                                                    applicable (N/A), 0/
                                                    100, 50/50, 100/0).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol, cherry,
                                                    wintergreen).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (2) Closed E-      --Package type (e.g.,
                                 Liquid.            cartridge, pod).
                                                   --Product quantity
                                                    (e.g., 1 cartridge,
                                                    5 cartridges).
                                                   --E-liquid volume
                                                    (e.g., 0.5 ml, 2 ml,
                                                    5.1 ml).
                                                   --Nicotine
                                                    concentration (e.g.,
                                                    0 mg/ml, 0.2 mg/ml,
                                                    0.4 mg/ml, 1%, 0.2
                                                    mg/bottle).
                                                   --PG/VG ratio (e.g.,
                                                    N/A, 0/100, 50/50,
                                                    100/0).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol, cherry,
                                                    wintergreen).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (3) Closed E-      --Package type (e.g.,
                                 Cigarette.         box, none, plastic
                                                    clamshell).
                                                   --Product quantity
                                                    (e.g., 1 e-
                                                    cigarette, 5 e-
                                                    cigarettes).
                                                   --Length (e.g., 100
                                                    mm, 120 mm)
                                                   --Diameter (e.g., 6
                                                    mm, 8 mm).
                                                   --Wattage (e.g., 100
                                                    watts (W), 200 W).
                                                   --Battery capacity
                                                    (e.g., 100
                                                    milliampere hours
                                                    (mAh), 200 mAh).
                                                   --E-liquid volume
                                                    (e.g., 0.5 ml, 2 ml,
                                                    5.1 ml).
                                                   --Nicotine
                                                    concentration (e.g.,
                                                    0 mg/ml, 0.2 mg/ml,
                                                    0.4 mg/ml, 1%, 0.2
                                                    mg/e-cigarette).
                                                   --PG/VG ratio (e.g.,
                                                    N/A, 0/100, 50/50,
                                                    100/0).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol, cherry,
                                                    wintergreen).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (4) Open E-        --Package type (e.g.,
                                 Cigarette.         box, none, plastic
                                                    clamshell).
                                                   --Product quantity
                                                    (e.g., 1 e-
                                                    cigarette, 5 e-
                                                    cigarettes).
                                                   --Length (e.g., 100
                                                    mm, 120 mm)
                                                   --Diameter (e.g., 6
                                                    mm, 8 mm).
                                                   --Wattage (e.g., 100
                                                    W, 200 W).
                                                   --Battery capacity
                                                    (e.g., 100 mAh, 200
                                                    mAh).
                                                   --E-liquid volume
                                                    (e.g., 0.5 ml, 2 ml,
                                                    5.1 ml).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol, cherry,
                                                    wintergreen).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (5) ENDS           --Package type (e.g.,
                                 Component.         box, none, plastic
                                                    clamshell).
                                                   --Product quantity
                                                    (e.g., 1 coil).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cherry, wintergreen,
                                                    tobacco).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (6) Other........  --Package type (e.g.,
                                                    box, none, plastic
                                                    clamshell).
                                                   --Product quantity
                                                    (e.g., 1 e-
                                                    cigarette, 5
                                                    bottles).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cherry, wintergreen,
                                                    tobacco).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product.
(E) Cigars....................  (1) Filtered,      --Package type (e.g.,
                                 Sheet-Wrapped.     hard pack, soft
                                                    pack, clam shell).
                                                   --Product quantity
                                                    (e.g., 20 filtered
                                                    cigars, 25 filtered
                                                    cigars).
                                                   --Length (e.g., 89.1
                                                    mm, 100 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Ventilation (e.g.,
                                                    none, 0%, 10%, 25%).
                                                   --Characterizing
                                                    flavor (e.g., none,
                                                    menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (2) Unfiltered,    --Package type (e.g.,
                                 Sheet-Wrapped.     box, film sleeve).
                                                   --Product quantity
                                                    (e.g., 1 cigar, 5
                                                    cigarillos).
                                                   --Length (e.g., 100.1
                                                    mm, 140 mm).
                                                   --Diameter (e.g., 8
                                                    mm, 10.1 mm).

[[Page 959]]

 
                                                   --Tip (e.g., none,
                                                    wood tips, plastic
                                                    tips).
                                                   --Characterizing
                                                    flavor (e.g., none,
                                                    menthol, cherry).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (3) Unfiltered,    --Package type (e.g.,
                                 Leaf-Wrapped.      box, film, sleeve,
                                                    none).
                                                   --Product quantity
                                                    (e.g., 1 cigar, 5
                                                    cigars).
                                                   --Length (e.g., 150.1
                                                    mm, 200 mm).
                                                   h;Diameter (e.g., 8
                                                    mm, 10.1 mm).
                                                   --Wrapper material
                                                    (e.g., burley
                                                    tobacco leaf,
                                                    Connecticut shade
                                                    grown tobacco leaf).
                                                   --Characterizing
                                                    flavor (e.g., none,
                                                    whiskey).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (4) Cigar          --Package type (e.g.,
                                 Component.         box, booklet).
                                                   --Product quantity
                                                    (e.g., 10 wrappers,
                                                    20 leaves).
                                                   --Characterizing
                                                    flavor (e.g., none,
                                                    menthol, cherry).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (5) Cigar Tobacco  --Package type (e.g.,
                                 Filler.            bag, pouch).
                                                   --Product quantity
                                                    (e.g., 20 g, 16.1
                                                    oz.).
                                                   --Characterizing
                                                    flavor (e.g., none,
                                                    tobacco, menthol,
                                                    cherry).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (6) Other........  --Package type (e.g.,
                                                    box, booklet).
                                                   --Product quantity
                                                    (e.g., 1 cigar, 5
                                                    cigars, 20 leaves,
                                                    16 g).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cherry).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product.
(F) Pipe Tobacco Products.....  (1) Pipe.........  --Package type (e.g.,
                                                    box, none).
                                                   --Product quantity
                                                    (e.g., 1 pipe).
                                                   --Length (e.g., 200
                                                    mm, 300.1 mm).
                                                   --Diameter (e.g.,
                                                    25.1 mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cavendish, cherry).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (2) Pipe Tobacco   --Package type (e.g.,
                                 Filler.            box, none).
                                                   --Product quantity
                                                    (e.g., 20 g, 16.1
                                                    oz.).
                                                   --Tobacco cut style
                                                    (e.g., standard cut,
                                                    such as shag cut,
                                                    bugler cut, loose
                                                    cut, etc., or a
                                                    pressed cut, such as
                                                    flake, cube cut,
                                                    roll cake, etc. or a
                                                    mixture).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cavendish, cherry).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (3) Pipe           --Package type (e.g.,
                                 Component.         box, bag, none).
                                                   --Product quantity
                                                    (e.g., 1 bowl, 1
                                                    stem, 100 filters).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, cherry).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (4) Other........  --Package type (e.g.,
                                                    box, bag, none).
                                                   --Product quantity
                                                    (e.g., 1 pipe, 1
                                                    bowl, 1 stem, 100
                                                    filters).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, cherry).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product.
(G) Waterpipe Tobacco Products  (1) Waterpipe....  --Package type (e.g.,
                                                    box, none).
                                                   --Product quantity
                                                    (e.g., 1 waterpipe).
                                                   --Height (e.g., 200
                                                    mm, 500.1 mm).
                                                   --Width (e.g., 100.1
                                                    mm, 300 mm).
                                                   --Diameter (e.g.,
                                                    100.1 mm, 300 mm).
                                                   --No. of hoses (e.g.,
                                                    1, 2, 4).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (2) Waterpipe      --Package type (e.g.,
                                 Tobacco Filler.    bag, pouch).
                                                   --Product quantity
                                                    (e.g., 20 g, 16.1
                                                    oz.).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol, apple).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (3) Waterpipe      --Package type (e.g.,
                                 Heat Source.       box, film sleeve,
                                                    bag, none).

[[Page 960]]

 
                                                   --Product quantity
                                                    (e.g., 150 g, 680
                                                    g).
                                                   --Portion count
                                                    (e.g., 20 fingers,
                                                    10 discs, 1 base).
                                                   --Portion mass (e.g.,
                                                    15 g/finger, 10 g/
                                                    brick).
                                                   --Portion length
                                                    (e.g., 40 mm, 100
                                                    mm).
                                                   --Portion width
                                                    (e.g., 10 mm, 40
                                                    mm).
                                                   --Portion thickness
                                                    (e.g., 10 mm, 40
                                                    mm).
                                                   --Source of energy
                                                    (e.g., charcoal,
                                                    battery,
                                                    electrical).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    apple).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (4) Waterpipe      --Package type (e.g.,
                                 Component.         box, bag, none).
                                                   --Product quantity
                                                    (e.g., 1 base, 1
                                                    bowl, 1 hose, 10
                                                    mouthpieces).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, cherry).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (5) Other........  --Package type (e.g.,
                                                    box, bag, none).
                                                   --Product quantity
                                                    (e.g., 1 base, 1
                                                    bowl, 1 hose, 10
                                                    mouthpieces).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, cherry).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
(H) Heated Tobacco Products     (1) Closed HTP...  --Package type (e.g.,
 (HTP).                                             box, none, plastic
                                                    clamshell).
                                                   --Product quantity
                                                    (e.g., 1 device, 1
                                                    HTP).
                                                   --Length (e.g., 100
                                                    mm, 120 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Wattage (e.g., 100
                                                    W, 200 W).
                                                   --Battery capacity
                                                    (e.g., 100 mAh, 200
                                                    mAh).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (2) Open HTP.....  --Package type (e.g.,
                                                    box, none, plastic
                                                    clamshell).
                                                   --Product quantity
                                                    (e.g., 1 device, 1
                                                    HTP).
                                                   --Length (e.g., 100
                                                    mm, 120 mm)
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Wattage (e.g., 100
                                                    W, 200 W).
                                                   --Battery capacity
                                                    (e.g., 100 mAh, 200
                                                    mAh).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (3) HTP            --Package type (e.g.,
                                 Consumable.        hard pack, soft
                                                    pack, plastic
                                                    clamshell).
                                                   --Product quantity
                                                    (e.g., 20 sticks, 25
                                                    cartridges).
                                                   --Length (e.g., 60
                                                    mm, 82 mm.)
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Ventilation (e.g.,
                                                    none, 10%, 25%).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (4) HTP Component  --Package type (e.g.,
                                                    box, none, plastic
                                                    clamshell).
                                                   --Product quantity
                                                    (e.g., 1 mouthpiece,
                                                    1 spacer).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (5) Other........  --Package type (e.g.,
                                                    box, bag, plastic
                                                    clamshell, none).
                                                   --Product quantity
                                                    (e.g., 1 base, 5
                                                    capsules).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol, cherry).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
Other.........................  Other............  --Package type (e.g.,
                                                    box, bag, plastic
                                                    clamshell, none).
                                                   --Product quantity
                                                    (e.g., 1 base, 5
                                                    capsules).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol, cherry).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
------------------------------------------------------------------------

    (8) Address and the FDA Establishment Identifier number(s) of the 
establishments involved in the manufacture

[[Page 961]]

and/or importation of the new and predicate tobacco products.
    (d) Summary. The SE Report must include a summary at the beginning 
of the SE Report that includes the following:
    (1) A concise description of the characteristics of the new tobacco 
product;
    (2) A statement as to whether the applicant believes the new tobacco 
product has the same characteristics as the predicate tobacco product or 
has different characteristics but any differences in characteristics do 
not cause the new tobacco product to raise different questions of public 
health; and
    (3) A concise description of the similarities and differences 
between the new tobacco product and the predicate tobacco product with 
respect to their characteristics (materials, ingredients, design, 
composition, heating source, or other features).
    (e) New tobacco product description. The applicant must identify one 
new tobacco product in the SE Report for comparison to one predicate 
tobacco product. The SE Report must describe the new tobacco product in 
sufficient detail to enable FDA to evaluate its characteristics. This 
part of the SE Report must include:
    (1) A narrative description of the new tobacco product and detailed 
drawings or schematics of the new tobacco product, including its 
container closure system, illustrating all components or parts of the 
product. For a portioned tobacco product, the SE Report must also 
include a diagram illustrating all components or parts of the individual 
unit of use;
    (2) A description and the function of each component or part of the 
new tobacco product, and an explanation of how each component or part is 
integrated into the design of the new tobacco product; and
    (3) A concise overview of the process used to manufacture the new 
tobacco product. If the manufacturing process for the new tobacco 
product does not affect the characteristics of the new tobacco product 
beyond what is described elsewhere in the SE Report, an applicant must 
state that to satisfy this provision.
    (f) Description of predicate tobacco product. (1) The applicant must 
identify a predicate tobacco product that is either a tobacco product 
commercially marketed (other than for test marketing) as of February 15, 
2007, or a tobacco product that FDA previously found to be substantially 
equivalent.
    (2) A tobacco product to which a new tobacco product is compared 
must:
    (i) Have been either:
    (A) Commercially marketed (other than for test marketing) in the 
United States as of February 15, 2007, as shown by either specific 
information sufficient to support this in the SE Report, including a 
statement that ``I, (insert name and position title of responsible 
official), confirm that the predicate tobacco product associated with 
this submission, (insert name of predicate tobacco product), was 
commercially marketed (other than for test marketing) in the United 
States as of February 15, 2007,'' and, if applicable, reference to an 
STN for a previous determination by FDA that the predicate product was 
commercially marketed (other than for test marketing) in the United 
States as of February 15, 2007; or
    (B) Previously determined to be substantially equivalent by FDA;
    (ii) Be an individual product and not a composite of multiple 
products;
    (iii) Not be the subject of a rescission action by FDA, as described 
in Sec. 1107.50; and
    (iv) Not have been removed from the market at the initiative of FDA 
and not have been determined by judicial order to be adulterated or 
misbranded.
    (g) Comparison information. The SE Report must include a comparison 
of the characteristics of the new tobacco product and the predicate 
tobacco product. If the new tobacco product has limited changes to a 
characteristic(s) when compared to the predicate tobacco product, and 
all other characteristics are identical (e.g., a change to product 
quantity), the applicant must provide comparison information related to 
any characteristic(s) that have changed, but may certify that the other 
characteristics are identical under paragraph (l)(2) of this section. 
The applicant must maintain records supporting the certification 
consistent with Sec. 1107.58.
    (h) Comparative testing information. Other than for characteristics 
that are

[[Page 962]]

identical, and for which the applicant has certified that the 
characteristics are identical under paragraph (l)(2) of this section, 
the SE Report must provide comparative testing information that has been 
demonstrated to be fully validated on the characteristics of the new and 
predicate tobacco products except where the applicant adequately 
justifies that such comparative testing information is not necessary to 
demonstrate that the new product:
    (1) Has the same characteristics as the predicate or
    (2) Does not raise different questions of public health.
    (i) Statement of compliance with applicable tobacco product 
standards. The SE Report must either:
    (1) List and describe the action(s) taken by the applicant to comply 
with applicable requirements under section 907 of the Federal Food, 
Drug, and Cosmetic Act; or
    (2) State there are no applicable requirements under section 907 of 
the Federal Food, Drug, and Cosmetic Act.
    (j) Health information summary or statement regarding availability 
of such information. The SE Report must include either a health 
information summary or a statement that such information will be made 
available upon request, as provided in section 910(a)(4) of the Federal 
Food, Drug, and Cosmetic Act, in accordance with the following:
    (1) Health information summary. If including a health information 
summary with the SE Report, the applicant must provide a copy of the 
full SE Report that excludes research subject identifiers and trade 
secret and confidential commercial information as defined in Sec. Sec. 
20.61 and 20.63 of this chapter; and either
    (i) Provide accurate, complete, and not false or misleading, 
additional health information, including information, research, or data 
about adverse health effects, that the applicant has or knows about 
concerning the new tobacco product that is not contained in the SE 
Report; or
    (ii) Provide the following statement, if true, about the new tobacco 
product: ``Applicant does not have or know of any additional health 
information, including information, research or data regarding adverse 
health effects, about the new tobacco product that is the subject of 
this SE Report.''
    (2) Statement regarding availability of health information. If the 
applicant chooses to make the health information available upon request, 
the SE Report must include the following statement, with the appropriate 
applicant information inserted as indicated by parenthetical text, 
signed by an authorized representative of the applicant, made on a 
separate page of the SE Report, and clearly identified as ``910(a)(4) 
health information statement'': ``I certify that, in my capacity as (the 
position held in company by person required to submit the SE Report, 
preferably the responsible official of the applicant) of (company name), 
I will make available, upon request, the information identified in 21 
CFR 1107.18(j)(3) within 30 calendar days of a request.''
    (3) Content of health information. The health information the 
applicant agrees to make available in paragraph (j)(2) of this section 
must be a copy of the full SE Report, excluding all research subject 
identifiers, trade secrets, and confidential commercial information, as 
defined in Sec. Sec. 20.61 and 20.63 of this chapter; and either:
    (i) Accurate, complete, and not false or misleading, additional 
health information, including information, research, or data about 
adverse health effects, that the applicant has or knows about concerning 
the new tobacco product and that is not contained in the SE Report; or
    (ii) The following statement, if true, about the new tobacco 
product: ``(Company name) does not have or know of any additional health 
information, including information, research or data regarding adverse 
health effects about the new tobacco product that is the subject of the 
provided SE Report.''
    (4) Requests for information. All requests for information under 
paragraph (j)(2) of this section must be made in writing to the 
authorized representative of the applicant, whose contact information 
will be posted on the FDA website listing substantial equivalence 
determinations. The applicant must provide FDA any updated information 
if the contact information changes.

[[Page 963]]

    (5) No modified risk violations. To the extent information is 
included in the health information summary or health information 
provided upon request under paragraphs (j)(1) and (2) of this section 
that is not required by section 910(a)(4) of the Federal Food, Drug, and 
Cosmetic Act or this paragraph (j), that information must not contain a 
statement that would cause the tobacco product to be in violation of 
section 911 of the Federal Food, Drug, and Cosmetic Act upon the 
introduction or delivery for introduction of the proposed new product 
into interstate commerce.
    (k) Compliance with part 25 of this chapter. (1) The SE Report must 
include an environmental assessment prepared in accordance with Sec. 
25.40 of this chapter, or a valid claim of categorical exclusion. If the 
applicant believes that the action qualifies for an available 
categorical exclusion, the applicant must state under Sec. 25.15(a) and 
(d) of this chapter that the action requested qualifies for a 
categorical exclusion, citing the particular exclusion that is claimed, 
and that to the applicant's knowledge, no extraordinary circumstances 
exist under Sec. 25.21.
    (2) The environmental assessment must include a statement explaining 
whether the new tobacco product is intended to replace the predicate 
tobacco product after the new tobacco product receives market 
authorization, is intended to be a line extension of the predicate 
tobacco product, is intended to be introduced as an additional product 
by the same manufacturer, or if the new tobacco product will be 
introduced as an additional product but by a different manufacturer.
    (l) Certification statement. (1) The SE Report must contain the 
following certification, with the appropriate information inserted (as 
indicated by parenthetical text), and be signed by an authorized 
representative of the applicant: ``I (name of responsible official) on 
behalf of (applicant), hereby certify that (applicant) will maintain all 
records to substantiate the accuracy of this SE Report for the period of 
time required in 21 CFR 1107.58 and ensure that such records remain 
readily available to the FDA upon request. I certify that this 
information and the accompanying submission are true and correct, that 
no material fact has been omitted, and that I am authorized to submit 
this on the applicant's behalf. I understand that under section 1001 of 
title 18 of the United States Code anyone who knowingly and willfully 
makes a materially false, fictitious, or fraudulent statement or 
representation in any matter within the jurisdiction of the executive, 
legislative, or judicial branch of the Government of the United States 
is subject to criminal penalties.''
    (2) The SE Report must include the following certification, as well 
as a justification for the certification, if an applicant chooses to 
certify that certain characteristics are identical in lieu of providing 
data for each characteristic of the new and predicate tobacco products. 
This certification must include the appropriate information inserted (as 
indicated by parenthetical text) and be signed by an authorized 
representative of the applicant: ``I, (name of responsible official), on 
behalf of (name of company), certify that (new tobacco product name) has 
the following modification(s) as compared to (name of predicate tobacco 
product): (describe modification(s), e.g., change in product quantity or 
change in container closure system). Aside from these modifications, the 
characteristics of (new tobacco product name) and (name of predicate 
tobacco product) are identical. I certify that (name of company) 
understands this means there is no other modification to the materials, 
ingredients, design features, heating source, or any other feature. I 
also certify that (name of company) will maintain records to support the 
comparison information in 21 CFR 1107.19 that substantiate the accuracy 
of this statement for the period of time required in 21 CFR 1107.58, and 
ensure that such records remain readily available to FDA upon request.''



Sec. 1107.19  Comparison information.

    The SE Report must include a comparison of the characteristics of 
the new tobacco product to the predicate tobacco product. Where test 
data is submitted, the testing information must include the test 
protocols, quantitative acceptance criteria, and test

[[Page 964]]

results (including means and variances, data sets, and a summary of the 
results). Comparison testing must be conducted on a sufficient sample 
size and on test samples that reflect the finished tobacco product 
composition and design. The SE report must state whether the same test 
methods were used for the new tobacco product and the predicate product, 
and if the methods differed, an explanation as to how the results of the 
different test methods can be compared. The SE report must identify 
national and international standards used to test the new and predicate 
tobacco products and explain any deviations from the standard, or state 
that no standards were used for the testing. The SE report must include 
the following:
    (a) Comparison of product design. The SE Report must include a 
description of the product designs of the new and predicate tobacco 
products and an identification of any differences. The SE Report must 
include, in a tabular format, a side-by-side comparison of each design 
parameter of the new and predicate tobacco products. The target 
specification and upper and lower range limits must be provided for each 
design parameter. Test data (including test protocols, quantitative 
acceptance criteria, data sets (i.e., measured values), and a summary of 
the results) must be provided for the new and predicate tobacco products 
when the target specification or range limits of the new tobacco product 
differ from the predicate tobacco product. For tobacco cut size or 
particle size, when target specifications and range limits are not 
available, the following alternative information may be submitted in 
place of this information: A description of the tobacco cutting process 
(including a complete description of the milling, cutting, and sifting 
process; the control parameters of the miller or cutter; and any sift 
specifications) or the measured particle size distribution for the new 
and predicate tobacco products.
    (1) Cigarettes. For cigarettes, the required design parameter 
information to be provided for each predicate and new tobacco product is 
as follows:

                     Table 1 to Sec. 1107.19(a)(1)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Provide Target Specification With Upper and Lower Range Limits for:
    --Cigarette length (mm).
    --Cigarette circumference or diameter (mm).
    --Tobacco filler mass (mg).
    --Tobacco rod density (g/cm\3\).
    --Tobacco moisture or oven volatiles (%).
    --Tobacco cut size (mm or cuts per inch (CPI)).
    --Filter ventilation (%).
    --Tipping paper length (mm).
    --Cigarette paper base paper porosity (CORESTA unit (CU)) or
     permeability.
    --Cigarette paper band porosity or permeability (CU) (alternately,
     band diffusivity (cm\2\/s)) (if applicable).
    --Cigarette paper band width (mm).
    --Cigarette paper band space (mm).
    --Filter efficiency (%) (If no filter efficiency data is available
     for the products, include information sufficient to show that the
     cigarette filter is unchanged (e.g., denier per filament (DPF),
     total denier (g/9000m), and filter density (g/cm\3\))).
    --Filter length (mm).
    --Filter pressure drop (mm H2O).
------------------------------------------------------------------------


                     Table 2 to Sec. 1107.19(a)(1)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Tobacco filler mass (mg).
    --Tobacco moisture (%) or oven volatiles (%).
    --Filter ventilation (%).

[[Page 965]]

 
    --Tobacco cut size (mm or CPI).
    --Cigarette paper base paper porosity (CU).
    --Cigarette paper band porosity or permeability (CU) (alternately,
     band diffusivity (cm\2\/s)).
    --Filter efficiency (%) (If no filter efficiency data is available
     for the products, include information sufficient to show that the
     cigarette filter is unchanged (e.g., DPF, total denier (g/9000m),
     and filter density (g/cm\3\))).
    --Filter pressure drop (mm H2O).
------------------------------------------------------------------------

    (2) Smokeless Tobacco. For portioned and non-portioned smokeless 
tobacco products, the required design parameter information to be 
provided for each predicate and new tobacco product is as follows:

                     Table 3 to Sec. 1107.19(a)(2)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Provide Target Specification With Upper and Lower Range Limits for:
    Portioned Smokeless Tobacco Products:
        --Tobacco cut size (mm or CPI) or tobacco particle size (mm or
         micron).
        --Tobacco moisture (%).
        --Portion length (mm).
        --Portion width (mm).
        --Portion mass (mg).
        --Pouch material thickness (mm) (if applicable).
        --Pouch material porosity or permeability (CU or L/m\2\/s) (if
         applicable).
        --Pouch material basis weight (g/m\2\). (if applicable).
        --Nicotine dissolution rate (%/min) (if applicable).
    Non-portioned Smokeless Tobacco Products:
        --Tobacco cut size (mm or CPI) or tobacco particle size (mm or
         micron).
        --Tobacco moisture (%).
------------------------------------------------------------------------


                     Table 4 to Sec. 1107.19(a)(2)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    Portioned Smokeless Tobacco Products:
        --Tobacco cut size (mm or CPI) or tobacco particle size (mm or
         micron).
        --Tobacco moisture (%).
        --Portion mass (mg).
        --Pouch material porosity or permeability (CU or L/m\2\/s).
        --Pouch material basis weight (g/m\2\).
        --Nicotine dissolution rate (%/min) (if applicable).
    Non-portioned Smokeless Tobacco Products:
        --Tobacco cut size (mm or CPI) or tobacco particle size (mm or
         micron).
        --Tobacco moisture (%).
------------------------------------------------------------------------

    (3) Roll-your-own tobacco, rolling papers. For roll-your-own tobacco 
rolling papers, the required design parameter information to be provided 
for each predicate and new tobacco product is as follows:

                     Table 5 to Sec. 1107.19(a)(3)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Paper length (mm).

[[Page 966]]

 
    --Paper width (mm).
    --Mass per paper (mg).
    --Cigarette paper base paper basis weight (g/m\2\).
    --Cigarette paper base paper porosity or permeability (CU).
    --Cigarette paper band porosity or permeability (CU) (alternately,
     band diffusivity (cm\2\/s)) (if applicable).
    --Cigarette paper band width (mm) (if applicable).
    --Cigarette paper band space (mm) (if applicable).
------------------------------------------------------------------------


                     Table 6 to Sec. 1107.19(a)(3)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Mass per paper (mg).
    --Cigarette paper base paper basis weight (g/m\2\).
    --Cigarette paper base paper porosity or permeability (CU).
    --Cigarette paper band porosity or permeability (CU) (alternately,
     band diffusivity (cm\2\/s)) (if applicable).
------------------------------------------------------------------------

    (4) Roll-your-own tobacco, non-filtered tubes. For roll-your-own 
tobacco non-filtered tubes, the required design parameter information to 
be provided for each predicate and new tobacco product is as follows:

                     Table 7 to Sec. 1107.19(a)(4)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Tube length (mm).
    --Tube circumference or diameter (mm).
    --Tube mass (mg).
    --Cigarette paper base paper basis weight (g/m\2\).
    --Cigarette paper base paper porosity (CU).
    --Cigarette paper band porosity or permeability (CU) (alternately,
     band diffusivity (cm\2\/s)) (if applicable).
    --Cigarette paper band width (mm) (if applicable).
    --Cigarette paper band space (mm) (if applicable).
------------------------------------------------------------------------


                     Table 8 to Sec. 1107.19(a)(4)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Tube mass (mg).
    --Cigarette paper base paper basis weight (g/m\2\).
    --Cigarette paper base paper porosity (CU).
    --Cigarette paper band porosity or permeability (CU) (alternately,
     band diffusivity (cm\2\/s)).
------------------------------------------------------------------------

    (5) Roll-your-own tobacco, filtered tubes. For roll-your-own tobacco 
filtered tubes, the required design parameter information to be provided 
for each predicate and new tobacco product is as follows:

[[Page 967]]



                     Table 9 to Sec. 1107.19(a)(5)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Tube length (mm).
    --Tube circumference or diameter (mm).
    --Tube mass (mg).
    --Tipping paper length (mm).
    --Filter ventilation (%).
    --Cigarette paper base paper basis weight (g/m\2\).
    --Cigarette paper base paper porosity or permeability (CU).
    --Cigarette paper band porosity or permeability (CU) (alternately,
     band diffusivity (cm\2\/s)) (if applicable).
    --Cigarette paper band width (mm) (if applicable).
    --Cigarette paper band space (mm) (if applicable).
    --Filter length (mm).
    --Filter efficiency (%) (If no filter efficiency data is available
     for the products, include information sufficient to show that the
     cigarette filter is unchanged (e.g., DPF, total denier (g/9000m),
     and filter density (g/cm\3\))).
    --Filter pressure drop (mm H2O).
------------------------------------------------------------------------


                    Table 10 to Sec. 1107.19(a)(5)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Tube mass (mg).
    --Filter ventilation (%).
    --Cigarette paper base paper basis weight (g/m\2\).
    --Cigarette paper base paper porosity or permeability (CU).
    --Cigarette paper band porosity or permeability (CU) (alternately,
     band diffusivity (cm\2\/s)) (if applicable).
    --Filter efficiency (%) (If no filter efficiency data is available
     for the products, include information sufficient to show that the
     cigarette filter is unchanged (e.g., DPF, total denier (g/9000m),
     and filter density (g/cm\3\))).
    --Filter pressure drop (mm H2O).
------------------------------------------------------------------------

    (6) Roll-your-own tobacco. For roll-your-own tobacco, the required 
design parameter information to be provided for each predicate and new 
tobacco product is as follows:

                    Table 11 to Sec. 1107.19(a)(6)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Tobacco cut size (mm or CPI).
    --Tobacco moisture (%) or oven volatiles (%).
------------------------------------------------------------------------


                    Table 12 to Sec. 1107.19(a)(6)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Tobacco cut size (mm or CPI).
    --Tobacco moisture (%) or oven volatiles (%).
------------------------------------------------------------------------

    (7) Filtered, sheet-wrapped cigars. For filtered, sheet-wrapped 
cigars, the required design parameter information to

[[Page 968]]

be provided for each predicate and new tobacco product is as follows:

                    Table 13 to Sec. 1107.19(a)(7)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Cigar mass (mg).
    --Cigar wrapper basis weight (g/m\2\).
    --Cigar binder length (mm).
    --Cigar binder width (mm).
    --Cigar binder basis weight (g/m\2\).
    --Cigar length (mm).
    --Cigar overall diameter (mm).
    --Cigar minimum diameter (mm) (if applicable).
    --Cigar maximum diameter (mm) (if applicable).
    --Tobacco filler mass (mg).
    --Tobacco rod density (g/cm\3\).
    --Tobacco moisture or oven volatiles (%).
    --Tobacco cut size (CPI or mm).
    --Cigar wrapper porosity or permeability (CU).
    --Cigar wrapper length (mm).
    --Cigar wrapper width (mm).
    --Cigar wrapper band porosity or permeability (CU) (alternately,
     band diffusivity (cm\2\/s)) (if applicable).
    --Cigar wrapper band width (mm) (if applicable).
    --Cigar wrapper band space (mm) (if applicable).
    --Tipping paper length (mm).
    --Cigar binder porosity or permeability (CU).
    --Cigar binder band porosity or permeability (CU) (alternately, band
     diffusivity (cm\2\/s)) (if applicable).
    --Cigar binder band width (mm) (if applicable).
    --Cigar binder band space (mm) (if applicable).
    --Filter efficiency (%) (If no filter efficiency data is available
     for the products, include information sufficient to show that the
     cigar filter is unchanged (e.g., DPF, total denier (g/9000m), and
     filter density(g/cm\3\))).
    --Filter pressure drop (mm H2O).
    --Filter length (mm).
    --Filter diameter (mm).
    --Filter ventilation (%).
------------------------------------------------------------------------


                    Table 14 to Sec. 1107.19(a)(7)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Cigar mass (mg).
    --Puff count.
    --Cigar wrapper basis weight (g/m\2\).
    --Cigar wrapper porosity or permeability (CU).
    --Cigar binder porosity or permeability (CU).
    --Cigar binder basis weight (g/m\2\).
    --Filter efficiency (%) (If no filter efficiency data is available
     for the products, include information sufficient to show that the
     filter is unchanged (e.g., DPF, total denier (g/9000m), and filter
     density (g/cm\3\))).
    --Tobacco filler mass (mg).
    --Tobacco rod density (g/cm\3\).
    --Tobacco cut size (CPI or mm).
    --Tobacco moisture or oven volatiles (%).
    --Cigar wrapper band porosity or permeability (CU) (alternately,
     band diffusivity (cm\2\/s)) (if applicable).

[[Page 969]]

 
    --Cigar binder band porosity or permeability (CU) (alternately, band
     diffusivity (cm\2\/s)) (if applicable).
    --Cigar binder band width (mm) (if applicable).
    --Cigar binder band space (mm) (if applicable).
    --Cigar minimum diameter (mm) (if applicable).
    --Cigar maximum diameter (mm) (if applicable).
    --Filter ventilation (%).
    --Filter pressure drop (mm H2O).
------------------------------------------------------------------------

    (8) Unfiltered, sheet-wrapped cigars. For unfiltered, sheet-wrapped 
cigars, the required design parameter information to be provided for 
each predicate and new tobacco product is as follows:

                    Table 15 to Sec. 1107.19(a)(8)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Cigar length (mm).
    --Cigar mass (mg).
    --Cigar overall diameter (mm).
    --Cigar minimum diameter (mm) (if applicable).
    --Cigar maximum diameter (mm) (if applicable).
    --Tobacco filler mass (mg).
    --Tobacco rod density (g/cm\3\).
    --Tobacco moisture or oven volatiles (%).
    --Tobacco cut size (CPI or mm).
    --Cigar wrapper porosity or permeability (CU).
    --Cigar wrapper length (mm).
    --Cigar wrapper width (mm).
    --Cigar wrapper basis weight (g/m\2\).
    --Cigar binder porosity or permeability (CU).
    --Cigar binder width (mm) (if applicable).
    --Cigar binder basis weight (g/m\2\).
    --Cigar tip mass (mg) (if applicable).
    --Tip length (mm) (if applicable).
    --Tip inner diameter (mm) (if applicable).
    --Cigar binder band porosity or permeability (CU) (alternately, band
     diffusivity (cm\2\/s)) (if applicable).
    --Cigar binder band width (mm) (if applicable).
    --Cigar binder band space (mm) (if applicable).
    --Cigar wrapper band porosity or permeability (CU) (alternately,
     band diffusivity (cm\2\/s)) (if applicable).
    --Cigar wrapper band width (mm) (if applicable).
    --Cigar wrapper band space (mm) (if applicable).
------------------------------------------------------------------------


                    Table 16 to Sec. 1107.19(a)(8)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Puff count.
    --Cigar mass (mg).
    --Tobacco rod density (g/cm\3\).
    --Tobacco cut size (CPI or mm).
    --Tobacco moisture or oven volatiles (%).
    --Tobacco filler mass (mg).
    --Cigar wrapper basis weight (g/m\2\).

[[Page 970]]

 
    --Cigar wrapper porosity or permeability (CU).
    --Cigar binder width (mm) (if applicable).
    --Cigar binder basis weight (g/m\2\).
    --Cigar binder porosity or permeability (CU).
    --Cigar wrapper band porosity or permeability (CU) (alternately,
     band diffusivity (cm\2\/s)) (if applicable).
    --Cigar binder band porosity or permeability (CU) (alternately, band
     diffusivity (cm\2\/s)) (if applicable).
    --Cigar tip mass (mg) (if applicable).
    --Cigar minimum diameter (mm) (if applicable).
    --Cigar maximum diameter (mm) (if applicable).
------------------------------------------------------------------------

    (9) Unfiltered, leaf-wrapped cigars. For unfiltered, leaf-wrapped 
cigars, the required design parameter information to be provided for 
each predicate and new tobacco product is as follows:

                    Table 17 to Sec. 1107.19(a)(9)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Cigar length (mm).
    --Cigar mass (mg).
    --Overall diameter (mm).
    --Cigar minimum diameter (mm) (if applicable).
    --Cigar maximum diameter (mm) (if applicable).
    --Tobacco filler mass (mg).
    --Tobacco rod density (g/cm\3\).
    --Tobacco moisture or oven volatiles (%).
    --Tobacco cut size (CPI or mm).
    --Cigar wrapper length (mm).
    --Cigar wrapper width (mm).
    --Cigar wrapper basis weight (g/m\2\).
    --Cigar binder width (mm).
    --Cigar binder basis weight (g/m\2\).
------------------------------------------------------------------------


                    Table 18 to Sec. 1107.19(a)(9)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Puff count.
    --Cigar mass (mg).
    --Tobacco filler mass (mg).
    --Tobacco rod density (g/cm\3\).
    --Tobacco cut size (CPI or mm).
    --Cigar wrapper basis weight (g/m\2\).
    --Cigar binder basis weight (g/m\2\).
    --Tobacco moisture or oven volatiles (%).
    --Cigar minimum diameter (mm) (if applicable).
    --Cigar maximum diameter (mm) (if applicable).
------------------------------------------------------------------------

    (10) Cigar filler. For cigar filler, the required design parameter 
information to be provided for each predicate and new tobacco product is 
as follows:

[[Page 971]]



                    Table 19 to Sec. 1107.19(a)(10)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Tobacco moisture or oven volatiles (%).
    --Tobacco cut size (CPI or mm).
------------------------------------------------------------------------


                    Table 20 to Sec. 1107.19(a)(10)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Tobacco moisture or oven volatiles (%).
    --Tobacco cut size (CPI or mm).
------------------------------------------------------------------------

    (11) Cigar component. For cigar components, the required design 
parameter information to be provided for each predicate and new tobacco 
product is as follows:

                    Table 21 to Sec. 1107.19(a)(11)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Cigar wrapper length (mm).
    --Cigar wrapper width (mm).
    --Cigar wrapper porosity (CU).
    --Cigar wrapper basis weight (g/m\2\).
------------------------------------------------------------------------


                    Table 22 to Sec. 1107.19(a)(11)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Cigar wrapper length (mm).
    --Cigar wrapper width (mm).
    --Cigar wrapper basis weight (g/m\2\).
------------------------------------------------------------------------

    (12) Pipes. For pipes, the required design parameter information to 
be provided for each predicate and new tobacco product is as follows:

                    Table 23 to Sec. 1107.19(a)(12)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Bowl chamber outer diameter (mm).
    --Bowl chamber inner diameter (mm).
    --Draught hole diameter (mm).
    --Draught hole location.
    --Draught hole shape.
    --Bowl chamber hole shape.
    --Bowl chamber volume (cm\3\).
    --Stem length (mm).
    --Stem diameter (mm).
    --Shank length (mm).
    --Shank diameter (mm).
    --Draught hole area (mm\2\).
    --Pressure drop through air valve (mm H2O).
    --Air flow through air valve (cc/min).

[[Page 972]]

 
    --Filter efficiency (%) (If no filter efficiency data is available
     for the products, include information sufficient to show that the
     filter is unchanged (e.g., DPF, total denier (g/9000m), and filter
     density (g/cm\3\))).
    --Filter pressure drop (mm H2O).
    --Filter length (mm).
------------------------------------------------------------------------


                    Table 24 to Sec. 1107.19(a)(12)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Bowl chamber volume (cm\3\).
    --Air flow through air valve (cc/min).
    --Filter length (mm).
    --Filter pressure drop (mm H2O).
    --Filter efficiency (%) (If no filter efficiency data is available
     for the products, include information sufficient to show that the
     filter is unchanged (e.g., DPF, total denier (g/9000m), and filter
     density (g/cm\3\))).
------------------------------------------------------------------------

    (13) Pipe filler. For pipe filler, the required design parameter 
information to be provided for each predicate and new tobacco product is 
as follows:

                    Table 25 to Sec. 1107.19(a)(13)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Tobacco moisture or oven volatiles (%).
    --Tobacco cut size (CPI or mm).
------------------------------------------------------------------------


                    Table 26 to Sec. 1107.19(a)(13)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Tobacco moisture or oven volatiles (%).
    --Tobacco cut size (CPI or mm).
------------------------------------------------------------------------

    (14) Waterpipes. For waterpipes, the required design parameter 
information to be provided for each predicate and new tobacco product is 
as follows:

                    Table 27 to Sec. 1107.19(a)(14)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Hose length (mm).
    --Hose internal diameter (mm).
    --Hose materials.
    --Stem length (mm).
    --Stem internal diameter (mm).
    --Base diameter (mm).
    --Base volume (cm\3\).
    --Base shape.
    --Pressure drop (mm H2O).
    --Water filter efficiency (%).
    --Hose air permeability (CU).
    --Head height (mm).
    --Head top diameter (mm).

[[Page 973]]

 
    --Head bottom diameter (mm).
    --No. of holes.
    --Head volume (mm\3\).
    --Heating source type.
    --Head materials.
------------------------------------------------------------------------


                    Table 28 to Sec. 1107.19(a)(14)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Hose length (mm).
    --Hose internal diameter (mm).
    --Stem length (mm).
    --Stem internal diameter (mm).
    --Base diameter (mm).
    --Base volume (cm\3\).
    --Pressure drop (mm H2O).
    --Water filter efficiency (%).
    --Head height (mm).
    --Head top diameter (mm).
    --Head bottom diameter (mm).
    --Head volume (mm\3\).
------------------------------------------------------------------------

    (15) Waterpipe, heating source. For waterpipe heating sources, the 
required design parameter information to be provided for each predicate 
and new tobacco product is as follows:

                    Table 29 to Sec. 1107.19(a)(15)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Heating element mass (mg).
    --Heating element density (g/cm\3\).
    --Heating element resistance (ohms) (if applicable).
    --No. of heating elements.
    --Heating element configuration.
    --Heating element diameter (gauge).
    --Battery current rating (mA) (if applicable).
    --Battery capacity (mAh) (if applicable).
    --Battery voltage operating range (volts) (if applicable).
    --Battery current operating range (amps) (if applicable).
    --Power delivery unit (PDU) voltage operating range (volts) (if
     applicable).
    --PDU current operating range (amps) (if applicable).
    --PDU wattage operating range (watts) (if applicable).
    --PDU temperature cut-off ( [deg]C) (if applicable).
------------------------------------------------------------------------


                    Table 30 to Sec. 1107.19(a)(15)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Heating element temperature range ( [deg]C) (if applicable).
    --Heating element mass (mg).
    --Heating element density (g/cm\3\).
    --Heating element resistance (ohms) (if applicable).
    --Heating element diameter (gauge).

[[Page 974]]

 
    --Battery current rating (mA) (if applicable).
    --Battery capacity (mAh) (if applicable).
    --Battery voltage operating range (volts) (if applicable).
    --Battery current operating range (amps) (if applicable).
    --Power delivery unit (PDU) voltage operating range (volts) (if
     applicable).
    --PDU current operating range (amps) (if applicable).
    --PDU wattage operating range (watts) (if applicable).
    --PDU temperature cut-off ( [deg]C) (if applicable).
------------------------------------------------------------------------

    (16) Waterpipe component, head. For waterpipe heads, the required 
design parameter information to be provided for each predicate and new 
tobacco product is as follows:

                    Table 31 to Sec. 1107.19(a)(16)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    1--Head height (mm).
    --Head top diameter (mm).
    --Head bottom diameter (mm).
    --No. of holes.
    --Head volume (mm\3\).
    --Head materials.
------------------------------------------------------------------------


                    Table 32 to Sec. 1107.19(a)(16)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Head height (mm).
    --Head top diameter (mm).
    --Head bottom diameter (mm).
    --Head volume (mm\3\).
------------------------------------------------------------------------

    (17) Waterpipe component, foil. For waterpipe foil, the required 
design parameter information to be provided for each predicate and new 
tobacco product is as follows:

                    Table 33 to Sec. 1107.19(a)(17)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Length (mm) (for square or rectangular shape foil).
    --Width (mm) (for square or rectangular shape foil).
    --Diameter (mm) (for circular shape foil).
    --Foil thickness (mm).
    --No. of holes.
    --Diameter of the holes (mm).
------------------------------------------------------------------------


                    Table 34 to Sec. 1107.19(a)(17)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Length (mm) (for square or rectangular shape foil).
    --Width (mm) (for square or rectangular shape foil).
    --Diameter (mm) (for circular shape foil).

[[Page 975]]

 
    --Foil thickness (mm).
    --Diameter of the holes (mm).
------------------------------------------------------------------------

    (18) Waterpipe filler. For waterpipe filler, the required design 
parameter information to be provided for each predicate and new tobacco 
product is as follows:

                    Table 35 to Sec. 1107.19(a)(18)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Tobacco moisture or oven volatiles (%).
    --Tobacco cut size (CPI or mm).
------------------------------------------------------------------------


                    Table 36 to Sec. 1107.19(a)(18)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Tobacco moisture or oven volatiles (%).
    --Tobacco cut size (CPI or mm).
------------------------------------------------------------------------

    (19) Electronic Nicotine Delivery System (ENDS). For ENDS (vapes), 
the required design parameter information to be provided for each 
predicate and new tobacco product is as follows:

                    Table 37 to Sec. 1107.19(a)(19)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Draw resistance (mm H2O).
    --Puff count (for full tank/cartridge).
    --Atomizer tank/cartridge volume (mL).
    --No. of heating elements (e.g., coil).
    --Heating element diameter (gauge).
    --Heating element length (mm).
    --Heating element resistance (Ohms).
    --Heating element temperature range ( [deg]C).
    --Heating element configuration (target only).
    --Battery voltage operating range (V).
    --Battery current operating range (mA).
    --Battery capacity (mAh).
    --Battery nominal voltage (V).
    --Battery current rating (mA).
    --Battery charging temperature limits ( [deg]C).
    --Battery discharge temperature limits ( [deg]C).
    --Battery end of discharge voltage (V).
    --Battery maximum charging current (mA).
    --Battery maximum discharging current (mA).
    --Battery upper limits charging voltage (V).
    --Power Delivery Unit (PDU) voltage operating range (V).
    --PDU current operating range (mA).
    --PDU wattage operating range (watts).
    --PDU temperature cut-off ( [deg]C) (if applicable).
    --PDU current cut-off (mA) (if applicable).
    --Airflow rate (L/min) (if applicable).
    --Ventilation (%).

[[Page 976]]

 
    --Inhaled aerosol temperature ( [deg]C).
------------------------------------------------------------------------


                    Table 38 to Sec. 1107.19(a)(19)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Draw resistance (mm H2O).
    --Puff count (for full tank/cartridge).
    --Atomizer tank/cartridge volume (mL).
    --Heating element diameter (gauge).
    --Heating element resistance (Ohms).
    --Heating element temperature range ( [deg]C).
    --Battery voltage operating range (V).
    --Battery current operating range (mA).
    --PDU voltage operating range (V).
    --PDU current operating range (mA).
    --PDU wattage operating range (watts).
    --PDU current cut-off (mA) (if applicable).
    --Inhaled aerosol temperature ( [deg]C).
    --PDU temperature cut-off ( [deg]C) (if applicable).
    --Battery capacity (mAh).
    --Battery nominal voltage (V).
    --Battery current rating (mA).
    --Heating element length (mm).
    --Battery charging temperature limits ( [deg]C).
    --Battery discharge temperature limits ( [deg]C).
    --Battery maximum charging current (mA).
    --Battery maximum discharging current (mA).
    --Battery upper limits charging voltage (V).
    --Airflow rate (L/min) (if applicable).
    --Ventilation (%).
------------------------------------------------------------------------

    (20) E-liquids. For e-liquids, the required design parameter 
information to be provided for each predicate and new tobacco product is 
as follows:

                    Table 39 to Sec. 1107.19(a)(20)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --E-liquid viscosity (at 20 [deg]C).
    --E-liquid volume (ml).
    --Particle number concentration (/cm\3\).
    --Count median diameter (nm).
    --PM2.5 ([micro]g/m\3\).
------------------------------------------------------------------------


                    Table 40 to Sec. 1107.19(a)(20)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --E-liquid viscosity (at 20 [deg]C).
    --E-liquid volume (ml).
    --Particle number concentration (/cm\3\).
    --Count median diameter (nm).
    --PM2.5 ([micro]g/m\3\).
------------------------------------------------------------------------


[[Page 977]]

    (21) Heated Tobacco Products (HTP). For HTPs, the required design 
parameter information to be provided for each predicate and new tobacco 
product is as follows:

                    Table 41 to Sec. 1107.19(a)(21)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Overall Device:
        --Mass (mg).
        --Length (mm).
        --Width (mm).
        --Height (mm).
        --Diameter (mm).
        --Draw resistance (mm H2O).
        --Puff count (for full tank/cartridge).
        --Puff volume (mL).
        --Product volume (mL).
        --Airflow rate (L/min) (if applicable).
        --Ventilation (%).
        --Operational temperature ( [deg]C).
        --Temperature sensor (if applicable).
        --Material wrapper length (mm) (if applicable).
        --Material wrapper width (mm) (if applicable).
        --Material wrapper basis weight (g/m\2\) (if applicable).
        --Material porosity or permeability (CU) (if applicable).
    --Heating element:
        --Heating element source/type/approach (electrical, carbon,
         aerosol, etc.).
        --Heating element temperature range ( [deg]C).
        --Heating element operational temperature ( [deg]C).
        --Heating element maximum temperature (boost temperature) (
         [deg]C).
        --Heating element material.
        --Heating element configuration.
        --Heating element length (mm).
        --Heating element mass (mg).
        --Heating element location.
        --No. of heating elements (e.g., coil).
        --Heating element diameter (gauge) (if applicable).
        --Heating element resistance (Ohms) (if applicable).
    --Tobacco/E-liquid:
        --Tobacco mass (mg) (if applicable).
        --Tobacco density (g/cm\3\) (if applicable).
        --Tobacco moisture or oven volatiles (%) (if applicable).
        --Tobacco cut size (CPI or mm) (if applicable).
        --E-liquid volume (mL) (if applicable).
        --E-liquid viscosity (at 20 [deg]C) (if applicable).
    --Battery (if applicable):
        --Battery capacity (mAh).
        --Battery voltage operating range (V) or wattage (W).
        --Battery current charging range (amps).
        --Battery nominal voltage (V).
        --Battery current rating (mA).
        --Battery charging temperature limits ( [deg]C).
        --Battery discharge temperature limits ( [deg]C).
        --Battery end of discharge voltage (V).
        --Battery maximum charging current (mA).
        --Battery maximum discharging current (mA).
        --Battery upper limits charging voltage (V).
        --Power Delivery Unit (PDU) voltage operating range (V).
        --PDU current operating range (mA).

[[Page 978]]

 
        --PDU wattage operating range (watts).
        --PDU temperature cut-off ( [deg]C) (if applicable).
        --PDU current cut-off (mA) (if applicable).
    --Aerosol:
        --Inhaled aerosol temperature ( [deg]C).
        --Aerosol particle number concentration (/cm\3\).
        --Count median diameter (nm).
        --PM2.5 ([micro]g/m\3\).
    --Filter (if applicable):
        --Filter efficiency (%) (If no filter efficiency data is
         available for the products, include information sufficient to
         show that the filter is unchanged (e.g., DPF, total denier (g/
         9000m), and filter density(g/cm\3\))).
        --Filter pressure drop (mm H2O).
        --Filter length (mm).
        --Filter diameter (mm).
        --Filter ventilation (%).
------------------------------------------------------------------------


                    Table 42 to Sec. 1107.19(a)(21)
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Overall device:
        --Draw resistance (mm H2O).
        --Puff count (for full tank/cartridge) (dimensionless).
        --Product volume (mL).
        --Airflow rate (L/min) (if applicable).
        --Ventilation (%).
        --Operational temperature ( [deg]C).
        --Temperature sensor (if applicable).
        --Material wrapper length (mm) (if applicable).
        --Material wrapper width (mm) (if applicable).
        --Material wrapper basis weight (g/m\2\) (if applicable).
        --Material porosity or permeability (CU) (if applicable).
    --Heating element:
        --Heating element diameter (gauge) (if applicable).
        --Heating element resistance (Ohms) (if applicable).
        --Heating element temperature range ( [deg]C).
    --E-liquid:
        --E-liquid viscosity (at 20 [deg]C) (if applicable).
        --E-liquid volume (ml) (if applicable).
    --Tobacco:
        --Tobacco moisture or oven volatiles (%) (if applicable).
        --Tobacco cut size (CPI or mm) (if applicable).
        --Tobacco density (g/cm\3\) (if applicable).
    --Battery:
        --Battery voltage operating range (V) or wattage (W).
        --Battery current operating range (mA).
        --PDU voltage operating range (V).
        --PDU current operating range (mA).
        --PDU wattage operating range (watts).
        --PDU current cut-off (mA) (if applicable).
        --PDU temperature cut-off ( [deg]C) (if applicable).
        --Battery capacity (mAh).
        --Battery nominal voltage (V).
        --Battery current rating (mA).
        --Battery charging temperature limits ( [deg]C).
        --Battery discharge temperature limits ( [deg]C).

[[Page 979]]

 
        --Battery maximum charging current (mA).
        --Battery maximum discharging current (mA).
        --Battery upper limits charging voltage (V).
    --Aerosol:
        --Inhaled aerosol temperature ( [deg]C).
        --Aerosol particle number concentration (/cm\3\).
        --Count median diameter (nm).
        --PM2.5 ([micro]g/m\3\).
    --Filter (if applicable):
        --Filter efficiency (%) (If no filter efficiency data is
         available for the products, include information sufficient to
         show that the filter is unchanged (e.g., DPF, total denier (g/
         9000m), and filter density(g/cm\3\))).
        --Filter ventilation (%).
        --Filter pressure drop (mm H2O).
------------------------------------------------------------------------

    (b) Comparison of heating sources. The SE Report must include a 
description of the heating source for the new and predicate tobacco 
products and identify any differences, or state that there is no heating 
source.
    (c) Comparison of product composition. The SE Report must include 
descriptions of the product composition of the new and predicate tobacco 
products and identify any differences. The SE Report must include, in a 
tabular format, a side-by-side comparison of the materials and 
ingredients for each component or part of the new and predicate tobacco 
products. For each material and ingredient quantity, the target 
specifications and range of acceptable values, actual measured value 
(where applicable), and range of measured values (where applicable) 
reported as mass per component or part, must be provided.
    (1) Materials. For each material in the products include:
    (i) The material name and common name(s), if applicable;
    (ii) The component or part of the tobacco product where the material 
is located;
    (iii) The subcomponent or subpart where the material is located, if 
applicable;
    (iv) The function of the material;
    (v) The quantities (including ranges or means, acceptance limits) of 
the material(s) in each new tobacco product and predicate tobacco 
product (with any specification variation, if applicable);
    (vi) The specification(s) (including quality/grades, suppliers) used 
for the new tobacco product and predicate tobacco product (with any 
specification variations, if applicable); and
    (vii) Any other material properties necessary to characterize the 
new and predicate tobacco products.
    (2) Ingredients other than tobacco. For each ingredient other than 
tobacco in each material or component or part of the product include:
    (i) The International Union of Pure and Applied Chemistry (IUPAC) 
chemical name and common name, if applicable;
    (ii) The Chemical Abstracts Service (CAS) number(s) or FDA Unique 
Ingredient Identifier (UNII);
    (iii) The function of the ingredient;
    (iv) The quantity with the unit of measure (including ranges or 
means, acceptance limits) of the ingredient in the new tobacco product 
and predicate tobacco product reported as mass per gram of tobacco for 
non-portioned tobacco products and as mass per portion for portioned 
tobacco products (with any specification variation, if applicable);
    (v) The specification(s) (including purity or grade and supplier);
    (vi) For complex purchased ingredients, each single chemical 
substance reported separately; and
    (vii) Any other ingredient information necessary to characterize the 
new and predicate tobacco products.
    (3) Tobacco ingredients. For tobacco include:

[[Page 980]]

    (i) The type (e.g., Bright, Burley, reconstituted);
    (ii) The curing method (e.g., flue cured, dark air cured);
    (iii) The quantity of each type with the unit of measure (including 
ranges or means, acceptance limits) of tobacco in the new tobacco 
product and predicate tobacco product reported as mass per gram of 
tobacco for non-portioned tobacco products and as mass per portion for 
portioned tobacco products;
    (iv) A description of any genetic engineering of the tobacco; and
    (v) Any other information necessary to characterize the new and 
predicate tobacco products.
    (vi) If the new tobacco product does not contain tobacco, then 
include a statement that the new tobacco product does not contain 
tobacco.
    (4) Container closure system. A description of the container closure 
system for the new and predicate tobacco products, including a side-by-
side quantitative comparison of the components and materials and 
annotated illustrations.
    (d) Comparison of other features. The SE Report must include 
descriptions of any other features of the new and predicate tobacco 
products, such as those described in paragraphs (d)(1) and (2) of this 
section, and identify any differences. If a specific feature specified 
in paragraphs (d)(1) and (2) of this section is not applicable to the 
product design, this must be stated clearly. If FDA requests a 
scientific justification explaining why a feature is not applicable, the 
applicant must provide the justification to FDA. The comparison of other 
features must include information on:
    (1) Constituents. HPHCs and other constituents, as appropriate, to 
demonstrate that:
    (i) The new tobacco product has the same characteristics as the 
predicate tobacco product, or
    (ii) Any differences in characteristics between the new and 
predicate product do not cause the new tobacco product to raise 
different questions of public health, including:
    (A) The constituent names in alphabetical order;
    (B) The common name(s);
    (C) The Chemical Abstract Services number(s);
    (D) The mean quantity and variance with unit of measure;
    (E) The number of samples and measurement replicates for each 
sample;
    (F) The analytical methods used, associated reference(s), and full 
validation reports for each analytical method;
    (G) The testing laboratory or laboratories and documentation showing 
that the laboratory or laboratories is (or are) accredited by a 
nationally or internationally recognized external accreditation 
organization;
    (H) Length of time between dates of manufacture and date(s) of 
testing;
    (I) Storage conditions of the tobacco product before it was tested;
    (J) Reference product datasets (if applicable);
    (K) Full test data (including test protocols, any deviation(s) from 
the test protocols, quantitative acceptance (pass/fail) criteria and 
complete data sets) for all testing performed. Test data for combusted 
or inhaled tobacco products must reflect testing conducted using both 
intense and non-intense smoking or aerosol-generating regimens, where 
established; and
    (L) Complete descriptions of any smoking or aerosol-generating 
regimens used for analytical testing that are not standardized or widely 
accepted by the scientific community, if applicable.
    (2) Any other features. A description and comparison of any other 
features of the new tobacco product and the predicate tobacco product.
    (e) Comparison of tobacco processing. The SE Report must include 
information on the tobacco processes in paragraphs (e)(1) and (2) of 
this section for the new and predicate tobacco products, if applicable, 
and identify any differences.
    (1) Fermentation process. For smokeless tobacco products and tobacco 
products that contain fermented tobacco (including naturally fermented 
tobacco), the SE Report must contain the following information regarding 
the fermentation process of the new and predicate tobacco products and 
identify any differences:

[[Page 981]]

    (i) Description of the fermentation process;
    (ii) Composition of the inoculum (starter culture) with genus and 
species name(s) and concentration(s) (if applicable);
    (iii) Any step(s) taken to reduce microbes already present during 
processing (e.g., cleaning of contact surfaces);
    (iv) Specifications and test data for pH, temperature, and moisture 
content or water activity;
    (v) Frequency of aeration or turning (if applicable);
    (vi) Duration of fermentation;
    (vii) Added ingredients;
    (viii) Method used to stabilize or stop fermentation ((e.g., heat 
treatment), if applicable), including parameters of the method (e.g., 
length of treatment, temperature) and method validation data; and
    (ix) Storage conditions of the fermented tobacco prior to further 
processing or packaging and duration of storage (if applicable).
    (2) Heat treatment process. For tobacco products that are heat 
treated, the SE Report must contain the following information regarding 
the heat treatment process of the new and predicate tobacco products and 
identify any differences:
    (i) Description of the heat treatment process;
    (ii) Type of heat treatment;
    (iii) Conditions of heat treatment, including time, temperature, and 
moisture; and
    (iv) Method validation data, including microbial loads (including 
bacteria, spores, yeast and fungi) and tobacco-specific nitrosamines 
(TSNAs) before and after heat treatment.
    (f) Shelf life and stability information. With the exception of SE 
Reports for roll-your-own tobacco products and cigarettes that are not 
HTPs, SE Reports for all tobacco products must contain information on 
the stability of the new and predicate tobacco products over the shelf 
life, including the following information:
    (1) The length of the shelf life, a description of how shelf life is 
determined, and a description of how shelf life is indicated on the 
tobacco product, if applicable. If a tobacco product does not have a 
defined shelf life, state as such;
    (2) Any known or expected impacts of the differences between the new 
and predicate products on the product stability. If no impact is known 
or expected, state that;
    (3) Stability data assessed at the beginning (zero time), middle, 
and end of the expected shelf life. If a tobacco product does not have a 
defined shelf life, provide stability data over a specified amount of 
time and a justification for why that time period is appropriate. 
Stability testing must be performed for the microbial and chemical 
endpoints as follows:
    (i) Microbial content data including total aerobic microbial count 
and total yeast and mold count;
    (ii) Water activity; and
    (iii) Tobacco-specific nitrosamine yields (total, N-
nitrosonornicotine (NNN), and 4-methylnitrosamino)-1-(3-pydridyl)-1-
butanone) (NNK)).
    (4) Stability testing details for each microbial and chemical 
endpoint, including:
    (i) The mean quantity and variance with unit of measure;
    (ii) The number of samples and measurement replicates for each 
sample;
    (iii) The methods used, associated reference(s), and full validation 
reports for each method (as applicable);
    (iv) The testing laboratory or laboratories and documentation 
showing that the laboratory or laboratories is (or are) accredited by a 
nationally or internationally recognized external accreditation 
organization;
    (v) Length of time between dates of tobacco product manufacture and 
date(s) of testing;
    (vi) Storage conditions of the tobacco products before they were 
tested;
    (vii) A statement that the testing was performed on a tobacco 
product in the same container closure system in which the tobacco 
product is intended to be marketed; and
    (viii) Full test data (including test protocols, any deviation(s) 
from the test protocols, quantitative acceptance (pass/fail) criteria, 
complete data sets, and a summary of the results) for all stability 
testing performed.
    (g) Applicant's basis for substantial equivalence determination. The 
applicant

[[Page 982]]

must state that the new tobacco product has either:
    (1) The same characteristics as the predicate tobacco product and 
the basis for this determination, or
    (2) Different characteristics than the predicate tobacco product. 
Where an applicant states that its new tobacco product has different 
characteristics than the predicate tobacco product, the applicant must 
also include an explanation as to why a difference in any of the 
following characteristics do not cause the new product to raise 
different questions of public health: Product design (paragraph (a) of 
this section); heating source (paragraph (b) of this section); materials 
and ingredients (paragraph (c) of this section); and other features 
(paragraph (d) of this section). In addition, to demonstrate that a new 
tobacco product is substantially equivalent, an applicant must also 
explain why any differences in the manufacturing process between the new 
tobacco product and the predicate tobacco product would not change the 
characteristics of the new tobacco product such that the new tobacco 
product could raise different questions of public health (Sec. 
1107.18(e)). Similarly, for smokeless tobacco products and tobacco 
products that contain fermented tobacco, an applicant must explain why 
any difference in stability between the new tobacco product and the 
predicate tobacco product does not cause the new tobacco product to 
raise different questions of public health (paragraph (f) of this 
section).
    (h) Comparison to original predicate tobacco product. If the 
applicant is comparing the new tobacco product to a predicate tobacco 
product that FDA has previously found to be substantially equivalent, 
FDA may request that the applicant include information related to the 
original predicate tobacco product that was commercially marketed (other 
than for test marketing) in the United States as of February 15, 2007, 
even if that original predicate tobacco product is back several 
predicate tobacco products. FDA will request this information when 
necessary to ensure that any order the Agency issues finding the new 
tobacco product substantially equivalent complies with section 
910(a)(2)(A)(i)(I) of the Federal Food, Drug, and Cosmetic Act. FDA may 
need to review the first SE Report that received a finding of 
substantial equivalence using the original predicate tobacco product as 
a predicate tobacco product in order to make this finding.



Sec. 1107.20  Amendments.

    (a) Except as provided in paragraphs (b) and (c) of this section, 
the applicant may submit an amendment to an SE Report in accordance with 
subpart C of this part. If an applicant chose to submit a health 
information summary with its SE Report under Sec. 1107.18(j)(1), the 
applicant must submit with the amendment a redacted copy of the 
amendment that excludes research subject identifiers and trade secret 
and confidential commercial information as defined in Sec. Sec. 20.61 
and 20.63 of this chapter.
    (b) An applicant may not amend an SE Report to change the predicate 
tobacco product.
    (c) An applicant may not amend an SE Report after FDA has closed the 
SE Report under Sec. 1107.44 or it has been withdrawn under Sec. 
1107.22.
    (d) In general, amendments will be reviewed in the next review cycle 
as described in Sec. 1107.42.



Sec. 1107.22  Withdrawal by applicant.

    (a) An applicant may at any time make a written request to withdraw 
an SE Report for which FDA has not issued an order. The withdrawal 
request must state:
    (1) Whether the withdrawal is due to a health or safety concern 
related to the tobacco product;
    (2) The submission tracking number; and
    (3) The name of the new tobacco product that is the subject of the 
SE Report.
    (b) An SE Report will be considered withdrawn when FDA issues a 
notice stating the SE Report has been withdrawn.
    (c) The SE Report is an Agency record, even if withdrawn. FDA will 
retain the withdrawn SE Report under Federal Agency records schedules. 
The

[[Page 983]]

availability of the withdrawn SE Report will be subject to FDA's public 
information regulations in part 20 of this chapter.



Sec. 1107.24  Change in ownership of an SE Report.

    An applicant may transfer ownership of its SE Report. On or before 
the time of transfer, the new and former applicants are required to 
submit information to FDA as follows:
    (a) The former applicant must sign and submit a notice to FDA that 
states that all of the former applicant's rights and responsibilities 
relating to the SE Report have been transferred to the new applicant. 
This notice must identify the name and address of the new applicant and 
the SE Report transferred.
    (b) The new applicant must sign and submit a notice to FDA 
containing the following:
    (1) The new applicant's commitment to agreements, promises, and 
conditions made by the former applicant and contained in the SE Report;
    (2) The date that the change in ownership is effective;
    (3) Either a statement that the new applicant has a complete copy of 
the SE Report and order (if applicable), including amendments and 
records that are required to be kept under Sec. 1107.58, or a request 
for a copy of the SE Report from FDA's files by submitting a request in 
accordance with part 20 of this chapter. In accordance with the Freedom 
of Information Act, FDA will provide a copy of the SE Report to the new 
applicant under the fee schedule in FDA's public information regulations 
in Sec. 20.45 of this chapter; and
    (4) A certification that no modifications have been made to the new 
tobacco product since the SE Report was submitted to FDA.



                          Subpart D_FDA Review

    Source: 86 FR 55275, Oct. 4, 2021, unless otherwise noted.



Sec. 1107.40  Communications between FDA and applicants.

    (a) General principles. During the course of reviewing an SE Report, 
FDA may communicate with applicants about relevant matters, including 
scientific, medical, and procedural issues that arise during the review 
process. These communications may take the form of telephone 
conversations, letters, or emails, and will be documented in the SE 
Report in accordance with Sec. 10.65 of this chapter.
    (b) Meeting. Meetings between FDA and applicants may be held to 
discuss scientific and other issues. Requests for meetings will be 
directed to the Office of Science, Center for Tobacco Products, and FDA 
will make every attempt to grant requests for meetings that involve 
important issues.
    (c) Acceptance of an SE Report for review. After receiving an SE 
Report under Sec. 1107.18, FDA will either refuse to accept the SE 
Report for review or issue an acceptance for review letter.
    (d) Notification of deficiencies in an SE Report submitted under 
Sec. 1107.18. FDA will make reasonable efforts to communicate to 
applicants the procedural, administrative, or scientific deficiencies 
found in an SE Report and any additional information and data needed for 
the Agency's review. The applicant must also provide additional 
comparison information under Sec. 1107.19 if requested by FDA.
    (e) Withdrawal of SE Report. An SE Report will be considered 
withdrawn when FDA issues a notice stating that the SE Report has been 
withdrawn.



Sec. 1107.42  Review cycles.

    (a) Initial review cycle. FDA intends to review the SE Report and 
either communicate with the applicant as described in Sec. 1107.40 or 
take an action under Sec. 1107.44 within 90 calendar days of FDA's 
receipt of the SE Report, or within 90 calendar days of determining that 
the predicate was found to be commercially marketed (other than for test 
marketing) in the United States as of February 15, 2007 (if applicable), 
whichever is later. This 90-day period is called the ``initial review 
cycle.''
    (b) Additional review cycles. If FDA issues a deficiency 
notification under Sec. 1107.40(d) during the initial review cycle, FDA 
will stop reviewing the SE Report until it receives a response from the 
applicant or the timeframe specified in the notification of deficiencies 
for response has elapsed. If the

[[Page 984]]

applicant fails to respond within the time period provided in the 
notification of deficiency, FDA will issue an order denying marketing 
authorization under the criteria set forth in Sec. 1107.48. If the 
applicant's response to the notification of deficiencies provides the 
information FDA requested, but FDA identifies additional deficiencies, 
FDA may issue an additional deficiency notification. Each response will 
begin a new 90-day review cycle.
    (c) Inadequate response. If the applicant's response to FDA's 
deficiency notification(s) does not provide the information FDA 
requested, or the applicant provides information but the SE Report is 
still deficient, FDA generally intends to issue an order denying market 
authorization under the criteria set forth in Sec. 1107.48. At any time 
before FDA issues an order, an applicant may make a written request to 
withdraw an SE Report under Sec. 1107.22.



Sec. 1107.44  FDA action on an SE Report.

    After receipt of an SE Report, FDA will:
    (a) Refuse to accept the SE Report for review if it does not comply 
with Sec. 1107.18 and Sec. 1105.10 of this chapter;
    (b) Request additional information as provided in Sec. 1107.40(d);
    (c) Issue a letter administratively closing the SE Report if it is 
not possible to make a determination on an SE Report;
    (d) Issue a letter canceling the SE Report if FDA finds the SE 
Report was created in error;
    (e) Issue an order as described in Sec. 1107.46 finding the new 
tobacco product to be substantially equivalent and in compliance with 
the requirements of the Federal Food, Drug, and Cosmetic Act; or
    (f) Issue an order as described in Sec. 1107.48 denying marketing 
authorization because the new tobacco product is:
    (1) Not substantially equivalent to a tobacco product commercially 
marketed (other than for test marketing) in the United States on 
February 15, 2007, or
    (2) Not in compliance with the requirements of the Federal Food, 
Drug, and Cosmetic Act.



Sec. 1107.46  Issuance of an order finding a new tobacco product
substantially equivalent.

    If FDA finds that the information submitted in the SE Report 
establishes that the new tobacco product is substantially equivalent to 
a predicate tobacco product that was commercially marketed (other than 
for test marketing) in the United States on February 15, 2007, and finds 
that the new tobacco product is in compliance with the requirements of 
the Federal Food, Drug, and Cosmetic Act, FDA will send the applicant an 
order authorizing marketing of the new tobacco product. A marketing 
authorization order becomes effective on the date the order is issued.



Sec. 1107.48  Issuance of an order denying marketing authorization.

    (a) General. FDA will issue an order that the new tobacco product 
cannot be marketed if FDA finds that:
    (1) The information submitted in the SE Report does not establish 
that the new tobacco product is substantially equivalent to a predicate 
tobacco product that was commercially marketed (other than for test 
marketing) in the United States on February 15, 2007; or
    (2) The new tobacco product is not in compliance with the Federal 
Food, Drug, and Cosmetic Act.
    (b) Basis for order. The order will describe the basis for denying 
marketing authorization.



Sec. 1107.50  Rescission of order.

    (a) Grounds for rescinding a substantially equivalent order. FDA may 
rescind a substantially equivalent order allowing a new tobacco product 
to be marketed if FDA determines that:
    (1) The tobacco product for which the order has been issued:
    (i) Does not have the same characteristics as the predicate tobacco 
product; or
    (ii) Has different characteristics and there is insufficient 
information demonstrating that it is not appropriate to require a 
premarket tobacco product application under section 910(b) of the 
Federal Food, Drug, and Cosmetic Act because the product does not raise 
different questions of public health; or

[[Page 985]]

    (2) The SE Report (including any submitted amendments) contains an 
untrue statement of material fact; or
    (3) Concerning an SE Report that compared the new tobacco product to 
a tobacco product that FDA previously found substantially equivalent,
    (i) The predicate tobacco product relied on in the SE Report has 
been found ineligible because its SE Report (including any amendments) 
contains an untrue statement of material fact; or
    (ii) A predicate tobacco product on which any of the previous 
substantial equivalence determinations was based, going back to the 
original predicate tobacco product, has been found ineligible because 
its SE Report (including any amendments) contains an untrue statement of 
material fact; or
    (4) FDA or the applicant has removed from the market, due to a 
health or safety concern related to the tobacco product:
    (i) The predicate tobacco product on which the substantial 
equivalence determination is based; or
    (ii) A predicate tobacco product on which any of the previous 
substantial equivalence determinations is based, going back to the 
original predicate tobacco product, if the substantial equivalence SE 
Report compared the new tobacco product to a tobacco product that FDA 
previously found substantially equivalent.
    (b) Opportunity for a hearing. (1) Except as provided in paragraphs 
(b)(2) and (3) of this section, FDA will rescind an order only after 
notice and opportunity for a hearing under part 16 of this chapter.
    (2) FDA may rescind a substantially equivalent order prior to notice 
and opportunity for a hearing under part 16 of this chapter if it finds 
that there is a reasonable probability that continued marketing of the 
tobacco product presents a serious risk to public health. In that case, 
FDA will provide the manufacturer an opportunity for a hearing as soon 
as possible after the rescission.
    (3) FDA may rescind a substantially equivalent order without notice 
and opportunity for a hearing under part 16 of this chapter if the 
applicant has notified the Agency of a mistake in the application, FDA 
has determined that the mistake is part of the underlying scientific 
determination of the order which makes the order invalid, and the 
applicant has agreed that FDA can rescind the order without providing 
notice and opportunity for a hearing under part 16 of this chapter.



                         Subpart E_Miscellaneous

    Source: 86 FR 55275, Oct. 4, 2021, unless otherwise noted.



Sec. 1107.58  Record retention.

    Each applicant that receives an order under Sec. 1107.46 
authorizing the marketing of a new tobacco product must maintain all 
records required by this subpart and that support the SE Report for a 
substantial equivalence order. These records must be legible, in the 
English language, and available for inspection and copying by officers 
or employees duly designated by the Secretary. All records must be 
retained for a period of not less than 4 years from the date of the 
order even if such product is discontinued.



Sec. 1107.60  Confidentiality.

    (a) General. FDA will determine the public availability of any part 
of an SE Report and other content related to such an SE Report under 
this section and part 20 of this chapter.
    (b) Confidentiality of data and information prior to an order. Prior 
to issuing an order under this section:
    (1) FDA will not publicly disclose the existence of an SE Report 
unless:
    (i) The tobacco product has been introduced or delivered for 
introduction into interstate commerce for commercial distribution; or
    (ii) The applicant has publicly disclosed or acknowledged the 
existence of the SE Report (as such disclosure is defined in Sec. 20.81 
of this chapter), or has authorized FDA in writing to publicly disclose 
or acknowledge, that the applicant has submitted the SE Report to FDA.
    (2) FDA will not disclose the existence of or contents of an FDA 
communication with an applicant regarding its SE Report except to the 
extent that the applicant has publicly disclosed or acknowledged, or 
authorized FDA in writing to publicly disclose or acknowledge, the 
existence of or contents

[[Page 986]]

of that particular FDA communication.
    (3) FDA will not disclose information contained in an SE Report 
unless the applicant has publicly disclosed or acknowledged, or 
authorized FDA in writing to publicly disclose or acknowledge, that 
particular information. If the applicant has publicly disclosed or 
acknowledged, or authorized FDA in writing to publicly disclose or 
acknowledge, that particular information contained in an SE Report, FDA 
may disclose that particular information.
    (c) Disclosure of data and information after issuance of an order 
under Sec. 1107.46. After FDA issues an order under Sec. 1107.46 
finding a new tobacco product substantially equivalent, it will make the 
following information related to the SE Report and order available for 
public disclosure upon request or at FDA's own initiative, including 
information from amendments to the SE Report and FDA's reviews of the SE 
Report:
    (1) All data previously disclosed to the public, as such disclosure 
is defined in Sec. 20.81 of this chapter;
    (2) Any protocol for a test or study, except to the extent it is 
shown to fall within the exemption established for trade secrets and 
confidential commercial information in Sec. 20.61 of this chapter;
    (3) Information and data submitted to demonstrate that the new 
tobacco product does not raise different questions of public health, 
except to the extent it is shown to fall within the exemptions 
established in Sec. 20.61 of this chapter for trade secrets and 
confidential commercial information, or in Sec. 20.63 of this chapter 
for personal privacy;
    (4) Correspondence between FDA and the applicant, including any 
requests FDA made for additional information and responses to such 
requests, and all written summaries of oral discussions between FDA and 
the applicant, except to the extent it is shown to fall within the 
exemptions in Sec. 20.61 of this chapter for trade secrets and 
confidential commercial information, or in Sec. 20.63 of this chapter 
for personal privacy; and
    (5) In accordance with Sec. 25.51 of this chapter, the 
environmental assessment or, if applicable, the claim of categorical 
exclusion from the requirement to submit an environmental assessment 
under part 25 of this chapter.
    (d) Disclosure of data and information after issuance of an order 
under Sec. 1107.48. After FDA issues an order under Sec. 1107.48 
(denying marketing authorization), FDA may make certain information 
related to the SE Report and the order available for public disclosure 
upon request or at FDA's own initiative except to the extent the 
information is otherwise exempt from disclosure under part 20 of this 
chapter. Information FDA may disclose includes the tobacco product 
category (e.g., cigarette), tobacco product subcategory (e.g., 
filtered), package size, and the basis for the order denying marketing 
authorization.
    (e) Health information summary or statement. Health information 
required by section 910(a)(4) of the Federal Food, Drug, and Cosmetic 
Act, if submitted as part of the SE Report (which includes any 
amendments), will be disclosed within 30 calendar days of issuing a 
substantially equivalent order. If the applicant has instead submitted a 
910(a)(4) statement as provided in Sec. 1107.18(j)(2), FDA will make 
publicly available on FDA's website the responsible official to whom a 
request for health information may be made.



Sec. 1107.62  Electronic submission.

    (a) Electronic format requirement. Applicants submitting any 
documents to the Agency under this part must provide all required 
information to FDA using the Agency's electronic system, except as 
provided in paragraph (b) of this section. The SE Report and all 
supporting information must be in an electronic format that FDA can 
process, read, review, and archive.
    (b) Waivers from electronic format requirement. An applicant may 
submit a written request that is legible and written in English, to the 
Center for Tobacco Products asking that FDA waive the requirement for 
electronic format and content. Waivers will be granted if use of 
electronic means is not reasonable for the person requesting the waiver. 
To request a waiver, applicants can send the written request

[[Page 987]]

to the address included on our website (www.fda.gov/tobaccoproducts). 
The request must include the following information:
    (1) The name and address of the applicant, list of individuals 
authorized for the applicant to serve as the contact person, and contact 
information including an email address. If the applicant has submitted 
an SE Report previously, the regulatory correspondence must also include 
any identifying information for the previous submission.
    (2) A statement that creation and/or submission of information in 
electronic format is not reasonable for the person requesting the 
waiver, and an explanation of why creation and/or submission in 
electronic format is not reasonable. This statement must be signed by 
the applicant or by an employee of the applicant who is authorized to 
make the declaration on behalf of the applicant.
    (c) Paper submission. An applicant who has obtained a waiver from 
filing electronically must send a written SE Report through the Document 
Control Center to the address provided in the FDA documentation granting 
the waiver.



PART 1114_PREMARKET TOBACCO PRODUCT APPLICATIONS--Table of Contents



                      Subpart A_General Provisions

Sec.
1114.1 Scope.
1114.3 Definitions.

            Subpart B_Premarket Tobacco Product Applications

1114.5 Application submission.
1114.7 Required content and format.
1114.9 Amendments.
1114.11 Withdrawal by applicant.
1114.13 Change in ownership of an application.
1114.15 Supplemental applications.
1114.17 Resubmissions.

                          Subpart C_FDA Review

1114.25 Communication between FDA and applicants.
1114.27 Review procedure.
1114.29 FDA action on an application.
1114.31 Issuance of a marketing granted order.
1114.33 Issuance of a marketing denial order.
1114.35 Withdrawal of a marketing granted order.
1114.37 Temporary suspension of a marketing granted order.

                    Subpart D_Postmarket Requirements

1114.39 Postmarket changes.
1114.41 Reporting requirements.

                         Subpart E_Miscellaneous

1114.45 Record retention.
1114.47 Confidentiality.
1114.49 Electronic submission.

    Authority: 21 U.S.C. 371, 374, 387a, 387i, 387j; Pub. L. 117-103, 
136 Stat. 49.

    Source: 86 FR 55412, Oct. 4, 2021, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 1114.1  Scope.

    (a) This part sets forth the procedures and requirements for 
submitting a premarket tobacco product application (PMTA), the general 
procedures FDA will follow when evaluating a PMTA, and postmarket 
reporting requirements.
    (b) This part does not apply to modified risk tobacco product 
applications, except that single applications seeking both a marketing 
granted order under section 910(c) of the Federal Food, Drug, and 
Cosmetic Act and an order under section 911(g) of the Federal Food, 
Drug, and Cosmetic Act must satisfy the requirements of this part in 
addition to the requirements of section 911 of the Federal Food, Drug, 
and Cosmetic Act.
    (c) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.
    (d) This part does not apply to ``premium'' cigars as defined in 
Sec. 1114.3.



Sec. 1114.3  Definitions.

    For purposes of this part:
    Accessory means any product that is intended or reasonably expected 
to be used with or for the human consumption of a tobacco product; does 
not contain tobacco and is not made or derived from tobacco; and meets 
either of the following:

[[Page 988]]

    (1) Is not intended or reasonably expected to affect or alter the 
performance, composition, constituents, or characteristics of a tobacco 
product; or
    (2) Is intended or reasonably expected to affect or maintain the 
performance, composition, constituents, or characteristics of a tobacco 
product, but:
    (i) Solely controls moisture and/or temperature of a stored tobacco 
product; or
    (ii) Solely provides an external heat source to initiate but not 
maintain combustion of a tobacco product.
    Additive means any substance the intended use of which results or 
may reasonably be expected to result, directly or indirectly, in its 
becoming a component or otherwise affecting the characteristic of any 
tobacco product (including any substances intended for use as a 
flavoring or coloring or in producing, manufacturing, packing, 
processing, preparing, treating, packaging, transporting, or holding), 
except that such term does not include tobacco, or a pesticide chemical 
residue in or on raw tobacco or a pesticide chemical.
    Adverse experience means any unfavorable physical or psychological 
effect in a person that is temporally associated with the use of or 
exposure to a tobacco product, whether or not the person uses the 
tobacco product, and whether or not the effect is considered to be 
related to the use of or exposure to the tobacco product.
    Applicant means any person that submits a premarket tobacco product 
application to receive a marketing granted order for a new tobacco 
product.
    Brand means a variety of tobacco product distinguished by the 
tobacco used, tar content, nicotine content, flavoring used, size, 
filtration, packaging, logo, registered trademark, brand name(s), 
identifiable pattern of colors, or any combination of such attributes.
    Characteristics means the materials, ingredients, design, 
composition, heating source, or other features of a tobacco product.
    Commercially marketed means selling or offering for sale a tobacco 
product in the United States to consumers or to any person for the 
eventual purchase by consumers in the United States.
    Component or part means any software or assembly of materials 
intended or reasonably expected:
    (1) To alter or affect the tobacco product's performance, 
composition, constituents, or characteristics; or
    (2) To be used with or for the human consumption of a tobacco 
product. Component or part excludes anything that is an accessory of a 
tobacco product.
    Composition means the materials in a tobacco product, including 
ingredients, additives, and biological organisms. The term includes the 
manner in which the materials, for example, ingredients, additives, and 
biological organisms, are arranged and integrated to produce a tobacco 
product.
    Constituent means any chemical or chemical compound in a tobacco 
product that is or potentially is inhaled, ingested, or absorbed into 
the body, any chemical or chemical compound in an emission (e.g., smoke, 
aerosol, droplets) from a tobacco product, that either transfers from 
any component or part of the tobacco product to the emission or that is 
formed by the product, including through combustion or heating of 
tobacco, additives, or other components of the tobacco product.
    Container closure system means any packaging materials that are a 
component or part of a tobacco product.
    Design means the form and structure concerning, and the manner in 
which components or parts, ingredients, software, and materials are 
integrated to produce a tobacco product.
    Finished tobacco product means a tobacco product, including all 
components and parts, sealed in final packaging (e.g., filters or filter 
tubes sold to consumers separately or as part of kits, or e-liquids 
sealed in final packaging sold to consumers either separately or as part 
of kits) or in the final form in which it is intended to be sold to 
consumers.
    Harmful or potentially harmful constituent or HPHC means any 
chemical or chemical compound in a tobacco product or tobacco smoke or 
emission that:
    (1) Is or potentially is inhaled, ingested, or absorbed into the 
body, including as an aerosol or any other emission; and

[[Page 989]]

    (2) Causes or has the potential to cause direct or indirect harm to 
users or nonusers of tobacco products.
    Heating source means the source of energy used to burn or heat the 
tobacco product.
    Ingredient means tobacco, substances, compounds, or additives 
contained within or added to the tobacco, paper, filter, or any other 
component or part of a tobacco product, including substances and 
compounds reasonably expected to be formed through a chemical reaction 
during tobacco product manufacturing.
    Label means a display of written, printed, or graphic matter upon 
the immediate container of any article.
    Labeling means all labels and other written, printed, or graphic 
matter upon any article or any of its containers or wrappers, or 
accompanying such article.
    Line data means an analyzable dataset of observations for each 
individual study participant, laboratory animal, or test replicate.
    Marketing denial order means the order described in section 
910(c)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act stating 
that the product may not be introduced or delivered for introduction 
into interstate commerce.
    Marketing granted order means the order described in section 
910(c)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act stating that 
the new tobacco product may be introduced or delivered for introduction 
into interstate commerce.
    Material means an assembly of ingredients. Materials are assembled 
to form a tobacco product or components or parts of a tobacco product.
    New tobacco product means:
    (1) Any tobacco product (including those products in test markets) 
that was not commercially marketed in the United States as of February 
15, 2007; or
    (2) Any modification (including a change in design, any component, 
any part, or any constituent, including a smoke constituent, or in the 
content, delivery or form of nicotine, or any other additive or 
ingredient) of a tobacco product where the modified product was 
commercially marketed in the United States after February 15, 2007.
    Other features means any distinguishing qualities of a tobacco 
product similar to those specifically enumerated in section 910(a)(3)(B) 
of the Federal Food, Drug, and Cosmetic Act. Such other features include 
harmful and potentially harmful constituents and any other product 
characteristics that relate to the chemical, biological, and physical 
properties of the tobacco product.
    Package or packaging means a pack, box, carton, or container of any 
kind or, if no other container, any wrapping (including cellophane), in 
which a tobacco product is offered for sale, sold, or otherwise 
distributed to consumers.
    Premarket tobacco product application or PMTA means the application 
described in section 910(b) of the Federal Food, Drug, and Cosmetic Act. 
This term includes the initial premarket tobacco product application and 
all subsequent amendments.
    ``Premium'' cigar means a type of cigar that:
    (1) Is wrapped in whole tobacco leaf;
    (2) Contains a 100 percent leaf tobacco binder;
    (3) Contains at least 50 percent (of the filler by weight) long 
filler tobacco (i.e., whole tobacco leaves that run the length of the 
cigar);
    (4) Is handmade or hand rolled (i.e., no machinery was used apart 
from simple tools, such as scissors to cut the tobacco prior to 
rolling);
    (5) Has no filter, nontobacco tip, or nontobacco mouthpiece;
    (6) Does not have a characterizing flavor other than tobacco;
    (7) Contains only tobacco, water, and vegetable gum with no other 
ingredients or additives; and
    (8) Weighs more than 6 pounds per 1,000 units.
    Serious adverse experience means an adverse experience that results 
in any of the following outcomes:
    (1) Death;
    (2) A life-threatening condition or illness;
    (3) Inpatient hospitalization or prolongation of existing 
hospitalization;
    (4) A persistent or significant incapacity or substantial disruption 
of the

[[Page 990]]

ability to conduct normal life functions;
    (5) A congenital anomaly/birth defect; or
    (6) Any other adverse experience that, based upon appropriate 
medical judgment, may jeopardize the health of a person and may require 
medical or surgical intervention to prevent one of the other outcomes 
listed in this definition.
    Submission tracking number or STN means the number that FDA assigns 
to submissions that are received from an applicant, such as a PMTA and a 
supplemental PMTA.
    Tobacco product means any product made or derived from tobacco, or 
containing nicotine from any source, that is intended for human 
consumption, including any component, part, or accessory of a tobacco 
product (except for raw materials other than tobacco used in 
manufacturing a component, part, or accessory of a tobacco product). The 
term ``tobacco product'' does not mean an article that under the Federal 
Food, Drug, and Cosmetic Act is: a drug (section 201(g)(1)); a device 
(section 201(h)); a combination product (section 503(g)); or a food 
(section 201(f)) if such article contains no nicotine or no more than 
trace amounts of naturally occurring nicotine.
    Tobacco product manufacturer means any person, including a repacker 
or relabeler, who:
    (1) Manufactures, fabricates, assembles, processes, or labels a 
tobacco product, or
    (2) Imports a finished tobacco product for sale or distribution in 
the United States.
    Unexpected adverse experience means an adverse experience occurring 
in one or more persons in which the nature, severity, or frequency of 
the experience is not consistent with:
    (1) The known or foreseeable risks of adverse experiences associated 
with the use or exposure to the tobacco product as described in the PMTA 
and other relevant sources of information, such as the product labeling 
and postmarket reports;
    (2) The expected natural progression of any underlying disease, 
disorder, or condition of the persons(s) experiencing the adverse 
experience and the person's predisposing risk factor profile for the 
adverse experience; or
    (3) The results of nonclinical investigations.
    Vulnerable populations means groups that are susceptible to tobacco 
product risk and harm due to disproportionate rates of tobacco product 
initiation, use, burden of tobacco-related diseases, or decreased 
cessation. Vulnerable populations can include, but are not limited to, 
youth and young adults, those with lower socioeconomic status, certain 
races or ethnicities, sexual or gender minorities, underserved rural 
populations, those pregnant or trying to become pregnant, those in the 
military or veterans, and those with mental health conditions or 
substance use disorders.

[86 FR 55412, Oct. 4, 2021, as amended at 88 FR 16553, Mar. 20, 2023]



            Subpart B_Premarket Tobacco Product Applications



Sec. 1114.5  Application submission.

    An applicant may submit a PMTA to demonstrate that a new tobacco 
product meets the requirements to receive a marketing granted order. A 
new tobacco product may not be introduced or delivered for introduction 
into interstate commerce under this part until FDA has issued a 
marketing granted order for the product.



Sec. 1114.7  Required content and format.

    (a) General. The PMTA must contain sufficient information for FDA to 
determine whether any of the grounds for marketing denial order 
specified in section 910(c)(2) of the Federal Food, Drug, and Cosmetic 
Act apply. The application must contain the following sections:
    (1) General information (as described in paragraph (c) of this 
section);
    (2) Descriptive information (as described in paragraph (d) of this 
section);
    (3) Product samples (as described in paragraph (e) of this section);
    (4) Labeling and description of marketing plans (as described in 
paragraph (f) of this section);

[[Page 991]]

    (5) Statement of compliance with 21 CFR part 25 (as described in 
paragraph (g) of this section);
    (6) Summary (as described in paragraph (h) of this section);
    (7) Product formulation (as described in paragraph (i) of this 
section);
    (8) Manufacturing (as described in paragraph (j) of this section);
    (9) Health risk investigations (as described in paragraph (k) of 
this section); and
    (10) The effect on the population as a whole (as described in 
paragraph (l) of this section);
    (11) Certification statement (as described in paragraph (m) of this 
section).
    (b) Format. (1) The application must be submitted using the form(s) 
that FDA provides, contain a comprehensive index (i.e., a listing of 
files and data associated with those files) and table of contents, be 
well-organized and legible, and be written in English. Documents that 
have been translated from another language into English (e.g., original 
study documents written in a language other than English) must be 
accompanied by: The original language version of the document, signed a 
statement by an authorized representative of the manufacturer certifying 
that the English language translation is complete and accurate, and a 
brief statement of the qualifications of the person that made the 
translation. As described in Sec. 1114.49, the applicant must submit 
the application and all information supporting the application in an 
electronic format that FDA can process, read, review, and archive, 
unless FDA has granted a waiver.
    (2) An applicant may include content in a submission by cross-
reference to a tobacco product master file or a pending modified risk 
tobacco product application for the same tobacco product. Applicants 
using a master file must provide documentation of their right of 
reference for the master file and clearly identify the specific content 
being incorporated into the PMTA submission. Except as provided for in 
Sec. Sec. 1114.15 and 1114.17, FDA will not consider content included 
by cross-reference to other sources of information outside of the 
submission.
    (c) General information. The applicant must, by using the form(s) 
FDA provides, specify the following general information:
    (1) Applicant name, address, and contact information;
    (2) Authorized representative or U.S. agent (for a foreign 
applicant), including the name, address, and contact information;
    (3) The following information to uniquely identify the product:
    (i) Manufacturer;
    (ii) Product name(s), including brand and subbrand (or other 
commercial name(s) used in commercial distribution); and
    (iii) The product category, product subcategory, and product 
properties as provided in the following table. If the product does not 
have a listed product property, such as ventilation or characterizing 
flavor, the application must state ``none'' for that property.

                                        Table 1 to Paragraph (c)(3)(iii)
----------------------------------------------------------------------------------------------------------------
                                           Tobacco product
       Tobacco product category              subcategory                       Product properties
----------------------------------------------------------------------------------------------------------------
(A) Cigarettes.......................  (1) Filtered...........  --Package type (e.g., hard pack, soft pack, clam
                                                                 shell).
                                                                --Product quantity (e.g., 20 cigarettes, 25
                                                                 cigarettes).
                                                                --Length (e.g., 89.1 millimeters (mm), 100.0
                                                                 mm).
                                                                --Diameter (e.g., 6.0 mm, 8.1 mm).
                                                                --Ventilation (e.g., none, 10.0%, 25.0%).
                                                                --Characterizing flavor(s) (e.g., none,
                                                                 menthol).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (2) Non-filtered.......  --Package type (e.g., hard pack, soft pack, clam
                                                                 shell).
                                                                --Product quantity (e.g., 20 cigarettes, 25
                                                                 cigarettes).
                                                                --Length (e.g., 89.1 mm, 100.0 mm).
                                                                --Diameter (e.g., 6.0 mm, 8.1 mm).
                                                                --Characterizing flavor(s) (e.g., none,
                                                                 menthol).
                                                                -- Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (3) Other..............  --Package type (e.g., hard pack, soft pack, clam
                                                                 shell).
                                                                --Product quantity (e.g., 20 cigarettes, 25
                                                                 cigarettes).

[[Page 992]]

 
                                                                --Length (e.g., 89.1 mm, 100.0 mm).
                                                                --Diameter (e.g., 6.0 mm, 8.1 mm).
                                                                --Ventilation (e.g., none, 10.0%, 25.0%).
                                                                --Characterizing flavor(s) (e.g., none,
                                                                 menthol).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
(B) Roll-Your-Own Tobacco Products...  (1) Roll-Your-Own        --Package type (e.g., bag, pouch).
                                        Tobacco Filler.
                                                                --Product quantity (e.g., 20.1 grams [g], 16.0
                                                                 ounces [oz.]).
                                                                --Characterizing flavor(s) (e.g., none,
                                                                 menthol).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (2) Rolling Paper......  --Package type (e.g., box, booklet).
                                                                --Product quantity (e.g., 50 sheets, 200
                                                                 papers).
                                                                --Length (e.g., 79.1 mm, 100.0 mm, 110.2 mm).
                                                                --Width (e.g., 28.1 mm, 33.0 mm, 45.2 mm).
                                                                --Characterizing flavor(s) (e.g., none,
                                                                 menthol).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (3) Cigarette Tube,      --Package type (e.g., bag, box).
                                        Filtered.
                                                                --Product quantity (e.g., 100 tubes, 200 tubes).
                                                                --Length (e.g., 89.1 mm, 100.0 mm).
                                                                --Diameter (e.g., 6.0 mm, 8.1 mm).
                                                                --Ventilation (e.g., none, 10.0%, 25.0%).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 tobacco).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (4) Cigarette Tube, Non- --Package type (e.g., bag, box).
                                        filtered.
                                                                --Product quantity (e.g., 100 tubes, 200 tubes).
                                                                --Length (e.g., 89.1 mm, 100.0 mm).
                                                                --Diameter (e.g., 6.0 mm, 8.1 mm).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 tobacco).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (5) Filter.............  --Package type (e.g., bag, box).
                                                                --Product quantity (e.g., 100 filters, 200
                                                                 filters).
                                                                --Length (e.g., 8.0 mm, 12.1 mm).
                                                                --Diameter (e.g., 6.0 mm, 8.1 mm).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 tobacco).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (6) Paper Tip..........  --Package type (e.g., bag, box).
                                                                --Product quantity (e.g., 200 tips, 275 tips).
                                                                --Length (e.g., 12.0 mm, 15.1 mm).
                                                                --Width (e.g., 27.1 mm).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 tobacco).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (7) Other..............  --Package type (e.g., bag, box).
                                                                --Product quantity (e.g., 200 tips, 100 filters,
                                                                 200 tubes.
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 tobacco).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product.
(C) Smokeless Tobacco Products.......  (1) Moist Snuff, Loose.  --Package type (e.g., plastic can with metal
                                                                 lid, plastic can with plastic lid).
                                                                --Product quantity (e.g., 20.0 g, 2.1 oz.).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cherry, wintergreen).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable,
                                                                 e.g., fine cut, long cut, straight cut).
                                       (2) Moist Snuff,         --Package type (e.g., plastic can with metal
                                        Portioned.               lid, plastic can with plastic lid).
                                                                --Product quantity (e.g., 22.5 g, 20.0 g).
                                                                --Portion count (e.g., 15 pouches, 20 pieces).
                                                                --Portion mass (e.g., 1.5 g/pouch, 1.0 g/piece).
                                                                --Portion length (e.g., 15.0 mm, 20.1 mm).
                                                                --Portion width (e.g., 10.0 mm, 15.1 mm).
                                                                --Portion thickness (e.g., 5.0 mm, 7.1 mm).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cherry, wintergreen).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).

[[Page 993]]

 
                                       (3) Snus, Loose........  --Package type (e.g., plastic can with metal
                                                                 lid, plastic can with plastic lid).
                                                                --Product quantity (e.g., 20.0 g, 2.1 oz.).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cherry, wintergreen).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (4) Snus, Portioned....  --Package type (e.g., plastic can with metal
                                                                 lid, plastic can with plastic lid).
                                                                --Product quantity (e.g., 22.5 g, 20.0 g).
                                                                --Portion count (e.g., 15 pouches, 20 pieces).
                                                                --Portion mass (e.g., 1.5 g/pouch, 1.0 g/piece).
                                                                --Portion length (e.g., 15.0 mm, 20.1 mm).
                                                                --Portion width (e.g., 10.0 mm, 15.1 mm).
                                                                --Portion thickness (e.g., 5.0 mm, 7.1 mm).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cherry, wintergreen).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (5) Dry Snuff, Loose...  --Package type (e.g., plastic can with metal
                                                                 lid, plastic can with plastic lid).
                                                                --Product quantity (e.g., 20.0 g, 2.1 oz.).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cherry, wintergreen).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (6) Dissolvable........  --Package type (e.g., plastic can with metal
                                                                 lid, plastic can with plastic lid).
                                                                --Product quantity (e.g., 22.5 g, 20.0 g)
                                                                --Portion count (e.g., 15 sticks, 20 pieces).
                                                                --Portion mass (e.g., 1.5 g/strip, 1.0 g/piece).
                                                                --Portion length (e.g., 10.0 mm, 15.1 mm).
                                                                --Portion width (e.g., 5.0 mm, 8.1 mm).
                                                                --Portion thickness (e.g., 3.0 mm, 4.1 mm).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cherry, wintergreen).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (7) Chewing Tobacco,     --Package type (e.g., bag, pouch, wrapped).
                                        Loose.
                                                                --Product quantity (e.g., 20.0 g, 3.1 oz).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cherry, wintergreen).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (8) Chewing Tobacco,     --Package type (e.g., plastic can with metal
                                        Portioned.               lid, plastic can with plastic lid).
                                                                --Product quantity (e.g., 22.5 g, 20.0 g)
                                                                --Portion count (e.g., 10 bits).
                                                                --Portion mass (e.g., 2.1 g/bit).
                                                                --Portion length (e.g., 8.0 mm, 10.1 mm).
                                                                --Portion width (e.g., 6.0 mm, 8.1 mm).
                                                                --Portion thickness (e.g., 5.1 mm, 7.0 mm).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cherry, wintergreen).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (9) Other..............  --Package type (e.g., bag, box, can).
                                                                --Product quantity (e.g., 20.1 g, 22.5 g, 3.0
                                                                 oz.).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cherry, wintergreen, tobacco).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product.
(D) Electronic Nicotine Delivery       (1) E-Liquid, Open.....  --Package type (e.g., bottle, box, pod).
 System (ENDS) (Also referred to as
 vapes).
                                                                --Product quantity (e.g., 1 bottle, 5 bottles).
                                                                --E-liquid volume (e.g., 0.5 milliliters [ml]),
                                                                 2.0 ml, 5.1 ml).
                                                                --Nicotine concentration (e.g., 0 milligrams/
                                                                 milliliter [mg/ml], 0.2 mg/ml, 0.4 mg/ml, 1%,
                                                                 0.2 mg/bottle).
                                                                --Propylene glycol (PG)/vegetable glycerin (VG)
                                                                 ratio (e.g., not applicable [N/A], 0/100, 50/
                                                                 50, 100/0).
                                                                --Characterizing flavor(s) (e.g., none, tobacco,
                                                                 menthol, cherry, wintergreen).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (2) E-Liquid, Closed...  --Package type (e.g., cartridge, pod).
                                                                --Product quantity (e.g., 1 cartridge, 5
                                                                 cartridges).
                                                                --E-liquid volume (e.g., 0.5 ml, 2.0 ml, 5.1
                                                                 ml).
                                                                --Nicotine concentration (e.g., 0 mg/ml, 0.2 mg/
                                                                 ml, 0.4 mg/ml, 1%, 2.0 mg/bottle).
                                                                --PG/VG ratio (e.g., N/A, 0/100, 50/50, 100/0).
                                                                --Characterizing flavor(s) (e.g., none, tobacco,
                                                                 menthol, cherry, wintergreen).

[[Page 994]]

 
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (3) E-Cigarette, Closed  --Package type (e.g., box, none, plastic
                                                                 clamshell).
                                                                --Product quantity (e.g., 1 e-cigarette, 5 e-
                                                                 cigarettes).
                                                                --Length (e.g., 100.0 mm, 120.0 mm).
                                                                --Diameter (e.g., 6.0 mm, 8.0 mm).
                                                                --Wattage (e.g., 100 watts [W], 200 W).
                                                                --Battery capacity (e.g., 100 milliampere hours
                                                                 [mAh], 200 mAh).
                                                                --E-liquid volume (e.g., 0.5 ml, 2.0 ml, 5.1
                                                                 ml).
                                                                --Nicotine concentration (e.g., 0 mg/ml, 0.2 mg/
                                                                 ml, 0.4 mg/ml, 1%, 0.2 mg/e-cigarette).
                                                                --PG/VG ratio (e.g., N/A, 0/100, 50/50, 100/0).
                                                                --Characterizing flavor(s) (e.g., none, tobacco,
                                                                 menthol, cherry, wintergreen).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product.
                                       (4) E-Cigarette, Open..  --Package type (e.g., box, none, plastic
                                                                 clamshell).
                                                                --Product quantity (e.g., 1 e-cigarette, 5 e-
                                                                 cigarettes).
                                                                --Length (e.g., 100.0 mm, 120.0 mm).
                                                                --Diameter (e.g., 6.0 mm, 8.0 mm).
                                                                --E-liquid volume (e.g., 0.5 ml, 2.0 ml, 5.1
                                                                 ml).
                                                                --Wattage (e.g., 100 W, 200 W).
                                                                --Battery capacity (e.g., 100 mAh, 200 mAh).
                                                                --Characterizing flavor(s) (e.g., none, tobacco,
                                                                 menthol, cherry, wintergreen).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (5) ENDS Component.....  --Package type (e.g., box, none, plastic
                                                                 clamshell).
                                                                --Product quantity (e.g.,1 coil).
                                                                --Characterizing flavor(s) (e.g., none, tobacco,
                                                                 menthol, cherry, wintergreen).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (6) ENDS Other.........  --Package type (e.g., box, none, plastic
                                                                 clamshell).
                                                                --Product quantity (e.g., 1 e-cigarette, 5
                                                                 bottles).
                                                                --Characterizing flavor(s) (e.g., none, cherry,
                                                                 wintergreen, tobacco, menthol).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product.
(E) Cigars...........................  (1) Cigar, Filtered      --Package type (e.g., hard pack, soft pack, clam
                                        Sheet-Wrapped.           shell).
                                                                --Product quantity (e.g., 20 filtered cigars, 25
                                                                 filtered cigars).
                                                                --Length (e.g., 89.1 mm, 100.0 mm).
                                                                --Diameter (e.g., 6.0 mm, 8.1 mm).
                                                                --Ventilation (e.g., none, 0%, 10.0%, 25.0%).
                                                                --Characterizing flavor (e.g., none, menthol).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (2) Cigar, Unfiltered    --Package type (e.g., box, film sleeve).
                                        Sheet-Wrapped.
                                                                --Product quantity (e.g., 1 cigar, 5
                                                                 cigarillos).
                                                                --Length (e.g., 100.1 mm, 140.0 mm).
                                                                --Diameter (e.g., 8.0 mm, 10.1 mm).
                                                                --Tip (e.g., none, wood tips, plastic tips).
                                                                --Characterizing flavor (e.g., none, menthol).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (3) Cigar, Unfiltered    --Package type (e.g., box, film, sleeve, none).
                                        Leaf-Wrapped.
                                                                --Product quantity (e.g., 1 cigar, 5 cigars).
                                                                --Length (e.g., 150.1 mm, 200.0 mm).
                                                                --Diameter (e.g., 8.0 mm, 10.1 mm).
                                                                --Wrapper material (e.g., burley tobacco leaf,
                                                                 Connecticut shade grown tobacco leaf).
                                                                --Characterizing flavor (e.g., none, whiskey).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (4) Cigar Component....  --Package type (e.g., box, booklet).
                                                                --Product quantity (e.g., 10 wrappers, 20
                                                                 leaves).
                                                                --Characterizing flavor (e.g., none, menthol,
                                                                 cherry).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (5) Cigar Tobacco        --Package type (e.g., bag, pouch).
                                        Filler.

[[Page 995]]

 
                                                                --Product quantity (e.g., 20.0 g, 16.1 oz.).
                                                                --Characterizing flavor (e.g., none, menthol,
                                                                 cherry).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (6) Other..............  --Package type (e.g., box, booklet).
                                                                --Product quantity (e.g., 1 cigar, 5 cigars, 20
                                                                 leaves, 16 g).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cherry).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product.
(F) Pipe Tobacco Products............  (1) Pipe...............  --Package type (e.g., box, none).
                                                                --Product quantity (e.g., 1 pipe).
                                                                --Length (e.g., 200.0 mm, 300.1 mm).
                                                                --Diameter (e.g., 25.1 mm).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cavendish, cherry).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (2) Pipe Tobacco Filler  --Package type (e.g., bag, none).
                                                                --Product quantity (e.g., 20.0 g, 16.1 oz).
                                                                --Tobacco cut style (e.g., standard cut, such as
                                                                 shag cut, bugler cut, loose cut, etc., or a
                                                                 pressed cut, such as flake, cube cut, roll
                                                                 cake, etc., or a mixture).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cavendish, cherry).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (3) Pipe Component.....  --Package type (e.g., box, bag, none).
                                                                --Product quantity (e.g., 1 bowl, 1 stem, 100
                                                                 filters).
                                                                --Characterizing flavor(s) (e.g., none, cherry).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (4) Other..............  --Package type (e.g., bag, box, none).
                                                                --Product quantity (e.g., 1 pipe, 1 bowl, 1
                                                                 stem, 100 filters).
                                                                --Characterizing flavor(s) (e.g., none, cherry).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product.
(G) Waterpipe Tobacco Products.......  (1) Waterpipe..........  --Package type (e.g., box, none).
                                                                --Product quantity (e.g., 1 waterpipe).
                                                                --Height (e.g., 200.0 mm, 500.1 mm).
                                                                --Width (e.g., 100.1 mm, 300.0 mm).
                                                                --Diameter (e.g., 100.1 mm, 300.0 mm)--Number of
                                                                 hoses (e.g., 1, 2, 4).
                                                                --Characterizing flavor(s) (e.g., none).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (2) Waterpipe Tobacco    --Package type (e.g., bag, pouch).
                                        Filler.
                                                                --Product quantity (e.g., 20.0 g, 16.1 oz.).
                                                                --Characterizing flavor(s) (e.g., none, tobacco,
                                                                 menthol, apple).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (3) Waterpipe Heat       --Package type (e.g., box, film sleeve, bag,
                                        Source.                  none).
                                                                --Product quantity (e.g., 150.0 g, 680.0 g).
                                                                --Portion count (e.g., 20 fingers, 10 discs, 1
                                                                 base).
                                                                --Portion mass (e.g., 15.0 g/finger, 10.0g/
                                                                 brick).
                                                                --Portion length (e.g., 40.0 mm, 100.0 mm).
                                                                --Portion width (e.g., 10.0 mm, 40.0 mm).
                                                                --Portion thickness (e.g., 10.0 mm, 40.0 mm).
                                                                --Source of energy (e.g., charcoal, battery,
                                                                 electrical).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 apple).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (4) Waterpipe Component  --Package type (e.g., bag, box, none).
                                                                --Product quantity (e.g., 1 base, 1 bowl, 1
                                                                 hose, 10 mouthpieces).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cherry).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (5) Waterpipe Other....  --Package type (e.g., bag, box, none).
                                                                --Product quantity (e.g., 1 base, 1 bowl, 1
                                                                 hose, 10 mouthpieces).
                                                                --Characterizing flavor(s) (e.g., none, cherry).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).

[[Page 996]]

 
(H) Heated Tobacco Products (HTP)....  (1) Closed HTP.........  --Package type (e.g., box, none, plastic
                                                                 clamshell).
                                                                --Product quantity (e.g., 1 device, 1 HTP).
                                                                --Length (e.g., 100.0 mm, 120.0 mm).
                                                                --Diameter (e.g., 6.0 mm, 8.1 mm).
                                                                --Wattage (e.g., 100 W, 200 W).
                                                                --Battery capacity (e.g., 100 mAh, 200 mAh).
                                                                --Characterizing flavor(s) (e.g., none).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (2) Open HTP...........  --Package type (e.g., box, none, plastic
                                                                 clamshell).
                                                                --Product quantity (e.g., 1 device, 1 HTP).
                                                                --Length (e.g., 100.0 mm, 120.0 mm).
                                                                --Diameter (e.g., 6.0 mm, 8.1 mm).
                                                                --Wattage (e.g., 100 W, 200 W).
                                                                --Battery capacity (e.g., 100 mAh, 200 mAh).
                                                                --Characterizing flavor(s) (e.g., none).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (3) HTP Consumable.....  --Package type (e.g., hard pack, soft pack,
                                                                 plastic clamshell).
                                                                --Product quantity (e.g., 20 sticks, 25
                                                                 cartridges).
                                                                --Length (e.g., 60.0 mm, 82.0 mm).
                                                                --Diameter (e.g., 6.0 mm, 8.1 mm).
                                                                --Ventilation (e.g., none, 10.0%, 25.0%).
                                                                --Characterizing flavor(s) (e.g., none,
                                                                 menthol).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (4) HTP Component......  --Package type (e.g., box, none, plastic
                                                                 clamshell).
                                                                --Product quantity (e.g., 1 mouthpiece, 1
                                                                 spacer).
                                                                --Characterizing flavor(s) (e.g., none, tobacco,
                                                                 menthol).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (5) Other..............  --Package type (e.g., box, bag, plastic
                                                                 clamshell, none).
                                                                --Product quantity (e.g., 1 base, 5 capsules).
                                                                --Characterizing flavor(s) (e.g., none, tobacco,
                                                                 menthol, cherry).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
(I) Other............................  (1) Other..............  --Package type (e.g., box, bag, plastic
                                                                 clamshell, none).
                                                                --Product quantity (e.g., 1 base, 5 capsules).
                                                                --Characterizing flavor(s) (e.g., none, tobacco,
                                                                 menthol, cherry).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
----------------------------------------------------------------------------------------------------------------

    (4) The type of PMTA (i.e., PMTA, supplemental PMTA, or 
resubmission);
    (5) Whether the applicant requests that FDA refer the PMTA to the 
Tobacco Products Scientific Advisory Committee (TPSAC);
    (6) Identifying information regarding any prior submissions 
regarding the tobacco product (e.g., submissions related to 
investigational tobacco products, substantial equivalence reports, 
PMTAs), including submission tracking numbers (STNs) where applicable;
    (7) Dates and purpose of any prior meetings with FDA regarding the 
new tobacco product;
    (8) If applicable, the dates when the tobacco product was 
commercially marketed in the United States;
    (9) Address and the Facility Establishment Identifier (FEI) 
number(s), if available, of the establishment(s) involved in the 
manufacture of the new tobacco product;
    (10) A brief statement regarding how the PMTA satisfies the content 
requirements of section 910(b)(1) of the Federal Food, Drug, and 
Cosmetic Act;
    (11) A brief description of how marketing of the new tobacco product 
would be appropriate for the protection of the public health; and
    (12) A list identifying all enclosures, labels, and labeling being 
submitted with the application.
    (d) Descriptive information. The application must contain 
descriptive information in this section that outlines

[[Page 997]]

the major aspects of the new tobacco product, including the following 
items:
    (1) A concise description of the new tobacco product;
    (2) A statement identifying all tobacco product standards issued 
under section 907 of the Federal Food, Drug, and Cosmetic Act that are 
applicable to the new tobacco product and a brief description of how the 
new tobacco product fully meets any identified tobacco product standard, 
or if the new tobacco product deviates from a product standard, if 
applicable, the application must include adequate information to 
identify and justify those deviations;
    (3) The name(s) of the product as designated on the product's label;
    (4) A description of problems that were identified in prototypes 
that are the subject of studies in the application and previous or 
similar versions of the new tobacco product that were marketed, if any. 
If there are previous or similar versions that are the subject of 
studies in the application or were marketed, the application must 
contain a bibliography of all reports regarding the previous or similar 
version of the product, whether adverse or supportive; and
    (5) Any restrictions on the sale, distribution, advertising, or 
promotion of the new tobacco product that the applicant proposes to be 
included as part of a marketing granted order under section 910(c)(1)(B) 
of the Federal Food, Drug, and Cosmetic Act to help support a showing 
that the marketing of the product is appropriate for the protection of 
the public health. If there are no proposed restrictions, the 
application must contain a statement to that effect.
    (e) Samples of new tobacco products. After FDA accepts a PMTA for 
review, it may require the submission of samples of the new tobacco 
product, including its components and parts. If required, the applicant 
must submit samples of the finished tobacco product or its components or 
parts in accordance with instructions provided by FDA. FDA may also 
require the submission of additional samples to further aid in its 
review.
    (f) Labeling and description of marketing plans--(1) Labeling. The 
application must contain specimens of all proposed labeling for the new 
tobacco product, including labels, inserts, onserts, instructions, and 
other accompanying information. The specimens of labeling must include 
all panels, reflect the actual size and color proposed to be used for 
the tobacco product, and include any warning label statements and other 
information required by regulation or statute, as applicable.
    (2) Description of Marketing Plans. A PMTA must contain a 
description of the applicant's plans to market the new tobacco product, 
for at least the first year the product would be marketed after 
receiving a marketing granted order, in way that is both consistent with 
the applicant's discussion of the increased or decreased likelihood of 
changes in tobacco product use behavior, including switching, 
initiation, cessation, and polyuse, under Sec. 1114.7(l), and permits 
FDA to determine permitting the new tobacco product to be marketed would 
be appropriate for the protection of public health. The description must 
include actions to market the product that would be taken by the 
applicant, on behalf of the applicant, or at the applicant's direction, 
and also discuss any restrictions on the sales and distribution the 
applicant proposes to be included in a marketing order under section 
910(c)(1)(B) of the Federal Food Drug and Cosmetic Act. The description 
of marketing plans must contain, at minimum:
    (i) A description of the specific group(s) to which the labeling, 
advertising, marketing, promotion, and other consumer-directed 
activities for the new tobacco product would be targeted (i.e., the 
intended audience(s));
    (ii) A discussion of how the labeling, advertising, marketing, 
promotion, and other consumer-directed activities for the new tobacco 
product would be targeted to reach the intended audience(s) identified 
in paragraph (i) and what other group(s) would foreseeably be exposed to 
those materials and activities as a result;
    (iii) A discussion of, for individuals below the minimum age of 
sale, how access to the new tobacco product would be restricted and 
exposure to the

[[Page 998]]

labeling, advertising, marketing, promotion, and other consumer-directed 
activities would be limited; and
    (iv) A concluding summary describing how the applicant's plans for 
marketing the new tobacco product are consistent with the applicant's 
discussion of the increased or decreased likelihood of changes in 
tobacco product use behavior, including switching, initiation, 
cessation, and polyuse, under Sec. 1114.7(l) and permits FDA to 
determine permitting the new tobacco product to be marketed would be 
appropriate for the protection of public health.
    (g) Statement of compliance with 21 CFR part 25. (1) The application 
must contain an environmental assessment prepared in accordance with 
Sec. 25.40 of this chapter, or a valid claim of categorical exclusion, 
if applicable. If the applicant believes that the action qualifies for 
an available categorical exclusion, the applicant must state under Sec. 
25.15(a) and (d) of this chapter that the action requested qualifies for 
a categorical exclusion, citing the particular exclusion that is 
claimed, and that to the applicant's knowledge, no extraordinary 
circumstances exist under Sec. 25.21 of this chapter.
    (h) Summary. The application must include a summary of all 
information contained in the application. The summary must include the 
following items, highlighting the effects on youth, young adults, and 
other relevant vulnerable populations:
    (1) A summary of the product formulation section of the application;
    (2) A summary of the manufacturing section of the application;
    (3) A summary of the health risk investigations section of the 
application, including all information regarding the following items, 
and identify areas in which there is a lack of information, where 
applicable:
    (i) The health risks of the tobacco product to both users and 
nonusers of the product and whether the tobacco product may present less 
health risk than other tobacco products;
    (ii) The impact the product and its marketing will have on the 
likelihood of changes in tobacco use behavior, including cessation, 
switching, and polyuse, of tobacco product users;
    (iii) The impact the product and its marketing will have on the 
likelihood of tobacco use initiation by tobacco product nonusers;
    (iv) How users and nonusers perceive the risk of the tobacco product 
based upon its label, labeling, and advertising, to the extent that 
advertising has been studied;
    (v) Whether users are able to understand the labeling and 
instructions for use, and use the product in accordance with those 
instructions; and
    (vi) The impact of human factors on the health risks to product 
users and nonusers (as described in paragraph (k)(1)(v) of this 
section);
    (4) A concluding discussion describing how the data and information 
contained in the PMTA both constitute valid scientific evidence and 
establish that permitting marketing of the new tobacco product is 
appropriate for the protection of the public health, as determined with 
respect to the risks and benefits to the population as a whole, 
including users and nonusers of the tobacco product. This discussion 
must specifically describe the effects on youth, young adults, and other 
relevant vulnerable populations with an emphasis on populations that are 
most likely to use the new tobacco product. The summary must also 
identify any key or pivotal studies on which an applicant is relying to 
establish that permitting the marketing of the new tobacco product would 
be APPH.
    (i) Product formulation. The application must contain a full 
statement of the components or parts, materials, ingredients, additives, 
constituents, properties, and the principle or principles of operation, 
of the tobacco product, including the following information:
    (1) Components or parts, materials, ingredients, additives, and 
constituents. The applicant must provide a full statement of:
    (i) Components or parts. The quantity, function, and purpose of, 
and, where applicable, target specification(s) of, each component or 
part in the product. Where the tobacco product contains software 
components, the applicant must provide:
    (A) A description of the software or technology (e.g., Bluetooth);

[[Page 999]]

    (B) The purpose of the software or technology, such as monitoring 
where tobacco products are located, activated, or used;
    (C) A description of the data collected by the software and how it 
will be used.
    (ii) Materials. For each material in the product, include:
    (A) The material name and common name(s), if applicable;
    (B) The component or part of the tobacco product where the material 
is located;
    (C) The subcomponent or subpart where the material is located, if 
applicable;
    (D) The function of the material;
    (E) The quantities (including ranges or means and acceptance limits) 
of the material(s) in the new tobacco product (with any specification 
variation, if applicable);
    (F) The specification(s) (including quality/grades and suppliers) 
used for the new tobacco product (including any specification 
variations, if applicable); and
    (G) Any other material properties to fully characterize the new 
tobacco product.
    (iii) Ingredients other than tobacco. For ingredients other than 
tobacco in each component or part of the product, include:
    (A) The International Union of Pure and Applied Chemistry (IUPAC) 
chemical name and common name, if applicable;
    (B) The Chemical Abstracts Service (CAS) number or FDA Unique 
Ingredient Identifier (UNII), if applicable;
    (C) The function of the ingredient;
    (D) The quantity of the ingredient in the tobacco product, with the 
unit of measure (including ranges or means and acceptance limits) 
reported as mass per gram of tobacco for nonportioned tobacco products 
and as mass per portion for portioned tobacco products (with any 
specification variation, if applicable);
    (E) The specification(s) (including purity or grade and supplier); 
and
    (F) For complex purchased ingredients, each single chemical 
substance reported separately.
    (iv) Tobacco ingredients. For tobacco ingredients in each component 
or part, include the following information or, if applicable, a 
statement that the product does not contain tobacco ingredients:
    (A) The type(s) (e.g., Bright, Burley, reconstituted);
    (B) The quantity with the unit of measure (including ranges or 
means, acceptance limits) of each tobacco ingredient in the tobacco 
product reported as mass per gram of tobacco for nonportioned tobacco 
products and as mass per portion for portioned tobacco products (with 
any specification variation, if applicable);
    (C) The specification of tobacco used for the new tobacco product 
(with any specification variation, if applicable); and
    (D) A description of any genetic engineering of the tobacco that 
impacts product characteristics.
    (v) Constituents. Constituents, including HPHCs and other 
constituents, contained within, or emitted from (including its smoke or 
aerosol), the product, including any reaction product from leaching or 
aging, by providing:
    (A) The constituent names in alphabetical order;
    (B) The common name(s);
    (C) The Chemical Abstract Services number;
    (D) The mean quantity and variance with unit of measure;
    (E) The number of samples and measurement replicates for each 
sample;
    (F) A description of method procedure, method validation information 
and rationale for selecting each test method;
    (G) The name and location of the testing laboratory or laboratories 
and documentation showing that the laboratory or laboratories is (or 
are) accredited by a nationally or internationally recognized external 
accreditation organization;
    (H) Length of time between dates of manufacture and date(s) of 
testing;
    (I) Storage conditions of the tobacco product before it was tested;
    (J) Test data including test protocols, any deviation(s) from the 
test protocols, quantitative acceptance (pass/fail) criteria, and line 
data for all testing performed. Test data for combusted or inhaled 
products must reflect testing conducted using both intense

[[Page 1000]]

and nonintense smoking or aerosol-generating regimens, where 
established; and
    (K) Complete descriptions of any smoking or aerosol-generating 
regimens used for analytical testing that are not standardized or widely 
accepted by the scientific community, if applicable.
    (vi) Container closure system. A description of the container 
closure system, including:
    (A) Information describing how the container closure system protects 
and preserves the product from damage during transport, environmental 
contaminants, and potential leaching and migration of packaging 
constituents into the new tobacco product; and
    (B) Information describing design features developed to prevent the 
risk of accidental exposure, if any.
    (vii) Statement of tobacco blending, reconstitution, or 
manipulation. Information regarding tobacco blending, reconstitution, or 
manipulation, where applicable.
    (2) Other properties. The applicant must provide a full description 
of the additional properties of the tobacco product that includes:
    (i) Product dimensions and construction. The product dimensions and 
the overall construction of the product using a diagram or schematic 
drawing that clearly depicts the finished tobacco product and its 
components with dimensions, operating parameters, and materials.
    (ii) Design parameters and test data. (A) All final design 
parameters of the product, specifying nominal values or the explicit 
range of values as well as the design tolerance (where appropriate), 
including, but not limited to, the parameters specified in tables 1 to 
22 of this paragraph as applicable. If a design parameter specified in 
tables 1 to 22 does not apply to the tobacco product, applicants must 
explain why the required design parameter does not apply or how an 
alternative design parameter would satisfy the required design 
parameter. If the product has additional design parameters that are not 
specified in tables 1 to 22, the application must contain a description 
of the design specifications as well as test data and processes to 
demonstrate that the design parameters and their associated processes 
are adequately controlled; and
    (B) A quantitative description of the performance criteria, 
including test protocols, line data, and a summary of the results, for 
each applicable intermediate and final design parameter and 
manufacturing step, that includes, but is not limited to the test data 
specified in tables 1 to 22 of this paragraph for the product category 
as applicable. If the test data specified in the applicable table does 
not apply to the tobacco product, applicants must explain why the test 
data does not apply or how alternative test data would satisfy this 
requirement. Where tobacco cut size or particle size is a required 
design parameter for a product category or subcategory and the target 
specifications and range limits are not available, the following 
alternative information may be submitted in place of this information: a 
description of the tobacco cutting process (including a complete 
description of the milling, cutting, and sifting process; the control 
parameters of the miller or cutter; and any sift specifications), or the 
measured particle size distribution;

 Table 2 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                             for Cigarettes
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Cigarette length (mm).    Tobacco
                                             filler mass (mg).
 Cigarette circumference   Tobacco
 or diameter (mm).                           rod density (g/cm\3\).
 Tobacco filler mass       Tobacco
 (mg).                                       cut size (mm or CPI).
 Tobacco rod density (g/   Tobacco
 cm\3\).                                     moisture or oven volatiles
                                             (%).
 Tobacco cut size (mm or   Cigarette
 CPI).                                       paper base paper porosity
                                             (permeability) (CU).
 Tobacco moisture or       Cigarette
 oven volatiles (%).                         paper band porosity or
                                             permeability (CU) or
                                             Cigarette paper band
                                             diffusivity (cm\2\/s).
 Cigarette paper length    Filter
 (mm).                                       pressure drop (mm H2O).
 Cigarette paper base
 paper porosity (permeability) (CU).

[[Page 1001]]

 
 Cigarette paper band      Filter
 porosity (permeability) (CU)                efficiency (%) (If no
 [alternatively, band diffusivity (cm\2\/    filter efficiency data is
 s)] (if applicable).                        available for the products,
                                             include information
                                             sufficient to show that the
                                             cigarette filter is
                                             unchanged (e.g., denier per
                                             filament, total denier, and
                                             filter density)).
 Cigarette paper band      Filter
 width (mm).                                 ventilation (%).
 Cigarette paper band
 space (mm).
 Filter length (mm).
 Filter pressure drop
 (mm H2O).
 Filter efficiency (%)
 (If no filter efficiency data is
 available for the products, include
 information sufficient to show that the
 cigarette filter is unchanged (e.g.,
 denier per filament, total denier, and
 filter density)).
 Tipping paper length
 (mm).
 Filter ventilation (%).
------------------------------------------------------------------------


 Table 3 to Paragraph (i)(2)(ii)--Required Design Parameter Information
        for Portioned and Nonportioned Smokeless Tobacco Products
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
                  Portioned Smokeless Tobacco Products
------------------------------------------------------------------------
 Tobacco cut size (mm or   Tobacco
 CPI) or tobacco particle size (mm or        cut size (mm or CPI) or
 micron).                                    tobacco particle size (mm
                                             or micron).
 Tobacco moisture (%).     Tobacco
                                             moisture (%).
 Portion length (mm).      Portion
                                             mass (mg).
 Portion width (mm).       Pouch
                                             material basis weight (g/
                                             m\2\) (if applicable).
 Portion mass (mg).        Pouch
                                             material porosity (CU)
                                             (permeability) (L/m\2\/s).
 Portion material          Nicotine
 thickness (mm) (if applicable).             dissolution rate (%/min).
 Pouch material basis
 weight (g/m\2\) (if applicable).
 Pouch material porosity
 (permeability) (CU or L/m\2\/s) (if
 applicable).
 Nicotine dissolution
 rate (%/min).
------------------------------------------------------------------------
                 Nonportioned Smokeless Tobacco Products
------------------------------------------------------------------------
 Tobacco cut size (mm or   Tobacco
 CPI) or tobacco particle size (mm or        cut size (mm or CPI) or
 micron)                                     tobacco particle size (mm
                                             or micron).
 Tobacco moisture (%)      Tobacco
                                             moisture (%).
------------------------------------------------------------------------


 Table 4 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                     for RYO Tobacco Rolling Papers
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Roll-your-own (RYO)       RYO mass
 paper length (mm).                          per paper (mg).
 RYO paper width (mm).     RYO paper
                                             base paper basis weight (g/
                                             m\2\).
 RYO mass per paper        RYO paper
 (mg).                                       base paper porosity
                                             (permeability) (CU).
 RYO paper base paper      RYO paper
 basis weight (g/m\2\).                      band porosity
                                             (permeability) (CU) or
                                             [alternatively, RYO paper
                                             band diffusivity (cm\2\/s)]
                                             (if applicable).
 RYO paper base paper
 porosity (permeability) (CU).
 RYO paper band porosity
 (permeability) (CU) or [alternatively,
 RYO paper band diffusivity (cm\2\/s)] (if
 applicable).
 RYO paper band width
 (mm) (if applicable).
 RYO paper band space
 (mm) (if applicable).
------------------------------------------------------------------------


[[Page 1002]]


 Table 5 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                          for RYO Tobacco Tubes
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Tube mass (mg).           Tube mass
                                             (mg).
 Tube length (mm).         Tube
                                             paper base paper basis
                                             weight (g/m\2\).
 Tube circumference or     Tube
 diameter (mm).                              paper base paper porosity
                                             (permeability) (CU).
 Tube paper width (mm).    Tube
                                             paper band porosity
                                             (permeability) (CU) (if
                                             applicable) or Tube paper
                                             band diffusivity (cm\2\/s)
                                             (if applicable).
 Tube paper base paper
 basis weight (g/m\2\).
 Tube paper base paper
 porosity (permeability) (CU).
 Tube paper band
 porosity (permeability) (CU) (if
 applicable) or Tube paper band
 diffusivity (cm\2\/s) (if applicable).
 Tube paper band width
 (mm) (if applicable).
 Tube paper band space
 (mm) (if applicable).
------------------------------------------------------------------------


 Table 6 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                     for RYO Tobacco Filtered Tubes
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Tube mass (mg).           Tube
                                             paper base paper basis
                                             weight (g/m\2\).
 Tube length (mm).         Tube
                                             paper base paper porosity
                                             (permeability) (CU).
 Tube circumference or     Tube mass
 diameter (mm).                              (mg).
 Tube paper length (mm).   Tube
                                             paper band porosity
                                             (permeability) (CU) (if
                                             applicable) or Tube paper
                                             band diffusivity (cm\2\/s)
                                             (if applicable).
 Nonfilter tube length     Filter
 (mm).                                       pressure drop (mm H2O).
 Tube paper width (mm).    Filter
                                             efficiency (%) (If no
                                             filter efficiency data is
                                             available for the products,
                                             include information
                                             sufficient to show that the
                                             cigarette filter is
                                             unchanged (e.g., denier per
                                             filament (DPF), total
                                             denier (g/9000m), and
                                             filter density (g/cm\3\))).
 Tube paper base paper     Filter
 basis weight (g/m\2\).                      ventilation (%).
 Tube paper base paper
 porosity (permeability) (CU).
 Tube paper band
 porosity (permeability) (CU) (if
 applicable) or Tube paper band
 diffusivity (cm\2\/s) (if applicable).
 Tube paper band width
 (mm) (if applicable).
 Tube paper band space
 (mm) (if applicable).
 Filter length (mm).
 Filter pressure drop
 (mm H2O).
 Filter efficiency (%)
 (If no filter efficiency data is
 available for the products, include
 information sufficient to show that the
 cigarette filter is unchanged (e.g.,
 denier per filament (DPF), total denier
 (g/9000m), and filter density (g/
 cm\3\))).
 Tipping paper length
 (mm).
 Filter ventilation (%).
------------------------------------------------------------------------


 Table 7 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                             for RYO Tobacco
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Tobacco cut size (mm or   Tobacco
 CPI).                                       cut size (mm or CPI).
 Tobacco moisture or       Tobacco
 oven volatiles (%).                         moisture or oven volatiles
                                             (%).
------------------------------------------------------------------------


 Table 8 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                       for RYO Tobacco Paper Tips
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 RYO paper tip length      RYO paper
 (mm).                                       base paper basis weight (g/
                                             m\2\).
 RYO paper tip width       RYO paper
 (mm).                                       porosity (permeability)
                                             (CU).
 RYO paper tip mass        RYO paper
 (mg).                                       tip ventilation (%).
 RYO paper base paper
 basis weight (g/m\2\).
 RYO paper porosity
 (permeability) (CU).
 RYO paper tip
 ventilation (%).
------------------------------------------------------------------------


[[Page 1003]]


 Table 9 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                    for Filtered Sheet-Wrapped Cigars
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Cigar mass (mg).          Cigar
                                             mass (mg).
 Cigar wrapper basis       Puff
 weight (g/m\2\).                            count.
 Cigar binder length       Cigar
 (mm).                                       wrapper basis weight (g/
                                             m\2\).
 Cigar binder width        Cigar
 (mm).                                       wrapper porosity
                                             (permeability) (CU).
 Cigar binder basis        Cigar
 weight (g/m\2\)                             binder porosity
                                             (permeability) (CU).
 Cigar length (mm).        Cigar
                                             binder basis weight (g/
                                             m\2\).
 Cigar overall diameter    Tobacco
 (mm).                                       filler mass (mg).
 Cigar minimum diameter    Tobacco
 (mm) if applicable.                         rod density (g/cm\3\).
 Cigar maximum diameter    Tobacco
 (mm) if applicable.                         cut size (CPI or mm).
 Tobacco filler mass       Tobacco
 (mg).                                       moisture or oven volatiles
                                             (%).
 Tobacco rod density (g/   Cigar
 cm\3\).                                     wrapper band porosity
                                             (permeability) (CU)
                                             [alternatively, band
                                             diffusivity (cm\2\/s)](if
                                             applicable).
 Tobacco cut size (CPI     Cigar
 or mm).                                     binder band porosity
                                             (permeability) (CU)
                                             [alternatively, band
                                             diffusivity (cm\2\/s)] (if
                                             applicable).
 Tobacco moisture or       Cigar
 oven volatiles (%).                         minimum diameter (mm) (if
                                             applicable).
 Cigar wrapper porosity    Cigar
 (permeability) (CU).                        maximum diameter (mm) (if
                                             applicable).
 Cigar wrapper length      Filter
 (mm).                                       pressure drop (mm H2O).
 Cigar wrapper width       Filter
 (mm).                                       efficiency (%) (if no
                                             filter efficiency data is
                                             available for the products,
                                             include information
                                             sufficient to show that the
                                             cigar filter is unchanged
                                             [e.g., denier per filament
                                             (DPF), total denier (g/
                                             9000m), and filter density
                                             (g/cm\3\)]{time} .
 Cigar wrapper band        Filter
 porosity (permeability) (CU) (if            ventilation (%).
 applicable).
 Cigar wrapper band
 width (mm) (if applicable).
 Cigar wrapper band
 space (mm) (if applicable).
 Cigar binder porosity
 (permeability) (CU).
 Cigar binder band
 porosity (permeability) (CU) (if
 applicable).
 Cigar binder band width
 (mm) (if applicable).
 Cigar binder band space
 (mm) (if applicable).
 Filter length (mm).
 Filter diameter (mm).
 Filter pressure drop
 (mm H2O).
 Filter efficiency (%)
 {If no filter efficiency data is
 available for the products, include
 information sufficient to show that the
 cigar filter is unchanged [e.g., denier
 per filament (DPF), total denier (g/
 9000m), and filter density(g/
 cm\3\)]{time} .
 Tipping paper length
 (mm).
 Filter ventilation (%).
------------------------------------------------------------------------


 Table 10 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                   for Unfiltered Sheet-Wrapped Cigars
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Cigar mass (mg).          Puff
                                             count.
 Cigar length (mm).        Cigar
                                             mass (mg).
 Cigar overall diameter    Tobacco
 (mm).                                       rod density (g/cm\3\).
 Cigar minimum diameter    Tobacco
 (mm) (if applicable).                       cut size (CPI or mm).
 Cigar maximum diameter    Tobacco
 (mm) (if applicable).                       moisture or oven volatiles
                                             (%).
 Tobacco rod density (g/   Tobacco
 cm\3\).                                     filler mass (mg).
 Tobacco moisture or       Cigar
 oven volatiles (%).                         minimum diameter (mm) (if
                                             applicable).
 Tobacco cut size (CPI     Cigar
 or mm).                                     maximum diameter (mm) (if
                                             applicable).
 Tobacco filler mass       Cigar
 (mg).                                       wrapper porosity
                                             (permeability) (CU).
 Cigar wrapper porosity    Cigar
 (permeability) (CU).                        wrapper basis weight (g/
                                             m\2\).
 Cigar wrapper length      Cigar
 (mm).                                       binder basis weight (g/
                                             m\2\).
 Cigar wrapper width       Cigar
 (mm).                                       binder porosity
                                             (permeability) (CU).
 Cigar wrapper basis       Cigar tip
 weight (g/m\2\).                            mass (mg) (if applicable).
 Cigar binder porosity     Cigar
 (permeability) (CU).                        wrapper band porosity
                                             (permeability) (CU)
                                             [alternately, band
                                             diffusivity (cm2/s)] (if
                                             applicable).
 Cigar binder width (mm)   Cigar
                                             binder band porosity
                                             (permeability) (CU)
                                             [alternately, band
                                             diffusivity (cm2/s)] (if
                                             applicable).
 Cigar binder basis
 weight (g/m\2\).
 Cigar tip length (mm)
 (if applicable).
 Cigar tip inner
 diameter (mm) (if applicable).
 Cigar tip mass (mg) (if
 applicable).
 Cigar wrapper band
 space (mm) (if applicable).

[[Page 1004]]

 
 Cigar wrapper band
 width (mm) (if applicable).
 Cigar binder band width
 (mm) (if applicable).
 Cigar binder band space
 (mm) (if applicable).
 Cigar wrapper band
 porosity or permeability (CU)
 [alternately, band diffusivity (cm2/s)]
 (if applicable).
 Cigar binder band
 porosity (permeability) (CU)
 [alternately, band diffusivity (cm2/s)]
 (if applicable).
------------------------------------------------------------------------


 Table 11 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                         for Leaf-Wrapped Cigars
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Cigar mass (mg).          Puff
                                             count.
 Cigar length (mm).        Cigar
                                             mass (mg).
 Overall diameter (mm).    Cigar
                                             minimum diameter (mm).
 Cigar minimum diameter    Cigar
 (mm).                                       maximum diameter (mm).
 Cigar maximum diameter    Cigar
 (mm).                                       wrapper basis weight (g/
                                             m\2\).
 Tobacco moisture or       Cigar
 oven volatiles (%).                         binder basis weight (g/
                                             m\2\).
 Tobacco filler mass       Tobacco
 (mg).                                       filler mass (mg).
 Tobacco rod density (g/   Tobacco
 cm\3\).                                     rod density (g/cm\3\).
 Tobacco cut size (CPI     Tobacco
 or mm).                                     cut size (CPI or mm).
 Tobacco moisture or       Tobacco
 oven volatiles (%).                         moisture or oven volatiles
                                             (%).
 Cigar wrapper length
 (mm).
 Cigar wrapper width
 (mm).
 Cigar wrapper basis
 weight (g/m\2\).
 Cigar binder width
 (mm).
 Cigar binder basis
 weight (g/m\2\).
------------------------------------------------------------------------


 Table 12 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                            for Cigar Tobacco
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Tobacco cut size (CPI     Tobacco
 or mm)                                      cut size (CPI or mm).
 Tobacco moisture or       Tobacco
 oven volatiles (%)                          moisture or oven volatiles
                                             (%).
------------------------------------------------------------------------


 Table 13 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                           for Cigar Wrappers
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Cigar wrapper length      Cigar
 (mm).                                       wrapper length (mm).
 Cigar wrapper width       Cigar
 (mm).                                       wrapper width (mm).
 Cigar wrapper basis       Cigar
 weight (g/cm\2\).                           wrapper basis weight (g/
                                             cm\2\).
------------------------------------------------------------------------


 Table 14 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                             for Waterpipes
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Hose length (mm).         Hose
                                             length (mm).
 Hose materials.           Hose
                                             internal diameter (mm).
 Hose internal diameter    Stem
 (mm).                                       length (mm).
 Stem length (mm).         Stem
                                             internal diameter (mm).
 Stem internal diameter    Base
 (mm).                                       diameter (mm).
 Base diameter (mm).       Base
                                             volume (cm\3\).
 Base volume (cm\3\).      Pressure
                                             drop (mm H2O).
 Base shape.               Water
                                             filter efficiency (%).

[[Page 1005]]

 
 Pressure drop (mm H2O).   Head
                                             height (mm).
 Water filter efficiency   Head top
 (%).                                        diameter (mm).
 Hose air permeability     Head
 (CU).                                       bottom diameter (mm).
 Head height (mm).         Head
                                             volume (mm\3\).
 Head top diameter (mm).
 Head bottom diameter
 (mm).
 Number of holes.
 Head volume (mm\3\).
 Heating source type.
 Head materials.
------------------------------------------------------------------------


 Table 15 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                          for Waterpipe Tobacco
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Tobacco cut size (CPI     Tobacco
 or mm).                                     cut size (CPI or mm).
 Tobacco moisture or       Tobacco
 oven volatiles (%).                         moisture or oven volatiles
                                             (%).
------------------------------------------------------------------------


 Table 16 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                      for Waterpipe Heating Sources
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Heating element           Heating
 temperature range ( [deg]C).                element temperature range (
                                             [deg]C).
 Heating element mass      Heating
 (mg).                                       element mass (mg).
 Heating element density   Heating
 (g/cm\3\).                                  element density (g/cm\3\).
 Heating element           Heating
 resistance (ohms) (if applicable).          element resistance (ohms)
                                             (if applicable).
 Number of heating         Heating
 elements.                                   element diameter (gauge).
 Heating element           Battery
 configuration.                              current rating (mA) (if
                                             applicable).
 Heating element           Battery
 diameter (gauge) (if applicable).           capacity (mAh) (if
                                             applicable).
 Battery current rating    Battery
 (mA) (if applicable).                       voltage operating range
                                             (volts) (if applicable).
 Battery capacity (mAh)    Battery
 (if applicable)                             current operating range
                                             (amps) (if applicable).
 Battery voltage           Power
 operating range (volts) (if applicable).    delivery unit (PDU)
                                             temperature cut-off (
                                             [deg]C) (if applicable).
 Battery current           Power
 operating range (amps) (if applicable).     delivery unit (PDU) voltage
                                             operating range (volts) (if
                                             applicable).
 Power delivery unit       PDU
 (PDU) temperature cut-off ( [deg]C) (if     current operating range
 applicable).                                (amps) (if applicable).
 Power delivery unit       PDU
 (PDU) voltage operating range (volts) (if   wattage operating range
 applicable).                                (watts) (if applicable).
 PDU current operating
 range (amps) (if applicable).
 PDU wattage operating    ............................
 range (watts) (if applicable).
------------------------------------------------------------------------


 Table 17 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                           for Waterpipe Foil
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Foil length (mm) (for     Foil
 square or rectangular shape foil).          length (mm) (for square or
                                             rectangular shape foil).
 Foil width (mm) (for      Foil
 square or rectangular shape foil).          width (mm) (for square or
                                             rectangular shape foil).
 Diameter (mm) (for        Diameter
 circular shape foil).                       (mm) (for circular shape
                                             foil).
 Foil thickness (mm).      Foil
                                             thickness (mm).
 Number of holes.          Diameter
                                             of the holes (mm).
 Diameter of the holes    ............................
 (mm).
------------------------------------------------------------------------


[[Page 1006]]


 Table 18 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                           for Waterpipe Head
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Head height (mm),         Head
                                             height (mm).
 Head top diameter (mm),   Head top
                                             diameter (mm).
 Head bottom diameter      Head
 (mm),                                       bottom diameter (mm).
 Number of holes,          Head
                                             volume (mm\3\).
 Head volume (mm\3\),
 Head materials,          ............................
------------------------------------------------------------------------


 Table 19 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                                for Pipes
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Bowl chamber cover        Bowl
 outer diameter (mm).                        chamber volume (cm\3\).
 Bowl chamber cover        Pipe
 inner diameter (mm).                        pressure drop (mm H2O).
 Draught hole diameter     Air flow
 (mm).                                       through air valve (cc/min).
 Screen (if applicable).   Airway
                                             volume (cm\3\).
 Draught hole shape.       Filter
                                             pressure drop (mm H2O).
 Draught hole location.    Filter
                                             efficiency (%) {If no
                                             filter efficiency data is
                                             available for the products,
                                             include information
                                             sufficient to show that the
                                             cigar filter is unchanged
                                             [e.g., denier per filament
                                             (DPF), total denier (g/
                                             9000m), and filter
                                             density(g/cm\3\)]{time} .
 Bowl chamber hole
 shape.
 Bowl chamber volume
 (cm\3\)
 Airway volume (cm\3\)
 Stem length (mm).
 Stem diameter (mm).
 Shank length (mm).
 Shank diameter (mm).
 Draught hole dimension.
 Pressure drop through
 air valve (mm H2O).
 Air flow through air
 valve (cc/min).
 Filter efficiency (%)
 {If no filter efficiency data is
 available for the products, include
 information sufficient to show that the
 cigar filter is unchanged [e.g., denier
 per filament (DPF), total denier (g/
 9000m), and filter density(g/
 cm\3\)]{time} .
 Filter pressure drop
 (mm H2O).
 Filter length (mm).      ............................
------------------------------------------------------------------------


 Table 20 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                            for Pipe Tobacco
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Tobacco cut size (CPI     Tobacco
 or mm).                                     cut size (CPI or mm).
 Tobacco moisture or       Tobacco
 oven volatiles (%).                         moisture or oven volatiles
                                             (%).
------------------------------------------------------------------------


 Table 21 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                                for ENDS
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Draw resistance (mm      ............................
 H2O).
 Puff count (for full      Draw
 tank/cartridge).                            resistance (mm H2O).
 Atomizer tank/cartridge   Puff
 volume (mL).                                count (for full tank/
                                             cartridge).
 Number of heating         Atomizer
 elements (e.g., coil).                      tank/cartridge volume (mL).
 Heating Element           Heating
 diameter (gauge).                           Element diameter (gauge).
 Heating Element length    Heating
 (mm).                                       Element resistance (Ohms).
 Heating Element           Heating
 resistance (Ohms).                          Element temperature range (
                                             [deg]C).
 Heating Element           Battery
 temperature range ( [deg]C).                voltage operating range
                                             (V).
 Heating Element           Battery
 configuration (target only).                current operating range
                                             (mA).
 Battery voltage           PDU
 operating range (V).                        voltage operating range
                                             (V).
 Battery current           PDU
 operating range (mA).                       current operating range
                                             (mA).
 Battery Capacity (mAh).   PDU
                                             wattage operating range
                                             (watts).

[[Page 1007]]

 
 Battery Nominal Voltage   PDU
 (V).                                        Current cut-off (mA) (if
                                             applicable).
 Battery Current rating    PDU
 (mA).                                       temperature cut-off (
                                             [deg]C) (if applicable).
 Battery charging          Battery
 temperature limits ( [deg]C).               Capacity (mAh).
 Battery discharge         Battery
 temperature limits ( [deg]C).               Nominal Voltage (V).
 Battery end of            Battery
 discharge voltage (V).                      Current rating (mA).
 Battery maximum           Battery
 charging current (mA).                      charging temperature limits
                                             ( [deg]C).
 Battery maximum           Battery
 discharging current (mA).                   discharge temperature
                                             limits ( [deg]C).
 Battery upper limits      Battery
 charging voltage (V).                       maximum charging current
                                             (mA).
 Power Delivery Unit       Battery
 (PDU) voltage operating range (V).          maximum discharging current
                                             (mA).
 PDU current operating     Battery
 range (mA).                                 upper limits charging
                                             voltage (V).
 PDU wattage operating     Inhaled
 range (watts).                              aerosol temperature (
                                             [deg]C).
 PDU temperature cut-off   Airflow
 ( [deg]C) (if applicable).                  rate (L/min) (if
                                             applicable).
 Airflow rate (L/min)     
 (if applicable).                            Ventilation (%).
 PDU Current cut-off
 (mA) (if applicable).
 PDU Temperature cut-off
 ( [deg]C) (if applicable).
 Inhaled aerosol
 temperature ( [deg]C).
 Ventilation (%).         ............................
------------------------------------------------------------------------


 Table 22 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                              for E-liquids
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 E-liquid viscosity (at    E-liquid
 20 [deg]C).                                 viscosity (at 20 [deg]C).
 E-liquid volume (ml).     E-liquid
                                             volume (ml).
 Particle number           Particle
 concentration (/cm\3\).                    number concentration (/
                                             cm\3\).
 Count median diameter     Count
 (nm).                                       median diameter (nm).
 PM2.5 ([micro]g/m\3\).    PM2.5
                                             ([micro]g/m\3\).
------------------------------------------------------------------------


 Table 23 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                    for Heated Tobacco Products (HTP)
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Overall Product.          Overall
                                             Product.
    [cir] Mass (mg).                         [cir] Draw resistance (mm
                                             H2O).
    [cir] Length (mm).                       [cir] Puff count (for full
                                             tank/cartridge).
    [cir] Width (mm).                        [cir] Product volume (mL).
    [cir] Height (mm).                       [cir] Airflow rate (L/min)
                                             (if applicable).
    [cir] Diameter (mm).                     [cir] Ventilation (%).
    [cir] Draw resistance (mm H20).          [cir] Operational
                                             Temperature ( [deg]C).
    [cir] Puff Count (for full tank/         [cir] Temperature sensor
     cartridge).                             (if applicable).
    [cir] Puff volume (mL).                  [cir] Material wrapper
                                             length (mm) (if
                                             applicable).
    [cir] Product volume (mL).               [cir] Material wrapper
                                             width (mm) (if applicable).
    [cir] Airflow rate (L/min) (if           [cir] Material wrapper
     applicable).                            basis weight (g/m\2\) (if
                                             applicable).
    [cir] Ventilation (%).                   [cir] Material porosity
                                             (permeability) (CU) (if
                                             applicable).
    [cir] Operational Temperature (          Heating
     [deg]C).                                element.
    [cir] Temperature sensor (if             [cir] Heating Element
     applicable).                            diameter (gauge).
    [cir] Material wrapper length (mm) (if   [cir] Heating Element
     applicable).                            resistance (Ohms).
    [cir] Material wrapper width (mm) (if    [cir] Heating Element
     applicable).                            temperature range (
                                             [deg]C).
    [cir] Material wrapper basis weight (g/  E-liquid.
     m\2\) (if applicable).
    [cir] Material porosity (permeability)   [cir] E-liquid viscosity
     (CU) (if applicable).                   (at 20 [deg]C).
 Heating element.          [cir] E-liquid volume (ml).
    [cir] Heating element source/type/       Tobacco
     approach (electrical, carbon,           (if applicable).
     aerosol, etc.).
    [cir] Heating element temperature        [cir] Tobacco moisture (%).
     range ( [deg]C).
    [cir] Heating element operational        [cir] Tobacco cut size (CPI
     temperature ( [deg]C).                  or mm).
    [cir] Heating element maximum            [cir] Tobacco density (g/
     temperature (boost temperature) (       cm\3\)
     [deg]C).
    [cir] Heating element material.          Battery.
    [cir] Heating element Configuration
     (i.e., the shape and design of the
     heating element. If the heating
     element is a coil, it is the shape
     and arrangement of the coil. If the
     heating element is a novel design,
     provide the configuration and its
     design targets.).

[[Page 1008]]

 
    [cir] Heating element length (mm).
    [cir] Heating element mass (mg).
    [cir] Heating element location.
    [cir] Number of heating elements         [cir] Battery voltage
     (e.g., coil) (dimensionless).           operating range (V).
    [cir] Heating Element diameter (gauge)   [cir] Battery current
     (if applicable).                        operating range (mA).
    [cir] Heating Element resistance         [cir] PDU voltage operating
     (Ohms) (if applicable).                 range (V).
 Tobacco/E-liquid.         [cir] PDU current operating
                                             range (mA) PCO wattage
                                             operating range (W).
    [cir] Tobacco mass (mg) (if
     applicable).
    [cir] Tobacco density (g/cm\3\) (if      [cir] PDU Current cut-off
     applicable).                            (mA) (if applicable).
    [cir] Tobacco moisture or oven           [cir] PDU temperature cut-
     volatiles (%) (if applicable).          off ( [deg]C).
    [cir] Tobacco cut size (CPI or mm) (if   [cir] Battery Capacity
     applicable).                            (mAh).
    [cir] E-liquid volume (mL) (if           [cir] Battery Nominal
     applicable).                            Voltage (V).
    [cir] E-liquid viscosity (at 20          [cir] Battery Current
     [deg]C) (if applicable).                rating (mA).
 Battery (if               [cir] Battery charging
 applicable).                                temperature limits (
                                             [deg]C).
    [cir] Battery capacity (mA).             [cir] Battery discharge
                                             temperature limits (
                                             [deg]C).
    [cir] Battery Voltage Operating Range    [cir] Battery maximum
     (V) or Wattage (W).                     charging current (mA).
    [cir] Battery Current Charging range     [cir] Battery maximum
     (amps).                                 discharging current (mA).
    [cir] Battery Nominal Voltage (V).       [cir] Battery upper limits
                                             charging voltage (V).
    [cir] Battery Current rating (mA).       Aerosol.
    [cir] Battery charging temperature
     limits ( [deg]C).
    [cir] Battery discharge temperature
     limits ( [deg]C).
    [cir] Battery end of discharge voltage   [cir] Inhaled aerosol
     (V).                                    temperature ( [deg]C).
    [cir] Battery maximum charging current   [cir] Aerosol Particle
     (mA).                                   number concentration (/
                                             cm\3\).
    [cir] Battery maximum discharging        [cir] Count median diameter
     current (mA).                           (nm).
    [cir] Battery upper limits charging      [cir] PM2.5 ([micro]g/
     voltage (V).                            m\3\).
    [cir] Power Delivery Unit (PDU)          Filter
     voltage operating range (V).            (if applicable).
    [cir] PDU current operating range        [cir] Filter efficiency (%)
     (mA).                                   {If no filter efficiency
                                             data is available for the
                                             products, include
                                             information sufficient to
                                             show that the cigar filter
                                             is unchanged [e.g., denier
                                             per filament (DPF), total
                                             denier (g/9000m), and
                                             filter density(g/
                                             cm\3\)]{time} .
    [cir] PDU wattage operating range        [cir] Filter ventilation
     (watts).                                (%).
    [cir] PDU temperature cut-off (          [cir] Filter pressure drop
     [deg]C) (if applicable)                 (mm H2O).
    [cir] PDU Current cut-off (mA) (if
     applicable).
 Aerosol.
    [cir] Inhaled aerosol temperature (
     [deg]C).
    [cir] Aerosol Particle number
     concentration (/cm\3\).
    [cir] Count median diameter (nm).
    [cir] PM2.5 ([micro]g/m\3\).
 Filter (if applicable).
    [cir] Filter efficiency (%) {If no
     filter efficiency data is available
     for the products, include information
     sufficient to show that the cigar
     filter is unchanged [e.g., denier per
     filament (DPF), total denier (g/
     9000m), and filter density(g/
     cm\3\)]{time} .
    [cir] Filter pressure drop (mm H2O).
    [cir] Filter length (mm).
    [cir] Filter diameter (mm).
    [cir] Filter ventilation (%).           ............................
------------------------------------------------------------------------

    (iii) Function. How the product is intended to function.
    (iv) Product pH and nicotine formulation. The pH of the product and 
the formulation of nicotine in the product, if applicable, including the 
form (e.g., unprotonated nicotine, nicotine salts) and quantity.
    (v) Fermentation process. For smokeless tobacco products and tobacco 
products that contain fermented tobacco (including naturally fermented 
tobacco), information on the fermentation process, including the 
following:
    (A) Description of the fermentation process;

[[Page 1009]]

    (B) Composition of the inoculum (starter culture) with genus and 
species name(s) and concentration(s) (if applicable);
    (C) Any step(s) taken to reduce endogenous microbes (e.g., cleaning 
of product contact surfaces);
    (D) Specifications and test data for pH, temperature, moisture 
content, and water activity;
    (E) Frequency of aeration or turning (if applicable);
    (F) Duration of fermentation;
    (G) Added ingredients;
    (H) Method used to stabilize or stop fermentation (e.g., heat 
treatment) (if applicable), including parameters of the method (e.g., 
length of treatment, temperature) and method validation data; and
    (I) Storage conditions of the fermented tobacco prior to further 
processing or packaging and duration of storage (if applicable).
    (vi) Heat treatment process. For tobacco products that are heat 
treated, the application must contain the following information 
regarding the heat treatment process:
    (A) Description of the heat treatment process;
    (B) Type of heat treatment;
    (C) Conditions of heat treatment, including time, temperature, and 
moisture; and
    (D) Method validation data, including microbial loads (including 
bacteria, spores, yeast, and fungi) and TSNAs before and after heat 
treatment.
    (vii) Shelf life and stability information. With the exception of 
applications for roll-your-own tobacco products and cigarettes that are 
not HTPs, the application must contain information on the stability of 
the tobacco product over the shelf life and including the following:
    (A) The length of the shelf life, a description of how the shelf 
life is determined, and a description of how shelf life is indicated on 
the tobacco product, if applicable;
    (B) Stability data assessed at the beginning (zero time), middle, 
and end of the expected shelf life. If a tobacco product does not have a 
defined shelf life, provide stability data over a specified amount of 
time and a justification for why that time period is appropriate. 
Stability testing must be performed for the microbial and chemical 
endpoints as follows: Microbial content data, including total aerobic 
microbial count and total yeast and mold count; water activity; tobacco-
specific nitrosamines (TSNAs) yields (total TSNAs, N[min]-nitrosonor-
nicotine (NNN), 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone) (NNK)); 
and preservatives content.
    (C) Stability testing details for each microbial and chemical 
endpoint, including: The mean quantity and variance with unit of 
measures; the number of samples and measurement replicates for each 
sample; the methods used, including any deviation(s) from the methods, 
associated reference(s), and full validations reports for each method; 
the testing laboratory or laboratories and documentation showing that 
the laboratory or laboratories is (or are) accredited by a nationally or 
internationally recognized external accreditation organization; length 
of time between date of tobacco product manufacture and date(s) of 
testing; storage conditions of the tobacco product before it was tested; 
a statement that the testing was performed on a tobacco product in the 
same container closure system in which the tobacco product is intended 
to be marketed; and full test data (including quantitative acceptance 
(pass/fail) criteria, complete data sets, and a summary for the results) 
for all stability testing performed.
    (viii) Product and packaging design risks and misuse hazards. A 
review and assessment of reasonably foreseeable risks associated with 
the design of the tobacco product and its package that may occur during 
normal use of the tobacco product or during any foreseeable misuse of 
the product, including user error, which may cause illness, injury, or 
death not normally associated with the use of the tobacco product. The 
review and assessment must identify the measures taken to reduce or 
eliminate each risk associated with the design of the tobacco product 
and package.
    (3) Principles of operation. The applicant must provide a full 
statement of the principle or principles of operation

[[Page 1010]]

of the tobacco product, including full narrative descriptions of:
    (i) The way in which a typical consumer will use the new tobacco 
product, including a description of how a consumer operates the product, 
how long a single unit of product is expected to last (e.g., total 
length of time of use to consume a unit, number of use sessions expected 
per unit), and, where applicable, how a consumer can change the product 
design and add or subtract ingredients;
    (ii) A justification for an applicant's determination of what 
constitutes a single unit of product as described in the PMTA; and
    (iii) Whether the product incorporates a heating source, and if so, 
a description of the heating source.
    (4) Product testing and analysis information. Each analysis required 
in this paragraph must be performed on test samples that reflect the 
finished tobacco product composition and design, and must be conducted 
using a sufficient sample size and number of replicates to substantiate 
the results of the type of testing conducted. Additionally, the 
applicant must provide the following information:
    (i) The name and location of the testing laboratory or laboratories 
and documentation showing that the laboratory or laboratories is (or 
are) accredited by a nationally or internationally recognized external 
accreditation organization;
    (ii) The length of time between dates of manufacture and date(s) of 
testing;
    (iii) The storage conditions of the tobacco product before it was 
tested;
    (iv) The number of samples and measurement replicates for each 
sample;
    (v) A description of method procedure, method validation information 
and rationale for selecting each test method, including relevant 
voluntary testing standards, test protocols, quantitative acceptance 
criteria, line data, and a summary of the results;
    (vi) Reports of product formulation testing that include test 
protocols, quantitative acceptance criteria, line data, and a summary of 
the results, for each applicable design parameter; and
    (vii) Complete descriptions of any smoking or aerosol-generating 
regimens used for analytical testing that are not standardized or widely 
accepted by the scientific community, if applicable.
    (j) Manufacturing. The application must contain a full description 
of the methods used in, and the facilities and controls used for, the 
design (including design validation and design verification, to assess 
whether the tobacco product, as manufactured, performs in accordance 
with design specifications), manufacture, packing, and storage of the 
tobacco product in sufficient detail to demonstrate whether the product 
meets manufacturing specifications, can be manufactured in a manner 
consistent with the information submitted in the application, and 
conforms to the requirements of any regulations issued under section 
906(e) of the Federal Food, Drug, and Cosmetic Act, including:
    (1) A list of all manufacturing, packaging, storage, and control 
facilities for the product, including the facility name, address, and 
FEI number, if applicable, and a contact name and telephone number for a 
representative from each facility;
    (2) A narrative description, accompanied by a list and summary, of 
all standard operating procedures (SOPs) and examples of relevant forms 
and records for the following categories of information for all 
manufacturing, design controls, packing, and storage for the tobacco 
product:
    (i) Manufacturing and production process activities at each 
establishment, including a description of each establishment, all 
production steps, and process controls, process specifications with 
relevant acceptance criteria, and monitoring and acceptance activities;
    (ii) Managerial oversight and employee training related to the 
manufacture, processing, packing, and installation of the tobacco 
product, as applicable;
    (iii) Monitoring procedures and manufacturing controls for product 
design, product characteristics, and changes in products, 
specifications, methods, processes, or procedures, including a hazard 
analysis that details the correlation of the product design attributes 
with public health risk, as

[[Page 1011]]

well as any mitigation strategies implemented;
    (iv) Activities related to identifying and monitoring suppliers and 
the products supplied (including, for example, purchase controls and 
product acceptance activities);
    (v) Handling of complaints, nonconforming products and processes, 
and corrective and preventative actions;
    (vi) Testing procedures carried out before the product is released 
to market, including:
    (A) A list and summary of any standards used for all testing 
methods;
    (B) Validation and verification activities for all test methods used 
to ensure that the tobacco product meets specifications;
    (C) Documentation of accreditation information for all testing 
laboratories;
    (D) Complete description of smoking or aerosol-generating regimes 
used for analytical testing, if any; and
    (E) Tobacco product specifications (including any physical, 
chemical, and biological specifications) and acceptance criteria for 
those specifications;
    (F) Reports of release testing performed on finished products to 
demonstrate conformity with established specifications, including test 
protocols, line data, and a summary of the results for each applicable 
testing.
    (k) Health risk investigations--(1) Study types. The application 
must contain full reports of all information, both favorable and 
unfavorable, published or known to, or which should reasonably be known 
to, the applicant concerning investigations, including nonclinical and 
human subject studies regarding the following topics. If no substantive 
information exists regarding the topics specified in Sec. 
1114.27(b)(1)(ii), including information from published literature or 
that may be bridged from an investigation of another tobacco product, an 
applicant may need to conduct its own investigation(s) to ensure 
substantive information is included in the PMTA to meet the application 
filing requirements.
    (i) Health risks of the product. The potential health risks of the 
tobacco product to users and nonusers, including potential exposures and 
information regarding risks to youth, young adults, and other relevant 
vulnerable populations, and whether the product may present different 
risks than other tobacco products, including:
    (A) The health effects of the constituents, including HPHCs, at the 
quantitative levels delivered to both users and nonusers under the range 
of conditions under which the product might be used;
    (B) The toxicological profile of the new tobacco product related to 
the route of administration, including the genotoxicity, 
carcinogenicity, reproductive toxicity, immunotoxicity, acute toxicity, 
and repeat dose (chronic) toxicity of the new tobacco product relative 
to other tobacco products. The toxicological profile also includes 
information on the toxicity of the ingredients, additives, and HPHCs, 
relative to the route of administration and the range of potential 
levels of exposure resulting from the use of, or exposure to, the new 
tobacco product, including studies which discuss the toxicological 
effects of any leachables and extractables that can appear from the 
container closure system and the ingredient mixture, such as additive or 
synergistic effects;
    (C) The pharmacological profile of the new tobacco product, 
including the pharmacokinetics, pharamacodynamics, metabolism, and 
elimination profile, of any of the ingredients, additives, and HPHCs for 
the range of potential levels of exposure resulting from the use of, or 
exposure to, the new tobacco product relative to other tobacco products. 
The applicant must specify whether the studies were conducted in vitro, 
in vivo, ex vivo, or in silico; and
    (D) The health risks of the tobacco product compared to other 
tobacco products on the market, never using tobacco products, quitting 
tobacco product use, and using the tobacco product in conjunction with 
other tobacco products.
    (ii) Impacts on tobacco use behavior of tobacco product users. How 
the product and its label, labeling, and advertising, to the extent that 
advertising has been studied, will affect the tobacco use behavior of 
tobacco product users, specifically considering youth, young

[[Page 1012]]

adults, and other relevant vulnerable populations, including:
    (A) The abuse liability of the tobacco product;
    (B) How users actually use the product, including use topography, 
product use frequency, use trends over time, and how such use affects 
the health risks of the product to individual users;
    (C) The likelihood that users will use the product in conjunction 
with other tobacco products;
    (D) The likelihood that current tobacco product users will start 
using the product;
    (E) The likelihood that current tobacco users who adopt the product 
will switch to or switch back to other tobacco products that may present 
increased risks to individual health; and
    (F) The likelihood that current tobacco users who may have otherwise 
quit using tobacco products will instead start or continue to use the 
product.
    (iii) Impacts on tobacco use initiation by nonusers, including 
youth, young adults, and other relevant vulnerable populations. The 
impact of the tobacco product and its label, labeling, or advertising, 
to the extent that advertising has been studied, on tobacco use 
initiation by nonusers, including:
    (A) The likelihood that consumers who have never used tobacco 
products, particularly youth, young adults, and other relevant 
vulnerable populations, will initiate use of the tobacco product;
    (B) The likelihood that nonusers of tobacco products who adopt the 
tobacco product will switch to other tobacco products that may present 
higher levels of individual health risk; and
    (C) The likelihood that former users of tobacco products will re-
initiate use with the tobacco product.
    (iv) Perceptions and use intentions. The impact of the product and 
its label, labeling, and advertising, to the extent that advertising has 
been studied, on individuals:
    (A) Perception of the product;
    (B) Use intentions; and
    (C) Ability to understand the labeling and instructions for use and 
use the product in accordance with those instructions.
    (v) Human factors. The impact of human factors on product risk, 
including discussion of use conditions, use environments, use related 
hazards, estimated use error risk, potential unintended uses, risk 
controls to ensure that harms and unintended consequences are minimized, 
and adverse experiences related to such uses.
    (2) Literature search. The applicant must conduct a literature 
search for each type of information described in paragraph (k)(1) of 
this section, and the application must contain a description of the 
literature search performed, including the databases searched and the 
date searched, search terms, reasons for inclusion or exclusion of 
documents, and the strategy for study quality assessment. The 
application must also contain a bibliography of all published studies 
and articles referenced in the application. If a literature search was 
performed and resulted in no information found, the application must 
contain a statement to that effect.
    (3) Study reports. The full report of each study included in the 
application must describe the specific product studied and include the 
following items, where applicable and to the extent reasonably 
available. For applicable items not contained in the full report of an 
investigation, the applicant must contain a description of the actions 
taken to obtain the information and why the document is not reasonably 
available.
    (i) Full copies of any published articles and other reference 
materials;
    (ii) Documentation of all actions taken to ensure the reliability of 
the study. For all studies, to the extent reasonably available or 
obtainable, the application must contain a certification that 
investigators do not have, or documentation fully disclosing, any 
financial conflicts of interest, such as the financial arrangements 
specified in the Financial Disclosure by Clinical Investigators 
regulation in part 54 of this chapter. Additionally, for nonclinical 
laboratory studies, the application must contain, for each study, 
documentation of all actions taken to ensure the reliability of the 
study, e.g., documentation of whether the study was conducted in 
accordance with good laboratory practices, such as those specified in 
part 58 of this chapter;

[[Page 1013]]

    (iii) Copies of all versions of protocols and amendments that were 
used in the study;
    (iv) Copies of all versions of investigator instructions, if any 
were produced in addition to the protocol;
    (v) The statistical analysis plan, including a detailed description 
of the statistical analyses used (including all variables, confounders, 
and subgroup analyses), the scientific rationale for the choice of 
sample sizes, and any amendments to the plan;
    (vi) Line data, including data definition files that include the 
names of the variables, codes, and formats in each dataset, and copies 
of programs and any necessary macro-programs used to create derived 
datasets, and the results included in the study reports;
    (vii) A list of sites and clinical investigators that conducted the 
study, including contact information and physical address(es);
    (viii) The location of all source data. If the site where the study 
was conducted has not maintained all of the source data, indicate where 
the data are located;
    (ix) The format of the records and data (e.g., electronic or hard 
copy);
    (x) A list of all sites that had early termination and the reason 
for early termination, if applicable;
    (xi) A list of contractors who participated in the study, the role 
of each contractor, and the initiation and termination dates of the 
participation of each contractor;
    (xii) A signed full report of all findings;
    (xiii) For human subject studies:
    (A) All versions of study materials (e.g., consent forms, 
questionnaires, stimuli) used;
    (B) All versions of case report forms used; and
    (C) Individual case report forms related to participant deaths, 
other serious and unexpected adverse experiences, withdrawals, and 
participant discontinuation where the study participant was exposed to 
the tobacco product that is the subject of the PMTA or similar products; 
and
    (xiv) For tobacco product perception and use intention studies that 
use advertising as stimuli, a statement describing whether the 
advertising used is representative of advertising that the applicant 
intends to use in marketing the product. If the advertising is not 
representative of the advertising an applicant intends to use in 
marketing the product, the applicant must describe whether the study 
results are still relevant to the likely impact of the advertising on 
tobacco product perceptions and use intentions.
    (l) The effect on the population as a whole. The application must 
contain an analysis and discussion of how the data and information 
contained in the application establish that permitting the tobacco 
product to be marketed would be appropriate for the protection of public 
health determined with respect to the population as a whole, including 
users and nonusers of the tobacco product. The analysis and discussion 
must integrate all of the information in the application regarding the 
product and its likely effects on health, and tobacco use behavior, 
including tobacco use cessation and initiation, to provide an overall 
assessment of the likely effect that the marketing of the tobacco 
product may have on overall tobacco-related morbidity and mortality.
    (m) Certification statement. The application must contain the 
following certification, with the appropriate information inserted (as 
indicated by parenthetical italicized text), signed by an authorized 
representative of the applicant:

    ``I (name of responsible official) on behalf of the applicant, 
(applicant name), hereby certify that the applicant will maintain all 
records to substantiate the accuracy of this application for the period 
of time required in 21 CFR 1114.45 and ensure that such records remain 
readily available to FDA upon request. I certify that this information 
and the accompanying submission are true and correct, that no material 
fact has been omitted, and that I am authorized to submit this on the 
applicant's behalf. I understand that under section 1001 of title 18 of 
the United States Code anyone who knowingly and willfully makes a 
materially false, fictitious, or fraudulent statement or representation 
in any matter within the jurisdiction of the executive, legislative, or 
judicial branch of the Government of the United States is subject to 
criminal penalties.''

[[Page 1014]]



Sec. 1114.9  Amendments.

    (a) General. FDA may request, or an applicant may submit on its own 
initiative, an amendment to a PMTA containing information that is 
necessary for FDA complete the review of a pending PMTA. An amendment 
must include the appropriate form and specify the STN assigned to the 
original submission and, if submitted other than at FDA's request, the 
reason for submitting the amendment. An amendment must also include the 
certification statement set forth in Sec. 1114.7(m), with the 
appropriate information inserted, and signed by an authorized 
representative of the applicant.
    (b) Review of an amendment. Submission of an amendment may affect 
the timing of review of an amended submission as follows:
    (1) If the amendment is a major amendment (e.g., an amendment that 
contains significant new data from a previously unreported study, 
detailed new analyses of previously submitted data, or substantial new 
manufacturing information), FDA will restart the 180-day review period 
after receipt of the amendment.
    (2) If FDA requests a minor amendment (i.e., an amendment that is 
not a major amendment) and receives a written response submitting the 
requested amendment, FDA may pause the review period for the number of 
days elapsed between the date of the request and the date that FDA 
receives the written response.
    (c) Failure to respond to amendment request. If FDA requests an 
amendment and the applicant does not respond within the time period 
specified in FDA's request, FDA may consider the applicant to have 
submitted a request to voluntarily withdraw the pending PMTA under Sec. 
1114.11 and issue an acknowledgment letter notifying the applicant of 
the withdrawal.
    (d) No amendment to closed or withdrawn application. An applicant 
may not amend an application after FDA has closed the application 
through an action under Sec. 1114.29 or it has been withdrawn under 
Sec. 1114.11.



Sec. 1114.11  Withdrawal by applicant.

    (a) An applicant may at any time make a written request using the 
appropriate form to withdraw a PMTA that FDA has not acted on as 
described in Sec. 1114.29. The withdrawal request must state:
    (1) Whether the withdrawal is due to a health concern related to the 
tobacco product and, if so, a description of those concerns, including 
the extent, duration, and frequency of the health effects, and what gave 
rise to the concerns, such as reports of adverse experiences;
    (2) The application STN; and
    (3) The name(s) of the new tobacco product that is the subject of 
the application.
    (b) An application will be considered withdrawn when FDA issues an 
acknowledgement letter stating that the application has been withdrawn.
    (c) The application is an Agency record, even if withdrawn. FDA will 
retain the withdrawn application under Federal Agency records schedules. 
The availability of the withdrawn application will be subject to FDA's 
public information regulation in Part 20 of this chapter.



Sec. 1114.13  Change in ownership of an application.

    An applicant may transfer ownership of a PMTA. At or before the time 
of transfer, the new owner and the former owner must submit information 
to FDA using the appropriate form as follows:
    (a) The new and former owner must sign and submit a notice to FDA 
stating that all of the former applicant's rights and responsibilities 
relating to the PMTA have been transferred to the new owner. This notice 
must identify the name and address of the new owner and the PMTA 
transferred by tobacco product name(s) and STN.
    (b) The new owner must sign and submit a notice to FDA containing 
the following:
    (1) The new owner's commitment to agreements, promises, and 
conditions made by the former owner and contained in the application and 
marketing granted order, if applicable;
    (2) The date that the change in ownership is effective;
    (3) Either a statement that the new owner has a complete copy of the 
application, including all amendments, the

[[Page 1015]]

marketing granted order (if applicable), and any records that are 
required to be kept under Sec. 1114.45, or a request for a copy of the 
application, including all amendments, and the modified risk order (if 
applicable) from FDA's files in accordance with part 20 of this chapter. 
In accordance with the Freedom of Information Act, FDA will provide a 
copy of the application to the new owner under the fee schedule in FDA's 
public information regulations in Sec. 20.45 of this chapter; and
    (4) A certification that no modifications have been made to the 
tobacco product since the application, including amendments (if any), 
was submitted to FDA.



Sec. 1114.15  Supplemental applications.

    (a) Supplemental PMTA submission. Applicants that have received a 
marketing granted order for a tobacco product may, as an alternative 
format of submitting an application that meets the content requirements 
of Sec. 1114.7, submit a supplemental PMTA to seek marketing 
authorization for modifications to such product, which result in a new 
tobacco product under section 910(a)(1) of the Federal Food, Drug, and 
Cosmetic Act. Supplemental PMTAs must include new information concerning 
modifications that create the new tobacco product but allow the 
applicant to satisfy the remaining application requirements by cross-
referencing applicable content from the previously submitted PMTA for 
the original tobacco product. Applicants may submit supplemental PMTAs 
only for modifications that require the submission of limited new 
information or where specified in a rule under section 907 of the FD&C 
Act. Except as permitted in a rule under section 907 of the Federal 
Food, Drug, and Cosmetic Act, an applicant may not submit a supplemental 
PMTA where:
    (1) Modifications to the product that result in the new tobacco 
product require the submission of new information or revisions to the 
PMTA for the original product to the extent that reviewing a 
supplemental application for the new tobacco product would be confusing, 
cumbersome, or otherwise inefficient and submitting a standard PMTA 
under Sec. 1114.7 would better facilitate review.
    (2) The marketing granted order for the original tobacco product has 
been withdrawn; or
    (3) The marketing granted order for the original tobacco product has 
been temporarily suspended or is subject to temporary suspension or 
withdrawal proceedings by FDA, except where authorized in writing by 
FDA.
    (b) Required format. The supplemental PMTA must comply with format 
requirements of Sec. 1114.7(b), except that an applicant must include 
certain content in a supplemental PMTA by cross-referencing a PMTA, or, 
where applicable, a supplemental PMTA, for an original tobacco product 
that is owned by that applicant, and may include other content by cross-
referencing a tobacco product master file and postmarket reports for the 
original tobacco product. FDA will not consider content included by 
cross-reference to other sources of information outside of the 
submission.
    (c) Required content. The supplemental PMTA must provide sufficient 
information for FDA to determine whether any of the grounds for denial 
listed in section 910(c)(2) of the Federal Food, Drug, and Cosmetic Act 
apply to the application.
    (1) The application must contain the full text of all the 
information described in the following sections:
    (i) General information that identifies the submission as a 
supplemental PMTA (as described in Sec. 1114.7(c));
    (ii) New product information (as described in paragraph (d) of this 
section);
    (iii) Statement of compliance with 21 CFR part 25 (as described in 
Sec. 1114.7(g));
    (iv) Labeling (as described in Sec. 1114.7(f)) if the labeling is 
not identical to the labeling submitted in the PMTA or postmarket 
reports for the original product;
    (v) Postmarket information (as described in paragraph (e) of this 
section); and
    (vi) Certification statement (as described in paragraph (f) of this 
section);
    (2) The application must include the following sections by cross-
reference to the PMTA for the original tobacco

[[Page 1016]]

product and contain any additional information that is necessary to 
supplement or update the cross-referenced information:
    (i) Descriptive information (as described in Sec. 1114.7(d));
    (ii) Product samples (as described in Sec. 1114.7(e));
    (iii) Labeling (as described in Sec. 1114.7(f)) if the labeling is 
identical to the labeling that was submitted in the PMTA or postmarket 
reports for the original tobacco product;
    (iv) Summary of all research findings (as described in Sec. 
1114.7(h));
    (v) Product formulation (as described in Sec. 1114.7(i));
    (vi) Manufacturing (as described in Sec. 1114.7(j)); and
    (vii) Health risk investigations (as described in Sec. 1114.7(k)).
    (d) New product information. The application must contain a section 
that includes:
    (1) Full descriptions of each modification to the product and 
comparisons to the original product version described in the previously 
authorized PMTA;
    (2) A statement as to whether the new tobacco product, if it 
receives a marketing granted order, will replace the original tobacco 
product, will be a line extension of the original tobacco product, or 
will be introduced as an additional product by the same manufacturer;
    (3) All data and information relating to each modification to the 
product that would be required in an application under Sec. 1114.7; and
    (4) A concluding summary of how the new tobacco product meets the 
requirements to receive a marketing granted order, including how the 
data and information contained in both the supplemental PMTA and cross-
referenced from the previously authorized PMTA constitute valid 
scientific evidence and establishes that the PMTA meets the requirements 
of section 910(c) of the Federal Food, Drug, and Cosmetic Act to receive 
a marketing granted order, including that permitting the new tobacco 
product to be marketed would be appropriate for the protection of the 
public health determined with respect to the risks and benefits to the 
population as a whole, including users and nonusers of the tobacco 
product.
    (e) Postmarket reports. (1) If an applicant has submitted postmarket 
reports for the original tobacco product, the applicant must include all 
such reports in the application by cross-reference.
    (2) If an applicant is required to, but has not yet submitted a 
postmarket report, the applicant must submit a report as part of its 
application that contains all of the information for the original 
tobacco product that would otherwise be required in a report under Sec. 
1114.41 covering the period of time from when it received a marketing 
granted order for the original tobacco product to when it submits the 
supplemental PMTA.
    (f) Certification statement. The application must contain the 
following certification, with the appropriate information inserted as 
indicated by parenthetical italicized text, signed by an authorized 
representative of the applicant:
    ``I, (name of responsible official), on behalf of (name of 
applicant), certify that (new tobacco product name) has a different 
(describe each modification to the product) than (name of original 
tobacco product) described in (STN of the PMTA for the original product) 
but is otherwise identical to (name(s) of original tobacco product). I 
certify that (name of applicant) understands this means there is no 
other modification to the materials, ingredients, design, composition, 
heating source, or any other feature of the original tobacco product. I 
also certify that (name of applicant) will maintain all records that 
substantiate the accuracy of this application and ensure that such 
records remain readily available to FDA upon request for the period of 
time required in 21 CFR 1114.45. I certify that this information and the 
accompanying submission are true and correct, and that I am authorized 
to submit this on the applicant's behalf. I understand that under 
section 1001 of title 18 of the United States Code, anyone who knowingly 
and willfully makes a materially false, fictitious, or fraudulent 
statement or representation in any matter within the jurisdiction of the 
executive, legislative, or judicial branch of the Government of the 
United States is subject to criminal penalties.''

[[Page 1017]]



Sec. 1114.17  Resubmissions.

    (a) General. An applicant may, as an alternative format of 
submitting an application that meets the content requirements of Sec. 
1114.7 or 1114.15 (if applicable), submit a resubmission to address 
deficiencies set forth in a marketing denial order. The resubmission 
must contain new information necessary to address application 
deficiencies and cross-reference applicable content from the PMTA that 
received the marketing denial order. An applicant may utilize the 
resubmission format for the same tobacco product for which FDA issued a 
marketing denial order or a new tobacco product that results from 
modifications to the product necessary to address the deficiencies 
described in a marketing denial order. An applicant may not submit a 
resubmission when:
    (1) It incorporates new information or revisions to the PMTA for the 
original product to the extent that reviewing a resubmission for the new 
tobacco product would be confusing, cumbersome, or otherwise inefficient 
and submitting a standard PMTA under Sec. 1114.7 would better 
facilitate review; or
    (2) The marketing denial order states that the applicant may not 
submit a resubmission.
    (b) Required format. The resubmission must comply with format 
requirements of Sec. 1114.7(b), except that an applicant must include 
content in the resubmission by cross-referencing the PMTA, or, where 
applicable, supplemental PMTA, that received the marketing denial order. 
An applicant may also include content in a resubmission by cross-
reference to a TPMF. FDA will not consider content included by cross-
reference to other sources of information outside of the submission.
    (c) Required content. The resubmission must provide sufficient 
information for FDA to determine whether any of the grounds for denial 
listed in section 910(c)(2) of the Federal Food, Drug, and Cosmetic Act 
apply to the application.
    (1) The application must include the full text of the information 
described in the following paragraphs:
    (i) General information that identifies the submission as a 
resubmission (as described in paragraph Sec. 1114.7(c));
    (ii) Response to deficiencies (as described in paragraph (d) of this 
section); and
    (iii) Certification statement (as described in paragraph (e) of this 
section).
    (2) The application must include the following sections from the 
PMTA that received a marketing denial order by cross-reference to the 
PMTA and contain all additional information, in full text or by 
reference to a tobacco product master file, that is necessary to 
supplement or update the cross-referenced information:
    (i) Descriptive information (as described in Sec. 1114.7(d));
    (ii) Product samples (as described in Sec. 1114.7(e));
    (iii) Labeling (as described in Sec. 1114.7(f));
    (iv) Statement of compliance with 21 CFR part 25 (as described in 
Sec. 1114.7(g));
    (v) Summary of all research findings (as described in Sec. 
1114.7(h));
    (vi) Product formulation (as described in Sec. 1114.7(i));
    (vii) Manufacturing (as described in Sec. 1114.7(j)); and
    (viii) Health risk investigations (as described in Sec. 1114.7(k)).
    (d) Response to deficiencies. (1) The application must include a 
section that lists and provides a separate response to each deficiency 
described by FDA in the original marketing denial order, including all 
data and information necessary to complete each response, and that also 
addresses any applicant-identified deficiencies.
    (2) Where an applicant modifies the product in a way that would 
result in a new tobacco product under section 910(a)(1) of the Federal 
Food, Drug, and Cosmetic Act in order to address the deficiencies, the 
application must also include:
    (i) A full description of each modification to the product and 
comparisons of that change to the original version of the product 
described in the previously submitted PMTA; and
    (ii) All data and information relating to each modification to the 
product that would be required in an application under Sec. 1114.7.

[[Page 1018]]

    (e) Certification statement. The application must contain one of the 
two following certifications that corresponds to the application, with 
the appropriate information inserted as indicated by parenthetical 
italicized text, signed by an authorized representative of the 
applicant.
    (1) Same tobacco product certification. An application for the same 
tobacco product must contain the following certification:

    ``I, (name of responsible official), on behalf of (name of 
applicant), certify that this submission for (new tobacco product 
name(s)) responds to all deficiencies outlined in the marketing denial 
order issued in response to (STN of the previously submitted PMTA) and 
the new tobacco product described herein is identical to the product 
described in the previously submitted PMTA. I certify that (name of 
applicant) understands this means there is no modification to the 
materials, ingredients, design, composition, heating source, or any 
other feature. I also certify that (name of applicant) will maintain all 
records that substantiate the accuracy of this statement, and ensure 
that such records remain readily available to FDA upon request for the 
period of time required in 21 CFR 1114.45. I certify that this 
information and the accompanying submission are true and correct, and 
that I am authorized to submit this on the company's behalf. I 
understand that under section 1001 of title 18 of the United States 
Code, anyone who knowingly and willfully makes a materially false, 
fictitious, or fraudulent statement or representation in any matter 
within the jurisdiction of the executive, legislative, or judicial 
branch of the Government of the United States is subject to criminal 
penalties.''

    (2) Different tobacco product certification. An application for a 
different tobacco product than the original tobacco product that results 
from changes necessary to address the deficiencies must contain the 
following certification:

    ``I, (name of responsible official), on behalf of (name of 
applicant), certify that this submission for (new tobacco product 
name(s)) responds to all deficiencies outlined in the marketing denial 
order issued in response to (STN of the previously submitted PMTA) and 
the new tobacco product described herein has a different (describe each 
modification to the product) than (name(s) of original tobacco product) 
described in (STN of the previously submitted PMTA) but is otherwise 
identical to (name(s) of original tobacco product) described in (STN of 
the previously submitted PMTA). I certify that (name of applicant) 
understands this means there is no modification to the materials, 
ingredients, design features, heating source, or any other feature of 
the original tobacco product, except for the (describe each modification 
to the tobacco product). I also certify that (name of applicant) will 
maintain all records that substantiate the accuracy of this statement, 
and ensure that such records remain readily available to FDA upon 
request for the period of time required in 21 CFR 1114.45. I certify 
that this information and the accompanying submission are true and 
correct, and that I am authorized to submit this on the company's 
behalf. I understand that under section 1001 of title 18 of the United 
States Code, anyone who knowingly and willfully makes a materially 
false, fictitious, or fraudulent statement or representation in any 
matter within the jurisdiction of the executive, legislative, or 
judicial branch of the Government of the United States is subject to 
criminal penalties.''



                          Subpart C_FDA Review



Sec. 1114.25  Communication between FDA and applicants.

    During the course of reviewing an application, FDA may communicate 
with an applicant about relevant matters, including scientific, medical, 
and procedural issues that arise during the review process and 
inspections. These communications may take the form of telephone 
conversations, letters, electronic communications, or meetings, and will 
be documented in the administrative file in accordance with Sec. 10.65 
of this chapter.



Sec. 1114.27  Review procedure.

    (a) Acceptance review. (1) After an applicant submits a PMTA, FDA 
will perform an initial review of the PMTA to determine whether it may 
be accepted for further review. FDA may refuse to accept an application 
that:
    (i) Does not comply with the applicable format requirements in Sec. 
1114.7(b), Sec. 1114.15, or Sec. 1114.17 (as applicable);
    (ii) Is not administratively complete because it does not appear to 
contain the information required by Sec. 1114.7 (excluding product 
samples), Sec. 1114.15 or Sec. 1114.17, as applicable;
    (iii) Does not pertain to a tobacco product subject to chapter IX of 
the Federal Food, Drug, and Cosmetic Act (as required by Sec. 1105.10 
of this chapter); or

[[Page 1019]]

    (iv) FDA can otherwise refuse to accept under Sec. 1105.10.
    (2) If FDA accepts an application for further review, FDA will issue 
an acknowledgement letter to the applicant that specifies the PMTA STN. 
If FDA determines that it will require product samples as part of the 
PMTA, it will send instructions on how and where to submit product 
samples, as described in Sec. 1114.7(e) of this chapter.
    (3) If FDA refuses to accept an application, FDA will issue a letter 
to the applicant identifying the deficiencies, where practicable, that 
prevented FDA from accepting the application.
    (b) Filing review. (1) After accepting a PMTA, FDA will make a 
threshold determination of whether the application contains sufficient 
information to permit a substantive review. FDA may refuse to file a 
PMTA if any of the following applies:
    (i) The PMTA does not contain sufficient information required by 
section 910(b)(1) of the Federal Food, Drug, and Cosmetic Act and by 
Sec. 1114.7, Sec. 1114.15, or Sec. 1114.17, as applicable, to permit 
a substantive review of the application;
    (ii) The application does not contain any substantive information, 
including information from published literature or bridged from an 
investigation of another tobacco product, regarding each of the 
following topics.
    (A) The health risks of the new tobacco product as described in 
either Sec. 1114.7(k)(1)(i)(A), (B), or (C));
    (B) The health risks of the new tobacco product compared to the 
health risks generally presented by products in the same product 
category as well as products in at least one different category that are 
used by the consumers an applicant expects will use its new tobacco 
product (as described in a portion of Sec. 1114.7(k)(1)(i)(D)).
    (C) The abuse liability of the new tobacco product (as set forth in 
Sec. 1114.7(k)(1)(ii)(A));
    (D) How consumers would be expected to actually use the product, 
such as use frequency, use trends over time, and how such use affects 
the health risks of the product to individual users (as described in 
Sec. 1114.7(k)(1)(ii)(B));
    (E) The potential impact that the marketing of the new tobacco 
product would have on the likelihood that current tobacco product users 
would change their tobacco product use behavior, such as starting to 
using the new tobacco product, using the product in conjunction with 
other tobacco products, or, after using the product, switching to or 
switch back to other tobacco products that may present increased risks 
to individual health (i.e., any of the information set forth in either 
Sec. 1114.7(k)(1)(ii)(C), (D), (E), or (F));
    (F) The impact of the tobacco product and its label, labeling, or 
advertising, to the extent that advertising has been studied, on tobacco 
product use behavior of current nonusers of tobacco products (i.e., any 
of the information described in Sec. 1114.7(k)(1)(iii));
    (G) The impact of the product and its label, labeling, or 
advertising, to the extent that advertising has been studied, on 
individuals' perception of the product and their use intentions (i.e., 
any of the information described in Sec. 1114.7(k)(1)(iv)); and
    (H) The ways in which human factors can affect the health risks of 
the new tobacco product (i.e., any of the information described in Sec. 
1114.7(k)(1)(v));
    (iii) The PMTA contains a false statement of material fact;
    (iv) The PMTA is a supplemental PMTA that does not comply with Sec. 
1114.15; or
    (v) The PMTA is a resubmission that does not comply with Sec. 
1114.17.
    (2) If FDA refuses to file an application, FDA will issue a letter 
to the applicant identifying the deficiencies, where practicable, that 
prevented FDA from filing the application.
    (3) If FDA files an application, FDA will issue a filing letter to 
the applicant.
    (c) Application review. (1) Except as described in this paragraph 
and Sec. 1114.9(b), within 180 days of receipt of an application 
described in section 910(b)(1) of the Federal Food, Drug, and Cosmetic 
Act meeting the filing requirements set out in 1114.27(b), FDA will 
complete its review of the PMTA and act on the application.
    (2) FDA will begin substantive review of the application after it is 
filed under paragraph (b) of this section. FDA may communicate with the 
applicant as set

[[Page 1020]]

forth under Sec. 1114.25 to seek additional or clarifying information.
    (3) FDA may refer the PMTA or portions of the PMTA, upon its own 
initiative or applicant request, to TPSAC for reference and for the 
submission of a report and recommendation respecting the application, 
together with all underlying data and the reasons or basis for the 
recommendation.
    (4) FDA may conduct inspections of the applicant's manufacturing 
sites, and sites and entities involved with clinical and nonclinical 
research (including third parties and contract research organizations) 
to support FDA's review of the PMTA. Where an applicant prevents FDA 
from scheduling and conducting inspections that are necessary for FDA to 
complete its review of the PMTA in a timely manner, FDA may pause the 
180-day review period for the number of days necessary to complete the 
inspection.
    (5) FDA may defer review of a PMTA for a new product that, if 
introduced or delivered for introduction into interstate commerce, would 
be adulterated or misbranded due to the manufacturer or importer's 
failure to comply with user fee payment and reporting requirements under 
part 1150.



Sec. 1114.29  FDA action on an application.

    After receipt of an application, FDA will:
    (a) Refuse to accept the application as described in Sec. 
1114.27(a);
    (b) Issue a letter administratively closing the application;
    (c) Issue a letter canceling the application if FDA finds that it 
mistakenly accepted the application or that the application was 
submitted in error;
    (d) Refuse to file the application as described in Sec. 1114.27(b);
    (e) Issue a marketing granted order as described in Sec. 1114.31; 
or
    (f) Issue a marketing denial order as described in Sec. 1114.33.



Sec. 1114.31  Issuance of a marketing granted order.

    (a) FDA will issue a marketing granted order if it finds that none 
of the grounds for denial listed in section 910(c)(2) of the Federal 
Food, Drug, and Cosmetic Act apply. A marketing granted order becomes 
effective on the date it is issued.
    (b) FDA may include, as part of the marketing granted order:
    (1) Restrictions on the sale and distribution of the product, 
including restrictions on the access to, and the advertising and 
promotion of, the tobacco product, to the extent that it would be 
authorized to impose such restrictions under a regulation issued under 
section 906(d) of the Federal Food, Drug, and Cosmetic Act;
    (2) Any restrictions on the sales, distribution, advertising, and 
promotion of the new tobacco product that the applicant proposed to be 
included as part of a marketing granted order under section 910(c)(1)(B) 
of the Federal Food, Drug, and Cosmetic Act to support a finding by FDA 
that permitting the product to be marketed would be appropriate for the 
protection of the public health; and
    (3) Requirements to establish and maintain records, and submit 
postmarket reports under section 910(f) of the Federal Food, Drug and 
Cosmetic Act in addition to those described in Sec. 1114.41, including 
but not limited to information such as labeling, advertising, marketing, 
promotional materials, or marketing plans not previously submitted to 
FDA.



Sec. 1114.33  Issuance of a marketing denial order.

    (a) Issuance. FDA will issue a marketing denial order if:
    (1) Upon the basis of the information submitted as part of the 
application and any other information before FDA with respect to the new 
tobacco product, FDA finds that any of the grounds for denial listed in 
section 910(c)(2) of the Federal Food, Drug, and Cosmetic Act apply;
    (2) The applicant does not permit an authorized FDA employee, at a 
reasonable time and in a reasonable manner, an opportunity to:
    (i) Inspect the facilities and controls described in the 
application; or
    (ii) Have access to, copy, and verify all records pertinent to the 
application,which results in FDA finding that one or more of the grounds 
for denial

[[Page 1021]]

specified in section 910(c)(2) of the Federal Food, Drug and Cosmetic 
Act apply.
    (b) Description of deficiencies. The marketing denial order will, 
where practicable, identify measures to remove the application from 
deniable form.



Sec. 1114.35  Withdrawal of a marketing granted order.

    (a) Grounds for withdrawal. FDA will withdraw a marketing granted 
order for a new tobacco product issued under this part if FDA determines 
that:
    (1) Any of the grounds for withdrawal under section 910(d)(1) of the 
Federal Food, Drug, and Cosmetic Act apply; or
    (2) Any postmarket requirement imposed by the marketing granted 
order or by this part has not been met, which results in FDA finding 
that one or more of the grounds for withdrawal specified in section 
910(d)(1) of the Federal Food, Drug and Cosmetic Act apply.
    (b) Advice and other information. (1) FDA may seek advice on 
scientific matters from any appropriate FDA advisory committee in 
deciding whether to withdraw a marketing granted order.
    (2) FDA may use information other than that submitted by the 
applicant in deciding whether to withdraw a marketing granted order.
    (c) Informal hearing. Prior to withdrawing a marketing granted 
order, FDA will offer the holder of the marketing granted order an 
opportunity for an informal hearing under part 16 of this chapter.
    (d) Order issuance. If the applicant does not request a hearing or, 
if after the part 16 hearing is held, the Agency decides to proceed with 
the withdrawal, FDA will issue to the holder of the marketing granted 
order an order withdrawing the marketing granted order for the new 
tobacco product.
    (e) Public notice. FDA will give the public notice of an order 
withdrawing a marketing granted order for a tobacco product and will 
announce the basis of the withdrawal.



Sec. 1114.37  Temporary suspension of a marketing granted order.

    (a) FDA will temporarily suspend a marketing granted order if FDA 
determines that there is a reasonable probability that the continued 
distribution of such tobacco product would cause serious, adverse health 
consequences or death, that is greater than ordinarily caused by tobacco 
products on the market.
    (b) Before temporarily suspending a marketing granted order of a 
tobacco product, FDA will offer the holder of the marketing granted 
order an opportunity for an informal hearing under part 16 of this 
chapter.
    (c) If, after offering the holder of the marketing granted order an 
opportunity for a part 16 hearing, the Agency decides to proceed with 
the temporary suspension, FDA will issue an order temporarily suspending 
the marketing granted order for a tobacco product.
    (d) After issuing an order temporarily suspending the marketing 
granted order, FDA will proceed expeditiously to withdraw the marketing 
granted order for the tobacco product.



                    Subpart D_Postmarket Requirements



Sec. 1114.39  Postmarket changes.

    A marketing granted order authorizes the marketing of a new tobacco 
product in accordance with the terms of the order. Prior to the 
introduction or delivery for introduction into interstate commerce of a 
new tobacco product that results from modification(s) to the product, an 
applicant must submit a new PMTA under Sec. 1114.7 or a supplemental 
PMTA under Sec. 1114.15 and obtain a marketing granted order for the 
new tobacco product, unless the new tobacco product can be legally 
marketed through another premarket pathway.



Sec. 1114.41  Reporting requirements.

    (a) Required reports. Each applicant that receives a marketing 
granted order must submit to FDA all information required by the terms 
of the marketing granted order and by this section as described below. 
Each

[[Page 1022]]

postmarket report must be well-organized, legible, and written in 
English. Documents that have been translated from another language into 
English (e.g., original study documents written in a language other than 
English) must be accompanied by the original language version of the 
document, a signed statement by an authorized representative of the 
manufacturer certifying that the English language translation is 
complete and accurate, and a brief statement of the qualifications of 
the person that made the translation.
    (1) Periodic reports. Each applicant must submit a periodic report 
to the Center for Tobacco Products (CTP) within 60 calendar days of the 
reporting dates specified in the applicant's marketing granted order for 
the life of the order and as may be required for the submission of a 
supplemental PMTA under Sec. 1114.15. The report must include the 
following:
    (i) A cover letter that contains the PMTA STN, tobacco product 
name(s) (including the original name described in the PMTA if 
different), company name, date of report, and reporting period;
    (ii) A description of all changes made to the manufacturing, 
facilities, or controls during the reporting period, including:
    (A) A comparison of each change to what was described in the PMTA;
    (B) The rationale for making each change and, if any, a listing of 
any associated changes; and
    (C) The basis for concluding that each change does not result in a 
new tobacco product that is outside the scope of the marketing granted 
order and will not result in a finding that the marketing granted order 
must be withdrawn or temporarily suspended under section 910(d) of the 
Federal Food, Drug, and Cosmetic Act;
    (iii) An inventory of ongoing and completed studies about the 
tobacco product conducted by, or on behalf of, the applicant that are 
within the scope of Sec. 1114.7(k) and that have not been previously 
reported;
    (iv) Full reports of information published or known to, or which 
should be reasonably known to, the applicant concerning scientific 
investigations and literature about the tobacco product that have not 
been previously reported, including significant findings from 
publications not previously reported;
    (v) A summary and analysis of all serious and unexpected adverse 
experiences associated with the tobacco product that have been reported 
to the applicant or that the applicant is aware of, accompanied by a 
statement of any changes to the overall risk associated with the tobacco 
product, and a summary of any changes in the health risks, including the 
nature and frequency of the adverse experience, and potential risk 
factors;
    (vi) A summary of sales and distribution of the tobacco product for 
the reporting period, to the extent that the applicant collects or 
receives such data, including:
    (A) Total U.S. sales reported in dollars, units, and volume with 
breakdowns by U.S. census region, major retail markets, and channels in 
which the product is sold;
    (B) The Universal Product Code that corresponds to the product(s) 
identified in the PMTA; and
    (C) Demographic characteristics of product(s) purchasers, such as 
age, gender, race or ethnicity, geographic region, and tobacco use 
status;
    (vii) A summary of the implementation and effectiveness of policies 
and procedures regarding verification of the age and identity of 
purchasers of the product; and
    (viii) A summary of all formative consumer research studies 
conducted (if any), among any audiences, in the formation of new 
labeling, advertising, marketing, or promotional materials, not 
previously submitted, including qualitative and quantitative research 
studies used to determine message effectiveness, consumer knowledge, 
attitudes, beliefs, intentions and behaviors toward using the products, 
and including the findings or these studies and copies of the stimuli 
used in testing;
    (xi) A summary of all consumer evaluation research studies conducted 
(if any), among any audiences, not previously submitted, to determine 
the effectiveness of labeling, advertising, marketing, or promotional 
materials

[[Page 1023]]

and shifts in consumer knowledge, attitudes, beliefs, intentions, and 
behaviors toward using the products, and including the findings of these 
studies and copies of the stimuli used in testing;
    (xii) A summary of the creation and dissemination of the products' 
labeling, advertising, marketing, and promotional materials (if any), 
including a list of all entities involved and a description of their 
involvement, including a description of contractual agreements with such 
entities;
    (xiii) Specimens of all labeling and descriptions of all labeling 
changes that have not been previously submitted under section 905(i) of 
the Federal Food, Drug, and Cosmetic Act, including the date the 
labeling was first disseminated and the date when dissemination was 
completely terminated;
    (xiv) Full color copies of all advertising for the tobacco product 
that has not been previously submitted, and the original date the 
materials were first disseminated and the date when their dissemination 
was completely terminated;
    (xv) A description of the implementation of all advertising and 
marketing plans, not previously submitted to FDA, by channel and by 
product, including strategic creative briefs and paid media plans, and 
the dollar amount(s) and flighting of such plans, by channel and by 
product, including a description of any of the following activities that 
an applicant may have engaged in:
    (A) Use of competent and reliable data sources, methodologies, and 
technologies to establish, maintain, and monitor highly targeted 
advertising and marketing plans and media buys, including a list of all 
data sources used to target advertising and marketing plans and media 
buys;
    (B) Targeting of specific group(s) by age-range(s), including young 
adults, ages 21 to 24, and other demographic or psychographic 
characteristics that reflect the intended target audience, including the 
source of such data;
    (C) With respect to individuals below the minimum age of sale, 
actions taken to restrict access to the products and exposure to the 
products' labeling, advertising, marketing, or promotion, or other 
consumer-directed activities;
    (D) Use of owned, earned, shared, or paid media to create labeling 
for, advertise, market, or promote the product;
    (E) Use of partners, influencers, bloggers, or brand ambassadors to 
create labeling for, advertise, market, or promote the product;
    (F) Consumer engagements conducted by the applicant, on its behalf, 
or at its direction, including events at which the products were 
demonstrated and how access was restricted to individuals at or above 
the minimum age of sale;
    (G) Use of public-relations or other communications outreach to 
create labeling for, advertise, market, or promote the products;
    (xvi) A summary of media tracking and optimization, by channel, by 
product, and by audience demographics (e.g., age, gender, race/
ethnicity, geographic region), including a summary of any real-time 
digital media monitoring and including a summary of implementation of 
any corrective and preventive measures to identify, correct, and prevent 
delivery of advertising to individuals below the minimum age of sale, 
not previously submitted;
    (xvii) An analysis of the actual delivery of advertising 
impressions, by channel, by product, and by audience demographics, that 
have not been previously submitted, and verified against post-launch 
delivery-verification reports submitted to the applicant from an 
accredited source, where applicable;
    (xviii) Additional information required to be reported under the 
terms of a marketing granted order (if applicable); and
    (xix) An overall assessment of how the tobacco product continues to 
be appropriate for the protection of the public health.
    (2) Serious and unexpected adverse experience reporting. The 
applicant must report all serious and unexpected adverse experiences 
associated with the tobacco product that have been reported to the 
applicant or of which the applicant is aware to CTP's Office of Science 
through the Health and Human Services' Safety Reporting Portal or in

[[Page 1024]]

another manner designated by FDA (if applicable) within 15 calendar days 
after the report is received by the applicant.
    (b) FDA review of postmarket reports. (1) As part of its review of a 
postmarket report, FDA may require the applicant to submit additional 
information to enable it to determine whether a change results in a new 
tobacco product, or to facilitate a determination of whether there are 
or may be grounds to withdraw or temporarily suspend the marketing 
granted order.
    (2) FDA may notify an applicant that FDA has determined that a 
change described in a periodic report made under this section results in 
a new tobacco product outside the scope of the marketing granted order, 
requiring the submission of a new PMTA under Sec. 1114.7 or a 
supplemental PMTA under Sec. 1114.15 and issuance of a marketing 
granted order if the applicant seeks to market the new tobacco product, 
unless the new tobacco product can be legally marketed through a 
different premarket pathway.



                         Subpart E_Miscellaneous



Sec. 1114.45  Record retention.

    (a) Record retention by the applicant. (1) Each applicant that 
receives a marketing granted order must maintain all records necessary 
to facilitate a determination of whether there are or may be grounds to 
withdraw or temporarily suspend the marketing granted order, including 
records related to both the application and postmarket reports, and 
ensure that such records remain readily available to the Agency upon 
request (including where records are maintained by a third party on an 
applicant's behalf). These records include, but are not limited to:
    (i) All documents submitted to FDA as part of an application, 
periodic postmarket reports, and adverse experience reports;
    (ii) All documentation demonstrating whether each:
    (A) Nonclinical laboratory study was conducted in accordance with 
good laboratory practices that support the reliability of the results, 
such as the records described in part 58 of this chapter; and
    (B) Clinical investigator has any financial conflicts of interest 
that may be a source of bias, such as the documentation described in 
part 54 of this chapter;
    (iii) All other documents generated during the course of a study 
necessary to substantiate the study results, including:
    (A) Communications related to the investigation between the 
investigator and the sponsor, the monitor, or FDA; and
    (B) All source data for human subject and nonclinical investigations 
included in the application and postmarket reports, including records of 
each study subject's case history and exposure to tobacco products used 
in the investigation, including case report forms, progress notes, 
hospital records, clinical charts, X-rays, lab reports, and subject 
diaries; and
    (iv) A list of each complaint, and a summary and analysis of all 
complaints, associated with the tobacco product reported to the 
applicant;
    (2) These records must be legible, in the English language, and 
available for inspection and copying by officers or employees duly 
designated by the Secretary. Documents that have been translated from 
another language into English (e.g., original study documents written in 
a language other than English) must be accompanied by the original 
language version of the document, a signed statement by an authorized 
representative of the manufacturer certifying that the English language 
translation is complete and accurate, and a brief statement of the 
qualifications of the person that made the translation.
    (3) All records must be retained as follows:
    (i) Records related to and including the PMTA must be retained for a 
period of at least 4 years from the date that the marketing granted 
order is issued.
    (ii) Records related to postmarket reports, including both periodic 
and adverse experience reports, must be retained for a period of at 
least 4 years from the date the report was submitted to FDA or until FDA 
inspects the records, whichever occurs sooner.

[[Page 1025]]

    (b) Record retention by FDA. FDA will retain information submitted 
to it in accordance with Federal Agency Records schedules and will 
provide a copy to persons to whom such information may legally be 
disclosed on request under the fee schedule in FDA's public information 
regulations in Sec. 20.45 of this chapter.



Sec. 1114.47  Confidentiality.

    (a) General. FDA will determine the public availability of any part 
of an application and other content related to such an application, 
including all data and information submitted with or incorporated by 
reference in the application, under this section and part 20 of this 
chapter.
    (b) Confidentiality of data and information prior to an order. Prior 
to issuing an order under this part:
    (1) FDA will not publicly disclose the existence of an application 
unless:
    (i) The applicant has publicly disclosed or acknowledged (as such 
disclosure is defined in Sec. 20.81 of this chapter), or has authorized 
FDA in writing to publicly disclose or acknowledge, that the applicant 
has submitted an application to FDA; or
    (ii) FDA refers the application to TPSAC.
    (2) Except as described in paragraph (b)(4) of this section, FDA 
will not disclose the existence or contents of an FDA communication with 
an applicant regarding its application except to the extent that the 
applicant has publicly disclosed or acknowledged, or authorized FDA in 
writing to publicly disclose or acknowledge, the existence or contents 
of that particular FDA communication.
    (3) Except as described in paragraph (b)(4) of this section, FDA 
will not disclose the existence or contents of information contained in 
an application unless the applicant has publicly disclosed or 
acknowledged, or authorized FDA in writing to publicly disclose or 
acknowledge, the existence or contents of that particular information. 
If the applicant has publicly disclosed or acknowledged, or authorized 
FDA in writing to publicly disclose or acknowledge, the existence or 
contents of that particular information contained in an application, FDA 
may disclose the existence or contents of that particular information.
    (4) If FDA refers an application to TPSAC, the contents of the 
application will be available for public disclosure, except information 
that is exempt from disclosure under part 20 of this chapter.
    (c) Disclosure of data and information after issuance of a marketing 
granted order. After FDA issues a marketing granted order, it may make 
the following information related to the application and order available 
for public disclosure upon request or at FDA's own initiative, including 
information from amendments to the application and FDA's reviews of the 
application:
    (1) All data previously disclosed to the public, as such disclosure 
is defined in Sec. 20.81 of this chapter;
    (2) Any protocol for a test or study, unless it is shown to fall 
within the exemption established for trade secrets and confidential 
commercial information in Sec. 20.61 of this chapter;
    (3) Information and data submitted to demonstrate that the new 
tobacco product is appropriate for the protection of public health, 
unless the information is shown to fall within the exemptions 
established in Sec. 20.61 of this chapter for trade secrets and 
confidential commercial information, or in Sec. 20.63 of this chapter 
for personal privacy;
    (4) Correspondence between FDA and the applicant, including any 
requests FDA made for additional information and responses to such 
requests, and all written summaries of oral discussions between FDA and 
the applicant, unless it is shown to fall within the exemptions in Sec. 
20.61 of this chapter for trade secrets and confidential commercial 
information, or in Sec. 20.63 of this chapter for personal privacy;
    (5) In accordance with Sec. 25.51(b) of this chapter, the 
environmental assessment or, if applicable, the claim for categorical 
exclusion from the requirement to submit an environmental assessment 
under part 25 of this chapter; and
    (6) Information and data contained in postmarket reports submitted 
to FDA, unless the information is shown to fall within the exemptions 
established in Sec. 20.61 of this chapter for trade secrets

[[Page 1026]]

and confidential commercial information, or in Sec. 20.63 of this 
chapter for personal privacy
    (d) Disclosure of data and information after the issuance of a 
marketing denial order. After FDA issues a marketing denial order, FDA 
may make certain information related to the application and the order 
available for public disclosure upon request or at FDA's own initiative 
unless the information is otherwise exempt from disclosure under part 20 
of this chapter. Information FDA may disclose includes, but is not 
limited to the tobacco product category (e.g., cigarette), tobacco 
product subcategory (e.g., filtered, combusted cigarette), package size, 
product quantity, characterizing flavor, and the basis for the marketing 
denial order.



Sec. 1114.49  Electronic submission.

    (a) Electronic format requirement. Applicants submitting any 
documents to the Agency under this part must provide all required 
information to FDA using the Agency's electronic system, except as 
provided in paragraph (b) of this section. The application and all 
supporting information must be submitted in an electronic format that 
FDA can process, review, and archive.
    (b) Waivers from electronic format requirement. An applicant may 
submit a written request, that is legible and in English, to the Center 
for Tobacco Products asking that FDA waive the requirement for 
electronic format and content. Waivers will be granted if use of 
electronic means is not reasonable for the applicant. To request a 
waiver, applicants can send the written request to the address included 
on our website (www.fda.gov/tobacco-products). The request must include 
the following information:
    (1) The name and address of the applicant, a list of individuals 
authorized by the applicant to serve as the contact person and contact 
information. If the applicant has submitted a PMTA previously, the 
regulatory correspondence should also include any identifying 
information about the previous submission.
    (2) A statement that creation and/or submission of information in 
electronic format is not reasonable for the applicant, and an 
explanation of why creation and/or submission in electronic format is 
not reasonable. This statement must be signed by the applicant or by a 
representative who is authorized to make the declaration on behalf of 
the applicant.
    (c) Paper submission. An applicant who has obtained a waiver from 
filing electronically must send a written application through the 
Document Control Center to the address provided in the FDA documentation 
granting the waiver.



PART 1140_CIGARETTES, SMOKELESS TOBACCO, AND COVERED TOBACCO PRODUCTS
--Table of Contents



                      Subpart A_General Provisions

Sec.
1140.1 Scope.
1140.2 Purpose.
1140.3 Definitions.

 Subpart B_Prohibition of Sale and Distribution to Persons Younger Than 
                             18 Years of Age

1140.10 General responsibilities of manufacturers, distributors, and 
          retailers.
1140.12 Additional responsibilities of manufacturers.
1140.14 Additional responsibilities of retailers.
1140.16 Conditions of manufacture, sale, and distribution.

Subpart C [Reserved]

                   Subpart D_Labeling and Advertising

1140.30 Scope of permissible forms of labeling and advertising.
1140.32 Format and content requirements for labeling and advertising.
1140.34 Sale and distribution of nontobacco items and services, gifts, 
          and sponsorship of events.

    Authority: 21 U.S.C. 301 et seq., 21 U.S.C. 387a-1, and Pub. L. 117-
103, 136 Stat. 49.

    Source: 75 FR 13230, Mar. 19, 2010, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 1140.1  Scope.

    (a) This part sets out the restrictions under the Federal Food, 
Drug, and Cosmetic Act on the sale, distribution, and use of cigarettes, 
smokeless tobacco, and covered tobacco products. Section

[[Page 1027]]

1140.16(d) sets out restrictions on the distribution of free samples for 
cigarettes, smokeless tobacco, and other tobacco products (as such term 
is defined in section 201 of the Federal Food, Drug, and Cosmetic Act).
    (b) The failure to comply with any applicable provision in this part 
in the sale, distribution, and use of cigarettes, smokeless tobacco, 
covered tobacco products, or other tobacco products renders the product 
misbranded under the Federal Food, Drug, and Cosmetic Act.
    (c) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.

[81 FR 29102, May 10, 2016]



Sec. 1140.2  Purpose.

    The purpose of this part is to establish restrictions on the sale, 
distribution, and use of cigarettes, smokeless tobacco, and covered 
tobacco products in order to reduce the number of children and 
adolescents who use these products, and to reduce the life-threatening 
consequences associated with tobacco use.

[81 FR 29102, May 10, 2016]



Sec. 1140.3  Definitions.

    For the purposes of this part:
    Accessory means any product that is intended or reasonably expected 
to be used with or for the human consumption of a tobacco product; does 
not contain tobacco and is not made or derived from tobacco; and meets 
either of the following:
    (1) Is not intended or reasonably expected to affect or alter the 
performance, composition, constituents, or characteristics of a tobacco 
product; or
    (2) Is intended or reasonably expected to affect or maintain the 
performance, composition, constituents, or characteristics of a tobacco 
product but
    (i) Solely controls moisture and/or temperature of a stored product; 
or
    (ii) Solely provides an external heat source to initiate but not 
maintain combustion of a tobacco product.
    Cigarette. (1) Means a product that:
    (i) Is a tobacco product and
    (ii) Meets the definition of the term ``cigarette'' in section 3(1) 
of the Federal Cigarette Labeling and Advertising Act; and
    (2) Includes tobacco, in any form, that is functional in the 
product, which, because of its appearance, the type of tobacco used in 
the filler, or its packaging and labeling, is likely to be offered to, 
or purchased by, consumers as a cigarette or as roll-your-own tobacco.
    Cigarette tobacco means any product that consists of loose tobacco 
that is intended for use by consumers in a cigarette. Unless otherwise 
stated, the requirements applicable to cigarettes under this chapter 
also apply to cigarette tobacco.
    Component or part means any software or assembly of materials 
intended or reasonably expected:
    (1) To alter or affect the tobacco product's performance, 
composition, constituents, or characteristics; or
    (2) To be used with or for the human consumption of a tobacco 
product. Component or part excludes anything that is an accessory of a 
tobacco product.
    Covered tobacco product means any tobacco product deemed to be 
subject to the Federal Food, Drug, and Cosmetic Act under Sec. 1100.2 
of this chapter, but excludes any component or part that is not made or 
derived from tobacco.
    Distributor means any person who furthers the distribution of a 
tobacco product, whether domestic or imported, at any point from the 
original place of manufacture to the person who sells or distributes the 
product to individuals for personal consumption. Common carriers are not 
considered distributors for the purposes of this part.
    Importer means any person who imports any tobacco product that is 
intended for sale or distribution to consumers in the United States.
    Manufacturer means any person, including any repacker and/or 
relabeler, who manufactures, fabricates, assembles, processes, or labels 
a finished tobacco product.
    Nicotine means the chemical substance named 3-(1-Methyl-2-
pyrrolidinyl)pyridine or C[10]H[14]N[2], including any salt or complex 
of nicotine.
    Package or packaging means a pack, box, carton, or container of any 
kind

[[Page 1028]]

or, if no other container, any wrapping (including cellophane) in which 
a tobacco product is offered for sale, sold, or otherwise distributed to 
consumers.
    Point of sale means any location at which a consumer can purchase or 
otherwise obtain tobacco products for personal consumption.
    Retailer means any person who sells tobacco products to individuals 
for personal consumption, or who operates a facility where vending 
machines or self-service displays are permitted under this part.
    Roll-your-own tobacco means any tobacco product that, because of its 
appearance, type, packaging, or labeling, is suitable for use and likely 
to be offered to, or purchased by, consumers as tobacco for making 
cigarettes.
    Smokeless tobacco means any tobacco product that consists of cut, 
ground, powdered, or leaf tobacco and that is intended to be placed in 
the oral or nasal cavity.
    Tobacco product, as stated in section 201(rr) of the Federal Food, 
Drug, and Cosmetic Act in relevant part:
    (1) Means any product made or derived from tobacco, or containing 
nicotine from any source, that is intended for human consumption, 
including any component, part, or accessory of a tobacco product (except 
for raw materials other than tobacco used in manufacturing a component, 
part, or accessory of a tobacco product); and
    (2) Does not mean an article that is a drug under section 201(g)(1) 
of the Federal Food, Drug, and Cosmetic Act; a device under section 
201(h) of the Federal Food, Drug, and Cosmetic Act; a combination 
product described in section 503(g) of the Federal Food, Drug, and 
Cosmetic Act; or a food under 201(f) of the Federal Food, Drug, and 
Cosmetic Act if such article contains no nicotine or no more than trace 
amounts of naturally occurring nicotine.

[81 FR 29102, May 10, 2016, as amended at 88 FR 16553, Mar. 20, 2023]



 Subpart B_Prohibition of Sale and Distribution to Persons Younger Than 
                             18 Years of Age



Sec. 1140.10  General responsibilities of manufacturers,
distributors, and retailers.

    Each manufacturer, distributor, importer, and retailer is 
responsible for ensuring that the cigarettes, smokeless tobacco, or 
covered tobacco products it manufactures, labels, advertises, packages, 
distributes, imports, sells, or otherwise holds for sale comply with all 
applicable requirements under this part.

[81 FR 29103, May 10, 2016]



Sec. 1140.12  Additional responsibilities of manufacturers.

    In addition to the other responsibilities under this part, each 
manufacturer shall remove from each point of sale all self-service 
displays, advertising, labeling, and other items that the manufacturer 
owns that do not comply with the requirements under this part.



Sec. 1140.14  Additional responsibilities of retailers.

    (a) In addition to the other requirements under this part, each 
cigarette and smokeless tobacco retailer is responsible for ensuring 
that all sales of cigarettes or smokeless tobacco to any person comply 
with the following requirements:
    (1) No retailer may sell cigarettes or smokeless tobacco to any 
person younger than 18 years of age;
    (2)(i) Except as otherwise provided in paragraph (a)(2)(ii) of this 
section and in Sec. 1140.16(c)(2)(i), each retailer must verify by 
means of photographic identification containing the bearer's date of 
birth that no person purchasing the product is younger than 18 years of 
age;
    (ii) No such verification is required for any person over the age of 
26;
    (3) Except as otherwise provided in Sec. 1140.16(c)(2)(ii), a 
retailer may sell cigarettes or smokeless tobacco only in a direct, 
face-to-face exchange without the assistance of any electronic or 
mechanical device (such as a vending machine);

[[Page 1029]]

    (4) No retailer may break or otherwise open any cigarette or 
smokeless tobacco package to sell or distribute individual cigarettes or 
a number of unpackaged cigarettes that is smaller than the quantity in 
the minimum cigarette package size defined in Sec. 1140.16(b), or any 
quantity of cigarette tobacco or smokeless tobacco that is smaller than 
the smallest package distributed by the manufacturer for individual 
consumer use; and
    (5) Each retailer must ensure that all self-service displays, 
advertising, labeling, and other items, that are located in the 
retailer's establishment and that do not comply with the requirements of 
this part, are removed or are brought into compliance with the 
requirements under this part.
    (b) Notwithstanding the requirements in paragraph (a) of this 
section and in addition to the other requirements under this part, each 
retailer of covered tobacco products is responsible for ensuring that 
all sales of such covered tobacco products to any person comply with the 
following requirements:
    (1) No retailer may sell covered tobacco products to any person 
younger than 18 years of age;
    (2)(i) Except as otherwise provided in paragraph (a)(2)(ii) of this 
section and in Sec. 1140.16(c)(2)(i), each retailer must verify by 
means of photographic identification containing the bearer's date of 
birth that no person purchasing the product is younger than 18 years of 
age;
    (ii) No such verification is required for any person over the age of 
26; and
    (3) A retailer may not sell covered tobacco products with the 
assistance of any electronic or mechanical device (such as a vending 
machine), except in facilities where the retailer ensures that no person 
younger than 18 years of age is present, or permitted to enter, at any 
time.

[81 FR 29103, May 10, 2016]



Sec. 1140.16  Conditions of manufacture, sale, and distribution.

    (a) Restriction on product names. A manufacturer shall not use a 
trade or brand name of a nontobacco product as the trade or brand name 
for a cigarette or smokeless tobacco product, except for a tobacco 
product whose trade or brand name was on both a tobacco product and a 
nontobacco product that were sold in the United States on January 1, 
1995.
    (b) Minimum cigarette package size. Except as otherwise provided 
under this section, no manufacturer, distributor, or retailer may sell 
or cause to be sold, or distribute or cause to be distributed, any 
cigarette package that contains fewer than 20 cigarettes.
    (c) Vending machines, self-service displays, mail-order sales, and 
other ``impersonal'' modes of sale. (1) Except as otherwise provided 
under this section, a retailer may sell cigarettes and smokeless tobacco 
only in a direct, face-to-face exchange between the retailer and the 
consumer. Examples of methods of sale that are not permitted include 
vending machines and self-service displays.
    (2) Exceptions. The following methods of sale are permitted:
    (i) Mail-order sales, excluding mail-order redemption of coupons and 
distribution of free samples through the mail; and
    (ii) Vending machines (including vending machines that sell 
packaged, single cigarettes) and self-service displays that are located 
in facilities where the retailer ensures that no person younger than 18 
years of age is present, or permitted to enter, at any time.
    (d)(1) Except as provided in paragraph (d)(2) of this section, no 
manufacturer, distributor, or retailer may distribute or cause to be 
distributed any free samples of cigarettes, smokeless tobacco, or other 
tobacco products (as such term is defined in section 201 of the Federal 
Food, Drug, and Cosmetic Act).
    (2)(i) Paragraph (d)(1) of this section does not prohibit a 
manufacturer, distributor, or retailer from distributing or causing to 
be distributed free samples of smokeless tobacco in a qualified adult-
only facility.
    (ii) Paragraph (d)(2) of this section does not affect the authority 
of a State or local government to prohibit or otherwise restrict the 
distribution of free samples of smokeless tobacco.
    (iii) For purposes of paragraph (d) of this section, the term 
``qualified adult-

[[Page 1030]]

only facility'' means a facility or restricted area that:
    (A) Requires each person present to provide to a law enforcement 
officer (whether on or off duty) or to a security guard licensed by a 
governmental entity government-issued identification showing a 
photograph and at least the minimum age established by applicable law 
for the purchase of smokeless tobacco;
    (B) Does not sell, serve, or distribute alcohol;
    (C) Is not located adjacent to or immediately across from (in any 
direction) a space that is used primarily for youth-oriented marketing, 
promotional, or other activities;
    (D) Is a temporary structure constructed, designated, and operated 
as a distinct enclosed area for the purpose of distributing free samples 
of smokeless tobacco in accordance with this paragraph (d)(2) of this 
section;
    (E) Is enclosed by a barrier that:
    (1) Is constructed of, or covered with, an opaque material (except 
for entrances and exits);
    (2) Extends from no more than 12 inches above the ground or floor 
(which area at the bottom of the barrier must be covered with material 
that restricts visibility but may allow airflow) to at least 8 feet 
above the ground or floor (or to the ceiling); and
    (3) Prevents persons outside the qualified adult-only facility from 
seeing into the qualified adult-only facility, unless they make 
unreasonable efforts to do so; and
    (F) Does not display on its exterior:
    (1) Any tobacco product advertising;
    (2) A brand name other than in conjunction with words for an area or 
enclosure to identify an adult-only facility; or
    (3) Any combination of words that would imply to a reasonable 
observer that the manufacturer, distributor, or retailer has a 
sponsorship that would violate Sec. 1140.34(c).
    (iv) Distribution of samples of smokeless tobacco under paragraph 
(d)(2) of this section permitted to be taken out of the qualified adult-
only facility shall be limited to one package per adult consumer 
containing no more than 0.53 ounces (15 grams) of smokeless tobacco. If 
such package of smokeless tobacco contains individual portions of 
smokeless tobacco, the individual portions of smokeless tobacco shall 
not exceed eight individual portions, and the collective weight of such 
individual portions shall not exceed 0.53 ounces (15 grams). Any 
manufacturer, distributor, or retailer who distributes or causes to be 
distributed free samples also shall take reasonable steps to ensure that 
the amounts in this paragraph (d)(2)(iv) are limited to one such package 
per adult consumer per day.
    (3) Notwithstanding paragraph (d)(2) of this section, no 
manufacturer, distributor, or retailer may distribute or cause to be 
distributed any free samples of smokeless tobacco:
    (i) To a sports team or entertainment group; or
    (ii) At any football, basketball, baseball, soccer, or hockey event 
or any other sporting or entertainment event determined by the Secretary 
to be covered by paragraph (d)(3) of this section.
    (4) The Secretary shall implement a program to ensure compliance 
with paragraph (d) of this section and submit a report to the Congress 
on such compliance not later than 18 months after the date of enactment 
of the Family Smoking Prevention and Tobacco Control Act.
    (5) Nothing in paragraph (d) of this section shall be construed to 
authorize any person to distribute or cause to be distributed any sample 
of a tobacco product to any individual who has not attained the minimum 
age established by applicable law for the purchase of such product.
    (e) Restrictions on labels, labeling, and advertising. No 
manufacturer, distributor, or retailer may sell or distribute, or cause 
to be sold or distributed, cigarettes or smokeless tobacco with labels, 
labeling, or advertising not in compliance with subpart D of this part, 
and other applicable requirements.

Subpart C [Reserved]

[[Page 1031]]



                   Subpart D_Labeling and Advertising



Sec. 1140.30  Scope of permissible forms of labeling and advertising.

    (a)(1) A manufacturer, distributor, or retailer may, in accordance 
with this subpart D, disseminate or cause to be disseminated advertising 
or labeling which bears a cigarette or smokeless tobacco brand name 
(alone or in conjunction with any other word) or any other indicia of 
tobacco product identification, in newspapers; in magazines; in 
periodicals or other publications (whether periodic or limited 
distribution); on billboards, posters, and placards; in nonpoint-of-sale 
promotional material (including direct mail); in point-of-sale 
promotional material; and in audio or video formats delivered at a 
point-of-sale.
    (2) A manufacturer, distributor, or retailer intending to 
disseminate, or to cause to be disseminated, advertising or labeling for 
cigarettes or smokeless tobacco in a medium that is not listed in 
paragraph (a)(1) of this section, shall notify the agency 30 days prior 
to the use of such medium. The notice shall describe the medium and 
discuss the extent to which the advertising or labeling may be seen by 
persons younger than 18 years of age. The manufacturer, distributor, or 
retailer shall send this notice to the Office of Compliance and 
Enforcement, Center for Tobacco Products, Food and Drug Administration, 
Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, 
Silver Spring, MD 20993.
    (b) [Reserved]
    (c) This subpart D does not apply to cigarette or smokeless tobacco 
package labels.

[75 FR 13230, Mar. 19, 2010, as amended at 83 FR 13183, Mar. 28, 2018]



Sec. 1140.32  Format and content requirements for labeling and advertising.

    (a) Except as provided in paragraph (b) of this section, each 
manufacturer, distributor, and retailer advertising or causing to be 
advertised, disseminating or causing to be disseminated, any labeling or 
advertising for cigarettes or smokeless tobacco shall use only black 
text on a white background. This section does not apply to advertising:
    (1) In any facility where vending machines and self- service 
displays are permitted under this part, provided that the advertising is 
not visible from outside the facility and that it is affixed to a wall 
or fixture in the facility; or
    (2) Appearing in any publication (whether periodic or limited 
distribution) that the manufacturer, distributor, or retailer 
demonstrates is an adult publication. For the purposes of this section, 
an adult publication is a newspaper, magazine, periodical, or other 
publication:
    (i) Whose readers younger than 18 years of age constitute 15 percent 
or less of the total readership as measured by competent and reliable 
survey evidence; and
    (ii) That is read by fewer than 2 million persons younger than 18 
years of age as measured by competent and reliable survey evidence.
    (b) Labeling and advertising in an audio or video format shall be 
limited as follows:
    (1) Audio format shall be limited to words only with no music or 
sound effects.
    (2) Video formats shall be limited to static black text only on a 
white background. Any audio with the video shall be limited to words 
only with no music or sound effects.



Sec. 1140.34  Sale and distribution of nontobacco items and services, gifts, and sponsorship of events.

    (a) No manufacturer and no distributor of imported cigarettes or 
smokeless tobacco may market, license, distribute, sell, or cause to be 
marketed, licensed, distributed, or sold any item (other than cigarettes 
or smokeless tobacco or roll-your-own paper) or service, which bears the 
brand name (alone or in conjunction with any other word), logo, symbol, 
motto, selling message, recognizable color or pattern of colors, or any 
other indicia of product identification identical or similar to, or 
identifiable with, those used for any brand of cigarettes or smokeless 
tobacco.
    (b) No manufacturer, distributor, or retailer may offer or cause to 
be offered any gift or item (other than cigarettes or smokeless tobacco) 
to any

[[Page 1032]]

person purchasing cigarettes or smokeless tobacco in consideration of 
the purchase thereof, or to any person in consideration of furnishing 
evidence, such as credits, proofs-of-purchase, or coupons, of such a 
purchase.
    (c) No manufacturer, distributor, or retailer may sponsor or cause 
to be sponsored any athletic, musical, artistic, or other social or 
cultural event, or any entry or team in any event, in the brand name 
(alone or in conjunction with any other word), logo, symbol, motto, 
selling message, recognizable color or pattern of colors, or any other 
indicia of product identification identical or similar to, or 
identifiable with, those used for any brand of cigarettes or smokeless 
tobacco. Nothing in this paragraph prevents a manufacturer, distributor, 
or retailer from sponsoring or causing to be sponsored any athletic, 
musical, artistic, or other social or cultural event, or team or entry, 
in the name of the corporation which manufactures the tobacco product, 
provided that both the corporate name and the corporation were 
registered and in use in the United States prior to January 1, 1995, and 
that the corporate name does not include any brand name (alone or in 
conjunction with any other word), logo, symbol, motto, selling message, 
recognizable color or pattern of colors, or any other indicia of product 
identification identical or similar to, or identifiable with, those used 
for any brand of cigarettes or smokeless tobacco.



PART 1141_CIGARETTE PACKAGE AND ADVERTISING WARNINGS 
(eff. until 11-6-23)--Table of Contents



                      Subpart A_General Provisions

Sec.
1141.1 Scope.
1141.3 Definitions.

          Subpart B_Cigarette Package and Advertising Warnings

1141.10 Required warnings.
1141.12 Incorporation by reference of required warnings.
1141.14 Misbranding of cigarettes.

Subpart C_Additional Disclosure Requirements for Cigarette Packages and 
                               Advertising

1141.16 Disclosures regarding cessation.

    Authority: 15 U.S.C. 1333; 21 U.S.C. 371, 387c, 387f; Secs. 201 and 
202, Pub. L. 111-31, 123 Stat. 1776.

    Source: 76 FR 36753, June 22, 2011, unless otherwise noted.

    Effective Date Note: At 85 FR 15708, Mar. 8, 2020, part 1141 was 
revised, effective June. 18, 2021. At 85 FR 32296, May 29, 2020, the 
effective date was delayed to delayed until Oct. 16, 2021. At 86 FR 
3793, Jan. 14, 2021, this amended was further delayed until Jan. 14, 
2022. At 86 FR 36509, July 12, 2021, this amendment was further delayed 
until July 13, 2022. At 86 FR 50855, Sept. 13, 2021, this amendment was 
further delayed until Oct. 11, 2022. At 86 FR 70052, Dec. 9, 2021, this 
amendment was further delayed until Jan. 9, 2023. At 87 FR 11295, Mar. 
1, 2022, this amendment further delayed until Apr. 9, 2023. At 87 FR 
32990, June 1, 2022, this amendment further delayed until July 8, 2023. 
At 87 FR 50765, Aug. 18, 2022, this amendment further delayed until Oct. 
9, 2023. At 87 FR 72387, Nov. 25, 2022, this amendment further delayed 
until Nov. 6, 2023. For the convenience of the user, the new part 1141 
follows the text of this part.



                      Subpart A_General Provisions



Sec. 1141.1  Scope.

    (a) This part sets forth the requirements for the display of health 
warnings on cigarette packages and in advertisements for cigarettes. FDA 
may require additional statements to be displayed on packages and in 
advertisements under the Federal Food, Drug, and Cosmetic Act or other 
authorities.
    (b) The requirements of this part do not apply to manufacturers or 
distributors of cigarettes that do not manufacture, package, or import 
cigarettes for sale or distribution within the United States.
    (c) A cigarette retailer shall not be considered in violation of 
this part as it applies to the display of health warnings on a cigarette 
package if the package:
    (1) Contains a health warning;
    (2) Is supplied to the retailer by a license- or permit-holding 
tobacco

[[Page 1033]]

product manufacturer, importer, or distributor; and
    (3) Is not altered by the retailer in a way that is material to the 
requirements of section 4(a) of the Federal Cigarette Labeling and 
Advertising Act (15 U.S.C. 1333(a)) or this part, including by obscuring 
the warning, by reducing its size, by severing it in whole or in part, 
or by otherwise changing it in a material way.
    (d) A cigarette retailer shall not be considered in violation of 
this part as it applies to the display of health warnings in an 
advertisement for cigarettes if the advertisement is not created by or 
on behalf of the retailer and the retailer is not otherwise responsible 
for the inclusion of the required warnings. This paragraph shall not 
relieve a retailer of liability if the retailer displays, in a location 
open to the public, an advertisement that does not contain a health 
warning or that contains a warning that has been altered by the retailer 
in a way that is material to the requirements of section 4(b) of the 
Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333(b)), this 
part, or section 4(c) of the Federal Cigarette Labeling and Advertising 
Act (15 U.S.C. 1333(c)), including by obscuring the warning, by reducing 
its size, by severing it in whole or in part, or by otherwise changing 
it in a material way.



Sec. 1141.3  Definitions.

    For the purposes of this part,
    Cigarette means:
    (1) Any roll of tobacco wrapped in paper or in any substance not 
containing tobacco; and
    (2) Any roll of tobacco wrapped in any substance containing tobacco 
which, because of its appearance, the type of tobacco used in the 
filler, or its packaging and labeling, is likely to be offered to, or 
purchased by, consumers as a cigarette described in paragraph (1) of 
this definition.
    Commerce means:
    (1) Commerce between any State, the District of Columbia, the 
Commonwealth of Puerto Rico, Guam, the U.S. Virgin Islands, American 
Samoa, Wake Island, Midway Islands, Kingman Reef, or Johnston Island and 
any place outside thereof;
    (2) Commerce between points in any State, the District of Columbia, 
the Commonwealth of Puerto Rico, Guam, the U.S. Virgin Islands, American 
Samoa, Wake Island, Midway Islands, Kingman Reef, or Johnston Island, 
but through any place outside thereof; or
    (3) Commerce wholly within the District of Columbia, Guam, the U.S. 
Virgin Islands, American Samoa, Wake Island, Midway Island, Kingman 
Reef, or Johnston Island.
    Distributor means any person who furthers the distribution of 
cigarettes at any point from the original place of manufacture to the 
person who sells or distributes the product to individuals for personal 
consumption. Common carriers are not considered distributors for the 
purposes of this part.
    Front panel and rear panel mean the two largest sides or surfaces of 
the package.
    Importer means any person who imports any cigarette that is intended 
for sale or distribution to consumers in the United States.
    Manufacturer means any person, including any repacker or relabeler, 
who manufactures, fabricates, assembles, processes, or labels a finished 
cigarette product.
    Package means a pack, box, carton, or container of any kind in which 
cigarettes are offered for sale, sold, or otherwise distributed to 
consumers.
    Person means an individual, partnership, corporation, or any other 
business or legal entity.
    Required warning means the combination of one of the textual warning 
statements and its accompanying color graphic, which are set forth in 
``Cigarette Required Warnings,'' which is incorporated by reference at 
Sec. 1141.12.
    Retailer means any person who sells cigarettes to individuals for 
personal consumption, or who operates a facility where vending machines 
or self-service displays of cigarettes are permitted.
    United States, when used in a geographical sense, includes the 
several States, the District of Columbia, the Commonwealth of Puerto 
Rico, Guam, the U.S. Virgin Islands, American Samoa, Wake Island, Midway 
Islands, Kingman Reef, and Johnston Island.

[[Page 1034]]

The term ``State'' includes any political division of any State.



          Subpart B_Cigarette Package and Advertising Warnings



Sec. 1141.10  Required warnings.

    (a) Packages. (1) It shall be unlawful for any person to 
manufacture, package, sell, offer to sell, distribute, or import for 
sale or distribution within the United States any cigarettes the package 
of which fails to bear, in accordance with section 4 of the Federal 
Cigarette Labeling and Advertising Act (15 U.S.C. 1333) and this part, 
one of the required warnings on the front and the rear panels.
    (2) The required warning shall be obtained from the electronic 
images contained in ``Cigarette Required Warnings,'' which is 
incorporated by reference at Sec. 1141.12, and accurately reproduced as 
specified in ``Cigarette Required Warnings.''
    (3) The required warning shall appear directly on the package and 
shall be clearly visible underneath the cellophane or other clear 
wrapping.
    (4) The required warning shall be located in the upper portion of 
the front and rear panels of the package and shall comprise at least the 
top 50 percent of these panels; Provided, however, that on cigarette 
cartons, the required warning shall be located on the left side of the 
front and rear panels of the carton and shall comprise at least the left 
50 percent of these panels.
    (5) The required warning shall be positioned such that the text of 
the required warning and the other information on that panel of the 
package have the same orientation.
    (b) Advertisements. (1) It shall be unlawful for any manufacturer, 
importer, distributor, or retailer of cigarettes to advertise or cause 
to be advertised within the United States any cigarette unless its 
advertising bears, in accordance with section 4 of the Federal Cigarette 
Labeling and Advertising Act (15 U.S.C. 1333) and this part, one of the 
required warnings.
    (2) The text in each required warning shall be in the English 
language, except that:
    (i) In the case of an advertisement that appears in a non-English 
publication, the text in the required warning shall appear in the 
predominant language of the publication whether or not the advertisement 
is in English; and
    (ii) In the case of an advertisement that appears in an English 
language publication but that is not in English, the text in the 
required warning shall appear in the same language as that principally 
used in the advertisement.
    (3) For English-language and Spanish-language warnings, each 
required warning shall be obtained from the electronic images contained 
in ``Cigarette Required Warnings,'' which is incorporated by reference 
at Sec. 1141.12, and accurately reproduced as specified in ``Cigarette 
Required Warnings.''
    (4) For foreign-language warnings, except for Spanish-language 
warnings, each required warning shall be obtained from the electronic 
images contained in ``Cigarette Required Warnings,'' which is 
incorporated by reference at Sec. 1141.12, and accurately reproduced as 
specified in ``Cigarette Required Warnings,'' including the insertion of 
a true and accurate translation of the textual warning. The inserted 
textual warning must comply with the requirements of section 4(b)(2) of 
the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 
1333(b)(2)).
    (5) The required warning shall occupy at least 20 percent of the 
area of each advertisement, and shall be placed in accordance with the 
requirements in the Federal Cigarette Labeling and Advertising Act.
    (c) Irremovable or permanent warnings. The required warnings shall 
be indelibly printed on or permanently affixed to the package or 
advertisement. Such warnings, for example, must not be printed or placed 
on a label affixed to a clear outer wrapper that is likely to be removed 
to access the product within the package.



Sec. 1141.12  Incorporation by reference of required warnings.

    ``Cigarette Required Warnings'' Edition 1.0 (June 2011), consisting 
of electronic files, U.S. Food and Drug Administration, referred to at 
Sec. 1141.3, Sec. 1141.10(a) and (b), and Sec. 1141.16(a), is 
incorporated by reference into this section with the approval of the 
Director

[[Page 1035]]

of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To 
enforce any edition other than that specified in this section, FDA must 
publish notice of change in the Federal Register and the material must 
be available to the public. All approved material is available for 
inspection at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030 or go to http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html. Also, you may obtain a 
copy of the material by contacting the Center for Tobacco Products, Food 
and Drug Administration, Office of Health Communication and Education, 
ATTN: Cigarette Warning File Requests, 9200 Corporate Blvd., Rockville, 
MD 20850, 1-877-CTP-1373, or [email protected]. You may 
also obtain the material at http://www.fda.gov/cigarettewarningfiles.



Sec. 1141.14  Misbranding of cigarettes.

    (a) A cigarette shall be deemed to be misbranded under section 
903(a)(1) of the Federal Food, Drug, and Cosmetic Act if its package 
does not bear one of the required warnings in accordance with section 4 
of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333) 
and this part. A cigarette shall be deemed to be misbranded under 
section 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act if its 
advertising does not bear one of the required warnings in accordance 
with section 4 of the Federal Cigarette Labeling and Advertising Act (15 
U.S.C. 1333) and this part.
    (b) A cigarette advertisement or package will be deemed to include a 
brief statement of relevant warnings for the purposes of section 
903(a)(8) of the Federal Food, Drug, and Cosmetic Act if it bears one of 
the required warnings in accordance with section 4 of the Federal 
Cigarette Labeling and Advertising Act (15 U.S.C. 1333) and this part. A 
cigarette distributed or offered for sale in any State shall be deemed 
to be misbranded under section 903(a)(8) of the Federal Food, Drug, and 
Cosmetic Act unless the manufacturer, packer, or distributor includes in 
all advertisements and packages issued or caused to be issued by the 
manufacturer, packer, or distributor with respect to the cigarette one 
of the required warnings in accordance with section 4 of the Federal 
Cigarette Labeling and Advertising Act (15 U.S.C. 1333) and this part.



Subpart C_Additional Disclosure Requirements for Cigarette Packages and 
                               Advertising



Sec. 1141.16  Disclosures regarding cessation.

    (a) The required warning shall include a reference to a smoking 
cessation assistance resource in accordance with, and as specified in, 
``Cigarette Required Warnings'' (incorporated by reference at Sec. 
1141.12).
    (b) In meeting the smoking cessation needs of an individual caller, 
the smoking cessation assistance resource required to be referenced by 
paragraph (a) of this section must, as appropriate:
    (1) Provide factual information about the harms to health associated 
with cigarette smoking and the health benefits of quitting smoking;
    (2) Provide factual information about what smokers can expect when 
trying to quit;
    (3) Provide practical advice (problem solving/skills training) about 
how to deal with common issues faced by smokers trying to quit;
    (4) Provide evidence-based advice about how to formulate a plan to 
quit smoking;
    (5) Provide evidence-based information about effective relapse 
prevention strategies;
    (6) Provide factual information on smoking cessation treatments, 
including FDA-approved cessation medications; and
    (7) Provide information, advice, and support that is evidence-based, 
unbiased (including with respect to products, services, persons, and 
other entities), and relevant to tobacco cessation.
    (c) The smoking cessation resource must:
    (1) Other than as described in this section, not advertise or 
promote any particular product or service;
    (2) Except to meet the particularized needs of an individual caller 
as determined in the context of individual

[[Page 1036]]

counseling, not selectively present information about a subset of FDA-
approved cessation products or product categories while failing to 
mention other FDA-approved cessation products or product categories;
    (3) Not provide or otherwise encourage the use of any drug or other 
medical product that FDA has not approved for tobacco cessation;
    (4) Not encourage the use of any non-evidence-based smoking 
cessation practices;
    (5) Ensure that staff providing smoking cessation information, 
advice, and support are trained specifically to help smokers quit by 
delivering unbiased and evidence-based information, advice, and support; 
and
    (6) Maintain appropriate controls to ensure the criteria described 
in paragraphs (b) and (c) of this section are met.
    (d) If the Secretary of the Department of Health and Human Services 
(Secretary) determines that a part of the smoking cessation assistance 
resource referenced by paragraph (a) of this section does not meet the 
criteria described in paragraphs (b) and (c) of this section, the 
Secretary shall take appropriate steps to address the noncompliance.

    Effective Date Note: At 85 FR 15708, Mar. 8, 2020, part 1141 was 
revised, effective June. 18, 2021. At 85 FR 32296, May 29, 2020, the 
effective date was delayed to delayed until Oct. 16, 2021. At 86 FR 
3793, Jan. 14, 2021, this amended was further delayed until Jan. 14, 
2022. At 86 FR 36509, July 12, 2021, this amendment was further delayed 
until July 13, 2022. At 86 FR 50855, Sept. 13, 2021, this amendment was 
further delayed until Oct. 11, 2022. At 86 FR 70052, Dec. 9, 2021, this 
amendment was further delayed until Jan. 9, 2023. At 87 FR 11295, Mar. 
1, 2022, this amendment further delayed until Apr. 9, 2023. At 87 FR 
32990, June 1, 2022, this amendment further delayed until July 8, 2023. 
At 87 FR 50765, Aug. 18, 2022, this amendment further delayed until Oct. 
9, 2023. At 87 FR 72387, Nov. 25, 2022, this amendment further delayed 
until Nov. 6, 2023. For the convenience of the user, the new part 1141 
is set forth as follows:



PART 1141_REQUIRED WARNINGS FOR CIGARETTE PACKAGES AND ADVERTISEMENTS
(eff. 11-6-23)

                      Subpart A_General Provisions

Sec.
1141.1 Scope.
1141.3 Definitions.
1141.5 Incorporation by reference.

  Subpart B_Required Warnings for Cigarette Packages and Advertisements

1141.10 Required warnings.
1141.12 Misbranding of cigarettes.

    Authority: 15 U.S.C. 1333; 21 U.S.C. 371, 374, 387c, 387e, 387i; 
Secs. 201 and 202, Pub. L. 111-31, 123 Stat. 1776.



                      Subpart A_General Provisions



Sec. 1141.1  Scope.

    (a) This part sets forth the requirements for the display of 
required warnings on cigarette packages and in advertisements for 
cigarettes.
    (b) The requirements of this part do not apply to manufacturers or 
distributors of cigarettes that do not manufacture, package, or import 
cigarettes for sale or distribution within the United States.
    (c) A cigarette retailer will not be in violation of Sec. 1141.10 
for packaging that:
    (1) Contains a warning;
    (2) Is supplied to the retailer by a license- or permit-holding 
tobacco product manufacturer, or distributor; and
    (3) Is not altered by the retailer in a way that is material to the 
requirements of section 4 of the Federal Cigarette Labeling and 
Advertising Act (15 U.S.C. 1333) or this part.
    (d) Section 1141.10(d) applies to a cigarette retailer only if that 
retailer is responsible for or directs the warnings required under Sec. 
1141.10 for advertising. However, this paragraph (d) does not relieve a 
retailer of liability if the retailer displays, in a location open to 
the public, an advertisement that does not contain a warning or has been 
altered by the retailer in a way that is material to the requirements of 
section 4 of the Federal Cigarette Labeling and Advertising Act or this 
part.



Sec. 1141.3  Definitions.

    For purposes of this part:
    Cigarette means--
    (1) Any roll of tobacco wrapped in paper or in any substance not 
containing tobacco; and
    (2) Any roll of tobacco wrapped in any substance containing tobacco 
which, because of its appearance, the type of tobacco used in the 
filler, or its packaging and labeling, is likely to be offered to, or 
purchased by, consumers as a cigarette described in paragraph (1) of 
this definition.

[[Page 1037]]

    Commerce means:
    (1) Commerce between any State, the District of Columbia, the 
Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa, 
Wake Island, Midway Islands, Kingman Reef, or Johnston Island and any 
place outside thereof;
    (2) Commerce between points in any State, the District of Columbia, 
the Commonwealth of Puerto Rico, Guam, the Virgin Islands, American 
Samoa, Wake Island, Midway Islands, Kingman Reef, or Johnston Island, 
but through any place outside thereof; or
    (3) Commerce wholly within the District of Columbia, Guam, the 
Virgin Islands, American Samoa, Wake Island, Midway Island, Kingman 
Reef, or Johnston Island.
    Distributor means any person who furthers the distribution of 
cigarettes, whether domestic or imported, at any point from the original 
place of manufacture to the person who sells or distributes the product 
to individuals for personal consumption. Common carriers are not 
considered distributors for the purposes of this part.
    Front panel and rear panel mean the two largest sides or surfaces of 
the package.
    Manufacturer means any person, including any repacker or relabeler, 
who manufactures, fabricates, assembles, processes, or labels a finished 
cigarette product; or imports any cigarette that is intended for sale or 
distribution to consumers in the United States.
    Package or packaging means a pack, box, carton, or container of any 
kind in which cigarettes are offered for sale, sold, or otherwise 
distributed to consumers.
    Person means an individual, partnership, corporation, or any other 
business or legal entity.
    Retailer means any person who sells cigarettes to individuals for 
personal consumption, or who operates a facility where vending machines 
or self-service displays of cigarettes are permitted.
    United States, when used in a geographical sense, includes the 
several States, the District of Columbia, the Commonwealth of Puerto 
Rico, Guam, the Virgin Islands, American Samoa, Wake Island, Midway 
Islands, Kingman Reef, and Johnston Island. The term ``State'' includes 
any political division of any State.



Sec. 1141.5  Incorporation by reference.

    (a) Certain material is incorporated by reference into this part 
with the approval of the Director of the Federal Register under 5 U.S.C. 
552(a) and 1 CFR part 51. All approved material is available for 
inspection at U.S. Food and Drug Administration, Division of Dockets 
Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is 
available from the source listed in paragraph (b) of this section. It is 
also available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, email [email protected] or go to www.archives.gov/
federal-register/cfr/ibr-locations.html.
    (b) Center for Tobacco Products, U.S. Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20993; 1-888-463-6332. You 
may also obtain the material at https://www.fda.gov/cigarette-warning-
files.
    (1) ``Required Cigarette Health Warnings, 2020'', IBR approved for 
Sec. 1141.10.
    (2) [Reserved]



  Subpart B_Required Warnings for Cigarette Packages and Advertisements



Sec. 1141.10  Required warnings.

    (a) Required warnings. A required warning must include the 
following:
    (1) One of the following textual warning label statements:
    (i) WARNING: Tobacco smoke can harm your children.
    (ii) WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.
    (iii) WARNING: Smoking causes type 2 diabetes, which raises blood 
sugar.
    (iv) WARNING: Smoking reduces blood flow to the limbs, which can 
require amputation.
    (v) WARNING: Smoking causes cataracts, which can lead to blindness.
    (vi) WARNING: Smoking causes bladder cancer, which can lead to 
bloody urine.
    (vii) WARNING: Smoking reduces blood flow, which can cause erectile 
dysfunction.
    (viii) WARNING: Smoking causes head and neck cancer.
    (ix) WARNING: Smoking can cause heart disease and strokes by 
clogging arteries.
    (x) WARNING: Smoking during pregnancy stunts fetal growth.
    (xi) WARNING: Smoking causes COPD, a lung disease that can be fatal.
    (2) A color graphic to accompany the textual warning label 
statement.
    (b) Accurately reproduced. Each required warning, comprising a 
combination of a textual warning label statement and its accompanying 
color graphic, must be accurately reproduced as shown in the materials 
contained in ``Required Cigarette Health Warnings, 2020,'' which is 
incorporated by reference at Sec. 1141.5.
    (c) Packages. It is unlawful for any person to manufacture, package, 
sell, offer to sell, distribute, or import for sale or distribution 
within the United States any cigarettes unless the package of which 
bears a required warning in accordance with section 4 of the Federal 
Cigarette Labeling and Advertising Act and this part.
    (1) The required warning must appear directly on the package and 
must be clearly visible underneath any cellophane or other clear 
wrapping.

[[Page 1038]]

    (2) The required warning must comprise at least the top 50 percent 
of the front and rear panels; provided, however, that on cigarette 
cartons, the required warning must be located on the left side of the 
front and rear panels of the carton and must comprise at least the left 
50 percent of these panels.
    (3) The required warning must be positioned such that the text of 
the required warning and the other information on that panel of the 
package have the same orientation.
    (d) Advertisements. It is unlawful for any manufacturer, 
distributor, or retailer of cigarettes to advertise or cause to be 
advertised within the United States any cigarette unless each 
advertisement bears a required warning in accordance with section 4 of 
the Federal Cigarette Labeling and Advertising Act and this part.
    (1) For print advertisements and other advertisements with a visual 
component (including, for example, advertisements on signs, retail 
displays, internet web pages, digital platforms, mobile applications, 
and email correspondence), the required warning must appear directly on 
the advertisement.
    (2) The required warning must comprise at least 20 percent of the 
area of the advertisement in a conspicuous and prominent format and 
location at the top of each advertisement within the trim area, if any.
    (3) The text in each required warning must be in the English 
language, except as follows:
    (i) In the case of an advertisement that appears in a non-English 
medium, the text in the required warning must appear in the predominant 
language of the medium whether or not the advertisement is in English; 
and
    (ii) In the case of an advertisement that appears in an English 
language medium but that is not in English, the text in the required 
warning must appear in the same language as that principally used in the 
advertisement.
    (4) For English-language and Spanish-language warnings, each 
required warning must be accurately reproduced as shown in the materials 
contained in ``Required Cigarette Health Warnings, 2020,'' which is 
incorporated by reference at Sec. 1141.5.
    (5) For non-English-language warnings, other than Spanish-language 
warnings, each required warning must be accurately reproduced as shown 
in the materials contained in ``Required Cigarette Health Warnings, 
2020,'' which is incorporated by reference at Sec. 1141.5, including 
the substitution and insertion of a true and accurate translation of the 
textual warning label statement in place of the English language 
version. The inserted textual warning label statement must comply with 
the requirements of section 4 of the Federal Cigarette Labeling and 
Advertising Act, including area and other formatting requirements, and 
this part.
    (e) Irremovable or permanent warnings. The required warnings must be 
indelibly printed on or permanently affixed to the package or 
advertisement. These warnings, for example, must not be printed or 
placed on a label affixed to a clear outer wrapper that is likely to be 
removed to access the product within the package.
    (f) Sale or distribution. No person may manufacture, package, sell, 
offer for sale, distribute, or import for sale or distribution within 
the United States cigarettes whose packages or advertisements are not in 
compliance with section 4 of the Federal Cigarette Labeling and 
Advertising Act and this part, except as provided by Sec. 1141.1(c) and 
(d).
    (g) Marketing requirements--(1) Random display. The required 
warnings for packages specified in paragraph (a) of this section must be 
randomly displayed in each 12-month period, in as equal a number of 
times as is possible on each brand of the product and be randomly 
distributed in all areas of the United States in which the product is 
marketed in accordance with a plan submitted by the tobacco product 
manufacturer, distributor, or retailer to, and approved by, the Food and 
Drug Administration.
    (2) Rotation. The required warnings for advertisements specified in 
paragraph (a) of this section must be rotated quarterly in alternating 
sequence in advertisements for each brand of cigarettes in accordance 
with a plan submitted by the tobacco product manufacturer, distributer, 
retailer to, and approved by, the Food and Drug Administration.
    (3) Review. The Food and Drug Administration will review each plan 
submitted under this section and approve it if the plan:
    (i) Will provide for the equal distribution and display on packaging 
and the rotation required in advertising under this subsection; and
    (ii) Assures that all of the labels required under this section will 
be displayed by the tobacco product manufacturer, distributor, or 
retailer at the same time.
    (4) Record retention. Each tobacco product manufacturer required to 
randomly and equally display and distribute warnings on packaging or 
rotate warnings in advertisements in accordance with an FDA-approved 
plan under section 4 of the Federal Cigarette Labeling and Advertising 
Act and this part must maintain a copy of such FDA-approved plan and 
make it available for inspection and copying by officers or employees 
duly designated by the Secretary of Health and Human Services. The FDA-
approved plan must be retained while in effect and for a period of not 
less than 4 years from the date it was last in effect.



Sec. 1141.12  Misbranding of cigarettes.

    (a) A cigarette will be deemed to be misbranded under section 
903(a)(1) of the Federal

[[Page 1039]]

Food, Drug, and Cosmetic Act if its package does not bear one of the 
required warnings in accordance with section 4 of the Federal Cigarette 
Labeling and Advertising Act and this part. A cigarette will be deemed 
to be misbranded under section 903(a)(7)(A) of the Federal Food, Drug, 
and Cosmetic Act if its advertising does not bear one of the required 
warnings in accordance with section 4 of the Federal Cigarette Labeling 
and Advertising Act and this part.
    (b) A cigarette advertisement and other descriptive printed matter 
issued or caused to be issued by the manufacturer, packer, or 
distributor will be deemed to include a brief statement of relevant 
warnings for the purposes of section 903(a)(8) of the Federal Food, 
Drug, and Cosmetic Act if it bears one of the required warnings in 
accordance with section 4 of the Federal Cigarette Labeling and 
Advertising Act and this part. A cigarette distributed or offered for 
sale in any State shall be deemed to be misbranded under section 
903(a)(8) of the Federal Food, Drug, and Cosmetic Act unless the 
manufacturer, packer, or distributor includes in all advertisements and 
other descriptive printed matter issued or caused to be issued by the 
manufacturer, packer, or distributor with respect to the cigarette one 
of the required warnings in accordance with section 4 of the Federal 
Cigarette Labeling and Advertising Act and this part.



PART 1143_MINIMUM REQUIRED WARNING STATEMENTS--Table of Contents



Sec.
1143.1 Definitions.
1143.3 Required warning statement regarding addictiveness of nicotine.
1143.5 Required warning statements for cigars.
1143.7 Language requirements for required warning statements.
1143.9 Irremovable or permanent required warning statements.
1143.11 Does not apply to foreign distribution.
1143.13 Effective date.

    Authority: 21 U.S.C. 387a(b), 387f(d), Pub. L. 117-103, 136 Stat. 
49.

    Source: 81 FR 29103, May 10, 2016, unless otherwise noted.



Sec. 1143.1  Definitions.

    For purposes of this part:
    Accessory means any product that is intended or reasonably expected 
to be used with or for the human consumption of a tobacco product; does 
not contain tobacco and is not made or derived from tobacco; and meets 
either of the following:
    (1) Is not intended or reasonably expected to affect or alter the 
performance, composition, constituents, or characteristics of a tobacco 
product; or
    (2) Is intended or reasonably expected to affect or maintain the 
performance, composition, constituents, or characteristics of a tobacco 
product but
    (i) Solely controls moisture and/or temperature of a stored tobacco 
product; or
    (ii) Solely provides an external heat source to initiate but not 
maintain combustion of a tobacco product
    Cigar means a tobacco product that:
    (1) Is not a cigarette and
    (2) Is a roll of tobacco wrapped in leaf tobacco or any substance 
containing tobacco.
    Cigarette tobacco means any product that consists of loose tobacco 
that is intended for use by consumers in a cigarette. Unless otherwise 
stated, the requirements applicable to cigarettes under this chapter 
also apply to cigarette tobacco.
    Component or part means any software or assembly of materials 
intended or reasonably expected:
    (1) To alter or affect the tobacco product's performance, 
composition, constituents, or characteristics; or
    (2) to be used with or for the human consumption of a tobacco 
product. Component or part excludes anything that is an accessory of a 
tobacco product.
    Covered tobacco product means any tobacco product deemed to be 
subject to the Federal Food, Drug, and Cosmetic Act pursuant to Sec. 
1100.2 of this chapter, but excludes any component or part that is not 
made or derived from tobacco.
    Package or packaging means a pack, box, carton, or container of any 
kind or, if no other container, any wrapping (including cellophane), in 
which a tobacco product is offered for sale, sold, or otherwise 
distributed to consumers.
    Point of sale means any location at which a consumer can purchase or 
otherwise obtain tobacco products for personal consumption.

[[Page 1040]]

    Principal display panels means the panels of a package that are most 
likely to be displayed, presented, shown, or examined by the consumer.
    Required warning statement means a textual warning statement 
required to be on packaging and in advertisements for cigarette tobacco, 
roll-your-own tobacco, cigars, and other covered tobacco products.
    Retailer means any person who sells tobacco products to individuals 
for personal consumption, or who operates a facility where vending 
machines or self-service displays are permitted under this part.
    Roll-your-own tobacco means any tobacco product that, because of its 
appearance, type, packaging, or labeling, is suitable for use and likely 
to be offered to, or purchased by, consumers as tobacco for making 
cigarettes.
    Tobacco product, as stated in section 201(rr) of the Federal Food, 
Drug, and Cosmetic Act in relevant part:
    (1) Means any product made or derived from tobacco, or containing 
nicotine from any source, that is intended for human consumption, 
including any component, part, or accessory of a tobacco product (except 
for raw materials other than tobacco used in manufacturing a component, 
part, or accessory of a tobacco product); and
    (2) Does not mean an article that is a drug under section 201(g)(1) 
of the Federal Food, Drug, and Cosmetic Act; a device under section 
201(h) of the Federal Food, Drug, and Cosmetic Act; a combination 
product described in section 503(g) of the Federal Food, Drug, and 
Cosmetic Act; or a food under 201(f) of the Federal Food, Drug, and 
Cosmetic Act if such article contains no nicotine or no more than trace 
amounts of naturally occurring nicotine.

[81 FR 29103, May 10, 2016, as amended at 88 FR 16553, Mar. 20, 2023]



Sec. 1143.3  Required warning statement regarding addictiveness of nicotine.

    (a) Packages. (1) For cigarette tobacco, roll-your-own tobacco, and 
covered tobacco products other than cigars, it is unlawful for any 
person to manufacture, package, sell, offer to sell, distribute, or 
import for sale or distribution within the United States such product 
unless the tobacco product package bears the following required warning 
statement on the package label: ``WARNING: This product contains 
nicotine. Nicotine is an addictive chemical.''
    (2) The required warning statement must appear directly on the 
package and must be clearly visible underneath any cellophane or other 
clear wrapping as follows:
    (i) Be located in a conspicuous and prominent place on the two 
principal display panels of the package and the warning area must 
comprise at least 30 percent of each of the principal display panels;
    (ii) Be printed in at least 12-point font size and ensures that the 
required warning statement occupies the greatest possible proportion of 
the warning area set aside for the required text;
    (iii) Be printed in conspicuous and legible Helvetica bold or Arial 
bold type (or other sans serif fonts) and in black text on a white 
background or white text on a black background in a manner that 
contrasts by typography, layout, or color, with all other printed 
material on the package;
    (iv) Be capitalized and punctuated as indicated in paragraph (a)(1) 
of this section; and
    (v) Be centered in the warning area in which the text is required to 
be printed and positioned such that the text of the required warning 
statement and the other information on the principal display panel have 
the same orientation.
    (3) A retailer of any tobacco product covered by paragraphs (a)(1) 
and (2) of this section will not be in violation of this section for 
packaging that:
    (i) Contains a health warning;
    (ii) Is supplied to the retailer by the tobacco product 
manufacturer, importer, or distributor, who has the required state, 
local, or Alcohol and Tobacco Tax and Trade Bureau (TTB)-issued license 
or permit, if applicable, and
    (iii) Is not altered by the retailer in a way that is material to 
the requirements of this section.
    (b) Advertisements. (1) For cigarette tobacco, roll-your-own 
tobacco, and

[[Page 1041]]

covered tobacco products other than cigars, it is unlawful for any such 
tobacco product manufacturer, packager, importer, distributor, or 
retailer of the tobacco product to advertise or cause to be advertised 
within the United States any tobacco product unless each advertisement 
bears the required warning statement specified in paragraph (a)(1) of 
this section.
    (2) For print advertisements and other advertisements with a visual 
component (including, for example, advertisements on signs, shelf-
talkers, Internet Web pages, and electronic mail correspondence), the 
required warning statement must appear in the upper portion of the area 
of the advertisement within the trim area as follows:
    (i) Occupy at least 20 percent of the area of the advertisement;
    (ii) Appear in at least 12-point font size and ensures that the 
required warning statement occupies the greatest possible proportion of 
the warning area set aside for the required text;
    (iii) Appear in conspicuous and legible Helvetica bold or Arial bold 
type (or other similar sans serif fonts) and in black text on a white 
background or white text on a black background in a manner that 
contrasts by typography, layout, or color, with all other material on 
the advertisement;
    (iv) Be capitalized and punctuated as indicated in paragraph (a)(1) 
of this section;
    (v) Be centered in the warning area in which the text is required to 
appear and positioned such that the text of the required warning 
statement and the other textual information in the advertisement have 
the same orientation; and
    (vi) Be surrounded by a rectangular border that is the same color as 
the text of the required warning statement and that is not less than 3 
millimeters (mm) or more than 4 mm.
    (3) This paragraph (b) applies to a retailer only if that retailer 
is responsible for or directs the health warning required under the 
paragraph. However, this paragraph does not relieve a retailer of 
liability if the retailer displays, in a location open to the public, an 
advertisement that does not contain a health warning or contains a 
health warning that has been altered by the retailer in a way that is 
material to the requirements of this section.
    (c) Self-certification. A tobacco product that would otherwise be 
required to bear the warning in paragraph (a)(1) of this section but 
does not contain nicotine is not required to bear the warning in 
paragraph (a)(1) of this section on packages or advertisements if the 
tobacco product manufacturer has submitted to FDA a confirmation 
statement certifying to be true and accurate that the product does not 
contain nicotine and that the tobacco product manufacturer has data to 
support that assertion. Any product not required to bear the warning in 
paragraph (a)(1) of this section must include the statement ``This 
product is made from tobacco.'' on all packages and advertisements in 
accordance with the requirements of this part.
    (d) Small packages. A tobacco product that would otherwise be 
required to bear the warning in paragraph (a)(1) of this section but is 
too small or otherwise unable to accommodate a label with sufficient 
space to bear such information is exempt from compliance with the 
requirement provided that the information and specifications required 
under paragraphs (a)(1) and (2) of this section appear on the carton or 
other outer container or wrapper if the carton, outer container, or 
wrapper has sufficient space to bear the information, or appear on a tag 
otherwise firmly and permanently affixed to the tobacco product package. 
In such cases, the carton, outer container, wrapper, or tag will serve 
as the location of the principal display panels.



Sec. 1143.5  Required warning statements for cigars.

    (a) Packages. (1) It is unlawful for any person to manufacture, 
package, sell, offer to sell, distribute, or import for sale or 
distribution within the United States any cigar product unless the 
product package bears one of the following required warning statements 
on the package label:
    (i) WARNING: Cigar smoking can cause cancers of the mouth and 
throat, even if you do not inhale.
    (ii) WARNING: Cigar smoking can cause lung cancer and heart disease.

[[Page 1042]]

    (iii) WARNING: Cigars are not a safe alternative to cigarettes.
    (iv) WARNING: Tobacco smoke increases the risk of lung cancer and 
heart disease, even in nonsmokers.
    (v)(A) WARNING: Cigar use while pregnant can harm you and your 
baby.; or
    (B) SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of 
Infertility, Stillbirth and Low Birth Weight.
    (vi) WARNING: This product contains nicotine. Nicotine is an 
addictive chemical.
    (2) Each required warning statement must appear directly on the 
package and must be clearly visible underneath any cellophane or other 
clear wrapping as follows:
    (i) Be located in a conspicuous and prominent place on the two 
principal display panels of the package and the warning area must 
comprise at least 30 percent of each of the principal display panels;
    (ii) Appear in at least 12-point font size and ensure that the 
required warning statement occupies the greatest possible proportion of 
the warning area set aside for the required text;
    (iii) Be printed in conspicuous and legible Helvetica bold or Arial 
bold type (or other similar sans serif fonts) and in black text on a 
white background or white text on a black background in a manner that 
contrasts by typography, layout, or color, with all other printed 
material on the package;
    (iv) Be capitalized and punctuated as indicated in paragraph (a)(1) 
of this section; and
    (v) Be centered in the warning area in which the text is required to 
be printed and positioned such that the text of the required warning 
statement and the other information on that principal display panel have 
the same orientation.
    (3) No person may manufacture, package, sell, offer to sell, 
distribute, or import for sale or distribution within the United States 
any cigar without a required warning statement, except for cigars that 
are sold individually and not in a product package. For cigars that are 
sold individually and not in a product package, the required warning 
statements must be posted at the retailer's point-of-sale in accordance 
with the following:
    (i) All of the warnings in paragraph (a) of this section must be 
placed on a sign that is a minimum of 8.5 x 11 inches, posted on or 
within 3 inches of each cash register where payment may be made so that 
the sign(s) are unobstructed in their entirety and can be read easily by 
each consumer making a purchase;
    (ii) The sign must be clear, legible, and conspicuous and be printed 
in black Helvetica bold or Arial bold type (or other similar sans serif 
fonts) against a solid white background in at least 17 point type with 
appropriate space between the warning statements;
    (iii) Be printed in a manner that contrasts by typography, layout, 
or color, with all other printed material; and
    (iv) Be capitalized and punctuated as indicated in paragraph (a)(1) 
of this section.
    (4) A retailer of any cigar covered by paragraphs (a)(1) and (2) of 
this section will not be in violation of this section for packaging 
that:
    (i) Contains a health warning;
    (ii) Is supplied to the retailer by the tobacco product 
manufacturer, importer, or distributor who has the required state, 
local, or Alcohol and Tobacco Tax and Trade Bureau (TTB)-issued license 
or permit, if applicable, and
    (iii) Is not altered by the retailer in a way that is material to 
the requirements of this section.
    (b) Advertisements. (1) It is unlawful for any tobacco product 
manufacturer, packager, importer, distributor, or retailer of cigars to 
advertise or cause to be advertised within the United States any cigar 
unless each advertisement bears one of the required warning statements 
specified in paragraph (a)(1) of this section.
    (2) For print advertisements and other advertisements with a visual 
component (including, for example, advertisements on signs, shelf-
talkers, Internet Web pages, and electronic mail correspondence), each 
required warning statement must appear in the upper portion of the area 
of the advertisement within the trim area as follows:

[[Page 1043]]

    (i) Occupy at least 20 percent of the area of the advertisement;
    (ii) Appear in at least 12-point font size that ensures that the 
required warning statement occupies the greatest possible proportion of 
the warning area set aside for the text required;
    (iii) Appear in conspicuous and legible Helvetica bold or Arial bold 
type (or other similar sans serif fonts) and in black text on a white 
background or white text on a black background in a manner that 
contrasts by typography, layout, or color, with all other material on 
the advertisement;
    (iv) Be capitalized and punctuated as indicated in paragraph (a)(1) 
of this section;
    (v) Be centered in the warning area in which the text is required to 
appear and positioned such that the text of the required warning 
statement and the other textual information in the advertisement have 
the same orientation; and
    (vi) Be surrounded by a rectangular border that is the same color as 
the text of the required warning statement and that is not less than 3 
mm or more than 4 mm.
    (3) This paragraph (b) applies to a retailer only if that retailer 
is responsible for or directs the warning statements required under the 
paragraph. However, this paragraph does not relieve a retailer of 
liability if the retailer displays, in a location open to the public, an 
advertisement that does not contain a health warning or contains a 
health warning that has been altered by the retailer in a way that is 
material to the requirements of this section.
    (c) Marketing requirements. (1) Except for cigars sold individually 
and not in a product package, the warning statements required for 
packages in paragraph (a)(1) of this section must be randomly displayed 
in each 12-month period, in as equal a number of times as is possible on 
each brand of cigar sold in product packaging and be randomly 
distributed in all areas of the United States in which the product is 
marketed in accordance with a plan submitted by the cigar manufacturer, 
importer, distributor, or retailer to, and approved by, the Food and 
Drug Administration.
    (2) The warning statements required for advertisements in paragraph 
(a)(1) of this section must be rotated quarterly in alternating sequence 
in each advertisement for each brand of cigar in accordance with a plan 
submitted by the cigar manufacturer, importer, distributor, or retailer 
to, and approved by, the Food and Drug Administration.
    (3) Each person required to randomly display and distribute or 
rotate warnings in accordance with an FDA-approved plan under this part 
shall submit a proposed warning plan to FDA no later than either 12 
months after May 10, 2016, or 12 months before advertising or 
commercially marketing a product that is subject to such requirement, 
whichever is later.



Sec. 1143.7  Language requirements for required warning statements.

    The text in each warning statement required in Sec. 1143.3 or Sec. 
1143.5 must be in the English language, except as follows:
    (a) In the case of an advertisement that appears in a non-English 
medium, the text in the required warning statement must appear in the 
predominant language of the medium whether or not the advertisement is 
in English, and;
    (b) In the case of an advertisement that appears in an English 
language medium but that is not in English, the text in the required 
warning statement must appear in the same language as that principally 
used in the advertisement.



Sec. 1143.9  Irremovable or permanent required warning statements.

    The warning statements required by this section must be indelibly 
printed on or permanently affixed to the package or advertisement. These 
warnings, for example, must not be printed or placed on a product label 
affixed to a clear outer wrapper that is likely to be removed to access 
the product within the package.



Sec. 1143.11  Does not apply to foreign distribution.

    The provisions of this part do not apply to a manufacturer or 
distributor of tobacco products that does not manufacture, package, or 
import tobacco

[[Page 1044]]

products for sale or distribution within the United States.



Sec. 1143.13  Effective date.

    (a) Except as stated in paragraph (b) of this section, this part 
will take effect 24 months after May 10, 2016. The effective date will 
be with respect to the date of manufacture, provided that, in any case, 
beginning 30 days after the effective date, a manufacturer may not 
introduce into the domestic commerce of the United States any product, 
irrespective of the date of manufacture, that is not in conformance with 
this part.
    (b) The requirement to submit a warning plan to FDA under Sec. 
1143.5(c)(3) will take effect 12 months after May 10, 2016.



PART 1150_USER FEES--Table of Contents



Sec.
1150.1 Scope.
1150.3 Definitions.
1150.5 Required information.
1150.7 Yearly class allocation.
1150.9 Domestic manufacturer or importer assessment.
1150.11 Notification of assessments.
1150.13 Payment of assessments.
1150.15 Disputes.
1150.17 Penalties.

    Authority: 21 U.S.C. 371, 387a, 387b, 387i, 387s, 21 CFR 1100.1.

    Source: 79 FR 39310, July 10, 2014, unless otherwise noted.



Sec. 1150.1  Scope.

    This part establishes requirements related to tobacco product user 
fees under section 919 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 387s). The total amount of user fees may not exceed the amount 
specified for that fiscal year in section 919(b) of the Federal Food, 
Drug, and Cosmetic Act. All domestic manufacturers and importers of 
tobacco products are required to pay to FDA their percentage share of 
the total assessment for a fiscal year.



Sec. 1150.3  Definitions.

    The following definitions are applicable to this part:
    Class of tobacco products means each of the following types of 
tobacco products as defined in 26 U.S.C. 5702 and for which taxes are 
required to be paid for the removal of such into domestic commerce: 
Cigarettes, cigars, snuff, chewing tobacco, pipe tobacco, and roll-your-
own tobacco.
    Domestic manufacturer means a person who is required to obtain a 
permit from the Alcohol and Tobacco Tax and Trade Bureau of the 
Department of the Treasury with respect to the production of tobacco 
products under title 27 of the Code of Federal Regulations.
    Fiscal year quarter means a quarter in a fiscal year (the fiscal 
year is October 1 through September 30). The fiscal year quarters are 
October 1-December 31, January 1-March 31, April 1-June 30, and July 1-
September 30.
    Importer means a person who is required to obtain a permit from the 
Alcohol and Tobacco Tax and Trade Bureau of the Department of the 
Treasury with respect to the importation of tobacco products under title 
27 of the Code of Federal Regulations.
    Total assessment means the total amount of user fees (in dollars) 
authorized to be assessed and collected for a specific fiscal year under 
section 919 of the Federal Food, Drug, and Cosmetic Act.
    Units of product means:
    (1) The number of sticks for cigarettes, or
    (2) The weight (measured in pounds) for snuff, chewing tobacco, and 
roll-your-own tobacco.
    Units of product means:
    (1) The number of sticks for cigarettes and cigars, or
    (2) The weight (measured in pounds) for snuff, chewing tobacco, pipe 
tobacco, and roll-your-own tobacco.
    Yearly class allocation means the amount of user fees (in dollars) 
assessed for a class of tobacco products for a particular fiscal year.

[79 FR 39310, July 10, 2014, as amended at 81 FR 28715, May 10, 2016]



Sec. 1150.5  Required information.

    (a) General. Each domestic manufacturer and importer of tobacco 
products that are part of a class of tobacco products must submit the 
information described in this section for such products each month, and 
the information must be received by FDA no later than

[[Page 1045]]

the 20th day of each month. The information must be submitted using the 
form that FDA provides. The information must be submitted even if the 
domestic manufacturer or importer had no removals subject to tax during 
the prior month. FDA will use the information submitted under this 
section and any other available information, as FDA determines 
appropriate, to make tobacco product user fee assessments.
    (b) Contents. Each domestic manufacturer and importer must submit 
the following:
    (1) Identification information. (i) Its name and the mailing address 
of its principal place of business;
    (ii) The name and a telephone number including area code of an 
office or individual that FDA may contact for further information;
    (iii) The email address and postal address at which it wishes to 
receive notifications FDA sends under this part;
    (iv) The Alcohol and Tobacco Tax and Trade Bureau (TTB) Permit 
Number(s); and
    (v) The Employer Identification Number(s) (EIN).
    (2) Removal information. The units of product, by class, removed and 
not tax exempt for the prior month and the Federal excise tax it paid, 
by class, for such removal.
    (i) This information must be reported for each TTB tobacco permit.
    (ii) If the domestic manufacturer or importer did not remove any 
amount of tobacco product, it must report that no tobacco product was 
removed into domestic commerce.
    (3) Certified copies. Certified copies of the returns and forms that 
relate to:
    (i) The removal of tobacco products into domestic commerce (as 
defined by section 5702 of the Internal Revenue Code of 1986); and
    (ii) The payment of the Federal excise taxes imposed under chapter 
52 of the Internal Revenue Code of 1986.
    (c) First report for cigars. Domestic manufacturers and importers of 
cigars must submit the information described in this section beginning 
no later than the 20th day of August, 2016. Domestic manufacturers and 
importers of cigars must submit the information described in this 
section for each of the prior months of fiscal year 2016 as their first 
monthly submission. The previous sentence only applies for the first 
report in fiscal year 2016.
    (d) First report for pipe tobacco. Domestic manufacturers and 
importers of pipe tobacco must submit the information described in this 
section beginning no later than the 20th day of August, 2016.

[79 FR 39310, July 10, 2014, as amended at 81 FR 28715, May 10, 2016]



Sec. 1150.7  Yearly class allocation.

    For each fiscal year, FDA will allocate the total assessment among 
the classes of tobacco products.
    (a) Calculation. FDA will calculate the percentage shares for each 
class as follows:
    (1) Except for cigars, FDA will multiply the units of product 
removed and not tax exempt for the most recent full calendar year by the 
2003 maximum Federal excise tax rate for that class (class dollar 
figure).
    (2) For cigars, FDA will:
    (i) Multiply the units of small cigars removed and not tax exempt 
for the most recent full calendar year by the 2003 maximum Federal 
excise tax rate for small cigars (small cigar subclass dollar figure).
    (ii) Multiply the units of large cigars removed and not tax exempt 
for the most recent full calendar year by the 2003 maximum Federal 
excise tax rate for large cigars (large cigar subclass dollar figure).
    (iii) Add the small cigar subclass dollar figure and the large cigar 
subclass dollar figure (cigar class dollar figure).
    (3) FDA will total the class dollar figures for all tobacco classes 
for the most recent full calendar year (total dollar figure).
    (4) FDA will divide the class dollar figure by the total dollar 
figure to determine the percentage share for each class.
    (5) FDA will calculate the allocation for each class of tobacco 
products by multiplying the percentage share for each class by the total 
assessment.
    (b) Reallocation. For any class of tobacco products that is not 
deemed by FDA to be subject to regulation under chapter IX of the 
Federal Food, Drug, and Cosmetic Act, the amount of user fees that would 
otherwise be assessed

[[Page 1046]]

to such class of tobacco products will be reallocated to the classes of 
tobacco products that are subject to chapter IX of the Federal Food, 
Drug, and Cosmetic Act in the same manner and based on the same relative 
percentages otherwise determined under paragraph (a) of this section.

[79 FR 39310, July 10, 2014, as amended at 81 FR 28716, May 10, 2016]



Sec. 1150.9  Domestic manufacturer or importer assessment.

    Each quarter, FDA will calculate the assessment owed by each 
domestic manufacturer or importer for that quarter.
    (a) Calculation. (1) For each class of tobacco products except 
cigars, FDA will calculate the percentage share for each domestic 
manufacturer and importer by dividing the Federal excise taxes that it 
paid for the class for the prior quarter by the total excise taxes that 
all domestic manufacturers and importers paid for the class for that 
same quarter.
    (2) For the cigar class, FDA will calculate the percentage share for 
each domestic manufacturer and importer by dividing the Federal excise 
taxes that it paid for the class for the prior fiscal year by the total 
excise taxes that all domestic manufacturers and importers paid for the 
class for the prior fiscal year.
    (3) If the percentage share calculated for a domestic manufacturer 
or importer in this section, as applicable, is less than 0.0001 percent, 
the share is excluded from the assessment for that class of tobacco 
products.
    (4) Within each class of tobacco products, the assessment owed by a 
domestic manufacturer or importer for the quarter is the yearly class 
allocation, determined as described in Sec. 1150.7, divided by four, 
multiplied by the domestic manufacturer's or importer's percentage 
share, truncated to the fourth decimal place, for that class of tobacco 
products.
    (b) Adjustments. Annually, FDA will make any necessary adjustments 
to individual domestic manufacturer or importer assessments if needed to 
account for any corrections (for example, to include domestic 
manufacturers or importers that were not included in a relevant 
assessment calculation).

[79 FR 39310, July 10, 2014, as amended at 81 FR 28716, May 10, 2016]



Sec. 1150.11  Notification of assessments.

    (a) Notification. No later than 30 calendar days before the end of 
each fiscal year quarter, FDA will notify each domestic manufacturer and 
importer of the amount of the quarterly assessment imposed on the 
domestic manufacturer or importer.
    (b) Content of notification. The notification under paragraph (a) of 
this section will include the following:
    (1) The amount of the quarterly assessment imposed on the domestic 
manufacturer or importer and the date that payment of the assessment 
must be received by FDA;
    (2) Class assessment information, including each class' initial 
percentage share, the reallocation amount (if any) and each class' 
percentage share after any such reallocation, and the quarterly 
assessment for each class;
    (3) Domestic manufacturer or importer assessment information, 
including the domestic manufacturer's or importer's percentage share of 
each relevant class of tobacco products and invoice amount;
    (4) Any adjustments FDA has made under Sec. 1150.9(b);
    (5) The manner in which assessments are to be remitted to FDA;
    (6) Information about the accrual of interest if a payment is late; 
and
    (7) Information regarding where to send a dispute and when it needs 
to be sent.



Sec. 1150.13  Payment of assessments.

    (a) Payment of an assessment must be received by FDA no later than 
the last day of each fiscal year quarter.
    (b) Payments must be submitted to FDA in U.S. dollars and in the 
manner specified in the notification.
    (c) Except as provided in paragraph (d) of this section, if an 
assessment is not received by the last day of the fiscal year quarter, 
FDA will begin assessing interest on the unpaid amount in accordance 
with 31 U.S.C. 3717.
    (d) If FDA does not send the notification described in Sec. 
1150.11(a) 30 calendar

[[Page 1047]]

days before the end of a quarter, no interest will be assessed by FDA 
under paragraph (c) of this section until 30 calendar days have elapsed 
from the date FDA sent notification of the amount owed.
    (e) If a domestic manufacturer or importer disputes the amount of an 
assessment, it must still pay the assessment in accordance with 
paragraphs (a) and (b) of this section.



Sec. 1150.15  Disputes.

    (a) A domestic tobacco manufacturer or importer may dispute an FDA 
assessment. The dispute must include the basis for the dispute, and the 
dispute must be:
    (1) Submitted in writing;
    (2) Received by FDA no later than 45 days after the date on the 
assessment notification;
    (3) Legible and in English; and
    (4) Sent to the address found on our Web site (http://www.fda.gov/
tobaccoproducts).
    (b) If FDA determines that there was an error related to the 
assessment and the assessment was too high, FDA will refund the amount 
assessed in error to the domestic manufacturer or importer.
    (c) FDA will provide a dated, written response, and its response 
will provide information about how to submit a request for further 
Agency review.
    (d) A request for further Agency review under Sec. 10.75 of this 
chapter may be submitted. Such a request must be submitted in writing by 
the domestic manufacturer or importer and received by FDA within 30 days 
from the date on FDA's response. The request for further Agency review 
must be legible, in English, and submitted to the address found on our 
Web site (http://www.fda.gov/tobaccoproducts).



Sec. 1150.17  Penalties.

    (a) Under section 902(4) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 387b), a tobacco product is deemed adulterated if the 
domestic manufacturer or importer of the tobacco product fails to pay a 
user fee assessed to such manufacturer or importer by the later of the 
date the assessment is due, 30 days from the date FDA sent notification 
of the amount owed, or 30 days after final Agency action on a resolution 
of any dispute as to the amount of the fee.
    (b) Under section 902(4) of the Federal Food, Drug, and Cosmetic 
Act, a tobacco product is deemed adulterated if the domestic 
manufacturer or importer of the tobacco product fails to report the 
information required by Sec. 1150.5 to calculate assessments under this 
part.
    (c) The failure to report the information required by Sec. 1150.5 
to calculate assessments under this part is a prohibited act under 
section 301(e) of the Federal Food, Drug, and Cosmetic Act.
    (d) Information submitted under Sec. 1150.5 is subject to 18 U.S.C. 
1001 and other appropriate civil and criminal statutes.

[[Page 1048]]



 SUBCHAPTER L_REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE 
                      FOOD AND DRUG ADMINISTRATION





PART 1210_REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT--Table of Contents



                      Subpart A_General Provisions

Sec.
1210.1 Authority.
1210.2 Scope of act.
1210.3 Definitions.

                    Subpart B_Inspection and Testing

1210.10 Availability for examination and inspection.
1210.11 Sanitary inspection of dairy farms.
1210.12 Physical examination of cows.
1210.13 Tuberculin test.
1210.14 Sanitary inspection of plants.
1210.15 Pasteurization; equipment and methods.
1210.16 Method of bacterial count.
1210.17 Authority to sample and inspect.
1210.18 Scoring.

                        Subpart C_Permit Control

1210.20 Application for permit.
1210.21 Permit number.
1210.22 Form of tag.
1210.23 Permits granted on certificates.
1210.24 Temporary permits.
1210.25 Permits for pasteurized milk or cream.
1210.26 Permits for raw milk or cream.
1210.27 Permits waiving clauses 2 and 5, section 2 of the Federal Import 
          Milk Act.
1210.28 Permits waiving clause 4, section 2 of the Federal Import Milk 
          Act.

                           Subpart D_Hearings

1210.30 Hearing procedure for permit denial, suspension, and revocation.
1210.31 Hearing before prosecution.

    Authority: 21 U.S.C. 141-149.

    Source: 38 FR 32104, Nov. 20, 1973, unless otherwise noted.

    Cross References: For Animal and Plant Health Inspection Service 
regulations concerning tubercular cattle, see 9 CFR parts 50 and 77. For 
Animal and Plant Health Inspection Service regulations, see 9 CFR 
chapter I. For customs regulations concerning importation of milk and 
cream, see 19 CFR 12.7. For regulations of the Agricultural Marketing 
Service (Marketing Agreements and Orders) covering marketing areas for 
milk, see 7 CFR chapter X.



                      Subpart A_General Provisions



Sec. 1210.1  Authority.

    For the purposes of the regulations in this part the act (44 Stat. 
1101; 21 U.S.C. 141-149) ``To regulate the importation of milk and cream 
into the United States for the purpose of promoting the dairy industry 
of the United States and protecting the public health'' shall be known 
and referred to as ``the Federal Import Milk Act.''



Sec. 1210.2  Scope of act.

    The provisions of the act apply to all milk and cream offered for 
import into the continental United States.



Sec. 1210.3  Definitions.

    (a) Secretary. Secretary means the Secretary of Health and Human 
Services.
    (b) Commissioner. Commissioner means the Commissioner of Food and 
Drugs.
    (c) Milk. For the purposes of the act and of the regulations in this 
part:

Milk is the whole, fresh, clean, lacteal secretion obtained by the 
complete milking of one or more healthy cows, properly fed and kept, 
excluding that obtained within 15 days before and 5 days after calving, 
or such longer period as may be necessary to render the milk practically 
colostrum free.
    (d) Condensed milk. Condensed milk, as the term is used in section 
3, paragraph 2, of the Federal Import Milk Act, includes evaporated milk 
in the manufacture of which sterilization of the milk and cream is a 
necessary and usual process; it includes sweetened condensed milk only 
if it is prepared by a process which insures sterilization of the milk 
and cream. Condensed milk, as the term is used in section 3, paragraph 
3, of the Federal Import Milk Act, means sweetened condensed milk.
    (e) Sweetened condensed milk. Sweetened condensed milk conforms to 
the definition and standard of identity for

[[Page 1049]]

such food as set out in Sec. 131.120 of this chapter.
    (f) Evaporated milk. Evaporated milk conforms to the definition and 
standard of identity for such food as set out in Sec. 131.130 of this 
chapter.
    (g) Cream. Cream is that portion of the milk, rich in milk fat, 
which rises to the surface of milk on standing or is separated from it 
by centrifugal force. (See Sec. Sec. 131.150 through 131.157 of this 
chapter).
    (h) Pasteurization. Pasteurization is the process of heating every 
particle of milk or cream to at least 143 [deg]F., and holding it at 
such temperature continuously for at least 30 minutes, or to at least 
161 [deg]F., and holding it at such temperature continuously for at 
least 15 seconds.
    (i) Shipper. A shipper is anyone, other than a common carrier, who 
ships, transports, or causes to be shipped or transported into the 
United States milk or cream owned by him.

[38 FR 32104, Nov. 20, 1973, as amended at 42 FR 14091, Mar. 15, 1977]



                    Subpart B_Inspection and Testing



Sec. 1210.10  Availability for examination and inspection.

    Dairy farms and plants from which milk or cream is shipped or 
transported into the United States shall be open at all reasonable times 
to authorized agents for necessary examinations and inspections. Failure 
to permit such examinations and inspections may be considered cause for 
the suspension or revocation of the permit.



Sec. 1210.11  Sanitary inspection of dairy farms.

    The sanitary conditions of any dairy farm producing milk or cream to 
be shipped or transported into the United States or to a plant from 
which milk or cream is to be shipped or transported into the United 
States must score at least 50 points out of 100 points, according to the 
methods for scoring as provided by the score card for sanitary 
inspection of dairy farms in the form prescribed by the Secretary.



Sec. 1210.12  Physical examination of cows.

    (a) Physical examination of any and all cows in herds producing milk 
or cream which is to be shipped or transported into the United States 
shall be made by an authorized veterinarian of the United States or of 
any State or municipality thereof or of the country in which such milk 
or cream is produced to determine whether such cow or cows are in a 
healthy condition. Such examination shall be made as often as the 
Secretary may deem necessary and, in any event, shall have been made 
within one year previous to the time of the importation.
    (b) The result of the physical examination shall be set forth in the 
form prescribed by the Secretary.



Sec. 1210.13  Tuberculin test.

    (a) Except as provided in Sec. 1210.27 any and all animals in herds 
producing milk or cream which is to be shipped or transported raw into 
the United States shall be free from tuberculosis, as determined by a 
tuberculin test applied by an official veterinarian of the United States 
or of any State or municipality thereof or of the country in which such 
milk or cream is produced. Such test shall be made as often as the 
Secretary may deem necessary and, in any event, shall have been made 
within 1 year previous to the time of the importation. All animals 
showing positive or suspicious reactions to the tuberculin test must be 
permanently removed from the herd.
    (b) The results of the tuberculin test and all facts concerning the 
disposal of reacting or suspected animals shall be set forth in the form 
prescribed by the Secretary.



Sec. 1210.14  Sanitary inspection of plants.

    The sanitary conditions of any plant handling milk or cream any part 
of which is to be shipped or transported into the United States shall 
score at least 50 points out of 100 points according to the methods for 
scoring as provided by the score card for sanitary inspection of such 
plants in the form prescribed by the Secretary.

[[Page 1050]]



Sec. 1210.15  Pasteurization; equipment and methods.

    All dairy farms and plants at which any milk or cream is pasteurized 
for shipment or transportation into the United States shall employ 
adequate pasteurization machinery of a type easily cleaned and of 
sanitary construction capable of holding every portion of the milk or 
cream at the required temperature for the required time. Such 
pasteurizing machinery shall be properly equipped with accurate time and 
temperature recording devices, which shall be kept at all times in good 
working order. The temperature at the time of heating and holding must 
invariably be recorded on thermograph charts, initialed, numbered, and 
dated by the official having jurisdiction over such farms and plants. 
All thermograph charts shall be held for a period of 2 years unless 
within that period they have been examined and released by such 
authorized agents as are designated by the Secretary.



Sec. 1210.16  Method of bacterial count.

    The bacterial count of milk and cream refers to the number of viable 
bacteria as determined by the standard plate method of the American 
Public Health Association in use at the time of the examination.



Sec. 1210.17  Authority to sample and inspect.

    Inspectors engaged in the enforcement of the Federal Import Milk Act 
are empowered to test for temperature, to take samples of milk or cream, 
and to use such means as may be necessary for these purposes.



Sec. 1210.18  Scoring.

    Scoring of sanitary conditions required by Sec. Sec. 1210.11, 
1210.14 shall be done by an official inspector of the United States or 
of any State or municipality thereof or of the country in which the 
dairy farm or plant is located.



                        Subpart C_Permit Control



Sec. 1210.20  Application for permit.

    Application for a permit to ship or transport milk or cream into the 
United States shall be made by the actual shipper upon forms prescribed 
by the Secretary. The request for forms of applications for permits 
should be addressed to Commissioner of Food and Drugs, Food and Drug 
Administration, Department of Health and Human Services, 5600 Fishers 
Lane, Rockville, MD 20857.



Sec. 1210.21  Permit number.

    Each permit issued under the Federal Import Milk Act, including each 
temporary permit, shall bear an individual number. The right to the use 
of such number is restricted solely to the permittee.



Sec. 1210.22  Form of tag.

    Each container of milk or cream shipped or transported into the 
United States by such permittee shall have firmly attached thereto a tag 
in the following form, bearing the required information in clear and 
legible type:

Product_________________________________________________________________
(State whether raw milk, pasteurized milk, raw cream, or pasteurized 
cream.)
Permit number___________________________________________________________
Federal Import Milk Act, Department of Health and Human Services.
Shipper_________________________________________________________________
Address of shipper______________________________________________________


Provided, That in case of unit shipments consisting of milk only or 
cream only under one permit number, in lieu of each container being so 
marked, the vehicle of transportation, if sealed, may be tagged with the 
above tag, which should, in addition, show the number of containers and 
quantity of contents of each.



Sec. 1210.23  Permits granted on certificates.

    In the discretion of the Secretary, a permit may be granted on a 
duly certified statement signed by a duly accredited official of an 
authorized department of any foreign government or of any State of the 
United States or any municipality thereof. Such statement shall be in 
the form of a certificate prescribed by the Secretary, and shall have 
attached thereto, as a part thereof, signed copies of reports prescribed 
by Sec. Sec. 1210.12, 1230.13, and also by Sec. Sec. 1210.11, 1210.14, 
as applicable. The necessary inspections and examinations upon which the 
reports are based

[[Page 1051]]

shall be made by persons who are acting under the direct supervision of 
the certifying official.



Sec. 1210.24  Temporary permits.

    A temporary permit will be granted only upon a satisfactory showing 
that the applicant therefor has been unable to obtain the necessary 
inspections required by the applicable provisions of section 2 of the 
Federal Import Milk Act. Temporary permits shall be valid until the 
Secretary shall provide for inspection to ascertain that clauses 1, 2, 
and 3 of section 2 of the Federal Import Milk Act have been complied 
with.



Sec. 1210.25  Permits for pasteurized milk or cream.

    Permits to ship or transport pasteurized milk or cream into the 
United States will be granted only upon compliance with the requirements 
of clauses 1 and 3 of section 2 of the Federal Import Milk Act, 
Sec. Sec. 1210.11, 1210.12, 1210.14, as applicable.



Sec. 1210.26  Permits for raw milk or cream.

    Except as provided in Sec. 1210.27, permits to ship or transport 
raw milk or cream into the United States will be granted only when the 
milk or cream comes from dairy farms or plants where pasteurization is 
not carried on and then only upon compliance with the requirements of 
clauses 1, 2, and 3 of section 2 of the Federal Import Milk Act, 
Sec. Sec. 1210.11 to 1210.14 as applicable.



Sec. 1210.27  Permits waiving clauses 2 and 5, section 2 of the 
Federal Import Milk Act.

    A permit to ship or transport raw milk into the United States will 
contain a waiver of clauses 2 and 5 of section 2 of the Federal Import 
Milk Act when the shipper is an operator of a creamery or condensery, or 
is a producer shipping or transporting to a creamery or condensery and 
the creamery or condensery is located in the United States within a 
radius of 20 miles of the point of production of such milk, and the 
milk, prior to its sale, use, or disposal, is pasteurized, condensed, or 
evaporated.



Sec. 1210.28  Permits waiving clause 4, section 2 of the Federal Import Milk Act.

    The Secretary, in his discretion, will issue to a shipper who is an 
operator of a condensery a permit waiving the requirements of clause 4, 
of section 2 of the Federal Import Milk Act and allowing milk and cream 
containing not to exceed 1,200,000 bacteria per cubic centimeter to be 
shipped or transported into the United States if the condensery is 
located within a radius of 15 miles of the point of production of the 
milk and cream and such milk and cream are to be sterilized in the 
manufacture of condensed milk.



                           Subpart D_Hearings



Sec. 1210.30  Hearing procedure for permit denial, suspension, and revocation.

    Any person who contests denial, suspension, or revocation of a 
permit shall have an opportunity for a regulatory hearing before the 
Food and Drug Administration pursuant to subpart F of part 16 of this 
chapter.

[41 FR 48269, Nov. 2, 1976, as amended at 42 FR 15676, Mar. 22, 1977]



Sec. 1210.31  Hearing before prosecution.

    Before violation of the act is referred to the Department of Justice 
for prosecution under section 5 of the Federal Import Milk Act, an 
opportunity to be heard will be given to the party against whom 
prosecution is under consideration. The hearing will be private and 
confined to questions of fact. The party notified may present evidence, 
either oral or written, in person or by attorney, to show cause why he 
should not be prosecuted. After a hearing is held, if it appears that 
the law has been violated, the facts will be reported to the Department 
of Justice.

[41 FR 48269, Nov. 2, 1976]



PART 1230_REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT--Table of Contents



                      Subpart A_General Provisions

Sec.
1230.2 Scope of the act.
1230.3 Definitions.

[[Page 1052]]

                           Subpart B_Labeling

1230.10 Placement.
1230.11 Required wording.
1230.12 Manufacturer; distributor.
1230.13 Labeling of ``poison''.
1230.14 Directions for treatment.
1230.15 Responsibility for labeling directions for treatment.
1230.16 Exemption from labeling directions for treatment.

                           Subpart C_Guaranty

1230.20 General guaranty.
1230.21 Specific guaranty.

                   Subpart D_Administrative Procedures

1230.30 Collection of samples.
1230.31 Where samples may be collected.
1230.32 Analyzing of samples.
1230.33 Investigations.
1230.34 Analysis.
1230.35 Hearings.
1230.36 Hearings; when not provided for.
1230.37 Publication.

                            Subpart E_Imports

1230.40 Required label information.
1230.41 Delivery of containers.
1230.42 Invoices.
1230.43 Enforcement.
1230.44 Samples.
1230.45 No violation; release.
1230.46 Violation.
1230.47 Rejected containers.
1230.48 Relabeling of containers.
1230.49 Penalties.

    Authority: 15 U.S.C. 1261-1276.

    Cross References: For regulations relating to invoices, entry, and 
assessment of duties, see 19 CFR parts 141, 142, 143, 151, 152. For 
regulations regarding the examination, classification, and disposition 
of foods, drugs, devices, cosmetics, insecticides, fungicides, and 
caustic or corrosive substances, see 19 CFR part 12. For regulations 
relating to consular invoices, and documentation of merchandise, see 22 
CFR parts 91 and 92.

    Source: 38 FR 32110, Nov. 20, 1973, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 1230.2  Scope of the act.

    The provisions of the act apply to any container which has been 
shipped or delivered for shipment in interstate or foreign commerce, as 
defined in section 2(c) of the act (44 Stat. 1407; 15 U.S.C. 402) or 
which has been received from shipment in such commerce for sale or 
exchange, or which is sold or offered for sale or held for sale or 
exchange in any Territory or possession or in the District of Columbia.



Sec. 1230.3  Definitions.

    (a) The word container as used in the regulations in this part means 
a retail parcel, package, or container suitable for household use and 
employed exclusively to hold any dangerous caustic or corrosive 
substance defined in the act.
    (b) The words suitable for household use mean and imply adaptability 
for ready or convenient handling in places where people dwell.



                           Subpart B_Labeling



Sec. 1230.10  Placement.

    The label or sticker shall be so firmly attached to the container 
that it will remain thereon while the container is being used, and be so 
placed as readily to attract attention.



Sec. 1230.11  Required wording.

    (a) The common name of the dangerous caustic or corrosive substance 
which shall appear on the label or sticker is the name given in section 
2(a) of the act (44 Stat. 1406; 15 U.S.C. 402) or any other name 
commonly employed to designate and identify such substance.
    (b) Preparations within the scope of the act bearing trade or 
fanciful names shall, in addition, be labeled with the common name of 
the dangerous caustic or corrosive substance contained therein and 
comply with all the other requirements of the act and of the regulations 
in this part.



Sec. 1230.12  Manufacturer; distributor.

    If the name on the label or sticker is other than that of the 
manufacturer, it shall be qualified by such words as ``packed for,'' 
``packed by,'' ``sold by,'' or ``distributed by,'' as the case may be, 
or by other appropriate expression.



Sec. 1230.13  Labeling of ``poison''.

    The following are styles of uncondensed Gothic capital letters 24-
point (type face) size:

[[Page 1053]]

[GRAPHIC] [TIFF OMITTED] TR01FE93.039


When letters of not less than 24-point size are required on a label in 
stating the word ``poison'' they must not be smaller than those above 
set forth.



Sec. 1230.14  Directions for treatment.

    Except as provided in Sec. 1230.16, the container shall bear in all 
cases upon the label or sticker thereof, immediately following the word 
``Poison,'' directions for treatment in the case of internal personal 
injury; in addition, if the substance may cause external injury, 
directions for appropriate treatment shall be given. The directions 
shall prescribe such treatments for personal injury as are sanctioned by 
competent medical authority, and the materials called for by such 
directions shall be, whenever practicable, such as are usually available 
in the household.



Sec. 1230.15  Responsibility for labeling directions for treatment.

    A person who receives from a manufacturer or wholesaler any 
container which under the conditions set forth in section 2(b)(4) of the 
act and Sec. 1230.16 does not bear at the time of shipment directions 
for treatment in the case of personal injury must place such directions 
on the label or sticker if he offers such container for general sale or 
exchange.



Sec. 1230.16  Exemption from labeling directions for treatment.

    Manufacturers and wholesalers only, at the time of shipment or 
delivery for shipment, are exempted from placing directions for 
treatment on the label or sticker of any container for other than 
household use, but in any event the information required by section 2(b) 
(1), (2), and (3) of the act (44 Stat. 1407; 15 U.S.C. 402) and the 
regulations in this part shall be given.



                           Subpart C_Guaranty



Sec. 1230.20  General guaranty.

    In lieu of a particular guaranty for each lot of dangerous caustic 
or corrosive substances, a general continuing guaranty may be furnished 
by the guarantor to actual or prospective purchasers. The following are 
forms of continuing guaranties:
    (a) Substances for both household use and other than household use:

    The undersigned guarantees that the retail parcels, packages, or 
containers of the dangerous caustic or corrosive substance or substances 
to be sold to _____ are not misbranded within the meaning of the Federal 
Caustic Poison Act.

    (Date)
                                               (Signature and address of
                                                              guarantor)

    (b) Substances for other than household use (this form may be issued 
only by a manufacturer or wholesaler) (Sec. Sec. 1230.15, 1230.16):

    The dangerous caustic or corrosive substance or substances in retail 
parcels, packages, or containers suitable for household use to be sold 
to _____ are for other than household use, and guaranteed not to be 
misbranded within the meaning of the Federal Caustic Poison Act.

    (Date)
                                               (Signature and address of
                                             manufacturer or wholesaler)



Sec. 1230.21  Specific guaranty.

    If a guaranty in respect to any specific lot of dangerous caustic or 
corrosive substances be given, it shall be incorporated in or attached 
to the bill of sale, invoice, or other schedule bearing the date and the 
name and quantity of the substance sold, and shall not appear on the 
label or package. The following are forms of specific guaranties:
    (a) Substances for both household use and other than household use:


[[Page 1054]]


    The undersigned guarantees that the retail parcels, packages, or 
containers of the dangerous caustic or corrosive substance or substances 
listed herein (or specifying the substances) are not misbranded within 
the meaning of the Federal Caustic Poison Act.

                                    (Signature and address of guarantor)

    (b) Substances for other than household use (this form may be issued 
only by a manufacturer or wholesaler (Sec. Sec. 1230.15, 1230.16):

    The dangerous caustic or corrosive substance or substances listed 
herein (or specifying the substances) in retail parcels, packages, or 
containers suitable for household use are for other than household use 
and are guaranteed not to be misbranded within the meaning of the 
Federal Caustic Poison Act.

                                       (Name and address of manufacturer
                                                          or wholesaler)



                   Subpart D_Administrative Procedures



Sec. 1230.30  Collection of samples.

    Samples for examination by or under the direction and supervision of 
the Food and Drug Administration shall be collected by:
    (a) An authorized agent in the employ of the Department of Health 
and Human Services;
    (b) Any officer of any State, Territory, or possession, or of the 
District of Columbia, authorized by the Secretary of Health and Human 
Services.



Sec. 1230.31  Where samples may be collected.

    Caustic or corrosive substances within the scope of this act (44 
Stat. 1406; 15 U.S.C. 401-411) may be sampled wherever found.



Sec. 1230.32  Analyzing of samples.

    Samples collected by an authorized agent shall be analyzed at the 
laboratory designated by the Food and Drug Administration. Only such 
samples as are collected in accordance with Sec. Sec. 1230.30, 1230.31 
may be analyzed by or under the direction and supervision of the Food 
and Drug Administration. Upon request one subdivision of the sample, if 
available, shall be delivered to the party or parties interested.



Sec. 1230.33  Investigations.

    Authorized agents in the employ of the Department of Health and 
Human Services may make investigations, including the inspection of 
premises where dangerous caustic and corrosive substances subject to the 
act are manufactured, packed, stored, or held for sale or distribution, 
and make examinations of freight and other transportation records.



Sec. 1230.34  Analysis.

    (a) The methods of examination or analysis employed shall be those 
prescribed by the Association of Official Agricultural Chemists, when 
applicable, provided, however, that any method of analysis or 
examination satisfactory to the Food and Drug Administration may be 
employed.
    (b) All percentages stated in the definitions in section 2(a) of the 
Federal Caustic Poison Act shall be determined by weight.



Sec. 1230.35  Hearings.

    Whenever it appears from the inspection, analysis, or test of any 
container that the provisions of section 3 or 6 of the Federal Caustic 
Poison Act (44 Stat. 1407, 1409; 15 U.S.C. 403, 406) have been violated 
and criminal proceedings are contemplated, notice shall be given to the 
party or parties against whom prosecution is under consideration and to 
other interested parties, and a date shall be fixed at which such party 
or parties may be heard. The hearing shall be held at the office of the 
Food and Drug Administration designated in the notice and shall be 
private and confined to questions of fact. The parties notified may 
present evidence, either oral or written, in person or by attorney, to 
show cause why the matter should not be referred for prosecution as a 
violation of the Federal Caustic Poison Act.



Sec. 1230.36  Hearings; when not provided for.

    No hearing is provided for when the health, medical, or drug officer 
or agent of any State, Territory, or possession, or of the District of 
Columbia, acts under the authority contained in section 8 of the Federal 
Caustic Poison

[[Page 1055]]

Act (44 Stat. 1409; 15 U.S.C. 408) in reporting a violation direct to 
the United States attorney.



Sec. 1230.37  Publication.

    (a) After judgment of the court in any proceeding under the Federal 
Caustic Poison Act, notice shall be given by publication. Such notice 
shall include the findings of the court and may include the findings of 
the analyst and such explanatory statements of fact as the Secretary of 
Health and Human Services may deem appropriate.
    (b) This publication may be made in the form of a circular, notice, 
or bulletin, as the Secretary of Health and Human Services may direct.
    (c) If an appeal be taken from the judgment of the court before such 
publication, that fact shall appear.



                            Subpart E_Imports



Sec. 1230.40  Required label information.

    Containers which are offered for import shall in all cases bear 
labels or stickers having thereon the information required by section 
2(b) (1), (2), and (3) of the Federal Caustic Poison Act and the 
directions for treatment in the case of personal injury, except such 
directions need not appear on the label or sticker at the time of 
shipment by a wholesaler or manufacturer for other than household use.



Sec. 1230.41  Delivery of containers.

    Containers shall not be delivered to the consignee prior to report 
of examination, unless a bond has been given on the appropriate form for 
the amount of the full invoice value of such containers, together with 
the duty thereon, and the refusal of the consignee to return such 
containers for any cause to the custody of the District Director of 
Customs when demanded, for the purpose of excluding them from the 
country or for any other purpose, the consignee shall pay an amount 
equal to the sum named in the bond, and such part of the duty, if any, 
as may be payable, as liquidated damages for failure to return to the 
District Director of Customs on demand all containers covered by the 
bond.



Sec. 1230.42  Invoices.

    As soon as the importer makes entry, the invoices covering 
containers and the public stores packages shall be made available, with 
the least possible delay, for inspection by the representative of the 
district. When no sample is desired the invoice shall be stamped by the 
district ``No sample desired, Food and Drug Administration, Department 
of Health and Human Services, per (initials of inspecting officer).''



Sec. 1230.43  Enforcement.

    (a) Enforcement agency. The Federal Caustic Poison Act shall be 
enforced by the Food and Drug Administration, Department of Health and 
Human Services.
    (b) Enforcement of provisions. The enforcement of the provisions of 
the Federal Caustic Poison Act as they relate to imported dangerous 
caustic or corrosive substances, will, as a general rule, be under the 
direction of the chief of the local inspection district of the Food and 
Drug Administration, Department of Health and Human Services, and 
District Directors of Customs acting as administrative officers in 
carrying out directions relative to the detention, exportation, and 
sale, or other disposition of such substances and action under the bond 
in case of noncompliance with the provisions of the Federal Caustic 
Poison Act.
    (c) Chief of district as customs officer. The chief of district 
shall be deemed a customs officer in enforcing import regulations.
    (d) Nonlaboratory ports. (1) At the ports of entry where there is no 
district of the Food and Drug Administration, the District Director of 
Customs or deputy, on the day when the first notice of expected shipment 
of containers is received, either by invoice or entry, shall notify the 
chief of district in whose territory the port is located.
    (2) On the day of receipt of such notice the chief of district shall 
mail to the District Director of Customs appropriate notice, if no 
sample is desired. This notice serves as an equivalent to stamping the 
invoices at district ports with the legend ``No sample desired,

[[Page 1056]]

Food and Drug Administration, Department of Health and Human Services, 
per (initials of inspecting officer).''
    (3) If samples are desired, the Chief of district shall immediately 
notify the District Director of Customs.
    (4) The District Director of Customs at once shall forward samples, 
accompanied by description of shipment.
    (5) When samples are desired from each shipment of containers, the 
chief of district shall furnish to District Director of Customs and 
deputies at ports within the district's territory a list of such 
containers, indicating the size of sample necessary. Samples should then 
be sent promptly on arrival of containers without awaiting special 
request.
    (6) In all other particulars the procedure shall be the same at 
nonlaboratory ports as at laboratory ports, except that the time 
consumed in delivery of notices by mail shall be allowed for.



Sec. 1230.44  Samples.

    On the same day that samples are requested by the district, the 
District Director of Customs or appraiser shall notify the importer that 
samples will be taken, that the containers must be held intact pending a 
notice of the result of inspection and analysis, and that in case the 
containers do not comply with the requirements of the Federal Caustic 
Poison Act, they must be returned to the District Director of Customs 
for disposition. This notification may be given by the District Director 
of Customs or appraiser through individual notices to the importer or by 
suitable bulletin notices posted daily in the customhouse.



Sec. 1230.45  No violation; release.

    As soon as examination of the samples is completed, if no violation 
of the act is detected, the chief of the district shall send a notice of 
release to the importer and a copy of this notice to the District 
Director of Customs for his information.



Sec. 1230.46  Violation.

    (a) If a violation of the Federal Caustic Poison Act is disclosed, 
the chief of the district shall send to the importer due notice of the 
nature of the violation and of the time and place where evidence may be 
presented, showing that the containers should not be refused admission. 
At the same time similar notice regarding detention of the containers 
shall be sent to the District Director of Customs, requesting him to 
refuse delivery thereof or to require their return to customs custody if 
by any chance the containers were released without the bond referred to 
in Sec. 1230.41. The time allowed the importer for representations 
regarding the shipment may be extended at his request for a reasonable 
period to permit him to secure such evidence.
    (b) If the importer does not reply to the notice of hearing in 
person or by letter within the time allowed on the notice, a second 
notice, marked ``second and last notice,'' shall be sent at once by the 
chief of the district, advising him that failure to reply will cause 
definite recommendation to the District Director of Customs that the 
containers be refused admission and that the containers be exported 
within 3 months under customs supervision.



Sec. 1230.47  Rejected containers.

    (a) In all cases where the containers are to be refused admission, 
the chief of the district within 1 day after hearing, or, if the 
importer does not appear or reply within 3 days after second notice, 
shall notify the District Director of Customs in duplicate accordingly.
    (b) Not later than 1 day after receipt of this notice the District 
Director of Customs shall sign and transmit to the importer one of the 
copies, which shall serve as notification to the importer that the 
containers must be exported under customs supervision within 3 months 
from such date, as provided by law; the other notice shall be retained 
as office record and later returned as a report to the chief of the 
district. In all cases the importer shall return his notice to the 
District Director of Customs, properly certified as to the information 
required, as the form provides.



Sec. 1230.48  Relabeling of containers.

    (a) If containers are to be released after relabeling, a notice 
shall be sent by the chief of district direct to the importer, a carbon 
copy being sent to the

[[Page 1057]]

District Director of Customs. This notice must state specifically the 
conditions to be performed, so as to bring the performance thereof under 
the provisions of the customs bonds on consumption and warehouse 
entries, these bonds including provisions requiring compliance with all 
of the requirements of the Federal Caustic Poison Act and all 
regulations and instructions issued thereunder. The notice will also 
state the officer to be notified by the importer when the containers are 
ready for inspection.
    (b) The importer must return the notice to the District Director of 
Customs or chief of district, as designated, with the certificate 
thereon filled out, stating that he has complied with the prescribed 
conditions and that the containers are ready for inspection at the place 
named.
    (c) This notice will be delivered to the inspection officer, who, 
after inspection, will endorse the result thereof on the back of the 
notice and return the same to the District Director of Customs or to the 
chief of district, as the case may be.
    (d) When the conditions to be complied with are under the 
supervision of the chief of district, and these conditions have been 
fully met, he shall release the containers to the importer, sending a 
copy of the notice of release to the District Director of Customs for 
his information. If the containers have not been properly relabeled 
within the period allowed, the chief of district shall immediately give 
notice in duplicate to the District Director of Customs of the results 
of inspection. The District Director of Customs shall sign and 
immediately transmit one copy of the notice to the importer and proceed 
in the usual manner.
    (e) If the containers are detained subject to relabeling to be 
performed under the supervision of the District Director of Customs, the 
District Director of Customs, as soon as relabeling is accomplished, 
will notify the importer that the containers are released.
    (f) If the containers have not been properly relabeled within the 
period allowed, their sale after labeling as required by the act or 
other disposition must be effected by the District Director of Customs.
    (g) When the final action has been taken on containers which have 
been refused admission, sold, or otherwise disposed of as provided for 
by the act or which have been relabeled under the supervision of the 
District Director of Customs, he shall send to the chief of district a 
notice of such final action, giving the date and disposition.
    (h) When relabeling is allowed the importer must furnish 
satisfactory evidence as to the identity of the containers before 
release is given. The relabeling must be done at a stated place and 
apart from other containers of a similar nature.
    (i) When containers are shipped to another port for relabeling or 
exportation, they must be shipped under customs carrier's manifest, in 
the same manner as shipments in bond.
    (j) District Directors of Customs will perform the inspection 
service whenever containers are to be exported, sold, or otherwise 
disposed of, and in other cases when there is no officer of the district 
available.
    (k) District Directors of Customs and representatives of the 
district will confer and arrange the apportionment of the inspection 
service according to local conditions. Officers of the district will, 
whenever feasible, perform the inspection service in connection with 
relabeling.



Sec. 1230.49  Penalties.

    (a) In case of failure to comply with the instructions or 
recommendations of the chief of district as to conditions under which 
containers may be disposed of, the District Director of Customs shall 
notify the chief of district in all cases coming to his attention within 
3 days after inspection or after the expiration of the 3 months allowed 
by law if no action is taken.
    (b) The chief of district, upon receipt of the above-described 
notice, and in all cases of failure to meet the conditions imposed in 
order to comply with the provisions of the Federal Caustic Poison Act 
coming directly under his supervision, shall transmit to the District 
Director of Customs such evidence as he may have at hand tending

[[Page 1058]]

to indicate the importer's liability and make a recommendation 
accordingly.
    (c) The District Director of Customs, within 3 days of the receipt 
of this recommendation, whether favorable or otherwise, shall notify the 
importer that, the legal period of 3 months for exportation or 
relabeling having expired, action will be taken within 30 days to 
enforce the terms of the bond.



PART 1240_CONTROL OF COMMUNICABLE DISEASES--Table of Contents



                      Subpart A_General Provisions

Sec.
1240.3 General definitions.
1240.10 Effective bactericidal treatment.

                   Subpart B_Administrative Procedures

1240.20 Issuance and posting of certificates following inspections.
1240.30 Measures in the event of inadequate local control.
1240.45 Report of disease.

Subpart C [Reserved]

    Subpart D_Specific Administrative Decisions Regarding Interstate 
                                Shipments

1240.60 Molluscan shellfish.
1240.61 Mandatory pasteurization for all milk and milk products in final 
          package form intended for direct human consumption.
1240.62 Turtles intrastate and interstate requirements.
1240.65 Psittacine birds.
1240.75 Garbage.

                Subpart E_Source and Use of Potable Water

1240.80 General requirements for water for drinking and culinary 
          purposes.
1240.83 Approval of watering points.
1240.86 Protection of pier water system.
1240.90 Approval of treatment aboard conveyances.
1240.95 Sanitation of water boats.

    Authority: 42 U.S.C. 216, 243, 264, 271.

    Cross References: For Department of Health and Human Services 
regulations relating to foreign quarantine, sanitation measures, and 
control of communicable diseases, see Centers for Disease Control's 
requirements as set forth in 42 CFR parts 71 and 72.

    Source: 40 FR 5620, Feb. 6, 1975, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 1240.3  General definitions.

    As used in this part, terms shall have the following meaning:
    (a) Bactericidal treatment. The application of a method or substance 
for the destruction of pathogens and other organisms as set forth in 
Sec. 1240.10.
    (b) Communicable diseases. Illnesses due to infectious agents or 
their toxic products, which may be transmitted from a reservoir to a 
susceptible host either directly as from an infected person or animal or 
indirectly through the agency of an intermediate plant or animal host, 
vector, or the inanimate environment.
    (c) Communicable period. The period or periods during which the 
etiologic agent may be transferred directly or indirectly from the body 
of the infected person or animal to the body of another.
    (d) Contamination. The presence of a certain amount of undesirable 
substance or material, which may contain pathogenic microorganisms.
    (e) Conveyance. Conveyance means any land or air carrier, or any 
vessel as defined in paragraph (n) of this section.
    (f) Garbage. (1) The solid animal and vegetable waste, together with 
the natural moisture content, resulting from the handling, preparation, 
or consumption of foods in houses, restaurants, hotels, kitchens, and 
similar establishments, or (2) any other food waste containing pork.
    (g) Incubation period. The period between the implanting of disease 
organisms in a susceptible person and the appearance of clinical 
manifestation of the disease.
    (h) Interstate traffic. (1) The movement of any conveyance or the 
transportation of persons or property, including any portion of such 
movement or transportation which is entirely within a State or 
possession,
    (i) From a point of origin in any State or possession to a point of 
destination in any other State or possession, or
    (ii) Between a point of origin and a point of destination in the 
same State or possession but through any other State, possession, or 
contiguous foreign country.

[[Page 1059]]

    (2) Interstate traffic does not include the following:
    (i) The movement of any conveyance which is solely for the purpose 
of unloading persons or property transported from a foreign country, or 
loading persons or property for transportation to a foreign country.
    (ii) The movement of any conveyance which is solely for the purpose 
of effecting its repair, reconstruction, rehabilitation, or storage.
    (i) Milk. Milk is the product defined in Sec. 131.110 of this 
chapter.
    (j) Milk products. Food products made exclusively or principally 
from the lacteal secretion obtained from one or more healthy milk-
producing animals, e.g., cows, goats, sheep, and water buffalo, 
including, but not limited to, the following: lowfat milk, skim milk, 
cream, half and half, dry milk, nonfat dry milk, dry cream, condensed or 
concentrated milk products, cultured or acidified milk or milk products, 
kefir, eggnog, yogurt, butter, cheese (where not specifically exempted 
by regulation), whey, condensed or dry whey or whey products, ice cream, 
ice milk, other frozen dairy desserts and products obtained by modifying 
the chemical or physical characteristics of milk, cream, or whey by 
using enzymes, solvents, heat, pressure, cooling, vacuum, genetic 
engineering, fractionation, or other similar processes, and any such 
product made by the addition or subtraction of milkfat or the addition 
of safe and suitable optional ingredients for the protein, vitamin, or 
mineral fortification of the product.
    (k) Minimum heat treatment. The causing of all particles in garbage 
to be heated to a boiling temperature and held at that temperature for a 
period of not less than 30 minutes.
    (l) Possession. Any of the possessions of the United States, 
including Puerto Rico and the Virgin Islands.
    (m) Potable water. Water which meets the standards prescribed in the 
Environmental Protection Agency's Primary Drinking Water Regulations as 
set forth in 40 CFR part 141 and the Food and Drug Administration's 
sanitation requirements as set forth in this part and part 1250 of this 
chapter.
    (n) State. Any State, the District of Columbia, Puerto Rico and the 
Virgin Islands.
    (o) Utensil. Includes any kitchenware, tableware, glassware, 
cutlery, containers, or equipment with which food or drink comes in 
contact during storage, preparation, or serving.
    (p) Vessel. Any passenger-carrying, cargo, or towing vessel 
exclusive of:
    (1) Fishing boats including those used for shell-fishing;
    (2) Tugs which operate only locally in specific harbors and adjacent 
waters;
    (3) Barges without means of self-propulsion;
    (4) Construction-equipment boats and dredges; and
    (5) Sand and gravel dredging and handling boats.
    (q) Watering point. The specific place or water boat from which 
potable water is loaded on a conveyance.
    (r) Molluscan shellfish. Any edible species of fresh or frozen 
oysters, clams, mussels, and scallops or edible portions thereof, except 
when the product consists entirely of the shucked adductor muscle.
    (s) Certification number means a unique combination of letters and 
numbers assigned by a shellfish control authority to a molluscan 
shellfish processor.
    (t) Shellfish control authority means a Federal, State, or foreign 
agency, or sovereign tribal government, legally responsible for the 
administration of a program that includes activities such as 
classification of molluscan shellfish growing areas, enforcement of 
molluscan shellfish harvesting controls, and certification of molluscan 
shellfish processors.
    (u) Tag means a record of harvesting information attached to a 
container of shellstock by the harvester or processor.

[40 FR 5620, Feb. 6, 1975, as amended at 48 FR 11431, Mar. 18, 1983; 57 
FR 57344, Dec. 4, 1992; 60 FR 65201, Dec. 18, 1995]



Sec. 1240.10  Effective bactericidal treatment.

    Whenever, under the provisions of this part, bactericidal treatment 
is required, it shall be accomplished by one or more of the following 
methods:

[[Page 1060]]

    (a) By immersion of the utensil or equipment for at least 2 minutes 
in clean hot water at a temperature of at least 170 [deg]F or for one-
half minute in boiling water;
    (b) By immersion of the utensil or equipment for at least 2 minutes 
in a lukewarm chlorine bath containing at least 50 ppm of available 
chlorine if hypochlorites are used or a concentration of equal 
bactericidal strength if chloramines are used;
    (c) By exposure of the utensil or equipment in a steam cabinet at a 
temperature of at least 170 [deg]F for at least 15 minutes or at a 
temperature of 200 [deg]F for at least 5 minutes;
    (d) By exposure of the utensil or equipment in an oven or hot air 
cabinet at a temperature of at least 180 [deg]F for at least 20 minutes;
    (e) In the case of utensils or equipment so designed or installed as 
to make immersion or exposure impractical, the equipment may be treated 
for the prescribed periods of time either at the temperatures or with 
chlorine solutions as specified above, (1) with live steam from a hose 
if the steam can be confined, (2) with boiling rinse water, or (3) by 
spraying or swabbing with chlorine solution;
    (f) Any other method determined by the Commissioner of Food and 
Drugs, upon application of an owner or operator of a conveyance, to be 
effective to prevent the spread of communicable disease.

[40 FR 5620, Feb. 6, 1975, as amended at 54 FR 24900, June 12, 1989]



                   Subpart B_Administrative Procedures



Sec. 1240.20  Issuance and posting of certificates following inspections.

    The Commissioner of Food and Drugs may issue certificates based upon 
inspections provided for in this part and part 1250. Such certificates 
shall be prominently posted on conveyances.

[40 FR 5620, Feb. 6, 1975, as amended at 48 FR 11431, Mar. 18, 1983]



Sec. 1240.30  Measures in the event of inadequate local control.

    Whenever the Commissioner of Food and Drugs determines that the 
measures taken by health authorities of any State or possession 
(including political subdivisions thereof) are insufficient to prevent 
the spread of any of the communicable diseases from such State or 
possession to any other State or possession, he may take such measures 
to prevent such spread of the diseases as he deems reasonably necessary, 
including inspection, fumigation, disinfection, sanitation, pest 
extermination, and destruction of animals or articles believed to be 
sources of infection.

[40 FR 5620, Feb. 6, 1975, as amended at 48 FR 11431, Mar. 18, 1983]



Sec. 1240.45  Report of disease.

    The master of any vessel or person in charge of any conveyance 
engaged in interstate traffic, on which a case or suspected case of a 
communicable disease develops shall, as soon as practicable, notify the 
local health authority at the next port of call, station, or stop, and 
shall take such measures to prevent the spread of the disease as the 
local health authority directs.

Subpart C [Reserved]



    Subpart D_Specific Administrative Decisions Regarding Interstate 
                                Shipments



Sec. 1240.60  Molluscan shellfish.

    (a) A person shall not offer for transportation, or transport, in 
interstate traffic any molluscan shellfish handled or stored in such an 
insanitary manner, or grown in an area so contaminated, as to render 
such molluscan shellfish likely to become agents in, and their 
transportation likely to contribute to the spread of communicable 
disease from one State or possession to another.
    (b) All shellstock shall bear a tag that discloses the date and 
place they were harvested (by State and site), type and quantity of 
shellfish, and by whom they were harvested (i.e., the identification 
number assigned to the harvester by the shellfish control authority, 
where applicable or, if such identification numbers are not assigned, 
the name of the harvester or the name or registration number of the 
harvester's vessel). In place of the tag,

[[Page 1061]]

bulk shellstock shipments may be accompanied by a bill of lading or 
similar shipping document that contains the same information.
    (c) All containers of shucked molluscan shellfish shall bear a label 
that identifies the name, address, and certification number of the 
packer or repacker of the molluscan shellfish.
    (d) Any molluscan shellfish without such a tag, shipping document, 
or label, or with a tag, shipping document, or label that does not bear 
all the information required by paragraphs (b) and (c) of this section, 
shall be subject to seizure or refusal of entry, and destruction.

[40 FR 5620, Feb. 6, 1975, as amended at 60 FR 65202, Dec. 18, 1995]



Sec. 1240.61  Mandatory pasteurization for all milk and milk products
in final package form intended for direct human consumption.

    (a) No person shall cause to be delivered into interstate commerce 
or shall sell, otherwise distribute, or hold for sale or other 
distribution after shipment in interstate commerce any milk or milk 
product in final package form for direct human consumption unless the 
product has been pasteurized or is made from dairy ingredients (milk or 
milk products) that have all been pasteurized, except where alternative 
procedures to pasteurization are provided for by regulation, such as in 
part 133 of this chapter for curing of certain cheese varieties.
    (b) Except as provided in paragraphs (c) and (d) of this section, 
the terms ``pasteurization,'' ``pasteurized,'' and similar terms shall 
mean the process of heating every particle of milk and milk product in 
properly designed and operated equipment to one of the temperatures 
given in the following table and held continuously at or above that 
temperature for at least the corresponding specified time:

------------------------------------------------------------------------
               Temperature                             Time
------------------------------------------------------------------------
145 [deg]F (63 [deg]C) \1\..............  30 minutes.
161 [deg]F (72 [deg]C) \1\..............  15 seconds.
191 [deg]F (89 [deg]C)..................  1 second.
------------------------------------------------------------------------
\1\ If the fat content of the milk product is 10 percent or more, or if
  it contains added sweeteners, the specified temperature shall be
  increased by 5 [deg]F (3 [deg]C).


------------------------------------------------------------------------
               Temperature                             Time
------------------------------------------------------------------------
194 [deg]F (90 [deg]C)..................  0.5 second.
201 [deg]F (94 [deg]C)..................  0.1 second.
204 [deg]F (96 [deg]C)..................  0.05 second.
212 [deg]F (100 [deg]C).................  0.01 second.
------------------------------------------------------------------------

    (c) Eggnog shall be heated to at least the following temperature and 
time specification:

------------------------------------------------------------------------
               Temperature                             Time
------------------------------------------------------------------------
155 [deg]F (69 [deg]C)..................  30 minutes.
175 [deg]F (80 [deg]C)..................  25 seconds.
180 [deg]F (83 [deg]C)..................  15 seconds.
------------------------------------------------------------------------

    (d) Neither paragraph (b) nor (c) of this section shall be construed 
as barring any other pasteurization process that has been recognized by 
the Food and Drug Administration to be equally efficient in the 
destruction of microbial organisms of public health significance.

[52 FR 29514, Aug. 10, 1987, as amended at 57 FR 57344, Dec. 4, 1992]



Sec. 1240.62  Turtles intrastate and interstate requirements.

    (a) Definition. As used in this section the term ``turtles'' 
includes all animals commonly known as turtles, tortoises, terrapins, 
and all other animals of the order Testudinata, class Reptilia, except 
marine species (families Dermachelidae and Chelonidae).
    (b) Sales; general prohibition. Except as otherwise provided in this 
section, viable turtle eggs and live turtles with a carapace length of 
less than 4 inches shall not be sold, held for sale, or offered for any 
other type of commercial or public distribution.
    (c) Exceptions. The provisions of this section are not applicable 
to:
    (1) The sale, holding for sale, and distribution of live turtles and 
viable turtle eggs for bona fide scientific, educational, or 
exhibitional purposes, other than use as pets.
    (2) The sale, holding for sale, and distribution of live turtles and 
viable turtle eggs not in connection with a business.
    (3) The sale, holding for sale, and distribution of live turtles and 
viable turtle eggs intended for export only, provided that the outside 
of the shipping package is conspicuously labeled ``For Export Only.''

[[Page 1062]]

    (4) Marine turtles excluded from this regulation under the 
provisions of paragraph (a) of this section and eggs of such turtles.
    (d) Petitions. The Commissioner of Food and Drugs, either on his own 
initiative or on behalf of any interested person who has submitted a 
petition, may publish a proposal to amend this regulation. Any such 
petition shall include an adequate factual basis to support the 
petition, and will be published for comment if it contains reasonable 
grounds for the proposed regulation. A petition requesting such a 
regulation, which would amend this regulation, shall be submitted to the 
Division of Dockets Management, Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

[40 FR 22545, May 23, 1975, as amended at 46 FR 8461, Jan. 27, 1981; 48 
FR 11431, Mar. 18, 1983; 54 FR 24900, June 12, 1989; 59 FR 14366, Mar. 
28, 1994; 66 FR 56035, Nov. 6, 2001; 70 FR 48073, Aug. 18, 2005; 78 FR 
44881, July 25, 2013]



Sec. 1240.65  Psittacine birds.

    (a) The term psittacine birds shall include all birds commonly known 
as parrots, Amazons, Mexican double heads, African grays, cocatoos, 
macaws, parakeets, love birds, lories, lorikeets, and all other birds of 
the psittacine family.
    (b) No person shall transport, or offer for transportation, in 
interstate traffic any psittacine bird unless the shipment is 
accompanied by a permit from the State health department of the State of 
destination where required by such department.
    (c) Whenever the Surgeon General finds that psittacine birds or 
human beings in any area are infected with psittacosis and there is such 
danger of transmission of psittacosis from such area as to endanger the 
public health, he may declare it an area of infection. No person shall 
thereafter transport, or offer for transportation, in interstate traffic 
any psittacine bird from such area, except shipments authorized by the 
Surgeon General for purposes of medical research and accompanied by a 
permit issued by him, until the Surgeon General finds that there is no 
longer any danger of transmission of psittacosis from such area. As used 
in this paragraph, the term ``area'' includes, but is not limited to, 
specific premises or buildings.



Sec. 1240.75  Garbage.

    (a) A person shall not transport, receive, or cause to be 
transported or received, garbage in interstate traffic and feed such 
garbage to swine unless, prior to the feeding, such garbage has received 
minimum heat treatment.
    (b) A person transporting garbage in interstate traffic shall not 
make, or agree to make, delivery thereof to any person with knowledge of 
the intent or customary practice of such person to feed to swine garbage 
which has not been subjected to minimum heat treatment.



                Subpart E_Source and Use of Potable Water



Sec. 1240.80  General requirements for water for drinking and culinary purposes.

    Only potable water shall be provided for drinking and culinary 
purposes by any operator of a conveyance engaged in interstate traffic, 
except as provided in Sec. 1250.84(b) of this chapter. Such water shall 
either have been obtained from watering points approved by the 
Commissioner of Food and Drugs, or, if treated aboard a conveyance, 
shall have been subjected to treatment approved by the Commissioner of 
Food and Drugs.

[40 FR 5620, Feb. 6, 1975, as amended at 48 FR 11431, Mar. 18, 1983]



Sec. 1240.83  Approval of watering points.

    (a) The Commissioner of Food and Drugs shall approve any watering 
point if (1) the water supply threat meets the standards prescribed in 
the Environmental Protection Agency's Primary Drinking Water Regulations 
as set forth in 40 CFR part 141, and (2) the methods of and facilities 
for delivery of such water to the conveyance and the sanitary conditions 
surrounding such delivery prevent the introduction, transmission, or 
spread of communicable diseases.
    (b) The Commissioner of Food and Drugs may base his approval or 
disapproval of a watering point upon investigations made by 
representatives

[[Page 1063]]

of State departments of health or of the health authorities of 
contiguous foreign nations.
    (c) If a watering point has not been approved, the Commissioner of 
Food and Drugs may permit its temporary use under such conditions as, in 
his judgment, are necessary to prevent the introduction, transmission, 
or spread of communicable diseases.
    (d) Upon request of the Commissioner of Food and Drugs, operators of 
conveyances shall provide information as to watering points used by 
them.

[40 FR 5620, Feb. 6, 1975, as amended at 48 FR 11431, Mar. 18, 1983; 48 
FR 13978, Apr. 1, 1983]



Sec. 1240.86  Protection of pier water system.

    No vessel engaged in interstate traffic shall make a connection 
between its nonpotable water system and any pier potable water system 
unless provisions are made to prevent backflow from the vessel to the 
pier.



Sec. 1240.90  Approval of treatment aboard conveyances.

    (a) The treatment of water aboard conveyances shall be approved by 
the Commissioner of Food and Drugs if the apparatus used is of such 
design and is so operated as to be capable of producing and in fact does 
produce, potable water.
    (b) The Commissioner of Food and Drugs may base his approval or 
disapproval of the treatment of water upon investigations made by 
representatives of State departments of health or of the health 
authorities of contiguous foreign nations.
    (c) Overboard water treated on vessels shall be from areas 
relatively free of contamination and pollution.

[40 FR 5620, Feb. 6, 1975, as amended at 48 FR 11431, Mar. 18, 1983]



Sec. 1240.95  Sanitation of water boats.

    No vessel engaged in interstate traffic shall obtain water for 
drinking and culinary purposes from any water boat unless the tanks, 
piping, and other appurtenances used by the water boat in the loading, 
transportation, and delivery of such drinking and culinary water, have 
been approved by the Commissioner of Food and Drugs.

[40 FR 5620, Feb. 6, 1975, as amended at 48 FR 11431, Mar. 18, 1983]



PART 1250_INTERSTATE CONVEYANCE SANITATION--Table of Contents



                      Subpart A_General Provisions

Sec.
1250.3 Definitions.

   Subpart B_Food Service Sanitation on Land and Air Conveyances, and 
                                 Vessels

1250.20 Applicability.
1250.21 Inspection.
1250.22 General requirements.
1250.25 Source identification and inspection of food and drink.
1250.26 Special food requirements.
1250.27 Storage of perishables.
1250.28 Source and handling of ice.
1250.30 Construction, maintenance and use of places where food is 
          prepared, served, or stored.
1250.32 Food-handling operations.
1250.33 Utensils and equipment.
1250.34 Refrigeration equipment.
1250.35 Health of persons handling food.
1250.38 Toilet and lavatory facilities for use of food-handling 
          employees.
1250.39 Garbage equipment and disposition.

      Subpart C_Equipment and Operation of Land and Air Conveyances

1250.40 Applicability.
1250.41 Submittal of construction plans.
1250.42 Water systems; constant temperature bottles.
1250.43 Ice.
1250.44 Drinking utensils and toilet articles.
1250.45 Food handling facilities on railroad conveyances.
1250.49 Cleanliness of conveyances.
1250.50 Toilet and lavatory facilities.
1250.51 Railroad conveyances; discharge of wastes.
1250.52 Discharge of wastes on highway conveyances.
1250.53 Discharge of wastes on air conveyances.

         Subpart D_Servicing Areas for Land and Air Conveyances

1250.60 Applicability.
1250.61 Inspection and approval.
1250.62 Submittal of construction plans.
1250.63 General requirements.
1250.65 Drainage.
1250.67 Watering equipment.
1250.70 Employee conveniences.
1250.75 Disposal of human wastes.

[[Page 1064]]

1250.79 Garbage disposal.

        Subpart E_Sanitation Facilities and Conditions on Vessels

1250.80 Applicability.
1250.81 Inspection.
1250.82 Potable water systems.
1250.83 Storage of water prior to treatment.
1250.84 Water in galleys and medical care spaces.
1250.85 Drinking fountains and coolers; ice; constant temperature 
          bottles.
1250.86 Water for making ice.
1250.87 Wash water.
1250.89 Swimming pools.
1250.90 Toilets and lavatories.
1250.93 Discharge of wastes.
1250.95 Insect control.
1250.96 Rodent control.

    Authority: 42 U.S.C. 216, 243, 264, 271.

    Cross References: For Department of Health and Human Services 
regulations relating to foreign quarantine and control of communicable 
diseases, see Centers for Disease Control's requirements as set forth in 
42 CFR parts 71 and 72.

    Source: 40 FR 5624, Feb. 6, 1975, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 1250.3  Definitions.

    As used in this part, terms shall have the following meaning:
    (a) Bactericidal treatment. The application of a method or substance 
for the destruction of pathogens and other organisms as set forth in 
Sec. 1240.10 of this chapter.
    (b) Communicable diseases. Illnesses due to infectious agents or 
their toxic products, which may be transmitted from a reservoir to a 
susceptible host either directly as from an infected person or animal or 
indirectly through the agency of an intermediate plant or animal host, 
vector, or the inanimate environment.
    (c) Communicable period. The period or periods during which the 
etiologic agent may be transferred directly or indirectly from the body 
of the infected person or animal to the body of another.
    (d) Contamination. The presence of a certain amount of undesirable 
substance or material, which may contain pathogenic microorganisms.
    (e) Conveyance. Conveyance means any land or air carrier, or any 
vessel as defined in paragraph (m) of this section.
    (f) Existing vessel. Any vessel the construction of which was 
started prior to the effective date of the regulations in this part.
    (g) Garbage. (1) The solid animal and vegetable waste, together with 
the natural moisture content, resulting from the handling, preparation, 
or consumption of foods in houses, restaurants, hotels, kitchens, and 
similar establishments, or (2) any other food waste containing pork.
    (h) Interstate traffic. (1) The movement of any conveyance or the 
transportation of persons or property, including any portion of such 
movement or transportation which is entirely within a State or 
possession, (i) from a point of origin in any State or possession to a 
point of destination in any other State or possession, or (ii) between a 
point of origin and a point of destination in the same State or 
possession but through any other State, possession, or contiguous 
foreign country.
    (2) Interstate traffic does not include the following:
    (i) The movement of any conveyance which is solely for the purpose 
of unloading persons or property transported from a foreign country, or 
loading persons or property for transportation to a foreign country.
    (ii) The movement of any conveyance which is solely for the purpose 
of effecting its repair, reconstruction, rehabilitation, or storage.
    (i) Possession. Any of the possessions of the United States, 
including Puerto Rico and the Virgin Islands.
    (j) Potable water. Water which meets the standards prescribed in the 
Environmental Protection Agency's Primary Drinking Water Regulations as 
set forth in 40 CFR part 141 and the Food and Drug Administration's 
sanitation regulations as set forth in this part and part 1240 of this 
chapter.
    (k) State. Any State, the District of Columbia, Puerto Rico and the 
Virgin Islands.
    (l) Utensil. Includes any kitchenware, tableware, glassware, 
cutlery, containers, or equipment with which food or drink comes in 
contact during storage, preparation, or serving.

[[Page 1065]]

    (m) Vessel. Any passenger-carrying, cargo, or towing vessel 
exclusive of:
    (1) Fishing boats including those used for shell-fishing;
    (2) Tugs which operate only locally in specific harbors and adjacent 
waters;
    (3) Barges without means of self-propulsion;
    (4) Construction-equipment boats and dredges; and
    (5) Sand and gravel dredging and handling boats.
    (n) Wash water. Water suitable for domestic uses other than for 
drinking and culinary purposes, and medical care purposes excluding 
hydrotherapy.
    (o) Shellfish. Any fresh, frozen, or incompletely cooked oysters, 
clams, or mussels, either shucked or in the shell, and any fresh, 
frozen, or incompletely cooked edible products thereof.

[40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]



   Subpart B_Food Service Sanitation on Land and Air Conveyances, and 
                                 Vessels



Sec. 1250.20  Applicability.

    All conveyances engaged in interstate traffic shall comply with the 
requirements prescribed in this subpart and Sec. 1240.20 of this 
chapter.



Sec. 1250.21  Inspection.

    The Commissioner of Food and Drugs may inspect such conveyance to 
determine compliance with the requirements of this subpart and Sec. 
1240.20 of this chapter.

[40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]



Sec. 1250.22  General requirements.

    All food and drink served on conveyances shall be clean, wholesome, 
and free from spoilage, and shall be prepared, stored, handled, and 
served in accordance with the requirements prescribed in this subpart 
and Sec. 1240.20 of this chapter.



Sec. 1250.25  Source identification and inspection of food and drink.

    (a) Operators of conveyances shall identify, when requested by the 
Commissioner of Food and Drugs, the vendors, distributors or dealers 
from whom they have acquired or are acquiring their food supply, 
including milk, fluid milk products, ice cream and other frozen 
desserts, butter, cheese, bottled water, sandwiches and box lunches.
    (b) The Commissioner of Food and Drugs may inspect any source of 
such food supply in order to determine whether the requirements of the 
regulations in this subpart and in Sec. 1240.20 of this chapter are 
being met, and may utilize the results of inspections of such sources 
made by representatives of State health departments or of the health 
authorities of contiguous foreign nations.

[40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]



Sec. 1250.26  Special food requirements.

    Milk, fluid milk products, ice cream and other frozen desserts, 
butter, cheese, and shellfish served or sold on conveyances shall 
conform to the following requirements:
    (a) Milk and fluid milk products, including cream, buttermilk, skim 
milk, milk beverages, and reconstituted milk, shall be pasteurized and 
obtained from a source of supply approved by the Commissioner of Food 
and Drugs. The Commissioner of Food and Drugs shall approve any source 
of supply at or from which milk or fluid milk products are produced, 
processed, and distributed so as to prevent the introduction, 
transmission, or spread of communicable diseases. If a source of supply 
of milk or fluid milk products has not been approved, the Commissioner 
of Food and Drugs may permit its temporary use under such conditions as, 
in his judgment, are necessary to prevent the introduction, 
transmission, or spread of communicable diseases. Containers of milk and 
fluid milk products shall be plainly labeled to show the contents, the 
word ``pasteurized'', and the identity of the plant at which the 
contents were packaged by name and address, provided that a code may be 
used in lieu of address.
    (b) Ice cream, other frozen desserts, and butter shall be 
manufactured from milk or milk products that have been pasteurized or 
subjected to equivalent heat treatment.

[[Page 1066]]

    (c) Cheese shall be (1) pasteurized or subjected to equivalent heat 
treatment, (2) made from pasteurized milk products or from milk products 
which have been subjected to equivalent heat treatment, or (3) cured for 
not less than 60 days at a temperature not less than 35 [deg]F.
    (d) Milk, buttermilk, and milk beverages shall be served in or from 
the original individual containers in which received from the 
distributor, or from a bulk container equipped with a dispensing device 
so designed, constructed, installed, and maintained as to prevent the 
transmission of communicable diseases.
    (e) Shellfish purchased for consumption on any conveyance shall 
originate from a dealer currently listed by the Public Health Service as 
holding an unexpired and unrevoked certificate issued by a State 
authority.
    (f) Shucked shellfish shall be purchased in the containers in which 
they are placed at the shucking plant and shall be kept therein until 
used. The State abbreviation and the certificate number of the packers 
shall be permanently recorded on the container.

[40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]



Sec. 1250.27  Storage of perishables.

    All perishable food or drink shall be kept at or below 50 [deg]F, 
except when being prepared or kept hot for serving.



Sec. 1250.28  Source and handling of ice.

    Ice coming in contact with food or drink and not manufactured on the 
conveyance shall be obtained from sources approved by competent health 
authorities. All ice coming in contact with food or drink shall be 
stored and handled in such manner as to avoid contamination.



Sec. 1250.30  Construction, maintenance and use of places where 
food is prepared, served, or stored.

    (a) All kitchens, galleys, pantries, and other places where food is 
prepared, served, or stored shall be adequately lighted and ventilated: 
Provided, however, That ventilation of cold storage rooms shall not be 
required. All such places where food is prepared, served, or stored 
shall be so constructed and maintained as to be clean and free from 
flies, rodents, and other vermin.
    (b) Such places shall not be used for sleeping or living quarters.
    (c) Water of satisfactory sanitary quality, under head or pressure, 
and adequate in amount and temperature, shall be easily accessible to 
all rooms in which food is prepared and utensils are cleaned.
    (d) All plumbing shall be so designed, installed, and maintained as 
to prevent contamination of the water supply, food, and food utensils.



Sec. 1250.32  Food-handling operations.

    (a) All food-handling operations shall be accomplished so as to 
minimize the possibility of contaminating food, drink, or utensils.
    (b) The hands of all persons shall be kept clean while engaged in 
handling food, drink, utensils, or equipment.



Sec. 1250.33  Utensils and equipment.

    (a) All utensils and working surfaces used in connection with the 
preparation, storage, and serving of food or beverages, and the cleaning 
of food utensils, shall be so constructed as to be easily cleaned and 
self-draining and shall be maintained in good repair. Adequate 
facilities shall be provided for the cleaning and bactericidal treatment 
of all multiuse eating and drinking utensils and equipment used in the 
preparation of food and beverages. An indicating thermometer, suitably 
located, shall be provided to permit the determination of the hot water 
temperature when and where hot water is used as the bactericidal agent.
    (b) All multiuse eating and drinking utensils shall be thoroughly 
cleaned in warm water and subjected to an effective bactericidal 
treatment after each use. All other utensils that come in contact with 
food and drink shall be similarly treated immediately following the 
day's operation. All equipment shall be kept clean.
    (c) After bactericidal treatment, utensils shall be stored and 
handled in such manner as to prevent contamination before reuse.

[[Page 1067]]



Sec. 1250.34  Refrigeration equipment.

    Each refrigerator shall be equipped with a thermometer located in 
the warmest portion thereof. Waste water drains from ice boxes, 
refrigerating equipment, and refrigerated spaces shall be so installed 
as to prevent backflow of contaminating liquids.



Sec. 1250.35  Health of persons handling food.

    (a) Any person who is known or suspected to be in a communicable 
period or a carrier of any communicable disease shall not be permitted 
to engage in the preparation, handling, or serving of water, other 
beverages, or food.
    (b) Any person known or suspected to be suffering from 
gastrointestinal disturbance or who has on the exposed portion of the 
body an open lesion or an infected wound shall not be permitted to 
engage in the preparation, handling, or serving of food or beverages.



Sec. 1250.38  Toilet and lavatory facilities for use of food
-handling employees.

    (a) Toilet and lavatory facilities of suitable design and 
construction shall be provided for use of food-handling employees. 
Railroad dining car crew lavatory facilities are regulated under Sec. 
1250.45.
    (b) Signs directing food-handling employees to wash their hands 
after each use of toilet facilities shall be posted so as to be readily 
observable by such employees. Hand washing facilities shall include 
soap, sanitary towels and hot and cold running water or warm running 
water in lieu of hot and cold running water.
    (c) All toilet rooms shall be maintained in a clean condition.



Sec. 1250.39  Garbage equipment and disposition.

    Watertight, readily cleanable nonabsorbent containers with close-
fitting covers shall be used to receive and store garbage. Garbage and 
refuse shall be disposed of as frequently as is necessary and 
practicable.



      Subpart C_Equipment and Operation of Land and Air Conveyances



Sec. 1250.40  Applicability.

    The sanitary equipment and facilities on land and air conveyances 
engaged in interstate traffic and the use of such equipment and 
facilities shall comply with the requirements prescribed in this 
subpart.



Sec. 1250.41  Submittal of construction plans.

    Plans for the construction or major reconstruction of sanitary 
equipment or facilities for such conveyances shall be submitted to the 
Commissioner of Food and Drugs for review of the conformity of such 
plans with the requirements of this subpart, except that submittal of 
plans shall not be required for any conveyance under reconstruction if 
the owner or operator thereof has made arrangements satisfactory to the 
Commissioner of Food and Drugs for inspections of such conveyances while 
under reconstruction for the purpose of determining conformity with 
those requirements.

[40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]



Sec. 1250.42  Water systems; constant temperature bottles.

    (a) The water system, whether of the pressure or gravity type, shall 
be complete and closed from the filling ends to the discharge taps, 
except for protected vent openings. The water system shall be protected 
against backflow.
    (b) Filling pipes or connections through which water tanks are 
supplied shall be provided on both sides of all new railway conveyances 
and on existing conveyances when they undergo heavy repairs. All filling 
connections shall be easily cleanable and so located and protected as to 
minimize the hazard of contamination of the water supply.
    (c) On all new or reconstructed conveyances, water coolers shall be 
an integral part of the closed system.
    (d) Water filters if used on dining cars and other conveyances will 
be permitted only if they are so operated and

[[Page 1068]]

maintained at all times as to prevent contamination of the water.
    (e) Constant temperature bottles and other containers used for 
storing or dispensing potable water shall be kept clean at all times and 
shall be subjected to effective bactericidal treatment as often as may 
be necessary to prevent the contamination of water so stored and 
dispensed.



Sec. 1250.43  Ice.

    Ice shall not be permitted to come in contact with water in coolers 
or constant temperature bottles.



Sec. 1250.44  Drinking utensils and toilet articles.

    (a) No cup, glass, or other drinking utensil which may be used by 
more than one person shall be provided on any conveyance unless such 
cup, glass, or drinking utensil shall have been thoroughly cleaned and 
subjected to effective bactericidal treatment after each individual use.
    (b) Towels, combs, or brushes for common use shall not be provided.



Sec. 1250.45  Food handling facilities on railroad conveyances.

    (a) Both kitchens and pantries of cars hereafter constructed or 
reconstructed shall be equipped with double sinks, one of which shall be 
of sufficient size and depth to permit complete immersion of a basket of 
dishes during bactericidal treatment; in the pantry a dishwashing 
machine may be substituted for the double sinks. If chemicals are used 
for bactericidal treatment, 3-compartment sinks shall be provided.
    (b) A sink shall be provided for washing and handling cracked ice 
used in food or drink and shall be used for no other purpose.
    (c) Lavatory facilities for the use of the dining car crew shall be 
provided on each dining car. Such facilities shall be conveniently 
located and used for hand and face washing only: Provided, however, That 
where the kitchen and pantry on a dining car hereafter constructed or 
reconstructed are so partitioned or separated as to impede free passage 
between them lavatory facilities shall be provided in both the kitchen 
and the pantry.
    (d) Wherever toilet and lavatory facilities required by paragraph 
(c) of this section are not on the dining car, a lavatory shall be 
provided on the dining car for the use of employees. The lavatory shall 
be conveniently located and used only for the purpose for which it is 
installed.



Sec. 1250.49  Cleanliness of conveyances.

    Conveyances while in transit shall be kept clean and free of flies 
and mosquitoes. A conveyance which becomes infected with vermin shall be 
placed out of service until such time as it shall have been effectively 
treated for the destruction of the vermin.



Sec. 1250.50  Toilet and lavatory facilities.

    Where toilet and lavatory facilities are provided on conveyances 
they shall be so designed as to permit ready cleaning. On conveyances 
not equipped with retention facilities, toilet hoppers shall be of such 
design and so located as to prevent spattering of water filling pipes or 
hydrants.



Sec. 1250.51  Railroad conveyances; discharge of wastes.

    (a) New railroad conveyances. Human wastes, garbage, waste water, or 
other polluting materials shall not be discharged from any new railroad 
conveyance except at servicing areas approved by the Commissioner of 
Food and Drugs. In lieu of retention pending discharge at approved 
servicing areas, human wastes, garbage, waste water, or other polluting 
materials that have been suitably treated to prevent the spread of 
communicable diseases may be discharged from such conveyances, except at 
stations. For the purposes of this section, ``new railroad conveyance'' 
means any such conveyance placed into service for the first time after 
July 1, 1972, and the terms ``waste water or other polluting materials'' 
do not include drainage of drinking water taps or lavatory facilities.
    (b) Nonnew railroad conveyances. Human wastes, garbage, waste water, 
or other polluting materials shall not be discharged from any railroad 
conveyance, other than passenger conveyances for which an extension has 
been granted pursuant to paragraph (f) of this section, after December 
31, 1977,

[[Page 1069]]

except at servicing areas approved by the Commissioner of Food and 
Drugs. In lieu of retention pending discharge at approved servicing 
areas, human wastes, garbage, waste water, or other polluting materials 
that have been suitably treated to prevent the spread of communicable 
diseases may be discharged from such conveyances, except at stations. 
The terms ``waste water or other polluting materials'' do not include 
drainage of drinking water taps or lavatory facilities.
    (c) Toilets. When railroad conveyances, occupied or open to 
occupancy by travelers, are at a station or servicing area, toilets 
shall be kept locked unless means are provided to prevent contamination 
of the area or station.
    (d) Submission of annual report. Each railroad company shall submit 
to the Center for Food Safety and Applied Nutrition (HFS-627), Food and 
Drug Administration, 5001 Campus Dr., College Park, MD 20740, an annual 
report of accomplishments made in modifying conveyances to achieve 
compliance with paragraph (b) of this section. Annual reports shall be 
required until a report is submitted showing that 100 percent of the 
company's conveyances can comply with the requirements of paragraph (b) 
of this section; annual reports shall be required subsequent to such 
report if conveyances not capable of complying with the requirements of 
paragraph (b) of this section are acquired. Every railroad company shall 
have not less than 10 percent of its nonpassenger conveyances that are 
in operation capable of complying with the requirements of paragraph (b) 
of this section by December 31, 1974, not less than 40 percent by 
December 31, 1975, and not less than 70 percent by December 31, 1976. 
All conveyances, other than passenger conveyances for which an extension 
has been granted pursuant to paragraph (f) of this section, in operation 
after December 31, 1977, shall be capable of complying with paragraph 
(b) of this section.
    (e) Requirements of annual report. Annual reports required by 
paragraph (d) of this section shall be submitted within 60 days of the 
end of each calendar year. Each report shall contain at least the 
following information:
    (1) Company name and address.
    (2) Name, title, and address of the company's chief operating 
official.
    (3) Name, title, address, and telephone number of the person 
designated by the company to be directly responsible for compliance with 
this section.
    (4) A statement that all new railroad conveyances placed into 
service after July 1, 1972 meet the requirements of this section.
    (5) A complete, factual, narrative statement explaining why 
retrofitting of noncomplying nonnew conveyances is incomplete, if it is 
incomplete.
    (6) A statement of the percentage of conveyances retrofitted with 
waste discharge facilities in compliance with this section as of the 
reporting date and the percentage expected to be completed by December 
31st of the following year.
    (7) A tabular report with the following vertical columns: equipment 
type, e.g., locomotive, caboose, passenger car, and any others having 
toilets; number of toilets per conveyance; number of each equipment type 
in operation; and number of each to be retrofitted by December 31st of 
each year until 100 percent compliance with this section is achieved.
    (f) Variances and extensions--(1) Variances. Upon application by a 
railroad company, the Director, Center for Food Safety and Applied 
Nutrition, may grant a variance from the compliance schedule prescribed 
in paragraph (d) of this section for nonpassenger conveyances when the 
requested variance is required to prevent substantial disruption of the 
railroad company's operations. Such variance shall not affect the final 
deadline of compliance established in paragraph (d) of this section.
    (2) Extensions. Upon application by a railroad company, the 
Director, Center for Food Safety and Applied Nutrition, may grant an 
extension of time for compliance with the requirements of paragraph (b) 
of this section beyond December 31, 1977, for passenger conveyances 
operated by railroad companies when compliance cannot be achieved 
without substantial disruption of the railroad company's operations.

[[Page 1070]]

    (3) Application for variance or extension. Application for variances 
or extensions shall be submitted to the Food and Drug Administration, 
Center for Food Safety and Applied Nutrition, Manager, Interstate Travel 
Sanitation Sub-Program, HFF-312, 5001 Campus Dr., College Park, MD 
20740, and shall include the following information:
    (i) A detailed description of the proposed deviation from the 
requirements of paragraphs (b) or (d) of this section.
    (ii) A report, current to the date of the request for a variance or 
extension, containing the information required by paragraph (e) of this 
section.
    (4) Administration of variances and extensions. (i) Written 
notification of the granting or refusal of a variance or extension will 
be provided to the applying railroad company by the Director, Center for 
Food Safety and Applied Nutrition. The notification of a granted 
variance will state the approved deviation from the compliance schedule 
provided for in paragraph (d) of this section. The notification of a 
granted extension will state the final date for compliance with the 
provisions of paragraph (b) of this section.
    (ii) A public file of requested variances and extensions, their 
disposition, and information relating to pending actions will be 
maintained in the Division of Dockets Management, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852.
    (iii) After notice to the railroad company and opportunity for 
hearing in accordance with part 16 of this chapter, a variance or 
extension may be withdrawn prior to its scheduled termination if the 
Director, Center for Food Safety and Applied Nutrition, determines that 
such withdrawal is necessary to protect the public health.

    Cross Reference: For statutory exemptions for ``intercity rail 
passenger service,'' see section 306(i) of 45 U.S.C. 546(i).

[40 FR 5624, Feb. 6, 1975, as amended at 40 FR 30110, July 17, 1975; 46 
FR 8461, Jan. 27, 1981; 48 FR 11432, Mar. 18, 1983; 54 FR 24900, June 
12, 1989; 59 FR 14366, Mar. 28, 1994; 61 FR 14481, Apr. 2, 1996; 66 FR 
56035, Nov. 6, 2001; 81 FR 49897, July 29, 2016]

    Effective Date Note: For a document staying the effectiveness of 
Sec. 1250.51 (b) and (d), see 42 FR 57122, Nov. 1, 1977.



Sec. 1250.52  Discharge of wastes on highway conveyances.

    There shall be no discharge of excrement, garbage, or waste water 
from a highway conveyance except at servicing areas approved by the 
Commissioner of Food and Drugs.

[40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]



Sec. 1250.53  Discharge of wastes on air conveyances.

    There shall be no discharge of excrement or garbage from any air 
conveyance except at servicing areas approved by the Commissioner of 
Food and Drugs.

[40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]



         Subpart D_Servicing Areas for Land and Air Conveyances



Sec. 1250.60  Applicability.

    Land and air conveyances engaged in interstate traffic shall use 
only such servicing areas within the United States as have been approved 
by the Commissioner of Food and Drugs as being in compliance with the 
requirements prescribed in this subpart.

[40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]



Sec. 1250.61  Inspection and approval.

    The Commissioner of Food and Drugs may inspect any such areas to 
determine whether they shall be approved. He may base his approval or 
disapproval on investigations made by representatives of State 
departments of health.

[40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]



Sec. 1250.62  Submittal of construction plans.

    Plans for construction or major reconstruction of sanitation 
facilities at servicing areas shall be submitted to the Commissioner of 
Food and Drugs for review of the conformity of the proposed facilities 
with the requirements of this subpart.

[40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]

[[Page 1071]]



Sec. 1250.63  General requirements.

    Servicing areas shall be provided with all necessary sanitary 
facilities so operated and maintained as to prevent the spread of 
communicable diseases.



Sec. 1250.65  Drainage.

    All platforms and other places at which water or food supplies are 
loaded onto or removed from conveyances shall be adequately drained so 
as to prevent pooling.



Sec. 1250.67  Watering equipment.

    (a) General requirements. All servicing area piping systems, 
hydrants, taps, faucets, hoses, buckets, and other appurtenances 
necessary for delivery of drinking and culinary water to a conveyance 
shall be designed, constructed, maintained and operated in such a manner 
as to prevent contamination of the water.
    (b) Outlets for nonpotable water. Outlets for nonpotable water shall 
be provided with fittings different from those provided for outlets for 
potable water and each nonpotable water outlet shall be posted with 
permanent signs warning that the water is unfit for drinking.
    (c) Ice. If bulk ice is used for the cooling of drinking water or 
other beverages, or for food preservation purposes, equipment 
constructed so as not to become a factor in the transmission of 
communicable diseases shall be provided for the storage, washing, 
handling, and delivery to conveyances of such bulk ice, and such 
equipment shall be used for no other purposes.



Sec. 1250.70  Employee conveniences.

    (a) There shall be adequate toilet, washroom, locker, and other 
essential sanitary facilities readily accessible for use of employees 
adjacent to places or areas where land and air conveyances are serviced, 
maintained, and cleaned. These facilities shall be maintained in a clean 
and sanitary condition at all times.
    (b) In the case of diners not in a train but with a crew on board, 
adequate toilet facilities shall be available to the crew within a 
reasonable distance but not exceeding 500 feet of such diners.
    (c) Drinking fountains and coolers shall be constructed of 
impervious, nonoxidizing material, and shall be so designed and 
constructed as to be easily cleaned. The jet of a drinking fountain 
shall be slanting and the orifice of the jet shall be protected by a 
guard in such a manner as to prevent contamination thereof by droppings 
from the mouth. The orifice of such a jet shall be located a sufficient 
distance above the rim of the basin to prevent backflow.



Sec. 1250.75  Disposal of human wastes.

    (a) At servicing areas and at stations where land and air 
conveyances are occupied by passengers the operations shall be so 
conducted as to avoid contamination of such areas and stations by human 
wastes.
    (b) Toilet wastes shall be disposed of through sanitary sewers or by 
other methods assuring sanitary disposal of such wastes. All soil cans 
and removable containers shall be thoroughly cleaned before being 
returned to use. Equipment for cleaning such containers and for flushing 
nonremovable containers and waste carts shall be so designed as to 
prevent backflow into the water line, and such equipment shall be used 
for no purpose connected with the handling of food, water or ice.
    (c) All persons who have handled soil cans or other containers which 
have come in contact with human wastes shall be required to wash their 
hands thoroughly with soap and warm water and to remove any garments 
which have become soiled with such wastes before engaging in any work 
connected with the loading, unloading, transporting or other handling of 
food, water or ice.



Sec. 1250.79  Garbage disposal.

    (a) Water-tight, readily cleanable, nonabsorbent containers with 
close-fitting covers shall be used to receive and store garbage.
    (b) Can washing and draining facilities shall be provided.
    (c) Garbage cans shall be emptied daily and shall be thoroughly 
washed before being returned for use.

[[Page 1072]]



        Subpart E_Sanitation Facilities and Conditions on Vessels



Sec. 1250.80  Applicability.

    The sanitation facilities and the sanitary conditions on vessels 
engaged in interstate traffic shall comply with the requirements 
prescribed in this subpart, provided that no major structural change 
will be required on existing vessels.



Sec. 1250.81  Inspection.

    The Commissioner of Food and Drugs may inspect such vessels to 
determine compliance with the requirements of this subpart.

[40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]



Sec. 1250.82  Potable water systems.

    The following conditions must be met by vessel water systems used 
for the storage and distribution of water which has met the requirements 
of Sec. 1240.80 of this chapter.
    (a) The potable water system, including filling hose and lines, 
pumps, tanks, and distributing pipes, shall be separate and distinct 
from other water systems and shall be used for no other purposes.
    (b) All potable water tanks shall be independent of any tanks 
holding nonpotable water or other liquid. All potable water tanks shall 
be independent of the shell of the ship unless (1) the bottom of the 
tank is at least 2 feet above the maximum load water line, (2) the seams 
in the shell are continuously welded, and (3) there are no rivets in 
that part of the shell which forms a side of a tank. A deck may be used 
as the top of a tank provided there are no access or inspection openings 
or rivets therein, and the seams are continuously welded. No toilet or 
urinal shall be installed immediately above that part of the deck which 
forms the top of a tank. All potable water tanks shall be located at a 
sufficient height above the bilge to allow for draining and to prevent 
submergence in bilge water.
    (c) Each potable water tank shall be provided with a means of 
drainage and, if it is equipped with a manhole, overflow, vent, or a 
device for measuring depth of water, provision shall be made to prevent 
entrance into the tank of any contaminating substance. No deck or 
sanitary drain or pipe carrying any nonpotable water or liquid shall be 
permitted to pass through the tank.
    (d) Tanks and piping shall bear clear marks of identification.
    (e) There shall be no backflow or cross connection between potable 
water systems and any other systems. Pipes and fittings conveying 
potable water to any fixture, apparatus, or equipment shall be installed 
in such way that backflow will be prevented. Waste pipes from any part 
of the potable water system, including treatment devices, discharging to 
a drain, shall be suitably protected against backflow.
    (f) Water systems shall be cleaned, disinfected, and flushed 
whenever the Commissioner of Food and Drugs shall find such treatment 
necessary to prevent the introduction, transmission, or spread of 
communicable diseases.

[40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]



Sec. 1250.83  Storage of water prior to treatment.

    The following requirements with respect to the storage of water on 
vessels prior to treatment must be met in order to obtain approval of 
treatment facilities under Sec. 1240.90 of this chapter.
    (a) The tank, whether independent or formed by the skin of the ship, 
deck, tank top, or partitions common with other tanks, shall be free of 
apparent leakage.
    (b) No sanitary drain shall pass through the tank.
    (c) The tank shall be adequately protected against both the backflow 
and discharge into it of bilge or highly contaminated water.



Sec. 1250.84  Water in galleys and medical care spaces.

    (a) Potable water, hot and cold, shall be available in the galley 
and pantry except that, when potable water storage is inadequate, 
nonpotable water may be piped to the galley for deck washing and in 
connection with garbage disposal. Any tap discharging nonpotable water 
which is installed for deck washing purposes shall not be more than 18 
inches above the deck and

[[Page 1073]]

shall be distinctly marked ``For deck washing only''.
    (b) In the case of existing vessels on which heat treated wash water 
has been used for the washing of utensils prior to the effective date of 
the regulations in this part, such water may continue to be so used 
provided controls are employed to insure the heating of all water to at 
least 170 [deg]F before discharge from the heater.
    (c) Potable water, hot and cold, shall be available in medical care 
spaces for hand-washing and for medical care purposes excluding 
hydrotherapy.



Sec. 1250.85  Drinking fountains and coolers; 
ice; constant temperature bottles.

    (a) Drinking fountains and coolers shall be constructed of 
impervious, nonoxidizing material, and shall be so designed and 
constructed as to be easily cleaned. The jet of a drinking fountain 
shall be slanting and the orifice of the jet shall be protected by a 
guard in such a manner as to prevent contamination thereof by droppings 
from the mouth. The orifice of such a jet shall be located a sufficient 
distance above the rim of the basin to prevent backflow.
    (b) Ice shall not be permitted to come in contact with water in 
coolers or constant temperature bottles.
    (c) Constant temperature bottles and other containers used for 
storing or dispensing potable water shall be kept clean at all times and 
shall be subjected to effective bactericidal treatment after each 
occupancy of the space served and at intervals not exceeding one week.



Sec. 1250.86  Water for making ice.

    Only potable water shall be piped into a freezer for making ice for 
drinking and culinary purposes.



Sec. 1250.87  Wash water.

    Where systems installed on vessels for wash water, as defined in 
Sec. 1250.3(n), do not comply with the requirements of a potable water 
system, prescribed in Sec. 1250.82, they shall be constructed so as to 
minimize the possibility of the water therein being contaminated. The 
storage tanks shall comply with the requirements of Sec. 1250.83, and 
the distribution system shall not be cross connected to a system 
carrying water of a lower sanitary quality. All faucets shall be labeled 
``Unfit for drinking''.



Sec. 1250.89  Swimming pools.

    (a) Fill and draw swimming pools shall not be installed or used.
    (b) Swimming pools of the recirculation type shall be equipped so as 
to provide complete circulation, replacement, and filtration of the 
water in the pool every six hours or less. Suitable means of 
chlorination and, if necessary, other treatment of the water shall be 
provided to maintain the residual chlorine in the pool water at not less 
than 0.4 part per million and the pH (a measure of the hydrogen ion 
concentration) not less than 7.0.
    (c) Flowing-through types of salt water pools shall be so operated 
that complete circulation and replacement of the water in the pool will 
be effected every 6 hours or less. The water delivery pipe to the pool 
shall be independent of all other pipes and shall originate at a point 
where maximum flushing of the pump and pipe line is effected after 
leaving polluted waters.



Sec. 1250.90  Toilets and lavatories.

    Toilet and lavatory equipment and spaces shall be maintained in a 
clean condition.



Sec. 1250.93  Discharge of wastes.

    Vessels operating on fresh water lakes or rivers shall not discharge 
sewage, or ballast or bilge water, within such areas adjacent to 
domestic water intakes as are designated by the Commissioner of Food and 
Drugs.

    Cross Reference: For Environmental Protection Agency's regulations 
for vessel sanitary discharges as related to authority under the Federal 
Water Pollution Control Act, as amended (33 U.S.C. 1314 et seq.), see 40 
CFR part 140.

[40 FR 5624, Feb. 6, 1975, as amended at 48 FR 11432, Mar. 18, 1983]



Sec. 1250.95  Insect control.

    Vessels shall be maintained free of infestation by flies, 
mosquitoes, fleas, lice, and other insects known to be vectors in the 
transmission of communicable diseases, through the use of

[[Page 1074]]

screening, insecticides, and other generally accepted methods of insect 
control.



Sec. 1250.96  Rodent control.

    Vessels shall be maintained free of rodent infestation through the 
use of traps, poisons, and other generally accepted methods of rodent 
control.

                       PARTS 1251	1270 [RESERVED]



PART 1271_HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
--Table of Contents



                      Subpart A_General Provisions

Sec.
1271.1 What are the purpose and scope of this part?
1271.3 How does FDA define important terms in this part?
1271.10 Are my HCT/P's regulated solely under section 361 of the PHS Act 
          and the regulations in this part, and if so what must I do?
1271.15 Are there any exceptions from the requirements of this part?
1271.20 If my HCT/P's do not meet the criteria in Sec. 1271.10, and I 
          do not qualify for any of the exceptions in Sec. 1271.15, 
          what regulations apply?

            Subpart B_Procedures for Registration and Listing

1271.21 When do I register, submit an HCT/P list, and submit updates?
1271.22 How do I register and submit an HCT/P list?
1271.23 How is a waiver from the electronic format requirements 
          requested?
1271.25 What information is required for establishment registration and 
          HCT/P listing?
1271.26 When must I amend my establishment registration?
1271.27 Will FDA assign me a registration number?
1271.37 Will establishment registrations and HCT/P listings be available 
          for inspection, and how do I request information on 
          registrations and listings?

                       Subpart C_Donor Eligibility

1271.45 What requirements does this subpart contain?
1271.47 What procedures must I establish and maintain?
1271.50 How do I determine whether a donor is eligible?
1271.55 What records must accompany an HCT/P after the donor-eligibility 
          determination is complete; and what records must I maintain?
1271.60 What quarantine and other requirements apply before the donor-
          eligibility determination is complete?
1271.65 How do I store an HCT/P from a donor determined to be 
          ineligible, and what uses of the HCT/P are not prohibited?
1271.75 How do I screen a donor?
1271.80 What are the general requirements for donor testing?
1271.85 What donor testing is required for different types of cells and 
          tissues?
1271.90 Are there exceptions from the requirement of determining donor 
          eligibility, and what labeling requirements apply?

                 Subpart D_Current Good Tissue Practice

1271.145 Prevention of the introduction, transmission, or spread of 
          communicable diseases.
1271.150 Current good tissue practice requirements.
1271.155 Exemptions and alternatives.
1271.160 Establishment and maintenance of a quality program.
1271.170 Personnel.
1271.180 Procedures.
1271.190 Facilities.
1271.195 Environmental control and monitoring.
1271.200 Equipment.
1271.210 Supplies and reagents.
1271.215 Recovery.
1271.220 Processing and process controls.
1271.225 Process changes.
1271.230 Process validation.
1271.250 Labeling controls.
1271.260 Storage.
1271.265 Receipt, predistribution shipment, and distribution of an HCT/
          P.
1271.270 Records.
1271.290 Tracking.
1271.320 Complaint file.

  Subpart E_Additional Requirements for Establishments Described in   
                                 1271.10

1271.330 Applicability.
1271.350 Reporting.
1271.370 Labeling.

 Subpart F_Inspection and Enforcement of Establishments Described in   
                                 1271.10

1271.390 Applicability.
1271.400 Inspections.
1271.420 HCT/Ps offered for import.
1271.440 Orders of retention, recall, destruction, and cessation of 
          manufacturing.

    Authority: 42 U.S.C. 216, 243, 263a, 264, 271.

[[Page 1075]]


    Source: 66 FR 5466, Jan. 19, 2001, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 1271.1  What are the purpose and scope of this part?

    (a) Purpose. The purpose of this part, in conjunction with 
Sec. Sec. 207.9(a)(5), 210.1(c), 210.2, 807.20(d), and 820.1(a) of this 
chapter, is to create an electronic registration and listing system for 
establishments that manufacture human cells, tissues, and cellular and 
tissue-based products (HCT/P's) and to establish donor-eligibility, 
current good tissue practice, and other procedures to prevent the 
introduction, transmission, and spread of communicable diseases by HCT/
P's.
    (b) Scope. (1) If you are an establishment that manufactures HCT/P's 
that are regulated solely under the authority of section 361 of the 
Public Health Service Act (the PHS Act), this part requires you to 
register and list your HCT/P's with the Food and Drug Administration's 
(FDA's) Center for Biologics Evaluation and Research and to comply with 
the other requirements contained in this part, whether or not the HCT/P 
enters into interstate commerce. Those HCT/P's that are regulated solely 
under the authority of section 361 of the PHS Act are described in Sec. 
1271.10.
    (2) If you are an establishment that manufactures HCT/P's that are 
regulated as drugs, devices and/or biological products under section 351 
of the PHS Act and/or the Federal Food, Drug, and Cosmetic Act, 
Sec. Sec. 207.9(a)(5) and 807.20(d) of this chapter require you to 
register and list your HCT/P's following the procedures in part 207 (if 
a drug and/or biological product) of this chapter or part 807 (if a 
device) of this chapter. Sections 210.1(c), 210.2, 211.1(b), and 
820.1(a) of this chapter require you to comply with the donor-
eligibility procedures in subpart C of this part and the current good 
tissue practice procedures in subpart D of this part, in addition to all 
other applicable regulations.

[66 FR 5466, Jan. 19, 2001, as amended at 69 FR 29829, May 25, 2004; 81 
FR 60223, Aug. 31, 2016]



Sec. 1271.3  How does FDA define important terms in this part?

    The following definitions apply only to this part:
    (a) Autologous use means the implantation, transplantation, 
infusion, or transfer of human cells or tissue back into the individual 
from whom the cells or tissue were recovered.
    (b) Establishment means a place of business under one management, at 
one general physical location, that engages in the manufacture of human 
cells, tissues, and cellular and tissue-based products. 
``Establishment'' includes:
    (1) Any individual, partnership, corporation, association, or other 
legal entity engaged in the manufacture of human cells, tissues, and 
cellular and tissue-based products; and
    (2) Facilities that engage in contract manufacturing services for a 
manufacturer of human cells, tissues, and cellular and tissue-based 
products.
    (c) Homologous use means the repair, reconstruction, replacement, or 
supplementation of a recipient's cells or tissues with an HCT/P that 
performs the same basic function or functions in the recipient as in the 
donor.
    (d) Human cells, tissues, or cellular or tissue-based products (HCT/
Ps) means articles containing or consisting of human cells or tissues 
that are intended for implantation, transplantation, infusion, or 
transfer into a human recipient. Examples of HCT/Ps include, but are not 
limited to, bone, ligament, skin, dura mater, heart valve, cornea, 
hematopoietic stem/progenitor cells derived from peripheral and cord 
blood, manipulated autologous chondrocytes, epithelial cells on a 
synthetic matrix, and semen or other reproductive tissue. The following 
articles are not considered HCT/Ps:
    (1) Vascularized human organs for transplantation;
    (2) Whole blood or blood components or blood derivative products 
subject to listing under parts 607 and 207 of this chapter, 
respectively;
    (3) Secreted or extracted human products, such as milk, collagen, 
and cell factors; except that semen is considered an HCT/P;

[[Page 1076]]

    (4) Minimally manipulated bone marrow for homologous use and not 
combined with another article (except for water, crystalloids, or a 
sterilizing, preserving, or storage agent, if the addition of the agent 
does not raise new clinical safety concerns with respect to the bone 
marrow);
    (5) Ancillary products used in the manufacture of HCT/P;
    (6) Cells, tissues, and organs derived from animals other than 
humans; and
    (7) In vitro diagnostic products as defined in Sec. 809.3(a) of 
this chapter.
    (8) Blood vessels recovered with an organ, as defined in 42 CFR 
121.2, that are intended for use in organ transplantation and labeled 
``For use in organ transplantation only.''
    (e) Manufacture means, but is not limited to, any or all steps in 
the recovery, processing, storage, labeling, packaging, or distribution 
of any human cell or tissue, and the screening or testing of the cell or 
tissue donor.
    (f) Minimal manipulation means:
    (1) For structural tissue, processing that does not alter the 
original relevant characteristics of the tissue relating to the tissue's 
utility for reconstruction, repair, or replacement; and
    (2) For cells or nonstructural tissues, processing that does not 
alter the relevant biological characteristics of cells or tissues.
    (g) Transfer means the placement of human reproductive cells or 
tissues into a human recipient.
    (h) Biohazard legend appears on the label as follows and is used to 
mark HCT/Ps that present a known or suspected relevant communicable 
disease risk.
[GRAPHIC] [TIFF OMITTED] TR25MY04.000

    (i) Blood component means a product containing a part of human blood 
separated by physical or mechanical means.
    (j) Colloid means:
    (1) A protein or polysaccharide solution, such as albumin, dextran, 
or hetastarch, that can be used to increase or maintain osmotic 
(oncotic) pressure in the intravascular compartment; or
    (2) Blood components such as plasma and platelets.
    (k) Crystalloid means an isotonic salt and/or glucose solution used 
for electrolyte replacement or to increase intravascular volume, such as 
saline solution, Ringer's lactate solution, or 5 percent dextrose in 
water.
    (l) Directed reproductive donor means a donor of reproductive cells 
or tissue (including semen, oocytes, and embryos to which the donor 
contributed the spermatozoa or oocyte) to a specific recipient, and who 
knows and is known by the recipient before donation. The term directed 
reproductive donor does not include a sexually intimate partner under 
Sec. 1271.90.
    (m) Donor means a person, living or dead, who is the source of cells 
or tissue for an HCT/P.
    (n) Donor medical history interview means a documented dialog about 
the donor's medical history and relevant social behavior, including 
activities, behaviors, and descriptions considered to increase the 
donor's relevant communicable disease risk:
    (1) With the donor, if the donor is living and able to participate 
in the interview, or
    (2) If not, with an individual or individuals able to provide the 
information sought in the interview (e.g., the donor's next-of-kin, the 
nearest available relative, a member of the donor's household, an 
individual with an affinity relationship, and/or the primary treating 
physician).
    (o) Physical assessment of a cadaveric donor means a limited autopsy 
or recent antemortem or postmortem physical examination of the donor to 
assess for signs of a relevant communicable disease and for signs 
suggestive of any risk factor for a relevant communicable disease.
    (p) Plasma dilution means a decrease in the concentration of the 
donor's plasma proteins and circulating antigens or antibodies resulting 
from the transfusion of blood or blood components and/or infusion of 
fluids.

[[Page 1077]]

    (q) Quarantine means the storage or identification of an HCT/P, to 
prevent improper release, in a physically separate area clearly 
identified for such use, or through use of other procedures, such as 
automated designation.
    (r) Relevant communicable disease agent or disease means:
    (1)(i) For all human cells and tissues, a communicable disease or 
disease agent listed as follows:
    (A) Human immunodeficiency virus, types 1 and 2;
    (B) Hepatitis B virus;
    (C) Hepatitis C virus;
    (D) Human transmissible spongiform encephalopathy, including 
Creutzfeldt-Jakob disease; and
    (E) Treponema pallidum.
    (ii) For viable, leukocyte-rich cells and tissues, a cell-associated 
disease agent or disease listed as follows:
    (A) Human T-lymphotropic virus, type I; and
    (B) Human T-lymphotropic virus, type II.
    (iii) For reproductive cells or tissues, a disease agent or disease 
of the genitourinary tract listed as follows:
    (A) Chlamydia trachomatis; and
    (B) Neisseria gonorrhea.
    (2) A disease agent or disease not listed in paragraph (r)(1) of 
this section:
    (i) For which there may be a risk of transmission by an HCT/P, 
either to the recipient of the HCT/P or to those people who may handle 
or otherwise come in contact with it, such as medical personnel, because 
the disease agent or disease:
    (A) Is potentially transmissible by an HCT/P and
    (B) Either of the following applies:
    (1) The disease agent or disease has sufficient incidence and/or 
prevalence to affect the potential donor population, or
    (2) The disease agent or disease may have been released accidentally 
or intentionally in a manner that could place potential donors at risk 
of infection;
    (ii) That could be fatal or life-threatening, could result in 
permanent impairment of a body function or permanent damage to body 
structure, or could necessitate medical or surgical intervention to 
preclude permanent impairment of body function or permanent damage to a 
body structure; and
    (iii) For which appropriate screening measures have been developed 
and/or an appropriate screening test for donor specimens has been 
licensed, approved, or cleared for such use by FDA and is available.
    (s) Relevant medical records means a collection of documents that 
includes a current donor medical history interview; a current report of 
the physical assessment of a cadaveric donor or the physical examination 
of a living donor; and, if available, the following:
    (1) Laboratory test results (other than results of testing for 
relevant communicable disease agents required under this subpart);
    (2) Medical records;
    (3) Coroner and autopsy reports; and
    (4) Records or other information received from any source pertaining 
to risk factors for relevant communicable disease (e.g., social 
behavior, clinical signs and symptoms of relevant communicable disease, 
and treatments related to medical conditions suggestive of risk for 
relevant communicable disease).
    (t) Responsible person means a person who is authorized to perform 
designated functions for which he or she is trained and qualified.
    (u) Urgent medical need means that no comparable HCT/P is available 
and the recipient is likely to suffer death or serious morbidity without 
the HCT/P.
    (v) Act means the Federal Food, Drug, and Cosmetic Act.
    (w) PHS Act means the Public Health Service Act.
    (x) FDA means the Food and Drug Administration.
    (y) Adverse reaction means a noxious and unintended response to any 
HCT/P for which there is a reasonable possibility that the HCT/P caused 
the response.
    (z) Available for distribution means that the HCT/P has been 
determined to meet all release criteria.
    (aa) Complaint means any written, oral, or electronic communication 
about a distributed HCT/P that alleges:
    (1) That an HCT/P has transmitted or may have transmitted a 
communicable disease to the recipient of the HCT/P; or

[[Page 1078]]

    (2) Any other problem with an HCT/P relating to the potential for 
transmission of communicable disease, such as the failure to comply with 
current good tissue practice.
    (bb) Distribution means any conveyance or shipment (including 
importation and exportation) of an HCT/P that has been determined to 
meet all release criteria, whether or not such conveyance or shipment is 
entirely intrastate. If an entity does not take physical possession of 
an HCT/P, the entity is not considered a distributor.
    (cc) Establish and maintain means define, document (in writing or 
electronically), and implement; then follow, review, and, as needed, 
revise on an ongoing basis.
    (dd) HCT/P deviation means an event:
    (1) That represents a deviation from applicable regulations in this 
part or from applicable standards or established specifications that 
relate to the prevention of communicable disease transmission or HCT/P 
contamination; or
    (2) That is an unexpected or unforeseeable event that may relate to 
the transmission or potential transmission of a communicable disease or 
may lead to HCT/P contamination.
    (ee) Importer of record means the person, establishment, or its 
representative responsible for making entry of imported goods in 
accordance with all laws affecting such importation.
    (ff) Processing means any activity performed on an HCT/P, other than 
recovery, donor screening, donor testing, storage, labeling, packaging, 
or distribution, such as testing for microorganisms, preparation, 
sterilization, steps to inactivate or remove adventitious agents, 
preservation for storage, and removal from storage.
    (gg) Quality audit means a documented, independent inspection and 
review of an establishment's activities related to core CGTP 
requirements. The purpose of a quality audit is to verify, by 
examination and evaluation of objective evidence, the degree of 
compliance with those aspects of the quality program under review.
    (hh) Quality program means an organization's comprehensive system 
for manufacturing and tracking HCT/Ps in accordance with this part. A 
quality program is designed to prevent, detect, and correct deficiencies 
that may lead to circumstances that increase the risk of introduction, 
transmission, or spread of communicable diseases.
    (ii) Recovery means obtaining from a human donor cells or tissues 
that are intended for use in human implantation, transplantation, 
infusion, or transfer.
    (jj) Storage means holding HCT/Ps for future processing and/or 
distribution.
    (kk) Validation means confirmation by examination and provision of 
objective evidence that particular requirements can consistently be 
fulfilled. Validation of a process, or process validation, means 
establishing by objective evidence that a process consistently produces 
a result or HCT/P meeting its predetermined specifications.
    (ll) Verification means confirmation by examination and provision of 
objective evidence that specified requirements have been fulfilled.
    (mm) Importer means a company or individual in the United States 
that is the owner, consignee, or recipient, at the time of entry, of the 
foreign establishment's HCT/P that is imported into the United States.
    (nn) United States agent means a person residing or maintaining a 
place of business in the United States whom a foreign establishment 
designates as its agent. This definition excludes mailboxes, answering 
machines or services, or other places where an individual acting as the 
foreign establishment's agent is not physically present.

[66 FR 5466, Jan. 19, 2001, as amended at 68 FR 3826, Jan. 27, 2004; 69 
FR 29829, May 25, 2004; 69 FR 68680, Nov. 24, 2004; 81 FR 60223, Aug. 
31, 2016]



Sec. 1271.10  Are my HCT/P's regulated solely under section 361
of the PHS Act and the regulations in this part, and if so what
must I do?

    (a) An HCT/P is regulated solely under section 361 of the PHS Act 
and the regulations in this part if it meets all of the following 
criteria:
    (1) The HCT/P is minimally manipulated;
    (2) The HCT/P is intended for homologous use only, as reflected by 
the labeling, advertising, or other indications of the manufacturer's 
objective intent;

[[Page 1079]]

    (3) The manufacture of the HCT/P does not involve the combination of 
the cells or tissues with another article, except for water, 
crystalloids, or a sterilizing, preserving, or storage agent, provided 
that the addition of water, crystalloids, or the sterilizing, 
preserving, or storage agent does not raise new clinical safety concerns 
with respect to the HCT/P; and
    (4) Either:
    (i) The HCT/P does not have a systemic effect and is not dependent 
upon the metabolic activity of living cells for its primary function; or
    (ii) The HCT/P has a systemic effect or is dependent upon the 
metabolic activity of living cells for its primary function, and:
    (a) Is for autologous use;
    (b) Is for allogeneic use in a first-degree or second-degree blood 
relative; or
    (c) Is for reproductive use.
    (b) If you are a domestic or foreign establishment that manufactures 
an HCT/P described in paragraph (a) of this section:
    (1) You must register with FDA;
    (2) You must submit to FDA a list of each HCT/P manufactured; and
    (3) You must comply with the other requirements contained in this 
part.

[66 FR 5466, Jan. 19, 2001, as amended at 69 FR 68681, Nov. 24, 2004]



Sec. 1271.15  Are there any exceptions from the requirements of this part?

    (a) You are not required to comply with the requirements of this 
part if you are an establishment that uses HCT/P's solely for 
nonclinical scientific or educational purposes.
    (b) You are not required to comply with the requirements of this 
part if you are an establishment that removes HCT/P's from an individual 
and implants such HCT/P's into the same individual during the same 
surgical procedure.
    (c) You are not required to comply with the requirements of this 
part if you are a carrier who accepts, receives, carries, or delivers 
HCT/P's in the usual course of business as a carrier.
    (d) You are not required to comply with the requirements of this 
part if you are an establishment that does not recover, screen, test, 
process, label, package, or distribute, but only receives or stores HCT/
P's solely for implantation, transplantation, infusion, or transfer 
within your facility.
    (e) You are not required to comply with the requirements of this 
part if you are an establishment that only recovers reproductive cells 
or tissue and immediately transfers them into a sexually intimate 
partner of the cell or tissue donor.
    (f) You are not required to register or list your HCT/P's 
independently, but you must comply with all other applicable 
requirements in this part, if you are an individual under contract, 
agreement, or other arrangement with a registered establishment and 
engaged solely in recovering cells or tissues and sending the recovered 
cells or tissues to the registered establishment.



Sec. 1271.20  If my HCT/P's do not meet the criteria in Sec. 1271.10,\
and I do not qualify for any of the exceptions in Sec. 1271.15, what 
regulations apply?

    If you are an establishment that manufactures an HCT/P that does not 
meet the criteria set out in Sec. 1271.10(a), and you do not qualify 
for any of the exceptions in Sec. 1271.15, your HCT/P will be regulated 
as a drug, device, and/or biological product under the act and/or 
section 351 of the PHS Act, and applicable regulations in title 21, 
chapter I. Applicable regulations include, but are not limited to, 
Sec. Sec. 207.9(a)(5), 210.1(c), 210.2, 211.1(b), 807.20(d), and 
820.1(a) of this chapter, which require you to follow the procedures in 
subparts C and D of this part.

[66 FR 5466, Jan. 19, 2001, as amended at 81 FR 60223, Aug. 31, 2016]



            Subpart B_Procedures for Registration and Listing



Sec. 1271.21  When do I register, submit an HCT/P list, and submit updates?

    (a) You must register and submit a list of every HCT/P that your 
establishment manufactures within 5 days after beginning operations or 
within 30 days of the effective date of this regulation, whichever is 
later.
    (b) You must update your establishment registration annually in 
December, except as required by Sec. 1271.26. You

[[Page 1080]]

may accomplish your annual registration in conjunction with updating 
your HCT/P list under paragraph (c) of this section.
    (c)(i) If no change described in Sec. 1271.25(c) has occurred since 
you previously submitted an HCT/P list, you are not required to update 
your listing.
    (ii) If a change described in Sec. 1271.25(c) has occurred, you 
must update your HCT/P listing with the new information:
    (a) At the time of the change, or
    (b) Each June or December, whichever month occurs first after the 
change.

[69 FR 68681, Nov. 24, 2004]



Sec. 1271.22  How do I register and submit an HCT/P list?

    (a) You must use the electronic registration and listing system at 
http://www.fda.gov/cber/tissue/tisreg.htm in accordance with Sec. 
1271.25 for:
    (1) Establishment registration,
    (2) HCT/P listings, and
    (3) Updates of registration and HCT/P listing.
    (b) FDA will periodically issue guidance on recommended procedures 
for providing registration and listing information in electronic format 
(for example, method of transmission, media, file formats, preparation, 
and organization of files).
    (c) You must provide the information under paragraph (a) of this 
section in accordance with part 11 of this chapter, except for the 
requirements in Sec. 11.10(b), (c), and (e) and the corresponding 
requirements in Sec. 11.30.

[81 FR 60223, Aug. 31, 2016]



Sec. 1271.23  How is a waiver from the electronic format requirements requested?

    (a) You may request a waiver from the requirement in Sec. 1271.22 
that information must be provided to FDA in electronic format. 
Submission of a request for waiver does not excuse timely compliance 
with the registration and listing requirements. FDA will grant a waiver 
request if FDA determines that the use of electronic means for 
submission of registration and listing information is not reasonable for 
the registrant making the waiver request.
    (b) Waiver requests under this section must be submitted in writing 
and must include the specific reasons why electronic submission is not 
reasonable for the registrant and a U.S. telephone number and mailing 
address where FDA can contact the registrant. Waiver requests may be 
sent to the Center for Biologics Evaluation and Research (CBER), 
Document Control Center (see addresses in Sec. 600.2 of this chapter).
    (c) If FDA grants the waiver request, FDA may limit its duration and 
will specify terms of the waiver and provide information on how to 
submit establishment registration, listings, other information, and 
updates, as applicable.

[81 FR 60224, Aug. 31, 2016]



Sec. 1271.25  What information is required for establishment
registration and HCT/P listing?

    (a) Your establishment registration must include:
    (1) The legal name(s) of the establishment;
    (2) Each physical location, including the street address, telephone 
number, email address, and the postal service ZIP code of the 
establishment;
    (3) The name, address, telephone number, email address, and title of 
the reporting official;
    (4) A dated signature by the reporting official affirming that all 
information contained in the establishment registration and HCT/P 
listing form is true and accurate, to the best of his or her knowledge.
    (5) Each foreign establishment must also submit the name, address, 
telephone number, and email address of each importer that is known to 
the establishment, and the name of each person who imports or offers for 
import such HCT/P to the United States for purposes of importation; and
    (6) Each foreign establishment must also submit the name, address, 
telephone number, and email address of its United States agent.
    (i) The United States agent must reside or maintain a place of 
business in the United States.
    (ii) Upon request from FDA, the United States agent must assist FDA

[[Page 1081]]

in communications with the foreign establishment, respond to questions 
concerning the foreign establishment's products that are imported or 
offered for import into the United States, and assist FDA in scheduling 
inspections of the foreign establishment. If the Agency is unable to 
contact the foreign establishment directly or expeditiously, FDA may 
provide information or documents to the United States agent, and such an 
action is equivalent to providing the same information or documents to 
the foreign establishment.
    (iii) The foreign establishment or the United States agent must 
report changes in the United States agent's name, address, telephone 
number, or email address to FDA within 30 calendar days of the change.
    (b) Your HCT/P listing must include all HCT/P's (including the 
established name and the proprietary name) that you recover, process, 
store, label, package, distribute, or for which you perform donor 
screening or testing. You must also state whether each HCT/P meets the 
criteria set out in Sec. 1271.10.
    (c) Your HCT/P listing update must include:
    (1) A list of each HCT/P that you have begun recovering, processing, 
storing, labeling, packaging, distributing, or for which you have begun 
donor screening or testing, that has not been included in any list 
previously submitted. You must provide all of the information required 
by Sec. 1271.25(b) for each new HCT/P.
    (2) A list of each HCT/P formerly listed in accordance with Sec. 
1271.21(a) for which you have discontinued recovery, processing, 
storage, labeling, packaging, distribution, or donor screening or 
testing, including for each HCT/P so listed, the identity by established 
name and proprietary name, and the date of discontinuance. We request 
but do not require that you include the reason for discontinuance with 
this information.
    (3) A list of each HCT/P for which a notice of discontinuance was 
submitted under paragraph (c)(2) of this section and for which you have 
resumed recovery, processing, storage, labeling, packaging, 
distribution, or donor screening or testing, including the identity by 
established name and proprietary name, the date of resumption, and any 
other information required by Sec. 1271.25(b) not previously submitted.
    (4) Any material change in any information previously submitted. 
Material changes include any change in registration and listing 
information, submitted, such as whether the HCT/P meets the criteria set 
out in Sec. 1271.10.
    (d) If your HCT/P is described under Sec. 1271.20 and is regulated 
under a BLA, you must submit the information required under part 207 of 
this chapter using the procedures under subpart E of part 207.

[66 FR 5466, Jan. 19, 2001, as amended at 81 FR 60224, Aug. 31, 2016]



Sec. 1271.26  When must I amend my establishment registration?

    If the ownership or location of your establishment changes, or if 
there is a change in the United States agent's name, address, telephone 
number, or email address, you must submit an amendment to registration 
within 30 calendar days of the change.

[81 FR 60224, Aug. 31, 2017]



Sec. 1271.27  Will FDA assign me a registration number?

    (a) FDA will assign each location a permanent registration number.
    (b) FDA acceptance of an establishment registration and HCT/P 
listing form does not constitute a determination that an establishment 
is in compliance with applicable rules and regulations or that the HCT/P 
is licensed or approved by FDA.



Sec. 1271.37  Will establishment registrations and HCT/P listings be
available for inspection, and how do I request information on
registrations and listings?

    (a) Any registration on Form FDA 3356 filed in paper or electronic 
format by each establishment will be available for public inspection 
through the Center for Biologics Evaluation and Research Human Cell and 
Tissue Establishment Registration--Public Query Web site by using the 
CBER electronic Web-based application or by going in person to the Food 
and Drug Administration, Division of Dockets Management Public Reading 
Room (see address in Sec. 20.120(a) of this chapter). The

[[Page 1082]]

following information submitted under the HCT/P requirements is 
illustrative of the type of information that will be available for 
public disclosure when it is compiled:
    (1) A list of all HCT/P's;
    (2) A list of all HCT/P's manufactured by each establishment;
    (3) A list of all HCT/P's discontinued; and
    (4) All data or information that has already become a matter of 
public record.
    (b) You should direct your other requests for information regarding 
HCT/P establishment registrations and HCT/P listings to the Food and 
Drug Administration, Center for Biologics Evaluation and Research, 
Office of Communication, Outreach and Development, 10903 New Hampshire 
Ave., Bldg. 71, Rm. 3103, Silver Spring, MD 20993-0002.

[80 FR 18094, Apr. 3, 2015]



                       Subpart C_Donor Eligibility

    Source: 69 FR 29830, May 25, 2004, unless otherwise noted.



Sec. 1271.45  What requirements does this subpart contain?

    (a) General. This subpart sets out requirements for determining 
donor eligibility, including donor screening and testing. The 
requirements contained in this subpart are a component of current good 
tissue practice (CGTP) requirements. Other CGTP requirements are set out 
in subpart D of this part.
    (b) Donor-eligibility determination required. A donor-eligibility 
determination, based on donor screening and testing for relevant 
communicable disease agents and diseases, is required for all donors of 
cells or tissue used in HCT/Ps, except as provided under Sec. 1271.90. 
In the case of an embryo or of cells derived from an embryo, a donor-
eligibility determination is required for both the oocyte donor and the 
semen donor.
    (c) Prohibition on use. An HCT/P must not be implanted, 
transplanted, infused, or transferred until the donor has been 
determined to be eligible, except as provided under Sec. Sec. 
1271.60(d), 1271.65(b), and 1271.90 of this subpart.
    (d) Applicability of requirements. If you are an establishment that 
performs any function described in this subpart, you must comply with 
the requirements contained in this subpart that are applicable to that 
function.

[69 FR 29830, May 25, 2004, as amended at 69 FR 68681, Nov. 24, 2004]



Sec. 1271.47  What procedures must I establish and maintain?

    (a) General. You must establish and maintain procedures for all 
steps that you perform in testing, screening, determining donor 
eligibility, and complying with all other requirements of this subpart. 
Establish and maintain means define, document (in writing or 
electronically), and implement; then follow, review, and as needed, 
revise on an ongoing basis. You must design these procedures to ensure 
compliance with the requirements of this subpart.
    (b) Review and approval. Before implementation, a responsible person 
must review and approve all procedures.
    (c) Availability. Procedures must be readily available to the 
personnel in the area where the operations to which they relate are 
performed, or in a nearby area if such availability is impractical.
    (d) Departures from procedures. You must record and justify any 
departure from a procedure relevant to preventing risks of communicable 
disease transmission at the time of its occurrence. You must not make 
available for distribution any HCT/P from a donor whose eligibility is 
determined under such a departure unless a responsible person has 
determined that the departure does not increase the risks of 
communicable disease transmission through the use of the HCT/P.
    (e) Standard procedures. You may adopt current standard procedures, 
such as those in a technical manual prepared by another organization, 
provided that you have verified that the procedures are consistent with 
and at least as stringent as the requirements of this part and 
appropriate for your operations.

[[Page 1083]]



Sec. 1271.50  How do I determine whether a donor is eligible?

    (a) Determination based on screening and testing. If you are the 
establishment responsible for making the donor-eligibility 
determination, you must determine whether a donor is eligible based upon 
the results of donor screening in accordance with Sec. 1271.75 and 
donor testing in accordance with Sec. Sec. 1271.80 and 1271.85. A 
responsible person, as defined in Sec. 1271.3(t), must determine and 
document the eligibility of a cell or tissue donor.
    (b) Eligible donor. A donor is eligible under these provisions only 
if:
    (1) Donor screening in accordance with Sec. 1271.75 indicates that 
the donor:
    (i) Is free from risk factors for, and clinical evidence of, 
infection due to relevant communicable disease agents and diseases; and
    (ii) Is free from communicable disease risks associated with 
xenotransplantation; and
    (2) The results of donor testing for relevant communicable disease 
agents in accordance with Sec. Sec. 1271.80 and 1271.85 are negative or 
nonreactive, except as provided in Sec. 1271.80(d)(1).



Sec. 1271.55  What records must accompany an HCT/P after the donor
-eligibility determination is complete; and what records must I retain?

    (a) Accompanying records. Once a donor-eligibility determination has 
been made, the following must accompany the HCT/P at all times:
    (1) A distinct identification code affixed to the HCT/P container, 
e.g., alphanumeric, that relates the HCT/P to the donor and to all 
records pertaining to the HCT/P and, except in the case of autologous 
donations, directed reproductive donations, or donations made by first-
degree or second-degree blood relatives, does not include an 
individual's name, social security number, or medical record number;
    (2) A statement whether, based on the results of screening and 
testing, the donor has been determined to be eligible or ineligible; and
    (3) A summary of the records used to make the donor-eligibility 
determination.
    (b) Summary of records. The summary of records required by paragraph 
(a)(3) of this section must contain the following information:
    (1) A statement that the communicable disease testing was performed 
by a laboratory:
    (i) Certified to perform such testing on human specimens under the 
Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. 263a) and 
42 CFR part 493; or
    (ii) That has met equivalent requirements as determined by the 
Centers for Medicare and Medicaid Services in accordance with those 
provisions;
    (2) A listing and interpretation of the results of all communicable 
disease tests performed;
    (3) The name and address of the establishment that made the donor-
eligibility determination; and
    (4) In the case of an HCT/P from a donor who is ineligible based on 
screening and released under paragraph (b) of Sec. 1271.65, a statement 
noting the reason(s) for the determination of ineligibility.
    (c) Deletion of personal information. The accompanying records 
required by this section must not contain the donor's name or other 
personal information that might identify the donor.
    (d) Record retention requirements. (1) You must maintain 
documentation of:
    (i) Results and interpretation of all testing for relevant 
communicable disease agents in compliance with Sec. Sec. 1271.80 and 
1271.85, as well as the name and address of the testing laboratory or 
laboratories;
    (ii) Results and interpretation of all donor screening for 
communicable diseases in compliance with Sec. 1271.75; and
    (iii) The donor-eligibility determination, including the name of the 
responsible person who made the determination and the date of the 
determination.
    (2) All records must be accurate, indelible, and legible. 
Information on the identity and relevant medical records of the donor, 
as defined in Sec. 1271.3(s), must be in English or, if in another 
language, must be retained and translated to English and accompanied by 
a statement of authenticity by the translator that specifically 
identifies the translated document.
    (3) You must retain required records and make them available for 
authorized inspection by or upon request from

[[Page 1084]]

FDA. Records that can be readily retrieved from another location by 
electronic means are considered ``retained.''
    (4) You must retain the records pertaining to a particular HCT/P at 
least 10 years after the date of its administration, or if the date of 
administration is not known, then at least 10 years after the date of 
the HCT/P's distribution, disposition, or expiration, whichever is 
latest.

[69 FR 29830, May 25, 2004, as amended at 70 FR 29952, May 25, 2005]



Sec. 1271.60  What quarantine and other requirements
apply before the donor-eligibility determination is complete?

    (a) Quarantine. You must keep an HCT/P in quarantine, as defined in 
Sec. 1271.3(q), until completion of the donor-eligibility determination 
required by Sec. 1271.50. You must quarantine semen from anonymous 
donors until the retesting required under Sec. 1271.85(d) is complete.
    (b) Identification of HCT/Ps in quarantine. You must clearly 
identify as quarantined an HCT/P that is in quarantine pending 
completion of a donor-eligibility determination. The quarantined HCT/P 
must be easily distinguishable from HCT/Ps that are available for 
release and distribution.
    (c) Shipping of HCT/Ps in quarantine. If you ship an HCT/P before 
completion of the donor-eligibility determination, you must keep it in 
quarantine during shipment. The HCT/P must be accompanied by records:
    (1) Identifying the donor (e.g., by a distinct identification code 
affixed to the HCT/P container);
    (2) Stating that the donor-eligibility determination has not been 
completed; and
    (3) Stating that the product must not be implanted, transplanted, 
infused, or transferred until completion of the donor-eligibility 
determination, except under the terms of paragraph (d) of this section.
    (d) Use in cases of urgent medical need. (1) This subpart C does not 
prohibit the implantation, transplantation, infusion, or transfer of an 
HCT/P from a donor for whom the donor-eligibility determination is not 
complete if there is a documented urgent medical need for the HCT/P, as 
defined in Sec. 1271.3(u).
    (2) If you make an HCT/P available for use under the provisions of 
paragraph (d)(1) of this section, you must prominently label it ``NOT 
EVALUATED FOR INFECTIOUS SUBSTANCES,'' and `` WARNING: Advise patient of 
communicable disease risks.'' The following information must accompany 
the HCT/P:
    (i) The results of any donor screening required under Sec. 1271.75 
that has been completed;
    (ii) The results of any testing required under Sec. 1271.80 or 
1271.85 that has been completed; and
    (iii) A list of any screening or testing required under Sec. 
1271.75, 1271.80 or 1271.85 that has not yet been completed.
    (3) If you are the establishment that manufactured an HCT/P used 
under the provisions of paragraph (d)(1) of this section, you must 
document that you notified the physician using the HCT/P that the 
testing and screening were not complete.
    (4) In the case of an HCT/P used for an urgent medical need under 
the provisions of paragraph (d)(1) of this section, you must complete 
the donor-eligibility determination during or after the use of the HCT/
P, and you must inform the physician of the results of the 
determination.



Sec. 1271.65  How do I store an HCT/P from a donor determined to
be ineligible, and what uses of the HCT/P are not prohibited?

    (a) Storage. If you are the establishment that stores the HCT/P, you 
must store or identify HCT/Ps from donors who have been determined to be 
ineligible in a physically separate area clearly identified for such 
use, or follow other procedures, such as automated designation, that are 
adequate to prevent improper release until destruction or other 
disposition of the HCT/P in accordance with paragraph (b) or (c) of this 
section.
    (b) Limited uses of HCT/P from ineligible donor. (1) An HCT/P from a 
donor who has been determined to be ineligible, based on the results of 
required testing and/or screening, is not prohibited by subpart C of 
this part from use

[[Page 1085]]

for implantation, transplantation, infusion, or transfer under the 
following circumstances:
    (i) The HCT/P is for allogeneic use in a first-degree or second-
degree blood relative;
    (ii) The HCT/P consists of reproductive cells or tissue from a 
directed reproductive donor, as defined in Sec. 1271.3(l); or
    (iii) There is a documented urgent medical need as defined in Sec. 
1271.3(u).
    (2) You must prominently label an HCT/P made available for use under 
the provisions of paragraph (b)(1) of this section with the Biohazard 
legend shown in Sec. 1271.3(h) with the statement ``WARNING: Advise 
patient of communicable disease risks,'' and, in the case of reactive 
test results, ``WARNING: Reactive test results for (name of disease 
agent or disease).'' The HCT/P must be accompanied by the records 
required under Sec. 1271.55.
    (3) If you are the establishment that manufactured an HCT/P used 
under the provisions of paragraph (b)(1) of this section, you must 
document that you notified the physician using the HCT/P of the results 
of testing and screening.
    (c) Nonclinical use. You may make available for nonclinical purposes 
an HCT/P from a donor who has been determined to be ineligible, based on 
the results of required testing and/or screening, provided that it is 
labeled:
    (1) ``For Nonclinical Use Only'' and
    (2) With the Biohazard legend shown in Sec. 1271.3(h).



Sec. 1271.75  How do I screen a donor?

    (a) All donors. Except as provided under Sec. 1271.90, if you are 
the establishment that performs donor screening, you must screen a donor 
of cells or tissue by reviewing the donor's relevant medical records 
for:
    (1) Risk factors for, and clinical evidence of, relevant 
communicable disease agents and diseases, including:
    (i) Human immunodeficiency virus;
    (ii) Hepatitis B virus;
    (iii) Hepatitis C virus;
    (iv) Human transmissible spongiform encephalopathy, including 
Creutzfeldt-Jakob disease;
    (v) Treponema pallidum; and
    (2) Communicable disease risks associated with xenotransplantation.
    (b) Donors of viable, leukocyte-rich cells or tissue. In addition to 
the relevant communicable disease agents and diseases for which 
screening is required under paragraph (a) of this section, and except as 
provided under Sec. 1271.90, you must screen the donor of viable, 
leukocyte-rich cells or tissue by reviewing the donor's relevant medical 
records for risk factors for and clinical evidence of relevant cell-
associated communicable disease agents and diseases, including Human T-
lymphotropic virus.
    (c) Donors of reproductive cells or tissue. In addition to the 
relevant communicable disease agents and diseases for which screening is 
required under paragraphs (a) and (b) of this section, as applicable, 
and except as provided under Sec. 1271.90, you must screen the donor of 
reproductive cells or tissue by reviewing the donor's relevant medical 
records for risk factors for and clinical evidence of infection due to 
relevant communicable diseases of the genitourinary tract. Such 
screening must include screening for the communicable disease agents 
listed in paragraphs (c)(1) and (c)(2) of this section. However, if the 
reproductive cells or tissues are recovered by a method that ensures 
freedom from contamination of the cells or tissue by infectious disease 
organisms that may be present in the genitourinary tract, then screening 
for the communicable disease agents listed in paragraphs (c)(1) and 
(c)(2) of this section is not required. Communicable disease agents of 
the genitourinary tract for which you must screen include:
    (1) Chlamydia trachomatis; and
    (2) Neisseria gonorrhea.
    (d) Ineligible donors. You must determine ineligible a donor who is 
identified as having either of the following:
    (1) A risk factor for or clinical evidence of any of the relevant 
communicable disease agents or diseases for which screening is required 
under paragraphs (a)(1), (b), or (c) of this section; or
    (2) Any communicable disease risk associated with 
xenotransplantation.
    (e) Abbreviated procedure for repeat donors. If you have performed a 
complete donor screening procedure on a living donor within the previous 
6 months,

[[Page 1086]]

you may use an abbreviated donor screening procedure on repeat 
donations. The abbreviated procedure must determine and document any 
changes in the donor's medical history since the previous donation that 
would make the donor ineligible, including relevant social behavior.

[66 FR 5466, Jan. 19, 2001, as amended at 71 FR 14798, Mar. 24, 2006]



Sec. 1271.80  What are the general requirements for donor testing?

    (a) Testing for relevant communicable diseases is required. To 
adequately and appropriately reduce the risk of transmission of relevant 
communicable diseases, and except as provided under Sec. 1271.90, if 
you are the establishment that performs donor testing, you must test a 
donor specimen for evidence of infection due to communicable disease 
agents in accordance with paragraph (c) of this section. You must test 
for those communicable disease agents specified in Sec. 1271.85. In the 
case of a donor 1 month of age or younger, you must test a specimen from 
the birth mother instead of a specimen from the donor.
    (b) Timing of specimen collection. You must collect the donor 
specimen for testing at the time of recovery of cells or tissue from the 
donor; or up to 7 days before or after recovery, except:
    (1) For donors of peripheral blood stem/progenitor cells, bone 
marrow (if not excepted under Sec. 1271.3(d)(4)), or oocytes, you may 
collect the donor specimen for testing up to 30 days before recovery; or
    (2) In the case of a repeat semen donor from whom a specimen has 
already been collected and tested, and for whom retesting is required 
under Sec. 1271.85(d), you are not required to collect a donor specimen 
at the time of each donation.
    (c) Tests. You must test using appropriate FDA-licensed, approved, 
or cleared donor screening tests, in accordance with the manufacturer's 
instructions, to adequately and appropriately reduce the risk of 
transmission of relevant communicable disease agents or diseases; 
however, until such time as appropriate FDA-licensed, approved, or 
cleared donor screening tests for Chlamydia trachomatis and for 
Neisseria gonorrhea are available, you must use FDA-licensed, approved, 
or cleared tests labeled for the detection of those organisms in an 
asymptomatic, low-prevalence population. You must use a test 
specifically labeled for cadaveric specimens instead of a more generally 
labeled test when applicable and when available. Required testing under 
this section must be performed by a laboratory that either is certified 
to perform such testing on human specimens under the Clinical Laboratory 
Improvement Amendments of 1988 (42 U.S.C. 263a) and 42 CFR part 493, or 
has met equivalent requirements as determined by the Centers for 
Medicare and Medicaid Services.
    (d) Ineligible donors. You must determine the following donors to be 
ineligible:
    (1) A donor whose specimen tests reactive on a screening test for a 
communicable disease agent in accordance with Sec. 1271.85, except for 
a donor whose specimen tests reactive on a non-treponemal screening test 
for syphilis and negative on a specific treponemal confirmatory test;
    (2)(i) A donor in whom plasma dilution sufficient to affect the 
results of communicable disease testing is suspected, unless:
    (A) You test a specimen taken from the donor before transfusion or 
infusion and up to 7 days before recovery of cells or tissue; or
    (B) You use an appropriate algorithm designed to evaluate volumes 
administered in the 48 hours before specimen collection, and the 
algorithm shows that plasma dilution sufficient to affect the results of 
communicable disease testing has not occurred.
    (ii) Clinical situations in which you must suspect plasma dilution 
sufficient to affect the results of communicable disease testing include 
but are not limited to the following:
    (A) Blood loss is known or suspected in a donor over 12 years of 
age, and the donor has received a transfusion or infusion of any of the 
following, alone or in combination:
    (1) More than 2,000 milliliters (mL) of blood (e.g., whole blood, 
red blood cells) or colloids within 48 hours before

[[Page 1087]]

death or specimen collection, whichever occurred earlier, or
    (2) More than 2,000 mL of crystalloids within 1 hour before death or 
specimen collection, whichever occurred earlier.
    (B) Regardless of the presence or absence of blood loss, the donor 
is 12 years of age or younger and has received a transfusion or infusion 
of any amount of any of the following, alone or in combination:
    (1) Blood (e.g., whole blood, red blood cells) or colloids within 48 
hours before death or specimen collection, whichever occurred earlier, 
or
    (2) Crystalloids within 1 hour before death or specimen collection, 
whichever occurred earlier.

[69 FR 29830, May 25, 2004, as amended at 70 FR 29952, May 25, 2005]



Sec. 1271.85  What donor testing is required for different types of cells and tissues?

    (a) All donors. To adequately and appropriately reduce the risk of 
transmission of relevant communicable diseases, and except as provided 
under Sec. 1271.90, you must test a specimen from the donor of cells or 
tissue, whether viable or nonviable, for evidence of infection due to 
relevant communicable disease agents, including:
    (1) Human immunodeficiency virus, type 1;
    (2) Human immunodeficiency virus, type 2;
    (3) Hepatitis B virus;
    (4) Hepatitis C virus; and
    (5) Treponema pallidum.
    (b) Donors of viable, leukocyte-rich cells or tissue. In addition to 
the relevant communicable disease agents for which testing is required 
under paragraph (a) of this section, and except as provided under Sec. 
1271.90,
    (1) You must test a specimen from the donor of viable, leukocyte-
rich cells or tissue to adequately and appropriately reduce the risk of 
transmission of relevant cell-associated communicable diseases, 
including:
    (i) Human T-lymphotropic virus, type I; and
    (ii) Human T-lymphotropic virus, type II.
    (2) You must test a specimen from the donor of viable, leukocyte-
rich cells or tissue for evidence of infection due to cytomegalovirus 
(CMV), to adequately and appropriately reduce the risk of transmission. 
You must establish and maintain a standard operating procedure governing 
the release of an HCT/P from a donor whose specimen tests reactive for 
CMV.
    (c) Donors of reproductive cells or tissue. In addition to the 
communicable disease agents for which testing is required under 
paragraphs (a) and (b) of this section, as applicable, and except as 
provided under Sec. 1271.90, you must test a specimen from the donor of 
reproductive cells or tissue to adequately and appropriately reduce the 
risk of transmission of relevant communicable disease agents of the 
genitourinary tract. Such testing must include testing for the 
communicable disease agents listed in paragraphs (c)(1) and (c)(2) of 
this section. However, if the reproductive cells or tissues are 
recovered by a method that ensures freedom from contamination of the 
cells or tissue by infectious disease organisms that may be present in 
the genitourinary tract, then testing for the communicable disease 
agents listed in paragraphs (c)(1) and (c)(2) of this section is not 
required. Communicable disease agents of the genitourinary tract for 
which you must test include:
    (1) Chlamydia trachomatis; and
    (2) Neisseria gonorrhea.
    (d) Retesting anonymous semen donors. Except as provided under Sec. 
1271.90 and except for directed reproductive donors as defined in Sec. 
1271.3(l), at least 6 months after the date of donation of semen from 
anonymous donors, you must collect a new specimen from the donor and 
test it for evidence of infection due to the communicable disease agents 
for which testing is required under paragraphs (a), (b), and (c) of this 
section.
    (e) Dura mater. For donors of dura mater, you must perform an 
adequate assessment designed to detect evidence of transmissible 
spongiform encephalopathy.



Sec. 1271.90  Are there other exceptions and what labeling requirements apply?

    (a) Donor-eligibility determination not required. You are not 
required to make a donor-eligibility determination under

[[Page 1088]]

Sec. 1271.50 or to perform donor screening or testing under Sec. Sec. 
1271.75, 1271.80 and 1271.85 for:
    (1) Cells and tissues for autologous use; or
    (2) Reproductive cells or tissue donated by a sexually intimate 
partner of the recipient for reproductive use; or
    (3) Cryopreserved cells or tissue for reproductive use, other than 
embryos, originally excepted under paragraphs (a)(1) or (a)(2) of this 
section at the time of donation, that are subsequently intended for 
directed donation, provided that:
    (i) Additional donations are unavailable, for example, due to the 
infertility or health of a donor of the cryopreserved reproductive cells 
or tissue; and
    (ii) Appropriate measures are taken to screen and test the donor(s) 
before transfer to the recipient.
    (4) A cryopreserved embryo, originally excepted under paragraph 
(a)(2) of this section at the time of recovery or cryopreservation, that 
is subsequently intended for directed or anonymous donation. When 
possible, appropriate measures should be taken to screen and test the 
semen and oocyte donors before transfer of the embryo to the recipient.
    (b) Exceptions for reproductive use. An embryo originally intended 
for reproductive use for a specific individual or couple that is 
subsequently intended for directed or anonymous donation for 
reproductive use is excepted from the prohibition on use under Sec. 
1271.45(c) even when the applicable donor eligibility requirements under 
subpart C of this part are not met. Nothing in this paragraph creates an 
exception for deficiencies that occurred in making the donor eligibility 
determination for either the oocyte donor or the semen donor as required 
under Sec. 1271.45(b), or for deficiencies in performing donor 
screening or testing, as required under Sec. Sec. 1271.75, 1271.80, and 
1271.85.
    (c) Required labeling. As applicable, you must prominently label an 
HCT/P described in paragraphs (a) and (b) of this section as follows:
    (1) ``FOR AUTOLOGOUS USE ONLY,'' if it is stored for autologous use.
    (2) ``NOT EVALUATED FOR INFECTIOUS SUBSTANCES,'' unless you have 
performed all otherwise applicable screening and testing under 
Sec. Sec. 1271.75, 1271.80, and 1271.85. This paragraph does not apply 
to reproductive cells or tissue labeled in accordance with paragraph 
(c)(6) of this section.
    (3) Unless the HCT/P is for autologous use only, ``WARNING: Advise 
recipient of communicable disease risks,''
    (i) When the donor-eligibility determination under Sec. 1271.50(a) 
is not performed or is not completed; or
    (ii) If the results of any screening or testing performed indicate:
    (A) The presence of relevant communicable disease agents and/or
    (B) Risk factors for or clinical evidence of relevant communicable 
disease agents or diseases.
    (4) With the Biohazard legend shown in Sec. 1271.3(h), if the 
results of any screening or testing performed indicate:
    (i) The presence of relevant communicable disease agents and/or
    (ii) Risk factors for or clinical evidence of relevant communicable 
disease agents or diseases.
    (5) ``WARNING: Reactive test results for (name of disease agent or 
disease),'' in the case of reactive test results.
    (6) ``Advise recipient that screening and testing of the donor(s) 
were not performed at the time of recovery or cryopreservation of the 
reproductive cells or tissue, but have been performed subsequently,'' 
for paragraphs (a)(3) or (a)(4) of this section.

[69 FR 29830, May 25, 2004, as amended at 70 FR 29952, May 25, 2005; 81 
FR 40517, June 22, 2016]



                 Subpart D_Current Good Tissue Practice

    Source: 69 FR 68681, Nov. 24, 2004, unless otherwise noted.



Sec. 1271.145  Prevention of the introduction, transmission, or
spread of communicable diseases.

    You must recover, process, store, label, package, and distribute 
HCT/Ps,

[[Page 1089]]

and screen and test cell and tissue donors, in a way that prevents the 
introduction, transmission, or spread of communicable diseases.



Sec. 1271.150  Current good tissue practice requirements.

    (a) General. This subpart D and subpart C of this part set forth 
current good tissue practice (CGTP) requirements. You must follow CGTP 
requirements to prevent the introduction, transmission, or spread of 
communicable diseases by HCT/Ps (e.g., by ensuring that the HCT/Ps do 
not contain communicable disease agents, that they are not contaminated, 
and that they do not become contaminated during manufacturing). 
Communicable diseases include, but are not limited to, those transmitted 
by viruses, bacteria, fungi, parasites, and transmissible spongiform 
encephalopathy agents. CGTP requirements govern the methods used in, and 
the facilities and controls used for, the manufacture of HCT/Ps, 
including but not limited to all steps in recovery, donor screening, 
donor testing, processing, storage, labeling, packaging, and 
distribution. The CGTP provisions specifically governing determinations 
of donor eligibility, including donor screening and testing, are set out 
separately in subpart C of this part.
    (b) Core CGTP requirements. The following are core CGTP 
requirements:
    (1) Requirements relating to facilities in Sec. 1271.190(a) and 
(b);
    (2) Requirements relating to environmental control in Sec. 
1271.195(a);
    (3) Requirements relating to equipment in Sec. 1271.200(a);
    (4) Requirements relating to supplies and reagents in Sec. 
1271.210(a) and (b);
    (5) Requirements relating to recovery in Sec. 1271.215;
    (6) Requirements relating to processing and process controls in 
Sec. 1271.220;
    (7) Requirements relating to labeling controls in Sec. 1271.250(a) 
and (b);
    (8) Requirements relating to storage in Sec. 1271.260 (a) through 
(d);
    (9) Requirements relating to receipt, predistribution shipment, and 
distribution of an HCT/P in Sec. 1271.265(a) through (d); and
    (10) Requirements relating to donor eligibility determinations, 
donor screening, and donor testing in Sec. Sec. 1271.50, 1271.75, 
1271.80, and 1271.85.
    (c) Compliance with applicable requirements--(1) Manufacturing 
arrangements (i) If you are an establishment that engages in only some 
operations subject to the regulations in this subpart and subpart C of 
this part, and not others, then you need only comply with those 
requirements applicable to the operations that you perform.
    (ii) If you engage another establishment (e.g., a laboratory to 
perform communicable disease testing, or an irradiation facility to 
perform terminal sterilization), under a contract, agreement, or other 
arrangement, to perform any step in manufacture for you, that 
establishment is responsible for complying with requirements applicable 
to that manufacturing step.
    (iii) Before entering into a contract, agreement, or other 
arrangement with another establishment to perform any step in 
manufacture for you, you must ensure that the establishment complies 
with applicable CGTP requirements. If, during the course of this 
contract, agreement, or other arrangement, you become aware of 
information suggesting that the establishment may no longer be in 
compliance with such requirements, you must take reasonable steps to 
ensure the establishment complies with those requirements. If you 
determine that the establishment is not in compliance with those 
requirements, you must terminate your contract, agreement, or other 
arrangement with the establishment.
    (2) If you are the establishment that determines that an HCT/P meets 
all release criteria and makes the HCT/P available for distribution, 
whether or not you are the actual distributor, you are responsible for 
reviewing manufacturing and tracking records to determine that the HCT/P 
has been manufactured and tracked in compliance with the requirements of 
this subpart and subpart C of this part and any other applicable 
requirements.
    (3) With the exception of Sec. Sec. 1271.150(c) and 1271.155 of 
this subpart, the regulations in this subpart are not being implemented 
for reproductive HCT/Ps described in Sec. 1271.10 and regulated solely 
under section 361 of the Public Health Service Act and the regulations 
in this

[[Page 1090]]

part, or for the establishments that manufacture them.
    (d) Compliance with parts 210, 211, and 820 of this chapter. With 
respect to HCT/Ps that are drugs (subject to review under an application 
submitted under section 505 of the Federal Food, Drug, and Cosmetic Act 
or under a biological product license application under section 351 of 
the Public Health Service Act) or that are devices (subject to premarket 
review or notification under the device provisions of the act or under a 
biological product license application under section 351 of the Public 
Health Service Act), the procedures contained in this subpart and in 
subpart C of this part and the current good manufacturing practice 
regulations in parts 210 and 211 of this chapter and the quality system 
regulations in part 820 of this chapter supplement, and do not 
supersede, each other unless the regulations explicitly provide 
otherwise. In the event that a regulation in part 1271 of this chapter 
is in conflict with a requirement in parts 210, 211, or 820 of this 
chapter, the regulations more specifically applicable to the product in 
question will supersede the more general.
    (e) Where appropriate. When a requirement is qualified by ``where 
appropriate,'' it is deemed to be ``appropriate'' unless you can 
document justification otherwise. A requirement is ``appropriate'' if 
nonimplementation of the requirement could reasonably be expected to 
result in the HCT/P not meeting its specified requirements related to 
prevention of introduction, transmission, or spread of communicable 
diseases, or in your inability to carry out any necessary corrective 
action.



Sec. 1271.155  Exemptions and alternatives.

    (a) General. You may request an exemption from or alternative to any 
requirement in subpart C or D of this part.
    (b) Request for exemption or alternative. Submit your request under 
this section to the Director of the appropriate Center (the Director), 
e.g., the Center for Biologics Evaluation and Research or the Center for 
Devices and Radiological Health. The request must be accompanied by 
supporting documentation, including all relevant valid scientific data, 
and must contain either:
    (1) Information justifying the requested exemption from the 
requirement, or
    (2) A description of a proposed alternative method of meeting the 
requirement.
    (c) Criteria for granting an exemption or alternative. The Director 
may grant an exemption or alternative if he or she finds that such 
action is consistent with the goals of protecting the public health and/
or preventing the introduction, transmission, or spread of communicable 
diseases and that:
    (1) The information submitted justifies an exemption; or
    (2) The proposed alternative satisfies the purpose of the 
requirement.
    (d) Form of request. You must ordinarily make your request for an 
exemption or alternative in writing (hard copy or electronically). 
However, if circumstances make it difficult (e.g., there is inadequate 
time) to submit your request in writing, you may make the request 
orally, and the Director may orally grant an exemption or alternative. 
You must follow your oral request with an immediate written request, to 
which the Director will respond in writing.
    (e) Operation under exemption or alternative. You must not begin 
operating under the terms of a requested exemption or alternative until 
the exemption or alternative has been granted. You may apply for an 
extension of an exemption or alternative beyond its expiration date, if 
any.
    (f) Documentation. If you operate under the terms of an exemption or 
alternative, you must maintain documentation of:
    (1) FDA's grant of the exemption or alternative, and
    (2) The date on which you began operating under the terms of the 
exemption or alternative.
    (g) Issuance of an exemption or alternative by the Director. In a 
public health emergency, the Director may issue an exemption from, or 
alternative to, any requirement in part 1271. The Director may issue an 
exemption or alternative under this section if the exemption or 
alternative is necessary to assure that

[[Page 1091]]

certain HCT/Ps will be available in a specified location to respond to 
an unanticipated immediate need for those HCT/Ps.



Sec. 1271.160  Establishment and maintenance of a quality program.

    (a) General. If you are an establishment that performs any step in 
the manufacture of HCT/Ps, you must establish and maintain a quality 
program intended to prevent the introduction, transmission, or spread of 
communicable diseases through the manufacture and use of HCT/Ps. The 
quality program must be appropriate for the specific HCT/Ps manufactured 
and the manufacturing steps performed. The quality program must address 
all core CGTP requirements listed in Sec. 1271.150(b).
    (b) Functions. Functions of the quality program must include:
    (1) Establishing and maintaining appropriate procedures relating to 
core CGTP requirements, and ensuring compliance with the requirements of 
Sec. 1271.180 with respect to such procedures, including review, 
approval, and revision;
    (2) Ensuring that procedures exist for receiving, investigating, 
evaluating, and documenting information relating to core CGTP 
requirements, including complaints, and for sharing any information 
pertaining to the possible contamination of the HCT/P or the potential 
for transmission of a communicable disease by the HCT/P with the 
following:
    (i) Other establishments that are known to have recovered HCT/Ps 
from the same donor;
    (ii) Other establishments that are known to have performed 
manufacturing steps with respect to the same HCT/P; and
    (iii) Relating to consignees, in the case of such information 
received after the HCT/P is made available for distribution, shipped to 
the consignee, or administered to the recipient, procedures must include 
provisions for assessing risk and appropriate followup, and evaluating 
the effect this information has on the HCT/P and for the notification of 
all entities to whom the affected HCT/P was distributed, the quarantine 
and recall of the HCT/P, and/or reporting to FDA, as necessary.
    (3) Ensuring that appropriate corrective actions relating to core 
CGTP requirements, including reaudits of deficiencies, are taken and 
documented, as necessary. You must verify corrective actions to ensure 
that such actions are effective and are in compliance with CGTP. Where 
appropriate, corrective actions must include both short-term action to 
address the immediate problem and long-term action to prevent the 
problem's recurrence. Documentation of corrective actions must include, 
where appropriate:
    (i) Identification of the HCT/P affected and a description of its 
disposition;
    (ii) The nature of the problem requiring corrective action;
    (iii) A description of the corrective action taken; and
    (iv) The date(s) of the corrective action.
    (4) Ensuring the proper training and education of personnel involved 
in activities related to core CGTP requirements;
    (5) Establishing and maintaining appropriate monitoring systems as 
necessary to comply with the requirements of this subpart (e.g., 
environmental monitoring);
    (6) Investigating and documenting HCT/P deviations and trends of 
HCT/P deviations relating to core CGTP requirements and making reports 
if required under Sec. 1271.350(b) or other applicable regulations. 
Each investigation must include a review and evaluation of the HCT/P 
deviation, the efforts made to determine the cause, and the 
implementation of corrective action(s) to address the HCT/P deviation 
and prevent recurrence.
    (c) Audits. You must periodically perform for management review a 
quality audit, as defined in Sec. 1271.3(gg), of activities related to 
core CGTP requirements.
    (d) Computers. You must validate the performance of computer 
software for the intended use, and the performance of any changes to 
that software for the intended use, if you rely upon the software to 
comply with core CGTP requirements and if the software either is custom 
software or is commercially

[[Page 1092]]

available software that has been customized or programmed (including 
software programmed to perform a user defined calculation or table) to 
perform a function related to core CGTP requirements. You must verify 
the performance of all other software for the intended use if you rely 
upon it to comply with core CGTP requirements. You must approve and 
document these activities and results before implementation.



Sec. 1271.170  Personnel.

    (a) General. You must have personnel sufficient to ensure compliance 
with the requirements of this part.
    (b) Competent performance of functions. You must have personnel with 
the necessary education, experience, and training to ensure competent 
performance of their assigned functions. Personnel must perform only 
those activities for which they are qualified and authorized.
    (c) Training. You must train all personnel, and retrain as 
necessary, to perform their assigned responsibilities adequately.



Sec. 1271.180  Procedures.

    (a) General. You must establish and maintain procedures appropriate 
to meet core CGTP requirements for all steps that you perform in the 
manufacture of HCT/Ps. You must design these procedures to prevent 
circumstances that increase the risk of the introduction, transmission, 
or spread of communicable diseases through the use of HCT/Ps.
    (b) Review and approval. Before implementation, a responsible person 
must review and approve these procedures.
    (c) Availability. These procedures must be readily available to the 
personnel in the area where the operations to which they relate are 
performed, or in a nearby area if such availability is impractical.
    (d) Standard procedures. If you adopt current standard procedures 
from another organization, you must verify that the procedures meet the 
requirements of this part and are appropriate for your operations.



Sec. 1271.190  Facilities.

    (a) General. Any facility used in the manufacture of HCT/Ps must be 
of suitable size, construction, and location to prevent contamination of 
HCT/Ps with communicable disease agents and to ensure orderly handling 
of HCT/Ps without mix-ups. You must maintain the facility in a good 
state of repair. You must provide lighting, ventilation, plumbing, 
drainage, and access to sinks and toilets that are adequate to prevent 
the introduction, transmission, or spread of communicable disease.
    (b) Facility cleaning and sanitation. (1) You must maintain any 
facility used in the manufacture of HCT/Ps in a clean, sanitary, and 
orderly manner, to prevent the introduction, transmission, or spread of 
communicable disease.
    (2) You must dispose of sewage, trash, and other refuse in a timely, 
safe, and sanitary manner.
    (c) Operations. You must divide a facility used in the manufacture 
of HCT/Ps into separate or defined areas of adequate size for each 
operation that takes place in the facility, or you must establish and 
maintain other control systems to prevent improper labeling, mix-ups, 
contamination, cross-contamination, and accidental exposure of HCT/Ps to 
communicable disease agents.
    (d) Procedures and records. (1) You must establish and maintain 
procedures for facility cleaning and sanitation for the purpose of 
preventing the introduction, transmission, or spread of communicable 
disease. These procedures must assign responsibility for sanitation and 
must describe in sufficient detail the cleaning methods to be used and 
the schedule for cleaning the facility.
    (2) You must document, and maintain records of, all cleaning and 
sanitation activities performed to prevent contamination of HCT/Ps. You 
must retain such records 3 years after their creation.



Sec. 1271.195  Environmental control and monitoring.

    (a) Environmental control. Where environmental conditions could 
reasonably be expected to cause contamination or cross-contamination of 
HCT/Ps or equipment, or accidental exposure of

[[Page 1093]]

HCT/Ps to communicable disease agents, you must adequately control 
environmental conditions and provide proper conditions for operations. 
Where appropriate, you must provide for the following control activities 
or systems:
    (1) Temperature and humidity controls;
    (2) Ventilation and air filtration;
    (3) Cleaning and disinfecting of rooms and equipment to ensure 
aseptic processing operations; and
    (4) Maintenance of equipment used to control conditions necessary 
for aseptic processing operations.
    (b) Inspections. You must inspect each environmental control system 
periodically to verify that the system, including necessary equipment, 
is adequate and functioning properly. You must take appropriate 
corrective action as necessary.
    (c) Environmental monitoring. You must monitor environmental 
conditions where environmental conditions could reasonably be expected 
to cause contamination or cross-contamination of HCT/Ps or equipment, or 
accidental exposure of HCT/Ps to communicable disease agents. Where 
appropriate, you must provide environmental monitoring for 
microorganisms.
    (d) Records. You must document, and maintain records of, 
environmental control and monitoring activities.



Sec. 1271.200  Equipment.

    (a) General. To prevent the introduction, transmission, or spread of 
communicable diseases, equipment used in the manufacture of HCT/Ps must 
be of appropriate design for its use and must be suitably located and 
installed to facilitate operations, including cleaning and maintenance. 
Any automated, mechanical, electronic, or other equipment used for 
inspection, measuring, or testing in accordance with this part must be 
capable of producing valid results. You must clean, sanitize, and 
maintain equipment according to established schedules.
    (b) Procedures and schedules. You must establish and maintain 
procedures for cleaning, sanitizing, and maintaining equipment to 
prevent malfunctions, contamination or cross-contamination, accidental 
exposure of HCT/Ps to communicable disease agents, and other events that 
could reasonably be expected to result in the introduction, 
transmission, or spread of communicable diseases.
    (c) Calibration of equipment. Where appropriate, you must routinely 
calibrate according to established procedures and schedules all 
automated, mechanical, electronic, or other equipment used for 
inspection, measuring, and testing in accordance with this part.
    (d) Inspections. You must routinely inspect equipment for 
cleanliness, sanitation, and calibration, and to ensure adherence to 
applicable equipment maintenance schedules.
    (e) Records. You must document and maintain records of all equipment 
maintenance, cleaning, sanitizing, calibration, and other activities 
performed in accordance with this section. You must display records of 
recent maintenance, cleaning, sanitizing, calibration, and other 
activities on or near each piece of equipment, or make the records 
readily available to the individuals responsible for performing these 
activities and to the personnel using the equipment. You must maintain 
records of the use of each piece of equipment, including the 
identification of each HCT/P manufactured with that equipment.



Sec. 1271.210  Supplies and reagents.

    (a) Verification. You must not use supplies and reagents until they 
have been verified to meet specifications designed to prevent 
circumstances that increase the risk of the introduction, transmission, 
or spread of communicable diseases. Verification may be accomplished by 
the establishment that uses the supply or reagent, or by the vendor of 
the supply or reagent.
    (b) Reagents. Reagents used in processing and preservation of HCT/Ps 
must be sterile, where appropriate.
    (c) In-house reagents. You must validate and/or verify the processes 
used for production of in-house reagents.
    (d) Records. You must maintain the following records pertaining to 
supplies and reagents:
    (1) Records of the receipt of each supply or reagent, including the 
type, quantity, manufacturer, lot number, date of receipt, and 
expiration date;

[[Page 1094]]

    (2) Records of the verification of each supply or reagent, including 
test results or, in the case of vendor verification, a certificate of 
analysis from the vendor; and
    (3) Records of the lot of supply or reagent used in the manufacture 
of each HCT/P.



Sec. 1271.215  Recovery.

    If you are an establishment that recovers HCT/Ps, you must recover 
each HCT/P in a way that does not cause contamination or cross-
contamination during recovery, or otherwise increase the risk of the 
introduction, transmission, or spread of communicable disease through 
the use of the HCT/P.



Sec. 1271.220  Processing and process controls.

    (a) General. If you are an establishment that processes HCT/Ps, you 
must process each HCT/P in a way that does not cause contamination or 
cross-contamination during processing, and that prevents the 
introduction, transmission, or spread of communicable disease through 
the use of the HCT/P.
    (b) Pooling. Human cells or tissue from two or more donors must not 
be pooled (placed in physical contact or mixed in a single receptacle) 
during manufacturing.
    (c) In-process control and testing. You must ensure that specified 
requirements, consistent with paragraph (a) of this section, for in-
process controls are met, and that each in-process HCT/P is controlled 
until the required inspection and tests or other verification activities 
have been completed, or necessary approvals are received and documented. 
Sampling of in-process HCT/Ps must be representative of the material to 
be evaluated.
    (d) Dura mater. (1) When there is a published validated process that 
reduces the risk of transmissible spongiform encephalopathy, you must 
use this process for dura mater (or an equivalent process that you have 
validated), unless following this process adversely affects the clinical 
utility of the dura mater.
    (2) When you use a published validated process, you must verify such 
a process in your establishment.



Sec. 1271.225  Process changes.

    Any change to a process must be verified or validated in accordance 
with Sec. 1271.230, to ensure that the change does not create an 
adverse impact elsewhere in the operation, and must be approved before 
implementation by a responsible person with appropriate knowledge and 
background. You must communicate approved changes to the appropriate 
personnel in a timely manner.



Sec. 1271.230  Process validation.

    (a) General. Where the results of processing described in Sec. 
1271.220 cannot be fully verified by subsequent inspection and tests, 
you must validate and approve the process according to established 
procedures. The validation activities and results must be documented, 
including the date and signature of the individual(s) approving the 
validation.
    (b) Written representation. Any written representation that your 
processing methods reduce the risk of transmission of communicable 
disease by an HCT/P, including but not limited to, a representation of 
sterility or pathogen inactivation of an HCT/P, must be based on a fully 
verified or validated process.
    (c) Changes. When changes to a validated process subject to 
paragraph (a) of this section occur, you must review and evaluate the 
process and perform revalidation where appropriate. You must document 
these activities.



Sec. 1271.250  Labeling controls.

    (a) General. You must establish and maintain procedures to control 
the labeling of HCT/Ps. You must design these procedures to ensure 
proper HCT/P identification and to prevent mix-ups.
    (b) Verification. Procedures must include verification of label 
accuracy, legibility, and integrity.
    (c) Labeling requirements. Procedures must ensure that each HCT/P is 
labeled in accordance with all applicable labeling requirements, 
including those in Sec. Sec. 1271.55, 1271.60, 1271.65, 1271.90, 
1271.290, and 1271.370, and that each HCT/P made available for 
distribution is accompanied by documentation of

[[Page 1095]]

the donor eligibility determination as required under Sec. 1271.55.



Sec. 1271.260  Storage.

    (a) Control of storage areas. You must control your storage areas 
and stock rooms to prevent:
    (1) Mix-ups, contamination, and cross-contamination of HCT/Ps, 
supplies, and reagents, and
    (2) An HCT/P from being improperly made available for distribution.
    (b) Temperature. You must store HCT/Ps at an appropriate 
temperature.
    (c) Expiration date. Where appropriate, you must assign an 
expiration date to each HCT/P based on the following factors:
    (1) HCT/P type;
    (2) Processing, including the method of preservation;
    (3) Storage conditions; and
    (4) Packaging.
    (d) Corrective action. You must take and document corrective action 
whenever proper storage conditions are not met.
    (e) Acceptable temperature limits. You must establish acceptable 
temperature limits for storage of HCT/Ps at each step of the 
manufacturing process to inhibit the growth of infectious agents. You 
must maintain and record storage temperatures for HCT/Ps. You must 
periodically review recorded temperatures to ensure that temperatures 
have been within acceptable limits.



Sec. 1271.265  Receipt, predistribution shipment, and distribution of an HCT/P.

    (a) Receipt. You must evaluate each incoming HCT/P for the presence 
and significance of microorganisms and inspect for damage and 
contamination. You must determine whether to accept, reject, or place in 
quarantine each incoming HCT/P, based upon pre-established criteria 
designed to prevent communicable disease transmission.
    (b) Predistribution shipment. If you ship an HCT/P within your 
establishment or between establishments (e.g., procurer to processor) 
and the HCT/P is not available for distribution as described in 
paragraph (c) of this section, you must first determine and document 
whether pre-established criteria designed to prevent communicable 
disease transmission have been met, and you must ship the HCT/P in 
quarantine.
    (c) Availability for distribution. (1) Before making an HCT/P 
available for distribution, you must review manufacturing and tracking 
records pertaining to the HCT/P, and, on the basis of that record 
review, you must verify and document that the release criteria have been 
met. A responsible person must document and date the determination that 
an HCT/P is available for distribution.
    (2) You must not make available for distribution an HCT/P that is in 
quarantine, is contaminated, is recovered from a donor who has been 
determined to be ineligible or for whom a donor-eligibility 
determination has not been completed (except as provided under 
Sec. Sec. 1271.60, 1271.65, and 1271.90), or that otherwise does not 
meet release criteria designed to prevent communicable disease 
transmission.
    (3) You must not make available for distribution any HCT/P 
manufactured under a departure from a procedure relevant to preventing 
risks of communicable disease transmission, unless a responsible person 
has determined that the departure does not increase the risk of 
communicable disease through the use of the HCT/P. You must record and 
justify any departure from a procedure at the time of its occurrence.
    (d) Packaging and shipping. Packaging and shipping containers must 
be designed and constructed to protect the HCT/P from contamination. For 
each type of HCT/P, you must establish appropriate shipping conditions 
to be maintained during transit.
    (e) Procedures. You must establish and maintain procedures, 
including release criteria, for the activities in paragraphs (a) through 
(d) of this section. You must document these activities. Documentation 
must include:
    (1) Identification of the HCT/P and the establishment that supplied 
the HCT/P;
    (2) Activities performed and the results of each activity;
    (3) Date(s) of activity;
    (4) Quantity of HCT/P subject to the activity; and
    (5) Disposition of the HCT/P (e.g., identity of consignee).

[[Page 1096]]

    (f) Return to inventory. You must establish and maintain procedures 
to determine if an HCT/P that is returned to your establishment is 
suitable to be returned to inventory.



Sec. 1271.270  Records.

    (a) General. You must maintain records concurrently with the 
performance of each step required in this subpart and subpart C of this 
part. Any requirement in this part that an action be documented involves 
the creation of a record, which is subject to the requirements of this 
section. All records must be accurate, indelible, and legible. The 
records must identify the person performing the work and the dates of 
the various entries, and must be as detailed as necessary to provide a 
complete history of the work performed and to relate the records to the 
particular HCT/P involved.
    (b) Records management system. You must establish and maintain a 
records management system relating to core CGTP requirements. Under this 
system, records pertaining to a particular HCT/P must be maintained in 
such a way as to facilitate review of the HCT/Ps history before making 
it available for distribution and, if necessary, subsequent to the HCT/
Ps release as part of a followup evaluation or investigation. Records 
pertinent to the manufacture of HCT/Ps (e.g., labeling and packaging 
procedures, and equipment logs) must also be maintained and organized 
under the records management system. If records are maintained in more 
than one location, then the records management system must be designed 
to ensure prompt identification, location, and retrieval of all records.
    (c) Methods of retention. You may maintain records required under 
this subpart electronically, as original paper records, or as true 
copies such as photocopies, microfiche, or microfilm. Equipment that is 
necessary to make the records available and legible, such as computer 
and reader equipment, must be readily available. Records stored in 
electronic systems must be backed up.
    (d) Length of retention. You must retain all records for 10 years 
after their creation, unless stated otherwise in this part. However, you 
must retain the records pertaining to a particular HCT/P at least 10 
years after the date of its administration, or if the date of 
administration is not known, then at least 10 years after the date of 
the HCT/Ps distribution, disposition, or expiration, whichever is 
latest. You must retain records for archived specimens of dura mater for 
10 years after the appropriate disposition of the specimens.
    (e) Contracts and agreements. You must maintain the name and address 
and a list of the responsibilities of any establishment that performs a 
manufacturing step for you. This information must be available during an 
inspection conducted under Sec. 1271.400.



Sec. 1271.290  Tracking.

    (a) General. If you perform any step in the manufacture of an HCT/P 
in which you handle the HCT/P, you must track each such HCT/P in 
accordance with this section, to facilitate the investigation of actual 
or suspected transmission of communicable disease and take appropriate 
and timely corrective action.
    (b) System of HCT/P tracking. (1) You must establish and maintain a 
system of HCT/P tracking that enables the tracking of all HCT/Ps from:
    (i) The donor to the consignee or final disposition; and
    (ii) The consignee or final disposition to the donor.
    (2) Alternatively, if you are an establishment that performs some 
but not all of the steps in the manufacture of an HCT/P in which you 
handle the HCT/P, you may participate in a system of HCT/P tracking 
established and maintained by another establishment responsible for 
other steps in the manufacture of the same HCT/P, provided that the 
tracking system complies with all the requirements of this section.
    (c) Distinct identification code. As part of your tracking system, 
you must ensure: That each HCT/P that you manufacture is assigned and 
labeled with a distinct identification code, e.g., alphanumeric, that 
relates the HCT/P to the donor and to all records pertaining to the HCT/
P; and that labeling includes information designed to facilitate 
effective tracking, using the distinct

[[Page 1097]]

identification code, from the donor to the recipient and from the 
recipient to the donor. Except as described in Sec. 1271.55(a)(1), you 
must create such a code specifically for tracking, and it may not 
include an individual's name, social security number, or medical record 
number. You may adopt a distinct identification code assigned by another 
establishment engaged in the manufacturing process, or you may assign a 
new code. If you assign a new code to an HCT/P, you must establish and 
maintain procedures for relating the new code to the old code.
    (d) Tracking from consignee to donor. As part of your tracking 
system, you must establish and maintain a method for recording the 
distinct identification code and type of each HCT/P distributed to a 
consignee to enable tracking from the consignee to the donor.
    (e) Tracking from donor to consignee or final disposition. As part 
of your tracking system, you must establish and maintain a method for 
documenting the disposition of each of your HCT/Ps, to enable tracking 
from the donor to the consignee or final disposition. The information 
you maintain must permit the prompt identification of the consignee of 
the HCT/P, if any.
    (f) Consignees. At or before the time of distribution of an HCT/P to 
a consignee, you must inform the consignee in writing of the 
requirements in this section and of the tracking system that you have 
established and are maintaining to comply with these requirements.
    (g) Requirements specific to dura mater donors. You must archive 
appropriate specimens from each donor of dura mater, under appropriate 
storage conditions, and for the appropriate duration, to enable testing 
of the archived material for evidence of transmissible spongiform 
encephalopathy, and to enable appropriate disposition of any affected 
nonadministered dura mater tissue, if necessary.

[69 FR 68681, Nov. 24, 2004, as amended at 70 FR 29952, May 25, 2005]



Sec. 1271.320  Complaint file.

    (a) Procedures. You must establish and maintain procedures for the 
review, evaluation, and documentation of complaints as defined in Sec. 
1271.3(aa), relating to core current good tissue practice (CGTP) 
requirements, and the investigation of complaints as appropriate.
    (b) Complaint file. You must maintain a record of complaints that 
you receive in a file designated for complaints. The complaint file must 
contain sufficient information about each complaint for proper review 
and evaluation of the complaint (including the distinct identification 
code of the HCT/P that is the subject of the complaint) and for 
determining whether the complaint is an isolated event or represents a 
trend. You must make the complaint file available for review and copying 
upon request from FDA.
    (c) Review and evaluation of complaints. You must review and 
evaluate each complaint relating to core CGTP requirements to determine 
if the complaint is related to an HCT/P deviation or to an adverse 
reaction, and to determine if a report under Sec. 1271.350 or another 
applicable regulation is required. As soon as practical, you must 
review, evaluate, and investigate each complaint that represents an 
event required to be reported to FDA, as described in Sec. 1271.350. 
You must review and evaluate a complaint relating to core CGTP 
requirements that does not represent an event required to be reported to 
determine whether an investigation is necessary; an investigation may 
include referring a copy of the complaint to another establishment that 
performed manufacturing steps pertinent to the complaint. When no 
investigation is made, you must maintain a record that includes the 
reason no investigation was made, and the name of the individual(s) 
responsible for the decision not to investigate.



  Subpart E_Additional Requirements for Establishments Described in   
                                 1271.10

    Source: 69 FR 68686, Nov. 24, 2004, unless otherwise noted.



Sec. 1271.330  Applicability.

    The provisions set forth in this subpart are being implemented for 
nonreproductive HCT/Ps described in

[[Page 1098]]

Sec. 1271.10 and regulated solely under section 361 of the Public 
Health Service Act and the regulations in this part, and for the 
establishments that manufacture those HCT/Ps. HCT/Ps that are drugs or 
devices regulated under the act, or are biological products regulated 
under section 351 of the Public Health Service Act, are not subject to 
the regulations set forth in this subpart.



Sec. 1271.350  Reporting.

    (a) Adverse reaction reports. (1) You must investigate any adverse 
reaction involving a communicable disease related to an HCT/P that you 
made available for distribution. You must report to FDA an adverse 
reaction involving a communicable disease if it:
    (i) Is fatal;
    (ii) Is life-threatening;
    (iii) Results in permanent impairment of a body function or 
permanent damage to body structure; or
    (iv) Necessitates medical or surgical intervention, including 
hospitalization.
    (2) You must submit each report on a Form FDA-3500A to the address 
in paragraph (a)(5) of this section within 15 calendar days of initial 
receipt of the information.
    (3) You must, as soon as practical, investigate all adverse 
reactions that are the subject of these 15-day reports and must submit 
followup reports within 15 calendar days of the receipt of new 
information or as requested by FDA. If additional information is not 
obtainable, a followup report may be required that describes briefly the 
steps taken to seek additional information and the reasons why it could 
not be obtained.
    (4) You may obtain copies of the reporting form (FDA-3500A) from the 
Center for Biologics Evaluation and Research (see address in paragraph 
(a)(5) of this section). Electronic Form FDA-3500A may be obtained at 
http://www.fda.gov/medwatch or at http://www.hhs.gov/forms.
    (5) You must submit two copies of each report described in this 
paragraph to the Food and Drug Administration, Center for Biologics 
Evaluation and Research, Document Control Center, 10903 New Hampshire 
Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002. FDA may waive 
the requirement for the second copy in appropriate circumstances.
    (b) Reports of HCT/P deviations. (1) You must investigate all HCT/P 
deviations related to a distributed HCT/P for which you performed a 
manufacturing step.
    (2) You must report any such HCT/P deviation relating to the core 
CGTP requirements, if the HCT/P deviation occurred in your facility or 
in a facility that performed a manufacturing step for you under 
contract, agreement, or other arrangement. Each report must contain a 
description of the HCT/P deviation, information relevant to the event 
and the manufacture of the HCT/P involved, and information on all 
follow-up actions that have been or will be taken in response to the 
HCT/P deviation (e.g., recalls).
    (3) You must report each such HCT/P deviation that relates to a core 
CGTP requirement on Form FDA 3486 within 45 days of the discovery of the 
event either electronically using the Center for Biologics Evaluation 
and Research electronic Web-based application or by mail to the Food and 
Drug Administration, Center for Biologics Evaluation and Research, 
Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, 
Silver Spring, MD 20993-0002.

[69 FR 68686, Nov. 24, 2004, as amended at 80 FR 18095, Apr. 3, 2015]



Sec. 1271.370  Labeling.

    The following requirements apply in addition to Sec. Sec. 1271.55, 
1271.60, 1271.65, and 1271.90:
    (a) You must label each HCT/P made available for distribution 
clearly and accurately.
    (b) The following information must appear on the HCT/P label:
    (1) Distinct identification code affixed to the HCT/P container, and 
assigned in accordance with Sec. 1271.290(c);
    (2) Description of the type of HCT/P;
    (3) Expiration date, if any; and
    (4) Warnings required under Sec. 1271.60(d)(2), Sec. 
1271.65(b)(2), or Sec. 1271.90(c), if applicable and physically 
possible. If it is not physically possible to include these warnings on 
the label, the warnings must, instead, accompany the HCT/P.

[[Page 1099]]

    (c) The following information must either appear on the HCT/P label 
or accompany the HCT/P:
    (1) Name and address of the establishment that determines that the 
HCT/P meets release criteria and makes the HCT/P available for 
distribution;
    (2) Storage temperature;
    (3) Other warnings, where appropriate; and
    (4) Instructions for use when related to the prevention of the 
introduction, transmission, or spread of communicable diseases.

[69 FR 68686, Nov. 24, 2004, as amended at 70 FR 29952, May 25, 2005; 81 
FR 40518, June 22, 2016]



 Subpart F_Inspection and Enforcement of Establishments Described in   
                                 1271.10

    Source: 69 FR 68687, Nov. 24, 2004, unless otherwise noted.



Sec. 1271.390  Applicability.

    The provisions set forth in this subpart are applicable only to HCT/
Ps described in Sec. 1271.10 and regulated solely under section 361 of 
the Public Health Service Act and the regulations in this part, and to 
the establishments that manufacture those HCT/Ps. HCT/Ps that are drugs 
or devices regulated under the act, or are biological products regulated 
under section 351 of the Public Health Service Act, are not subject to 
the regulations set forth in this subpart.



Sec. 1271.400  Inspections.

    (a) If you are an establishment that manufactures HCT/Ps described 
in Sec. 1271.10, whether or not under contract, you must permit the 
Food and Drug Administration (FDA) to inspect any manufacturing location 
at any reasonable time and in a reasonable manner to determine 
compliance with applicable provisions of this part. The inspection will 
be conducted as necessary in the judgment of the FDA and may include 
your establishment, facilities, equipment, finished and unfinished 
materials, containers, processes, HCT/Ps, procedures, labeling, records, 
files, papers, and controls required to be maintained under the part. 
The inspection may be made with or without prior notification and will 
ordinarily be made during regular business hours.
    (b) The frequency of inspection will be at the agency's discretion.
    (c) FDA will call upon the most responsible person available at the 
time of the inspection of the establishment and may question the 
personnel of the establishment as necessary to determine compliance with 
the provisions of this part.
    (d) FDA's representatives may take samples, may review and copy any 
records required to be kept under this part, and may use other 
appropriate means to record evidence of observations during inspections 
conducted under this subpart.
    (e) The public disclosure of records containing the name or other 
positive identification of donors or recipients of HCT/Ps will be 
handled in accordance with FDA's procedures on disclosure of information 
as set forth in parts 20 and 21 of this chapter.



Sec. 1271.420  HCT/Ps offered for import.

    (a) Except as provided in paragraphs (c) and (d) of this section, 
when an HCT/P is offered for import, the importer of record must notify, 
either before or at the time of importation, the director of the 
district of the Food and Drug Administration (FDA) having jurisdiction 
over the port of entry through which the HCT/P is imported or offered 
for import, or such officer of the district as the director may 
designate to act in his or her behalf in administering and enforcing 
this part, and must provide sufficient information, including 
information submitted in the Automated Commercial Environment (ACE) 
system or any other electronic data interchange system authorized by the 
U.S. Customs and Border Protection Agency as required in part 1, subpart 
D of this chapter, for FDA to make an admissibility decision.
    (b) Except as provided in paragraphs (c) and (d) of this section, an 
HCT/P offered for import must be held intact by the importer or 
consignee, under conditions necessary to prevent transmission of 
communicable disease, until an admissibility decision is made by FDA. 
The HCT/P may be transported

[[Page 1100]]

under quarantine to the consignee, while the FDA district reviews the 
documentation accompanying the HCT/P. When FDA makes a decision 
regarding the admissibility of the HCT/P, FDA will notify the importer 
of record.
    (c) This section does not apply to reproductive HCT/Ps regulated 
solely under section 361 of the Public Health Service Act and the 
regulations in this part, and donated by a sexually intimate partner of 
the recipient for reproductive use.
    (d) This section does not apply to peripheral blood stem/progenitor 
cells regulated solely under section 361 of the Public Health Service 
Act and the regulations in this part, except that paragraphs (a) and (b) 
of this section apply when circumstances occur under which such imported 
peripheral blood stem/progenitor cells may present an unreasonable risk 
of communicable disease transmission which indicates the need to review 
the information referenced in paragraph (a) of this section.

[69 FR 68687, Nov. 24, 2004, as amended at 81 FR 85873, Nov. 29, 2016]



Sec. 1271.440  Orders of retention, recall, destruction,
and cessation of manufacturing.

    (a) Upon an agency finding that there are reasonable grounds to 
believe that an HCT/P is a violative HCT/P because it was manufactured 
in violation of the regulations in this part and, therefore, the 
conditions of manufacture of the HCT/P do not provide adequate 
protections against risks of communicable disease transmission; or the 
HCT/P is infected or contaminated so as to be a source of dangerous 
infection to humans; or an establishment is in violation of the 
regulations in this part and, therefore, does not provide adequate 
protections against the risks of communicable disease transmission, the 
Food and Drug Administration (FDA) may take one or more of the following 
actions:
    (1) Serve upon the person who distributed the HCT/P a written order 
that the HCT/P be recalled and/or destroyed, as appropriate, and upon 
persons in possession of the HCT/P that the HCT/P must be retained until 
it is recalled by the distributor, destroyed, or disposed of as agreed 
by FDA, or the safety of the HCT/P is confirmed;
    (2) Take possession of and/or destroy the violative HCT/P; or
    (3) Serve upon the establishment an order to cease manufacturing 
until compliance with the regulations of this part has been achieved. 
When FDA determines there are reasonable grounds to believe there is a 
danger to health, such order will be effective immediately. In other 
situations, such order will be effective after one of the following 
events, whichever is later:
    (i) Passage of 5 working days from the establishment's receipt of 
the order; or
    (ii) If the establishment requests a hearing in accordance with 
paragraph (e) of this section and part 16 of this chapter, a decision 
in, and in accordance with, those proceedings.
    (b) A written order issued under paragraph (a) of this section will 
state with particularity the facts that justify the order.
    (c)(1) A written order issued under paragraph (a)(1) of this section 
will ordinarily provide that the HCT/P be recalled and/or destroyed 
within 5 working days from the date of receipt of the order. After 
receipt of an order issued under paragraph (a)(1) of this section, the 
establishment in possession of the HCT/P must not distribute or dispose 
of the HCT/P in any manner except to recall and/or destroy the HCT/P 
consistent with the provisions of the order, under the supervision of 
FDA.
    (2) In lieu of paragraph (c)(1) of this section, other arrangements 
for assuring the proper disposition of the HCT/P may be agreed upon by 
the person receiving the written order and FDA. Such arrangements may 
include, among others, providing FDA with records or other written 
information that adequately ensure that the HCT/P has been recovered, 
processed, stored, and distributed in conformance with this part, and 
that, except as provided under Sec. Sec. 1271.60, 1271.65, and 1271.90, 
the donor of the cells or tissue for the HCT/P has been determined to be 
eligible.
    (d) A written order issued under paragraph (a)(3) of this section 
will specify the regulations with which you must achieve compliance and 
will ordinarily

[[Page 1101]]

specify the particular operations covered by the order. After receipt of 
an order that is in effect and issued under paragraph (a)(3) of this 
section, you must not resume operations without prior written 
authorization of FDA.
    (e) The recipient of an order issued under this section may request 
a hearing in accordance with part 16 of this chapter. To request a 
hearing, the recipient of the written order or prior possessor of such 
HCT/P must make the request within 5 working days of receipt of a 
written order for retention, recall, destruction, and/or cessation (or 
within 5 working days of the agency's possession of an HCT/P under 
paragraph (a)(2) of this section), in accordance with part 16 of this 
chapter. An order of destruction will be held in abeyance pending 
resolution of the hearing request. Upon request under part 16 of this 
chapter, FDA will provide an opportunity for an expedited hearing for an 
order of cessation that is not stayed by the Commissioner of Food and 
Drugs.
    (f) FDA will not issue an order for the destruction of reproductive 
tissue under paragraph (a)(1) of this section, nor will it carry out 
such destruction itself under paragraph (a)(2) of this section.

                       PARTS 1272	1299 [RESERVED]

[[Page 1103]]



                              FINDING AIDS




  --------------------------------------------------------------------

  A list of CFR titles, subtitles, chapters, subchapters and parts and 
an alphabetical list of agencies publishing in the CFR are included in 
the CFR Index and Finding Aids volume to the Code of Federal Regulations 
which is published separately and revised annually.


  Table of CFR Titles and Chapters
  Alphabetical List of Agencies Appearing in the CFR
  List of CFR Sections Affected

[[Page 1105]]



                    Table of CFR Titles and Chapters




                      (Revised as of April 1, 2023)

                      Title 1--General Provisions

         I  Administrative Committee of the Federal Register 
                (Parts 1--49)
        II  Office of the Federal Register (Parts 50--299)
       III  Administrative Conference of the United States (Parts 
                300--399)
        IV  Miscellaneous Agencies (Parts 400--599)
        VI  National Capital Planning Commission (Parts 600--699)

                    Title 2--Grants and Agreements

            Subtitle A--Office of Management and Budget Guidance 
                for Grants and Agreements
         I  Office of Management and Budget Governmentwide 
                Guidance for Grants and Agreements (Parts 2--199)
        II  Office of Management and Budget Guidance (Parts 200--
                299)
            Subtitle B--Federal Agency Regulations for Grants and 
                Agreements
       III  Department of Health and Human Services (Parts 300--
                399)
        IV  Department of Agriculture (Parts 400--499)
        VI  Department of State (Parts 600--699)
       VII  Agency for International Development (Parts 700--799)
      VIII  Department of Veterans Affairs (Parts 800--899)
        IX  Department of Energy (Parts 900--999)
         X  Department of the Treasury (Parts 1000--1099)
        XI  Department of Defense (Parts 1100--1199)
       XII  Department of Transportation (Parts 1200--1299)
      XIII  Department of Commerce (Parts 1300--1399)
       XIV  Department of the Interior (Parts 1400--1499)
        XV  Environmental Protection Agency (Parts 1500--1599)
     XVIII  National Aeronautics and Space Administration (Parts 
                1800--1899)
        XX  United States Nuclear Regulatory Commission (Parts 
                2000--2099)
      XXII  Corporation for National and Community Service (Parts 
                2200--2299)
     XXIII  Social Security Administration (Parts 2300--2399)
      XXIV  Department of Housing and Urban Development (Parts 
                2400--2499)
       XXV  National Science Foundation (Parts 2500--2599)
      XXVI  National Archives and Records Administration (Parts 
                2600--2699)

[[Page 1106]]

     XXVII  Small Business Administration (Parts 2700--2799)
    XXVIII  Department of Justice (Parts 2800--2899)
      XXIX  Department of Labor (Parts 2900--2999)
       XXX  Department of Homeland Security (Parts 3000--3099)
      XXXI  Institute of Museum and Library Services (Parts 3100--
                3199)
     XXXII  National Endowment for the Arts (Parts 3200--3299)
    XXXIII  National Endowment for the Humanities (Parts 3300--
                3399)
     XXXIV  Department of Education (Parts 3400--3499)
      XXXV  Export-Import Bank of the United States (Parts 3500--
                3599)
     XXXVI  Office of National Drug Control Policy, Executive 
                Office of the President (Parts 3600--3699)
    XXXVII  Peace Corps (Parts 3700--3799)
     LVIII  Election Assistance Commission (Parts 5800--5899)
       LIX  Gulf Coast Ecosystem Restoration Council (Parts 5900--
                5999)
        LX  Federal Communications Commission (Parts 6000--6099)

                        Title 3--The President

         I  Executive Office of the President (Parts 100--199)

                           Title 4--Accounts

         I  Government Accountability Office (Parts 1--199)

                   Title 5--Administrative Personnel

         I  Office of Personnel Management (Parts 1--1199)
        II  Merit Systems Protection Board (Parts 1200--1299)
       III  Office of Management and Budget (Parts 1300--1399)
        IV  Office of Personnel Management and Office of the 
                Director of National Intelligence (Parts 1400--
                1499)
         V  The International Organizations Employees Loyalty 
                Board (Parts 1500--1599)
        VI  Federal Retirement Thrift Investment Board (Parts 
                1600--1699)
      VIII  Office of Special Counsel (Parts 1800--1899)
        IX  Appalachian Regional Commission (Parts 1900--1999)
        XI  Armed Forces Retirement Home (Parts 2100--2199)
       XIV  Federal Labor Relations Authority, General Counsel of 
                the Federal Labor Relations Authority and Federal 
                Service Impasses Panel (Parts 2400--2499)
       XVI  Office of Government Ethics (Parts 2600--2699)
       XXI  Department of the Treasury (Parts 3100--3199)
      XXII  Federal Deposit Insurance Corporation (Parts 3200--
                3299)
     XXIII  Department of Energy (Parts 3300--3399)
      XXIV  Federal Energy Regulatory Commission (Parts 3400--
                3499)
       XXV  Department of the Interior (Parts 3500--3599)

[[Page 1107]]

      XXVI  Department of Defense (Parts 3600--3699)
    XXVIII  Department of Justice (Parts 3800--3899)
      XXIX  Federal Communications Commission (Parts 3900--3999)
       XXX  Farm Credit System Insurance Corporation (Parts 4000--
                4099)
      XXXI  Farm Credit Administration (Parts 4100--4199)
    XXXIII  U.S. International Development Finance Corporation 
                (Parts 4300--4399)
     XXXIV  Securities and Exchange Commission (Parts 4400--4499)
      XXXV  Office of Personnel Management (Parts 4500--4599)
     XXXVI  Department of Homeland Security (Parts 4600--4699)
    XXXVII  Federal Election Commission (Parts 4700--4799)
        XL  Interstate Commerce Commission (Parts 5000--5099)
       XLI  Commodity Futures Trading Commission (Parts 5100--
                5199)
      XLII  Department of Labor (Parts 5200--5299)
     XLIII  National Science Foundation (Parts 5300--5399)
       XLV  Department of Health and Human Services (Parts 5500--
                5599)
      XLVI  Postal Rate Commission (Parts 5600--5699)
     XLVII  Federal Trade Commission (Parts 5700--5799)
    XLVIII  Nuclear Regulatory Commission (Parts 5800--5899)
      XLIX  Federal Labor Relations Authority (Parts 5900--5999)
         L  Department of Transportation (Parts 6000--6099)
       LII  Export-Import Bank of the United States (Parts 6200--
                6299)
      LIII  Department of Education (Parts 6300--6399)
       LIV  Environmental Protection Agency (Parts 6400--6499)
        LV  National Endowment for the Arts (Parts 6500--6599)
       LVI  National Endowment for the Humanities (Parts 6600--
                6699)
      LVII  General Services Administration (Parts 6700--6799)
     LVIII  Board of Governors of the Federal Reserve System 
                (Parts 6800--6899)
       LIX  National Aeronautics and Space Administration (Parts 
                6900--6999)
        LX  United States Postal Service (Parts 7000--7099)
       LXI  National Labor Relations Board (Parts 7100--7199)
      LXII  Equal Employment Opportunity Commission (Parts 7200--
                7299)
     LXIII  Inter-American Foundation (Parts 7300--7399)
      LXIV  Merit Systems Protection Board (Parts 7400--7499)
       LXV  Department of Housing and Urban Development (Parts 
                7500--7599)
      LXVI  National Archives and Records Administration (Parts 
                7600--7699)
     LXVII  Institute of Museum and Library Services (Parts 7700--
                7799)
    LXVIII  Commission on Civil Rights (Parts 7800--7899)
      LXIX  Tennessee Valley Authority (Parts 7900--7999)
       LXX  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 8000--8099)
      LXXI  Consumer Product Safety Commission (Parts 8100--8199)

[[Page 1108]]

    LXXIII  Department of Agriculture (Parts 8300--8399)
     LXXIV  Federal Mine Safety and Health Review Commission 
                (Parts 8400--8499)
     LXXVI  Federal Retirement Thrift Investment Board (Parts 
                8600--8699)
    LXXVII  Office of Management and Budget (Parts 8700--8799)
      LXXX  Federal Housing Finance Agency (Parts 9000--9099)
   LXXXIII  Special Inspector General for Afghanistan 
                Reconstruction (Parts 9300--9399)
    LXXXIV  Bureau of Consumer Financial Protection (Parts 9400--
                9499)
    LXXXVI  National Credit Union Administration (Parts 9600--
                9699)
     XCVII  Department of Homeland Security Human Resources 
                Management System (Department of Homeland 
                Security--Office of Personnel Management) (Parts 
                9700--9799)
    XCVIII  Council of the Inspectors General on Integrity and 
                Efficiency (Parts 9800--9899)
      XCIX  Military Compensation and Retirement Modernization 
                Commission (Parts 9900--9999)
         C  National Council on Disability (Parts 10000--10049)
        CI  National Mediation Board (Parts 10100--10199)
       CII  U.S. Office of Special Counsel (Parts 10200--10299)
       CIV  Office of the Intellectual Property Enforcement 
                Coordinator (Part 10400--10499)

                      Title 6--Domestic Security

         I  Department of Homeland Security, Office of the 
                Secretary (Parts 1--199)
         X  Privacy and Civil Liberties Oversight Board (Parts 
                1000--1099)

                         Title 7--Agriculture

            Subtitle A--Office of the Secretary of Agriculture 
                (Parts 0--26)
            Subtitle B--Regulations of the Department of 
                Agriculture
         I  Agricultural Marketing Service (Standards, 
                Inspections, Marketing Practices), Department of 
                Agriculture (Parts 27--209)
        II  Food and Nutrition Service, Department of Agriculture 
                (Parts 210--299)
       III  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 300--399)
        IV  Federal Crop Insurance Corporation, Department of 
                Agriculture (Parts 400--499)
         V  Agricultural Research Service, Department of 
                Agriculture (Parts 500--599)
        VI  Natural Resources Conservation Service, Department of 
                Agriculture (Parts 600--699)
       VII  Farm Service Agency, Department of Agriculture (Parts 
                700--799)

[[Page 1109]]

      VIII  Agricultural Marketing Service (Federal Grain 
                Inspection Service, Fair Trade Practices Program), 
                Department of Agriculture (Parts 800--899)
        IX  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Fruits, Vegetables, Nuts), Department 
                of Agriculture (Parts 900--999)
         X  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Milk), Department of Agriculture 
                (Parts 1000--1199)
        XI  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Miscellaneous Commodities), Department 
                of Agriculture (Parts 1200--1299)
       XIV  Commodity Credit Corporation, Department of 
                Agriculture (Parts 1400--1499)
        XV  Foreign Agricultural Service, Department of 
                Agriculture (Parts 1500--1599)
       XVI  [Reserved]
      XVII  Rural Utilities Service, Department of Agriculture 
                (Parts 1700--1799)
     XVIII  Rural Housing Service, Rural Business-Cooperative 
                Service, Rural Utilities Service, and Farm Service 
                Agency, Department of Agriculture (Parts 1800--
                2099)
        XX  [Reserved]
       XXV  Office of Advocacy and Outreach, Department of 
                Agriculture (Parts 2500--2599)
      XXVI  Office of Inspector General, Department of Agriculture 
                (Parts 2600--2699)
     XXVII  Office of Information Resources Management, Department 
                of Agriculture (Parts 2700--2799)
    XXVIII  Office of Operations, Department of Agriculture (Parts 
                2800--2899)
      XXIX  Office of Energy Policy and New Uses, Department of 
                Agriculture (Parts 2900--2999)
       XXX  Office of the Chief Financial Officer, Department of 
                Agriculture (Parts 3000--3099)
      XXXI  Office of Environmental Quality, Department of 
                Agriculture (Parts 3100--3199)
     XXXII  Office of Procurement and Property Management, 
                Department of Agriculture (Parts 3200--3299)
    XXXIII  Office of Transportation, Department of Agriculture 
                (Parts 3300--3399)
     XXXIV  National Institute of Food and Agriculture (Parts 
                3400--3499)
      XXXV  Rural Housing Service, Department of Agriculture 
                (Parts 3500--3599)
     XXXVI  National Agricultural Statistics Service, Department 
                of Agriculture (Parts 3600--3699)
    XXXVII  Economic Research Service, Department of Agriculture 
                (Parts 3700--3799)
   XXXVIII  World Agricultural Outlook Board, Department of 
                Agriculture (Parts 3800--3899)
       XLI  [Reserved]

[[Page 1110]]

      XLII  Rural Business-Cooperative Service and Rural Utilities 
                Service, Department of Agriculture (Parts 4200--
                4299)
         L  Rural Business-Cooperative Service, and Rural 
                Utilities Service, Department of Agriculture 
                (Parts 5000--5099)

                    Title 8--Aliens and Nationality

         I  Department of Homeland Security (Parts 1--499)
         V  Executive Office for Immigration Review, Department of 
                Justice (Parts 1000--1399)

                 Title 9--Animals and Animal Products

         I  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 1--199)
        II  Agricultural Marketing Service (Fair Trade Practices 
                Program), Department of Agriculture (Parts 200--
                299)
       III  Food Safety and Inspection Service, Department of 
                Agriculture (Parts 300--599)

                           Title 10--Energy

         I  Nuclear Regulatory Commission (Parts 0--199)
        II  Department of Energy (Parts 200--699)
       III  Department of Energy (Parts 700--999)
         X  Department of Energy (General Provisions) (Parts 
                1000--1099)
      XIII  Nuclear Waste Technical Review Board (Parts 1300--
                1399)
      XVII  Defense Nuclear Facilities Safety Board (Parts 1700--
                1799)
     XVIII  Northeast Interstate Low-Level Radioactive Waste 
                Commission (Parts 1800--1899)

                      Title 11--Federal Elections

         I  Federal Election Commission (Parts 1--9099)
        II  Election Assistance Commission (Parts 9400--9499)

                      Title 12--Banks and Banking

         I  Comptroller of the Currency, Department of the 
                Treasury (Parts 1--199)
        II  Federal Reserve System (Parts 200--299)
       III  Federal Deposit Insurance Corporation (Parts 300--399)
        IV  Export-Import Bank of the United States (Parts 400--
                499)
         V  [Reserved]
        VI  Farm Credit Administration (Parts 600--699)
       VII  National Credit Union Administration (Parts 700--799)
      VIII  Federal Financing Bank (Parts 800--899)
        IX  (Parts 900--999)[Reserved]

[[Page 1111]]

         X  Consumer Financial Protection Bureau (Parts 1000--
                1099)
        XI  Federal Financial Institutions Examination Council 
                (Parts 1100--1199)
       XII  Federal Housing Finance Agency (Parts 1200--1299)
      XIII  Financial Stability Oversight Council (Parts 1300--
                1399)
       XIV  Farm Credit System Insurance Corporation (Parts 1400--
                1499)
        XV  Department of the Treasury (Parts 1500--1599)
       XVI  Office of Financial Research, Department of the 
                Treasury (Parts 1600--1699)
      XVII  Office of Federal Housing Enterprise Oversight, 
                Department of Housing and Urban Development (Parts 
                1700--1799)
     XVIII  Community Development Financial Institutions Fund, 
                Department of the Treasury (Parts 1800--1899)

               Title 13--Business Credit and Assistance

         I  Small Business Administration (Parts 1--199)
       III  Economic Development Administration, Department of 
                Commerce (Parts 300--399)
        IV  Emergency Steel Guarantee Loan Board (Parts 400--499)
         V  Emergency Oil and Gas Guaranteed Loan Board (Parts 
                500--599)

                    Title 14--Aeronautics and Space

         I  Federal Aviation Administration, Department of 
                Transportation (Parts 1--199)
        II  Office of the Secretary, Department of Transportation 
                (Aviation Proceedings) (Parts 200--399)
       III  Commercial Space Transportation, Federal Aviation 
                Administration, Department of Transportation 
                (Parts 400--1199)
         V  National Aeronautics and Space Administration (Parts 
                1200--1299)
        VI  Air Transportation System Stabilization (Parts 1300--
                1399)

                 Title 15--Commerce and Foreign Trade

            Subtitle A--Office of the Secretary of Commerce (Parts 
                0--29)
            Subtitle B--Regulations Relating to Commerce and 
                Foreign Trade
         I  Bureau of the Census, Department of Commerce (Parts 
                30--199)
        II  National Institute of Standards and Technology, 
                Department of Commerce (Parts 200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  Foreign-Trade Zones Board, Department of Commerce 
                (Parts 400--499)
       VII  Bureau of Industry and Security, Department of 
                Commerce (Parts 700--799)

[[Page 1112]]

      VIII  Bureau of Economic Analysis, Department of Commerce 
                (Parts 800--899)
        IX  National Oceanic and Atmospheric Administration, 
                Department of Commerce (Parts 900--999)
        XI  National Technical Information Service, Department of 
                Commerce (Parts 1100--1199)
      XIII  East-West Foreign Trade Board (Parts 1300--1399)
       XIV  Minority Business Development Agency (Parts 1400--
                1499)
        XV  Office of the Under-Secretary for Economic Affairs, 
                Department of Commerce (Parts 1500--1599)
            Subtitle C--Regulations Relating to Foreign Trade 
                Agreements
        XX  Office of the United States Trade Representative 
                (Parts 2000--2099)
            Subtitle D--Regulations Relating to Telecommunications 
                and Information
     XXIII  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                2300--2399) [Reserved]

                    Title 16--Commercial Practices

         I  Federal Trade Commission (Parts 0--999)
        II  Consumer Product Safety Commission (Parts 1000--1799)

             Title 17--Commodity and Securities Exchanges

         I  Commodity Futures Trading Commission (Parts 1--199)
        II  Securities and Exchange Commission (Parts 200--399)
        IV  Department of the Treasury (Parts 400--499)

          Title 18--Conservation of Power and Water Resources

         I  Federal Energy Regulatory Commission, Department of 
                Energy (Parts 1--399)
       III  Delaware River Basin Commission (Parts 400--499)
        VI  Water Resources Council (Parts 700--799)
      VIII  Susquehanna River Basin Commission (Parts 800--899)
      XIII  Tennessee Valley Authority (Parts 1300--1399)

                       Title 19--Customs Duties

         I  U.S. Customs and Border Protection, Department of 
                Homeland Security; Department of the Treasury 
                (Parts 0--199)
        II  United States International Trade Commission (Parts 
                200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  U.S. Immigration and Customs Enforcement, Department 
                of Homeland Security (Parts 400--599) [Reserved]

[[Page 1113]]

                     Title 20--Employees' Benefits

         I  Office of Workers' Compensation Programs, Department 
                of Labor (Parts 1--199)
        II  Railroad Retirement Board (Parts 200--399)
       III  Social Security Administration (Parts 400--499)
        IV  Employees' Compensation Appeals Board, Department of 
                Labor (Parts 500--599)
         V  Employment and Training Administration, Department of 
                Labor (Parts 600--699)
        VI  Office of Workers' Compensation Programs, Department 
                of Labor (Parts 700--799)
       VII  Benefits Review Board, Department of Labor (Parts 
                800--899)
      VIII  Joint Board for the Enrollment of Actuaries (Parts 
                900--999)
        IX  Office of the Assistant Secretary for Veterans' 
                Employment and Training Service, Department of 
                Labor (Parts 1000--1099)

                       Title 21--Food and Drugs

         I  Food and Drug Administration, Department of Health and 
                Human Services (Parts 1--1299)
        II  Drug Enforcement Administration, Department of Justice 
                (Parts 1300--1399)
       III  Office of National Drug Control Policy (Parts 1400--
                1499)

                      Title 22--Foreign Relations

         I  Department of State (Parts 1--199)
        II  Agency for International Development (Parts 200--299)
       III  Peace Corps (Parts 300--399)
        IV  International Joint Commission, United States and 
                Canada (Parts 400--499)
         V  United States Agency for Global Media (Parts 500--599)
       VII  U.S. International Development Finance Corporation 
                (Parts 700--799)
        IX  Foreign Service Grievance Board (Parts 900--999)
         X  Inter-American Foundation (Parts 1000--1099)
        XI  International Boundary and Water Commission, United 
                States and Mexico, United States Section (Parts 
                1100--1199)
       XII  United States International Development Cooperation 
                Agency (Parts 1200--1299)
      XIII  Millennium Challenge Corporation (Parts 1300--1399)
       XIV  Foreign Service Labor Relations Board; Federal Labor 
                Relations Authority; General Counsel of the 
                Federal Labor Relations Authority; and the Foreign 
                Service Impasse Disputes Panel (Parts 1400--1499)
        XV  African Development Foundation (Parts 1500--1599)
       XVI  Japan-United States Friendship Commission (Parts 
                1600--1699)
      XVII  United States Institute of Peace (Parts 1700--1799)

[[Page 1114]]

                          Title 23--Highways

         I  Federal Highway Administration, Department of 
                Transportation (Parts 1--999)
        II  National Highway Traffic Safety Administration and 
                Federal Highway Administration, Department of 
                Transportation (Parts 1200--1299)
       III  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 1300--1399)

                Title 24--Housing and Urban Development

            Subtitle A--Office of the Secretary, Department of 
                Housing and Urban Development (Parts 0--99)
            Subtitle B--Regulations Relating to Housing and Urban 
                Development
         I  Office of Assistant Secretary for Equal Opportunity, 
                Department of Housing and Urban Development (Parts 
                100--199)
        II  Office of Assistant Secretary for Housing-Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 200--299)
       III  Government National Mortgage Association, Department 
                of Housing and Urban Development (Parts 300--399)
        IV  Office of Housing and Office of Multifamily Housing 
                Assistance Restructuring, Department of Housing 
                and Urban Development (Parts 400--499)
         V  Office of Assistant Secretary for Community Planning 
                and Development, Department of Housing and Urban 
                Development (Parts 500--599)
        VI  Office of Assistant Secretary for Community Planning 
                and Development, Department of Housing and Urban 
                Development (Parts 600--699) [Reserved]
       VII  Office of the Secretary, Department of Housing and 
                Urban Development (Housing Assistance Programs and 
                Public and Indian Housing Programs) (Parts 700--
                799)
      VIII  Office of the Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Section 8 Housing Assistance 
                Programs, Section 202 Direct Loan Program, Section 
                202 Supportive Housing for the Elderly Program and 
                Section 811 Supportive Housing for Persons With 
                Disabilities Program) (Parts 800--899)
        IX  Office of Assistant Secretary for Public and Indian 
                Housing, Department of Housing and Urban 
                Development (Parts 900--1699)
         X  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Interstate Land Sales 
                Registration Program) (Parts 1700--1799) 
                [Reserved]
       XII  Office of Inspector General, Department of Housing and 
                Urban Development (Parts 2000--2099)
        XV  Emergency Mortgage Insurance and Loan Programs, 
                Department of Housing and Urban Development (Parts 
                2700--2799) [Reserved]

[[Page 1115]]

        XX  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 3200--3899)
      XXIV  Board of Directors of the HOPE for Homeowners Program 
                (Parts 4000--4099) [Reserved]
       XXV  Neighborhood Reinvestment Corporation (Parts 4100--
                4199)

                           Title 25--Indians

         I  Bureau of Indian Affairs, Department of the Interior 
                (Parts 1--299)
        II  Indian Arts and Crafts Board, Department of the 
                Interior (Parts 300--399)
       III  National Indian Gaming Commission, Department of the 
                Interior (Parts 500--599)
        IV  Office of Navajo and Hopi Indian Relocation (Parts 
                700--899)
         V  Bureau of Indian Affairs, Department of the Interior, 
                and Indian Health Service, Department of Health 
                and Human Services (Part 900--999)
        VI  Office of the Assistant Secretary, Indian Affairs, 
                Department of the Interior (Parts 1000--1199)
       VII  Office of the Special Trustee for American Indians, 
                Department of the Interior (Parts 1200--1299)

                      Title 26--Internal Revenue

         I  Internal Revenue Service, Department of the Treasury 
                (Parts 1--End)

           Title 27--Alcohol, Tobacco Products and Firearms

         I  Alcohol and Tobacco Tax and Trade Bureau, Department 
                of the Treasury (Parts 1--399)
        II  Bureau of Alcohol, Tobacco, Firearms, and Explosives, 
                Department of Justice (Parts 400--799)

                   Title 28--Judicial Administration

         I  Department of Justice (Parts 0--299)
       III  Federal Prison Industries, Inc., Department of Justice 
                (Parts 300--399)
         V  Bureau of Prisons, Department of Justice (Parts 500--
                599)
        VI  Offices of Independent Counsel, Department of Justice 
                (Parts 600--699)
       VII  Office of Independent Counsel (Parts 700--799)
      VIII  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 800--899)
        IX  National Crime Prevention and Privacy Compact Council 
                (Parts 900--999)

[[Page 1116]]

        XI  Department of Justice and Department of State (Parts 
                1100--1199)

                            Title 29--Labor

            Subtitle A--Office of the Secretary of Labor (Parts 
                0--99)
            Subtitle B--Regulations Relating to Labor
         I  National Labor Relations Board (Parts 100--199)
        II  Office of Labor-Management Standards, Department of 
                Labor (Parts 200--299)
       III  National Railroad Adjustment Board (Parts 300--399)
        IV  Office of Labor-Management Standards, Department of 
                Labor (Parts 400--499)
         V  Wage and Hour Division, Department of Labor (Parts 
                500--899)
        IX  Construction Industry Collective Bargaining Commission 
                (Parts 900--999)
         X  National Mediation Board (Parts 1200--1299)
       XII  Federal Mediation and Conciliation Service (Parts 
                1400--1499)
       XIV  Equal Employment Opportunity Commission (Parts 1600--
                1699)
      XVII  Occupational Safety and Health Administration, 
                Department of Labor (Parts 1900--1999)
        XX  Occupational Safety and Health Review Commission 
                (Parts 2200--2499)
       XXV  Employee Benefits Security Administration, Department 
                of Labor (Parts 2500--2599)
     XXVII  Federal Mine Safety and Health Review Commission 
                (Parts 2700--2799)
        XL  Pension Benefit Guaranty Corporation (Parts 4000--
                4999)

                      Title 30--Mineral Resources

         I  Mine Safety and Health Administration, Department of 
                Labor (Parts 1--199)
        II  Bureau of Safety and Environmental Enforcement, 
                Department of the Interior (Parts 200--299)
        IV  Geological Survey, Department of the Interior (Parts 
                400--499)
         V  Bureau of Ocean Energy Management, Department of the 
                Interior (Parts 500--599)
       VII  Office of Surface Mining Reclamation and Enforcement, 
                Department of the Interior (Parts 700--999)
       XII  Office of Natural Resources Revenue, Department of the 
                Interior (Parts 1200--1299)

                 Title 31--Money and Finance: Treasury

            Subtitle A--Office of the Secretary of the Treasury 
                (Parts 0--50)
            Subtitle B--Regulations Relating to Money and Finance

[[Page 1117]]

         I  Monetary Offices, Department of the Treasury (Parts 
                51--199)
        II  Fiscal Service, Department of the Treasury (Parts 
                200--399)
        IV  Secret Service, Department of the Treasury (Parts 
                400--499)
         V  Office of Foreign Assets Control, Department of the 
                Treasury (Parts 500--599)
        VI  Bureau of Engraving and Printing, Department of the 
                Treasury (Parts 600--699)
       VII  Federal Law Enforcement Training Center, Department of 
                the Treasury (Parts 700--799)
      VIII  Office of Investment Security, Department of the 
                Treasury (Parts 800--899)
        IX  Federal Claims Collection Standards (Department of the 
                Treasury--Department of Justice) (Parts 900--999)
         X  Financial Crimes Enforcement Network, Department of 
                the Treasury (Parts 1000--1099)

                      Title 32--National Defense

            Subtitle A--Department of Defense
         I  Office of the Secretary of Defense (Parts 1--399)
         V  Department of the Army (Parts 400--699)
        VI  Department of the Navy (Parts 700--799)
       VII  Department of the Air Force (Parts 800--1099)
            Subtitle B--Other Regulations Relating to National 
                Defense
       XII  Department of Defense, Defense Logistics Agency (Parts 
                1200--1299)
       XVI  Selective Service System (Parts 1600--1699)
      XVII  Office of the Director of National Intelligence (Parts 
                1700--1799)
     XVIII  National Counterintelligence Center (Parts 1800--1899)
       XIX  Central Intelligence Agency (Parts 1900--1999)
        XX  Information Security Oversight Office, National 
                Archives and Records Administration (Parts 2000--
                2099)
       XXI  National Security Council (Parts 2100--2199)
      XXIV  Office of Science and Technology Policy (Parts 2400--
                2499)
     XXVII  Office for Micronesian Status Negotiations (Parts 
                2700--2799)
    XXVIII  Office of the Vice President of the United States 
                (Parts 2800--2899)

               Title 33--Navigation and Navigable Waters

         I  Coast Guard, Department of Homeland Security (Parts 
                1--199)
        II  Corps of Engineers, Department of the Army, Department 
                of Defense (Parts 200--399)
        IV  Great Lakes St. Lawrence Seaway Development 
                Corporation, Department of Transportation (Parts 
                400--499)

[[Page 1118]]

                          Title 34--Education

            Subtitle A--Office of the Secretary, Department of 
                Education (Parts 1--99)
            Subtitle B--Regulations of the Offices of the 
                Department of Education
         I  Office for Civil Rights, Department of Education 
                (Parts 100--199)
        II  Office of Elementary and Secondary Education, 
                Department of Education (Parts 200--299)
       III  Office of Special Education and Rehabilitative 
                Services, Department of Education (Parts 300--399)
        IV  Office of Career, Technical, and Adult Education, 
                Department of Education (Parts 400--499)
         V  Office of Bilingual Education and Minority Languages 
                Affairs, Department of Education (Parts 500--599) 
                [Reserved]
        VI  Office of Postsecondary Education, Department of 
                Education (Parts 600--699)
       VII  Office of Educational Research and Improvement, 
                Department of Education (Parts 700--799) 
                [Reserved]
            Subtitle C--Regulations Relating to Education
        XI  [Reserved]
       XII  National Council on Disability (Parts 1200--1299)

                          Title 35 [Reserved]

             Title 36--Parks, Forests, and Public Property

         I  National Park Service, Department of the Interior 
                (Parts 1--199)
        II  Forest Service, Department of Agriculture (Parts 200--
                299)
       III  Corps of Engineers, Department of the Army (Parts 
                300--399)
        IV  American Battle Monuments Commission (Parts 400--499)
         V  Smithsonian Institution (Parts 500--599)
        VI  [Reserved]
       VII  Library of Congress (Parts 700--799)
      VIII  Advisory Council on Historic Preservation (Parts 800--
                899)
        IX  Pennsylvania Avenue Development Corporation (Parts 
                900--999)
         X  Presidio Trust (Parts 1000--1099)
        XI  Architectural and Transportation Barriers Compliance 
                Board (Parts 1100--1199)
       XII  National Archives and Records Administration (Parts 
                1200--1299)
        XV  Oklahoma City National Memorial Trust (Parts 1500--
                1599)
       XVI  Morris K. Udall Scholarship and Excellence in National 
                Environmental Policy Foundation (Parts 1600--1699)

             Title 37--Patents, Trademarks, and Copyrights

         I  United States Patent and Trademark Office, Department 
                of Commerce (Parts 1--199)
        II  U.S. Copyright Office, Library of Congress (Parts 
                200--299)

[[Page 1119]]

       III  Copyright Royalty Board, Library of Congress (Parts 
                300--399)
        IV  National Institute of Standards and Technology, 
                Department of Commerce (Parts 400--599)

           Title 38--Pensions, Bonuses, and Veterans' Relief

         I  Department of Veterans Affairs (Parts 0--199)
        II  Armed Forces Retirement Home (Parts 200--299)

                       Title 39--Postal Service

         I  United States Postal Service (Parts 1--999)
       III  Postal Regulatory Commission (Parts 3000--3099)

                  Title 40--Protection of Environment

         I  Environmental Protection Agency (Parts 1--1099)
        IV  Environmental Protection Agency and Department of 
                Justice (Parts 1400--1499)
         V  Council on Environmental Quality (Parts 1500--1599)
        VI  Chemical Safety and Hazard Investigation Board (Parts 
                1600--1699)
       VII  Environmental Protection Agency and Department of 
                Defense; Uniform National Discharge Standards for 
                Vessels of the Armed Forces (Parts 1700--1799)
      VIII  Gulf Coast Ecosystem Restoration Council (Parts 1800--
                1899)
        IX  Federal Permitting Improvement Steering Council (Part 
                1900)

          Title 41--Public Contracts and Property Management

            Subtitle A--Federal Procurement Regulations System 
                [Note]
            Subtitle B--Other Provisions Relating to Public 
                Contracts
        50  Public Contracts, Department of Labor (Parts 50-1--50-
                999)
        51  Committee for Purchase From People Who Are Blind or 
                Severely Disabled (Parts 51-1--51-99)
        60  Office of Federal Contract Compliance Programs, Equal 
                Employment Opportunity, Department of Labor (Parts 
                60-1--60-999)
        61  Office of the Assistant Secretary for Veterans' 
                Employment and Training Service, Department of 
                Labor (Parts 61-1--61-999)
   62--100  [Reserved]
            Subtitle C--Federal Property Management Regulations 
                System
       101  Federal Property Management Regulations (Parts 101-1--
                101-99)
       102  Federal Management Regulation (Parts 102-1--102-299)
  103--104  [Reserved]
       105  General Services Administration (Parts 105-1--105-999)

[[Page 1120]]

       109  Department of Energy Property Management Regulations 
                (Parts 109-1--109-99)
       114  Department of the Interior (Parts 114-1--114-99)
       115  Environmental Protection Agency (Parts 115-1--115-99)
       128  Department of Justice (Parts 128-1--128-99)
  129--200  [Reserved]
            Subtitle D--Federal Acquisition Supply Chain Security
       201  Federal Acquisition Security Council (Parts 201-1--
                201-99).
            Subtitle E [Reserved]
            Subtitle F--Federal Travel Regulation System
       300  General (Parts 300-1--300-99)
       301  Temporary Duty (TDY) Travel Allowances (Parts 301-1--
                301-99)
       302  Relocation Allowances (Parts 302-1--302-99)
       303  Payment of Expenses Connected with the Death of 
                Certain Employees (Part 303-1--303-99)
       304  Payment of Travel Expenses from a Non-Federal Source 
                (Parts 304-1--304-99)

                        Title 42--Public Health

         I  Public Health Service, Department of Health and Human 
                Services (Parts 1--199)
   II--III  [Reserved]
        IV  Centers for Medicare & Medicaid Services, Department 
                of Health and Human Services (Parts 400--699)
         V  Office of Inspector General-Health Care, Department of 
                Health and Human Services (Parts 1000--1099)

                   Title 43--Public Lands: Interior

            Subtitle A--Office of the Secretary of the Interior 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Lands
         I  Bureau of Reclamation, Department of the Interior 
                (Parts 400--999)
        II  Bureau of Land Management, Department of the Interior 
                (Parts 1000--9999)
       III  Utah Reclamation Mitigation and Conservation 
                Commission (Parts 10000--10099)

             Title 44--Emergency Management and Assistance

         I  Federal Emergency Management Agency, Department of 
                Homeland Security (Parts 0--399)
        IV  Department of Commerce and Department of 
                Transportation (Parts 400--499)

[[Page 1121]]

                       Title 45--Public Welfare

            Subtitle A--Department of Health and Human Services 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Welfare
        II  Office of Family Assistance (Assistance Programs), 
                Administration for Children and Families, 
                Department of Health and Human Services (Parts 
                200--299)
       III  Office of Child Support Enforcement (Child Support 
                Enforcement Program), Administration for Children 
                and Families, Department of Health and Human 
                Services (Parts 300--399)
        IV  Office of Refugee Resettlement, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 400--499)
         V  Foreign Claims Settlement Commission of the United 
                States, Department of Justice (Parts 500--599)
        VI  National Science Foundation (Parts 600--699)
       VII  Commission on Civil Rights (Parts 700--799)
      VIII  Office of Personnel Management (Parts 800--899)
        IX  Denali Commission (Parts 900--999)
         X  Office of Community Services, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 1000--1099)
        XI  National Foundation on the Arts and the Humanities 
                (Parts 1100--1199)
       XII  Corporation for National and Community Service (Parts 
                1200--1299)
      XIII  Administration for Children and Families, Department 
                of Health and Human Services (Parts 1300--1399)
       XVI  Legal Services Corporation (Parts 1600--1699)
      XVII  National Commission on Libraries and Information 
                Science (Parts 1700--1799)
     XVIII  Harry S. Truman Scholarship Foundation (Parts 1800--
                1899)
       XXI  Commission of Fine Arts (Parts 2100--2199)
     XXIII  Arctic Research Commission (Parts 2300--2399)
      XXIV  James Madison Memorial Fellowship Foundation (Parts 
                2400--2499)
       XXV  Corporation for National and Community Service (Parts 
                2500--2599)

                          Title 46--Shipping

         I  Coast Guard, Department of Homeland Security (Parts 
                1--199)
        II  Maritime Administration, Department of Transportation 
                (Parts 200--399)
       III  Coast Guard (Great Lakes Pilotage), Department of 
                Homeland Security (Parts 400--499)
        IV  Federal Maritime Commission (Parts 500--599)

[[Page 1122]]

                      Title 47--Telecommunication

         I  Federal Communications Commission (Parts 0--199)
        II  Office of Science and Technology Policy and National 
                Security Council (Parts 200--299)
       III  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                300--399)
        IV  National Telecommunications and Information 
                Administration, Department of Commerce, and 
                National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 400--499)
         V  The First Responder Network Authority (Parts 500--599)

           Title 48--Federal Acquisition Regulations System

         1  Federal Acquisition Regulation (Parts 1--99)
         2  Defense Acquisition Regulations System, Department of 
                Defense (Parts 200--299)
         3  Department of Health and Human Services (Parts 300--
                399)
         4  Department of Agriculture (Parts 400--499)
         5  General Services Administration (Parts 500--599)
         6  Department of State (Parts 600--699)
         7  Agency for International Development (Parts 700--799)
         8  Department of Veterans Affairs (Parts 800--899)
         9  Department of Energy (Parts 900--999)
        10  Department of the Treasury (Parts 1000--1099)
        12  Department of Transportation (Parts 1200--1299)
        13  Department of Commerce (Parts 1300--1399)
        14  Department of the Interior (Parts 1400--1499)
        15  Environmental Protection Agency (Parts 1500--1599)
        16  Office of Personnel Management, Federal Employees 
                Health Benefits Acquisition Regulation (Parts 
                1600--1699)
        17  Office of Personnel Management (Parts 1700--1799)
        18  National Aeronautics and Space Administration (Parts 
                1800--1899)
        19  Broadcasting Board of Governors (Parts 1900--1999)
        20  Nuclear Regulatory Commission (Parts 2000--2099)
        21  Office of Personnel Management, Federal Employees 
                Group Life Insurance Federal Acquisition 
                Regulation (Parts 2100--2199)
        23  Social Security Administration (Parts 2300--2399)
        24  Department of Housing and Urban Development (Parts 
                2400--2499)
        25  National Science Foundation (Parts 2500--2599)
        28  Department of Justice (Parts 2800--2899)
        29  Department of Labor (Parts 2900--2999)
        30  Department of Homeland Security, Homeland Security 
                Acquisition Regulation (HSAR) (Parts 3000--3099)
        34  Department of Education Acquisition Regulation (Parts 
                3400--3499)

[[Page 1123]]

        51  Department of the Army Acquisition Regulations (Parts 
                5100--5199) [Reserved]
        52  Department of the Navy Acquisition Regulations (Parts 
                5200--5299)
        53  Department of the Air Force Federal Acquisition 
                Regulation Supplement (Parts 5300--5399) 
                [Reserved]
        54  Defense Logistics Agency, Department of Defense (Parts 
                5400--5499)
        57  African Development Foundation (Parts 5700--5799)
        61  Civilian Board of Contract Appeals, General Services 
                Administration (Parts 6100--6199)
        99  Cost Accounting Standards Board, Office of Federal 
                Procurement Policy, Office of Management and 
                Budget (Parts 9900--9999)

                       Title 49--Transportation

            Subtitle A--Office of the Secretary of Transportation 
                (Parts 1--99)
            Subtitle B--Other Regulations Relating to 
                Transportation
         I  Pipeline and Hazardous Materials Safety 
                Administration, Department of Transportation 
                (Parts 100--199)
        II  Federal Railroad Administration, Department of 
                Transportation (Parts 200--299)
       III  Federal Motor Carrier Safety Administration, 
                Department of Transportation (Parts 300--399)
        IV  Coast Guard, Department of Homeland Security (Parts 
                400--499)
         V  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 500--599)
        VI  Federal Transit Administration, Department of 
                Transportation (Parts 600--699)
       VII  National Railroad Passenger Corporation (AMTRAK) 
                (Parts 700--799)
      VIII  National Transportation Safety Board (Parts 800--999)
         X  Surface Transportation Board (Parts 1000--1399)
        XI  Research and Innovative Technology Administration, 
                Department of Transportation (Parts 1400--1499) 
                [Reserved]
       XII  Transportation Security Administration, Department of 
                Homeland Security (Parts 1500--1699)

                   Title 50--Wildlife and Fisheries

         I  United States Fish and Wildlife Service, Department of 
                the Interior (Parts 1--199)
        II  National Marine Fisheries Service, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 200--299)
       III  International Fishing and Related Activities (Parts 
                300--399)

[[Page 1124]]

        IV  Joint Regulations (United States Fish and Wildlife 
                Service, Department of the Interior and National 
                Marine Fisheries Service, National Oceanic and 
                Atmospheric Administration, Department of 
                Commerce); Endangered Species Committee 
                Regulations (Parts 400--499)
         V  Marine Mammal Commission (Parts 500--599)
        VI  Fishery Conservation and Management, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 600--699)

[[Page 1125]]





           Alphabetical List of Agencies Appearing in the CFR




                      (Revised as of April 1, 2023)

                                                  CFR Title, Subtitle or 
                     Agency                               Chapter

Administrative Conference of the United States    1, III
Advisory Council on Historic Preservation         36, VIII
Advocacy and Outreach, Office of                  7, XXV
Afghanistan Reconstruction, Special Inspector     5, LXXXIII
     General for
African Development Foundation                    22, XV
  Federal Acquisition Regulation                  48, 57
Agency for International Development              2, VII; 22, II
  Federal Acquisition Regulation                  48, 7
Agricultural Marketing Service                    7, I, VIII, IX, X, XI; 9, 
                                                  II
Agricultural Research Service                     7, V
Agriculture, Department of                        2, IV; 5, LXXIII
  Advocacy and Outreach, Office of                7, XXV
  Agricultural Marketing Service                  7, I, VIII, IX, X, XI; 9, 
                                                  II
  Agricultural Research Service                   7, V
  Animal and Plant Health Inspection Service      7, III; 9, I
  Chief Financial Officer, Office of              7, XXX
  Commodity Credit Corporation                    7, XIV
  Economic Research Service                       7, XXXVII
  Energy Policy and New Uses, Office of           2, IX; 7, XXIX
  Environmental Quality, Office of                7, XXXI
  Farm Service Agency                             7, VII, XVIII
  Federal Acquisition Regulation                  48, 4
  Federal Crop Insurance Corporation              7, IV
  Food and Nutrition Service                      7, II
  Food Safety and Inspection Service              9, III
  Foreign Agricultural Service                    7, XV
  Forest Service                                  36, II
  Information Resources Management, Office of     7, XXVII
  Inspector General, Office of                    7, XXVI
  National Agricultural Library                   7, XLI
  National Agricultural Statistics Service        7, XXXVI
  National Institute of Food and Agriculture      7, XXXIV
  Natural Resources Conservation Service          7, VI
  Operations, Office of                           7, XXVIII
  Procurement and Property Management, Office of  7, XXXII
  Rural Business-Cooperative Service              7, XVIII, XLII
  Rural Development Administration                7, XLII
  Rural Housing Service                           7, XVIII, XXXV
  Rural Utilities Service                         7, XVII, XVIII, XLII
  Secretary of Agriculture, Office of             7, Subtitle A
  Transportation, Office of                       7, XXXIII
  World Agricultural Outlook Board                7, XXXVIII
Air Force, Department of                          32, VII
  Federal Acquisition Regulation Supplement       48, 53
Air Transportation Stabilization Board            14, VI
Alcohol and Tobacco Tax and Trade Bureau          27, I
Alcohol, Tobacco, Firearms, and Explosives,       27, II
     Bureau of
AMTRAK                                            49, VII
American Battle Monuments Commission              36, IV
American Indians, Office of the Special Trustee   25, VII
Animal and Plant Health Inspection Service        7, III; 9, I
Appalachian Regional Commission                   5, IX
Architectural and Transportation Barriers         36, XI
   Compliance Board
[[Page 1126]]

Arctic Research Commission                        45, XXIII
Armed Forces Retirement Home                      5, XI; 38, II
Army, Department of                               32, V
  Engineers, Corps of                             33, II; 36, III
  Federal Acquisition Regulation                  48, 51
Benefits Review Board                             20, VII
Bilingual Education and Minority Languages        34, V
     Affairs, Office of
Blind or Severely Disabled, Committee for         41, 51
     Purchase from People Who Are
  Federal Acquisition Regulation                  48, 19
Career, Technical, and Adult Education, Office    34, IV
     of
Census Bureau                                     15, I
Centers for Medicare & Medicaid Services          42, IV
Central Intelligence Agency                       32, XIX
Chemical Safety and Hazard Investigation Board    40, VI
Chief Financial Officer, Office of                7, XXX
Child Support Enforcement, Office of              45, III
Children and Families, Administration for         45, II, III, IV, X, XIII
Civil Rights, Commission on                       5, LXVIII; 45, VII
Civil Rights, Office for                          34, I
Coast Guard                                       33, I; 46, I; 49, IV
Coast Guard (Great Lakes Pilotage)                46, III
Commerce, Department of                           2, XIII; 44, IV; 50, VI
  Census Bureau                                   15, I
  Economic Affairs, Office of the Under-          15, XV
       Secretary for
  Economic Analysis, Bureau of                    15, VIII
  Economic Development Administration             13, III
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 13
  Foreign-Trade Zones Board                       15, IV
  Industry and Security, Bureau of                15, VII
  International Trade Administration              15, III; 19, III
  National Institute of Standards and Technology  15, II; 37, IV
  National Marine Fisheries Service               50, II, IV
  National Oceanic and Atmospheric                15, IX; 50, II, III, IV, 
       Administration                             VI
  National Technical Information Service          15, XI
  National Telecommunications and Information     15, XXIII; 47, III, IV
       Administration
  National Weather Service                        15, IX
  Patent and Trademark Office, United States      37, I
  Secretary of Commerce, Office of                15, Subtitle A
Commercial Space Transportation                   14, III
Commodity Credit Corporation                      7, XIV
Commodity Futures Trading Commission              5, XLI; 17, I
Community Planning and Development, Office of     24, V, VI
     Assistant Secretary for
Community Services, Office of                     45, X
Comptroller of the Currency                       12, I
Construction Industry Collective Bargaining       29, IX
     Commission
Consumer Financial Protection Bureau              5, LXXXIV; 12, X
Consumer Product Safety Commission                5, LXXI; 16, II
Copyright Royalty Board                           37, III
Corporation for National and Community Service    2, XXII; 45, XII, XXV
Cost Accounting Standards Board                   48, 99
Council on Environmental Quality                  40, V
Council of the Inspectors General on Integrity    5, XCVIII
     and Efficiency
Court Services and Offender Supervision Agency    5, LXX; 28, VIII
     for the District of Columbia
Customs and Border Protection                     19, I
Defense, Department of                            2, XI; 5, XXVI; 32, 
                                                  Subtitle A; 40, VII
  Advanced Research Projects Agency               32, I
  Air Force Department                            32, VII
  Army Department                                 32, V; 33, II; 36, III; 
                                                  48, 51
  Defense Acquisition Regulations System          48, 2
  Defense Intelligence Agency                     32, I

[[Page 1127]]

  Defense Logistics Agency                        32, I, XII; 48, 54
  Engineers, Corps of                             33, II; 36, III
  National Imagery and Mapping Agency             32, I
  Navy, Department of                             32, VI; 48, 52
  Secretary of Defense, Office of                 2, XI; 32, I
Defense Contract Audit Agency                     32, I
Defense Intelligence Agency                       32, I
Defense Logistics Agency                          32, XII; 48, 54
Defense Nuclear Facilities Safety Board           10, XVII
Delaware River Basin Commission                   18, III
Denali Commission                                 45, IX
Disability, National Council on                   5, C; 34, XII
District of Columbia, Court Services and          5, LXX; 28, VIII
     Offender Supervision Agency for the
Drug Enforcement Administration                   21, II
East-West Foreign Trade Board                     15, XIII
Economic Affairs, Office of the Under-Secretary   15, XV
     for
Economic Analysis, Bureau of                      15, VIII
Economic Development Administration               13, III
Economic Research Service                         7, XXXVII
Education, Department of                          2, XXXIV; 5, LIII
  Bilingual Education and Minority Languages      34, V
       Affairs, Office of
  Career, Technical, and Adult Education, Office  34, IV
       of
  Civil Rights, Office for                        34, I
  Educational Research and Improvement, Office    34, VII
       of
  Elementary and Secondary Education, Office of   34, II
  Federal Acquisition Regulation                  48, 34
  Postsecondary Education, Office of              34, VI
  Secretary of Education, Office of               34, Subtitle A
  Special Education and Rehabilitative Services,  34, III
       Office of
Educational Research and Improvement, Office of   34, VII
Election Assistance Commission                    2, LVIII; 11, II
Elementary and Secondary Education, Office of     34, II
Emergency Oil and Gas Guaranteed Loan Board       13, V
Emergency Steel Guarantee Loan Board              13, IV
Employee Benefits Security Administration         29, XXV
Employees' Compensation Appeals Board             20, IV
Employees Loyalty Board                           5, V
Employment and Training Administration            20, V
Employment Policy, National Commission for        1, IV
Employment Standards Administration               20, VI
Endangered Species Committee                      50, IV
Energy, Department of                             2, IX; 5, XXIII; 10, II, 
                                                  III, X
  Federal Acquisition Regulation                  48, 9
  Federal Energy Regulatory Commission            5, XXIV; 18, I
  Property Management Regulations                 41, 109
Energy, Office of                                 7, XXIX
Engineers, Corps of                               33, II; 36, III
Engraving and Printing, Bureau of                 31, VI
Environmental Protection Agency                   2, XV; 5, LIV; 40, I, IV, 
                                                  VII
  Federal Acquisition Regulation                  48, 15
  Property Management Regulations                 41, 115
Environmental Quality, Office of                  7, XXXI
Equal Employment Opportunity Commission           5, LXII; 29, XIV
Equal Opportunity, Office of Assistant Secretary  24, I
     for
Executive Office of the President                 3, I
  Environmental Quality, Council on               40, V
  Management and Budget, Office of                2, Subtitle A; 5, III, 
                                                  LXXVII; 14, VI; 48, 99
  National Drug Control Policy, Office of         2, XXXVI; 21, III
  National Security Council                       32, XXI; 47, II
  Presidential Documents                          3
  Science and Technology Policy, Office of        32, XXIV; 47, II
  Trade Representative, Office of the United      15, XX
     States
[[Page 1128]]

Export-Import Bank of the United States           2, XXXV; 5, LII; 12, IV
Family Assistance, Office of                      45, II
Farm Credit Administration                        5, XXXI; 12, VI
Farm Credit System Insurance Corporation          5, XXX; 12, XIV
Farm Service Agency                               7, VII, XVIII
Federal Acquisition Regulation                    48, 1
Federal Acquisition Security Council              41, 201
Federal Aviation Administration                   14, I
  Commercial Space Transportation                 14, III
Federal Claims Collection Standards               31, IX
Federal Communications Commission                 2, LX; 5, XXIX; 47, I
Federal Contract Compliance Programs, Office of   41, 60
Federal Crop Insurance Corporation                7, IV
Federal Deposit Insurance Corporation             5, XXII; 12, III
Federal Election Commission                       5, XXXVII; 11, I
Federal Emergency Management Agency               44, I
Federal Employees Group Life Insurance Federal    48, 21
     Acquisition Regulation
Federal Employees Health Benefits Acquisition     48, 16
     Regulation
Federal Energy Regulatory Commission              5, XXIV; 18, I
Federal Financial Institutions Examination        12, XI
     Council
Federal Financing Bank                            12, VIII
Federal Highway Administration                    23, I, II
Federal Home Loan Mortgage Corporation            1, IV
Federal Housing Enterprise Oversight Office       12, XVII
Federal Housing Finance Agency                    5, LXXX; 12, XII
Federal Labor Relations Authority                 5, XIV, XLIX; 22, XIV
Federal Law Enforcement Training Center           31, VII
Federal Management Regulation                     41, 102
Federal Maritime Commission                       46, IV
Federal Mediation and Conciliation Service        29, XII
Federal Mine Safety and Health Review Commission  5, LXXIV; 29, XXVII
Federal Motor Carrier Safety Administration       49, III
Federal Permitting Improvement Steering Council   40, IX
Federal Prison Industries, Inc.                   28, III
Federal Procurement Policy Office                 48, 99
Federal Property Management Regulations           41, 101
Federal Railroad Administration                   49, II
Federal Register, Administrative Committee of     1, I
Federal Register, Office of                       1, II
Federal Reserve System                            12, II
  Board of Governors                              5, LVIII
Federal Retirement Thrift Investment Board        5, VI, LXXVI
Federal Service Impasses Panel                    5, XIV
Federal Trade Commission                          5, XLVII; 16, I
Federal Transit Administration                    49, VI
Federal Travel Regulation System                  41, Subtitle F
Financial Crimes Enforcement Network              31, X
Financial Research Office                         12, XVI
Financial Stability Oversight Council             12, XIII
Fine Arts, Commission of                          45, XXI
Fiscal Service                                    31, II
Fish and Wildlife Service, United States          50, I, IV
Food and Drug Administration                      21, I
Food and Nutrition Service                        7, II
Food Safety and Inspection Service                9, III
Foreign Agricultural Service                      7, XV
Foreign Assets Control, Office of                 31, V
Foreign Claims Settlement Commission of the       45, V
     United States
Foreign Service Grievance Board                   22, IX
Foreign Service Impasse Disputes Panel            22, XIV
Foreign Service Labor Relations Board             22, XIV
Foreign-Trade Zones Board                         15, IV
Forest Service                                    36, II
General Services Administration                   5, LVII; 41, 105
  Contract Appeals, Board of                      48, 61
  Federal Acquisition Regulation                  48, 5

[[Page 1129]]

  Federal Management Regulation                   41, 102
  Federal Property Management Regulations         41, 101
  Federal Travel Regulation System                41, Subtitle F
  General                                         41, 300
  Payment From a Non-Federal Source for Travel    41, 304
       Expenses
  Payment of Expenses Connected With the Death    41, 303
       of Certain Employees
  Relocation Allowances                           41, 302
  Temporary Duty (TDY) Travel Allowances          41, 301
Geological Survey                                 30, IV
Government Accountability Office                  4, I
Government Ethics, Office of                      5, XVI
Government National Mortgage Association          24, III
Grain Inspection, Packers and Stockyards          7, VIII; 9, II
     Administration
Great Lakes St. Lawrence Seaway Development       33, IV
     Corporation
Gulf Coast Ecosystem Restoration Council          2, LIX; 40, VIII
Harry S. Truman Scholarship Foundation            45, XVIII
Health and Human Services, Department of          2, III; 5, XLV; 45, 
                                                  Subtitle A
  Centers for Medicare & Medicaid Services        42, IV
  Child Support Enforcement, Office of            45, III
  Children and Families, Administration for       45, II, III, IV, X, XIII
  Community Services, Office of                   45, X
  Family Assistance, Office of                    45, II
  Federal Acquisition Regulation                  48, 3
  Food and Drug Administration                    21, I
  Indian Health Service                           25, V
  Inspector General (Health Care), Office of      42, V
  Public Health Service                           42, I
  Refugee Resettlement, Office of                 45, IV
Homeland Security, Department of                  2, XXX; 5, XXXVI; 6, I; 8, 
                                                  I
  Coast Guard                                     33, I; 46, I; 49, IV
  Coast Guard (Great Lakes Pilotage)              46, III
  Customs and Border Protection                   19, I
  Federal Emergency Management Agency             44, I
  Human Resources Management and Labor Relations  5, XCVII
       Systems
  Immigration and Customs Enforcement Bureau      19, IV
  Transportation Security Administration          49, XII
HOPE for Homeowners Program, Board of Directors   24, XXIV
     of
Housing and Urban Development, Department of      2, XXIV; 5, LXV; 24, 
                                                  Subtitle B
  Community Planning and Development, Office of   24, V, VI
       Assistant Secretary for
  Equal Opportunity, Office of Assistant          24, I
       Secretary for
  Federal Acquisition Regulation                  48, 24
  Federal Housing Enterprise Oversight, Office    12, XVII
       of
  Government National Mortgage Association        24, III
  Housing--Federal Housing Commissioner, Office   24, II, VIII, X, XX
       of Assistant Secretary for
  Housing, Office of, and Multifamily Housing     24, IV
       Assistance Restructuring, Office of
  Inspector General, Office of                    24, XII
  Public and Indian Housing, Office of Assistant  24, IX
       Secretary for
  Secretary, Office of                            24, Subtitle A, VII
Housing--Federal Housing Commissioner, Office of  24, II, VIII, X, XX
     Assistant Secretary for
Housing, Office of, and Multifamily Housing       24, IV
     Assistance Restructuring, Office of
Immigration and Customs Enforcement Bureau        19, IV
Immigration Review, Executive Office for          8, V
Independent Counsel, Office of                    28, VII
Independent Counsel, Offices of                   28, VI
Indian Affairs, Bureau of                         25, I, V
Indian Affairs, Office of the Assistant           25, VI
     Secretary
Indian Arts and Crafts Board                      25, II

[[Page 1130]]

Indian Health Service                             25, V
Industry and Security, Bureau of                  15, VII
Information Resources Management, Office of       7, XXVII
Information Security Oversight Office, National   32, XX
     Archives and Records Administration
Inspector General
  Agriculture Department                          7, XXVI
  Health and Human Services Department            42, V
  Housing and Urban Development Department        24, XII, XV
Institute of Peace, United States                 22, XVII
Intellectual Property Enforcement Coordinator,    5, CIV
     Office of
Inter-American Foundation                         5, LXIII; 22, X
Interior, Department of                           2, XIV
  American Indians, Office of the Special         25, VII
       Trustee
  Endangered Species Committee                    50, IV
  Federal Acquisition Regulation                  48, 14
  Federal Property Management Regulations System  41, 114
  Fish and Wildlife Service, United States        50, I, IV
  Geological Survey                               30, IV
  Indian Affairs, Bureau of                       25, I, V
  Indian Affairs, Office of the Assistant         25, VI
       Secretary
  Indian Arts and Crafts Board                    25, II
  Land Management, Bureau of                      43, II
  National Indian Gaming Commission               25, III
  National Park Service                           36, I
  Natural Resource Revenue, Office of             30, XII
  Ocean Energy Management, Bureau of              30, V
  Reclamation, Bureau of                          43, I
  Safety and Environmental Enforcement, Bureau    30, II
       of
  Secretary of the Interior, Office of            2, XIV; 43, Subtitle A
  Surface Mining Reclamation and Enforcement,     30, VII
       Office of
Internal Revenue Service                          26, I
International Boundary and Water Commission,      22, XI
     United States and Mexico, United States 
     Section
International Development, United States Agency   22, II
     for
  Federal Acquisition Regulation                  48, 7
International Development Cooperation Agency,     22, XII
     United States
International Development Finance Corporation,    5, XXXIII; 22, VII
     U.S.
International Joint Commission, United States     22, IV
     and Canada
International Organizations Employees Loyalty     5, V
     Board
International Trade Administration                15, III; 19, III
International Trade Commission, United States     19, II
Interstate Commerce Commission                    5, XL
Investment Security, Office of                    31, VIII
James Madison Memorial Fellowship Foundation      45, XXIV
Japan-United States Friendship Commission         22, XVI
Joint Board for the Enrollment of Actuaries       20, VIII
Justice, Department of                            2, XXVIII; 5, XXVIII; 28, 
                                                  I, XI; 40, IV
  Alcohol, Tobacco, Firearms, and Explosives,     27, II
       Bureau of
  Drug Enforcement Administration                 21, II
  Federal Acquisition Regulation                  48, 28
  Federal Claims Collection Standards             31, IX
  Federal Prison Industries, Inc.                 28, III
  Foreign Claims Settlement Commission of the     45, V
       United States
  Immigration Review, Executive Office for        8, V
  Independent Counsel, Offices of                 28, VI
  Prisons, Bureau of                              28, V
  Property Management Regulations                 41, 128
Labor, Department of                              2, XXIX; 5, XLII
  Benefits Review Board                           20, VII
  Employee Benefits Security Administration       29, XXV
  Employees' Compensation Appeals Board           20, IV
  Employment and Training Administration          20, V
  Federal Acquisition Regulation                  48, 29

[[Page 1131]]

  Federal Contract Compliance Programs, Office    41, 60
       of
  Federal Procurement Regulations System          41, 50
  Labor-Management Standards, Office of           29, II, IV
  Mine Safety and Health Administration           30, I
  Occupational Safety and Health Administration   29, XVII
  Public Contracts                                41, 50
  Secretary of Labor, Office of                   29, Subtitle A
  Veterans' Employment and Training Service,      41, 61; 20, IX
       Office of the Assistant Secretary for
  Wage and Hour Division                          29, V
  Workers' Compensation Programs, Office of       20, I, VI
Labor-Management Standards, Office of             29, II, IV
Land Management, Bureau of                        43, II
Legal Services Corporation                        45, XVI
Libraries and Information Science, National       45, XVII
     Commission on
Library of Congress                               36, VII
  Copyright Royalty Board                         37, III
  U.S. Copyright Office                           37, II
Management and Budget, Office of                  5, III, LXXVII; 14, VI; 
                                                  48, 99
Marine Mammal Commission                          50, V
Maritime Administration                           46, II
Merit Systems Protection Board                    5, II, LXIV
Micronesian Status Negotiations, Office for       32, XXVII
Military Compensation and Retirement              5, XCIX
     Modernization Commission
Millennium Challenge Corporation                  22, XIII
Mine Safety and Health Administration             30, I
Minority Business Development Agency              15, XIV
Miscellaneous Agencies                            1, IV
Monetary Offices                                  31, I
Morris K. Udall Scholarship and Excellence in     36, XVI
     National Environmental Policy Foundation
Museum and Library Services, Institute of         2, XXXI
National Aeronautics and Space Administration     2, XVIII; 5, LIX; 14, V
  Federal Acquisition Regulation                  48, 18
National Agricultural Library                     7, XLI
National Agricultural Statistics Service          7, XXXVI
National and Community Service, Corporation for   2, XXII; 45, XII, XXV
National Archives and Records Administration      2, XXVI; 5, LXVI; 36, XII
  Information Security Oversight Office           32, XX
National Capital Planning Commission              1, IV, VI
National Counterintelligence Center               32, XVIII
National Credit Union Administration              5, LXXXVI; 12, VII
National Crime Prevention and Privacy Compact     28, IX
     Council
National Drug Control Policy, Office of           2, XXXVI; 21, III
National Endowment for the Arts                   2, XXXII
National Endowment for the Humanities             2, XXXIII
National Foundation on the Arts and the           45, XI
     Humanities
National Geospatial-Intelligence Agency           32, I
National Highway Traffic Safety Administration    23, II, III; 47, VI; 49, V
National Imagery and Mapping Agency               32, I
National Indian Gaming Commission                 25, III
National Institute of Food and Agriculture        7, XXXIV
National Institute of Standards and Technology    15, II; 37, IV
National Intelligence, Office of Director of      5, IV; 32, XVII
National Labor Relations Board                    5, LXI; 29, I
National Marine Fisheries Service                 50, II, IV
National Mediation Board                          5, CI; 29, X
National Oceanic and Atmospheric Administration   15, IX; 50, II, III, IV, 
                                                  VI
National Park Service                             36, I
National Railroad Adjustment Board                29, III
National Railroad Passenger Corporation (AMTRAK)  49, VII
National Science Foundation                       2, XXV; 5, XLIII; 45, VI
  Federal Acquisition Regulation                  48, 25
National Security Council                         32, XXI; 47, II

[[Page 1132]]

National Technical Information Service            15, XI
National Telecommunications and Information       15, XXIII; 47, III, IV, V
     Administration
National Transportation Safety Board              49, VIII
Natural Resource Revenue, Office of               30, XII
Natural Resources Conservation Service            7, VI
Navajo and Hopi Indian Relocation, Office of      25, IV
Navy, Department of                               32, VI
  Federal Acquisition Regulation                  48, 52
Neighborhood Reinvestment Corporation             24, XXV
Northeast Interstate Low-Level Radioactive Waste  10, XVIII
     Commission
Nuclear Regulatory Commission                     2, XX; 5, XLVIII; 10, I
  Federal Acquisition Regulation                  48, 20
Occupational Safety and Health Administration     29, XVII
Occupational Safety and Health Review Commission  29, XX
Ocean Energy Management, Bureau of                30, V
Oklahoma City National Memorial Trust             36, XV
Operations Office                                 7, XXVIII
Patent and Trademark Office, United States        37, I
Payment From a Non-Federal Source for Travel      41, 304
     Expenses
Payment of Expenses Connected With the Death of   41, 303
     Certain Employees
Peace Corps                                       2, XXXVII; 22, III
Pennsylvania Avenue Development Corporation       36, IX
Pension Benefit Guaranty Corporation              29, XL
Personnel Management, Office of                   5, I, IV, XXXV; 45, VIII
  Federal Acquisition Regulation                  48, 17
  Federal Employees Group Life Insurance Federal  48, 21
       Acquisition Regulation
  Federal Employees Health Benefits Acquisition   48, 16
       Regulation
  Human Resources Management and Labor Relations  5, XCVII
       Systems, Department of Homeland Security
Pipeline and Hazardous Materials Safety           49, I
     Administration
Postal Regulatory Commission                      5, XLVI; 39, III
Postal Service, United States                     5, LX; 39, I
Postsecondary Education, Office of                34, VI
President's Commission on White House             1, IV
     Fellowships
Presidential Documents                            3
Presidio Trust                                    36, X
Prisons, Bureau of                                28, V
Privacy and Civil Liberties Oversight Board       6, X
Procurement and Property Management, Office of    7, XXXII
Public and Indian Housing, Office of Assistant    24, IX
     Secretary for
Public Contracts, Department of Labor             41, 50
Public Health Service                             42, I
Railroad Retirement Board                         20, II
Reclamation, Bureau of                            43, I
Refugee Resettlement, Office of                   45, IV
Relocation Allowances                             41, 302
Research and Innovative Technology                49, XI
     Administration
Rural Business-Cooperative Service                7, XVIII, XLII, L
Rural Development Administration                  7, XLII
Rural Housing Service                             7, XVIII, XXXV, L
Rural Utilities Service                           7, XVII, XVIII, XLII, L
Safety and Environmental Enforcement, Bureau of   30, II
Science and Technology Policy, Office of          32, XXIV; 47, II
Secret Service                                    31, IV
Securities and Exchange Commission                5, XXXIV; 17, II
Selective Service System                          32, XVI
Small Business Administration                     2, XXVII; 13, I
Smithsonian Institution                           36, V
Social Security Administration                    2, XXIII; 20, III; 48, 23
Soldiers' and Airmen's Home, United States        5, XI
Special Counsel, Office of                        5, VIII
Special Education and Rehabilitative Services,    34, III
     Office of
State, Department of                              2, VI; 22, I; 28, XI

[[Page 1133]]

  Federal Acquisition Regulation                  48, 6
Surface Mining Reclamation and Enforcement,       30, VII
     Office of
Surface Transportation Board                      49, X
Susquehanna River Basin Commission                18, VIII
Tennessee Valley Authority                        5, LXIX; 18, XIII
Trade Representative, United States, Office of    15, XX
Transportation, Department of                     2, XII; 5, L
  Commercial Space Transportation                 14, III
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 12
  Federal Aviation Administration                 14, I
  Federal Highway Administration                  23, I, II
  Federal Motor Carrier Safety Administration     49, III
  Federal Railroad Administration                 49, II
  Federal Transit Administration                  49, VI
  Great Lakes St. Lawrence Seaway Development     33, IV
       Corporation
  Maritime Administration                         46, II
  National Highway Traffic Safety Administration  23, II, III; 47, IV; 49, V
  Pipeline and Hazardous Materials Safety         49, I
       Administration
  Secretary of Transportation, Office of          14, II; 49, Subtitle A
  Transportation Statistics Bureau                49, XI
Transportation, Office of                         7, XXXIII
Transportation Security Administration            49, XII
Transportation Statistics Bureau                  49, XI
Travel Allowances, Temporary Duty (TDY)           41, 301
Treasury, Department of the                       2, X; 5, XXI; 12, XV; 17, 
                                                  IV; 31, IX
  Alcohol and Tobacco Tax and Trade Bureau        27, I
  Community Development Financial Institutions    12, XVIII
       Fund
  Comptroller of the Currency                     12, I
  Customs and Border Protection                   19, I
  Engraving and Printing, Bureau of               31, VI
  Federal Acquisition Regulation                  48, 10
  Federal Claims Collection Standards             31, IX
  Federal Law Enforcement Training Center         31, VII
  Financial Crimes Enforcement Network            31, X
  Fiscal Service                                  31, II
  Foreign Assets Control, Office of               31, V
  Internal Revenue Service                        26, I
  Investment Security, Office of                  31, VIII
  Monetary Offices                                31, I
  Secret Service                                  31, IV
  Secretary of the Treasury, Office of            31, Subtitle A
Truman, Harry S. Scholarship Foundation           45, XVIII
United States Agency for Global Media             22, V
United States and Canada, International Joint     22, IV
     Commission
United States and Mexico, International Boundary  22, XI
     and Water Commission, United States Section
U.S. Copyright Office                             37, II
U.S. Office of Special Counsel                    5, CII
Utah Reclamation Mitigation and Conservation      43, III
     Commission
Veterans Affairs, Department of                   2, VIII; 38, I
  Federal Acquisition Regulation                  48, 8
Veterans' Employment and Training Service,        41, 61; 20, IX
     Office of the Assistant Secretary for
Vice President of the United States, Office of    32, XXVIII
Wage and Hour Division                            29, V
Water Resources Council                           18, VI
Workers' Compensation Programs, Office of         20, I, VII
World Agricultural Outlook Board                  7, XXXVIII

[[Page 1135]]



List of CFR Sections Affected



All changes in this volume of the Code of Federal Regulations (CFR) that 
were made by documents published in the Federal Register since January 
1, 2018 are enumerated in the following list. Entries indicate the 
nature of the changes effected. Page numbers refer to Federal Register 
pages. The user should consult the entries for chapters, parts and 
subparts as well as sections for revisions.
For changes to this volume of the CFR prior to this listing, consult the 
annual edition of the monthly List of CFR Sections Affected (LSA). The 
LSA is available at www.govinfo.gov. For changes to this volume of the 
CFR prior to 2001, see the ``List of CFR Sections Affected, 1949-1963, 
1964-1972, 1973-1985, and 1986-2000'' published in 11 separate volumes. 
The ``List of CFR Sections Affected 1986-2000'' is available at 
www.govinfo.gov.

                                  2018

21 CFR
                                                                   83 FR
                                                                    Page
Chapter I
801 Policy statement................................................2057
801.4 Regulation at 82 FR 2217 eff. date delayed indefinitely......11639
803 Policy statement................................................2057
    Notification...................................................40973
806 Policy statement................................................2057
807 Authority citation revised......................................7385
807.87 (j), (k) and (l) redesignated as (k), (l) and (m); new (j) 
        added.......................................................7385
810 Policy statement................................................2057
812 Authority citation revised......................................7385
812.3 (t) added.....................................................7385
812.27 (b)(4) added.................................................7385
812.28 Added........................................................7386
812.140 (d) revised.................................................7387
814 Policy statement................................................2057
    Authority citation revised......................................7387
814.15 (a) revised; (b) and (c) removed; (d) and (e) redesignated 
        as (b) and (c); section amended.............................7387
814.20 (b)(6)(ii)(A) and (B) revised; (b)(6)(ii)(C) added...........7387
814.45 (a)(5) revised...............................................7387
814.46 (a)(4) revised...............................................7388
814.104 (b)(4)(i) revised...........................................7388
820 Policy statement................................................2057
821 Policy statement................................................2057
822 Policy statement................................................2057
830 Policy statement................................................2057
860.3 (f) and (g) removed..........................................64454
860.7 (b) introductory text and (d)(2) revised; (c)(2) and (g)(1) 
        amended....................................................64454
860.10 Added.......................................................64455
860.15 Added.......................................................64455
860.84 Heading, (a), (d)(2), (4), (5), (6), (e), (g)(2), and (3) 
        revised; (c)(2) amended; (c)(3) and (4) removed; (c)(5) 
        redesignated as new (c)(3).................................64455
860.90 Added.......................................................64456
860.93 Removed.....................................................64456
860.95 Removed.....................................................64456
860.120 (b) and (c) revised........................................64456
860.123 (a)(3) and (4) removed; (a)(5) through (10) redesignated 
        as new (a)(3) through (8); new (a)(7) amended; (b)(2) 
        revised....................................................64456
860.125 (a)(2) removed; (a)(3) and (c) redesignated as new (a)(2) 
        and (d); (a) introductory text, (1), and new (d) revised; 
        new (c) added..............................................64456
860.130 Heading and (c) through (g) revised........................64456
860.132 (b) redesignated as (d); heading, (a), new (d) 
        introductory text, new (1), and new (3) revised; new (b) 
        and (c) added..............................................64457

[[Page 1136]]

860.133 Added......................................................64457
860.134 Heading, (a)(3), (b) introductory text, (4), and (6) 
        revised; undesignated paragraph following (a)(3) removed; 
        (a)(4), (c), and (d) added.................................64457
860.136 (b)(3) removed; (b)(4), (5), and (6) redesignated as new 
        (b)(3), (4), and (5); heading, (a), (b) introductory text, 
        and new (4) revised; (c) and (d) added.....................64458
862.1358 Added.....................................................54874
862.1840 (b) introductory text revised.............................25914
862.3590 Added.....................................................54876
864 Authority citation revised........................................22
    Technical correction...........................................11144
864.1865 Added.......................................................234
864.1866 Added......................................................8357
864.3700 Added........................................................22
864.9165 Added.....................................................23217
866.3309 Added.....................................................52314
866.5830 Added.....................................................27701
866.5950 (b) introductory text revised.............................25914
866.6080 Added.....................................................28995
868.5273 Added.....................................................52966
868.5454 Added.....................................................54007
870.1251 Added......................................................4140
872 Authority citation revised.....................................11145
872.3570 (b) introductory text revised.............................11145
874 Authority citation revised.....................................54009
874.3340 Added.....................................................54009
876.1500 (b)(1) revised............................................25914
876.4310 Added.....................................................27703
876.4350 Added.....................................................27897
878.4040 (b)(1) revised............................................22848
878.4165 Added.....................................................52968
878.4371 Added........................................................24
878.4430 Added.....................................................26577
878.4454 Added......................................................6794
878.4456 Added.....................................................52971
878.4685 Added......................................................9699
878.4860 Added.....................................................52969
878.5050 Added......................................................4143
880.6210 Added.....................................................19628
880.6710 (b) revised...............................................25915
882.5893 Added.....................................................52973
882.5896 Added......................................................5034
882.5897 Added.....................................................52316
882.5940 Revised...................................................66123
884.5330 Heading and (a) revised...................................48714
884.5340 Added.....................................................48714
884.5960 (b) revised...............................................25915
886.5310 Added.....................................................52975
888 Authority citation revised.....................................26579
888.3023 Added.....................................................26579
890.5525 (b)(2)(i)(A) revised......................................13864
892.5725 Added.......................................................601
900.3 (b)(1) revised...............................................13864
900.11 (b)(2)(i) revised...........................................13864
1020.30 (c) revised................................................13864
1040.10 (a)(3)(i), (f)(6)(ii), and (g)(10) revised.................13864
1040.20 (d)(3)(iii) and (iv) revised...............................13865
1100.5 Regulation at 82 FR 2217 eff. date confirmed................11639
1140.30 (a)(2) amended.............................................13183

                                  2019

21 CFR
                                                                   84 FR
                                                                    Page
Chapter I
800 Authority citation revised.....................................31477
800.75 Added.......................................................31477
806.1 (b)(2), (3), and (4) revised.................................12083
807 Authority citation revised.....................................68339
807.90 (a) and (c) revised; (b) removed............................68339
807.95 (b)(1) introductory text revised............................68339
812 Authority citation revised.....................................68339
812.19 (a)(1) and (2) revised......................................68339
812.20 (a)(3) revised..............................................68339
814 Authority citation revised.....................................68339
814.20 (b) introductory text, (2), (c), (e) introductory text, 
        (f), (h)(1), and (2) revised; (b)(5) introductory text, 
        (i), (10), and (e)(1) and (2) amended......................68339
814.39 (c)(1) revised..............................................68340
814.104 (d) introductory text, (1), and (2) revised................68340
862.1020 (b) revised...............................................71796
862.1090 (b) revised...............................................71796
862.1100 (b) revised...............................................71796
862.1150 (b) revised...............................................71796
862.1345 (b) revised...............................................71796
862.1350 (b) introductory text revised.............................71796
862.1410 (b) revised...............................................71796
862.1415 (b) revised...............................................71796
862.1445 (b) revised...............................................71796
862.1509 (b) revised...............................................71796
862.1580 (b) revised...............................................71796
862.1660 (b) revised...............................................71796
862.1685 (b) revised...............................................71797
862.1700 (b) revised...............................................71797
862.1775 (b) revised...............................................71797

[[Page 1137]]

862.2120 Added.....................................................57817
862.2265 (b) introductory text revised.............................71797
862.2570 (b) revised...............................................71797
862.3050 (b) revised...............................................71797
862.3100 (b) revised...............................................71797
862.3150 (b) revised...............................................71797
862.3170 (b) revised...............................................71797
862.3200 (b) revised...............................................71797
862.3220 (b) revised...............................................71797
862.3240 (b) revised...............................................71797
862.3250 (b) revised...............................................71797
862.3270 (b) revised...............................................71798
862.3280 (b) revised...............................................71798
862.3580 (b) revised...............................................71798
862.3610 (b) revised...............................................71798
862.3620 (b) revised...............................................71798
862.3630 (b) revised...............................................71798
862.3640 (b) revised...............................................71798
862.3650 (b) revised...............................................71798
862.3700 (b) revised...............................................71798
862.3870 (b) revised...............................................71799
862.3910 (b) revised...............................................71799
864.5400 (b) revised...............................................71799
864.5425 (b) revised...............................................71799
864.6550 (b) revised...............................................71799
864.7040 (b) revised...............................................71799
864.7275 (b) revised...............................................71799
864.7300 (b) revised...............................................71799
864.7340 (b) revised...............................................71799
864.7375 (b) revised...............................................71799
864.7415 (b) revised...............................................71799
864.7455 (b) revised...............................................71799
864.7500 (b) revised...............................................71799
864.7720 (b) revised...............................................71800
864.7735 (b) revised...............................................71800
864.8150 (b) revised...............................................71800
864.8165 (b) revised...............................................71800
864.8175 (b) revised...............................................71800
864.8185 (b) revised...............................................71800
864.8625 (b) revised...............................................71800
864.9400 (b) revised...............................................71800
866.2900 (b) revised...............................................71800
866.3045 Added; eff. 5-1-19........................................12088
866.3395 (b) revised...............................................71800
866.3985 Added......................................................9228
866.5210 (b) revised...............................................71800
866.5470 (b) revised...............................................71800
866.5620 (b) revised...............................................71800
866.5630 (b) revised...............................................71800
866.5750 (b) revised...............................................71800
866.5910 (b) revised...............................................71811
868.1040 (b) revised...............................................71811
868.1505 Added.....................................................15098
868.2385 (b) revised...............................................71811
868.2500 (b) revised...............................................71811
868.2550 (b) revised...............................................71811
868.5180 (b) revised...............................................71811
868.6250 (b) revised...............................................71811
870.1330 (b) revised...............................................71811
870.1390 (b) revised...............................................71811
870.1650 (b) revised...............................................71811
870.1875 (b)(2) revised............................................71811
870.2675 (b) revised...............................................71812
870.2770 (b) revised...............................................71812
870.4280 (b) revised...............................................71812
870.4290 (b) revised...............................................71812
870.4340 (b) revised...............................................71812
870.4400 (b) revised...............................................71812
870.4420 (b) revised...............................................71812
870.4430 (b) revised...............................................71812
872.1720 (b) revised...............................................71812
872.3260 (b) revised...............................................71812
872.3300 (b) revised...............................................71812
872.3540 (b)(2) introductory text revised..........................71812
872.3560 (b) introductory text revised.............................71812
872.3590 (b) revised...............................................71812
872.3600 (b) introductory text revised.............................71812
872.3890 (b) revised...............................................71812
872.5550 (b)(2) revised............................................71812
872.5571 Added......................................................5000
872.6770 (b) revised...............................................71813
874.1090 (b) revised...............................................71813
874.1120 (b) revised...............................................71813
874.1325 (b) revised...............................................71813
874.3310 (b) revised...............................................71813
874.3320 (b) revised...............................................71813
874.3325 Added.....................................................57612
874.3330 (b) revised...............................................71813
874.3430 (b) revised...............................................71813
874.3730 (b) revised...............................................71813
876.1080 Added.....................................................14869
876.1500 (b)(1) revised............................................71813
876.3500 Added.....................................................14869
876.4020 (b) revised...............................................71813
876.4270 (b) revised...............................................71813
876.4400 (b) revised...............................................71813
876.4500 (b) revised...............................................71813
876.4630 Added.....................................................14870
876.4770 (b) revised...............................................71813
876.5010 (b) revised...............................................71814
876.5012 Added.....................................................14870
876.5025 (b) introductory text revised.............................71814
876.5100 Added.....................................................14870
876.5160 Heading and (b) revised...................................71814
876.5290 Added.....................................................14870
876.5365 (b) revised...............................................71814

[[Page 1138]]

876.5520 (b)(1) revised............................................71814
876.5630 (b) revised...............................................71814
876.5665 (b) revised...............................................71814
876.5895 (b) revised...............................................71814
876.5980 (b)(1) revised............................................71814
878.4370 (b) revised...............................................71814
878.4495 (b) revised...............................................71814
878.4580 (b) revised...............................................71814
878.5070 (b) revised...............................................71814
878.5080 Added.....................................................14870
880.5580 (b) introductory text revised.............................71815
880.5680 (b) revised...............................................71815
880.5780 (a)(2) revised............................................71815
880.6250 (b) revised...............................................71815
880.6375 (b) revised...............................................71815
880.6760 (b) revised...............................................71815
882.1020 (b) revised...............................................71815
882.1030 (b) revised...............................................71815
882.1470 (b) introductory text revised.............................71815
882.1540 (b) revised...............................................71815
882.1560 (b) revised...............................................71815
882.1855 (b) revised...............................................71815
882.4060 (b) revised...............................................71815
882.4545 (b) revised...............................................71815
882.5800 Revised...................................................70013
882.5802 Added......................................................9230
882.5895 (b) introductory text revised.............................71815
884.1630 (b) revised...............................................71816
884.2990 (b) revised...............................................71816
884.3200 (b) revised...............................................71816
884.4400 (b) revised...............................................71816
884.4530 (b)(1) revised............................................71816
884.4900 (b) revised...............................................71816
884.5200 (b) introductory text revised.............................71816
884.5370 Added......................................................7995
884.5390 (b) revised...............................................71816
884.5400 (b) revised...............................................71816
884.5425 (b)(2) revised............................................71816
884.5435 (b) revised...............................................71816
884.6120 (b) revised...............................................71816
884.6130 (b) revised...............................................71816
884.6150 (b) revised...............................................71816
884.6160 (b) revised...............................................71816
886 Technical correction...........................................22702
886.1120 (b) revised...............................................71817
886.1250 (b) revised...............................................71817
886.1570 (b) revised...............................................71817
886.1780 (b)(1) revised............................................71817
886.1850 (b) revised...............................................71817
886.1945 (b) revised...............................................71817
886.3320 (b) revised...............................................71817
886.4070 (b) revised...............................................71817
886.4150 (b) revised...............................................71817
886.4250 (b) revised...............................................71817
886.4335 (b) revised...............................................71817
886.4355 Added.....................................................14870
886.4400 (b) revised...............................................71817
886.4440 (b) revised...............................................71817
886.4790 (b) revised...............................................71817
888.1240 (b) revised...............................................71818
888.3075 Added; eff. 5-1-19........................................12092
888.4505 Added.....................................................57321
888.4580 (b) revised...............................................71818
890 Authority citation added.......................................57323
890.1450 (b) revised...............................................71818
890.5100 (b) revised...............................................71818
890.5110 (b) revised...............................................71818
890.5250 (b) revised...............................................71818
890.5360 (b) revised...............................................71818
890.5500 (b) revised...............................................71818
890.5575 (b) revised...............................................71818
890.5670 Added.....................................................57323
892.1000 (b) revised...............................................71818
892.1560 (b) revised...............................................71818
892.1610 (b) revised...............................................71818
892.1650 (b) revised...............................................71818
892.1670 (b) revised...............................................71818
892.1680 (b) revised...............................................71818
892.1730 (b) revised...............................................71819
892.1820 (b) revised...............................................71819
892.1850 (b) revised...............................................71819
892.1860 (b) revised...............................................71819
892.1870 (b) revised...............................................71819
892.1900 (b) revised...............................................71819
892.2030 (b) revised...............................................71819
892.2040 (b) revised...............................................71819
892.5730 (b) revised...............................................71819
1100 Notification..................................................27200
1140 Notification..................................................27200
1143 Notification..................................................27200

                                  2020

21 CFR
                                                                   85 FR
                                                                    Page
Chapter I
801 Policy statement...............................................39477
800.55 (c), (e), and (g)(1) amended; (h) heading added; 
        (d)(3)(xi), (g)(3)(ii), (iv), (4), (h)(1), (2), (3) 
        introductory text, (iv), and (4) revised...................16555
801.55 (b)(2) revised..............................................18441
801.57 (c)(2) revised..............................................18441
803.11 (d) revised.................................................18441
803.19 (b) amended.................................................18441
803.21 (a) revised.................................................18441
803.33 (a) revised.................................................18442

[[Page 1139]]

807.21 (b) introductory text revised...............................18442
807.34 (a) revised.................................................18442
807.37 (a) revised.................................................18442
814.42 (d)(2) revised..............................................18442
814.100 (e)(2) revised.............................................18442
820.1 (e)(1) revised...............................................18442
821.2 (b) introductory text revised................................18443
822.7 (a)(1) revised...............................................18443
822.22 (a)(1) revised..............................................18443
830.110 (a)(1) revised.............................................18443
830.320 (c)(1) and (3) revised.....................................18443
860.123 (b)(1) revised.............................................18443
862.1345 (b) revised...............................................18445
862.1775 (b) revised...............................................18445
866.2900 (b) revised...............................................18445
866.3955 Added......................................................7217
882.5235 (b) revised; eff. 4-6-20..................................13354
882.5235 Regulation at 85 FR 13354 stayed in part..................50950
884.5360 (c) removed...............................................18443
884.6120 (b) revised...............................................44188
884.6180 (b) revised...............................................44188
888 Notification...................................................26350
888.4505 (b) introductory text revised.............................44188
890.3690 (b) revised................................................2020
890.5360 (b) revised...............................................44188
890.5670 (b) introductory text revised.............................44188
892.2060 Added......................................................3542
892.2070 Added......................................................3548
892.2080 Added......................................................3544
895.105 Added; eff. 4-6-20.........................................13354
895.105 Regulation at 85 FR 13354 stayed in part...................50950
900.3 (b)(1) revised...............................................18443
900.15 (d)(3)(i) revised...........................................18443
900.18 (c) introductory text revised...............................18444
900.21 (b)(1) revised..............................................18444
1002.50 (c)(3) revised.............................................18444
1005.11 Amended....................................................50783
1005.24 (b) and (c) revised........................................50783
1141 Revised; eff. 6-18-21.........................................15708
1141 Notification..................................................15708
1141 Regulation at 85 FR 15708 eff. date delayed to 10-16-21.......32293
1271 Notification..................................................43989

                                  2021

21 CFR
                                                                   86 FR
                                                                    Page
Chapter I
801.4 Revised......................................................41401
821.2 (b) introductory text and (c) revised........................17065
860 Authority citation revised.....................................54846
860 Nomenclature change............................................54846
860.1 (b) revised..................................................54846
860.3 Revised......................................................54846
860.5 (g) added....................................................54847
860.200--860.260 (Subpart D) Added.................................54847
862.1350 Heading and (a) revised...................................20283
862.2100 (a) revised...............................................20283
866.3169 Added.....................................................66176
866.3170 Added.....................................................66172
866.4750 (a) revised...............................................20283
868.5095 Added.....................................................73678
868.5480 Added.....................................................68397
876.1050 Added.....................................................71145
876.1450 Added.....................................................68399
876.2100 Added.....................................................70735
876.5330 Added.....................................................73971
876.5340 Added.....................................................71143
876.5982 Added.....................................................70372
878.4740 Added.....................................................56204
878.4783 Added.....................................................70374
878.4800 (a) revised........................................56204, 66188
878.4805 Added.....................................................71569
878.4825 Added.....................................................66458
878.4850 (d)(3) added..............................................66179
878.4850 Added.....................................................66188
880.6310 (a) revised...............................................20283
882.1455 Added.....................................................71384
882.4950 Added.....................................................73973
882.5060 Added.....................................................68403
882.5560 Added.....................................................73975
882.5898 Added.....................................................70377
882.5899 Added.....................................................68401
882.5955 Added.....................................................70733
884.2730 (a) revised...............................................20283
888.3090 Added.....................................................68405
890 Order..........................................................69583
892.2010 (a) revised...............................................20284
892.2020 (a) revised...............................................20284
892.2050 Heading and (a) revised...................................20284
1100 Heading and authority citation revised........................55411
1100.1--1100.5 (Subpart A) Added...................................55411
1100.200--1100.204 (Subpart C) Added...............................55411
1107 Heading revised; authority citation revised............55275, 55412
1107.3 Added.......................................................55412
1107.10--1107.12 (Subpart B) Added.................................55275

[[Page 1140]]

1107.16--1107.24 (Subpart C) Added.................................55275
1107.40--1107.50 (Subpart D) Added.................................55275
1107.58--1107.62 (Subpart E) Added.................................55275
1114 Added.........................................................55412
1141 Regulation at 85 FR 15708 eff. date delayed to 1-14-22.........3793
1141 Regulation at 85 FR 15708 eff. date further delayed to 7-13-
        22.........................................................36509
1141 Regulation at 85 FR 15708 eff. date further delayed to 11-11-
        22.........................................................50854
1141 Regulation at 85 FR 15708 eff. date further delayed to 1-9-23
                                                                   70052

                                  2022

21 CFR
                                                                   87 FR
                                                                    Page
Chapter I
800 Notification...................................................50568
800 Authority citation revised.....................................50748
800.30 Added.......................................................50748
801 Guidance.......................................................43987
801 Notification...................................................50568
801 Authority citation revised.....................................50755
801.420 Removed....................................................50755
801.421 Removed....................................................50755
801.422 Added......................................................50755
808 Notification...................................................50568
808 Authority citation revised.....................................50761
808 Amended........................................................50761
808.1 (a) through (f) headings and (g) added.......................50761
808.3 Revised......................................................50762
808.53 Removed.....................................................50762
808.55 Revised.....................................................50762
808.57 Removed.....................................................50762
808.59 Removed.....................................................50762
808.61 Removed.....................................................50762
808.67 Removed.....................................................50762
808.69 Removed.....................................................50762
808.71 Removed.....................................................50762
808.73 Removed.....................................................50762
808.74 Removed.....................................................50762
808.77 Removed.....................................................50762
808.80 Removed.....................................................50762
808.81 Removed.....................................................50762
808.82 Removed.....................................................50762
808.85 Removed.....................................................50762
808.87 Removed.....................................................50762
808.88 Removed.....................................................50762
808.89 Removed.....................................................50762
808.93 Removed.....................................................50762
808.97 Removed.....................................................50762
808.98 Removed.....................................................50762
808.101 Removed....................................................50762
814.40 Amended......................................................2045
814.44 (d)(1), (2), (e)(2)(ii), and (f)(2) amended..................2045
814.45 (d)(1) and (e)(3) amended....................................2045
814.116 (b) amended.................................................2045
814.118 (c)(3) amended..............................................2045
822.8 Revised......................................................17950
822.12 Amended.....................................................17950
822.21 Revised.....................................................17950
862.1355 Added......................................................9238
862.1356 Added.....................................................14172
866.1655 Added......................................................6417
866.3956 Added.....................................................29665
866.3957 Added.....................................................29667
866.3958 Added.....................................................66548
866.5960 Added.....................................................79252
870.1252 Added......................................................9241
870.1342 Added.....................................................26991
870.1345 Added.....................................................34778
870.1405 Added.....................................................79803
870.1420 Added.....................................................32990
870.2210 Added......................................................8191
870.2345 Added......................................................2549
870.2790 Added......................................................6419
870.2220 Added.....................................................79254
870.4150 Added.....................................................80039
874 Notification...................................................50568
874.3300 Revised...................................................50762
874.3302 Added.....................................................50762
874.3305 (a) amended; (b) revised..................................50762
874.3315 (a) revised...............................................50762
874.3325 (a) amended; (b)(5) revised; (b)(7) removed...............50762
874.3950 (a) amended...............................................50762
876.1310 Added.....................................................26993
876.5026 Added.....................................................34166
878.3510 Added......................................................6421
878.4550 Added.....................................................24273
878.4961 Added.....................................................26995
880.5730 Added......................................................6424
880.6887 Added......................................................8194
882.1491 Added.....................................................80445
882.5975 Removed....................................................2049
886.1100 Added......................................................3205
886.5305 Added......................................................9243
888.3043 Added.....................................................11294
888.3044 Added.....................................................80041
1141 Regulation at 85 FR 15708 eff. date further delayed to 4-9-23
                                                                   11295
1141 Regulation at 85 FR 15708 eff. date delayed to 7-8-23.........32990

[[Page 1141]]

1141 Regulation at 85 FR 15708 eff. date further delayed to 10-6-
        23.........................................................50765
1141 Regulation at 85 FR 15708 eff. date further delayed to 11-6-
        23.........................................................72384
1270 Removed........................................................2049
1271 Notification..................................................65681

                                  2023

   (Regulations published from January 1, 2023, through April 1, 2023)

21 CFR
                                                                   88 FR
                                                                    Page
Chapter I
803.19 (b) revised.................................................16879
812.38 (b)(4) revised..............................................16880
812.47 (a) revised.................................................16880
822.1 Introductory text, (b), and (c) revised; (d) added...........16880
822.4 Introductory text, (b), and (c) revised; (d) added...........16880
822.7 (a)(1) revised...............................................16880
822.24 Revised.....................................................16880
862.1622 Added......................................................2519
864.3750 Added......................................................7009
870.2785 Added......................................................6167
870.2786 Added.......................................................976
874.4450 Added.......................................................979
876.1520 Added........................................................10
876.5960 Added......................................................3636
882.5705 Added......................................................2223
882.5855 Added.......................................................751
886.5201 Added......................................................3638
888.1600 Added.......................................................755
888.3083 Added; eff. 5-1-23........................................18990
888.3083 (c) added; eff. 5-1-23....................................18993
888.3600 Added.......................................................753
888.3630 Added.......................................................981
890.5420 Added.......................................................983
890.5800 Added.......................................................985
900.2 (c)(2), (k), (z), (aa)(1), (2), and (ii) revised; (aa)(3) 
        added; eff. 9-10-24........................................15168
900.4 (a)(6) and (f)(1)(ii)(B) revised; eff. 9-10-24...............15168
900.11 (c)(4) revised; eff. 9-10-24................................15168
900.12 (a)(40), (b)(11), (c)(1), (2), (3)(ii), (4), (f)(1), and 
        (j) revised; (b)(2)(i), (ii), (16), and (f)(4) added; eff. 
        9-10-24....................................................15168
900.14 (a) introductory text, (3), (5), and (6) revised; (a)(7) 
        added; eff. 9-10-24........................................15171
900.15 (d)(1) revised; eff. 9-10-24................................15171
1000.3 (a) revised; (s) removed; (t) and (u) redesignated as new 
        (s) and (t).................................................3652
1000.50--1000.60 (Subpart C) Removed................................3652
1002.1 Table 1 revised..............................................3652
1002.13 (c) removed.................................................3653
1002.20 Revised.....................................................3653
1010.2 (e) added....................................................3653
1010.3 (a)(2)(ii) revised...........................................3654
1010.4 (b) introductory text, (1), and (2) introductory text 
        revised.....................................................3654
1020.10 (a) revised.................................................3654
1020.30 (d)(1) and (2)(ii) revised..................................3654
1030.10 (c)(6)(iv) introductory text revised........................3654
1050 Removed........................................................3654
1100 Authority citation revised....................................16552
1100.1--1100.5 (Subpart A) Heading added...........................16552
1100.1 Revised.....................................................16552
1100.2 Amended.....................................................16552
1100.3 Amended.....................................................16552
1100.202 Amended...................................................16552
1107 Authority citation revised....................................16552
1107.12 Amended....................................................16552
1114 Authority citation revised....................................16553
1114.3 Amended.....................................................16553
1140 Authority citation revised....................................16553
1140.3 Amended.....................................................16553
1143 Authority citation revised....................................16553
1143.1 Amended.....................................................16553


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