[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 1998 Edition]
[From the U.S. Government Printing Office]


[[Page i]]

          21



          Food and Drugs



          PARTS 800 TO 1299

                         Revised as of April 1, 1998

          CONTAINING
          A CODIFICATION OF DOCUMENTS
          OF GENERAL APPLICABILITY
          AND FUTURE EFFECT
          AS OF APRIL 1, 1998

          With Ancillaries
          Published by
          the Office of the Federal Register
          National Archives and Records
          Administration
          as a Special Edition of
          the Federal Register



[[Page ii]]

                                      




                     U.S. GOVERNMENT PRINTING OFFICE
                            WASHINGTON : 1998



               For sale by U.S. Government Printing Office
 Superintendent of Documents, Mail Stop: SSOP, Washington, DC 20402-9328



[[Page iii]]




                            Table of Contents



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

  Title 21:
    Chapter I--Food and Drug Administration, Department of 
        Health and Human Services (Continued).................       3
  Finding Aids:
    Material Approved for Incorporation by Reference..........     657
    Table of CFR Titles and Chapters..........................     659
    Alphabetical List of Agencies Appearing in the CFR........     675
    List of CFR Sections Affected.............................     685



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   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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[[Page v]]



                               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 
issues of the Federal Register. These two publications must be used 
together to determine the latest version of any given rule.
    To determine whether a Code volume has been amended since its 
revision date (in this case, April 1, 1998), consult the ``List of CFR 
Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative 
List of Parts Affected,'' which appears in the Reader Aids section of 
the daily Federal Register. These two lists will identify the Federal 
Register page number of the latest amendment of any given rule.

EFFECTIVE AND EXPIRATION DATES

    Each volume of the Code contains amendments published in the Federal 
Register since the last revision of that volume of the Code. Source 
citations for the regulations are referred to by volume number and page 
number of the Federal Register and date of publication. Publication 
dates and effective dates are usually not the same and care must be 
exercised by the user in determining the actual effective date. In 
instances where the effective date is beyond the cut-off date for the 
Code a note has been inserted to reflect the future effective date. In 
those instances where a regulation published in the Federal Register 
states a date certain for expiration, an appropriate note will be 
inserted following the text.

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 
amendments to existing regulations in the CFR. These OMB numbers are 
placed as close as possible to the applicable recordkeeping or reporting 
requirements.

OBSOLETE PROVISIONS

    Provisions that become obsolete before the revision date stated on 
the cover of each volume are not carried. Code users may find the text 
of provisions in effect on a given date in the past by using the 
appropriate numerical list of sections affected. For the period before 
January 1, 1986, consult either the List of CFR Sections Affected, 1949-
1963, 1964-1972, or 1973-1985, published in seven separate volumes. For 
the period beginning January 1, 1986, a ``List of CFR Sections 
Affected'' is published at the end of each CFR volume.

INCORPORATION BY REFERENCE

    What is incorporation by reference? Incorporation by reference was 
established by statute and allows Federal agencies to meet the 
requirement to publish regulations in the Federal Register by referring 
to materials already published elsewhere. For an incorporation to be 
valid, the Director of the Federal Register must approve it. The legal 
effect of incorporation by reference is that the material is treated as 
if it were published in full in the Federal Register (5 U.S.C. 552(a)). 
This material, like any other properly issued regulation, has the force 
of law.
    What is a proper incorporation by reference? The Director of the 
Federal Register will approve an incorporation by reference only when 
the requirements of 1 CFR part 51 are met. Some of the elements on which 
approval is based are:
    (a) The incorporation will substantially reduce the volume of 
material published in the Federal Register.
    (b) The matter incorporated is in fact available to the extent 
necessary to afford fairness and uniformity in the administrative 
process.
    (c) The incorporating document is drafted and submitted for 
publication in accordance with 1 CFR part 51.
    Properly approved incorporations by reference in this volume are 
listed in the Finding Aids at the end of this volume.
    What if the material incorporated by reference cannot be found? If 
you have any problem locating or obtaining a copy of material listed in 
the Finding Aids of this volume as an approved incorporation by 
reference, please contact the agency that issued the regulation 
containing that incorporation. If, after contacting the agency, you find 
the material is not available, please notify the Director of the Federal 
Register, National Archives and Records Administration, Washington DC 
20408, or call (202) 523-4534.

CFR INDEXES AND TABULAR GUIDES

    A subject index to the Code of Federal Regulations is contained in a 
separate volume, revised annually as of January 1, entitled CFR Index 
and Finding Aids. This volume contains the Parallel Table of Statutory 
Authorities and Agency Rules (Table I), and Acts Requiring Publication 
in the Federal Register (Table II). A list of CFR titles, chapters, and 
parts and an alphabetical list of agencies publishing in the CFR are 
also included in this volume.
    An index to the text of ``Title 3--The President'' is carried within 
that volume.
    The Federal Register Index is issued monthly in cumulative form. 
This index is based on a consolidation of the ``Contents'' entries in 
the daily Federal Register.

[[Page vii]]

    A List of CFR Sections Affected (LSA) is published monthly, keyed to 
the revision dates of the 50 CFR titles.

REPUBLICATION OF MATERIAL

    There are no restrictions on the republication of material appearing 
in the Code of Federal Regulations.

INQUIRIES

    For a legal interpretation or explanation of any regulation in this 
volume, contact the issuing agency. The issuing agency's name appears at 
the top of odd-numbered pages.
    For inquiries concerning CFR reference assistance, call 202-523-5227 
or write to the Director, Office of the Federal Register, National 
Archives and Records Administration, Washington, DC 20408.

SALES

    The Government Printing Office (GPO) processes all sales and 
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ELECTRONIC SERVICES

    The full text of the Code of Federal Regulations, The United States 
Government Manual, the Federal Register, Public Laws, Weekly Compilation 
of Presidential Documents and the Privacy Act Compilation are available 
in electronic format at www.access.gpo.gov/nara (``GPO Access''). For 
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    The Office of the Federal Register also offers a free service on the 
National Archives and Records Administration's (NARA) World Wide Web 
site for public law numbers, Federal Register finding aids, and related 
information. Connect to NARA's web site at www.nara.gov/fedreg. The NARA 
site also contains links to GPO Access.

                              Raymond A. Mosley,
                                    Director,
                          Office of the Federal Register.

April 1, 1998.



[[Page ix]]



                               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-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, 1998.

    Redesignation tables for Chapter I--Food and Drug Administration 
appear in the Finding Aids section for the volumes containing parts 170-
199 and 500-599.

    For this volume, Melanie L. Marcec was Chief Editor. The Code of 
Federal Regulations publication program is under the direction of 
Frances D. McDonald, assisted by Alomha S. Morris.

[[Page x]]




[[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

Cross References: Food Safety and Inspection Service, Department of 
  Agriculture: See Meat and Poultry Inspection, 9 CFR chapter III.

  Federal Trade Commission: See Commercial Practices, 16 CFR chapter I.

  U.S. Customs Service, Department of the Treasury: See Customs Duties, 
19 CFR chapter I.

  Internal Revenue Service, Department of the Treasury: See Internal 
Revenue, 26 CFR chapter I. Bureau of Alcohol, Tobacco, and Firearms, 
Department of the Treasury: See Alcohol, Tobacco Products and Firearms, 
27 CFR chapter I.

[[Page 3]]



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




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

                      SUBCHAPTER H--MEDICAL DEVICES
Part                                                                Page
800             General.....................................           5
801             Labeling....................................          13
803             Medical device reporting....................          38
804             Medical device distributor reporting........          53
805             Cardiac pacemaker registry..................          59
806             Medical device corrections and removals.....          61
807             Establishment registration and device 
                    listing for manufacturers and 
                    distributors of devices.................          65
808             Exemptions from Federal preemption of State 
                    and local medical device requirements...          80
809             In vitro diagnostic products for human use..          90
810             Medical device recall authority.............          97
812             Investigational device exemptions...........         104
813

[Reserved]

814             Premarket approval of medical devices.......         121
820             Quality system regulation...................         143
821             Medical device tracking requirements........         156
860             Medical device classification procedures....         162
861             Procedures for performance standards 
                    development.............................         174
862             Clinical chemistry and clinical toxicology 
                    devices.................................         178
864             Hematology and pathology devices............         209
866             Immunology and microbiology devices.........         228
868             Anesthesiology devices......................         262
870             Cardiovascular devices......................         281
872             Dental devices..............................         300
874             Ear, nose, and throat devices...............         322
876             Gastroenterology-urology devices............         332
878             General and plastic surgery devices.........         347
880             General hospital and personal use devices...         359
882             Neurological devices........................         375

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884             Obstetrical and gynecological devices.......         390
886             Ophthalmic devices..........................         407
888             Orthopedic devices..........................         428
890             Physical medicine devices...................         448
892             Radiology devices...........................         463
895             Banned devices..............................         474
897             Cigarettes and smokeless tobacco............         479
898             Performance standard for electrode lead 
                    wires and patient cables................         483
             SUBCHAPTER I--MAMMOGRAPHY QUALITY STANDARDS ACT
900             Mammography.................................         485
                    SUBCHAPTER J--RADIOLOGICAL HEALTH
1000            General.....................................         520
1002            Records and reports.........................         529
1003            Notification of defects or failure to comply         537
1004            Repurchase, repairs, or replacement of 
                    electronic products.....................         541
1005            Importation of electronic products..........         543
1010            Performance standards for electronic 
                    products: general.......................         546
1020            Performance standards for ionizing radiation 
                    emitting products.......................         552
1030            Performance standards for microwave and 
                    radio frequency emitting products.......         580
1040            Performance standards for light-emitting 
                    products................................         583
1050            Performance standards for sonic, infrasonic, 
                    and ultrasonic radiation-emitting 
                    products................................         607
                        SUBCHAPTER K  [RESERVED]
 SUBCHAPTER L--REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE 
                      FOOD AND DRUG ADMINISTRATION
1210            Regulations under the Federal Import Milk 
                    Act.....................................         611
1220            Regulations under the Tea Importation Act...         614
1230            Regulations under the Federal Caustic Poison 
                    Act.....................................         623
1240            Control of communicable diseases............         629
1250            Interstate conveyance sanitation............         638
1251-1269

  [Reserved]

1270            Human tissue intended for transplantation...         648
1271-1299

  [Reserved]

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                      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 solution; 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.

           Subpart C--Administrative Practices and Procedures

800.55  Administrative detention.

    Authority:  21 U.S.C. 321, 334, 351, 352, 355, 356, 357, 360e, 360i, 
360k, 361, 362, 371.



                          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 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

[[Page 6]]

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. This 
information collection requirement has been approved by the Office of 
Management and Budget under number 0910-0150.
    (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 composition 
of the closure component in contact with the contents (cap liner

[[Page 7]]

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]

    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 cots, however, are excluded from the

[[Page 8]]

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) Test method. For the purposes of this regulation, FDA's analysis 
of gloves for leaks will be conducted by a water leak method, using 
1,000 milliliters (mL) of water. Each medical glove will be analyzed 
independently. When packaged as pairs, each glove is considered 
separately, and both gloves will be analyzed. A defect on one of the 
gloves is counted as one defect; a defect in both gloves is counted as 
two defects. Defects are defined as leaks, tears, mold, embedded foreigh 
objects, etc. 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. Leaks within 1 and \1/2\ inches of the 
cuff are to be disregarded.
    (1) The following materials are required for testing: A 2\3/8\-inch 
by 15-inch (clear) plastic cylinder with a hook on one end and a mark 
scored 1\1/2\ inches 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); elastic strapping with velcro or other fastening 
material; automatic water-dispensing apparatus or manual device capable 
of delivering 1,000 mL of water; a stand with horizontal rod for hanging 
the hook end of the plastic tube. The 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 11 pounds.
    (2) The following methodology is used: Examine the sample and 
identify code/ lot number, size, and brand as appropriate. Examine 
gloves for defects as follows: carefully remove the glove from the 
wrapper, box, etc., visually examining each glove for defects. Visual 
defects in the top 1\1/2\ inches of a glove will not be counted as a 
defect for the purposes of this rule. Visually defective gloves do not 
require further testing but are to be included in the total number of 
defective gloves counted for the sample. Attach the glove to the plastic 
fill tube by bringing the cuff end to the 1\1/2\-inch mark and fastening 
with elastic strapping to make a watertight seal. 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 shall 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.)
    (3) Immediately after adding the water, examine the glove for water 
leaks. Do not squeeze the glove; use only minimal manipulation to spread 
the fingers to check for leaks. Water drops may be blotted to confirm 
leaking. If the glove does not leak immediately, keep the glove/filling 
tube assembly upright and hang the assembly vertically from the 
horizontal rod, using the wire hook on the open end of the fill tube (do 
not support the filled glove while transferring). Make a second 
observation for leaks 2 minutes after addition of the water to the 
glove. Use only minimal manipulation of the fingers to check for leaks. 
Record the number of defective gloves.
    (c) Sample plans. FDA will collect samples from lots of gloves to 
perform the test for defects described in paragraph (b) of this section 
in accordance with FDA's sampling inspection plans which are based on 
the tables of MIL-STD-105E (the military sampling standard, ``Sampling 
Procedures and Tables for Inspection by Attributes,'' May 10, 1989). 
Based on the acceptable quality levels found in this standard, FDA has 
defined adulteration as follows: 2.5 or higher for surgeons' gloves and 
4.0 or higher for patient examination gloves at a general inspection 
level II. FDA will use single normal sampling for lots of 1,200 gloves 
or less and multiple normal sampling for all larger lots. For 
convenience, the sample plans (sample size and accept/reject numbers) 
are shown in the following tables:

[[Page 9]]



                                 Adulteration Level at 2.5 for Surgeons' Gloves                                 
----------------------------------------------------------------------------------------------------------------
                                                                                              Number defective  
                Lot size                            Sample              Sample     Number  ---------------------
                                                                         size     examined    Accept     Reject 
----------------------------------------------------------------------------------------------------------------
35,001 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
35,000 to 10,001........................  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
10,000 to 3,201.........................  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
3,200 to 1,201..........................  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
1,200 to 501............................  Single sample.............  .........         80          5          6
500 to 281..............................  Single sample.............  .........         50          3          4
280 to 151..............................  Single sample.............  .........         32          2          3
150 to 51...............................  Single sample.............  .........         20          1          2
50 to 0.................................  Single sample.............  .........          5          0          1
----------------------------------------------------------------------------------------------------------------


                            Adulteration Level at 4.0 for Patient Examination Gloves                            
----------------------------------------------------------------------------------------------------------------
                                                                                              Number defective  
                Lot size                            Sample              Sample     Number  ---------------------
                                                                         size     examined    Accept     Reject 
----------------------------------------------------------------------------------------------------------------
10,001 and above........................  First.....................         80         80          2          9
                                          Second....................         80        160          7         14
                                          Third.....................         80        240         13         19
                                          Fourth....................         80        320         19         25
                                          Fifth.....................         80        400         25         29
                                          Sixth.....................         80        480         31         33
                                          Seventh...................         80        560         37         38
10,000 to 3,201.........................  First.....................         50         50          1          7
                                          Second....................         50        100          4         10
                                          Third.....................         50        150          8         13
                                          Fourth....................         50        200         12         17
                                          Fifth.....................         50        250         17         20
                                          Sixth.....................         50        300         21         23
                                          Seventh...................         50        350         25         26
3,200 to 1,201..........................  First.....................         32         32          0          5
                                          Second....................         32         64          3          8
                                          Third.....................         32         96          6         10
                                          Fourth....................         32        128          8         13
                                          Fifth.....................         32        160         11         15
                                          Sixth.....................         32        192         14         17
                                          Seventh...................         32        224         18         19
1,200 to 501............................  Single sample.............  .........         80          7          8
500 to 281..............................  Single sample.............  .........         50          5          6
280 to 151..............................  Single sample.............  .........         32          3          4
150 to 91...............................  Single sample.............  .........         20          2          3
90 to 26................................  Single sample.............  .........         13          1          2
25 to 0.................................  Single sample.............  .........          3          0          1

[[Page 10]]

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

    (d) Lots of gloves which are tested and rejected using the test 
method according to paragraph (b) of this section, are adulterated 
within the meaning of section 501(c) of the Federal Food, Drug, and 
Cosmetic Act, and are subject to regulatory action, such as detention of 
imported products and seizure of domestic products.
[55 FR 51256, Dec. 12, 1990]



           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 District Director in whose district the devices 
are located determines that a greater period is required to seize the 
devices, to institute injuction proceedings, or to evaluate the need for 
legal action, in which case the District 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 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

[[Page 11]]

regulatory hearing under part 16 of this chapter, with certain 
exceptions described in paragraph (g)(3) of this section; and (xi) the 
location and telephone number of the FDA district office and the name of 
the FDA District Director.
    (e) Approval of detention order. A detention order, before issuance, 
shall be approved by the FDA District Director in whose district 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 District Director in 
whose district 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(y) 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 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 District 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, i.e., regional food and drug 
directors, 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 a regional 
food and drug director (i.e., a director of an FDA regional office 
listed in Sec. 5.115 of this chapter) 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

[[Page 12]]

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)(1) Movement of detained devices. Except as provided in this 
paragraph, 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 this purpose, the individual responsible 
for their movement shall orally notify the FDA representative who issued 
the detention order, or another responsible district 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 
district 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 district office official, may 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 district 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 
district 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

[[Page 13]]

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 
is 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]



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.
801.4  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.

                          Subpart B  [Reserved]

      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.
801.126  Exemptions for cigarettes and smokeless tobacco.
801.127  Medical devices; expiration of exemptions.

                       Subpart E--Other Exemptions

801.150  Medical devices; processing, labeling, or repacking.

[[Page 14]]

                        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.
801.420  Hearing aid devices; professional and patient labeling.
801.421  Hearing aid devices; conditions for sale.
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, 351, 352, 357, 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 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. 801.4  Meaning of ``intended uses.''

    The words intended uses or words of similar import in Secs. 801.5, 
801.119, and 801.122 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 by the circumstances that 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 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 devices, such packer, distributor, or seller is required to supply 
adequate labeling in accordance with the new intended uses. But if a 
manufacturer knows, or has knowledge of facts that would give him notice 
that a device introduced into interstate commerce by him is to be used 
for conditions, purposes, or uses

[[Page 15]]

other than the ones for which he offers it, he is required to provide 
adequate labeling for such a device which accords with such other uses 
to which the article is to be put.



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.

    (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
    (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,

[[Page 16]]

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) All words, statements, and other information required by or 
under authority of the act to appear on the label or labeling shall 
appear thereon in the English language: Provided, however, That in the 
case of articles distributed solely in the Commonwealth of Puerto Rico 
or in a Territory where the predominant language is one other than 
English, the predominant language may be substituted for English.
    (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.



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).



                          Subpart B  [Reserved]



      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

[[Page 17]]

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.
    (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

[[Page 18]]

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 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

[[Page 19]]

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.''
    (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

[[Page 20]]

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 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 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 he 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

[[Page 21]]

which it is advertised or represented: 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.



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 section and section 502(f)(1) of the act if it meets the 
requirements of Sec. 809.10 of this chapter.



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. 801.126  Exemptions for cigarettes and smokeless tobacco.

    Cigarettes and smokeless tobacco as defined in part 897 of this 
chapter are exempt from section 502(f)(1) of the Federal Food, Drug, and 
Cosmetic Act.
[61 FR 44615, Aug. 28, 1996]

[[Page 22]]



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 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 Secs. 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.



                       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

[[Page 23]]

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 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

[[Page 24]]

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.''
    (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

[[Page 25]]

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 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 
40plus-minus5, as determined by ASTM Method D 1415-68 ``Test 
for International Hardness of Vulcanized Rubber,'' a minimum tensile 
strength of 1,200 pounds, as determined by ASTM Method D 412-68 
``Tension Test of Vulcanized Rubber,'' 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, 1916 Race St., Philadelphia, PA 19103, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408). The 
diameter or contour of the lens support may be

[[Page 26]]

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 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]



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.

[[Page 27]]

    (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 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. 801.420  Hearing aid devices; professional and patient labeling.

    (a) Definitions for the purposes of this section and Sec. 801.421. 
(1) Hearing aid means any wearable instrument or device designed for, 
offered for the purpose of, or represented as aiding persons with or 
compensating for, impaired hearing.
    (2) Ear specialist means any licensed physician who specializes in 
diseases of the ear and is medically trained to identify the symptoms of 
deafness in the context of the total health of the patient, and is 
qualified by special training to diagnose and treat hearing loss. Such 
physicians are also known as otolaryngologists, otologists, and 
otorhinolaryngologists.
    (3) Dispenser means any person, partnership, corporation, or 
association engaged in the sale, lease, or rental of hearing aids to any 
member of the consuming public or any employee, agent, sales person, 
and/or representative of such a person, partnership, corporation, or 
association.
    (4) Audiologist means any person qualified by training and 
experience to specialize in the evaluation and rehabilitation of 
individuals whose communication disorders center in whole or in part in 
the hearing function. In some states audiologists must satisfy specific 
requirements for licensure.
    (5) Sale or purchase includes any lease or rental of a hearing aid 
to a member of the consuming public who is a user or prospective user of 
a hearing aid.
    (6) Used hearing aid means any hearing aid that has been worn for 
any period of time by a user. However, a hearing aid shall not be 
considered ``used'' merely because it has been worn by a prospective 
user as a part of a bona fide hearing aid evaluation conducted to 
determine whether to select that particular hearing aid for that 
prospective user, if such evaluation has been conducted in the presence 
of the dispenser or a hearing aid health professional selected by the 
dispenser to assist the buyer in making such a determination.
    (b) Label requirements for hearing aids. Hearing aids shall be 
clearly and permanently marked with:
    (1) The name of the manufacturer or distributor, the model name or 
number, the serial number, and the year of manufacture.
    (2) A ``+'' symbol to indicate the positive connection for battery 
insertion, unless it is physically impossible to insert the battery in 
the reversed position.
    (c) Labeling requirements for hearing aids--(1) General. All 
labeling information required by this paragraph shall be included in a 
User Instructional Brochure that shall be developed by the manufacturer 
or distributor, shall accompany the hearing aid, and shall

[[Page 28]]

be provided to the prospective user by the dispenser of the hearing aid 
in accordance with Sec. 801.421(c). The User Instructional Brochure 
accompanying each hearing aid shall contain the following information 
and instructions for use, to the extent applicable to the particular 
requirements and characteristics of the hearing aid:
    (i) An illustration(s) of the hearing aid, indicating operating 
controls, user adjustments, and battery compartment.
    (ii) Information on the function of all controls intended for user 
adjustment.
    (iii) A description of any accessory that may accompany the hearing 
aid, e.g., accessories for use with a television or telephone.
    (iv) Specific instructions for:
    (a) Use of the hearing aid.
    (b) Maintenance and care of the hearing aid, including the procedure 
to follow in washing the earmold, when replacing tubing on those hearing 
aids that use tubing, and in storing the hearing aid when it will not be 
used for an extended period of time.
    (c) Replacing or recharging the batteries, including a generic 
designation of replacement batteries.
    (v) Information on how and where to obtain repair service, including 
at least one specific address where the user can go, or send the hearing 
aid to, to obtain such repair service.
    (vi) A description of commonly occurring avoidable conditions that 
could adversely affect or damage the hearing aid, such as dropping, 
immersing, or exposing the hearing aid to excessive heat.
    (vii) Identification of any known side effects associated with the 
use of a hearing aid that may warrant consultation with a physician, 
e.g., skin irritation and accelerated accumulation of cerumen (ear wax).
    (viii) A statement that a hearing aid will not restore normal 
hearing and will not prevent or improve a hearing impairment resulting 
from organic conditions.
    (ix) A statement that in most cases infrequent use of a hearing aid 
does not permit a user to attain full benefit from it.
    (x) A statement that the use of a hearing aid is only part of 
hearing habilitation and may need to be supplemented by auditory 
training and instruction in lipreading.
    (xi) The warning statement required by paragraph (c)(2) of this 
section.
    (xii) The notice for prospective hearing aid users required by 
paragraph (c)(3) of this section.
    (xiii) The technical data required by paragraph (c)(4) of this 
section, unless such data is provided in separate labeling accompanying 
the device.
    (2) Warning statement. The User Instructional Brochure shall contain 
the following warning statement:

                    Warning to Hearing Aid Dispensers

    A hearing aid dispenser should advise a prospective hearing aid user 
to consult promptly with a licensed physician (preferably an ear 
specialist) before dispensing a hearing aid if the hearing aid dispenser 
determines through inquiry, actual observation, or review of any other 
available information concerning the prospective user, that the 
prospective user has any of the following conditions:
    (i) Visible congenital or traumatic deformity of the ear.
    (ii) History of active drainage from the ear within the previous 90 
days.
    (iii) History of sudden or rapidly progressive hearing loss within 
the previous 90 days.
    (iv) Acute or chronic dizziness.
    (v) Unilateral hearing loss of sudden or recent onset within the 
previous 90 days.
    (vi) Audiometric air-bone gap equal to or greater than 15 decibels 
at 500 hertz (Hz), 1,000 Hz, and 2,000 Hz.
    (vii) Visible evidence of significant cerumen accumulation or a 
foreign body in the ear canal.
    (viii) Pain or discomfort in the ear.
    Special care should be exercised in selecting and fitting a hearing 
aid whose maximum sound pressure level exceeds 132 decibels because 
there may be risk of impairing the remaining hearing of the hearing aid 
user. (This provision is required only for those hearing aids with a 
maximum sound pressure capability greater than 132 decibels (dB).)

    (3) Notice for prospective hearing aid users. The User Instructional 
Brochure shall contain the following notice:

           Important Notice for Prospective Hearing Aid Users

    Good health practice requires that a person with a hearing loss have 
a medical evaluation by a licensed physician (preferably a physician who 
specializes in diseases of the ear) before purchasing a hearing aid. 
Licensed physicians who specialize in diseases

[[Page 29]]

of the ear are often referred to as otolaryngologists, otologists or 
otorhinolaryngologists. The purpose of medical evaluation is to assure 
that all medically treatable conditions that may affect hearing are 
identified and treated before the hearing aid is purchased.
    Following the medical evaluation, the physician will give you a 
written statement that states that your hearing loss has been medically 
evaluated and that you may be considered a candidate for a hearing aid. 
The physician will refer you to an audiologist or a hearing aid 
dispenser, as appropriate, for a hearing aid evaluation.
    The audiologist or hearing aid dispenser will conduct a hearing aid 
evaluation to assess your ability to hear with and without a hearing 
aid. The hearing aid evaluation will enable the audiologist or dispenser 
to select and fit a hearing aid to your individual needs.
    If you have reservations about your ability to adapt to 
amplification, you should inquire about the availability of a trial-
rental or purchase-option program. Many hearing aid dispensers now offer 
programs that permit you to wear a hearing aid for a period of time for 
a nominal fee after which you may decide if you want to purchase the 
hearing aid.
    Federal law restricts the sale of hearing aids to those individuals 
who have obtained a medical evaluation from a licensed physician. 
Federal law permits a fully informed adult to sign a waiver statement 
declining the medical evaluation for religious or personal beliefs that 
preclude consultation with a physician. The exercise of such a waiver is 
not in your best health interest and its use is strongly discouraged.

                       children with hearing loss

    In addition to seeing a physician for a medical evaluation, a child 
with a hearing loss should be directed to an audiologist for evaluation 
and rehabilitation since hearing loss may cause problems in language 
development and the educational and social growth of a child. An 
audiologist is qualified by training and experience to assist in the 
evaluation and rehabilitation of a child with a hearing loss.

    (4) Technical data. Technical data useful in selecting, fitting, and 
checking the performance of a hearing aid shall be provided in the User 
Instructional Brochure or in separate labeling that accompanies the 
device. The determination of technical data values for the hearing aid 
labeling shall be conducted in accordance with the test procedures of 
the American National Standard ``Specification of Hearing Aid 
Characteristics,'' ANSI S3.22-1987 (ASA 70-1987) (Revision of S3.22-
1982), which is incorporated by reference in accordance with 5 U.S.C. 
552(a). Copies are available from the American National Standards 
Institute, 1430 Broadway, New York, NY 10018, or are available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408. As a minimum, the User 
Instructional Brochure or such other labeling shall include the 
appropriate values or information for the following technical data 
elements as these elements are defined or used in such standard:
    (i) Saturation output curve (SSPL 90 curve).
    (ii) Frequency response curve.
    (iii) Average saturation output (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) Battery current drain.
    (x) Induction coil sensitivity (telephone coil aids only).
    (xi) Input-output curve (ACG aids only).
    (xii) Attack and release times (ACG aids only).
    (5) Statement if hearing aid is used or rebuilt. If a hearing aid 
has been used or rebuilt, this fact shall be declared on the container 
in which the hearing aid is packaged and on a tag that is physically 
attached to such hearing aid. Such fact may also be stated in the User 
Instructional Brochure.
    (6) Statements in User Instructional Brochure other than those 
required. A User Instructional Brochure may contain statements or 
illustrations in addition to those required by paragraph (c) of this 
section if the additional statements:
    (i) Are not false or misleading in any particular, e.g., diminishing 
the impact of the required statements; and
    (ii) Are not prohibited by this chapter or by regulations of the 
Federal Trade Commission.
    (d) Submission of all labeling for each type of hearing aid. Any 
manufacturer of a hearing aid described in paragraph (a) of this section 
shall submit to the Food and Drug Administration, Bureau

[[Page 30]]

of Medical Devices and Diagnostic Products, Division of Compliance, HFK-
116, 8757 Georgia Ave., Silver Spring, MD 20910, a copy of the User 
Instructional Brochure described in paragraph (c) of this section and 
all other labeling for each type of hearing aid on or before August 15, 
1977.
[42 FR 9294, Feb. 15, 1977, as amended at 47 FR 9398, Mar. 5, 1982; 50 
FR 30154, July 24, 1985; 54 FR 52396, Dec. 21, 1989]



Sec. 801.421  Hearing aid devices; conditions for sale.

    (a) Medical evaluation requirements--(1) General. Except as provided 
in paragraph (a)(2) of this section, a hearing aid dispenser shall not 
sell a hearing aid unless the prospective user has presented to the 
hearing aid dispenser a written statement signed by a licensed physician 
that states that the patient's hearing loss has been medically evaluated 
and the patient may be considered a candidate for a hearing aid. The 
medical evaluation must have taken place within the preceding 6 months.
    (2) Waiver to the medical evaluation requirements. If the 
prospective hearing aid user is 18 years of age or older, the hearing 
aid dispenser may afford the prospective user an opportunity to waive 
the medical evaluation requirement of paragraph (a)(1) of this section 
provided that the hearing aid dispenser:
    (i) Informs the prospective user that the exercise of the waiver is 
not in the user's best health interest;
    (ii) Does not in any way actively encourage the prospective user to 
waive such a medical evaluation; and
    (iii) Affords the prospective user the opportunity to sign the 
following statement:

    I have been advised by ________ ________ (Hearing aid dispenser's 
name) that the Food and Drug Administration has determined that my best 
health interest would be served if I had a medical evaluation by a 
licensed physician (preferably a physician who specializes in diseases 
of the ear) before purchasing a hearing aid. I do not wish a medical 
evaluation before purchasing a hearing aid.

    (b) Opportunity to review User Instructional Brochure. Before 
signing any statement under paragraph (a)(2)(iii) of this section and 
before the sale of a hearing aid to a prospective user, the hearing aid 
dispenser shall:
    (1) Provide the prospective user a copy of the User Instructional 
Brochure for a hearing aid that has been, or may be selected for the 
prospective user;
    (2) Review the content of the User Instructional Brochure with the 
prospective user orally, or in the predominate method of communication 
used during the sale;
    (3) Afford the prospective user an opportunity to read the User 
Instructional Brochure.
    (c) Availability of User Instructional Brochure. (1) Upon request by 
an individual who is considering purchase of a hearing aid, a dispenser 
shall, with respect to any hearing aid that he dispenses, provide a copy 
of the User Instructional Brochure for the hearing aid or the name and 
address of the manufacturer or distributor from whom a User 
Instructional Brochure for the hearing aid may be obtained.
    (2) In addition to assuring that a User Instructional Brochure 
accompanies each hearing aid, a manufacturer or distributor shall with 
respect to any hearing aid that he manufactures or distributes:
    (i) Provide sufficient copies of the User Instructional Brochure to 
sellers for distribution to users and prospective users;
    (ii) Provide a copy of the User Instructional Brochure to any 
hearing aid professional, user, or prospective user who requests a copy 
in writing.
    (d) Recordkeeping. The dispenser shall retain for 3 years after the 
dispensing of a hearing aid a copy of any written statement from a 
physician required under paragraph (a)(1) of this section or any written 
statement waiving medical evaluation required under paragraph 
(a)(2)(iii) of this section.
    (e) Exemption for group auditory trainers. Group auditory trainers, 
defined as a group amplification system purchased by a qualified school 
or institution for the purpose of communicating with and educating 
individuals with hearing impairments, are exempt from the requirements 
of this section.
[42 FR 9296, Feb. 15, 1977]

[[Page 31]]



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;
    (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;

------------------------------------------------------------------------
                                                Corresponding term of   
     Ranges of absorbency in grams \1\               absorbency         
------------------------------------------------------------------------
6 and under...............................  Junior absorbency.          
6 to 9....................................  Regular absorbency.         
9 to 12...................................  Super absorbency.           
12 to 15..................................  Super plus absorbency.      
15 to 18..................................  None.                       
above 18..................................  None.                       
------------------------------------------------------------------------
\1\ These ranges are defined, respectively, as follows: less than or    
  equal to 6 grams; greater than 6 grams up to and including 9 grams;   
  greater than 9 grams up to and including 12 grams; greater than 12    
  grams up to and including 15 grams; greater than 15 grams up to and   
  including 18 grams; and greater than 18 grams.                        

    (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.

[[Page 32]]

    (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 3492-83, ``Standard Specification for Rubber Contraceptives 
(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 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\ Copies of the standard are available from the American Society 
for Testing and Materials, 1916 Race St., Philadelphia, PA 19103, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street NW., suite 700, Washington, DC.

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

[[Page 33]]

[GRAPHIC] [TIFF OMITTED] TR01FE93.026


[[Page 34]]


[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 35]]

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]



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


[[Page 36]]


    (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.
    (g) If a manufacturer uses testing data from one product to support 
expiration dating on any variation of that

[[Page 37]]

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.''

This statement shall appear on all device labels, and other labeling, 
and shall appear on the principal display

[[Page 38]]

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)).
[62 FR 51029, Sept. 30, 1997]

    Effective Date Note: At 62 FR 51029, Sept. 30, 1997, Sec. 801.437 
was added to subpart H, effective Sept. 30, 1998.



PART 803--MEDICAL DEVICE REPORTING--Table of Contents




                      Subpart A--General Provisions

Sec.
803.1  Scope.
803.3  Definitions.
803.9  Public availability of reports.
803.10  General description of reports required from user facilities and 
          manufacturers.
803.11  Obtaining the forms.
803.12  Where to submit reports.
803.13  English reporting requirement.
803.14  Electronic reporting.
803.15  Requests for additional information.
803.16  Disclaimers.
803.17  Written MDR procedures.
803.18  Files.
803.19  Exemptions, variances, and alternative reporting requirements.

  Subpart B--Generally Applicable Requirements for Individual Adverse 
                              Event Reports

803.20  How to report.
803.21  Reporting codes.
803.22  When not to file.

             Subpart C--User Facility Reporting Requirements

803.30  Individual adverse event reports; user facilities.
803.32  Individual adverse event report data elements.
803.33  Semiannual reports.

                          Subpart D  [Reserved]

             Subpart E--Manufacturer Reporting Requirements

803.50  Individual adverse event reports; manufacturers.
803.52  Individual adverse event report data elements.
803.53  Five-day reports.
803.55  Baseline reports.
803.56  Supplemental reports.
803.57  Annual certification.
803.58  Foreign manufacturers.

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

    Source:  60 FR 63597, Dec. 11, 1995, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 803.1  Scope.

    (a) This part establishes requirements for medical device reporting.

[[Page 39]]

Under this part, medical device user facilities and manufacturers must 
report deaths and serious injuries to which a device has or may have 
caused or contributed, and manufacturers must also report certain device 
malfunctions. Additionally, user facilities and manufacturers must 
establish and maintain adverse event files, and must submit to FDA 
specified followup and summary reports. These reports will assist FDA in 
protecting the public health by helping to ensure that devices are not 
adulterated or misbranded and are safe and effective for their intended 
use.
    (b) This part supplements and does not supersede other provisions of 
this subchapter, 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.
[60 FR 63597, Dec. 11, 1995, as amended at 62 FR 13306, Mar. 20, 1997]



Sec. 803.3  Definitions.

    (a) Act means the Federal Food, Drug, and Cosmetic Act.
    (b) 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.
    (c) Become aware means that an employee of the entity required to 
report has acquired information reasonably suggesting a reportable 
adverse event has occurred. Device user facilities are considered to 
have ``become aware'' when medical personnel, as defined in paragraph 
(r) of this section, who are employed by or otherwise formally 
affiliated with the facility, acquire such information about a 
reportable event. Manufacturers are considered to have ``become aware'' 
of an event when:
    (1) Any employee becomes aware of a reportable event that is 
required to be reported within 30 days, or that is required to be 
reported within 5 days pursuant to a written request from FDA under 
803.53(b); and
    (2) Any employee, who is a person with management or supervisory 
responsibilities over persons with regulatory, scientific, or technical 
responsibilities, or a person whose duties relate to the collection and 
reporting of adverse events, becomes aware that a reportable MDR event 
or events, from any information, including any trend analysis, 
necessitate remedial action to prevent an unreasonable risk of 
substantial harm to the public health.
    (d) 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.
    (e)(1) Device family means a group of one or more devices 
manufactured by or for the same manufacturer and having the same:
    (i) Basic design and performance characteristics related to device 
safety and effectiveness,
    (ii) Intended use and function, and
    (iii) Device classification and product code.
    (2) Devices that differ only in minor ways not related to safety or 
effectiveness can be considered to be in the same device family. Factors 
such as brand name and common name of the device and whether the devices 
were introduced into commercial distribution under the same 510(k) or 
premarket approval application (PMA), may be considered in grouping 
products into device families.
    (f) Device user facility means a hospital, ambulatory surgical 
facility, nursing home, outpatient diagnostic

[[Page 40]]

facility, or outpatient treatment facility as defined in paragraphs (l), 
(b), (s), (t), and (u), respectively, of this section, which is not a 
``physician's office,'' as defined in paragraph (w) of this section. 
School nurse offices and employee health units are not device user 
facilities.
    (g)-(h) [Reserved]
    (i) Expected life of a device (required on the manufacturer's 
baseline report) 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 
maintenance, repair, upgrades, etc., for an estimated period of time.
    (j) FDA means the Food and Drug Administration.
    (k) Five-day report means a medical device report that must be 
submitted by a manufacturer to FDA pursuant to Sec. 803.53, on FDA Form 
3500A or electronic equivalent as approved under Sec. 803.14, within 5 
work days.
    (l) Hospital means a distinct entity that operates for the primary 
purpose of providing diagnostic, therapeutic (medical, occupational, 
speech, physical, etc.), 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.
    (m) 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 marketed, as defined in Sec. 801.4 of 
this chapter.
    (n) 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:
    (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 which 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.
    (o) Manufacturer report number means the number that uniquely 
identifies each individual adverse event report submitted by a 
manufacturer. This number consists of three parts as follows:
    (1) The FDA registration number for the manufacturing site of the 
reported device. (If the manufacturing site does not have a registration 
number, FDA will assign a temporary number until the site is officially 
registered. The manufacturer will be informed of the temporary 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 1234567-1995-00001.)
    (p) MDR means medical device report.
    (q) MDR reportable event (or reportable event) means:
    (1) An event about which user facilities become aware of information 
that reasonably suggests that a device has

[[Page 41]]

or may have caused or contributed to a death or serious injury; or
    (2) An event about which manufacturers have received or become aware 
of information 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 would be likely to cause or contribute to a 
death or serious injury if the malfunction were to recur.
    (r) Medical personnel, as used in this part, 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 such persons.
    (s)(1) Nursing home means 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.
    (t)(1) Outpatient diagnostic facility means a distinct entity that:
    (i) Operates for the primary purpose of conducting medical 
diagnostic tests on patients;
    (ii) Does not assume ongoing responsibility for patient care; and
    (iii) Provides its services for use by other medical personnel. 
(Examples include diagnostic radiography, mammography, ultrasonography, 
electrocardiography, magnetic resonance imaging, computerized axial 
tomography and in-vitro testing).
    (2) 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.
    (u)(1) 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 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: Cardiac 
defibrillation, chemotherapy, radiotherapy, pain control, dialysis, 
speech or physical therapy, and treatment for substance abuse.
    (2) 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

[[Page 42]]

event regardless of the nature or location of the medical service 
provided by the outpatient treatment facility.
    (v) 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. For the purposes of this part, the 
definition encompasses 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.
    (w) Physician's office means a facility that operates as the office 
of a physician or other health care professional (e.g., dentist, 
chiropractor, optometrist, nurse practitioner, school nurse offices, 
school clinics, employee health clinics, or free-standing care units) 
for the primary purpose of examination, evaluation, and treatment or 
referral of patients. A physician's office may be independent, a group 
practice, or part of a Health Maintenance Organization.
    (x) [Reserved]
    (y) Remedial action means, for the purposes of this subpart, any 
action other than routine maintenance or servicing, of a device where 
such action is necessary to prevent recurrence of a reportable event.
    (z) [Reserved]
    (aa)(1) Serious injury means an injury or illness that:
    (i) Is life-threatening;
    (ii) Results in permanent impairment of a body function or permanent 
damage to body structure; or
    (iii) Necessitates medical or surgical intervention to preclude 
permanent impairment of a body function or permanent damage to a body 
structure.
    (2) Permanent means, for purposes of this subpart, irreversible 
impairment or damage to a body structure or function, excluding trivial 
impairment or damage.
    (bb) Shelf life, as required on the manufacturer's baseline report, 
means the maximum time a device will remain functional from the date of 
manufacture until it is used in patient care. Some devices have an 
expiration date on their labeling indicating the maximum time they can 
be stored before losing their ability to perform their intended 
function.
    (cc) [Reserved]
    (dd)(1) User facility report number means the number that uniquely 
identifies each report submitted by a user facility to manufacturers and 
FDA. This number consists of three parts as follows:
    (i) The user facility's 10-digit Health Care Financing 
Administration (HCFA) number (if the HCFA number has fewer than 10 
digits, fill the remaining spaces with zeros);
    (ii) The four-digit calendar year in which the report is submitted; 
and
    (iii) The four-digit sequence number of the reports submitted for 
the year, starting with 0001. (For example, a complete number will 
appear as follows: 1234560000-1995-0001.)
    (2) If a facility has more than one HCFA number, it must select one 
that will be used for all of its MDR reports. If a facility has no HCFA 
number, it should use all zeros in the appropriate space in its initial 
report (e.g., 0000000000-1995-0001) and FDA will assign a number for 
future use. The number assigned will be used in FDA's record of that 
report and in any correspondence with the user facility. All zeros 
should be used subsequent to the first report if the user does not 
receive FDA's assigned number before the next report is submitted. If a 
facility has multiple sites, the primary site can report centrally and 
use one reporting number for all sites if the primary site provides the 
name, address and HCFA number for each respective site.
    (ee) Work day means Monday through Friday, excluding Federal 
holidays.

    Effective Date Note:  At 61 FR 38347, July 23, 1996, in Sec. 803.3, 
paragraph (n)(4) was stayed indefinitely.



Sec. 803.9  Public availability of reports.

    (a) Any report, including any FDA record of a telephone 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;

[[Page 43]]

    (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. FDA will disclose 
to a patient who requests a report, 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 
voluntarily submitting an adverse event report.
    (c) FDA may not disclose the identity of a device user facility 
which makes a report under this part except in connection with:
    (1) An action brought to enforce section 301(q) of the act, 
including the failure or refusal to furnish material or information 
required by section 519 of the act;
    (2) A communication to a manufacturer of a device which is the 
subject of a report required by a user facility under Sec. 803.30;
    (3) A disclosure relating to a manufacturer or distributor adverse 
event report that is required under section 519(a) of the act; or
    (4) 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.



Sec. 803.10  General description of reports required from user facilities and manufacturers.

    (a) Device user facilities. User facilities must submit the 
following reports, which are described more fully in subpart C of this 
part.
    (1) User facilities must submit MDR reports of individual adverse 
events within 10 days after the user facility becomes aware of an MDR 
reportable event as described in Secs. 803.30 and 803.32.
    (i) User facilities must submit reports of device-related deaths to 
FDA and to the manufacturer, if known.
    (ii) User facilities must submit reports of device-related serious 
injuries to manufacturers, or to FDA, if the manufacturer is unknown.
    (2) User facilities must submit semiannual reports as described in 
Sec. 803.33.
    (b) [Reserved]
    (c) Device manufacturers. Manufacturers must submit the following 
reports as described more fully in subpart E of this part:
    (1) MDR reports of individual adverse events within 30 days after 
the manufacturer becomes aware of a reportable death, serious injury, or 
malfunction as described in Secs. 803.50 and 803.52.
    (2) MDR reports of individual adverse events within 5 days of:
    (i) Becoming aware that a reportable MDR event requires remedial 
action to prevent an unreasonable risk of substantial harm to the public 
health or,
    (ii) Becoming aware of an MDR reportable event for which FDA has 
made a written request, as described in Sec. 803.53.
    (3) Annual baseline reports as described in Sec. 803.55.
    (4) Supplemental reports if they obtain information that was not 
provided in an initial report as described in Sec. 803.56.
    (5) Annual certification to FDA of the number of MDR reports filed 
during the preceding year as described in Sec. 803.57.



Sec. 803.11  Obtaining the forms.

    User facilities and manufacturers must submit all reports of 
individual adverse events on FDA Form 3500A (MEDWATCH form) or in an 
electronic equivalent as approved under Sec. 803.14. This form and all 
other forms referenced in this section can also be obtained from the 
Consolidated Forms and Publications Office, Washington Commerce Center, 
3222 Hubbard Rd., Landover, MD 20785, or from the Division of Small 
Manufacturers Assistance, Office of Health and Industry Programs, Center 
for Devices and Radiological Health, 1350 Piccard Dr. (HFZ-220), 
Rockville, MD 20850, telephone facsimile (FAX) 301-443-8818. FDA Form 
3500A may also be obtained from the Food and Drug Administration, 
MEDWATCH (HF-2), 5600 Fishers Lane, rm. 9-57, Rockville, MD 20850, 301-
443-0117.



Sec. 803.12  Where to submit reports.

    (a) Any written report or additional information required under this 
part shall be submitted to: Food and Drug Administration, Center for 
Devices and

[[Page 44]]

Radiological Health, Medical Device Reporting, PO Box 3002, Rockville, 
MD 20847-3002.
    (b) Each report and its envelope shall be specifically identified, 
e.g., ``User Facility Report,'' ``SemiAnnual Report,'' ``Manufacturer 
Report,'' ``5-Day Report,'' ``Baseline Report,'' etc.
    (c) If an entity is confronted with a public health emergency, this 
can be brought to FDA's attention by contacting the FDA Emergency 
Operations Branch (HFC-162), Office of Regional Operations, at 301-443-
1240, and should be followed by the submission of a FAX report to 301-
443-3757.
    (d) A voluntary telephone report may be submitted to, or information 
regarding voluntary reporting may be obtained from, the MEDWATCH hotline 
at 800-FDA-1088.



Sec. 803.13  English reporting requirement.

    (a) All reports required in this part which are submitted in writing 
or electronic equivalent shall be submitted to FDA in English.
    (b) All reports required in this part which are submitted on an 
electronic medium shall be submitted to FDA in a manner consistent with 
Sec. 803.14.



Sec. 803.14  Electronic reporting.

    (a) Any report required by this part may be submitted electronically 
with prior written consent from FDA. Such consent is revocable. 
Electronic report submissions include alternative reporting media 
(magnetic tape, disc, etc.) and computer-to-computer communication.
    (b) Any electronic report meeting electronic reporting standards, 
guidelines, or other procedures developed by the agency for MDR 
reporting will be deemed to have prior approval for use.



Sec. 803.15  Requests for additional information.

    (a) FDA may determine that protection of the public health requires 
additional or clarifying information for medical device reports 
submitted to FDA under this part. In these instances, and in cases when 
the additional information is beyond the scope of FDA reporting forms or 
is not readily accessible, the agency will notify the reporting entity 
in writing of the additional information that is required.
    (b) Any request under this section shall state the reason or purpose 
for which the information is being requested, specify the date that the 
information is to be submitted and clearly relate the request to a 
reported event. All verbal requests will be confirmed in writing by the 
agency.



Sec. 803.16  Disclaimers.

    A report or other information submitted by a reporting entity under 
this part, and any release by FDA of that report or information, does 
not necessarily reflect a conclusion by the party submitting the report 
or by FDA that the report or information constitutes an admission that 
the device, or the reporting entity or its employees, caused or 
contributed to the reportable event. The reporting entity need not admit 
and may deny that the report or information submitted under this part 
constitutes an admission that the device, the party submitting the 
report, or employees thereof, caused or contributed to a reportable 
event.



Sec. 803.17  Written MDR procedures.

    User facilities and manufacturers shall 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 medical device reporting 
requirements;
    (2) A standardized review process/procedure for determining when an 
event meets the criteria for reporting under this part; and
    (3) Timely transmission of complete medical device reports to FDA 
and/or manufacturers;
    (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 FDA and 
manufacturers;
    (3) Any information that was evaluated for the purpose of preparing 
the submission of semiannual reports or certification; and

[[Page 45]]

    (4) Systems that ensure access to information that facilitates 
timely followup and inspection by FDA.



Sec. 803.18  Files.

    (a) User facilities and manufacturers shall establish and maintain 
MDR event files. All MDR event files shall be prominently identified as 
such and filed to facilitate timely access.
    (b)(1) For purposes of this part, ``MDR event files'' are written or 
electronic files maintained by user facilities and manufacturers. MDR 
event files may incorporate references to other information, e.g., 
medical records, patient files, engineering reports, etc., in lieu of 
copying and maintaining duplicates in this file. MDR event files must 
contain:
    (i) Information in the possession of the reporting entity or 
references to information related to the adverse event, including all 
documentation of the entity's deliberations and decisionmaking 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 MDR forms, as required by this part, and other 
information related to the event that was submitted to FDA and other 
entities (e.g., a distributor or manufacturer).
    (2) User facilities and manufacturers shall permit any authorized 
FDA employee during all reasonable times to access, to copy, and to 
verify the records required by this part.
    (c) User facilities shall retain an MDR event file relating to an 
adverse event for a period of 2 years from the date of the event. 
Manufacturers shall 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. MDR event files must be maintained for the time periods 
described in this paragraph even if the device is no longer distributed.
    (d) [Reserved]
    (e) The manufacturer may maintain MDR event files as part of its 
complaint file, under Sec. 820.198 of this chapter, provided that such 
records are prominently identified as MDR reportable events. A report 
submitted under this subpart A shall not be considered to comply with 
this part unless the event has been evaluated in accordance with the 
requirements of Secs. 820.162 and 820.198 of this chapter. MDR files 
shall contain an explanation of why any information required by this 
part was not submitted or could not be obtained. The results of the 
evaluation of each event are to be documented and maintained in the 
manufacturer's MDR event file.



Sec. 803.19  Exemptions, variances, and alternative reporting requirements.

    (a) The following persons are exempt from the reporting requirements 
under this part.
    (1) An individual who is a licensed practitioner who prescribes or 
administers devices intended for use in humans and who 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 such person's use in research or teaching and not for 
sale, including any person who is subject to alternative reporting 
requirements under the investigational device exemption regulations, 
parts 812 and 813 of this chapter, which require reporting of all 
adverse device effects.
    (3) Dental laboratories, or optical laboratories.
    (b) Manufacturers or user facilities may request exemptions or 
variances from any or all of the reporting requirements in this part. 
The request shall be in writing and include information necessary to 
identify the firm and device, a complete statement of the request for 
exemption, variance, or alternative reporting, and an explanation why 
the request is justified.
    (c) FDA may grant in writing, to a manufacturer or user facility, an 
exemption, variance or alternative from, or 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. These modifications may be initiated by a request as 
specified in this section, or at the discretion of FDA. When granting

[[Page 46]]

such modifications, FDA may impose other reporting requirements to 
ensure the protection of public health.
    (d) FDA may revoke or modify in writing an exemption, variance, or 
alternative reporting requirements if FDA determines that protection of 
the public health justifies the modification or a return to the 
requirements as stated in this part.
    (e) Firms granted a reporting modification by FDA shall provide any 
reports or information required by that approval. The conditions of the 
approval will replace and supersede the reporting requirement specified 
in this part until such time that FDA revokes or modifies the 
alternative reporting requirements in accordance with paragraph (d) of 
this section.
    (f) Manufacturers as defined in part 897 of this chapter shall 
submit medical device reports concerning cigarettes and smokeless 
tobacco under this part only for serious adverse events that are not 
well-known or well-documented by the scientific community, including 
events related to contamination, or a change in any ingredient or any 
manufacturing process.
    (g) User facilities are exempt from submitting medical device 
reports concerning cigarettes and smokeless tobacco under this part.
[60 FR 63597, Dec. 11, 1995, as amended at 61 FR 44615, Aug. 28, 1996]



  Subpart B--Generally Applicable Requirements for Individual Adverse 
                              Event Reports



Sec. 803.20  How to report.

    (a) Description of form. There are two versions of the MEDWATCH form 
for individual reports of adverse events. FDA Form 3500 is available for 
use by health professionals and consumers for the submission of 
voluntary reports regarding FDA-regulated products. FDA Form 3500A is 
the mandatory reporting form to be used for submitting reports by user 
facilities and manufacturers of FDA-regulated products. The form has 
sections that must be completed by all reporters and other sections that 
must be completed only by the user facility or manufacturer.
    (1) The front of FDA Form 3500A is to be filled out by all 
reporters. The front of the form requests information regarding the 
patient, the event, the device and ``initial reporter'' (i.e., the first 
person or entity that submitted the information to the user facility, 
manufacturer, or distributor).
    (2) The back part of the form contains sections to be completed by 
user facilities and manufacturers. User facilities must complete section 
F; device manufacturers must complete sections G and H. Manufacturers 
are not required to recopy information submitted to them on a Form 3500A 
unless the information is being copied onto an electronic medium. If the 
manufacturer corrects or supplies information missing from the other 
reporter's 3500A form, it should attach a copy of that form to the 
manufacturer's report form. If the information from the other reporter's 
3500A form is complete and correct, the manufacturer can fill in the 
remaining information on the same form.
    (b) Reporting standards. (1) User facilities are required to submit 
MDR reports to:
    (i) The device manufacturer and to FDA within 10 days of becoming 
aware of information that reasonably suggests that a device has or may 
have caused or contributed to a death; or
    (ii) The manufacturer within 10 days of becoming aware of 
information that reasonably suggests that a device has or may have 
caused or contributed to a serious injury. Such reports shall be 
submitted to FDA if the device manufacturer is not known.
    (2) [Reserved]
    (3) Manufacturers are required to submit MDR reports to FDA:
    (i) Within 30 days of becoming aware of information that reasonably 
suggests that a device may have caused or contributed to a death or 
serious injury; or
    (ii) Within 30 days of becoming aware of information that reasonably 
suggests a device has malfunctioned and that device or a similar device 
marketed by the manufacturer would be likely to cause a death or serious 
injury if the malfunction were to recur; or

[[Page 47]]

    (iii) Within 5 days if required by Sec. 803.53.
    (c) Information that reasonably suggests a reportable event 
occurred. (1) Information that reasonably suggests that a device has or 
may have caused or contributed to an MDR reportable event (i.e., death, 
serious injury, and, for manufacturers, a malfunction that would be 
likely to cause or contribute to a death or serious injury if the 
malfunction were to recur) includes any information, such as 
professional, scientific or medical facts and observations or opinions, 
that would reasonably suggest that a device has caused or may have 
caused or contributed to a reportable event.
    (2) Entities required to report under this part do not have to 
report adverse events for which there is information that would cause a 
person who is qualified to make a medical judgment (e.g., a physician, 
nurse, risk manager, or biomedical engineer) to reach a reasonable 
conclusion 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. Information 
which leads the qualified person to determine that a device-related 
event is or is not reportable must be contained in the MDR event files, 
as described in Sec. 803.18.



Sec. 803.21  Reporting codes.

    (a) FDA has developed a MEDWATCH Mandatory Reporting Form Coding 
Manual for use with medical device reports. This manual contains codes 
for hundreds of adverse events for use with FDA Form 3500A. The coding 
manual is available from the Division of Small Manufacturer Assistance, 
Center for Devices and Radiological Health, 1350 Piccard Dr., Rockville, 
MD 20850, FAX 301-443-8818.
    (b) FDA may use additional coding of information on the reporting 
forms or modify the existing codes on an ad hoc or generic basis. In 
such cases, FDA will ensure that the new coding information is available 
to all reporters.



Sec. 803.22  When not to file.

    (a) Only one medical device report from the user facility or 
manufacturer is required under this part if the reporting entity becomes 
aware of information from multiple sources regarding the same patient 
and same event.
    (b) A medical device report that would otherwise be required under 
this section is not required if:
    (1) The user facility or manufacturer determines that the 
information received is erroneous in that a device-related adverse event 
did not occur. Documentation of such reports shall be retained in MDR 
files for time periods specified in Sec. 803.18.
    (2) The manufacturer determines that the device was manufactured by 
another manufacturer. Any reportable event information that is 
erroneously sent to a manufacturer shall be forwarded to FDA, with a 
cover letter explaining that the device in question was not manufactured 
by that firm.



             Subpart C--User Facility Reporting Requirements



Sec. 803.30  Individual adverse event reports; user facilities.

    (a) Reporting standard. A user facility shall submit the following 
reports to the manufacturer or to FDA, or both, as specified below:
    (1) Reports of death. Whenever a user facility receives or otherwise 
becomes 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 the facility, the facility shall as soon as practicable, but 
not later than 10 work days after becoming aware of the information, 
report the information required by Sec. 803.32 to FDA, on FDA Form 
3500A, or an electronic equivalent as approved under Sec. 803.14, and if 
the identity of the manufacturer is known, to the device manufacturer.
    (2) Reports of serious injury. Whenever a user facility receives or 
otherwise becomes 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 the facility, the facility shall, as soon 
as practicable but not later than 10 work days after becoming aware of 
the information, report the information required by Sec. 803.32, on FDA 
Form 3500A or electronic equivalent, as approved under Sec. 803.14, to 
the

[[Page 48]]

manufacturer of the device. If the identity of the manufacturer is not 
known, the report shall be submitted to FDA.
    (b) Information that is reasonably known to user facilities. User 
facilities must provide all information required in this subpart C that 
is reasonably known to them. Such information includes information found 
in documents in the possession of the user facility and any information 
that becomes available as a result of reasonable followup within the 
facility. A user facility is not required to evaluate or investigate the 
event by obtaining or evaluating information that is not reasonably 
known to it.



Sec. 803.32  Individual adverse event report data elements.

    User facility reports shall contain the following information, 
reasonably known to them as described in 803.30(b), which corresponds to 
the format of FDA Form 3500A:
    (a) Patient information (Block A) shall contain 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 (Block B) shall contain the 
following:
    (1) Identification of adverse event or product problem;
    (2) Outcomes attributed to the adverse event, e.g., death; or 
serious injury, that is:
    (i) Life threatening injury or illness;
    (ii) Disability resulting in permanent impairment of a body function 
or permanent damage to a body structure; or
    (iii) Injury or illness that requires intervention to prevent 
permanent impairment of a body structure or function;
    (3) Date of event;
    (4) Date of report by the initial reporter;
    (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 pre- existing 
medical conditions.
    (c) Device information (Block D) shall contain the following:
    (1) Brand name;
    (2) Type of device;
    (3) Manufacturer name and address;
    (4) Operator of the device (health professional, patient, lay user, 
other);
    (5) Expiration date;
    (6) Model number, catalog number, serial number, lot number, or 
other identifying number;
    (7) Date of device implantation (month, day, year);
    (8) Date of device explantation (month, day, year);
    (9) Whether device was available for evaluation and whether device 
was returned to the manufacturer; if so, the date it was returned to the 
manufacturer; and
    (10) Concomitant medical products and therapy dates. (Do not list 
products that were used to treat the event.)
    (d) Initial reporter information (Block E) shall contain the 
following:
    (1) Name, address, and telephone number of the reporter who 
initially provided information to the user facility, manufacturer, or 
distributor;
    (2) Whether the initial reporter is a health professional;
    (3) Occupation; and
    (4) Whether initial reporter also sent a copy of the report to FDA, 
if known.
    (e) User facility information (Block F) shall contain the following:
    (1) Whether reporter is a user facility;
    (2) User facility number;
    (3) User facility address;
    (4) Contact person;
    (5) Contact person's telephone number;
    (6) Date the user facility became aware of the event (month, day, 
year);
    (7) Type of report (initial or followup (if followup, include report 
number of initial report));
    (8) Date of the user facility report (month, day, year);
    (9) Approximate age of device;
    (10) Event problem codes--patient code and device code (refer to FDA 
``Coding Manual For Form 3500A'');

[[Page 49]]

    (11) Whether a report was sent to FDA and the date it was sent 
(month, day, year);
    (12) Location, where event occurred;
    (13) Whether report was sent to the manufacturer and the date it was 
sent (month, day, year); and
    (14) Manufacturer name and address; if available.



Sec. 803.33  Semiannual reports.

    (a) Each user facility shall submit to FDA a semiannual report on 
FDA Form 3419, or electronic equivalent as approved by FDA under 
Sec. 803.14. Semiannual reports shall be submitted by January 1 (for 
reports made July through December) and by July 1 (for reports made 
January through June) of each year. The semiannual report and envelope 
shall be clearly identified and submitted to FDA with information that 
includes:
    (1) User facility's HCFA provider number used for medical device 
reports, or number assigned by FDA for reporting purposes in accordance 
with Sec. 803.3(dd);
    (2) Reporting year and period, e.g., January through June or July 
through December;
    (3) Facility's name and complete address;
    (4) Total number of reports attached or summarized;
    (5) Date of the semiannual report and the lowest and highest user 
facility report number of medical device reports submitted during the 
report period, e.g., 1234567890-1995-0001 through 1000;
    (6) Name, position title, and complete address of the individual 
designated as the facility contact person responsible for reporting to 
FDA and whether that person is a new contact for that facility; and
    (7) Information for each reportable event that occurred during the 
semiannual reporting period including:
    (i) User facility 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;
    (v) A brief description of the event reported to the manufacturer 
and/or FDA; and
    (vi) Where the report was submitted, i.e., to FDA, manufacturer, 
distributor, etc.
    (b) In lieu of submitting the information in paragraph (a)(7) of 
this section, a user facility may submit a copy of FDA Form 3500A, or an 
electronic equivalent as approved under section 803.14, for each medical 
device report submitted to FDA and/or manufacturers by that facility 
during the reporting period.
    (c) If no reports are submitted to either FDA or manufacturers 
during these time periods, no semiannual report is required.



                          Subpart D  [Reserved]



             Subpart E--Manufacturer Reporting Requirements



Sec. 803.50  Individual adverse event reports; manufacturers.

    (a) Reporting standards. Device manufacturers are required to report 
within 30 days whenever the manufacturer receives or otherwise becomes 
aware of information, from any source, that reasonably suggests that a 
device marketed by the manufacturer:
    (1) May have caused or contributed to a death or serious injury; or
    (2) Has malfunctioned and such device or similar device marketed by 
the manufacturer would be likely to cause or contribute to a death or 
serious injury, if the malfunction were to recur.
    (b) Information that is reasonably known to manufacturers. (1) 
Manufacturers must provide all information required in this subpart E 
that is reasonably known to them. FDA considers the following 
information to be reasonably known to the manufacturer:
    (i) Any information that can be obtained by contacting a user 
facility, distributor and/or other initial reporter;
    (ii) Any information in a manufacturer's possession; or
    (iii) Any information that can be obtained by analysis, testing or 
other evaluation of the device.
    (2) Manufacturers are responsible for obtaining and providing FDA 
with information that is incomplete or missing from reports submitted by 
user facilities, distributors, and other initial

[[Page 50]]

reporters. Manufacturers are also responsible for conducting an 
investigation of each event, and evaluating the cause of the event. If a 
manufacturer cannot provide complete information on an MDR report, it 
must provide a statement explaining why such information was incomplete 
and the steps taken to obtain the information. Any required information 
not available at the time of the report, which is obtained after the 
initial filing, must be provided by the manufacturer in a supplemental 
report under Sec. 803.56.



Sec. 803.52  Individual adverse event report data elements.

    Individual medical device manufacturer reports shall contain the 
following information, known or reasonably known to them as described in 
Sec. 803.50(b), which corresponds to the format of FDA Form 3500A:
    (a) Patient information (Block A) shall contain 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 (Block B) shall contain the 
following:
    (1) Adverse event or product problem;
    (2) Outcomes attributed to the adverse event, e.g., death; or 
serious injury, that is:
    (i) Life threatening injury or illness;
    (ii) Disability resulting in permanent impairment of a body function 
or permanent damage to a body structure; or
    (iii) Injury or illness that requires intervention to prevent 
permanent impairment of a body structure or function;
    (3) Date of event;
    (4) Date of report by the initial reporter;
    (5) Description of the event or problem to include 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 pre-existing medical 
conditions.
    (c) Device information (Block D) shall contain the following:
    (1) Brand name;
    (2) Type of device;
    (3) Manufacturer name and address;
    (4) Operator of the device (health professional, patient, lay user, 
other);
    (5) Expiration date;
    (6) Model number, catalog number, serial number, lot number or other 
identifying number;
    (7) Date of device implantation (month, day, year);
    (8) Date of device explantation (month, day, year);
    (9) 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
    (10) Concomitant medical products and therapy dates. (Do not list 
products that were used to treat the event.)
    (d) Initial reporter information (Block E) shall contain the 
following:
    (1) Name, address, and phone number of the reporter who initially 
provided information to the user facility, 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 
FDA, if known.
    (e) All manufacturers (Block G) shall contain the following:
    (1) Contact office name and address and device manufacturing site;
    (2) Telephone number;
    (3) Report sources;
    (4) Date received by manufacturer (month, day, year);
    (5) Type of report being submitted (e.g., 5-day, initial, 
supplemental); and
    (6) Manufacturer report number.
    (f) Device manufacturers (Block H) shall contain 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 the manufacturer and evaluated by 
the manufacturer, a summary of the evaluation. If no evaluation was 
performed, provide an explanation why no evaluation was performed;

[[Page 51]]

    (4) Device manufacture date (month, day, year);
    (5) Was device labeled for single use;
    (6) Evaluation codes (including event codes, method of evaluation, 
result, and conclusion codes) (refer to FDA ``Coding Manual for Form 
3500A'');
    (7) Whether remedial action was taken and type;
    (8) Whether use of device was initial, reuse, or unknown;
    (9) Whether remedial action was reported as a removal or correction 
under section 519(f) of the act (list the correction/removal report 
number); and
    (10) Additional manufacturer narrative; and/or
    (11) Corrected data, including:
    (i) Any information missing on the user facility report or 
distributor report, including missing event codes, or information 
corrected on such forms after manufacturer verification;
    (ii) For each event code provided by the user facility under 
Sec. 803.32(d)(10) or a distributor, a statement of whether the type of 
the event represented by the code is addressed in the device labeling; 
and
    (iii) If any required information was not provided, an explanation 
of why such information was not provided and the steps taken to obtain 
such information.



Sec. 803.53  Five-day reports.

    A manufacturer shall submit a 5-day report to FDA, on Form 3500A or 
electronic equivalent as approved by FDA under Sec. 803.14 within 5 
workdays of:
    (a) Becoming aware that a reportable MDR event or events, from any 
information, including any trend analysis, necessitates remedial action 
to prevent an unreasonable risk of substantial harm to the public 
health; or
    (b) Becoming aware of an MDR reportable event for which FDA has made 
a written request for the submission of a 5-day report. When such a 
request is made, the manufacturer shall 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. The time period stated in the original written 
request can be extended by FDA if it is in the interest of the public 
health.



Sec. 803.55  Baseline reports.

    (a) A manufacturer shall submit a baseline report on FDA Form 3417, 
or electronic equivalent as approved by FDA under Sec. 803.14 for a 
device when the device model is first reported under Sec. 803.50.
    (b) Each baseline report shall be updated annually, on the 
anniversary month of the initial submission, after the initial baseline 
report is submitted. Changes to baseline information shall be reported 
in the manner described in Sec. 803.56 (i.e., include only the new, 
changed, or corrected information in the appropriate portion(s) of the 
report form). Baseline reports shall contain the following:
    (1) Name, complete address, and registration number of the 
manufacturer's reporting site. If the reporting site is not registered, 
FDA will assign a temporary registration number until the reporting site 
officially registers. The manufacturer will be informed of the temporary 
registration number;
    (2) FDA registration number of each site where the device is 
manufactured;
    (3) Name, complete address, and telephone number of the individual 
who has been designated by the manufacturer as its MDR contact and date 
of the report. For foreign manufacturers, a confirmation that the 
individual submitting the report is the agent of the manufacturer 
designated under Sec. 803.58(a) is required;
    (4) Product identification, including device family, brand name, 
generic name, model number, catalog number, product code and any other 
product identification number or designation;
    (5) Identification of any device previously reported in a baseline 
report that is substantially similar (e.g., same device with a different 
model number, or same device except for cosmetic differences in color or 
shape) to the device being reported, including the identification of the 
previously reported device by model number, catalog number or other 
product identification, and the date of the baseline report for the 
previously reported device;
    (6) Basis for marketing, including 510(k) premarket notification 
number

[[Page 52]]

or PMA number, if applicable, and whether the device is currently the 
subject of an approved post-market study under section 522 of the act;
    (7) Date the device was initially marketed and, if applicable, the 
date on which the manufacturer ceased marketing the device;
    (8) Shelf life, if applicable, and expected life of the device;
    (9) The number of devices manufactured and distributed in the last 
12 months and, an estimate of the number of devices in current use; and
    (10) Brief description of any methods used to estimate the number of 
devices distributed and the method used to estimate the number of 
devices in current use. If this information was provided in a previous 
baseline report, in lieu of resubmitting the information, it may be 
referenced by providing the date and product identification for the 
previous baseline report.

    Effective Date Note:  At 61 FR 39869, July 31, 1996, in Sec. 803.55, 
paragraphs (b)(9) and (10) were stayed indefinitely.



Sec. 803.56  Supplemental reports.

    When a manufacturer obtains information required under this part 
that was not provided because it was not known or was not available when 
the initial report was submitted, the manufacturer shall submit to FDA 
the supplemental information within 1 month following receipt of such 
information. In supplemental reports, the manufacturer shall:
    (a) Indicate on the form and the envelope, that the reporting form 
being submitted is a supplemental report. If the report being 
supplemented is an FDA Form 3500A report, the manufacturer must select, 
in Item H-2, the appropriate code for the type of supplemental 
information being submitted;
    (b) Provide the appropriate identification numbers of the report 
that will be updated with the supplemental information, e.g., original 
manufacturer report number and user facility report number, if 
applicable;
    (c) For reports that cross reference previous reports, include only 
the new, changed, or corrected information in the appropriate portion(s) 
of the respective form(s).



Sec. 803.57  Annual certification.

    (a) All manufacturers required to report under this section shall 
submit an annual certification report to FDA, on FDA Form 3381, or 
electronic equivalent as approved under Sec. 803.14. The date for 
submission of certification coincides with the date for the firm's 
annual registration, as designated in Sec. 807.21 of this chapter. 
Foreign manufacturers shall submit their certification by the date on 
which they would be required to register under Sec. 807.21 of this 
chapter if they were domestic manufacturers. The certification period 
will be the 12-month period ending 1 month before the certification 
date, except that the first certification period shall cover at least a 
6-month period from the effective date of this section, ending 1 month 
before the certification date.
    (b) The manufacturer shall designate, as the certifying official, an 
individual with oversight responsibilities for, and knowledge of, the 
firm's MDR reporting system. A manufacturer may determine, based upon 
its organizational structure, that one individual cannot oversee or have 
complete knowledge of the operation of the reporting system at all 
organizational components or manufacturing sites owned by the firm. In 
this circumstance, the firm may designate more than one certifying 
official, each of whom will sign a certification statement pertaining to 
his/her respective identified organizational component(s) or site(s), 
provided that all organizational components and sites are covered under 
a certification statement.
    (c) The report shall contain the following information:
    (1) Name, address, and FDA registration number or FDA assigned 
identification number of the reporting site and whether the firm is a 
manufacturer;
    (2) Name, title, address, telephone number, signature, and date of 
signature of the person making the certification;
    (3) Name, address, and FDA registration number or FDA assigned 
identification number for each manufacturing site covered by the 
certification and the number of reports submitted for devices 
manufactured at each site;

[[Page 53]]

    (4) A statement certifying that:
    (i) The individual certifying for the firm has read the MDR 
requirements under this part;
    (ii) The firm has established a system to implement MDR reporting;
    (iii) Following the procedures of its MDR reporting system, the 
reporting site submitted the specified number of reports, or no reports, 
during the certification period; and
    (iv) The certification is made to the best of the certifying 
official's knowledge and belief.
    (d) The name of the manufacturer and the registration number 
submitted under paragraph (c)(1) of this section shall be the same as 
the reporting site that submitted the reports required by Secs. 803.52, 
803.53, and 803.55. Multireporting site manufacturers who choose to 
certify centrally must identify the reporting sites, by registration 
number and name covered by the certification, and provide the 
information required by paragraphs (c)(2) and (c)(3) of this section for 
each reporting site.
[62 FR 13306, Mar. 20, 1997]

    Effective Date Note: At 61 FR 38347, July 23, 1996, Sec. 803.57 was 
stayed indefinitely.



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 Secs. 803.50, 803.52, 803.53, 
803.55, 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) Certify in accordance with Sec. 803.57;
    (4) Forward MDR complaints to the foreign manufacturer and maintain 
documentation of this requirement;
    (5) Maintain complaint files in accordance with Sec. 803.18; and
    (6) Register, list, and submit premarket notifications in accordance 
with part 807 of this chapter.

    Effective Date Note:  At 61 FR 38347, July 23, 1996, Sec. 803.58 was 
stayed indefinitely.



PART 804--MEDICAL DEVICE DISTRIBUTOR REPORTING--Table of Contents




                      Subpart A--General Provisions

Sec.
804.1  Scope.
804.3  Definitions.
804.9  Public availability of reports.

                     Subpart B--Reports and Records

804.25  Reports by distributors.
804.27  Where to submit a report.
804.28  Reporting form.
804.30  Annual certification.
804.31  Additional requirements.
804.32  Supplemental information.
804.33  Alternative reporting requirements.
804.34  Written MDR procedures.
804.35  Files.

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

    Source:  58 FR 46519, Sept. 1, 1993, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 804.1  Scope.

    (a) FDA is requiring medical device distributors to report deaths, 
serious illnesses, and serious injuries that are attributed to medical 
devices. Distributors are also required to report certain device 
malfunctions and to submit a report to FDA annually certifying the 
number of medical device reports filed during the preceding year, or 
that no reports were filed. These reports enable FDA to protect the 
public health by helping to ensure that devices are not adulterated or 
misbranded and are otherwise safe and effective for their intended use. 
In addition, device distributors are required to establish and maintain 
complaint files

[[Page 54]]

or incident files as described in Sec. 804.35, and to permit any 
authorized FDA employee at all reasonable times to have access to, and 
to copy and verify, the records contained in this file. This part 
supplements, and does not supersede, other provisions of this 
subchapter, including the provisions of part 820 of this chapter.
    (b) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.



Sec. 804.3  Definitions.

    (a) Act means the Federal Food, Drug, and Cosmetic Act.
    (b)-(c) [Reserved]
    (d) Distributor means any person, including any person who imports a 
device into the United States, 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. One who repackages or otherwise changes the container, 
wrapper, or labeling, is a manufacturer under Sec. 804.3(k).
    (e) Distributor Report Number means the number that uniquely 
identifies each report submitted by a distributor. Distributors who 
receive or submit reports shall use their seven digit FDA registration 
number, calendar year that the report is received, and a sequence 
number. For example, the complete number will appear as follows: 
1234567-1991-0001. Distributor report numbers shall also be required on 
FDA form 3500A.
    (f) FDA means the Food and Drug Administration.
    (g) [Reserved]
    (h) Incident files are those files containing documents or other 
information, which are related to adverse events that may have been 
caused by a device.
    (i) Information that reasonably suggests that there is a probability 
that a device has caused or contributed to a death or serious injury or 
serious illness means information, including professional, scientific, 
or medical facts, observations, or opinions, which would cause a 
reasonable person to believe that a device caused or contributed to a 
death, serious injury, or serious illness.
    (j) Malfunction means the failure of a device to meet any of its 
performance specifications or otherwise to perform as intended. 
Performance specifications include all claims made in the labeling for 
the device. The intended performance of a device refers to the objective 
intent of the persons legally responsible for the labeling of the 
device. The intent is determined by such persons' expressions or may be 
shown by the circumstances surrounding the distribution of the device. 
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 also may be shown by the circumstances that 
the device is, with the knowledge of such persons or their 
representatives, offered and used to perform a function for which it is 
neither labeled nor advertised.
    (k) Manufacturer means any person who manufactures, prepares, 
propagates, compounds, assembles, or processes a device chemically, 
physically, biologically, or by 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.
    (l) MDR means medical device report.
    (m) MDR reportable event means:

[[Page 55]]

    (1) The event for which a distributor, other than an importer, 
required to report under this part has received or become aware of 
information that reasonably suggests that there is a probability that a 
device has caused or contributed to a death, serious illness, or serious 
injury; or
    (2) The event for which an importer required to report under this 
part has received or become aware of information that reasonably 
suggests that a device may have caused or contributed to a death or 
serious injury; or
    (3) A malfunction, for which a distributor, other than an importer, 
required to report under this part has received or become aware of 
information that reasonably suggests that there is a probability that 
the device, if the malfunction were to recur, would be likely to cause 
or contribute to a death, serious illness, or serious injury; or
    (4) A malfunction, for which an importer required to report under 
this part has received or become aware of information that reasonably 
suggests that a device has malfunctioned and that such device or a 
similar device would be likely to cause or contribute to a death or 
serious injury if the malfunction were to recur.
    (n)-(p) [Reserved]
    (q) Permanent means nonreversible impairment or damage.
    (r) Probability, probable, or probably means, for purposes of this 
section, that a person would have reason to believe, based upon an 
analysis of the event and device, that the device has caused or 
contributed to an adverse event. This term does not signify statistical 
probability.
    (s) A remedial action is any recall, repair, modification, 
adjustment, relabeling, destruction, inspection, patient monitoring, 
notification, or any other action relating to a device that is initiated 
by a distributor, in response to information that it receives or 
otherwise becomes aware of, that reasonably suggests that one of its 
marketed devices has caused or contributed to an MDR reportable event.
    (t) Serious illness means an event that:
    (1) Is life threatening;
    (2) Results in permanent impairment of a body function or permanent 
damage to the body structure; or
    (3) Necessitates immediate medical or surgical intervention to 
preclude permanent impairment of a body function or permanent damage to 
a body structure.
    (u) Serious injury means an event 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.
    (v) [Reserved]
    (w) Work day means Monday through Friday excluding Federal holidays. 
Federal holidays include New Year's Day, Martin Luther King Jr.'s 
Birthday, Presidents' Day, Memorial Day, Independence Day, Labor Day, 
Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day.
    (x) Any term defined in section 201 of the act shall have the same 
definition unless otherwise defined in this part.



Sec. 804.9  Public availability of reports.

    (a) Any report, including any FDA record of a telephone 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, and 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; provided, that, except for the information under Sec. 20.61 of 
this chapter, FDA will disclose to a patient who requests a report all 
the information in the report concerning that patient.

[[Page 56]]



                     Subpart B--Reports and Records



Sec. 804.25  Reports by distributors.

    (a)(1) A distributor, other than an importer, shall submit to FDA a 
report, and a copy of such report to the manufacturer, containing the 
information required by Sec. 804.28 on FDA form 3500A as soon as 
practicable, but not later than 10 working days after the distributor 
receives or otherwise becomes aware of information from any source, 
including user facilities, individuals, or medical or scientific 
literature, whether published or unpublished, that reasonably suggests 
that there is a probability that a device marketed by the distributor 
has caused or contributed to a death, serious illness, or serious 
injury.
    (2) An importer shall submit to FDA a report, and a copy of such 
report to the manufacturer, containing the information required by 
Sec. 804.28 on FDA form 3500A as soon as practicable, but not later than 
10 working days after the importer receives or otherwise becomes 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 its marketed devices may have 
caused or contributed to a death or serious injury.
    (b)(1) A distributor, other than an importer, shall submit to the 
manufacturer a report containing information required by Sec. 804.28 on 
FDA form 3500A, as soon as practicable, but not later than 10 working 
days after the distributor receives or otherwise becomes aware of 
information from any source, including user facilities, individuals, or 
through the distributor's own research, testing, evaluation, servicing, 
or maintenance of one of its devices, that one of the devices marketed 
by the distributor has malfunctioned and such information reasonably 
suggests that there is a probability that the device or any other device 
marketed by the distributor would cause a death, serious illness, or 
serious injury, if the malfunction were to recur.
    (2) An importer shall submit to the manufacturer a report containing 
information required by Sec. 804.28 on FDA form 3500A, as soon as 
practicable, but not later than 10 working days after the importer 
receives or otherwise becomes aware of information from any source, 
including user facilities, individuals, or through the distributor's own 
research, testing, evaluation, servicing, or maintenance of one of its 
devices, that one of the devices marketed by the importer has 
malfunctioned and that such device or a similar device marketed by the 
importer would be likely to cause or contribute to a death or serious 
injury if the malfunction were to recur.
    (c) Distributors as defined in part 897 of this chapter shall submit 
medical device reports concerning cigarettes and smokeless tobacco under 
this part only for adverse events related to contamination.
[58 FR 46519, Sept. 1, 1993, as amended at 61 FR 44615, Aug. 28, 1996]



Sec. 804.27  Where to submit a report.

    (a) Any telephone report required under this part shall be provided 
to 301-427-7500.
    (b) Any facsimile report required under this part shall be provided 
to 301-881-6670.
    (c) Any written report or additional information required under this 
part shall be submitted to:

Food and Drug Administration,
Center for Devices and Radiological   Health,
Distributor Report,
P.O. Box 3002,
Rockville, MD 20847-3002.



Sec. 804.28  Reporting form.

    (a) Each distributor that submits a report on an MDR reportable 
event shall complete and submit the applicable portions of FDA form 
3500A in so far as the information is known or should be known to the 
distributor, and submit it to FDA, and to the manufacturer as required 
by Sec. 804.25.
    (b) Each distributor shall submit the information requested on FDA 
form 3500A, including:
    (1) Identification of the source of the report.
    (i) Type of source that reported the event to thedistributor (e.g., 
lay user

[[Page 57]]

owner; lay user lessee, hospital, nursing home, outpatient diagnostic 
facility, outpatient treatment facility, ambulatory surgical facility);
    (ii) Distributor report number;
    (iii) Name, address, and telephone number of the reporting 
distributor and the source that reported the event to the distributor; 
and
    (iv) Name of the manufacturer of the device.
    (2) Date information.
    (i) The date of the occurrence of the event;
    (ii) The date the source that reported the event to the distributor 
became aware of the event;
    (iii) The date the event was reported to the manufacturer and/or 
FDA; and
    (iv) The date of this report.
    (3) The type of MDR reportable event, e.g., death, serious illness, 
serious injury, or malfunction, and whether an imminent hazard was 
involved;
    (4) Patient information including age, sex, diagnosis, and medical 
status immediately prior to the event and after the event;
    (5) Device information including brand and labeled name, generic 
name, model number or catalog number or other identifying numbers, 
serial number or lot number, purchase date, expected shelf life/
expiration date (if applicable), whether the device was labeled for 
single use, and date of implant (if applicable);
    (6) Maintenance/service information data including the last date of 
service performed on the device, where service was performed, whether 
service documentation is available, and whether service was in 
accordance with the service schedule;
    (7) Whether the device is available for evaluation and, if not, the 
disposition of the device;
    (8) Description of the event.
    (i) Who was operating or using the device when the eventoccurred;
    (ii) Whether the device was being used as labeled or as otherwise 
intended;
    (iii) The location of the event;
    (iv) Whether there was multi-patient involvement, and if so, how 
many patients were involved;
    (v) A list of any other devices whose performance may have 
contributed to the event and their manufacturers, and the results of any 
analysis or evaluation with respect to such device (or a statement of 
why no analysis or evaluation was performed); and
    (vi) A complete description of the event including, but not limited 
to, what happened, how the device was involved, the nature of the 
problem, patient followup/treatment required, and any environmental 
conditions that may have influenced the event.
    (9) The results of any analysis of the device and the event, 
including:
    (i) The method of evaluation or an explanation of why no evaluation 
was necessary or possible;
    (ii) The results and conclusions of the evaluation;
    (iii) The corrective actions taken; and
    (iv) The degree of certainty concerning whether the device caused or 
contributed to the reported event;
    (10) The name, title, address, telephone number, and signature of 
the person who prepared the report.



Sec. 804.30  Annual certification.

    (a) All distributors required to report under this section shall 
submit an annual certification report to FDA, on FDA Form 3381, or 
electronic equivalent as approved under Sec. 803.14 of this chapter. The 
date for submission of certification coincides with the date for the 
firm's annual registration, as designated in Sec. 807.21 of this 
chapter. The certification period will be the 12-month period ending 1 
month before the certification date, except that the first certification 
period shall cover at least a 6-month period from the effective date of 
this section, ending 1 month before the certification date.
    (b) The distributor shall designate, as the certifying official, an 
individual with oversight responsibilities for, and knowledge of, the 
firm's MDR reporting system. A distributor may determine, based upon its 
organizational structure, that one individual cannot oversee or have 
complete knowledge of the operation of the reporting system at all 
organizational components or distribution sites owned by the firm. In 
this circumstance, the firm may designate more than one certifying 
official (one for each component or site),

[[Page 58]]

each of whom will sign a certification statement pertaining to their 
respective identified organizational component(s) or site(s), provided 
that all organizational components and sites are covered under a 
certification statement.
    (c) The report shall contain the following information:
    (1) Name, address, and FDA registration number or FDA assigned 
identification number of the firm;
    (2) Name, title, address, telephone number, signature, and date of 
signature of the person making the certification;
    (3) Name, address, and FDA registration number or FDA assigned 
identification number for the distributor covered by the certification, 
and the number of reports submitted for devices distributed by the 
distributor;
    (4) A statement certifying that:
    (i) The individual certifying for the firm has read the MDR 
requirements under part 804;
    (ii) The firm has established a system to implement MDR reporting;
    (iii) Following the procedures of its MDR reporting system, the firm 
submitted the specified number of reports, or no reports, during the 
certification period; and
    (iv) The certification is made to the best of the certifying 
official's knowledge and belief.
[62 FR 13306, Mar. 20, 1997]



Sec. 804.31  Additional requirements.

    Requests for additional information. If FDA determines that the 
protection of the public health requires information in addition to that 
included in the medical device reports submitted to FDA under this part, 
the distributor shall, upon FDA's request, submit such additional 
information. Any request by FDA under this section shall state the 
reason or purpose for which the information is being requested, and 
specify a due date for the submission of such information.



Sec. 804.32  Supplemental information.

    (a) Only one MDR is required under this part if the distributor 
becomes aware, from more than one source, of information concerning the 
same patient and the same event.
    (b) An MDR that would otherwise be required under this section is 
not required by the distributor if:
    (1) The distributor determines that the information received is 
erroneous in that a death, serious injury, serious illness, or the 
malfunction did not occur; or
    (2) The distributor determines that the information received is 
erroneous in that the device that is the subject of the information was 
distributed by another distributor. A distributor shall forward to FDA 
any report that is erroneously sent to the distributor, with a cover 
letter explaining that the product in question is not distributed by 
that firm.
    (c) A report or information submitted by a distributor under this 
part (and any release by FDA of that report or information) does not 
necessarily reflect a conclusion by the party submitting the report or 
by FDA that the report or information constitutes an admission that the 
device, the establishment submitting the report, or employees thereof, 
caused or contributed to a death, serious injury, serious illness, or 
malfunction. A distributor need not admit, and may deny, that the report 
or information submitted under this part constitutes an admission that 
the device, the party submitting the report, or employees thereof, 
caused or contributed to a death or serious injury, serious illness, or 
malfunction.



Sec. 804.33  Alternative reporting requirements.

    (a) Distributors may request exemptions from any or all of the 
reporting requirements in this part. These requests are required to be 
in writing and to include both the information necessary to identify the 
firm and device and an explanation why the request is justified.
    (b) FDA may grant a distributor, in writing, an exemption from 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 periods. In granting such exemptions, FDA may impose 
other reporting requirements to ensure the protection of public health 
and safety. FDA may also

[[Page 59]]

authorize the use of alternative reporting media such as magnetic tape 
or disk, in lieu of FDA forms.
    (c) FDA may revoke alternative reporting options, in writing, if FDA 
determines that protection of the public health justifies a return to 
the requirements as stated in this part.



Sec. 804.34  Written MDR procedures.

    Device distributors shall maintain and implement written MDR 
procedures in the following areas:
    (a) Training and education programs informing employees about 
obligations under this section, including how to identify and report MDR 
reportable events;
    (b) Internal systems that provide for timely and effective 
identification, communication, and evaluation of events that may be 
subject to MDR requirements, a standardized review process/procedure for 
determining when an event meets the criteria for reporting under this 
part, and timely transmission of complete MDR's to FDA and/or 
manufacturers; and
    (c) Documentation and recordkeeping requirements for:
    (1) Information that may be the subject of an MDR;
    (2) All MDR's and information submitted to FDA and manufacturers;
    (3) Information that facilitates the submission of certification 
reports; and
    (4) Systems that ensure access to information that facilitates 
timely followup and inspection by FDA.



Sec. 804.35  Files.

    (a) A device distributor shall establish a device complaint file in 
accordance with Sec. 820.198 of this chapter and maintain a record of 
any information, including any written or oral communication, received 
by the distributor concerning all events that were considered for 
possible reporting under this part. Device incident records shall be 
prominently identified as such and shall be filed by device. The file 
shall also contain a copy of any MDR along with any additional 
information submitted to FDA under this part. A distributor shall 
maintain records that document the submission of copies of MDR's to 
manufacturers.
    (b) A device distributor shall retain copies of the records required 
to be maintained under this section for a period of 2 years from the 
date that the report or additional information is submitted to FDA under 
Sec. 804.25, or for a period of time equivalent to the design and 
expected life of the device, whichever is greater, even if the 
distributor has ceased to distribute the device that is the subject of 
the report or the additional information.
    (c) A device distributor shall maintain the device complaint files 
established under this section at the distributor's principal business 
establishment. A distributor that is also a manufacturer may maintain 
the file at the same location as the manufacturer maintains its 
complaint file under Secs. 820.180 and 820.198 of this chapter. A device 
distributor shall permit any authorized FDA employee, during all 
reasonable times, to have access to, and to copy and verify, the records 
required by this part.



PART 805--CARDIAC PACEMAKER REGISTRY--Table of Contents




                      Subpart A--General Provisions

Sec.
805.1  Scope.
805.3  Definitions.

                  Subpart B--Submission of Information

805.10  Submission of information by physicians and providers.
805.20  How to submit information.
805.25  Confidentiality.

    Authority:  42 U.S.C. 1395y(h), 1395y note.

    Source:  52 FR 27763, July 23, 1987, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 805.1  Scope.

    (a) This part provides for a nationwide cardiac pacemaker registry 
and requires any physician and any provider of services who requests or 
receives payment from Medicare for the implantation, removal, or 
replacement of permanent cardiac pacemakers and pacemaker leads to 
submit certain information to the registry. If the physician or the 
provider of services does not submit the information according

[[Page 60]]

to this part and 42 CFR 409.19(a) and 410.64(a), HCFA, which administers 
the Medicare program, will deny payment to the physician or the 
provider. FDA will use the information submitted to the registry to 
track the performance of permanent pacemakers and pacemaker leads and to 
perform studies and analyses regarding the use of the devices, and to 
transmit data to HCFA to assist HCFA in administering the Medicare 
program and to other Department of Health and Human Services' components 
to carry out statutory responsibilities.
    (b) Information submitted to the registry by a physician or a 
provider of services (and any release by FDA or HCFA of that 
information) does not necessarily reflect a conclusion by the submitter, 
FDA, or HCFA that the information constitutes an admission that a 
pacemaker device or lead failed to operate within its performance 
specifications. A submitter need not admit, and may deny, that the 
information submitted to the registry constitutes an admission that the 
pacemaker device or lead failed to operate within its performance 
specifications.
    (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. 805.3  Definitions.

    (a) FDA means the Food and Drug Administration.
    (b) HCFA means the Health Care Financing Administration.
    (c) A pacemaker or pacemaker device is a device that produces 
periodic electrical impulses to stimulate the heart. It consists of two 
basic components: a pulse generator and one or more leads. See 
Sec. 870.3610 for a more detailed definition.
    (d) A pacemaker lead is a flexible, insulated wire connected at one 
end to a pacemaker's pulse generator and at the other end to the heart. 
It transmits electrical stimuli to and from the heart. See 
Sec. 870.3680(b) for a more detailed definition.
    (e) A physician is a doctor of medicine or osteopathy legally 
authorized to practice medicine and surgery by applicable laws of the 
State in which he or she performs such function or actions. (This 
definition includes an osteopathic practitioner.)
    (f) A PRO is a Utilization and Quality Control Peer Review 
Organization that contracts with the Secretary of Health and Human 
Services to review health care services funded by the Medicare program 
to determine whether those services are reasonable, medically necessary, 
furnished in the appropriate setting, and are of a quality which meets 
professionally recognized standards.
    (g) A provider is a hospital, skilled nursing facility, 
comprehensive outpatient rehabilitation facility, home health agency, or 
a hospice that has in effect an agreement to participate in Medicare.
    (h) A warranty is an express or implied guarantee, under contract or 
State law, of the integrity of a pacemaker device or pacemaker lead and 
of the manufacturer's responsibility for the repair or replacement of 
defective parts of a pacemaker device or pacemaker lead.
    (i) Any terms defined in section 201 of the Federal Food, Drug, and 
Cosmetic Act will have that definition.



                  Subpart B--Submission of Information



Sec. 805.10  Submission of information by physicians and providers.

    A physician or a provider of services that requests or receives 
payment from Medicare for the implantation, removal, or replacement of a 
permanent cardiac pacemaker device or pacemaker lead shall submit the 
following information on a specified form to HCFA for inclusion in the 
pacemaker registry provided for by FDA under Sec. 805.1:
    (a) Provider number.
    (b) Patient's health insurance claim number (HICN).
    (c) Patient's name.
    (d) Date of the procedure.
    (e) Identification number (used by PRO's) and name of the physician 
who ordered the procedure.
    (f) Identification number (used by PRO's) and name of the operating 
physician.
    (g) For each device (pulse generator, atrial lead, ventricular lead) 
implanted

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during the procedure about which the report is being made: the name of 
the manufacturer, model number, serial number, and the warranty 
expiration date.
    (h) For each device (pulse generator, atrial lead, ventricular lead) 
removed or replaced during the procedure about which the report is being 
made: the name of the manufacturer; model number; serial number; the 
warranty expiration date, if known; the date the device was initially 
implanted, if known; whether a device that was replaced was left in the 
body; if the device was not left in the body, whether it was returned to 
the manufacturer.

(Information collection requirements approved by the Office of 
Management and Budget under control number 0910-0234)



Sec. 805.20  How to submit information.

    Information shall be submitted to the registry in the form and 
manner required under general instructions of the Medicare program (see 
42 CFR 409.19(a) and 410.64(a)).



Sec. 805.25  Confidentiality.

    (a) FDA and HCFA will keep confidential, and will not reveal to the 
public, any specific information that identifies by name a recipient of 
any pacemaker device or lead or that would otherwise identify a specific 
recipient.
    (b) Public disclosure of all other information under this part will 
be governed by the Freedom of Information Act (5 U.S.C. 552), the 
Privacy Act of 1974 (5 U.S.C. 552a), the Department of Health and Human 
Services' public information regulations (45 CFR part 5), FDA's public 
information regulations (21 CFR part 20), and HCFA's public information 
regulations (subpart B of 42 CFR part 401).



PART 806--MEDICAL DEVICE 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:  Secs. 502, 510, 519, 520, 701, and 704, of the Federal 
Food, Drug, and Cosmetic Act (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(f) of the 
Federal Food, Drug, and Cosmetic Act (the act) requiring device 
manufacturers and distributors, including 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 undertaken by device manufacturers and distributors, 
including 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.
    (2) Market withdrawals as defined in Sec. 806.2(h).
    (3) Routine servicing as defined in Sec. 806.2(k).
    (4) Stock recoveries as defined in Sec. 806.2(l).



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.

[[Page 62]]

    (e) ``Correction or removal report number'' means the number that 
uniquely identifies each report submitted.
    (f) ``Distributor'' means any person, including any person who 
imports a device into the United States, 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.
    (g) ``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.
    (h) ``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.
    (i) ``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.
    (j) ``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.
    (k) ``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.
    (l) ``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.



                     Subpart B--Reports and Records



Sec. 806.10  Reports of corrections and removals.

    (a) Each device manufacturer, importer, or distributor shall submit 
a written report to FDA of any correction or removal of a device 
initiated by such manufacturer or distributor 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, importer, or distributor shall submit any 
report required by paragraph (a) of this section within 10-working days 
of initiating such correction or removal. The report shall be submitted 
to the appropriate FDA district office listed in Sec. 5.115 of this 
chapter. A foreign manufacturer or owner or operator of devices must 
submit reports of corrective or removal actions.

[[Page 63]]

    (c) The manufacturer, importer, or distributor 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, 
importer, or distributor and the name, title, address, and telephone 
number of the manufacturer, importer, or distributor's 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, importer, or distributor that does not have an FDA 
establishment registration number shall indicate in the report whether 
it has ever registered with FDA.
    (5) The 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.
    (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, 
distributor, or importer determines that the same correction or removal 
should be extended to additional lots or batches of the same device, the 
manufacturer, distributor, 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, 
distributor, or importer shall also provide a statement in accordance 
with paragraph (c)(13) of

[[Page 64]]

this section for any required information that is not readily available.
    (e) A report submitted by a manufacturer, distributor, or importer 
under this section (and any release by FDA of that report or 
information) does not necessarily reflect a conclusion by the 
manufacturer, distributor, 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, distributor, 
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 a 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, 804, or 1004 of this chapter.

    Effective Date Note: At 62 FR 67274, Dec. 24, 1997, Sec. 806.10 was 
stayed. This section contains information collection requirements and 
will not become effective until approval has been given by the Office of 
Management and Budget.



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

    (a) Each device manufacturer, importer, or distributor 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 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, importer, or distributor shall retain all 
records required under this section for a period of 2 years beyond the 
expected life of the device, even if the manufacturer, importer, or 
distributor has ceased to manufacture, import, or distribute the device. 
Records required to be maintained under paragraph (b) of this section 
must be transferred to the new manufacturer, importer, or distributor of 
the device and maintained for the required period of time.

    Effective Date Note: At 62 FR 67274, Dec. 24, 1997, Sec. 806.20 was 
stayed. This section contains information collection requirements and 
will not become effective until approval has been given by the Office of 
Management and Budget.



Sec. 806.30  FDA access to records.

    Each device manufacturer, importer, or distributor required under 
this part to maintain records concerning corrections or removals 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.



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

[[Page 65]]

who requests a report all the information in the report concerning that 
patient.



PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND DISTRIBUTORS OF DEVICES--Table of Contents




                      Subpart A--General Provisions

Sec.
807.3  Definitions.

        Subpart B--Procedures for Domestic Device Establishments

807.20  Who must register and submit a device list.
807.21  Times for establishment registration and device listing.
807.22  How and where to register establishments and list devices.
807.25  Information required or requested for establishment registration 
          and device listing.
807.26  Amendments to establishment registration.
807.30  Updating device listing information.
807.31  Additional listing information.
807.35  Notification of registrant.
807.37  Inspection of establishment registration and device listings.
807.39  Misbranding by reference to establishment registration or to 
          registration number.

  Subpart C--Registration Procedures for Foreign Device Establishments

807.40  Establishment registration and device listing for U.S. agents of 
          foreign manufacturers of devices.

                          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. 331, 351, 352, 360, 360c, 360e, 360i, 360j, 
371, 374.

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



                      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 pursuant to section 
520(g) of the act and part 812 of this chapter; or
    (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.
    (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

[[Page 66]]

original place of manufacture to the person who makes final delivery or 
sale to the ultimate consumer;
    (2) Distribution of domestic or imported devices; 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;
    (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; and
    (5) The annual certification of medical device reports required by 
Sec. 804.30 of this chapter or forwarding the certification form to the 
person designated by the firm as responsible for the certification.
    (f) Owner or operator means the corporation, subsidiary, affiliated 
company, partnership, or proprietor directly responsible for the 
activities of the registering establishment.
    (g) Distributor means any person who furthers the marketing of a 
device from the original place of manufacture, whether domestic or 
imported, to the person who makes final delivery or sale 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 the Commissioner, by 
regulation under Sec. 801.109 of this chapter or otherwise under section 
520(e) of the act, has restricted sale, distribution, or use only upon 
the written or oral authorization of a practitioner licensed by law to 
administer or use the device or upon such other conditions as the 
Commissioner may prescribe.
    (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) Representative sampling of advertisements means typical 
advertising material that gives the promotional claims made for the 
device.
    (l) Representative sampling of any other labeling means typical 
labeling material (excluding labels and package inserts) that gives the 
promotional claims made for the device.
    (m) 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.
    (n) 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.
    (o) 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

[[Page 67]]

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.
    (p) 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.
    (q) 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.
    (r) U.S.-designated agent means the person, residing in the United 
States, designated and authorized by the owner or operator of a foreign 
manufacturer who exports devices into the United States and is 
responsible for:
    (1) Submitting MDR reports,
    (2) Submitting annual certifications,
    (3) Acting as the official correspondent,
    (4) Submitting registration information,
    (5) Submitting device listing information, and
    (6) Submitting premarket notifications on behalf of the foreign 
manufacturer.
[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]

    Effective Date Note:  At 61 FR 38347, July 23, 1996, in Sec. 807.3, 
paragraph (r) was stayed indefinitely.



        Subpart B--Procedures for Domestic 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 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 is required to register 
and to submit listing information for those devices in commercial 
distribution, except that 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 is required 
to register its name, places of business, and all establishments and to 
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:
    (1) Initiates or develops specifications for a device that is to be 
manufactured by a second party for commercial distribution by the person 
initiating specifications;
    (2) Manufactures for commercial distribution a device either for 
itself or for another person. However, a person who only manufactures 
devices according to another person's specifications, for commercial 
distribution by the person initiating specifications, is not required to 
list those devices.
    (3) Repackages or relabels a device;
    (4) Distributors;
    (5) Manufactures components or accessories which 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.
    (6) Acts as the U.S.-designated agent as defined in Sec. 807.3(r).
    (b) No registration or listing fee is required. Registration or 
listing does not constitute an admission or agreement or determination 
that a product is a

[[Page 68]]

device within the meaning of section 201(h) of the act.
    (c) Distributors of domestic or imported devices must register and 
fulfill their listing obligations as described in Sec. 807.22(c) of this 
part. Distributors with multiple sites may submit one registration for 
all sites or submit a registration for each site. If a multisite 
distributor chooses to file one registration, the registration must be 
from the principal business establishment which maintains the MDR 
complaint files.
    (d) Registration and listing requirements shall not pertain to any 
person who:
    (1) Manufacturers devices for another party who both initiated the 
specifications and commercially distributes the device;
    (2) Sterilizes devices on a contract basis for other registered 
facilities who commercially distribute the devices.
[42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37997, Aug. 25, 1978; 
58 FR 46522, Sept. 1, 1993; 60 FR 63606, Dec. 11, 1995]

    Effective Date Note:  At 61 FR 38347, July 23, 1996, in Sec. 807.20, 
paragraph (a)(6) was stayed indefinitely.



Sec. 807.21  Times for establishment registration and device listing.

    (a) An owner or operator of an establishment who has not previously 
entered into an operation defined in Sec. 807.20 shall register within 
30 days after entering into such an operation and submit device listing 
information at that time. An owner or operator of an establishment shall 
update its registration information annually within 30 days after 
receiving registration forms from FDA. FDA will mail form FDA-2891a to 
the owners or operators of registered establishments according to a 
schedule based on the first letter of the name of the owner or operator. 
The schedule is as follows:

                                                                        
------------------------------------------------------------------------
  First letter of owner or operator name      Date FDA will mail forms  
------------------------------------------------------------------------
A, B, C, D, E.............................   March.                     
F, G, H, I, J, K, L, M....................   June.                      
N, O, P, Q, R.............................   August.                    
S, T, U, V, W, X, Y, Z....................   November.                  
------------------------------------------------------------------------

    (b) Owners or operators of all registered establishments shall 
update their device listing information every June and December or, at 
their discretion, at the time the change occurs.
[58 FR 46522, Sept. 1, 1993]



Sec. 807.22  How and where to register establishments and list devices.

    (a) The first registration of a device establishment shall be on 
Form FDA-2891 (Initial Registration of Device Establishment). Forms are 
available upon request from the Office of Compliance, Center for Devices 
and Radiological Health (HFZ-307), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, or from Food and Drug Administration 
district offices. Subsequent annual registration shall be accomplished 
on Form FDD-2891a (Annual Registration of Device Establishment), which 
will be furnished by FDA to establishments whose registration for that 
year was validated under Sec. 807.35(a). The forms will be mailed to the 
owner or operators of all establishments via the official correspondent 
in accordance with the schedule as described in Sec. 807.21(a). The 
completed form shall be mailed to the address designated in this 
paragraph 30 days after receipt from FDA.
    (b) The initial listing of devices and subsequent June and December 
updatings shall be on form FD-2892 (Medical Device Listing). Forms are 
obtainable upon request as described in paragraph (a) of this section. A 
separate form FD-2892 shall be submitted for each device or device class 
listed with the Food and Drug Administration. Devices having variations 
in physical characteristics such as size, package, shape, color, or 
composition should be considered to be one device: Provided, The 
variation does not change the function or intended use of the device. In 
lieu of form FD-2892, tapes for computer input or hard copy computer 
output may by submitted if equivalent in all elements of information as 
specified in form FD-2892. All formats proposed for use in lieu of form 
FD-2892 require initial review and approval by the Food and Drug 
Administration.
    (c) The listing obligations of the distributor are satisfied as 
follows:
    (1) The distributor is not required to submit a form FDA-2892 for 
those devices for which such distributor did not

[[Page 69]]

initiate or develop the specifications for the device or repackage or 
relabel the device. However, the distributor shall submit, for each 
device, the name and address of the manufacturer. Distributors 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 distributors; and
    (2) The distributor shall update the information required by 
paragraphs (c)(1) of this section at the intervals specified in 
Sec. 807.30.
[43 FR 37997, Aug. 25, 1978, as amended at 58 FR 46522, Sept. 1, 1993; 
60 FR 63606, Dec. 11, 1995]



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

    (a) Form FD-2891 and Form FD-2891(a) are the approved forms for 
initially providing the information required by the act and for 
providing annual registration, respectively. The required information 
includes the name and street address of the device establishment, 
including post office ZIP Code, all trade names used by the 
establishment, and the business trading name of the owner or operator of 
such establishment.
    (b) The owner or operator shall identify the device activities of 
the establishment such as manufacturing, repackaging, or distributing 
devices.
    (c) Each owner or operator is required to maintain a listing of all 
officers, directors, and partners for each establishment he registers 
and to furnish this information to the Food and Drug Administration upon 
request.
    (d) Each owner or operator shall provide the name of an official 
correspondent who will serve as a point of contact between the Food and 
Drug Administration and the establishment for matters relating to the 
registration of device establishments and the listing of device 
products. All future correspondence relating to registration, including 
requests for the names of partners, officers, and directors, will be 
directed to this official correspondent. In the event no person is 
designated by the owner or operator, the owner or operator of the 
establishment will be the official correspondent.
    (e) 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 act.
    (f) Form FD-2892 is the approved form for providing the device 
listing information required by the act. This required information 
includes the following:
    (1) The identification by classification name and number, 
proprietary name, and common or usual name of each device being 
manufactured, prepared, propagated, compounded, or processed for 
commercial distribution that has not been included in any list of 
devices previously submitted on form FD-2892.
    (2) The Code of Federal Regulations citation for any applicable 
standard for the device under section 514 of the act or section 358 of 
the Public Health Service Act.
    (3) The assigned Food and Drug Administration number of the approved 
application for each device listed that is subject to section 505, 507, 
or 515 of the act.
    (4) The name, registration number, and establishment type of every 
domestic or foreign device establishment under joint ownership and 
control of the owner or operator at which the device is manufactured, 
repackaged, or relabeled.
    (5) Whether the device, as labeled, is intended for distribution to 
and use by the general public.
    (6) Other general information requested on form FD-2892, i.e., (i) 
if the submission refers to a previously listed device, as in the case 
of an update, the document number from the initial listing document for 
the device, (ii) the reason for submission, (iii) the date on which the 
reason for submission occurred, (iv) the date that the form FD-2892 was 
completed, (v) the owner's or operator's name and identification number.
    (7) Labeling or other descriptive information (e.g., specification 
sheets or catalogs) adequate to describe the intended use of a device 
when the owner or operator is unable to find on the Food and Drug 
Administration list in

[[Page 70]]

the device listing package, an appropriate classification name for the 
device.
[42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37998, Aug. 25, 1978; 
58 FR 46523, Sept. 1, 1993]



Sec. 807.26  Amendments to establishment registration.

    Changes in individual ownership, corporate or partnership structure, 
or location of an operation defined in Sec. 807.3(c) shall be submitted 
on Form FD-2891(a). This information shall be submitted within 30 days 
of such changes. Changes in the names of officers and/or directors of 
the corporation(s) shall be filed with the establishment's official 
correspondent and shall be provided to the Food and Drug Administration 
upon receipt of a written request for this information.



Sec. 807.30  Updating device listing information.

    (a) Form FD-2892 shall be used to update device listing information. 
The preprinted original document number of each form FD-2892 on which 
the device was initially listed shall appear in block 2 on the form 
subsequently used to update the listing information for the device and 
on any correspondence related to the device.
    (b) An owner or operator shall update the device listing information 
during each June and December or, at its discretion, at the time the 
change occurs. Conditions that require updating and information to be 
submitted for each of these updates are as follows:
    (1) If an owner or operator introduces into commercial distribution 
a device identified with a classification name not currently listed by 
the owner or operator, then the owner or operator must submit form FD-
2892 containing all the information required by Sec. 807.25(f).
    (2) If an owner or operator discontinues commercial distribution of 
all devices in the same device class, i.e., with the same classification 
name, the owner or operator must submit form FD-2892 containing the 
original document number of the form FD-2892 on which the device class 
was initially listed, the reason for submission, the date of 
discontinuance, the owner or operator's name and identification number, 
the classification name and number, the proprietary name, and the common 
or usual name of the discontinued device.
    (3) If commercial distribution of a discontinued device identified 
on a form FD-2892 filed under paragraph (b)(2) of this section is 
resumed, the owner or operator must submit on form FD-2892 a notice of 
resumption containing: the original document number of the form 
initially used to list that device class, the reason for submission, 
date of resumption, and all other information required by 
Sec. 807.25(f).
    (4) If one or more classification names for a previously listed 
device with multiple classification names has been added or deleted, the 
owner or operator must supply the original document number from the form 
FD-2892 on which the device was initially listed and a supplemental 
sheet identifying the names of any new or deleted classification names.
    (5) Other changes to information on form FD-2892 will be updated as 
follows:
    (i) Whenever a change occurs only in the owner or operator name 
(block 6) or number (block 7), e.g., whenever one company's device line 
is purchased by another owner or operator, it will not be necessary to 
supply a separate form FD-2892 for each device. In such cases, the new 
owner or operator must follow the procedures in Sec. 807.26 and submit a 
letter informing the Food and Drug Administration of the original 
document number from form FD-2892 on which each device was initially 
listed for those devices affected by the change in ownership.
    (ii) The owner or operator must also submit update information 
whenever changes occur to the responses to the questions in blocks 12, 
12a, 13, 13a, and 14 on form FD-2892, or whenever establishment 
registration numbers, establishment names, and/or activities are added 
to or deleted from blocks 15, 16, and 17 of form FD-2892. The owner or 
operator must supply the original document number from the form FD-2892 
on which the device was initially listed, the reason for submission, and 
all other information required by Sec. 807.25(f).

[[Page 71]]

    (6) Updating is not required if the above information has not 
changed since the previously submitted list. Also, updating is not 
required if changes occur in proprietary names, in common or usual names 
(blocks 10 and 11 of form FD-2892), or to supplemental lists of 
unclassified components or accessories.
[43 FR 37998, Aug. 25, 1978]



Sec. 807.31  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.
    (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.
[43 FR 37999, Aug. 25, 1978, as amended at 51 FR 33033, Sept. 18, 1986; 
63 FR 5253, Feb. 2, 1998]

    Effective Date Note: At 63 FR 5253, Feb. 2, 1998, Sec. 807.31 was 
amended by adding new paragraph (d)(3), effective Feb. 2, 1999.

[[Page 72]]



Sec. 807.35  Notification of registrant.

    (a) The Commissioner will provide to the official correspondent, at 
the address listed on the form, a validated copy of Form FD-2891 or Form 
FD-2891(a) (whichever is applicable) as evidence of registration. A 
permanent registration number will be assigned to each device 
establishment registered in accordance with these regulations.
    (b) Owners and operators of device establishments who also 
manufacture or process blood or drug products at the same establishment 
shall also register with the Center for Biologics Evaluation and 
Research and Center for Drug Evaluation and Research, as appropriate. 
Blood products shall be listed with the Center for Biologics Evaluation 
and Research, Food and Drug Administration, pursuant to part 607 of this 
chapter; drug products shall be listed with the Center for Drug 
Evaluation and Research, Food and Drug Administration, pursuant to part 
207 of this chapter.
    (c) Although establishment registration and device listing are 
required to 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.
[42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37999, Aug. 25, 1978; 
53 FR 11252, Apr. 6, 1988]



Sec. 807.37  Inspection of establishment registration and device listings.

    (a) A copy of the forms FD-2891 and FD-2891a filed by the registrant 
will be available for inspection in accordance with section 510(f) of 
the act, at the Center for Devices and Radiological Health (HFZ-342), 
Food and Drug Administration, Department of Health and Human Services, 
1390 Piccard Dr., Rockville, MD 20850. 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 office. Upon request, verification of registration 
number or location of a registered establishment will be provided.
    (b)(1) The following information filed under the device listing 
requirements will be available for public disclosure:
    (i) Each form FD-2892 submitted;
    (ii) All labels submitted;
    (iii) All labeling submitted;
    (iv) All advertisements submitted;
    (v) All data or information that has already become a matter of 
public knowledge.
    (2) Requests for device listing information identified in paragraph 
(b)(1) of this section should be directed to the Center for Devices and 
Radiological Health (HFZ-342), Food and Drug Administration, Department 
of Health and Human Services, 1390 Piccard Dr., Rockville, MD 20850.
    (3) Requests for device listing information not identified in 
paragraph (b)(1) of this section shall be submitted and handled in 
accordance with part 20 of this chapter.
[43 FR 37999, Aug. 25, 1978, as amended at 53 FR 11252, Apr. 6, 1988; 55 
FR 11169, Mar. 27, 1990]



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--Registration Procedures for Foreign Device Establishments



Sec. 807.40  Establishment registration and device listing for U.S. agents of foreign manufacturers of devices.

    (a) Each foreign device manufacturer who exports devices into the 
United States shall designate a person as their U.S.-designated agent, 
who is responsible for:
    (1) Submitting MDR reports,
    (2) Submitting annual certifications,
    (3) Acting as the official correspondent,

[[Page 73]]

    (4) Submitting registration information,
    (5) Submitting device listing information, and
    (6) Submitting premarket notifications.
    (b) The foreign manufacturer shall provide FDA with a statement of 
authorization for their U.S.-designate to perform MDR reporting duties 
under part 803 of this chapter, and to register, list, and submit 
premarket notifications under this part. The foreign manufacturer must 
provide this statement of authorization along with the name, address, 
and telephone number of the person initially designated, or any 
subsequent person designated as the U.S.-designated agent, within 5 days 
of the initial or subsequent designation. Information shall be sent to 
the Center for Devices and Radiological Health, Medical Device 
Reporting, Food and Drug Administration, P.O. Box 3002, Rockville, MD 
20847-3002.
    (c) The U.S.-designated agent of a foreign device manufacturer that 
exports devices into the United States is required to register the 
foreign manufacturer's establishments or places of business, and to list 
the foreign manufacturer's devices, in accordance with subpart B of this 
part, unless exempt under subpart D of this part, and to submit 
premarket notifications in accordance with subpart E of this part. The 
information submitted shall be in the English language.
[60 FR 63606, Dec. 11, 1995]

    Effective Date Note:  At 61 FR 38347, July 23, 1996, Sec. 807.40 was 
stayed indefinitely.



                          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), 
(2), and (3) of the act, or because the Commissioner has found, under 
section 510(g)(4) of the act, that such registration is not necessary 
for the protection of the public health:
    (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 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.
    (j) Distributors of cigarettes or smokeless tobacco as defined in 
part 897 of this chapter.
[42 FR 42526, Aug. 23, 1977, as amended at 58 FR 46523, Sept. 1, 1993; 
61 FR 44615, Aug. 28, 1996]

[[Page 74]]



              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) 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.
    (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.



Sec. 807.85  Exemption from premarket notification.

    (a) A device is exempt from the premarket notification requirements 
of this subpart if the device intended for introduction into commercial 
distribution is not generally available in finished form for purchase 
and is not offered through labeling or advertising by the manufacturer, 
importer, or distributor thereof for commercial distribution, and the 
device meets one of the following conditions:
    (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.



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

[[Page 75]]

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 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.
    (k) 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.
    (l) 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

[[Page 76]]

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]

    Effective Date Note: At 63 FR 5253, Feb. 2, 1998, Sec. 807.87 was 
amended by redesignating paragraphs (i) through (k) as paragraphs (j) 
through (l), respectively, and by adding a new paragraph (i), effective 
Feb. 2, 1999.



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 Food and Drug Administration, 
Center for Devices and Radiological Health (HFZ-401), 1390 Piccard Dr., 
Rockville, MD 20850.
    (2) For devices regulated by the Center for Biologics Evaluation and 
Research, be addressed to the Food and Drug Administration, Center for 
Biologics Evaluation and Research, Division of Product Certification 
(HFB-240), 8800 Rockville Pike, Bethesda, MD 20892.
    (3) All inquiries regarding a premarket notification submission 
should be in writing and sent to one of the addresses above.
    (b) Be bound into a volume or volumes, where necessary.
    (c) Be submitted in duplicate on standard size paper, including the 
original and two copies of the cover letter.
    (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]



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

[[Page 77]]

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 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

[[Page 78]]

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 
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 written 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

[[Page 79]]

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 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]



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;

[[Page 80]]

    (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]

    Effective Date Note: At 63 FR 5253, Feb. 2, 1998, Sec. 807.100 was 
amended by redesignating paragraph (a)(4) as paragraph (a)(5) and by 
adding a new paragraph (a)(4), effective Feb. 2, 1999.



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

808.51  Alabama.
808.52  Alaska.
808.53  Arizona.
808.55  California
808.57  Connecticut.
808.59  Florida.
808.61  Hawaii.
808.67  Kentucky.
808.69  Maine.
808.71  Massachusetts.
808.73  Minnesota.
808.74  Mississippi.
808.77  Nebraska.
808.80  New Jersey.
808.81  New Mexico.
808.82  New York.
808.85  Ohio.
808.87  Oregon.
808.88  Pennsylvania.
808.89  Rhode Island.
808.93  Texas.
808.94  Utah.
808.97  Washington.
808.98  West Virginia.
808.101  District of Columbia.

    Authority:  21 U.S.C. 360j, 360k, 371.

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



                      Subpart A--General Provisions



Sec. 808.1  Scope.

    (a) 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 act.
    (b) Section 521(a) of the 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 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 act.
    (c) Section 521(b) of the 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 
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 
act. The Commissioner may promulgate an exemption

[[Page 81]]

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 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 act.
    (d) 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 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 act because they are not ``requirements 
applicable to a device'' within the meaning of section 521(a) of the 
act. The following are examples of State or local requirements that are 
not regarded as preempted by section 521 of the 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 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 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 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 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 act.
    (7) Section 521(a) does not preempt State or local provisions 
respecting delegations of authority and related administrative matters 
relating to devices.

[[Page 82]]

    (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, the Radiation Control for Health and 
Safety Act of 1968 (Pub. L. 90-602 (42 U.S.C. 263b et seq.)) 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.
    (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) 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 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) 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.
[43 FR 18665, May 2, 1978, as amended at 45 FR 67336, Oct. 10, 1980; 61 
FR 52654, Oct. 7, 1996]



Sec. 808.3  Definitions.

    (a) Act means the Federal Food, Drug, and Cosmetic Act.
    (b) 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.
    (c) 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 
act.
    (d) 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.
    (e) State means a State, American Samoa, the Canal Zone, the 
Commonwealth of Puerto Rico, the District of Columbia, Guam, Johnston 
Island, Kingman Reef, Midway Island, the Trust Territory of the Pacific 
Islands, the Virgin Islands, and Wake Island.
    (f) Substantially identical to refers to the fact that a State or 
local requirement does not significantly differ in effect from a Federal 
requirement.



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.
    (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.

[[Page 83]]

    (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 act because it is: (i) Equal to 
or substantially identical to a requirement under the act applicable to 
the device, or (ii) is not a requirement within the meaning of section 
521 of the 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.



                     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 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr. Rockville, MD 20857. 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.
    (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 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 act.

[[Page 84]]

    (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 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 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]



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 Dockets Management Branch 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 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

[[Page 85]]

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 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 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.



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 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 application for exemption under 
Sec. 808.20.



        Subpart C--Listing of Specific State and Local Exemptions



Sec. 808.51  Alabama.

    To the extent that the age restriction on the sale, barter, and 
exchange of cigarettes and smokeless tobacco found in Alabama Code, 
section 13A-12-3, is preempted under section 521(a) of the act, the Food 
and Drug Administration has exempted it from preemption under section 
521(b) of the act.
[62 FR 63274, Nov. 28, 1997]



Sec. 808.52  Alaska.

    To the extent that the age restriction on the sale and exchange of 
cigarettes and smokeless tobacco found in Alaska Statutes, sections 
11.76.100(a), is preempted under section 521(a) of the act, the Food and 
Drug Administration has exempted it from preemption under section 521(b) 
of the act.
[62 FR 63274, Nov. 28, 1997]

[[Page 86]]



Sec. 808.53  Arizona.

    The following Arizona medical device requirements are preempted by 
section 521(a) of the act, and the Food and Drug Administration has 
denied them exemptions from preemption under section 521(b) of the act:
    (a) Arizona Revised Statutes, Chapter 17, sections 36-1901.7(s) and 
36-1901.7(t).
    (b) Arizona Code of Revised Regulations, Title 9, Article 3, 
sections R9-16-303 and R9-16-304.
[45 FR 67336, Oct. 10, 1980]



Sec. 808.55  California.

    (a) The following California medical device requirements are 
enforceable notwithstanding section 521 of the act because the Food and 
Drug Administration exempted them from preemption under section 521(b) 
of the act: Business and Professions Code sections 3365 and 3365.6.
    (b) The following California medical device requirements are 
preempted by section 521 of the act, and FDA has denied them an 
exemption from preemption:
    (1) Sherman Food, Drug, and Cosmetic Law (Division 21 of the 
California Health and Safety Code), sections 26207, 26607, 26614, 26615, 
26618, 26631, 26640, and 26641, to the extent that they apply to 
devices.
    (2) Sherman Food, Drug, and Cosmetic Law, section 26463(m) to the 
extent that it applies to hearing aids.
    (3) Business and Professions Code section 2541.3, to the extent that 
it requires adoption of American National Standards Institute standards 
Z-80.1 and Z-80.2.
[45 FR 67324, Oct. 10, 1980]



Sec. 808.57  Connecticut.

    The following Connecticut medical device requirements are 
enforceable notwithstanding section 521(a) of the act because the Food 
and Drug Administration has exempted them from preemption under section 
521(b) of the act: Connecticut General Statutes, sections 20-403 and 20-
404.
[45 FR 67336, Oct. 10, 1980]



Sec. 808.59  Florida.

    The following Florida medical device requirements are preempted by 
section 521(a) of the act, and the Food and Drug Administration has 
denied them an exemption from preemption under section 521(b) of the 
act:
    (a) Florida Statutes, section 468.135(5).
    (b) Florida Administrative Code, section 10D-48.25(26).
[45 FR 67336, Oct. 10, 1980]



Sec. 808.61  Hawaii.

    (a) The following Hawaii medical device requirements are enforceable 
notwithstanding section 521 of the act, because the Food and Drug 
Administration has exempted them from preemption under section 521(b) of 
the act: Hawaii Revised Statutes, chapter 451A, Sec. 14.1, subsection 
(a) with respect to medical examination of a child 10 years of age or 
under, and subsection (c).
    (b) The following Hawaii medical device requirements are preempted 
by section 521(a) of the act, and the Food and Drug Administration has 
denied them exemption from preemption: Hawaii Revised Statutes, chapter 
451A, Sec. 14.1, subsection (a) to the extent that it requires a written 
authorization by a physician and does not allow adults to waive this 
requirement for personal, as well as religious reasons, and subsection 
(b).
[50 FR 30699, July 29, 1985; 50 FR 32694, Aug. 14, 1985]



Sec. 808.67  Kentucky.

    The following Kentucky medical device requirement is preempted by 
section 521(a) of the act, and the Food and Drug Administration has 
denied it an exemption from preemption under section 521(b) of the act: 
Kentucky Revised Statutes, section 334.200(1).
[45 FR 67336, Oct. 10, 1980]



Sec. 808.69  Maine.

    (a) The following Maine medical device requirement is enforceable 
notwithstanding section 521(a) of the act because the Food and Drug 
Administration has exempted it from preemption under section 521(b) of 
the act: Maine Revised Statutes Annotated,

[[Page 87]]

Title 32, section 1658-C, on the condition that, in enforcing this 
requirement, Maine apply the definition of ``used hearing aid'' in 
Sec. 801.420(a)(6) of this chapter.
    (b) The following Maine medical device requirement is preempted by 
section 521(a) of the act, and the Food and Drug Administration has 
denied it an exemption from preemption under section 521(b) of the act: 
Maine Revised Statutes Annotated, Title 32, section 1658-D and the last 
sentence of section 1658-E.
[45 FR 67336, Oct. 10, 1980]



Sec. 808.71  Massachusetts.

    (a) The following Massachusetts medical device requirements are 
enforceable notwithstanding section 521 of the act because the Food and 
Drug Administration has exempted them from preemption under section 
521(b) of the act:
    (1) Massachusetts General Laws, Chapter 93, Section 72, to the 
extent that it requires a hearing test evaluation for a child under the 
age of 18.
    (2) Massachusetts General Laws, Chapter 93, Section 74, except as 
provided in paragraph (6) of the Section, on the condition that, in 
enforcing this requirement, Massachusetts apply the definition of ``used 
hearing aid'' in Sec. 801.420(a)(6) of this chapter.
    (b) The following Massachusetts medical device requirements are 
preempted by section 521(a) of the act, and the Food and Drug 
Administration has denied them exemptions from preemption under section 
521(b) of the act.
    (1) Massachusetts General Laws, Chapter 93, Section 72, except as 
provided in paragraph (a) of this section.
    (2) Massachusetts General Laws, Chapter 93, Section 74, to the 
extent that it requires that the sales receipt contain a statement that 
State law requires a medical examination and a hearing test evaluation 
before the sale of a hearing aid.
[45 FR 67326, Oct. 10, 1980]



Sec. 808.73  Minnesota.

    The following Minnesota medical device requirements are preempted by 
section 521(a) of the act, and the Food and Drug Administration has 
denied them an exemption from preemption under section 521(b) of the 
act: Minnesota Statutes, sections 145.43 and 145.44.
[45 FR 67336, Oct. 10, 1980]



Sec. 808.74  Mississippi.

    The following Mississippi medical device requirement is preempted by 
section 521(a) of the act, and the Food and Drug Administration has 
denied it an exemption from preemption under section 521(b) of the act: 
Mississippi Code, section 73-14-3(g)(9).
[45 FR 67336, Oct. 10, 1980]



Sec. 808.77  Nebraska.

    (a) The following Nebraska medical device requirement is enforceable 
notwithstanding section 521(a) of the act because the Food and Drug 
Administration has exempted it from preemption under section 521(b) of 
the act: Nebraska Revised Statutes, section 71-4712(2)(c)(vi).
    (b) The following Nebraska medical device requirement is preempted 
by section 521(a) of the act, and the Food and Drug Administration has 
denied it an exemption from preemption under section 521(b) of the act: 
Nebraska Revised Statutes, section 71-4712(2)(c)(vii).
[45 FR 67336, Oct. 10, 1980]



Sec. 808.80  New Jersey.

    (a) The following New Jersey medical device requirements are 
enforceable notwithstanding section 521(a) of the act because the Food 
and Drug Administration has exempted them from preemption under section 
521(b) of the act:
    (1) New Jersey Statutes Annotated, section 45:9A-23 on the condition 
that, in enforcing this requirement, New Jersey apply the definition of 
``used hearing aid'' in Sec. 801.420(a)(6) of this chapter;
    (2) New Jersey Statutes Annotated, sections 45:9A-24 and 45:9A-25;
    (3) Chapter 3, Section 5 of the Rules and Regulations adopted 
pursuant to New Jersey Statutes Annotated 45:9A-1 et seq. except as 
provided in paragraph (b) of this section.
    (b) The following New Jersey medical device requirement is preempted 
by section 521(a) of the act, and the Food and Drug Administration has 
denied it

[[Page 88]]

an exemption from preemption under section 521(b) of the act: Chapter 3, 
Section 5 of the Rules and Regulations adopted pursuant to New Jersey 
Statutes Annotated 45:9A-1 et seq. to the extent that it requires 
testing to be conducted in an environment which meets or exceeds the 
American National Standards Institute S3.1 Standard.
[45 FR 67337, Oct. 10, 1980]



Sec. 808.81  New Mexico.

    The following New Mexico medical device requirement is enforceable 
notwithstanding section 521(a) of the act because the Food and Drug 
Administration has exempted it from preemption under section 521(b) of 
the act: New Mexico Statutes Annotated, section 67-36-16(F).
[45 FR 67337, Oct. 10, 1980]



Sec. 808.82  New York.

    (a) The following New York medical device requirements are 
enforceable notwithstanding section 521(a) of the act because the Food 
and Drug Administration has exempted them from preemption under section 
521(b) of the act:
    (1) General Business Law, Article 37, sections 784(3) and (4).
    (2) Official Compilation of Codes, Rules and Regulations of the 
State of New York, Chapter V, Title 19, Subchapter G, section 191.10 and 
section 191.11(a) on the condition that, in enforcing these 
requirements, New York apply the definition of ``used hearing aid'' in 
Sec. 801.420(a)(6) of this chapter and section 191.11(b), (c), (d), and 
(e).
    (b) The following New York medical device requirements are preempted 
by section 521(a) of the act, and the Food and Drug Administration has 
denied them an exemptions from preemption under section 521(b) of the 
act:
    (1) General Business Law, Article 37, section 784.1.
    (2) Official Compilation of Codes, Rules and Regulations of the 
State of New York, Chapter V, Title 19, Subchapter G, sections 191.6, 
191.7, 191.8, and 191.9.
[45 FR 67337, Oct. 10, 1980]



Sec. 808.85  Ohio.

    (a) The following Ohio medical device requirement is enforceable 
notwithstanding section 521(a) of the act because the Food and Drug 
Administration has exempted it from preemption under section 521(b) of 
the act: Ohio Revised Code, section 4747.09, the first two sentences 
with respect to disclosure of information to purchasers on the condition 
that, in enforcing these requirements, Ohio apply the definition of 
``used hearing aid'' in Sec. 801.420(a)(6) of this chapter.
    (b) The following Ohio medical device requirement is preempted by 
section 521(a) of the act, and the Food and Drug Administration has 
denied it an exemption from preemption under section 521(b) of the act: 
Ohio Revised Code, section 4747.09, the last two sentences with respect 
to medical examination of children.
[45 FR 67337, Oct. 10, 1980]



Sec. 808.87  Oregon.

    (a) The following Oregon medical device requriements are enforceable 
notwithstanding section 521(a) of the act because the Food and Drug 
Administration has exempted them from preemption under section 521(b) of 
the act: Oregon Revised Statutes, section 694.036 on the condition that, 
in enforcing this requirement, Oregon apply the definition of ``used 
hearing aid'' in Sec. 801.420(a)(6) of this chapter.
    (b) The following Oregon medical device requirements are preempted 
by section 521(a) of the act, and the Food and Drug Administration has 
denied them exemptions from preemption under section 521(b) of the act: 
Oregon Revised Statutes, sections 694.136(6) and (7).
[45 FR 67337, Oct. 10, 1980, as amended at 53 FR 11252, Apr. 6, 1988]



Sec. 808.88  Pennsylvania.

    (a) The following Pennsylvania medical device requirements are 
enforceable notwithstanding section 521(a) of the act because the Food 
and Drug Administration has exempted them from preemption under section 
521(b) of the act: 35 Purdon's Statutes 6700, section 504(4) on the 
condition that, in enforcing this requirement, Pennsylvania apply the

[[Page 89]]

definition of ``used hearing aid'' in Sec. 801.420(a)(6) of this 
chapter; section 506; and, section 507(2).
    (b) The following Pennsylvania medical device requirement is 
preempted by section 521(a) of the act and the Food and Drug 
Administration has denied it an exemption from preemption under section 
521(b) of the act: 35 Purdon's Statutes 6700, section 402.
[45 FR 67326, Oct. 10, 1980]



Sec. 808.89  Rhode Island.

    The following Rhode Island medical device requirements are preempted 
by section 521(a) of the act, and the Food and Drug Administration has 
denied them an exemption from preemption under section 521(b) of the 
act: Rhode Island General Laws, Section 5-49-2.1, and Section 2.2, to 
the extent that Section 2.2 requires hearing aid dispensers to keep 
copies of the certificates of need.
[45 FR 67337, Oct. 10, 1980]



Sec. 808.93  Texas.

    (a) The following Texas medical device requirement is enforceable 
notwithstanding section 521(a) of the act because the Food and Drug 
Administration has exempted it from preemption under section 521(b) of 
the act: Vernon's Civil Statutes, Article 4566, section 14(b) on the 
condition that, in enforcing this requirement, Texas apply the 
definition of ``used hearing aid'' in Sec. 801.420(a)(6) of this 
chapter.
    (b) The following Texas medical device requirement is preempted by 
section 521(a) of the act, and the Food and Drug Administration has 
denied it an exemption from preemption under section 521(b) of the act: 
Vernon's Civil Statutes, Article 4566, section 14(d).
[45 FR 67337, Oct. 10, 1980]



Sec. 808.94  Utah.

    To the extent that the age restriction on sales of cigarettes and 
smokeless tobacco found in the Utah Code Annotated, section 76-10-104, 
is preempted under section 521(a) of the act, the Food and Drug 
Administration has exempted it from preemption under section 521(b) of 
the act.
[62 FR 63274, Nov. 28, 1997]



Sec. 808.97  Washington.

    (a) The following Washington medical device requirement is 
enforceable notwithstanding section 521(a) of the act because the Food 
and Drug Administration has exempted it from preemption under section 
521(b) of the act: Revised Code of Washington 18.35.110(2)(e) (i) and 
(iii) on the condition that it is enforced in addition to the applicable 
requirements of this chapter.
    (b) The following Washington medical device requirements are 
preempted by section 521(a) of the act, and the Food and Drug 
Administration has denied them an exemption from preemption under 
section 521(b) of the act: Revised Code of Washington 
18.35.110(2)(e)(ii).
[45 FR 67337, Oct. 10, 1980]



Sec. 808.98  West Virginia.

    (a) The following West Virginia medical device requirements are 
enforceable notwithstanding section 521(a) of the act because the Food 
and Drug Administration has exempted them from preemption: West Virginia 
Code, sections 30-26-14 (b) and (c) and section 30-26-15(a) on the 
condition that in enforcing section 30-26-15(a) West Virginia apply the 
definition of ``used hearing aid'' in Sec. 801.420(a)(6) of this 
chapter.
    (b) The following West Virginia medical device requirement is 
preempted by section 521(a) of the act, and the Food and Drug 
Administration has denied it an exemption from preemption under section 
521(b) of the act: West Virginia Code, section 30-26-14(a).
[45 FR 67337, Oct. 10, 1980, as amended at 53 FR 35314, Sept. 13, 1988]



Sec. 808.101  District of Columbia.

    (a) The following District of Columbia medical device requirements 
are enforceable, notwithstanding section 521 of the act, because the 
Food and Drug Administration has exempted them from preemption under 
section 521(b) of the act:
    (1) Act 2-79, section 5, to the extent that it requires an 
audiological evaluation for children under the age of 18.
    (2) Act 2-79, section 6, on the condition that in enforcing section 
6(a)(5),

[[Page 90]]

the District of Columbia apply the definition of ``used hearing aid'' in 
Sec. 801.420(a)(6) of this chapter.
    (b) The following District of Columbia medical device requirement is 
preempted by section 521(a) of the act, and the Food and Drug 
Administration has denied it an exemption from preemption under section 
521(b) of the act: Act 2-79, section 5, except as provided in paragraph 
(a) of this section.
[46 FR 59236, Dec. 4, 1981]



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.
809.5  Exemption from batch certification requirements for in vitro 
          antibiotic susceptibility devices subject to section 507 of 
          the act.
809.6  Conditions on the effectiveness of exemptions of antibiotic 
          susceptibility devices from batch certification requirements.

                           Subpart B--Labeling

809.10  Labeling for in vitro diagnostic products.

         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.

    Authority:  21 U.S.C. 331, 351, 352, 355, 357, 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]



Sec. 809.5  Exemption from batch certification requirements for in vitro antibiotic susceptibility devices subject to section 507 of the act.

    (a) Antibiotic susceptibility devices subject to section 507 of the 
act are exempt from the batch certification requirements of part 431 of 
this chapter if the following conditions are met:
    (1) The antibiotic susceptibility device is approved for marketing 
under an appropriate antibiotic application.
    (2) The antibiotic susceptibility device is packaged and labeled for 
dispensing in accordance with the applicable regulation (monograph) in 
this chapter except where other labeling has been approved in an 
applicable antibiotic application.
    (3) The bulk antibiotic drug used in preparing the antibiotic 
susceptibility device meets the standards of identity, strength, 
quality, and purity specified

[[Page 91]]

in the applicable regulation (monograph) in this chapter except where 
other standards have been approved in an applicable antibiotic 
application.
    (4) The antibiotic susceptibility device meets the standards of 
identity, strength, quality, and purity specified in the applicable 
regulation (monograph) in this chapter except where other standards have 
been approved in an applicable antibiotic application.
    (b) For each antibiotic susceptibility device subject to an 
exemption under this section, an approved antibiotic application is 
regarded to be an approved premarket approval application under section 
515 of the act.
    (c) Nothing in this section prevents a manufacturer from applying 
for batch certification of an antibiotic susceptibility device as 
provided in section 507(c) of the act.
    (d) All exemptions from batch certification requirements for 
antibiotic susceptibility devices under this section are subject to the 
conditions of effectiveness under Sec. 809.6.
[47 FR 39160, Sept. 7, 1982, as amended at 53 FR 11252, Apr. 6, 1988]



Sec. 809.6  Conditions on the effectiveness of exemptions of antibiotic susceptibility devices from batch certification requirements.

    (a) If at any time after an exemption from batch certification 
requirements for an antibiotic susceptibility device has been granted, 
the Commissioner finds on the basis of new information before the agency 
with respect to such exempted device evaluated together with the 
evidence available to the agency when such exemption was granted, that 
certification of each batch is necessary to ensure its safety and 
efficacy of use, the Commissioner shall act immediately to revoke all 
exemptions from batch certification requirements granted for such 
device.
    (b) If the Commissioner finds that the person granted an exemption 
from batch certification requirements for an antibiotic susceptibility 
device has failed to comply with the requirements of section 507 of the 
act and the regulations promulgated thereunder; or if the Commissioner 
finds that the requirements of Sec. 809.5 have not been met; or if the 
Commissioner finds that the petition for exemption from batch 
certification contains any false statements of fact, the Commissioner 
may revoke the exemption from batch certification requirements 
immediately and require batch certification of the device until such 
person shows adequate cause why the exemption from batch certification 
requirements should be reinstated.
    (c) If the Commissioner repeals or suspends an exemption from batch 
certification requirements for an antibiotic susceptibility device, a 
notice to that effect and the reasons therefor will be published in the 
Federal Register.
    (d) Any person who contests the revocation or suspension or denial 
of reinstatement of an exemption from batch certification requirements 
for an antibiotic susceptibility device shall have an opportunity for a 
regulatory hearing before the Food and Drug Administration under part 16 
of this chapter.
[47 FR 39160, Sept. 7, 1982]



                           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

[[Page 92]]

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.
    (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.
    (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

[[Page 93]]

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.
    (iii) Adequate instructions for reconstitution, mixing, dilution, 
etc.
    (iv) 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. 
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

[[Page 94]]

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.
    (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,

[[Page 95]]

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.
    (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;

[[Page 96]]

    (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.
[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]

    Effective Date Note: At 62 FR 62259, Nov. 21, 1997, Sec.  809.10 was 
amended in paragraph (a) by adding at the end of the first sentence ``or 
as provided in paragraph (e) of this section'' and by adding new 
paragraph (e), effective Nov. 23, 1998.



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



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

[[Page 97]]

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.'' 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]

    Effective Date Note: At 62 FR 62259, Nov. 21, 1997, Sec. 809.30 was 
added to subpart C, effective Nov. 23, 1998.



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, 360h, 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 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

[[Page 98]]

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) Reasonable probability means that it is more likely than not 
that an event will occur.
    (i) 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.
    (j) 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.
    (k) 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.



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 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; and
    (iv) The manufacturing lot numbers or serial numbers of the device 
or other identification numbers; 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.

[[Page 99]]

    (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.



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

[[Page 100]]

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 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

[[Page 101]]

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 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

[[Page 102]]

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:
    (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

[[Page 103]]

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;
    (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.

[[Page 104]]

    (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.
812.30  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.
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, 356, 357, 360, 360c-
360f, 360h-360j, 371, 372, 374, 379e, 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

[[Page 105]]

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 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.

[[Page 106]]

    (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) Custom device means a device that:
    (1) Necessarily deviates from devices generally available or from an 
applicable performance standard or premarket approval requirement in 
order to comply with the order of an individual physician or dentist;
    (2) Is not generally available to, or generally used by, other 
physicians or dentists;
    (3) Is not generally available in finished form for purchase or for 
dispensing upon prescription;
    (4) Is not offered for commercial distribution through labeling or 
advertising; and
    (5) Is intended for use by an individual patient named in the order 
of a physician or dentist, and is to be made in a specific form for that 
patient, or is intended to meet the special needs of the physician or 
dentist in the course of professional practice.
    (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.
    (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

[[Page 107]]

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 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.
[45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8956, Jan. 27, 1981; 48 
FR 15622, Apr. 12, 1983]



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:

[[Page 108]]

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



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.



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.

    All applications, supplemental applications, reports, requests for 
waivers, requests for import or export approval, and other 
correspondence relating to matters covered by this part shall be 
addressed to the Center for Devices and Radiological Health, Document 
Mail Center (HFZ-401), Food and Drug Administration, 1390 Piccard Dr., 
Rockville, MD 20850. The outside wrapper of each submission shall state 
what the submission is, for example an ``IDE application,'' a 
``supplemental IDE application,'' or ``correspondence concerning an IDE 
(or an IDE application).''
[45 FR 3751, Jan. 18, 1980, as amended at 53 FR 11252, Apr. 6, 1988; 55 
FR 11169, Mar. 27, 1990]

[[Page 109]]



            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 three copies of a signed ``Application 
for an Investigational Device Exemption'' (IDE application), together 
with accompanying materials, by registered mail or by hand to the 
address in Sec. 812.19. Subsequent correspondence concerning an 
application or a supplemental application shall be submitted 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 such written authorization 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 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

[[Page 110]]

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 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]



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 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.
[45 FR 3751, Jan. 18, 1980, as amended at 50 FR 7518, Feb. 22, 1985]



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:

[[Page 111]]

    (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 
inadquate, 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. A sponsor shall: (1) Submit to 
FDA a supplemental application if the sponsor or an investigator 
proposes a change in the investigational plan that may affect its 
scientific soundness or the rights, safety, or welfare of subjects, and 
(2) obtain FDA approval under Sec. 812.30(a) of any such change, and IRB 
approval when the change involves the rights, safety, or welfare of 
subjects (see Secs. 56.110 and 56.111), before implementation. These 
requirements 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, which deviation shall be reported to FDA within 
5 working days after the sponsor learns of it (see Sec. 812.150(a)(4)). 
Whenever a sponsor intends to conduct a clinical investigation with an 
exception from informed consent for emergency research as set forth in 
Sec. 50.24 of this chapter, the sponsor shall submit a separate IDE for 
such investigation.
    (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

[[Page 112]]

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; 61 FR 51531, 
Oct. 2, 1996]



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;
    (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;

[[Page 113]]

    (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 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

[[Page 114]]

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 95S-0158 in the Dockets 
Management Branch (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.
    (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]



                 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.

[[Page 115]]

    (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]

    Effective Date Note: At 63 FR 5253, Feb. 2, 1998, Sec. 812.43 was 
amended by adding new paragraph (c)(5), effective Feb. 2, 1999.



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 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 (a)(7)(iii) of 
this chapter, the sponsor shall promptly submit to the IDE file and to 
Docket

[[Page 116]]

Number 95S-0158 in the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
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]



                   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 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

[[Page 117]]

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]

    Effective Date Note: At 63 FR 5253, Feb. 2, 1998, Sec. 812.110 was 
amended by redesignating paragraph (d) as paragraph (e) and adding new 
paragraph (d), effective Feb. 2, 1999.



Sec. 812.119  Disqualification of a clinical investigator.

    (a) If FDA has information indicating that an 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 false information either to the sponsor of the 
investigation or in any required report, the Center for Devices and 
Radiological Health will furnish the investigator written notice of the 
matter under complaint 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 
Center for Devices and Radiological Health, the disqualification process 
will be terminated. If an explanation is offered but not accepted by the 
Center for Devices and Radiological Health, 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 entitled to 
receive investigational devices.
    (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 deliberately or repeatedly submitted false 
information either to the sponsor of the investigation or 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 IRB that the investigator is not 
entitled to receive investigational devices. The notification will 
provide a statement of basis for such determination.
    (c) Each investigational device exemption (IDE) and each cleared or 
approved application submitted under this part, subpart E of part 807 of 
this chapter, or part 814 of this chapter containing data reported by an 
investigator who has been determined to be ineligible to receive 
investigational devices will be examined to determine whether the 
investigator has submitted unreliable data that are essential to the 
continuation of the investigation or essential to the approval or 
clearance of any marketing application.
    (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 IDE immediately 
and notify the sponsor and the reviewing IRB of the determination. 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.
    (e) If the Commissioner determines, after the unreliable data 
submitted by

[[Page 118]]

the investigator are eliminated from consideration, that the continued 
clearance or approval of the marketing application for which the data 
were submitted cannot be justified, the Commissioner will proceed to 
withdraw approval or rescind clearance of the medical device in 
accordance with the applicable provisions of the act.
    (f) An investigator who has been determined to be ineligible to 
receive investigational devices may be reinstated as eligible when the 
Commissioner determines that the investigator has presented adequate 
assurances that the investigator will employ investigational devices 
solely in compliance with the provisions of this part and of parts 50 
and 56 of this chapter.
[62 FR 12096, Mar. 14, 1997]



                          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.
    (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.
    (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:

[[Page 119]]

    (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 or a notice of completion of a product 
development protocol.
    (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]

    Effective Date Note: At 63 FR 5253, Sec. 812.140 was amended by 
revising paragraph (b)(3), effective Feb. 2, 1999. For the convenience 
of the user, the revised text is set forth as follows:

Sec. 812.140  Records.

                                * * * * *

    (b)* * * 
    (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.

                                * * * * *



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,

[[Page 120]]

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 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

[[Page 121]]

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 PMA's.
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.
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  Requests for extension.
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, 371, 372, 373, 
374, 375, 379, 379e, 381.

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



                           Subpart A--General



Sec. 814.1  Scope.

    (a) This part implements section 515 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

[[Page 122]]

    (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.



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 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 fewer than

[[Page 123]]

4,000 individuals in the United States per year.
[51 FR 26364, July 22, 1986, as amended at 61 FR 15190, Apr. 5, 1996; 61 
FR 33244, June 26, 1996]



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 Dockets Management 
Branch (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.
    (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 
Secs. 20.103 and 20.104.

[[Page 124]]

    (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) A study conducted outside the United States submitted in support 
of a PMA and conducted under an IDE shall comply with part 812. A study 
conducted outside the United States submitted in support of a PMA and 
not conducted under an IDE shall comply with the provisions in paragraph 
(b) or (c) of this section, as applicable.
    (b) Research begun on or after effective date. FDA will accept 
studies submitted in support of a PMA which have been conducted outside 
the United States and begun on or after November 19, 1986, if the data 
are valid and the investigator has conducted the studies in conformance 
with the ``Declaration of Helsinki'' or the laws and regulations of the 
country in which the research is conducted, whichever accords greater 
protection to the human subjects. If the standards of the country are 
used, the applicant shall state in detail any differences between those 
standards and the ``Declaration of Helsinki'' and explain why they offer 
greater protection to the human subjects.
    (c) Research begun before effective date. FDA will accept studies 
submitted in support of a PMA which have been conducted outside the 
United States and begun before November 19, 1986, if FDA is satisfied 
that the data are scientifically valid and that the rights, safety, and 
welfare of human subjects have not been violated.
    (d) 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

[[Page 125]]

validate the data through an on-site inspection or other appropriate 
means.
    (e) 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.

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

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



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 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:
    (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 in six 
copies each bound in one or more numbered volumes of reasonable size. 
The applicant shall include information that it believes to be trade 
secret or confidential commercial or financial information in all copies 
of the PMA and identify in at least one copy 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

[[Page 126]]

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 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 
act or the Radiation Control for Health and Safety Act of 1968 (42 
U.S.C. 263b et seq.) 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 act or under the Radiation Control 
for Health and Safety Act, 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

[[Page 127]]

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 identified as such. 
Information on clinical investigations involving human subjects shall 
include the following:
    (A) A statement with respect to each study that it either was 
conducted in compliance with the institutional review board regulations 
in part 56, 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; or if the study was not conducted in 
compliance with those regulations, a brief statement of the reason for 
the noncompliance.
    (B) A statement that each study was conducted in compliance with 
part 812 or part 813 concerning sponsors of clinical investigations and 
clinical investigators, or if the study was not conducted in compliance 
with those regulations, a brief statement of the reason for the 
noncompliance.
    (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 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.
    (13) 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 writing 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

[[Page 128]]

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 three copies of any update report 
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 706 of the 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, 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 three copies each bound 
in one or more numbered volumes of reasonable size. A PMA for a device 
that contains a color additive that is subject to section 706 of the act 
will not be approved until the color additive is listed for use in or on 
the device.
    (g) FDA has issued a PMA guideline to assist the applicant in the 
arrangement and content of a PMA. This guideline is available from the 
Center for Devices and Radiological Health, Office of Standards and 
Regulations (HFZ-80), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857.
    (h) A PMA, PMA amendment, PMA supplement, or correspondence with 
respect to a PMA shall be sent to the PMA Document Mail Center (HFZ-
401), Center for Devices and Radiological Health, Food and Drug 
Administration, 1390 Piccard Dr., Rockville, MD 20850.

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

[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]

    Effective Date Note: At 63 FR 5253, Feb. 2, 1998, Sec. 814.20 was 
amended by redesignating paragraph (b)(12) as paragraph (b)(13) and 
adding a new paragraph (b)(12), effective Feb. 2, 1999.



Sec. 814.37  PMA amendments and resubmitted PMA's.

    (a) An applicant may amend a pending PMA or PMA supplement to revise 
existing information or provide additional information.
    (b) 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.
    (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.

[[Page 129]]

    (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.



Sec. 814.39  PMA supplements.

    (a) After FDA 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. 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 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 manufacturing facilities, methods, or quality control 
procedures.
    (5) Changes in sterilization procedures.
    (6) Changes in packaging.
    (7) Changes in the performance or design specifications, circuits, 
components, ingredients, principle of operation, or physical layout of 
the device.
    (8) 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) 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 three copies of a PMA supplement 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 copies and additional 
information if requested by FDA. 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.
    (d)(1) After FDA approves a PMA, any change described in paragraph

[[Page 130]]

(d)(2) of this section 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.
    (ii) Labeling changes that add or strengthen an instruction that is 
intended to enhance the safe use of the device.
    (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) 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--
    (1) A periodic report under Sec. 814.84 or
    (2) A 30-day PMA supplement under this paragraph.

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. lf 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.

(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]



                     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 under Sec. 814.45 and to request 
administrative review under section 515 (d)(3) and (g) of the act.



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

[[Page 131]]

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 Office of Device Evaluation 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 Center 
for Devices and Radiological Health. 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]

    Effective Date Note: At 63 FR 5254, Feb. 2, 1998, Sec. 814.42 was 
amended by adding new paragraph (e)(5), effective Feb. 2, 1999.



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 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

[[Page 132]]

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)(3) 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. FDA will publish in 
the Federal Register after each quarter a list of the approvals 
announced in that quarter. 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 Dockets Management Branch (HFA-305), Food and 
Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
    (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) 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;
    (iii) Restrictions imposed on the device under section 
515(d)(1)(B)(ii) or 520(e) of the act;
    (iv) 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)(3) 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 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:

[[Page 133]]

    (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)(3) 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]



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 or informed consent regulations in part 50, was not conducted in 
compliance with those regulations such that the rights or safety of 
human subjects were not adequately protected.
    (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)(3) 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 (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. FDA will publish in the Federal 
Register after each quarter a list of the denials announced in that 
quarter. 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.

[[Page 134]]

    (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 (HFI-35), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
    (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)(3) 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]



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 or informed consent regulations in part 50, was not conducted in 
compliance with those regulations such that the rights or safety of 
human subjects were not adequately protected.
    (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, data and information in the PMA file will be 
available for public disclosure in accordance with Sec. 814.9.



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

[[Page 135]]

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 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

[[Page 136]]

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.

(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]



                        Subparts F-G  [Reserved]



                   Subpart H--Humanitarian Use Devices

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



Sec. 814.100  Purpose and scope.

    (a) This subpart H implements section 520(m) of the act. 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 fewer than 4,000 individuals in the United States per 
year. This subpart provides procedures for obtaining:
    (1) HUD designation of a medical device; and
    (2) Temporary 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.
    (b) 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

[[Page 137]]

notification as required under part 807 of this chapter.
    (c) 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 Device Evaluation (ODE), 
Center for Devices and Radiological Health (CDRH).
    (d) The approval by ODE of an HDE under this subpart H shall be 
effective for a period of 18 months from the date of the approval 
letter, and shall permit the applicant to market the HUD in the United 
States in accordance with the restrictions described in this subpart H. 
Extensions of the approval may be granted in accordance with this 
subpart H.



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 fewer than 4,000 people in 
the United States per year. If the device is for diagnostic purposes, 
the documentation must demonstrate that fewer than 4,000 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 
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 fewer than 4,000 people in the 
United States per year;
    (ii) FDA determines that, for a diagnostic device, 4,000 or more 
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

[[Page 138]]

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.



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) Time for submission. An original HDE may only be submitted to 
the agency between October 24, 1996, and April 27, 2001, unless 
otherwise permitted by statute.
    (c) 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 Secs. 814.20(b)(3)(v)(B), (b)(3)(vi), and 
(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 to 
an assessment of the risks and probable benefits of the device; 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; and
    (5)  The amount to be charged for the device and 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, verifying that the amount 
charged does not exceed the costs of the device's research, development, 
fabrication, and distribution.
    (d) Omission of information. If the applicant believes that certain 
information required under paragraph (c) 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.
    (e) Address for submissions and correspondence. Copies of all 
original HDE's, amendments, supplements, and requests for extension, as 
well as any correspondence relating to an HDE, shall be sent or 
delivered to the Document Mail Center (HFZ-401), Office of

[[Page 139]]

Device Evaluation, Center for Devices and Radiological Health, Food and 
Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850.



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. 
The timeframes and extension of review times set forth in Sec. 814.37 
for PMA's shall also be applicable to HDE's.



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 the requirements set forth in Sec. 814.110.



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 45 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(c);
    (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 180-day review period, and applicant's options in response to FDA 
refuse to file decisions shall apply to HDE's submitted under this 
subpart as well as to PMA's submitted under Sec. 814.20.
[61 FR 33244, June 26, 1996, as amended at 63 FR 5254, Feb. 2, 1998]

    Effective Date Note: At 63 FR 5254, Feb. 2, 1998, Sec. 814.112 was 
amended by adding new paragraph (a)(4), effective Feb. 2, 1999.



Sec. 814.114  Timeframes for reviewing an HDE.

    Within 180 days after receipt of an HDE that is accepted for filing 
and to which the applicant does not submit a major amendment, FDA will 
send the applicant an approval order, an approvable letter, or a not 
approvable letter (under Sec. 814.116), or an order denying approval 
(under Sec. 814.118).



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.
    (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 deficiencies in the draft 
final labeling.

[[Page 140]]

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 published in the Federal 
Register in accordance with the rules and policies applicable to PMA's 
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) Restrictions imposed on the device under section 520(e) of the 
act;
    (3) Postapproval requirements as described in subpart E of this 
part; and
    (4) 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).



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;
    (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

[[Page 141]]

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; and
    (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)(3) 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.
    (e) Unless FDA otherwise determines that continued marketing under 
the HDE is inconsistent with the intent of section 520(m) of the act, 
FDA will not withdraw approval of an HDE solely because it is 
subsequently determined that the disease or condition for which the HUD 
is intended affects or is manifested in more than 4,000 people in the 
United States per year. However, this fact may serve as a basis for 
disapproving an extension request.



Sec. 814.120  Requests for extension.

    (a) Eligibility. In response to a request by the holder of an HDE, 
FDA may extend the HDE for an additional 18-month term. An exemption may 
be extended more than once, and may be extended after the expiration of 
the 5-year period that began on October 24, 1996, as provided by section 
520(m)(5) of the act. If the approval term for an HDE has lapsed, the 
HDE is ineligible for extension under this section and the applicant 
must cease marketing the device until a new HDE has been submitted and 
approved in accordance with this part.
    (b) Submission. In order to avoid the risk of a lapse in marketing 
approval, the holder of an HDE wishing to obtain an extension shall 
submit such a request to FDA at least 90 days prior to the expiration of 
the HDE. A request for extension must be submitted in writing, together 
with a new, separately bound, request for HUD designation. The request 
for extension and the request for HUD designation shall be submitted to 
the Office of Device Evaluation, CDRH at the address specified for the 
submission of original HDE's (Sec. 814.104(e)), and the outside envelope 
should be plainly marked: ``Request for Extension of HDE Approval.'' The 
submission shall state the applicant's name and address, the HDE number, 
and shall include the following information based upon the first 12 
months of experience with the device following the most recent HDE 
approval or extension:
    (1) An update of the information required under Sec. 814.102(a) in a 
separately bound volume;
    (2) An update of the information required under Secs. 814.104(c)(2), 
(c)(3), and (c)(5);
    (3) The number of devices that have been shipped or sold since 
initial marketing approval under this subpart and, if the number shipped 
or sold exceeds 4,000, 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;

[[Page 142]]

    (4) Information describing the applicant's clinical experience with 
the device since the HDE was initially approved. This shall include 
safety information that is known or reasonably should be known to the 
applicant, medical device reports made pursuant to part 803 of this 
chapter, any data generated from 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 labeling; and
    (5) A summary of any changes made to the device in accordance with 
supplements submitted under Sec. 814.108.
    (c) Action. Within 90 days of receipt of a request for an extension 
of an HDE that is submitted in accordance with this section, FDA will 
send the applicant either an approval order, approvable letter, a not 
approvable letter, or an order denying approval, applying the same 
criteria under this subpart as are applicable to the original HUD 
designation and HDE application. The effective date of an extension 
shall be the day the extension was granted or the day following the last 
effective day of the original HDE approval or the most recent extension, 
whichever is later. An extension request not acted upon by FDA within 90 
days shall be deemed approved.
    (d) Waiver of final report. An HDE holder seeking a request for 
extension under this section is exempt from the requirement of 
submitting a final report under Sec. 814.126(b).



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 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 the IRB located at the facility or by a similarly 
constituted IRB that has agreed to oversee such use and to which the 
local IRB has deferred in a letter to the HDE holder, signed by the IRB 
chair or an authorized designee.
    (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.



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. 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 required under subpart E of this 
part, the holder of an approved HDE shall prepare and submit the 
following complete, accurate, and timely reports:
    (1) Final report. Unless a request for extension is submitted in 
accordance with Sec. 814.120, a final report shall be submitted no later 
than 90 days following the expiration of the period of marketing 
approval. The final report shall include: An estimate of the number of 
patients who were treated or diagnosed with the device and the number of 
devices shipped or sold since initial marketing approval under this 
subpart H. (If the number of devices shipped or

[[Page 143]]

sold exceeds 4,000 per year, an explanation and estimate of the number 
of devices used per patient shall be included. Similarly, 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.) The holder 
of the HDE shall also report information regarding retrieval or 
disabling of unused devices, a summary of results and conclusions with 
regard to clinical use of the device, and a summary of the medical 
device reports submitted under part 803 of this chapter. The report 
shall also contain a summary and bibliography of published and 
unpublished data, reports, and studies involving the device that are 
known to or that reasonably should be known to the applicant and were 
not previously submitted to FDA. If, after reviewing the summary and 
bibliography, FDA concludes that FDA needs a copy of the unpublished or 
published information, FDA will notify the applicant that copies shall 
be submitted.
    (2) Other. An HDE holder shall, for the duration of the period that 
a HUD is approved for marketing, 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.



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.
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.

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

[[Page 144]]



                      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 
human blood and blood components are not subject to this part, but are 
subject to part 606 of this chapter.
    (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) Limitations. The quality system regulation in this part 
supplements regulations in other parts of this chapter except where 
explicitly stated otherwise. In the event that it is impossible to 
comply with all applicable regulations, both 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 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. Guidance is available from the Center for 
Devices and Radiological Health, Division of Small Manufacturers 
Assistance, (HFZ-220), 1350 Piccard Dr., Rockville, MD 20850, U.S.A., 
telephone 1-800-638-2041 or 1-301-443-6597, FAX 301-443-8818.

[[Page 145]]

    (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.
    (f) This part does not apply to distributors of cigarettes or 
smokeless tobacco as defined in part 897 of this chapter.



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.
    (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.

[[Page 146]]

    (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.
    (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.



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 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.

[[Page 147]]

    (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 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

[[Page 148]]

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 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

[[Page 149]]

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.



               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;

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    (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.
    (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

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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.
    (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:

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    (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.



               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;

[[Page 153]]

    (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 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.



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.



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.

[[Page 154]]



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, 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;

[[Page 155]]

    (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 device identification(s) and control number(s) used.



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 or 804 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 or 804 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 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 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.

[[Page 156]]



                          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 or 804 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 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.



                    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.

                    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 requires the 
adoption of a method of device tracking by any person who registers 
under section 510 of the act and is engaged in the manufacture and 
distribution of devices the failure of which would be reasonably likely 
to have serious adverse health consequences if the devices are life-
sustaining or life-supporting devices used outside of a device user 
facility or are permanently implantable devices. This part also applies 
to any other device that the Food and Drug Administration (FDA) 
designates as requiring a method of tracking to protect the public 
health. A device subject to this part either by statutory requirement or 
by FDA designation is referred to herein 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

[[Page 157]]

other commercial enterprises, device user facilities and licensed 
practitioners) and, ultimately, to any person for whom the device is 
intended 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 must register 
under section 510 of the act, and that responsibility cannot be altered, 
modified, or in any way abrogated by contracts or other agreements.
    (c) Each manufacturer of a tracked device shall implement a method 
of tracking devices by August 29, 1993.
    (d) 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 501(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.
    (e) 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.



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, Office of Compliance, 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, 
Office of Compliance and Surveillance, CDRH, approves the request under 
Sec. 10.30(e)(2)(i) of this chapter.
    (d) For petitions received under this section before August 29, 
1993, FDA will, within 60 days, approve or disapprove the petition or 
extend the effective date of this part for the device that is the 
subject of the petition. Any extension that FDA grants to the effective 
date will be based upon the additional time FDA needs to complete its 
review of the petition.
[58 FR 43447, Aug. 16, 1993, as amended at 59 FR 31138, June 17, 1994]



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 required to register under section 510 of

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the act and Sec. 807.20 of this chapter. ``Importer'' does not include 
anyone who only performs a service for the person who furthers the 
marketing, i.e., 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) Permanently implantable device means a device that is intended 
to be placed into a surgically or naturally formed cavity of the human 
body 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 any device which is intended 
and used for temporary purposes or which is intended for explantation.
    (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 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.



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 device the failure of which would be 
reasonably likely to have a serious adverse health consequence, that is 
either a life-sustaining or life-supporting device used outside of a 
device user facility or a permanently implantable device, or a 
manufacturer of any other device that FDA, in its discretion, designates 
for tracking, shall track that device in accordance with this part.

[[Page 159]]

    (b) Manufacturers have the responsibility to identify devices that 
meet the criteria for tracking and to initiate tracking. By way of 
illustration and to provide guidance, FDA has set out below a list of 
example devices it regards as subject to tracking under the criteria set 
forth in this regulation.
    (1) Permanently implantable devices.

                                                                        
------------------------------------------------------------------------
  21 CFR                           Classification                       
------------------------------------------------------------------------
870.3450.  Vascular graft prosthesis of less than 6 millimeters diameter
870.3460.  Vascular graft prosthesis of 6 millimeters and greater       
            diameter                                                    
(no cite)  Total temporomandibular joint prosthesis.                    
(no cite)  Glenoid fossa prosthesis.                                    
(no cite)  Mandibular condyle prosthesis.                               
(no cite)  Interarticular disc prosthesis (interpositional implant).    
870.3545.  Ventricular bypass (assist) device                           
870.3610.  Implantable pacemaker pulse generator                        
870.3680.  Cardiovascular permanent pacemaker electrode                 
870.3800.  Annuloplasty ring                                            
870.3925.  Replacement heart valve                                      
(no cite)  Automatic implantable cardioverter/defibrillator             
878.3720.  Tracheal prosthesis                                          
882.5820.  Implanted cerebellar stimulator                              
882.5830.  Implanted diaphragmatic/phrenic nerve stimulator             
(no cite)  Implantable infusion pumps                                   
------------------------------------------------------------------------

    (2) Life-sustaining or life-supporting devices used outside device 
user facilities

                                                                        
------------------------------------------------------------------------
  21 CFR                           Classification                       
------------------------------------------------------------------------
868.2375.  Breathing frequency monitors (apnea monitors) (including     
            ventilatory efforts monitors)                               
868.5895.  Continuous ventilator                                        
870.5300.  DC-defibrillator and paddles                                 
------------------------------------------------------------------------

    (c) FDA designates the following devices as subject to tracking. 
Manufacturers must track these devices in accordance with this part.

                                                                        
------------------------------------------------------------------------
  21 CFR                           Classification                       
------------------------------------------------------------------------
876.3350.  Penile inflatable implant                                    
878.3530.  Silicone inflatable breast prosthesis                        
878.3540.  Silicone gel-filled breast prosthesis                        
876.3750.  Testicular prosthesis, silicone gel-filled                   
(no cite)  Silicone gel-filled chin prosthesis                          
(no cite)  Silicone gel-filled angel chik reflux valve                  
880.5725.  Infusion pumps                                               
------------------------------------------------------------------------

    (d) FDA, when responding to premarket notification submissions and 
approving premarket approval applications, will notify the sponsor that 
FDA believes the device meets the criteria of section 519(e)(1) and 
therefore should be tracked. FDA will also, after notifying the sponsor, 
publish a notice in the Federal Register announcing that FDA believes a 
new generic type of device is subject to tracking and soliciting comment 
on FDA's position. If the device is a new generic type of device not 
already on the example list above, FDA will add it to this list.
[58 FR 43447, Aug. 16, 1993, as amended at 58 FR 43455, Aug. 16, 1993; 
59 FR 15052, Mar. 31, 1994.]



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;
    (2) Within 10 working days of a request from FDA for life-sustaining 
or life-supporting devices used outside a device user facility that are 
intended for use by a single patient over the life of the device and 
permanent implants that are tracked devices, after distribution to or 
implantation in a patient:
    (i) The 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;
    (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

[[Page 160]]

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) within 10 
working days of a request from FDA for life-sustaining or life-
supporting devices used outside device user facilities that are intended 
for use by more than one patient and that are tracked devices, after the 
distribution of the device to the multiple distributor:
    (i) The lot model number, batch number, serial number of the device 
or other identifier necessary to provide for effective tracking of the 
device;
    (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;
    (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 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.

[[Page 161]]



         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 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 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;
    (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 lot number, batch number, or 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;
    (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
    (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.



                   Subpart D--Records and Inspections



Sec. 821.50  Availability.

    (a) Manufacturers, distributors, multiple distributors, and final 
distributors shall, upon the presentation by an

[[Page 162]]

FDA representative of official credentials and the issuance of Form FD 
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.



Sec. 821.55  Confidentiality.

    (a) 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.
    (b) 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.



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.



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.

                        Subpart B--Classification

860.84  Classification procedures for ``old devices.''
860.93  Classification of implants, life-supporting or life-sustaining 
          devices.
860.95  Exemptions from sections 510, 519, and 520(f) of the act.

                       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 act.
860.132  Procedures when the Commissioner initiates a performance 
          standard or premarket approval proceeding under section 514(b) 
          or 515(b) of the act.
860.134  Procedures for ``new devices'' under section 513(f) of the act 
          and reclassification of certain devices.
860.136  Procedures for transitional products under section 520(l) of 
          the act.

    Authority:  21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374.

    Source:  43 FR 32993, July 28, 1978, unless otherwise noted.



                           Subpart A--General



Sec. 860.1  Scope.

    (a) This part implements sections 513, 514(b), 515(b), and 520(l) of 
the 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 
classification panels 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

[[Page 163]]

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 kind of data required for determination of the safety and 
effectiveness of a device, and the circumstances under which information 
submitted to classification panels or to the Commissioner in connection 
with classification and reclassification proceedings will be available 
to the public.



Sec. 860.3  Definitions.

    For the purposes of this part:
    (a) Act means the Federal Food, Drug, and Cosmetic Act.
    (b) 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.
    (c) Class means one of the three categories of regulatory control 
for medical devices, defined below:
    (1) Class I means the class of devices that are subject to only 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 the act. A device is in class I if (i) general 
controls are sufficient to provide reasonable assurance of the safety 
and effectiveness of the device, or (ii) 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 substanial importance in preventing impairment of human health, 
and which does not present a potential unreasonable risk of illness of 
injury.
    (2) 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 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, that are necessary to provide 
adequate assurance of safety and effectiveness and describe how such 
controls provide such assurance.
    (3) Class III means the class of devices for which premarket 
approval is or will be required in accordance with section 515 of the 
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 paragraph (c)(2) of this section 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.
    (d) 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 in order to protect human health.
    (e) 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.
    (f) Classification questionnaire means a specific series of 
questions prepared by

[[Page 164]]

the Commissioner for use as guidelines by classification panels 
preparing recommendations to the Commissioner regarding classification 
and by petitioners submitting petitions for reclassification. The 
questions relate to the safety and effectiveness characteristics of a 
device and the answers are designed to help the Commissioner determine 
the proper classification of the device.
    (g) Supplemental data sheet means information compiled by a 
classification panel or submitted in a petition for reclassification, 
including:
    (1) A summary of the reasons for the recommendation (or petition);
    (2) A summary of the data upon which the recommendation (or 
petition) is based;
    (3) An identification of the risks to health (if any) presented by 
the device;
    (4) To the extent practicable in the case of a class II or class III 
device, a recommendation for the assignment of a priority for the 
application of the requirements of performance standards or premarket 
approval;
    (5) In the case of a class I device, a recommendation whether the 
device should be exempted from any of the requirements of registration, 
record-keeping and reporting, or good manufacturing practice 
regulations;
    (6) In the case of an implant or a life-supporting or life-
sustaining device for which classification in class III is not 
recommended, a statement of the reasons for not recommending that the 
device be classified in class III;
    (7) Identification of any needed restrictions on the use of the 
device, e.g., whether the device requires special labeling, should be 
banned, or should be used only upon authorization of a practitioner 
licensed by law to administer or use such device; and
    (8) Any known existing standards applicable to the device, device 
components, or device materials.
    (h) Classification panel means one of the several advisory 
committees established by the Commissioner under section 513 of the 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 act or by the Commissioner.
    (i) 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 controls are sufficient to provide 
reasonable assurance of safety and effectiveness.
    (j) Petition means a submission seeking reclassification of a device 
in accordance with Sec. 860.123.
[43 FR 32993, July 28, 1978, as amended at 57 FR 58403, Dec. 10, 1992]



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

[[Page 165]]

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 
Dockets Management Branch, 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 
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 Dockets Management Branch 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 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

[[Page 166]]

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.



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 performance standards 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 the safety and effectiveness of which 
is questionable.
    (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 with the use of the device for its intended uses and 
conditions of use.

[[Page 167]]

    (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, and nonclinical investigations 
including in vitro studies.
    (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;
    (d) Historical control. In certain circumstances, such as those 
involving

[[Page 168]]

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 performance 
standards, 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 act.
    (3) A requirement for a report or other information under this 
paragraph will comply with section 519 of the 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 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]



                        Subpart B--Classification



Sec. 860.84  Classification procedures for ``old devices.''

    (a) This subpart sets forth the procedures for the original 
classification of a device that either was in commercial distribution 
before May 28, 1976, or is substantially equivalent to a device that was 
in commercial distribution before that date. 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) of the 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) through (3) of the act because the device was regarded 
previously as a new drug. This subpart does apply to a device that was 
previously regarded as an antibiotic drug and that is subject to section 
520(l)(4) of the act. In classifying a device under this section, 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 act and part 14 of this chapter.

[[Page 169]]

    (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 the types of scientific evidence set forth in Sec. 860.7;
    (3) Answers the questions in the classification questionnaire 
applicable to the device being classified;
    (4) Completes a supplemental data sheet for the device;
    (5) 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, 
accompanied by references to the sources containing such data;
    (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 act: 
section 510 (registration, product listing, and premarket notification) 
section 519 (records and reports) and section 520(f) (good manufacturing 
practice regulations) in accordance with Sec. 860.95;
    (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;
    (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, 
accompanied by references to 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.
    (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 in the Dockets Management 
Branch's office upon receipt and are available to the public upon 
request.
    (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 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 or class III, at the 
discretion of the Commissioner, establish priorities for the application 
to the device of a performance standard or a premarket approval 
requirement;
    (3) If classifying an implant, or life-supporting or life-sustaining 
device, comply with Sec. 860.93(b).
[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992]

[[Page 170]]



Sec. 860.93  Classification of implants, life-supporting or life-sustaining devices.

    (a) The 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 together with references to 
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.
    (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 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.



Sec. 860.95  Exemptions from sections 510, 519, and 520(f) of the 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 act: 
Section 510 (registration, product listing and premarket notification), 
section 519 (records and reports), and section 520(f) (good 
manufacturing practice regulations).
    (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 act the device is to be exempted from, 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.



                       Subpart C--Reclassification



Sec. 860.120  General.

    (a) Sections 513(e) and (f), 514(b), 515(b), and 520(l) of the 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 substantially 
equivalent devices within that generic type. Accordingly, a petition for 
the reclassification of a specific device will be considered a petition 
for reclassification of all substantially equivalent 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). A manufacturer or importer may 
submit a petition for reclassification under section 513(f) or 520(l). 
The Commissioner may initiate the reclassification of a device 
classified into class III under sections 513(f) and 520(l) of the act.
[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992]

[[Page 171]]



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 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 completed supplemental data sheet applicable to the device for 
which reclassification is requested;
    (4) A completed classification questionnaire applicable to the 
device for which reclassification is requested;
    (5) A statement of the basis for disagreement with the present 
classification status of the device;
    (6) 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;
    (7) Representative data and information known by the petitioner that 
are unfavorable to the petitioner's position;
    (8) If the petition is based upon new information under section 
513(e), 514(b), or 515(b) of the act, a summary of the new information;
    (9) Copies of source documents from which new information used to 
support the petition has been obtained (attached as appendices to the 
petition).
    (10) 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) Addressed to the Food and Drug Administration, Center for 
Devices and Radiological Health, Office of Standards and Regulations 
(HFZ-84), 5600 Fishers Lane, Rockville, MD 20857;
    (2) Marked clearly with the section of the act under which the 
petition is being submitted, i.e., ``513(e),'' ``513(f),'' ``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]

    Effective Date Note: At 63 FR 5254, Feb. 2, 1998, Sec. 860.123 was 
amended by adding new paragraph (a)(10), effective Feb. 2, 1999.



Sec. 860.125  Consultation with panels.

    (a) When the Commissioner is required to refer a reclassification 
petition to a classification panel for its recommendation under 
Sec. 860.134, or is required, or chooses, to consult with a panel 
concerning a reclassification petition, such as under Sec. 860.130, 
Sec. 860.132, or Sec. 860.136, the Commissioner will distribute a copy 
of the petition, or its relevant portions, 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;
    (2) Consultation by mail with at least a majority of current voting 
panel members and, when possible, nonvoting panel members; and
    (3) 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) When a petition is submitted under Sec. 860.134 for a post-
enactment, not substantially equivalent device (``new device''), in 
consulting 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, 
Sec. 860.132, or Sec. 860.136, the Commissioner may or may not obtain a 
formal recommendation.

[[Page 172]]



Sec. 860.130  General procedures under section 513(e) of the act.

    (a) Section 513(e) of the act applies to reclassification 
proceedings under the 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 act (see Sec. 860.132); or
    (3) In response to the petition of an interested person, based upon 
new information, filed in accordance with Sec. 860.123.
    (c) By regulation promulgated under this section, the Commissioner 
may change the classification from class III into:
    (1) Class II if the Commissioner determines that special controls in 
addition to general controls would provide reasonable assurance of the 
safety and effectiveness of the device and there is sufficient 
information to establish special controls to provide assurance; or
    (2) Class I if the Commissioner determines that general controls 
would provide reasonable assurance of the safety and effectiveness of 
the device.
    (d) The rulemaking procedures in Sec. 10.40 of this chapter apply to 
proceedings to reclassify a device under section 513(e), except that the 
Commissioner may secure a recommendation with respect to a proposed 
reclassification from the classification panel to which the device was 
last referred. The panel will consider a proposed reclassification 
submitted to it by the Commissioner in accordance with the consultation 
procedures of Sec. 860.125. Any recommendation submitted to the 
Commissioner by the panel will be published in the Federal Register when 
the Commissioner promulgates a regulation under this section.
    (e) Within 180 days after the filing of a petition for 
reclassification under this section, the Commissioner, by order 
published in the Federal Register, will either deny the petition or give 
notice of his intent to initiate a change in the classification of the 
device.
    (f) If a device is reclassified under this section, the regulation 
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) A regulation under this section changing the classification of a 
device from class III to class II may provide that such classification 
will not take effect until the effective date of a special control for 
the device established under section 514 of the act.
[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992]



Sec. 860.132  Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section 514(b) or 515(b) of the act.

    (a) Sections 514(b) and 515(b) of the act require the Commissioner 
to provide, by notice in the Federal Register, an opportunity for 
interested parties to request a change in the classification of a device 
based upon new information relevant to its classification when the 
Commissioner initiates a proceeding either to develop a performance 
standard for the device if in class II, or to promulgate a regulation 
requiring premarket approval for the device if in class III. In either 
case, if the Commissioner agrees that the new information warrants a 
change in classification, the Commissioner will publish in the Federal 
Register notice of the Commissioner's intent to initiate a proceeding 
under section 513(e) of the act and Sec. 860.130 to effect such a 
change.
    (b) The procedures for effecting a change in classification under 
sections 514(b) and 515(b) of the act are as follows:
    (1) Within 15 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)

[[Page 173]]

of this section, the Commissioner, by order published in the Federal 
Register, either denies the petition or gives notice of his intent to 
initiate a change in classification in accordance with Sec. 860.130.



Sec. 860.134  Procedures for ``new devices'' under section 513(f) of the act and reclassification of certain devices.

    (a) Section 513(f)(2) of the act applies to proceedings for 
reclassification of a device currently in class III by operation of 
section 513(f)(1) of the 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.

The Commissioner determines whether a device is ``substantially 
equivalent'' for purposes of the application of this section. If a 
manufacturer or importer believes that a device is not ``substantially 
equivalent'' but that it should not be in class III under the criteria 
in Sec. 860.3(c), the manufacturer or importer may petition for 
reclassification under this section. A manufacturer or importer who 
believes that a device is ``substantially equivalent'' and wishes to 
proceed to market the device shall submit a premarket notification in 
accordance with part 807 of this chapter. After considering a premarket 
notification, the Commissioner will determine whether the device is 
``substantially equivalent'' and will notify the manufacturer or 
importer of such determination in accordance with part 807 of this 
chapter.
    (b) The procedures for effecting reclassification under section 
513(f) of the act 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 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 an ``old'' 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 in the Dockets Management 
Branch upon receipt and are available to the public upon request.
    (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. 860.93, relating to the classification 
of implants, life-supporting or life-sustaining devices, and

[[Page 174]]

Sec. 860.95, relating to exemptions from certain requirements of the 
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.
[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992]



Sec. 860.136  Procedures for transitional products under section 520(l) of the act.

    (a) Section 520(l)(2) of the act applies to reclassification 
proceedings initiated by a manufacturer or importer for reclassification 
of a device currently in class III by operation of section 520(l)(1) of 
the act. 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) 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 provides the petitioner an opportunity for a 
regulatory hearing conducted in accordance with part 16 of this chapter.
    (4) The Commissioner consults with the appropriate classification 
panel with regard to the petition in accordance with Sec. 860.125.
    (5) 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).
    (6) Within a reasonable time after issuance of an order under this 
section, the Commissioner announces the order by notice published in the 
Federal Register.



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.

[[Page 175]]

    (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 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

[[Page 176]]

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:
    (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.

[[Page 177]]

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.
    (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 Secs. 14.82 and 
14.84, except that no member may be a regular full-time FDA employee. 
Each advisory committee established under

[[Page 178]]

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 Dockets Management Branch, Food 
and Drug Administration.
    (d) Where appropriate, each proposed regulation establishing a 
standard published in the Federal Register will 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 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.
862.1060  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.
862.1120  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.
862.1165  Catecholamines (total) test system.
862.1170  Chloride test system.
862.1175  Cholesterol (total) test system.
862.1177  Cholylglycine test system.

[[Page 179]]

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.
862.1225  Creatinine test system.
862.1230  Cyclic AMP 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.
862.1360  Gamma-glutamyl transpeptidase and isoenzymes test system.
862.1365  Glutathione test system.
862.1370  Human growth hormone 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.
862.1625  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.

[[Page 180]]

862.1670  Sorbitol dehydrogenase test system.
862.1675  Blood specimen collection device.
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 B 12 test system.
862.1815  Vitamin E test system.
862.1820  Xylose 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.
862.2140  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.
862.2270  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.
862.2680  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.
862.3100  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.
862.3380  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.
862.3600  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.
862.3660  Phenobarbital test system.
862.3670  Phenothiazine test system.
862.3680  Primidone test system.
862.3700  Propoxyphene test system.
862.3750  Quinine test system.
862.3830  Salicylate 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.


[[Page 181]]


    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    Source:  52 FR 16122, May 1, 1987, unless otherwise noted.



                      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 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.



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 (Secs. 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

[[Page 182]]

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. 862.9  Limitations of exemptions from section 510(k) of the act.

    FDA's decision to grant an exemption from the requirement of 
premarket notification (section 510(k) of the act) for a generic type of 
class I device is based upon the existing and reasonably foreseeable 
characteristics of commercially distributed devices within that generic 
type. Because FDA cannot anticipate every change in intended use or 
characteristic that could significantly affect a device's safety or 
effectiveness, manufacturers of any commercially distributed class I 
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 its intended use 
before May 28, 1976, or the device is intended for a use different from 
the intended use of a preamendments device to which it had been 
determined to be substantially equivalent; 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; or
    (b) The modified device operates using a different fundamental 
scientific technology than that in use in the device before May 28, 
1976; 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 a deoxyribonucleic acid 
(DNA) probe or nucleic acid hybridization technology rather than culture 
or immunoassay technology.
[53 FR 21448, June 8, 1988]



               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.



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 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.



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.

[[Page 183]]



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.



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. 862.1060  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.



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.



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.



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

[[Page 184]]

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.



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.



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.



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.



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.



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.

[[Page 185]]



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.



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 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. 862.1165  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.



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

[[Page 186]]

in the blood and lipid and lipoprotein metabolism disorders.
    (b) Classification. Class I.



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.



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.



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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807.
[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



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.



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.



Sec. 862.1205  Cortisol (hydrocortisone and hydroxycorticosterone) test system.

    (a) Identification. A cortisol (hydrocortisone and 
hydroxycorticosterone) test system is a device intended to 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

[[Page 187]]

used in the diagnosis and treatment of muscle diseases and endocrine 
disorders including hyperthyroidism.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.
[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



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. 862.1225  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.



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.



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.



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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807.
[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]

[[Page 188]]



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.



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.



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.



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.



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.



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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807.
[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



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

[[Page 189]]

the diagnosis and treatment of pituitary gland and gonadal disorders.
    (b) Classification. Class I.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807.
[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807.
[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



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.



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.



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.



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

[[Page 190]]

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.



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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807.
[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



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.



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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807.
[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



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

[[Page 191]]

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.
[52 FR 16122, May. 1, 1987; 52 FR 29468, Aug. 7, 1987]



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.



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.



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.



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.



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.



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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807.
[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



Sec. 862.1430  17-Ketosteroids test system.

    (a) Identification. A 17-ketosteroids test system is a device 
intended to

[[Page 192]]

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.



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.



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 such as 
myocardial infarction, and tumors of the lung or kidneys.
    (b) Classification. Class II.



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.



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.



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.



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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807.
[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]

[[Page 193]]



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.



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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807.
[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



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.



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.



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 treatment of methylmalonic aciduria, a heritable metabolic disorder 
which, if untreated, may cause mental retardation.
    (b) Classification. Class II.



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.



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.

[[Page 194]]

    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.
[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



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.



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.



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.



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 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.



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.



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.



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.

[[Page 195]]



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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807.
[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807.
[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



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.



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.



Sec. 862.1595  Porphyrins test system.

    (a) Identification. A porphyrins test system is a device intended to 
measure porphyrins (compounds formed during

[[Page 196]]

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.
    (b) Classification. Class I.



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.



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.



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.



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.



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.



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 a aid in recognizing abnormal proteins in body fluids and 
genetic variants of proteins produced in diseases with tissue 
destruction.
    (b) Classification. Class I.



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.



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.

[[Page 197]]

    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.
[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



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.



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.



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.



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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807.
[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



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.

[[Page 198]]



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.



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 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.



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.



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.



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.



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

[[Page 199]]

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. The device is exempt from the premarket 
notification procedures in subpart E of part 807.
[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



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.



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.



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.



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.



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 (primarily 
inherited diseases associated with disturbed porphyrin metabolism), lead 
poisoning, and other diseases characterized by alterations in the heme 
pathway.
    (b) Classification. Class I.



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.

[[Page 200]]



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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807.
[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



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.



               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. The device identified in paragraph (a) 
of this section is exempt from the premarket notification procedures in 
subpart E of part 807 and is exempt from the current good manufacturing 
practice regulations 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. 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 store, retrieve, and process 
laboratory data.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.
[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988]



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.



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.

[[Page 201]]



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.



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, 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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 16122, May 1, 1987, as amended at 61 FR 1119, Jan. 16, 1996]



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.



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.



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. 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 regulations 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. 862.2300  Colorimeter, photometer, or spectrophotometer for clinical use.

    (a) Identification. A colorimeter, a photometer, or a 
spectrophotometer

[[Page 202]]

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.
    (b) Classification. Class I.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 16122, May 1, 1987, as amended at 60 FR 38899, July 28, 1995]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995]



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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995]



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.



Sec. 862.2540  Flame emission photometer for clinical use.

    (a) Identification. A flame emission photometer for clinical use is 
a device 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.



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

[[Page 203]]

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.



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.



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.



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 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995]



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.



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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995]



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.

[[Page 204]]

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.



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 the compound under 
investigation and separating the resulting ions by means of an 
electrical and megnetic field according to their mass.
    (b) Classification. Class I.



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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995]



               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.



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

[[Page 205]]

amphetamine to ensure appropriate therapy.
    (b) Classification. Class II.



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.



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 overdose 
and in monitoring levels of benzodiazepines to ensure appropriate 
therapy.
    (b) Classification. Class II.



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.



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.



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.



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.

[[Page 206]]



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.



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.



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. 862.3380  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.

[[Page 207]]



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.



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.



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 to determine 
compliance with regulations in methadone maintenance treatment.
    (b) Classification. Class II.



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.



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.



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.



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.

[[Page 208]]

    (b) Classification. Class II.



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 
propoxyphene to ensure appropriate therapy.
    (b) Classification. Class II.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807.
[52 FR 16122, May 1, 1987, as amended at 53 FR 21450, June 8, 1988]



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. 862.3850  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. The device is exempt from the premarket 
notification procedures in subpart E of part 807.
[52 FR 16122, May 1, 1987, as amended at 53 FR 21450, June 8, 1988]



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, 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.

[[Page 209]]



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.



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.
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.

               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.
864.3300  Cytocentrifuge.
864.3400  Device for sealing microsections.
864.3600  Microscopes and accessories.
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.

[[Page 210]]

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

864.7040  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.
864.7290  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.
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.
864.9175  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.

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

[[Page 211]]



                      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.
[52 FR 17732, May 11, 1987]



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 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 Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 510(k) 
of the act) for a generic type of class I device is based upon the 
existing and reasonably foreseeable characteristics of commercially 
distributed devices within that generic type. Because FDA cannot 
anticipate every change in intended use

[[Page 212]]

or characteristic that could significantly affect a device's safety or 
effectiveness, manufacturers of any commercially distributed class I 
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 its intended use 
before May 28, 1976, or the device is intended for a use different from 
the intended use of a preamendments device to which it had been 
determined to be substantially equivalent; 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; or
    (b) The modified device operates using a different fundamental 
scientific technology than that in use in the device before May 28, 
1976, 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 a deoxyribonucleic acid 
(DNA) probe or nucleic acid hybridization technology rather than culture 
or immunoassay technology.
[54 FR 25043, June 12, 1989]



                      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. These devices are exempt from the 
premarket notification procedures in subpart E of part 807. The devices 
are also exempt from the current good manufacturing practice regulations 
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]



               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, etc.) that are 
essential for the survival and development of cell lines of humans and 
other animals.
    (b) Classification. Class I. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[45 FR 60583, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989]



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. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter. If the devices are not labeled or otherwise represented as 
sterile, they are exempt from the current good manufacturing practice 
regulations 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]



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,

[[Page 213]]

fetal calf serum, antibiotics, and heparin) used to culture tissues for 
diagnosis of congenital chromosome abnormalities.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 60585, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989]



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).
[45 FR 60585, Sept. 12, 1980]



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. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[45 FR 60586, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989]



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. The devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[45 FR 60586, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989]



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. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[45 FR 60586, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989]



          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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. The 
device is also exempt from the current good manufacturing practice 
regulations 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]



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.
    (b) Classification. Class I (general controls). If the device is not 
intended for over-the-counter (OTC) distribution, it

[[Page 214]]

is exempt from the premarket notification procedures in subpart E of 
part 807 of this chapter. If the device is not labeled or otherwise 
represented as sterile, it is exempt from the current good manufacturing 
practice regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to the general requirements concerning 
records, and Sec. 820.198, with respect to complaint files.
[54 FR 47206, Nov. 13, 1989]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 60588, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 60589, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989]



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. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter. The devices are also exempt from the current good manufacturing 
practice regulations 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]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 60591, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 60591, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989]



                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

[[Page 215]]

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 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is exempt 
from the current good manufacturing practice regulations 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]

    Effective Date Note: At 62 FR 62260, Nov. 21, 1997, Sec. 864.4010 
was amended by revising paragraph (a), effective Nov. 23, 1998. For the 
convenience of the user, the text remaining in effect until Nov. 23, 
1998, is set forth as follows:

Sec. 864.4010  General purpose reagent.

    (a) Identification. 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 
histopathology, cytology, and hematology, and that is not labeled or 
otherwise intended for a specific diagnostic application. General 
purpose reagents include cytological preservatives, decalcifying 
reagents, fixatives and adhesives, tissue processing reagents, isotonic 
solutions, and pH buffers.

                                * * * * *



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

[[Page 216]]

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 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]

    Effective Date Note: At 62 FR 62260, Nov. 21, 1997, Sec. 864.4020 
was added to subpart E, effective Nov. 23, 1998.



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. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[45 FR 60592, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989]



       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 and classify one or more of the formed elements 
of the blood.
    (b) Classification. (1) Class II (performance standards) when the 
device is intended to flag or identify specimens containing abnormal 
blood cells.
    (2) Class III (premarket approval) when the device is intended for 
other uses, including to count or classify abnormal cells of the blood.
    (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

[[Page 217]]

identified in paragraph (b)(2) of this section. See Sec. 864.3.
[45 FR 60596, Sept. 12, 1980, as amended at 55 FR 23511, June 8, 1990]



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).
[45 FR 60596, Sept. 12, 1980]



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 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 60598, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994]



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 (performance standards).
[45 FR 60598, Sept. 12, 1980]



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 (performance standards).
[45 FR 60599, Sept. 12, 1980]



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]

[[Page 218]]



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.
    (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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 60602, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 60603, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989]



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 (performance standards).
[45 FR 60604, Sept. 12, 1980]



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. If the device is not intended for over-
the-counter (OTC) distribution, it is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 60604, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989]



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.

[[Page 219]]

    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 60605, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989]



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) Clasification. Class II (performance standards).
[45 FR 60606, Sept. 12, 1980]



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 (performance standards).
[45 FR 60606, Sept. 12, 1980]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 60607, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 60608, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989]



                 Subpart H--Hematology Kits and Packages



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).
[45 FR 60609, Sept. 12, 1980]



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

[[Page 220]]

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]



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 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. See Sec. 864.3.
[45 FR 60612, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987]



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 (performance standards).
[45 FR 60612, Sept. 12, 1980]



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 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. See Sec. 864.3.
[45 FR 60614, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987]

[[Page 221]]



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 (performance standards).
[45 FR 60615, Sept. 12, 1980]



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 (performance standards).
[45 FR 60616, Sept. 12, 1980]



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 (performance standards).
[45 FR 60618, Sept. 12, 1980]



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]

[[Page 222]]



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 (performance standards).
[45 FR 60620, Sept. 12, 1980]



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 (performance standards).
[45 FR 60622, Sept. 12, 1980]



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

[[Page 223]]

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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 60623, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 60624, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994]



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 (performance standards).
[45 FR 60625, Sept. 12, 1980]



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 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 (performance standards).
[45 FR 60626, Sept. 12, 1980]



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]

[[Page 224]]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 60628, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994]



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 have been precisely and accurately determined.
    (b) Classification. Class II (performance standards).
[45 FR 60631, Sept. 12, 1980]



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 (performance standards).
[45 FR 60632, Sept. 12, 1980]



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 (performance standards).
[45 FR 60633, Sept. 12, 1980]



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

[[Page 225]]

or cells whose size, shape, concentration, and other characteristics 
have been precisely and accurately determined.
    (b) Classification. Class II (performance standards).
[45 FR 60634, Sept. 12, 1980]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 60635, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 60636, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 60636, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989]



Sec. 864.8625  Hematology quality control mixture.

    (a) Identification. A hematology quality control mixture is a device 
used to 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 (performance standards).
[45 FR 60637, Sept. 12, 1980]



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]

[[Page 226]]



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).
[45 FR 60639, Sept. 12, 1980]



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.
    (b) Classification. Class II (performance standards).
[45 FR 60640, Sept. 12, 1980, as amended at 53 FR 11253, Apr. 6, 1988]



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).
[45 FR 60641, Sept. 12, 1980]



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).
[45 FR 60642, Sept. 12, 1980]



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.
    (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]

[[Page 227]]



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).
[45 FR 60643, Sept. 12, 1980]



Sec. 864.9245  Automated blood cell separator.

    (a) Identification. An automated blood cell separator is a device 
that automatically removes whole blood from a donor, separates the blood 
into components (red blood cells, white blood cells, plasma, and 
platelets), retains one or more of the components, and returns the 
remainder of the blood to the donor. The components obtained are 
transfused or used to prepare blood products for administration. These 
devices operate on either a centrifugal separation principle or a 
filtration principle. The separation bowls of centrifugal blood cell 
separators may be reusable or disposable.
    (b) Classification. 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. See Sec. 864.3.
[45 FR 60645, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987]



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).
[45 FR 60645, Sept. 12, 1980]



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).
    (b) Classification. Class I (general controls).
[45 FR 60647, Sept. 12, 1980]



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 (performance standards).
[45 FR 60647, Sept. 12, 1980]



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

[[Page 228]]

used to detect blood group antigens for in vitro diagnostic purposes.
    (b) Classification. Class II (performance standards).
[45 FR 60648, Sept. 12, 1980]



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 (performance standards).
[45 FR 60648, Sept. 12, 1980]



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 (performance standards).
[45 FR 60649, Sept. 12, 1980]



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 (performance standards).
[45 FR 60650, Sept. 12, 1980]



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).
[45 FR 60650, Sept. 12, 1980]



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]



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.
866.1700  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.
866.2300  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.

[[Page 229]]

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.
866.2850  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.
866.3060  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.
866.3125  Citrobacter spp. serological reagents.
866.3135  Coccidioides immitis serological reagents.
866.3140  Corynebacterium spp. serological reagents.
866.3145  Coxsackievirus serological reagents.
866.3165  Cryptococcus neoformans serological reagents.
866.3175  Cytomegalovirus serological reagents.
866.3200  Echinococcus spp. serological reagents.
866.3205  Echovirus serological reagents.
866.3220  Entamoeba histolytica serological reagents.
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 reagents.
866.3320  Histoplasma capsulatum serological reagents.
866.3330  Influenza 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.
866.3370  Mycobacterium tuberculosis immunofluorescent reagents.
866.3375  Mycoplasma spp. serological reagents.
866.3380  Mumps virus serological reagents.
866.3390  Neisseria spp. direct serological test reagents.
866.3400  Parainfluenza virus serological reagents.
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.
866.3870  Trypanosoma spp. serological reagents.
866.3900  Varicella-zoster virus serological reagents.
866.3930  Vibrio cholerae serological reagents.

         Subpart E--Immunology Laboratory Equipment and Reagents

866.4100  Complement reagent.
866.4500  Immunoelectrophoresis equipment.
866.4520  Immunofluorometer equipment.
866.4540  Immunonephelometer equipment.
866.4600  Ouchterlony agar plate.
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.

[[Page 230]]

866.5060  Prealbumin immunological test system.
866.5065  Human allotypic marker immunological test system.
866.5080  Alpha-1-antichymotrypsin immunological test system.
866.5090  Antimitochondrial antibody immunological test system.
866.5100  Antinuclear antibody immunological test system.
866.5110  Antiparietal antibody immunological 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.
866.5200  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 immunological test system.
866.5250  Complement C1 inhibitor (inactivator) 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 immunological test system.
866.5400  Alpha-globulin immunological test system.
866.5420  Alpha-1-glycoproteins immunological test system.
866.5425  Alpha-2-glycoproteins immunological test system.
866.5430  Beta-2-glycoprotein I immunological test system.
866.5440  Beta-2-glycoprotein III immunological test system.
866.5460  Haptoglobin immunological test system.
866.5470  Hemoglobin immunological test system.
866.5490  Hemopexin immunological test system.
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 immunological 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 immunological test system.
866.5620  Alpha-2-macroglobulin immunological test system.
866.5630  Beta-2-microglobulin immunological test system.
866.5640  Infectious mononucleosis immunological test system.
866.5660  Multiple autoantibodies 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) immunological test system.
866.5765  Retinol-binding protein immunological test system.
866.5775  Rheumatoid factor immunological test system.
866.5800  Seminal fluid (sperm) immunological test system.
866.5820  Systemic lupus erythematosus immunological test system.
866.5860  Total spinal fluid immunological test system.
866.5870  Thyroid autoantibody immunological test system.
866.5880  Transferrin immunological test system.
866.5890  Inter-alpha trypsin inhibitor immunological test system.

     Subpart G--Tumor Associated Antigen Immunological Test Systems

866.6010  Tumor associated antigen immunological test system.

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

[[Page 231]]


    Source:  47 FR 50823, Nov. 9, 1982, unless otherwise noted.



                      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.
    (d) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.
[52 FR 17733, May 11, 1987]



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

[[Page 232]]

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 Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 510(k) 
of the act) for a generic type of class I device is based upon the 
existing and reasonably foreseeable characteristics of commercially 
distributed devices within that generic type. Because FDA cannot 
anticipate every change in intended use or characteristic that could 
significantly affect a device's safety or effectiveness, manufacturers 
of any commercially distributed class I 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 its intended use 
before May 28, 1976, or the device is intended for a use different from 
the intended use of a preamendments device to which it had been 
determined to be substantially equivalent; 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; or
    (b) The modified device operates using a different fundamental 
scientific technology than that in use in the device before May 28, 1976 
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 a deoxyribonucleic acid (DNA) 
probe or nucleic acid hybridization technology rather than culture or 
immunoassay technology.
[54 FR 25045, June 12, 1989]



                      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).



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

[[Page 233]]

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. The 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 54 FR 25045, June 12, 1989]



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. The 
device also is exempt from the good manufacturing practice 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. 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 the genus Staphylococcus and 
provide epidemiological information on disease caused by these 
microorganisms.
    (b) Classification. Class I. The 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 61 FR 1119, Jan. 16, 1996]



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. The 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 54 FR 25045, June 12, 1989]



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. The 
device also is exempt from the good manufacturing practice 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. 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

[[Page 234]]

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. The 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 54 FR 25046, June 12, 1989]



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. The 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 54 FR 25046, June 12, 1989]



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. The 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 54 FR 25046, June 12, 1989]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



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. The 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 54 FR 25046, June 12, 1989]

[[Page 235]]



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 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). This device is 
exempt from the premarket notification procedures in subpart E of part 
807. This device also is exempt from the good manufacturing practice 
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. 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. The 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 54 FR 25046, June 12, 1989]



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

[[Page 236]]

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. The 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 54 FR 25046, June 12, 1989]



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. The 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 54 FR 25046, June 12, 1989]



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.
    (b) Classification. Class I (general controls). This device is 
exempt from premarket notification procedures in subpart E of part 807. 
The device also is exempt from the good manufacturing practice 
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. 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. The 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 54 FR 25046, June 12, 1989]



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. The 
device also is exempt from the good manufacturing practice 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. 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

[[Page 237]]

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).



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).



                     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 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. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



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. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



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. These devices are exempt from the 
premarket

[[Page 238]]

notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



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).



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 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 (performance standards).



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. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



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 (performance standards).



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).

[[Page 239]]



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).



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. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



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 (performance standards).



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).



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. 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).

[[Page 240]]



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 (performance standards).



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).



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. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



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 241]]

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 (performance standards).
[47 FR 50823, Nov. 9, 1982; 47 FR 56846, Dec. 21, 1982]



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).



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. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



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. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



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

[[Page 242]]

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. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]



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 (performance standards).



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.
    (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 (performance standards).



Sec. 866.3305  Herpes simplex virus serological reagents.

    (a) Identification. Herpes simplex virus serological reagents 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 reagents consist of herpes simplex 
virus antisera conjugated with a fluorescent dye (immunofluorescent 
reagents) 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

[[Page 243]]

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 an mild infection to a severe generalized disease 
with a fatal outcome.
    (b) Classification. 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. See Sec. 866.3.
[47 FR 50823, Nov. 9, 1982, as amended at 52 FR 17734, May 11, 1987]



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 (performance standards).



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. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]



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. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]



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 (performance standards).

[[Page 244]]



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 high mortality rate for 
infants before or after birth.
    (b) Classification. Class I (general controls).



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).



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. 866.3375  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 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).



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

[[Page 245]]

(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).



Sec. 886.3390  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. 866.3400  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. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]



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).



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. These devices are exempt from the 
premarket

[[Page 246]]

notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]



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 (performance standards).



Sec. 866.3460  Rabiesvirus immunofluorescent 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. These devices are exempt from premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]



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).



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. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]

[[Page 247]]



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).



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 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. See Sec. 866.3.
[47 FR 50823, Nov. 9, 1982, as amended at 52 FR 17734, May 11, 1987]



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. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]



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 (performance standards).



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.,

[[Page 248]]

swimmer's itch), a skin disease marked by intense itching.
    (b) Classification. Class I (general controls).



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. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982 as amended at 54 FR 25047, June 12, 1989]



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 (performance standards).



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).



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. These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989]



Sec. 866.3720  Streptococcus spp. exoenzyme 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. The 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 61 FR 1119, Jan. 16, 1996]



Sec. 866.3740  Streptococcus spp. serological reagents.

    (a) Identification. Streptococcus spp. serological reagents are 
devices that

[[Page 249]]

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).



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 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 nontreponemal 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 treponemal 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).



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

[[Page 250]]

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. 866.3930  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 (performance standards).



         Subpart E--Immunology Laboratory Equipment and Reagents



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.



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. The 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 54 FR 25047, June 12, 1989]



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

[[Page 251]]

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.
    (b) Classification. Class I. The 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 54 FR 25047, June 12, 1989]



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. The 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 54 FR 25047, June 12, 1989]



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. The 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 54 FR 25047, June 12, 1989]



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.



Sec. 866.4830  Rocket immunoelectrophoresis 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. The 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 54 FR 25047, June 12, 1989]

[[Page 252]]



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. The 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 54 FR 25047, June 12, 1989]



                  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 (performance standards).



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 serum may aid in the 
assessment of the patient's nutritional status.
    (b) Classification. Class I (general controls).



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).



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, Sjogren's syndrome (arthritis 
with inflammation of the eye, eyelid,

[[Page 253]]

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 
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 immunological 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).

[[Page 254]]



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. The 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 59 FR 63007, Dec. 7, 1994]



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).



Sec. 866.5210  Ceruloplasmin immunological 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 (performance standards).



Sec. 866.5220  Cohn fraction II immunological 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. The 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 59 FR 63007, Dec. 7, 1994]



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. The 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 59 FR 63007, Dec. 7, 1994]



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]



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

[[Page 255]]

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 immunological 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 immunological 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 (performance standards).



Sec. 866.5330  Factor XIII, A, S, immunological 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).



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 immunological test system.

    (a) Identification. A fibrinopeptide A immunological test system is 
a device that consists of the reagents used to

[[Page 256]]

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 immunological 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 50823, Nov. 9, 1982; 47 FR 56846, Dec. 21, 1982, as amended at 59 
FR 63007, Dec. 7, 1994]



Sec. 866.5370  Cohn fraction V immunological 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. The 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 59 FR 63007, Dec. 7, 1994]



Sec. 866.5380  Free secretory component immunological 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 (performance standards).



Sec. 866.5400  Alpha-globulin immunological 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.
    (b) Classification. Class I (general controls).



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).



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

[[Page 257]]

alpha-2-glycoproteins aids in the diagnosis of some cancers and 
genetically inherited deficiencies of these plasma proteins.
    (b) Classification. Class I (general controls).



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).




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).



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.
    (b) Classification. Class II (performance standards).



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 (performance standards).



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 (performance standards).



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.

[[Page 258]]

    (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 lymphoma (tumor of the lymphoid tissues).
    (b) Classification. Class I. The 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 61 FR 1119, Jan. 16, 1996]



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. The 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 61 FR 1119, Jan. 16, 1996]



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. The 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 59 FR 63007, Dec. 7, 1994]



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

[[Page 259]]

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).



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).



Sec. 866.5580  Alpha-1-lipoprotein immunological 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 immunological 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).



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 (performance standards).



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.

[[Page 260]]

    (b) Classification. Class II (performance standards).



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. 866.5680  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. The 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 59 FR 63007, Dec. 7, 1994]



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).



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).



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.

[[Page 261]]

    (b) Classification. Class II (performance standards).



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).



Sec. 866.5775  Rheumatoid factor immunological 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. 866.5800  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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[54 FR 25047, June 12, 1989]



Sec. 866.5820  Systemic lupus erythematosus 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-
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. 866.5860  Total spinal fluid immunological 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. The 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 61 FR 1119, Jan. 16, 1996]



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.

[[Page 262]]

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).



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).
[47 FR 50823, Nov. 9, 1982, as amended at 53 FR 11253, Apr. 6, 1988]



     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]



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.
868.1575  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.
868.2340  Compensated thorpe tube flowmeter.

[[Page 263]]

868.2350  Gas calibration flowmeter.
868.2375  Breathing frequency monitor.
868.2450  Lung water monitor.
868.2480  Cutaneous carbon dioxide (PcCO2) monitor.
868.2500  Cutaneous oxygen 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.
868.5100  Nasopharyngeal airway.
868.5110  Oropharyngeal airway.
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.
868.5170  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.
868.5280  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.
868.5460  Therapeutic humidifier for home use.
868.5470  Hyperbaric chamber.
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.
868.5610  Membrane lung for long-term pulmonary support.
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.

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    Source:  47 FR 31142, July 16, 1982, unless otherwise noted.



                      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.

[[Page 264]]

    (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.
[52 FR 17734, May 11, 1987]



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 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 Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 510(k) 
of the act) for a generic type of class I device is based upon the 
existing and reasonably foreseeable characteristics of commercially 
distributed devices within that generic type. Because FDA cannot 
anticipate every change in intended use or characteristic that could 
significantly affect a device's safety or effectiveness, manufacturers 
of any commercially distributed class I device for which FDA has granted 
an exemption

[[Page 265]]

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 its intended use 
before May 28, 1976, or the device is intended for a use different from 
the intended use of a preamendments device to which it had been 
determined to be substantially equivalent; 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; or
    (b) The modified device operates using a different fundamental 
scientific technology than that in use in the device before May 28, 
1976, 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 a deoxyribonucleic acid 
(DNA) probe or nucleic acid hybridization technology rather than culture 
or immunoassay technology.
[54 FR 25047, June 12, 1989]



                      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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. The 
device is also exempt from the current good manufacturing practice 
regulations 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]



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 (performance standards).



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. 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 1119, Jan. 16, 1996]



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 a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 868.3.
[47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 52 
FR 22577, June 12, 1987]



Sec. 868.1150  Indwelling blood carbon dioxide partial pressure (PCO2) 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,

[[Page 266]]

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 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. See Sec. 868.3.
[47 FR 31142, July 16, 1982; 47 FR 40410, Sept. 14, 1982, as amended at 
52 FR 17735, May 11, 1987]



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 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. See Sec. 868.3.
[47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987]



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 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. See Sec. 868.3.
[47 FR 31142, July 16, 1982; 47 FR 40410, Sept. 14, 1982, as amended at 
52 FR 17735, May 11, 1987]



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. 868.1575  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. 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 1119, Jan. 16, 1996]



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

[[Page 267]]

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).



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

[[Page 268]]

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. 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 1119, Jan. 16, 1996]



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).



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 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. 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 54 FR 25048, June 12, 1989]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. The 
device is also exempt from the current good manufacturing practice 
regulations 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]

[[Page 269]]



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. 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 1119, Jan. 16, 1996]



                      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. 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 1119, Jan. 16, 1996]



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. 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 1119, Jan. 16, 1996]



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. 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 1119, Jan. 16, 1996]



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. 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 1119, Jan. 16, 1996]



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 
is outside predetermined limits.
    (b) Classification. Class II (performance standards).



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 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. No 
effective date has

[[Page 270]]

been established of the requirement for premarket approval. See 
Sec. 868.3.
[47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987]



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 (performance standards).
[54 FR 27160, June 28, 1989]



Sec. 868.2500  Cutaneous oxygen monitor.

    (a) Cutaneous oxygen monitor for an infant patient who is not under 
gas anesthesia--(1) Identification. A cutaneous oxygen monitor for an 
infant patient who is not under gas anesthesia is a device that uses a 
noninvasive sensor (e.g., a Clark-type polarographic electrode) placed 
on the patient's skin and that is intended to monitor relative changes 
in the cutaneous oxygen tension in an infant patient who is not under 
gas anesthesia.
    (2) Classification. Class II (performance standards).
    (b) Cutaneous oxygen monitor for all other uses--(1) Identification. 
A cutaneous oxygen monitor for all other uses is a device that uses a 
noninvasive sensor (e.g., a Clark-type polarographic electrode) placed 
on the patient's skin and that is intended to monitor relative changes 
in the cutaneous oxygen tension in a noninfant patient or in any 
patient, including an infant, who is under gas anesthesia.
    (2) Classification. 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. 868.3.
[47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987]



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 (performance standards).



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. 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 1119, Jan. 16, 1996]



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. 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 1119, Jan. 16, 1996]



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.

[[Page 271]]

    (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 1119, Jan. 16, 1996]



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. 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 1119, Jan. 16, 1996]



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. 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 1119, Jan. 16, 1996]



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. 868.5100  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. 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]



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. 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]



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).

[[Page 272]]



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. 868.5170  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 (performance standards).



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is exempt 
from the current good manufacturing practice regulations 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]



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. 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]



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

[[Page 273]]

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).



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. 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 54 FR 25048, June 12, 1989]



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. 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]



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. 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]



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. 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]



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. 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 59 FR 63007, Dec. 7, 1994]



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. 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 59 FR 63007, Dec. 7, 1994]

[[Page 274]]



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. 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 54 FR 25048, June 12, 1989]



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. 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]



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 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is exempt 
from the current good manufacturing practice regulations 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]



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).

[[Page 275]]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 31142, July 16, 1982; 47 FR 40410, Sept. 14, 1982, as amended at 
61 FR 1120, Jan. 16, 1996]



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. 868.5530  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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 41107, Sept. 17, 1982, as amended at 61 FR 1120, Jan. 16, 1996]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 41107, Sept. 17, 1982, as amended at 61 FR 1120, Jan. 16, 1996]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 41107, Sept. 17, 1982, as amended at 61 FR 1120, Jan. 16, 1996]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[47 FR 41107, Sept. 17, 1982, as amended at 54 FR 25048, June 12, 1989]



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. 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]



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. 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]



Sec. 868.5590  Scavenging mask.

    (a) Identification. A scavenging mask is a device positioned over a 
patient's nose to deliver anesthetic or analgesic

[[Page 276]]

gases to the upper airway and to remove excess and exhaled gas. It is 
usually used during dentistry.
    (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]



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. 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]



Sec. 868.5610  Membrane lung for long-term pulmonary support.

    (a) Identification. A membrane lung for long-term pulmonary support 
is a device used to provide to a patient extracorporeal blood 
oxygenation for longer than 24 hours.
    (b) Classification. 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. See Sec. 868.3.
[47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987]



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).



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.
    (b) Classification. Class I (general controls).



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.

[[Page 277]]

    (b) Classification. Class I (general controls). If the device is not 
labeled or otherwise represented as sterile, it is exempt from the good 
manufacturing practice 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. 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).



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.
    (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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is exempt 
from the current good manufacturing practice regulations 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]



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. 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]



Sec. 868.5780  Tube introduction forceps.

    (a) Identification. Tube introduction forceps (e.g., Magill forceps) 
are a

[[Page 278]]

right-angled device used to grasp a tracheal tube and place it in a 
patient's trachea.
    (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]



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. 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]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807. If the device is not 
labeled or otherwise represented as sterile, it is exempt from the 
current good manufacturing practice regulations 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.
[51 FR 40388, Nov. 6, 1986]



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 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. 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]



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. 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]



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. 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]



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.

[[Page 279]]

    (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).



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. 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]



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.

[[Page 280]]

    (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]



                        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. 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 54 FR 25048, June 12, 1989]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. The 
device is also exempt from the current good manufacturing practice 
regulations 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]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. The 
device is also exempt from the current good manufacturing practice 
regulations 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]



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 (performance standards).



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. 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 1121, Jan. 16, 1996]



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. 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 54 FR 25049, June 12, 1989]



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 I (general controls).



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.

[[Page 281]]

    (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 1121, Jan. 16, 1996]



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. 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 1121, Jan. 16, 1996]



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.
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.
870.1270  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.
870.1350  Catheter balloon repair kit.
870.1360  Trace microsphere.
870.1370  Catheter tip occluder.
870.1380  Catheter stylet.
870.1390  Trocar.
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.
870.2300  Cardiac monitor (including cardiotachometer and rate alarm).
870.2310  Apex cardiograph (vibrocardiograph).
870.2320  Ballistocardiograph.
870.2330  Echocardiograph.
870.2340  Electrocardiograph.
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.
870.2800  Medical magnetic tape recorder.
870.2810  Paper chart recorder.
870.2840  Apex cardiographic transducer.
870.2850  Extravascular blood pressure transducer.
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.

[[Page 282]]

              Subpart D--Cardiovascular Prosthetic Devices

870.3250  Vascular clip.
870.3260  Vena cava clip.
870.3300  Arterial embolization device.
870.3375  Cardiovascular intravascular filter.
870.3450  Vascular graft prosthesis of less than 6 millimeters diameter.
870.3460  Vascular graft prosthesis of 6 millimeters and greater 
          diameter.
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.
870.3610  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.
870.4200  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 cardiopulmonary bypass 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.
870.4875  Intraluminal artery stripper.
870.4885  External vein stripper.

              Subpart F--Cardiovascular Therapeutic Devices

870.5050  Patient care suction apparatus.
870.5150  Embolectomy catheter.
870.5175  Septostomy catheter.
870.5200  External cardiac compressor.
870.5225  External counter-pulsating device.
870.5300  DC-defibrillator (including paddles).
870.5325  Defibrillator tester.
870.5550  External transcutaneous cardiac pacemaker (noninvasive).
870.5800  Compressible limb sleeve.
870.5900  Thermal regulating system.
870.5925  Automatic rotating tourniquet.

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    Source:  45 FR 7907-7971, Feb. 5, 1980, unless otherwise noted.



                      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.

[[Page 283]]

    (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.
[52 FR 17735, May 11, 1987]



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.
    (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 Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 510(k) 
of the act) for a generic type of class I device is based upon the 
existing and reasonably foreseeable characteristics of commercially 
distributed devices within that generic type. Because FDA cannot 
anticipate every change in intended use or characteristic that could 
significantly affect a device's safety or effectiveness, manufacturers 
of any commercially distributed class I device for which FDA has granted 
an exemption

[[Page 284]]

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 its intended use 
before May 28, 1976, or the device is intended for a use different from 
the intended use of a preamendments device to which it had been 
determined to be substantially equivalent; 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; or
    (b) The modified device operates using a different fundamental 
scientific technology than that in use in the device before May 28, 
1976; 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 a deoxyribonucleic acid 
(DNA) probe or nucleic acid hybridization technology rather than culture 
or immunoassay technology.
[54 FR 25049, June 12, 1989]



              Subpart B--Cardiovascular Diagnostic Devices



Sec. 870.1025  Arrhythmia detector and alarm.

    (a) Identification. An arrhythmia detector and alarm is a system 
that monitors the electrocardiogram and is designed to produce a visible 
or audible signal or alarm when an atrial or ventricular arrhythmia, 
such as a premature contraction or ventricular fibrillation, exists.
    (b) Classification. 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. See Sec. 870.3.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987]



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

[[Page 285]]

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).



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. 870.1270  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).

[[Page 286]]



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 (performance standards).



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. 870.1350  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 7907-7971, 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 7907-7971, 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 (performance standards).



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).

[[Page 287]]



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 (performance standards).



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.
    (2) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
    (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 (performance standards).
[45 FR 7907-7971, Feb. 5, 1980, as amended at 59 FR 63007, Dec. 7, 1994]



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).

[[Page 288]]



              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. 870.2300  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. 870.2350  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).

[[Page 289]]



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 (performance standards).



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996]



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 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996]



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 (performance standards).



Sec. 870.2700  Oximeter.

    (a) Identification. An oximeter is a device used to transmit 
radiation at a known wavelength(s) through blood

[[Page 290]]

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 (performance standards).



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. 870.2800  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.
    (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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996]



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. 870.2860  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,

[[Page 291]]

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 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  Arterial embolization device.

    (a) Identification. An arterial embolization device is an 
intravascular implanted device used to control internal hemorrhage or to 
halt blood flow in arteries supplying blood to certain types of 
abdominal tumors (e.g., nephroma, hepatoma) and arteriovenous 
malformations. This device is not used in intracranial arteries.
    (b) Classification. 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. See Sec. 870.3.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987]

[[Page 292]]



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 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. See Sec. 870.3.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987]



Sec. 870.3450  Vascular graft prosthesis of less than 6 millimeters diameter.

    (a) Identification. A vascular graft prosthesis of less than 6 
millimeters (mm) diameter is a device used to replace sections of small 
arteries. This prosthesis is commonly constructed of woven or knitted 
materials such as polyethylene terephthalate and polytetrafluoroethylene 
and is not made of materials of animal origin, including human umbilical 
cords.
    (b) Classification. 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. See Sec. 870.3.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987]



Sec. 870.3460  Vascular graft prosthesis of 6 millimeters and greater diameter.

    (a) Identification. A vascular graft prosthesis of 6 millimeters 
(mm) and greater diameter is a device used to replace sections of 
arteries. This prosthesis is commonly constructed of woven or knitted 
materials such as polyethylene terephthalate and polytetrafluoroethylene 
and is not made of materials of animal origin, including human umbilical 
cords.
    (b) Classification. Class II (performance standards).



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. A intra-aortic balloon and control system is a 
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. 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. See Sec. 870.3.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987]



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 a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 870.3.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987]

[[Page 293]]



Sec. 870.3600  External pacemaker pulse generator.

    (a) Identification. An external 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, which is 
used outside the body, is used as a temporary substitute for the heart's 
intrinsic pacing sytem 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 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. See Sec. 870.3.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987]



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 
includes triggered, inhibited, and asynchronous devices implanted in the 
human body.
    (b) Classification. 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. See Sec. 870.3.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987]



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 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. See Sec. 870.3.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996]



Sec. 870.3670  Pacemaker charger.

    (a) Identification. A pacemaker charger is a device used 
transcutaneously to recharge the batteries of a rechargeable pacemaker.

[[Page 294]]

    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996]



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 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. 870.3.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996]



Sec. 870.3700  Pacemaker programmers.

    (a) Identification. A pacemaker programmer is a device used to 
change noninvasively 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 a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 870.3.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987]



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 a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 870.3.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987]



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. These devices are exempt from the 
premarket notification procedures of subpart E of part 807 of this 
chapter.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 54 FR 25049, June 12, 
1989]

[[Page 295]]



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 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. See Sec. 870.3.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987]



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 7907-7971, 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 7907-7971, Feb. 5, 1980, as amended at 52 FR 18163, May 13, 1987; 
52 FR 23137, June 17, 1987]



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 7907-7971, 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996]



               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.

[[Page 296]]

    (b) Classification. Class II (performance standards).



Sec. 870.4200  Cardiopulmonary bypass accessory equipment.

    (a) Identification. Cardiopulmonary bypass accessory equipment are 
devices that have no contact with blood and that are 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. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 54 FR 25049, June 12, 
1989]



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.
    (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 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. See Sec. 870.3.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987]



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 III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has

[[Page 297]]

been established of the requirement for premarket approval. See 
Sec. 870.3.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987]



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 (performance standards).



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 (performance standards).



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 a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 870.3.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987]



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 (performance standards).



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.

[[Page 298]]

    (b) Classification. 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. See Sec. 870.3.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987]



Sec. 870.4360  Nonroller-type cardiopulmonary bypass blood pump.

    (a) Identification. A nonroller-type cardiopulmonary bypass blood 
pump is a device that uses a method other than revolving rollers to pump 
the blood through the cardiopulmonary bypass circuit during bypass 
surgery.
    (b) Classification. 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. See Sec. 870.3.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987]



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 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 (performance standards), except that a 
reservoir that contains a defoamer or filter is classified into the same 
class as the defoamer or filter.



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 (performance standards).



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 (performance standards).



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).

[[Page 299]]



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. The devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 54 FR 25049, June 12, 
1989]



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. 870.5150  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 external 
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.
    (b) Classification. 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. See Sec. 870.3.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987]



Sec. 870.5225  External counter-pulsating device.

    (a) Identification. An external counter-pulsating device is a 
noninvasive 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. 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. See Sec. 870.3.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987]



Sec. 870.5300  DC-defribrillator (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

[[Page 300]]

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 7907-7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 
61 FR 50706, Sept. 27, 1996]



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 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. 870.3.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987]



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. 870.5925  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

[[Page 301]]

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.
872.1800  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.
872.1905  Dental x-ray film holder.

                          Subpart C  [Reserved]

                      Subpart D--Prosthetic Devices

872.3050  Amalgam alloy.
872.3060  Gold based alloys and precious metal alloys for clinical use.
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.
872.3640  Endosseous implant.
872.3645  Subperiosteal implant material.
872.3660  Impression material.
872.3670  Resin impression tray material.
872.3680  Polytetrafluoroethylene (PTFE) vitreous carbon material.
872.3690  Tooth shade resin material.
872.3700  Dental mercury.
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.
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  Tricalcium phosphate granules for dental bone repair.
872.3940  Total temporomandibular joint prosthesis.
872.3950  Glenoid fossa prosthesis.
872.3960  Mandibular condyle prosthesis.
872.3970  Interarticular disc prosthesis (interpositional implant).

                       Subpart E--Surgical Devices

872.4120  Bone cutting instrument and accessories.
872.4130  Intraoral dental drill.
872.4200  Dental handpiece and accessories.

[[Page 302]]

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.
872.4840  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.

                    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  Procelain 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, 371.

    Source:  52 FR 30097, Aug. 12, 1987, unless otherwise noted.



                      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.



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

[[Page 303]]

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 Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 510(k) 
of the act) for a generic type of class I device is based upon the 
existing and reasonably foreseeable characteristics of commercially 
distributed devices within that generic type. Because FDA cannot 
anticipate every change in intended use or characteristic that could 
significantly affect a device's safety or effectiveness, manufacturers 
of any commercially distributed class I 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 its intended use 
before May 28, 1976, or the device is intended for a use different from 
the intended use of a preamendments device to which it had been 
determined to be substantially equivalent; 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; or
    (b) The modified device operates using a different fundamental 
scientific technology than that in use in the device before May 28, 
1976; 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 a deoxyribonucleic acid 
(DNA) probe or nucleic acid hybridization technology rather than culture 
or immunoassay technology.
[54 FR 13829, Apr. 5, 1989]



                      Subpart B--Diagnostic Devices



Sec. 872.1500  Gingival fluid measurer.

    (a) Identification. A gingival fluid measurer is a gauge device 
intended to

[[Page 304]]

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. 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 63007, Dec. 7, 1994]



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.



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. 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 54 FR 13830, Apr. 5, 1989]



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.



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. 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. 872.1830  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. 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 61 FR 1121, Jan. 16, 1996]

[[Page 305]]



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 divergent radiation, and to prevent leakage of 
radiation.
    (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 61 FR 1121, Jan. 16, 1996]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations 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]



                          Subpart C  [Reserved]



                      Subpart D--Prosthetic Devices



Sec. 872.3050  Amalgam alloy.

    (a) Identification. An amalgam alloy is a device that consists of a 
metallic substance intended to be mixed with mercury to form filling 
material for treatment of dental caries.
    (b) Classification. Class II.



Sec. 872.3060  Gold-based alloys and precious metal alloys for clinical use.

    (a) Identification. Gold-based alloys and precious metal alloys for 
clinical use are mixtures of metals, the major components of which are 
gold, silver, or palladium. They also may contain a small quantity of 
copper or platinum. The device is intended to fabricate dental 
appliances, such as crowns and bridges, for patients.
    (b) Classification. Class II



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. 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 54 FR 13830, Apr. 5, 1989]



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. The device 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 63008, Dec. 7, 1994]



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. 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 54 FR 13830, Apr. 5, 1989]



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.

[[Page 306]]

    (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. 872.3140  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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations 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]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations 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]



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. 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. 872.3200  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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations 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]



Sec. 872.3240  Dental bur.

    (a) Identification. A dental bur is a rotary cutting device made 
from carbon steel or tungsten carbide intended to

[[Page 307]]

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. 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. 872.3250  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.



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.
    (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 devices such as crowns or bridges, or to be 
applied to a tooth to protect the tooth pulp.
    (2) Classification. Class II.



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. 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. 872.3300  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.



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.

[[Page 308]]

    (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. 872.3350  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. 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. 872.3360  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.
    (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. 872.3400  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 if the device contains less than 12 
percent by weight of sodium borate.
    (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]



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. 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. 872.3420  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

[[Page 309]]

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 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. 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. 872.3480  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. 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. 872.3500  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

[[Page 310]]

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 
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. 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. 872.3530  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. The device 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 63008, Dec. 7, 1994]



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 OTC denture cushion or pad 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.
    (2) Class III 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) of this 
section.
    (c) Data PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval of the device described in paragraph (b)(2). See Sec. 872.3.



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 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 OTC 
denture reliner 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 OTC denture reliner that was in 
commercial distribution before May 28, 1976. Any

[[Page 311]]

other OTC denture reliner 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. 872.3570  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 III.
    (c) Data PMA or notice of completion of PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 872.3.



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. 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. 872.3590  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.



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 III.
    (c) Data PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 872.3.



Sec. 872.3640  Endosseous implant.

    (a) Identification. An endosseous implant is a device made of a 
material such as titanium 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, and to restore the patient's chewing 
function.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 872.3.



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.
    (b) Classification. Class II.



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

[[Page 312]]

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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is exempt 
from the current good manufacturing practice regulations 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]



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. 872.3700  Dental mercury.

    (a) Identification. Dental mercury is a device composed of mercury 
intended for use as a component of amalgam alloy in the restoration of a 
dental cavity or a broken tooth.
    (b) Classification. Class I.



Sec. 872.3710  Base metal alloy.

    (a) Identification. A base metal alloy is a device composed of a 
material, such as a mixture of nickel and chromium, intended for use in 
fabrication of a custom-made dental device, such as porcelain veneer for 
a tooth.
    (b) Classification. Class II.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807. If the device is not 
labeled or otherwise represented as sterile, it is exempt from the 
current good manufacturing practice regulations 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. 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. 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 60 FR 38900, July 28, 1995]

[[Page 313]]



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. 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 60 FR 38900, July 28, 1995]



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. 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 54 FR 13830, Apr. 5, 1989]



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.

[[Page 314]]

    (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 54 FR 13830, Apr. 5, 1989]



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. 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 54 FR 13830, Apr. 5, 1989]



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.



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).
    (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. 872.3910  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. 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. 872.3920  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  Tricalcium phosphate granules for dental bone repair.

    (a) Identification. Tricalcium phosphate granules for dental bone 
repair is a device intended to be implanted into the upper or lower jaw 
to provide support for prosthetic devices.
    (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. 872.3.



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. The 
effective date of the requirement for premarket approval has not been 
established. See Sec. 872.3.
[59 FR 65478, Dec. 20, 1994]



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

[[Page 315]]

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. The 
effective date of the requirement for premarket approval has not been 
established. See Sec. 872.3.
[59 FR 65478, Dec. 20, 1994]



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. The 
effective date of the requirement for premarket approval has not been 
established. See Sec. 872.3.
[59 FR 65478, Dec. 20, 1994]



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. The 
effective date of the requirement for premarket approval hasnot been 
established. See Sec. 872.3.
[59 FR 65478, Dec. 20, 1994]



                       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 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. 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. 872.4200  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

[[Page 316]]

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 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. 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.
[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989]



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. The device 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 63008, Dec. 7, 1994]



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. 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 61 FR 1121, Jan. 16, 1996]



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.

[[Page 317]]

    (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. 872.4760  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. 872.4840  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. 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 63009, Dec. 7, 1994]



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

[[Page 318]]

a final position or to maintain the teeth in their corrected position.
    (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 63009, Dec. 7, 1994]



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 if the teething ring contains a fluid, such as water.
[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994]



                    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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations 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]



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. 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 63009, Dec. 7, 1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations 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]



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 III.

[[Page 319]]

    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 872.3.
[52 FR 30097, Aug. 12, 1987; 52 FR 49250, Dec. 30, 1987]



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. 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 60 FR 38900, July 28, 1995]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is exempt 
from the current good manufacturing practice regulations 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]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations 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]



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 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise respresented as sterile, it is also 
exempt from the current good manufacturing practice regulations 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 13831, Apr. 5, 1989]



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 duing dental procedures, such 
as filling a cavity preparation. The device is stretched around a tooth 
by inserting the tooth through the hole in the center. The device 
includes the rubber dam, rubber dam

[[Page 320]]

clamp, rubber dam frame, and forceps for a rubber dam clamp.
    (b) Classification. Class I. The accessories to the device, i.e., 
rubber dam clamp, rubber dam frame and forceps for a rubber dam clamp, 
are exempt from the premarket notification procedures in subpart E of 
part 807 of this chapter. If the device is not labeled or otherwise 
represented as sterile, it is exempt from the current good manufacturing 
practice regulations 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]



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. If the device is made of inert 
materials and is not coated or impregnated with chemicals intended to 
provide a therapeutic benefit or interact with tissues of the oral 
cavity, it 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 61 FR 1121, Jan. 16, 1996]



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. The device 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. 872.6510  Oral irrigation unit.

    (a) Identification. An oral irrigation unit is an AC-powered device 
intended to provide a pressurized stream of water to remove food 
particles from between the teeth and promote good periodontal (gum) 
condition.
    (b) Classification. Class I. The device 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. 872.6570  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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations 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 13831, Apr. 5, 1989]



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.

[[Page 321]]

    (b) Classification. Class I. The accessories tray to the dental 
operative unit 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. 872.6650  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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations 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 13831, Apr. 5, 1989]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations 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 13831, Apr. 5, 1989]



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.
[55 FR 48439, Nov. 20, 1990]



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

[[Page 322]]

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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations 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 13831, Apr. 5, 1989]



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.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994]



Sec. 872.6870  Disposable flouride 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations 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 13831, Apr. 5, 1989]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations 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 13832, Apr. 5, 1989]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is exempt 
from the current good manufacturing practice regulations in part 820 of 
this chapter, with the exception of Sec. 820.180, with respect to 
general requirements concerning records, and

[[Page 323]]

Sec. 820.198, with respect to complaint files.
[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994]



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 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.
874.1800  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  Hearing aid.
874.3310  Hearing aid calibrator and analysis system.
874.3320  Group hearing aid or group auditory trainer.
874.3330  Master hearing aid.
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.
874.3930  Tympanostomy tube with semipermeable membrane.

                       Subpart E--Surgical Devices

874.4100  Epistaxis balloon.
874.4140  Ear, nose, and throat bur.
874.4175  Nasopharyngeal catheter.
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.
874.4490  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.

                     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.

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    Source:  51 FR 40389, Nov. 6, 1986, unless otherwise noted.



                      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

[[Page 324]]

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.



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 act.

    FDA's decision to grant an exemption from the requirement of 
premarket notification (section 510(k) of the act) for a generic type of 
class I device is based upon the existing and reasonably foreseeable 
characteristics of commercially distributed devices within that generic 
type. Because FDA cannot anticipate every change in intended use or 
characteristic that could significantly affect a device's safety or 
effectiveness, manufacturers of any commercially distributed class I 
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 its intended use 
before May 28, 1976, or the device is intended for a use different from 
the intended use of a preamendments device to which it had been 
determined to be substantially equivalent; e.g., the device is intended 
for a different medical

[[Page 325]]

purpose, or the device is intended for lay use where the former intended 
use was by health care professionals only; or
    (b) The modified device operates using a different fundamental 
scientific technology than that in use in the device before May 28, 
1976; 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 a deoxyribonucleic acid 
(DNA) probe or nucleic acid hybridization technology rather than culture 
or immunoassay technology.
[52 FR 32111, Aug. 25, 1987]



                      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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1121, Jan. 16, 1996]



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.
[55 FR 48440, Nov. 20, 1990]



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 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1121, Jan. 16, 1996]



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.



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

[[Page 326]]

connection path) between the audiometer earphone and the patient's ear.
    (b) Classification. Class I. 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.
[51 FR 40389, Nov. 9, 1986; 52 FR 18495, May 15, 1987, as amended at 52 
FR 32111, Aug. 25, 1987]



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.



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.



Sec. 874.1500  Gustometer.

    (a) Identification. A gustometer is a battery-powered device that 
consists of two electrodes that are intended to be 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. If the device is not labeled or 
otherwise represented as sterile, it is exempt from the current good 
manufacturing practice regulations 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. 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.
[55 FR 48440, Nov. 20, 1990]



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.



                          Subpart C  [Reserved]



                      Subpart D--Prosthetic Devices



Sec. 874.3300  Hearing Aid.

    (a) Identification. A hearing aid is wearable sound-amplifying 
device that is intended to compensate for impaired hearing. This generic 
type of device includes the air-conduction hearing aid and the bone-
conduction hearing aid, but excludes the group hearing aid or group 
auditory trainer (Sec. 874.3320), master hearing aid (Sec. 874.3330), 
and tinnitus masker (Sec. 874.3400).
    (b) Classification. (1) Class I for the air-conduction hearing aid. 
(2) Class II for the bone-conduction hearing aid.



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

[[Page 327]]

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.



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.



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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is exempt 
from the current good manufacturing practice regulations 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 40389, Nov. 6, 1986, as amended at 59 FR 63009, Dec. 7, 1994]



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 III.
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 874.3.



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.



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.

[[Page 328]]



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. 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. If 
the device is not labeled or otherwise represented as sterile, it is 
exempt from the current good manufacturing practice regulations 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.
[51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987]



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 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.



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

[[Page 329]]

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 the symptoms of 
vertigo. The device directs excess endolymph from the distended end of 
the endolymphatic system into the mastoid cavity where resorption 
occurs. The function of the pressure-limiting inner ear valve is to 
impede the flow of endolymph so that a physiologically normal 
endolymphatic pressure is maintained. The device is made of silicone 
elastomer and polyamide and contains gold radiopaque markers within the 
silicone elastomer sheath.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 874.3.



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. 874.3930  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 III.
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 874.3.



                       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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1122, Jan. 16, 1996]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1122, Jan. 16, 1996]

[[Page 330]]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1122, Jan. 16, 1996]



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 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 tub; 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 tub; 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. 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.
[51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987]



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

[[Page 331]]

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 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994]



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

[[Page 332]]

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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter only 
when used in the external ear canal.
[55 FR 48440, Nov. 20, 1990, as amended at 61 FR 1122, Jan. 16, 1996]]



                     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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is exempt 
from the current good manufacturing practice regulations 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 40389, Nov. 6, 1986, as amended at 59 FR 63009, Dec. 7, 1994]



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.
[55 FR 48440, Nov. 20, 1990]



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 or completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 874.3.



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 a PDP is required. A No 
effective date has been established of the requirement for premarket 
approval. See Sec. 874.3.



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.
[55 FR 48440, Nov. 20, 1990]



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.

[[Page 333]]

    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987; 59 
FR 63009, Dec. 7, 1994]



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.



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

876.1075  Gastroenterology-urology biopsy instrument.
876.1400  Stomach pH electrode.
876.1500  Endoscope and accessories.
876.1620  Urodynamics measurement system.
876.1725  Gastrointestinal motility monitoring system.
876.1800  Urine flow or volume measuring system.

                      Subpart C--Monitoring Devices

876.2040  Enuresis alarm.

                      Subpart D--Prosthetic Devices

876.3350  Penile inflatable implant.
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.
876.4370  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.
876.4650  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.
876.5030  Continent ileostomy catheter.
876.5090  Suprapubic urological catheter and accessories.
876.5130  Urological catheter and accessories.
876.5160  Urological clamp for males.
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.
876.5320  Nonimplanted electrical continence device.
876.5365  Esophageal dilator.
876.5450  Rectal dilator.
876.5470  Ureteral dilator.
876.5520  Urethral dilator.
876.5540  Blood access device and accessories.
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.
876.5895  Ostomy irrigator.
876.5900  Ostomy pouch and accessories.
876.5920  Protective garment for incontinence.
876.5955  Peritoneo-venous shunt.
876.5970  Hernia support.
876.5980  Gastrointestinal tube and accessories.

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    Source:  48 FR 53023, Nov. 23, 1983, unless otherwise noted.

[[Page 334]]



                      Subpart A--General Provisions



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.
[52 FR 17737, May 11, 1987; 52 FR 22577, June 12, 1987]



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 commerically 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 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 Food and Drug Administration (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 510(k) 
of the act) for a generic type of class I device is based

[[Page 335]]

upon the existing and reasonably foreseeable characteristics of 
commercially distributed devices within that generic type. Because FDA 
cannot anticipate every change in intended use or characteristic that 
could significantly affect a device's safety or effectiveness, 
manufacturers of any commercially distributed class I 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 its intended use 
before May 28, 1976, or the device is intended for a use different from 
the intended use of a preamendments device to which it had been 
determined to be substantially equivalent; 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; or
    (b) The modified device operates using a different fundamental 
scientific technology than that in use in the device before May 28, 
1976; 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 a deoxyribonucleic acid 
(DNA) probe or nucleic acid hybridization technology rather than culture 
or immunoassay technology.
[54 FR 25049, June 12, 1989]



                      Subpart B--Diagnostic Devices



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.
[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996]



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. 876.1500  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 
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

[[Page 336]]

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 (performance standards).
    (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 807 of this 
chapter.
[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996]



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 (performance standards).



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. 876.1800  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 (performance standards).
    (2) Class I for the disposable, nonelectrical urine flow rate 
measuring device, and nonelectrical urinometer. The devices subject to 
this paragraph (b)(2) are 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]

[[Page 337]]



                      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 (performance standards).



                      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 PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 876.3.
[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987]



Sec. 876.3630  Penile rigidity implant.

    (a) Identification. A penile rigidity implant is a device that 
consists of a single semi-rigid rod or a pair of semi-rigid rods 
implanted in the penis to provide rigidity. It is used in the treatment 
of erectile impotence.
    (b) Classification. Class III (permarket 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. See Sec. 876.3.
[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987]



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 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 (performance standards).



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 (performance standards).



Sec. 876.4300  Endoscopic electrosurgical unit and accessories.

    (a) Identification. An endoscopic electrosurgical unit and 
accessories is

[[Page 338]]

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. 876.4370  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 (performance standards) for the 
gastroenterology-urology evacuator when other than manually powered.
    (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]



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 (performance standards).



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 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. See Sec. 876.3.
[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987]



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 (performance standards).



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. 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 54 FR 25049, June 12, 1989]



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. 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 54 FR 25049, June 12, 1989]



Sec. 876.4590  Interlocking urethal 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

[[Page 339]]

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. 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. 876.4620  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. 876.4650  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 (performance standards).



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 type of device includes the metal basket and 
the flexible ureteral stone dislodger.
    (b) Classification. Class II (performance standards).



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.
    (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 54 FR 25049, June 12, 1989]



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 (performance standards).



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 (performance standards) for the 
electrically powered urological table and accessories.
    (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

[[Page 340]]

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]



                     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 (performance standards).



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. 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 54 FR 25050, June 12, 1989]



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).
    (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.
[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996]



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, coude 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 gastro-
urological 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.
[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996]



Sec. 876.5160  Urological clamp for males.

    (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.

[[Page 341]]

    (b) Classification. Class I (general controls).



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 current good manufacturing practice regulations 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. 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.
    (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 (performance standards) for a urine 
collector and accessories intended to be connected to an indwelling 
catheter.
    (2) Class I (general controls) for a urine collector and accessories 
not intended to be connected to an indwelling catheter. If the device is 
not labeled or otherwise represented as sterile, it is exempt from the 
current good manufacturing practice regulations 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.

[[Page 342]]



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 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. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 876.3.
[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987]



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. 876.5365  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 (performance standards).



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. 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. 876.5470  Ureteral dilator.

    (a) Identification. A ureteral dilator is a device that consists of 
a specially

[[Page 343]]

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 (performance standards).
    (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.
[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996]



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 consists of various flexible 
or rigid tubes, 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 
shunts and connectors specifically designed to provide access to  blood, 
 such  as  the  arteriovenous (A-V) shunt cannula and vessel tip.
    (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 (Secs. 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 III (premarket approval) for the 
implanted blood access device.
    (2) Class II (performance standards) for the nonimplanted blood 
access device.
    (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.
    (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. 876.3.
[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 61 
FR 1122, Jan. 16, 1996]



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

[[Page 344]]

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 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 (performance standards).



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 (performance standards).



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

[[Page 345]]

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 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.
[48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25050, June 12, 1989]



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 that is used as an artificial kidney system for the treatment of 
patients with renal failure or toxemic conditions, and that has a 
dialyzer with a semipermeable membrane that is more permeable to water 
than the semipermeable membrane of the conventional dialyzer. The device 
system consists of an extracorporeal blood system, a high permeability 
dialyzer, and a controlled dialysate delivery system that incorporates 
an ultrafiltration controller to

[[Page 346]]

prevent excessive loss of water from the patient's blood. This highly 
permeable, semipermeable membrane may also permit greater loss of higher 
molecular weight substances from the blood, compared with the 
conventional dialyzer of the hemodialysis system and accessories 
(Sec. 876.5820). The extracorporeal blood system is the same generic 
type of extracorporeal blood system that is used in the hemodialysis 
system and accessories (Sec. 876.5820). The controlled dialysate 
delivery system also is similar to the conventional disalysate delivery 
system of the hemodialysis system and accessories (Sec. 876.5820), with 
the addition of an ultrafiltration controller to regulate the rate of 
the removal of water from the patient's blood and ensure that the 
pressure on the dialysate side of the membrane is always lower than on 
the blood side. This generic type of device includes the sealed 
dialysate delivery system.
    (b) Classification. 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. See Sec. 876.3.
[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987]



Sec. 876.5870  Sorbent hemoperfusion system.

    (a) Identification. A sorbent hemoperfusion system is a 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. 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. See Sec. 876.3.
[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987]



Sec. 876.5880  Isolated kidney perfusion and transport system and accessories.

    (a) Identification. An isolated kidney perfusion and transport 
system and accesssories 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. 876.5895  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 (performance standards).



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 
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

[[Page 347]]

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. 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 54 FR 25050, June 12, 1989]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. The 
device is also exempt from the current good manufacturing practice 
regulations 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]



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 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. See Sec. 876.3.
[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations 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]



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 (performance standards).
    (2) Class I (general controls) for the dissolvable nasogastric feed 
tube guide for the nasogastric tube.
[49 FR 573, Jan. 5, 1984]



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.

[[Page 348]]

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.
878.3530  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

878.4040  Surgical apparel.
878.4100  Organ bag.
878.4160  Surgical camera and accessories.
878.4200  Introduction/drainage catheter and accessories.
878.4300  Implantable clip.
878.4320  Removable skin clip.
878.4350  Cryosurgical unit and accessories.
878.4370  Surgical drape and drape accessories.
878.4380  Drape adhesive.
878.4400  Electrosurgical cutting and coagulation device and 
          accessories.
878.4440  Eye pad.
878.4450  Nonabsorbable gauze for internal use.
878.4460  Surgeon's glove.
878.4470  Surgeon's gloving cream.
878.4480  Absorbable powder for lubricating a surgeon's glove.
878.4490  Absorbable hemostatic agent and dressing.
878.4493  Absorbable poly(glycolide/L-lactide) surgical suture.
878.4520  Polytetrafluoroethylene injectable.
878.4580  Surgical lamp.
878.4630  Ultraviolet lamp for dermatologic disorders.
878.4635  Ultraviolet lamp for tanning.
878.4660  Skin marker.
878.4680  Nonpowered, single patient, portable suction apparatus.
878.4700  Surgical microscope and accessories.
878.4730  Surgical skin degreaser or adhesive tape solvent.
878.4750  Implantable staple.
878.4760  Removable skin staple.
878.4780  Powered suction pump.
878.4800  Manual surgical instrument for general use.
878.4810  Laser surgical instrument for use in general and plastic 
          surgery and in dermatology.
878.4820  Surgical instrument motors and accessories/attachments.
878.4830  Absorbable surgical gut suture.
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.
878.5000  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.
878.5040  Suction lipoplasty system.

                     Subpart F--Therapeutic Devices

878.5070  Air-handling apparatus for a surgical operating room.
878.5350  Needle-type epilator.
878.5360  Tweezer-type epilator.
878.5650  Topical oxygen chamber for extremities.
878.5900  Nonpneumatic tourniquet.
878.5910  Pneumatic tourniquet.

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    Source:  53 FR 23872, June 24, 1988, unless otherwise noted.



                      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

[[Page 349]]

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.



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 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 Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 510(k) 
of the act) for a generic type of class I device is based upon the 
existing and reasonably foreseeable characteristics of commercially 
distributed devices within that generic type. Because FDA cannot 
anticipate every change in intended use or characteristic that could 
significantly affect a device's safety or effectiveness, manufacturers 
of any commercially distributed class I device for

[[Page 350]]

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 its intended use 
before May 28, 1976, or the device is intended for a use different from 
the intended use of a preamendments device to which it has been 
determined to be substantially equivalent; 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; or
    (b) The modified device operates using a different fundamental 
scientific technology than that in use in the device before May 28, 
1976; 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 a deoxyribonucleic acid 
(DNA) probe or nucleic acid hybridization technology rather than culture 
or immunoassay technology.
[54 FR 13827, Apr. 5, 1989; 54 FR 16438-T, Apr. 24, 1989]



                      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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 59 
FR 63010, Dec. 7, 1994]



                          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. 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.
[53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989]



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. 878.3530  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. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 878.3.

[[Page 351]]



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 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 plastic tube or 
tube-like device that may have mesh reinforcement that is intended to be 
implanted in, or affixed externally to, the chest and throat to restore 
the esophagus or provide pharyngoesophageal continuity.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 878.3.



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. A tracheal prosthesis is a tubular device 
intended to be implanted to reconstruct the trachea.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 878.3.



Sec. 878.3750  External prosthesis adhesive.

    (a) Identification. An external prosthesis adhesive is a silicone-
type adhesive intended to be used to fasten to

[[Page 352]]

the body an external aesthetic restoration prosthesis, such as an 
artificial nose.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If 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 regulations 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]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994]



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. 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. If the device is not labeled or otherwise represented as 
sterile, it is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to the general requirements concerning 
records, and Sec. 820.198, with respect to complaint files.
[53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989]



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. 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.
[53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989]



                       Subpart E--Surgical Devices



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. Class II for surgical gowns and surgical masks. 
Class I for surgical apparel other than surgical gowns and surgical 
masks.

[[Page 353]]



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. The intestinal organ bag device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter.
[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989]



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.



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.



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 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. 878.4370  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.

[[Page 354]]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994]



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. 878.4440  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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996]



Sec. 878.4460  Surgeon's glove.

    (a) Identification. A surgeon's glove is a device made of natural or 
synthetic rubber intended to be worn by operating room personnel to 
protect a surgical wound from contamination. The lubricating or dusting 
powder used in the glove is excluded.
    (b) Classification. Class I.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994]



Sec. 878.4480  Absorbable powder for lubricating a surgeon's glove.

    (a) Identification. Absorbable powder for lubricating a surgeon's 
glove is a powder made from corn starch 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.
    (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. 878.4490  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.

[[Page 355]]



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, 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.
[56 FR 47151, Sept. 18, 1991]



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. 878.4580  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.



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  Ultraviolet lamp for tanning.

    (a) Identification. An ultraviolet lamp for tanning is a device that 
is a lamp (including a fixture) intended to provide ultraviolet 
radiation to tan the skin. See Sec. 1040.20 of this chapter.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63010, Dec. 7, 1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994]



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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63010, Dec. 7, 1994]

[[Page 356]]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994]



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. 878.4760  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.



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. 878.4800  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, blood lancet, 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.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989; 59 
FR 63010, Dec. 7, 1994]



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.
[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996]



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

[[Page 357]]

bit, hammerhead, pin driver, and saw blade.
    (b) Classification. Class I.
[55 FR 48440, Nov. 20, 1990]



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 sheep (ovine) intestine, and is intended 
for use in soft tissue approximation.
    (b) Classification. Class II.
[54 FR 50738, Dec. 11, 1989]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989; 59 
FR 63010, Dec. 7, 1994]



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.
[55 FR 48440, Nov. 20, 1990]



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.
[56 FR 24685, May 31, 1991]



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.
[56 FR 24685, May 31, 1991]



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.

[[Page 358]]

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.
[56 FR 24685, May 31, 1991]



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).
[58 FR 57558, Oct. 26, 1993]



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]



                     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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996]



Sec. 878.5360  Tweezer-type epilator.

    (a) Identification. A tweezer-type epilator is an electrical device 
intended for hair removal. The device provides a high-frequency electric 
current at the tip of a tweezer used for removing hair.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 878.3.

[[Page 359]]



Sec. 878.5650  Topical oxygen chamber for extremities.

    (a) Identification. A topical oxygen chamber for extremities is a 
device intended to surround hermetically a patient's limb and apply 
humidified oxygen topically at a pressure slightly greater than 
atmospheric pressure to aid healing of chronic skin ulcers or bed sores.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 878.3.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989; 59 
FR 63010, Dec. 7, 1994]



Sec. 878.5910  Pneumatic tourniquet.

    (a) Identification. A pneumatic tourniquet is an air-powered device 
consisting of a pressure-regulating unit, 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996]



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.
880.2800  Sterilization process indicator.
880.2900  Clinical color change thermometer.
880.2910  Clinical electronic thermometer.
880.2920  Clinical mercury thermometer.

                        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 hospital bed.
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.
880.5450  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.

[[Page 360]]

880.5725  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.

   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.
880.6190  Mattress cover for medical purposes.
880.6200  Ring cutter.
880.6230  Tongue depressor.
880.6250  Patient examination glove.
880.6265  Examination gown.
880.6280  Medical insole.
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.
880.6710  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  Washer 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.
880.6900  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.

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    Source:  45 FR 69682-69737, Oct. 21, l980, unless otherwise noted.



                      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.
[52 FR 17738, May 11, 1987]



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 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

[[Page 361]]

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 Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 510(k) 
of the act) for a generic type of class I device is based upon the 
existing and reasonably foreseeable characteristics of commercially 
distributed devices within that generic type. Because FDA cannot 
anticipate every change in intended use or characteristic that could 
significantly affect a device's safety or effectiveness, manufacturers 
of any commercially distributed class I 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 its intended use 
before May 28, 1976, or the device is intended for a use different from 
the intended use of a preamendments device to which it had been 
determined to be substantially equivalent; 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; or
    (b) The modified device operates using a different fundamental 
scientific technology than that in use in the device before May 28, 
1976; 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 a deoxyribonucleic acid 
(DNA) probe or nucleic acid hybridization technology rather than culture 
or immunoassay technology.
[54 FR 25050, June 12, 1989]



                          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.

[[Page 362]]

The liquid crystals, which are cholesteric esters, are sealed in 
plastic.
    (b) Classification. Class II (performance standards).



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 69682-69737, Oct. 21, l980, as amended at 59 FR 63010, Dec. 7, 
1994]



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. The 
device also is exempt from the good manufacturing practice 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. 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 69682-69737, Oct. 21, l980, as amended at 61 FR 1123, Jan. 16, 
1996]



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. The 
device also is exempt from the good manufacturing practice regulation in 
part 820 with the exception of Sec. 820.180, with respect to

[[Page 363]]

general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 69682-69737, Oct. 21, l980, as amended at 61 FR 1123, Jan. 16, 
1996]



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 (performance standards).



                        Subparts D-E  [Reserved]



    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 premarket notification procedures in subpart E of part 807. If the 
device is not

[[Page 364]]

labeled or otherwise represented as sterile, it also is exempt from the 
good manufacturing practice 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. 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).



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 (performance standards).



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. The 
device is also exempt from the current good manufacturing practice 
regulations 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.
[45 FR 69682-69737, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 
1989]



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 hospital bed.

    (a) Identification. A pediatric hospital bed is a device intended 
for medical purposes that consists of a bed or crib designed for the use 
of a pediatric patient, with fixed end rails and movable and latchable 
side rails. The contour of the bed surface may be adjustable.

[[Page 365]]

    (b) Classification. Class II (performance standards).



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. The 
device also is exempt from the good manufacturing practice 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. 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 notifiction procedures in subpart E of part 807. If 
the device is not labeled or otherwise represented as sterile, it also 
is exempt from the good manufacturing practice 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. 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 69682-69737, Oct. 21, l980, as amended at 59 FR 63011, Dec. 7, 
1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 69682-69737, Oct. 21, l980, as amended at 59 FR 63011, Dec. 7, 
1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 69682-69737, Oct. 21, l980, as amended at 59 FR 63011, Dec. 7, 
1994]

[[Page 366]]



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). If the device is not 
labeled or otherwise represented as sterile, it is exempt from the good 
manufacturing practice regulation 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. 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 subpart E of part 807. If 
the device is not labeled or otherwise represented as sterile, it also 
is exempt from the good manufacturing practice 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. 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).



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 (performance standards).

[[Page 367]]



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 (performance standards).



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 (performance standards).



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 69682-69737, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 
1989]



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 (performance standards).



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 69682-69737, Oct. 21, l980, as amended at 61 FR 1123, Jan. 16, 
1996]



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).

[[Page 368]]



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). 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]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 69682-69737, Oct. 21, l980, as amended at 59 FR 63011, Dec. 7, 
1994]



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. If 
the device is not labeled or otherwise represented as sterile, it also 
is exempt from the good manufacturing practice 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. 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). The device is exempt 
from the good manufacturing practice 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. 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. 880.5740  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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 69682-69737, Oct. 21, l980, as amended at 59 FR 63011, Dec. 7, 
1994]

[[Page 369]]



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 69682-69737, 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 (performance standards).
    (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. The 
device is exempt from the current good manufacturing practice 
regulations 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 69682-69737, Oct. 21, l980, as amended at 59 FR 63011, Dec. 7, 
1994]



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. The 
device also is exempt from the good manufacturing practice 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. 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 69682-69737, Oct. 21, l980, as amended at 59 FR 63011, Dec. 7, 
1994]

[[Page 370]]



   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. If 
the device is not labeled or otherwise represented as sterile, it also 
is exempt from the good manufacturing practice 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. 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. If 
the device is not labeled or otherwise represented as sterile, it also 
is exempt from the good manufacturing practice 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. 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is exempt 
from the current good manufacturing practice regulations 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 69682-69737, Oct. 21, l980, as amended at 59 FR 63011, Dec. 7, 
1994]



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. The 
device also is exempt from the good manufacturing practice 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. 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 premarket notification procedures in subpart E of part 807. The 
device also is exempt from the good manufacturing practice 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. 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. The 
device also is exempt from the good manufacturing practice regulation in 
part 820, with

[[Page 371]]

the exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.



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. The 
device also is exempt from the good manufacturing practice 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. 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.
[45 FR 69682-69737, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 
1989; 59 FR 63011, Dec. 7, 1994]



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 premarket notification procedures in subpart 807. If the device is 
not labeled or otherwise represented as sterile it is also exempt from 
the good manufacturing practice 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. 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is exempt 
from the good manufacturing practice regulations 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 69682-69737, Oct. 21, l980, as amended at 59 FR 63011, Dec. 7, 
1994]



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

[[Page 372]]

subpart E of part 807. The device also is exempt from the good 
manufacturing practice 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. 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. If 
the device is not labeled or otherwise represented as sterile, it also 
is exempt from the good manufacturing practice 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. 880.6250  Patient examination glove.

    (a) Identification. A 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.
    (b) Classification. Class I (general controls).
[45 FR 69682-69737, Oct. 21, 1980, as amended at 53 FR 1604, Jan. 13, 
1989]



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. If 
the device is not labeled or otherwise represented as sterile, it also 
is exempt from the good manufacturing practice 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. 880.6280  Medical insole.

    (a) Identification. A medical insole is a device intended for 
medical purposes that is placed inside a shoe to relieve the symptoms of 
athlete's foot infection by absorbing moisture.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 69682-69737, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 
1989]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 69682-69737, Oct. 21, l980, as amended at 61 FR 1123, Jan. 16, 
1996]



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 premarket notification procedures in subpart E of part 807. The 
device also is exempt from the good manufacturing practice 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. 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).

[[Page 373]]



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. The 
device also is exempt from the good manufacturing practice 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. 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. The 
device also is exempt from the good manufacturing practice 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. 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. 880.6710  Medical ultraviolet water purifier.

    (a) Identification. A medical ultraviolet water purifier is a device 
intended for medical purposes that is used to destroy bacteria in water 
by exposure to ultraviolet radiation.
    (b) Classification. Class II (performance standards).



Sec. 880.6730  Body waste receptacle.

    (a) Identification. A body waste receptacle is a device intended for 
medical purposes tht 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. The 
device also is exempt from the good manufacturing practice 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. 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 (performance standards).



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).
[61 FR 8439, Mar. 4, 1996]



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 (performance standards).

[[Page 374]]



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 premarket notification procedures in subpart E of part 807. The 
divice also is exempt from the good manufacturing practice 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. 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. The 
device also is exempt from the good manufacturing practice 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. 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 premarket notification procedures in subpart E of part 807.



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. 880.6900  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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations 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 69682-69737, Oct. 21, l980, as amended at 59 FR 63011, Dec. 7, 
1994]



Sec. 880.6910  Wheeled stretcher.

    (a) Identification. A wheeled stretcher is a device consisting of a 
platform

[[Page 375]]

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 (performance standards).



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.
    (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. If 
the device is not labeled or otherwise represented as sterile, it also 
is exempt from the good manufacturing practice 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. 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 69682-69737, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 
1989]



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. If 
the device is not labeled or otherwise represented as sterile, it is 
also exempt from the good manufacturing practice regulation in part 820, 
with the exception of Sec. 820.180, general requirements concerning 
records, and Sec. 820.198, with respect to complaint files.



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.
882.1460  Nystagmograph.
882.1480  Neurological endoscope.
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.
882.1570  Powered direct-contact temperature measurement device.
882.1610  Alpha monitor.

[[Page 376]]

882.1620  Intracranial pressure monitoring 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.
882.1950  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.
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  Cottonoid 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.

               Subpart F--Neurological Therapeutic Devices

882.5030  Methyl methacrylate for aneurysmorrhaphy.
882.5050  Biofeedback device.
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.
882.5800  Cranial electrotheraphy stimulator.
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.
882.5860  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.
882.5900  Preformed craniosynostosis strip.
882.5910  Dura substitute.
882.5940  Electroconvulsive therapy device.
882.5950  Artificial embolization device.
882.5960  Skull tongs for traction.

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    Source:  44 FR 51730-51778, Sept. 4, 1979, unless otherwise noted.



                      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 will be, subject 
to the regulation. A

[[Page 377]]

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.
[52 FR 17739, May 11, 1987]



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 Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 510(k) 
of the act) for a generic type of class I device is based upon the 
existing and reasonably foreseeable characteristics of commercially 
distributed devices within that generic type. Because FDA cannot 
anticipate every change in intended use or characteristic that could 
significantly affect a device's safety or effectiveness, manufacturers 
of any commercially distributed class I device for which FDA has granted 
an exemption

[[Page 378]]

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 its intended use 
before May 28, 1976, or the device is intended for a use different from 
the intended use of a preamendments device to which it had been 
determined to be substantially equivalent; 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; or
    (b) The modified device operates using a different fundamental 
scientific technology than that in use in the device before May 28, 
1976; 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 a deoxyribonucleic acid 
(DNA) probe or nucleic acid hybridization technology rather than culture 
or immunoassay technology.
[54 FR 25051, June 12, 1989]



               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 (performance standards).



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).



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. If the device is made of the same 
material (single, surgical-grade, stainless steel alloy) that was 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. The device is also exempt from the current good manufacturing 
practice regulations 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 51730-51778, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 
1989]



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.

[[Page 379]]

    (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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[44 FR 51730-51778, Sept. 4, 1979, as amended at 61 FR 1123, Jan. 16, 
1996]



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).



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[44 FR 51730-51778, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 
1994]



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. 882.1480  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. 882.1500  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. If the device is composed entirely of a 
single material, the device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter. The device is also 
exempt from the current good manufacturing practice regulations 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 51730-51778, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 
1989]

[[Page 380]]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. The 
device is also exempt from the current good manufacturing practice 
regulations 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 51730-51778, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 
1989]



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 (performance standards).



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 (performance standards).



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. 882.1610  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. 882.1700  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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. The 
device is also exempt from the current good manufacturing practice 
regulations 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 51730-51778, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 
1989; 59 FR 63011, Dec. 7, 1994]

[[Page 381]]



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. If the device is made of the same 
material (single, surgical-grade, stainless steel alloy) that was used 
in the device before May 28, 1976, and it is manually operated, the 
device is exempt from the premarket notification procedures in subpart E 
of part 807 of this chapter.
[44 FR 51730-51778, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 
1989]



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 a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 882.3.
[44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17739, May 11, 
1987]



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 inpedance 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 51730-51778, 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 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 (performance standards).



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.

[[Page 382]]

    (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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[44 FR 51730-51778, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 
1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[44 FR 51730-51778, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 
1994]



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).



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[44 FR 51730-51778, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 
1994]



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

[[Page 383]]

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 51730-51778, 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[44 FR 51730-51778, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 
1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[44 FR 51730-51778, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 
1989; 59 FR 63012, Dec. 7, 1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[44 FR 51730-51778, Sept. 4, 1979, as amended at 61 FR 1123, Jan. 16, 
1996]



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.

[[Page 384]]

    (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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[44 FR 51730-51778, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 
1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[44 FR 51730-51778, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 
1994]



Sec. 882.4525  Microsurgical instrument.

    (a) Identification. A microsurgical instrument is a nonpowered 
surgical instrument used in neurological microsurgery procedures.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[44 FR 51730-51778, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 
1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[44 FR 51730-51778, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 
1994]



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).



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[44 FR 51730-51778, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 
1994]

[[Page 385]]



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. If the device is made of the same 
material (single, surgical-grade, stainless steel alloy) that was 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.
[44 FR 51730-51778, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 
1989]



Sec. 882.4700  Cottonoid paddie.

    (a) Identification. A cottonoid paddie is a cotton pad used during 
surgery to protect nervous tissue, absorb fluids, or stop bleeding.
    (b) Classification. Class II (performance standards).



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).



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[44 FR 51730-51778, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 
1994]



               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 (performance standards).

[[Page 386]]



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).



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 51730-51778, 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 (performance standards).



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

[[Page 387]]

self-curing acrylic that a surgeon uses to repair a skull defect in a 
patient. At 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. 882.5800  Cranial electrotheraphy stimulator.

    (a) Identification. A cranial electrotheraphy stimulator is a device 
that applies electrical current to a patient's head to treat insomnia, 
depression, or anxiety.
    (b) Classification. Class III (premarket approval).
    (c) Date a PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 882.3.
[44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 
1987; 60 FR 43969, Aug. 24, 1995; 62 FR 30457, June 4, 1997]



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

[[Page 388]]

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 51730-51778, Sept. 4, 1979 and 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 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 51730-51778, 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 51730-51778, Sept. 4, 1979, as amended at 53 FR 48621, Dec. 1, 
1988]

[[Page 389]]



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 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 
1987; 61 FR 50708, Sept. 27, 1996]



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 a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 882.3.
[44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 
1987]



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 inplanted 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).



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. 882.5900  Preformed craniosynostosis strip.

    (a) Identification. A preformed craniosynostosis strip is a plastic 
strip

[[Page 390]]

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 device 
used for treating severe psychiatric disturbances (e.g., severe 
depression) by inducing in the patient a major motor seizure by applying 
a brief intense electrical current to the patient's head.
    (b) Classification. 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. See Sec. 882.3.
[44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 
1987]



Sec. 882.5950  Artificial embolization device.

    (a) Identification. An artificial embolization device is an object 
that is placed in a blood vessel to permanently obstruct blood flow to 
an aneurysm or other vascular malformation.
    (b) Classification. 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. See Sec. 882.3.
[44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 
1987]



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).



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.
884.1720  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 391]]

884.2720  External uterine contraction monitor and accessories.
884.2740  Perinatal monitoring system and accessories.
884.2900  Fetal stethoscope.
884.2960  Obstetric ultrasonic transducer and accessories.
884.2980  Telethermographic system.
884.2982  Liquid crystal thermographic 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

884.4100  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.
884.4400  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.

      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.
884.5225  Abdominal decompression chamber.
884.5250  Cervical cap.
884.5300  Condom.
884.5310  Condom with spermicidal lubricant.
884.5320  Glans sheath.
884.5350  Contraceptive diaphragm and accessories.
884.5360  Contraceptive intrauterine device (IUD) and introducer.
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.

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    Source:  45 FR 12684-12720, Feb. 26, 1980, unless otherwise noted.



                      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, a 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.
[52 FR 17740, May 11, 1987]



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

[[Page 392]]

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]



Sec. 884.9  Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    The Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 510(k) 
of the act) for a generic type of class I device is based upon the 
existing and reasonably foreseeable characteristics of commercially 
distributed devices within that generic type. Because FDA cannot 
anticipate every change in intended use or characteristic that could 
significantly affect a device's safety or effectiveness, manufacturers 
of any commercially distributed class I 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 its intended use 
before May 28, 1976, or the device is intended for a use different from 
the intended use of a preamendments device to which it had been 
determined to be substantially equivalent; 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; or
    (b) The modified device operates using a different fundamental 
scientific technology than that in use in the device before May 28, 
1976, 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 a deoxyribonucleic acid 
(DNA) probe or nucleic acid hybridization technology rather than culture 
or immunoassay technology.
[54 FR 25051, June 12, 1989]

[[Page 393]]



       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).
[47 FR 14706, Apr. 6, 1982]



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.
    (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 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. See Sec. 884.3.
[45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 
1987]



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 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. See Sec. 884.3.
[45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 
1987]



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 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. See Sec. 884.3.
[45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 
1987]



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

[[Page 394]]

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 
amniocenteses 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[61 FR 1123, Jan. 16, 1996]



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--12720, 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.
    (b) Classification. Class II (performance standards).



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).

[[Page 395]]

    (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 (non-inflatable) 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.
[45 FR 12684-12720, Feb. 26, 1980, as amended at 61 FR 1123, Jan. 16, 
1996]



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.
[45 FR 12684-12720, Feb. 26, 1980, as amended at 61 FR 1123, Jan. 16, 
1996]



Sec. 884.1700  Hysteroscopic insufflator.

    (a) Identification. A hysteroscopic insufflator is a device designed 
to distend the uterus by filling the uterine 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 which 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.
[45 FR 12684-12720, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 
1996]



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 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

[[Page 396]]

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 
laparoscope 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.
[45 FR 12684-12720, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 
1996]



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 which are not used to effect intra-abdominal 
access, Verres needles etc.; and single-use tubing kits used for only 
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.
[45 FR 12684-12720, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 
1996]



       Subpart C--Obstetrical and Gynecological Monitoring Devices



Sec. 884.2050  Obstetric data analyzer.

    (a) Identification. An obstetric data analyzer (i.e., fetal status 
data analyzer) is a device used during labor to analyze electronic 
signal data obtained from fetal and maternal monitors and to indicate 
clinical diagnosis of fetal well-being. 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 a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 884.3.
[45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 
1987]



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 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 signal (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).

[[Page 397]]



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 12684-12720, 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).



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

[[Page 398]]

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 12684-12720, 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. 884.2740  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. This 
generic type of device may include any of the devices subject to 
Secs. 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. 884.2900  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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.



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)

[[Page 399]]

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.
    (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 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]



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.
    (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]



       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 (performance standards).



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

[[Page 400]]

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. 884.4100  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 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. See Sec. 884.3.
[45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 
1987]



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 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. See Sec. 884.3.
[45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 
1987]



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.

[[Page 401]]

    (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 12684-12720, 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 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 
1987; 61 FR 50708, Sept. 27, 1996]



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. 884.4400  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 (performance standards).



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.

[[Page 402]]

    (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.
    (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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 12684-12720, Feb. 26, 1980, as amended at 54 FR 25052, June 12, 
1989]



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 (performance standards).

[[Page 403]]

    (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 in subpart 
E of part 807 of this chapter.
[45 FR 12684-12720, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 
1996]



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 (performance standards).



      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.
    (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 12684-12720, 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 if the 
device is using either a bulb or telescoping mechanism which does not 
develop more than 250

[[Page 404]]

mm Hg suction, and the device materials that contact breast or breast 
milk do not produce cytotoxicity, irritation, or sensitization effects.
[45 FR 12684-12720, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 
1996]



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. 884.5225  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 12684-12720, 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 
venereal disease). The device may also be used to collect semen to aid 
in the diagnosis of infertility.
    (b) Classification. Class II (performance standards).



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).
    (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. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 884.3.
[59 FR 67187, Dec. 29, 1994]



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

[[Page 405]]

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) Labeling. Labeling requirements for contraceptive IUD's are set 
forth in Sec. 801.427.
    (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 12684-12720, Feb. 26, 1980, as amended at 51 FR 16649, May 5, 
1986]



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 12684-12720, 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 (performance standards).



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 (performance standards).



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.

[[Page 406]]

    (b) Classification. (1) Class I (general controls) for menstrual 
pads made of 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. 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).
[45 FR 12684-12720, Feb. 26, 1980, as amended at 45 FR 51185, Aug. 1, 
1980; 61 FR 67714, Dec. 24, 1996]



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 only when the device is made of common cellulosic and 
synthetic material with an established safety profile. This exemption 
does not include the intralabial pads and reusable menstrual pads.
[45 FR 12684-12720, Feb. 26, 1980, as amended at 61 FR 67714, Dec. 24, 
1996]



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 12684-12720, 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.
[45 FR 12684-12720, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 
1996]



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.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[45 FR 12684-12720, Feb. 26, 1980, as amended at 54 FR 25052, June 12, 
1989]

[[Page 407]]



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. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 884.3.
[45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 
1987]



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).



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 act.

                      Subpart B--Diagnostic Devices

886.1040  Ocular esthesiometer.
886.1050  Adaptometer (biophotometer).
886.1070  Anomaloscope.
886.1090  Haidlinger brush.
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.
886.1350  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.
886.1930  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).

[[Page 408]]

886.3320  Eye sphere implant.
886.3340  Extraocular orbital implant.
886.3400  Keratoprosthesis.
886.3600  Intraocular lens.
886.3800  Scleral shell.
886.3920  Eye valve implant.

                       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.
886.4170  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.
886.4300  Intraocular lens guide.
886.4335  Operating headlamp.
886.4350  Manual ophthalmic surgical instrument.
886.4360  Ocular surgery irrigation device.
886.4370  Keratome.
886.4390  Ophthalmic laser.
886.4392  Nd:YAG laser for posterior capsulotomy.
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.
886.5420  Contact lens inserter/remover.
886.5540  Low-vision magnifier.
886.5600  Ptosis crutch.
886.5800  Ophthalmic bar reader.
886.5810  Ophthalmic prism reader.
886.5820  Closed-circuit television reading system.
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.
886.5910  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, 371.

    Source:  52 FR 33355, Sept. 2, 1987, unless otherwise noted.



                      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.



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 409]]

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 act.

    FDA's decision to grant an exemption from the requirement of 
premarket notification (section 510(k) of the act) for a generic type of 
class I device is based upon the existing and reasonably foreseeable 
characteristics of commercially distributed devices within that generic 
type. Because FDA cannot anticipate every change in intended use or 
characteristic that could significantly affect a device's safety or 
effectiveness, manufacturers of any commercially distributed class I 
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 its intended use 
before May 28, 1976, or the device is intended for a use different from 
the intended use of a preamendments device to which it had been 
determined to be substantially equivalent; 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; or
    (b) The modified device operates using a different fundamental 
scientific technology than that in use in the device before May 28, 
1976; 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 a deoxyribonucleic acid 
(DNA) probe or nucleic acid hybridization technology rather than culture 
or immunoassay technology.
[53 FR 35603, Sept. 14, 1988]

[[Page 410]]



                      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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988; 
59 FR 63012, Dec. 7, 1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]



Sec. 886.1090  Haidlinger brush.

    (a) Identification. A Haidlinger 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]



Sec. 886.1120  Opthalmic 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.
[55 FR 48441, Nov. 20, 1990]



Sec. 886.1140  Ophthalmic chair.

    (a) Identification. An ophthalmic chair is an AC-powered or manual 
device with adjustable positioning in 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. The manual device is also exempt from the 
current good manufacturing practice regulations 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]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations 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]

[[Page 411]]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations 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]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations 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]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations 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]



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. Class I for the battery powered device. The 
battery powered device is exempt from premarket notification procedures 
in subpart E of part 807 of this chapter. Class II for the AC-powered 
device.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]

[[Page 412]]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]



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).
    (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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations 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]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations 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]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]



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.

[[Page 413]]

    (b) Classification. Class I. The AC-powered device is exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter only when the device does not include computer software in the 
unit. The battery-powered device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. The 
battery-powered device is also exempt from the current good 
manufacturing practice regulations 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]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations 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]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations 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]



Sec. 886.1385  Polymethylmethacrylate (PMMA) diagnostic contact lens.

    (a) Identification. A polymethylmethacrylate (PMMA) diagnostic 
contact lens is a device that is a 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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations 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]



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

[[Page 414]]

fundus of the eye under slitlamp illumination and magnification.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations 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]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations 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]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 61 FR 1124, Jan. 16, 1996]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations 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]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations 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]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]



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

[[Page 415]]

and dial gauge intended to measure the radius of a contact lens.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 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]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations 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]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations 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]



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.



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. The manual device is exempt from the 
premarket notification procedures in part 807, subpart E of this 
chapter, and it is also exempt from the current good manufacturing 
practice regulations 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 the complaint files.
[55 FR 48442, Nov. 20, 1990]

[[Page 416]]



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.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations 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]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations 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]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 
59 FR 63013, Dec. 7, 1994]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations 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]



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

[[Page 417]]

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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]



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.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]



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. The AC-powered device and the manual 
device are exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter. The manual device is also exempt from the 
current good manufacturing practice regulations 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]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 61 FR 1124, Jan. 16, 1996]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 61 FR 1124, Jan. 16, 1996]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations 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]



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. Class I for the battery-powered device. Class II 
for the AC-powered device. The battery-powered device is exempt from the 
current good manufacturing practice regulations in part 820 of this 
chapter, with the exception of Sec. 820.180, with respect to general 
requirements concerning

[[Page 418]]

records, and Sec. 820.198, with respect to complaint files.
[55 FR 48442, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations 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]



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. 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 part 807, 
subpart E of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988]



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. 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. The battery-powered device is 
also exempt from the current good manufacturing practice regulations 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]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations 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]



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.



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.

[[Page 419]]

    (b) Classification. Class I. 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. The battery-powered device is 
also exempt from the current good manufacturing practice regulations 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]



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. 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. The battery-powered device is 
also exempt from the current good manufacturing practice regulations 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]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations 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]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations 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]



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. 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. The battery-powered device is 
also exempt from the current good manufacturing practice regulations 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]



Sec. 886.1930  Tonometer and accessories.

    (a) Identification. A tonometer and accessories is a manual device 
intended

[[Page 420]]

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.
[55 FR 48443, Nov. 20, 1990]



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. Class I for the battery-powered device. Class II 
for the AC-powered device. The battery-powered Class I device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter.
[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]



                          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.



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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 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]



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.



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.



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 made of plastic 
intended to be implanted to replace the central area of an opacified 
natural cornea of the eye to maintain or restore sight.
    (b) Classification. Class III.

[[Page 421]]

    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 886.3.



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.



Sec. 886.3920  Eye valve implant.

    (a) Identification. An eye valve implant is a one-way, pressure-
sensitive, valve-like device intended to be implanted to normalize 
intraocular pressure. The device may be used in the treatment of 
glaucoma.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 886.3.



                       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.
[55 FR 48443, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990]



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.



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 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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations 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]

[[Page 422]]



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. Class I for the battery-powered device. Class II 
for the AC-powered device. The battery-powered Class I device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter.
[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]



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.



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. Class I for the battery-powered device. Class II 
for the AC-powered device. The battery powered-device is exempt from the 
premarket notification procedures in part 807, subpart E of this 
chapter.
[55 FR 48443, Nov. 20, 1990]



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.

[[Page 423]]

    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[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]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 
59 FR 63013, Dec. 7, 1994]



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.



Sec. 886.4392  Nd:YAG laser for posterior capsulotomy.

    (a) Identification. The Nd:YAG laser for posterior capsulotomy 
consists of a mode-locked or Q-switched solid state Nd:YAG laser 
intended for posterior capsulotomy, which 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.
[53 FR 38947, Oct. 4, 1988]



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.



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.



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations 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]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 
59 FR 63013, Dec. 7, 1994]



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,

[[Page 424]]

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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations 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 59 FR 63014, Dec. 7, 1994]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations 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]



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.



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. The AC-powered device and the manual 
device are exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter. The manual device is also exempt from the 
current good manufacturing practice regulations 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]



                     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 two eyepieces, each with a lens or lens system, intended for 
medical purposes to magnify the appearance of objects.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E

[[Page 425]]

of this chapter. The device also is exempt from the current good 
manufacturing practice regulations 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]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations 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]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations 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]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations 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]



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations 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]



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.

[[Page 426]]

    (b) Classification. Class I. The AC-powered device is exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter.
[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 
59 FR 63014, Dec. 7, 1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 63014, Dec. 7, 1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 
59 FR 63014, Dec. 7, 1994]



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.



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. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations 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]



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 images of objects into tactile or auditory signals.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994]



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.

[[Page 427]]

    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations 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]



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. 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. The battery-powered device is 
also exempt from the current good manufacturing practice regulations 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]



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

[[Page 428]]

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 act.

                      Subpart B--Diagnostic Devices

888.1100  Arthroscope.
888.1240  AC-powered dynamometer.
888.1250  Nonpowered dynamometer.
888.1500  Goniometer.
888.1520  Nonpowered goniometer.

                          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.
888.3025  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.
888.3050  Spinal interlaminal fixation orthosis.
888.3060  Spinal intervertebral body fixation orthosis.
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/metal or 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 semi-constrained resurfacing cemented 
          prosthesis.
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.
888.3540  Knee joint patellofemoral polymer/metal semi-constrained 
          cemented prosthesis.

[[Page 429]]

888.3550  Knee joint patellofemorotibial polymer/metal/metal constrained 
          cemented prosthesis.
888.3560  Knee joint patellofemorotibial polymer/metal/polymer semi-
          constrained cemented 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.
888.3640  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.
888.3680  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.
888.4540  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, 371.

    Source:  52 FR 33702, Sept. 4, 1987, unless otherwise noted.



                      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.



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 a device that has been 
found substantially equivalent to such a device, has an approval under 
section 515 of the

[[Page 430]]

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 act.

    FDA's decision to grant an exemption from the requirement of 
premarket notification (section 510(k) of the act) for a generic type of 
class I device is based upon the existing and reasonably foreseeable 
characteristics of

[[Page 431]]

commercially distributed devices within that generic type. Because FDA 
cannot anticipate every change in intended use or characteristic that 
could significantly affect a device's safety or effectiveness, 
manufacturers of any commercially distributed class I 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 its intended use 
before May 28, 1976, or the device is intended for a use different from 
the intended use of a preamendments device to which it had been 
determined to be substantially equivalent; 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; or
    (b) The modified device operates using a different fundamental 
scientific technology than that in use in the device before May 28, 
1976; 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 a deoxyribonucleic acid 
(DNA) probe or nucleic acid hybridization technology rather than culture 
or immunoassay technology.
[53 FR 52953, Dec. 29, 1988]



                      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.
[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 1124, Jan. 16, 1996]



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.



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 device intended to 
evaluate joint function by measuring and recording ranges of motion, 
acceleration, or forces exerted by a joint.
    (b) Classification. Class I.
[55 FR 48443, Nov. 20, 1990]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807.

[[Page 432]]



                          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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 1124, Jan. 16, 1996]



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. 888.3025  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 
(luting agent) is a device intended to be implanted that is made from 
methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid 
or copolymers containing polymethylmethyacrylate 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 the living bone.
    (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. 888.3030  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

[[Page 433]]

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. 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. 888.3050  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. 888.3100  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).

[[Page 434]]

    (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 a 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/metal or metal/polymer constrained cemented prosthesis.

    (a) Identification. An elbow joint metal/metal or metal/polymer 
constrained cemented prosthesis is a device intended to be implanted 
made exclusively of alloys, such as cobalt-chromium-molybdenum, or made 
from these alloys with a ultra-high molecular weight polyethylene 
bushing, and used to replace an elbow 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 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. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 888.3.



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 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

[[Page 435]]

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 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

[[Page 436]]

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 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. This generic type of device 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/polymer 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

[[Page 437]]

joint metal/polymer constrained cemented or uncemented prosthesis that 
was in commercial distribution before May 28, 1976. Any other hip joint 
metal/polymer 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 50710, Sept. 27, 1996]



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 a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 888.3.



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 a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 888.3.



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

[[Page 438]]

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 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]

[[Page 439]]



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 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 semi-constrained resurfacing cemented prosthesis.

    (a) Identification. A hip joint metal/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 alloy, such as cobalt-chromium-molybdenum, 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. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 888.3.



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

[[Page 440]]

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]



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

[[Page 441]]

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 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. 888.3540  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 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 patellofemoral polymer/metal semi-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 patellofemoral polymer/metal semi-constrained cemented 
prosthesis that was in commercial distribution before May 28, 1976. Any 
other knee joint patellofemoral polymer/metal semi-constrained cemented 
prosthesis shall have an approved PMA or a declared completed

[[Page 442]]

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. 888.3550  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 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. 888.3570  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,

[[Page 443]]

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 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. 888.3640  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 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

[[Page 444]]

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 III.
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 888.3.



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 III.
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 888.3.



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.

[[Page 445]]



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.



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-

[[Page 446]]

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.



                       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. The device is exempt from the premarket 
notification procedures in subpart E of part 807.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52953, Dec. 29, 1988; 
59 FR 63014, Dec. 7, 1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52953, Dec. 29, 1988; 
59 FR 63014, Dec. 7, 1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988; 
59 FR 63014, Dec. 7, 1994]



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.

[[Page 447]]

    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33702, Sept. 4, 1987, as amended at 59 FR 63014, Dec. 7, 1994]



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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807. The device is exempt 
from the current good manufacturing practice regulations in part 820 
with the exception of Sec. 820.180, regarding general requirements 
concerning records, and Sec. 820.198, regarding complaint files.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations 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]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807

[[Page 448]]

of this chapter. The device is also exempt from the current good 
manufacturing practice regulations 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]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48443, Nov. 20, 1990, as amended at 61 FR 1125, Jan. 16, 1996]]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. The 
device is exempt from the current good manufacturing regulations 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]



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.
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.
890.3475  Limb orthosis.
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.

[[Page 449]]

                          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.
890.5500  Infrared lamp.
890.5525  Iontophoresis device.
890.5575  Powered external limb overload warning device.
890.5650  Powered inflatable tube massager.
890.5660  Therapeutic massager.
890.5700  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.
890.5765  Pressure-applying device.
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, 371.

    Source:  48 FR 53047, Nov. 23, 1983, unless otherwise noted.



                      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 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 the chapter I of title 21, unless otherwise 
noted.
[52 FR 17741, May 11, 1987]



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

[[Page 450]]

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 
commerically 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 Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 510(k) 
of the act) for a generic type of class I device is based upon the 
existing and reasonably foreseeable characteristics of commercially 
distributed devices within that generic type. Because FDA cannot 
anticipate every change in intended use or characteristic that could 
significantly affect a device's safety or effectiveness, manufacturers 
of any commercially distributed class I 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 its intended use 
before May 28, 1976, or the device is intended for a use different from 
the intended use of a preamendments device to which it had been 
determined to be substantially equivalent; 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; or
    (b) The modified device operates using a different fundamental 
scientific technology than that in use in the device before May 28, 
1976; 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 a deoxyribonucleic acid 
(DNA) probe or nucleic acid hybridization technology rather than culture 
or immunoassay technology.
[54 FR 25052, June 12, 1989]



             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 I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. The 
devices are also exempt from the current good manufacturing practice 
regulations 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 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994]



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.

[[Page 451]]

    (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.
    (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 
medial 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 (performance standards).



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996]



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 (performance standards).

[[Page 452]]



                          Subpart C  [Reserved]



             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. The 
device also is exempt from the current good manufacturing practice 
regulations 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. 890.3075  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. The 
device also is exempt from the current good manufacturing practice 
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. 890.3100  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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994]



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 (performance standards).



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. The 
device is also exempt from the current good manufacturing practice 
regulations 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. 890.3175  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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996]

[[Page 453]]



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. The 
device also is exempt from the current good manufacturing practice 
regulations 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. 890.3420  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. The 
device also is exempt from the current good manufacturing practice 
regulations 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. 890.3475  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. The 
device also is exempt from the current good manufacturing practice 
regulations 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. 890.3490  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 precedures in subpart E of part 807. The 
device also is exempt from the current good manufacturing practice 
regulations 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. 890.3500  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 (performance standards).



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). This device is 
exempt from the premarket notification procedure in subpart E of part 
807. The device is also

[[Page 454]]

exempt from the current good manufacturing practice regulations 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. 890.3610  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. The 
device also is exempt from the current good manufacturing practice 
regulations 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. 890.3665  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. The 
device also is exempt from the current good manufacturing practice 
regulations 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. 890.3675  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. The 
device also is exempt from the current good manufacturing practice 
regulations 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. 890.3690  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).



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807

[[Page 455]]

of this chapter. The device is also exempt from the current good 
manufacturing practice regulations 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]



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 (performance standards).



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 (performance standards).



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996]



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. The 
device also is exempt from the current good manufacturing practice 
regulations 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. 890.3800  Motorized three-wheeled vehicle.

    (a) Identification. A motorized three-wheeled vehicle is a gasoline-
fueled or battery-powered device intended for 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.

[[Page 456]]

    (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 
regulations 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. 890.3850  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 by means of two endless belt tracks that are lowered from 
under the chair and adjusted to the angle of the stairs.
    (b) Classification. 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. See Sec. 890.3.
[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987; 52 
FR 22577, June 12, 1987]



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, and is also exempt from 
current good manufacturing practice regulations 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.
[61 FR 8439, Mar. 4, 1996]



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

[[Page 457]]

holder, leg rest, heel loops, and toe loops.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994]



Sec. 890.3930  Wheelchair elevator.

    (a) Identification. A wheelchair elevator is a motorized lift device 
intended for medical purposes to provide a means for a disabled person 
to move a wheelchair from one level to another.
    (b) Classification. Class II (performance standards).



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. The 
device is also exempt from the current good manufacturing practice 
regulations 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 53047, Nov. 23, 1983, as amended at 59 FR 63015, Dec. 7, 1994]



                          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. If 
the device is not labeled or otherwise represented as sterile, it also 
is exempt from the current good manufacturing practice regulations 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. 890.5100  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 healing process of inflamed and traumatized tissue, and it 
serves as a setting for removal of contaminated tissue.
    (b) Classification. Class II (performance standards).



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 (performance standards).



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. The 
device is also exempt from the current good manufacturing practice 
regulations 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]

[[Page 458]]



Sec. 890.5150  Powered patient transport.

    (a) Identification. A powered patient transport is a motorized 
device intended for medical purposes to assist transfers of patients to 
and from the bath, beds, chairs, treatment modalities, transport 
vehicles, and up and down flights of stairs. This generic type of device 
does not include motorized threewheeled vehicles or wheelchairs.
    (b) Classification. Class II (performance standards).



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 (performance standards).



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 (performance standards).



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).



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 (performance standards).



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 (performance standards).



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).
    (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 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. 890.3.
[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987]

[[Page 459]]



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 radio frequency bands of 13 megahertz to 
27.12 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).
    (b) Shortwave diathermy for all other uses--(1) Identification. A 
shortwave diathermy for all other uses except for the treatment of 
malignancies is a device that applies to the body electromagnetic energy 
in the radio frequency bands of 13 megahertz to 27.12 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 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. 890.3.
[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987]



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 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. 890.3.
[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987]



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. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820, with the exemption of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.



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 460]]

measuring instrumentation, and a rowing machine with measuring 
instrumentation.
    (b) Classification. Class II (performance standards).



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 devices are 
exempt from the premarket notification procedures in subpart E of part 
807. The devices also are exempt from the current good manufacturing 
practice regulations 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. 890.5380  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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996]



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 (performance standards).



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 is a device that is intended to 
use a direct current to introduce ions of soluble salts or other drugs 
into the body for medical purposes other than those specified in 
paragraph (a) of this section.
    (2) Classification. 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. 890.3.
[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987]



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

[[Page 461]]

underload in the amount of pressure placed on a leg.
    (b) Classification. Class II (performance standards).



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996]



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.
    (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 
regulations 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).



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 (performance standards).



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. The 
device also is exempt from the current good manufacturing practice 
regulations 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. 890.5740  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 (performance standards).



Sec. 890.5765  Presssure-applying device.

    (a) Identification. A presssure-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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63015, Dec. 7, 1994]

[[Page 462]]



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 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. 890.3.
[48 FR 53047, Nov. 23, 1983, as amended at 52 FR 17742, May 11, 1987]



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 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. The 
device is also exempt from the current good manufacturing practice 
regulations 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 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996]

[[Page 463]]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996]



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.
892.1200  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.
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.
892.1720  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.

                        Subparts C-E  [Reserved]

                     Subpart F--Therapeutic Devices

892.5050  Medical charged-particle radiation therapy system.
892.5300  Medical neutron radiation therapy system.

[[Page 464]]

892.5650  Manual radionuclide applicator system.
892.5700  Remote controlled radionuclide applicator system.
892.5710  Radiation therapy beam-shaping block.
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, 371.

    Source:  53 FR 1567, Jan. 20, 1988, unless otherwise noted.



                      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 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.



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

[[Page 465]]

before the device is commercially distributed unless it is reclassified. 
If FDA knows that a device being commerically 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 Food and Drug Administration's (FDA's) decision to grant an 
exemption from the requirement of premarket notification (section 510(k) 
of the act) for a generic type of class I device is based upon the 
existing and reasonably foreseeable characteristics of commercially 
distributed devices within that generic type. Because FDA cannot 
anticipate every change in intended use or characteristic that could 
significantly affect a device's safety or effectiveness, manufacturers 
of any commercially distributed class I 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 its intended use 
before May 28, 1976, or the device is intended for a use different from 
the intended use of a preamendments device to which it had been 
determined to be substantially equivalent; 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; or
    (b) The modified device operates using a different fundamental 
scientific technology than that in use in the device before May 28, 
1976; 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 a deoxyribonucleic acid 
(DNA) probe or nucleic acid hybridization technology rather than culture 
or immunoassay technology.
[54 FR 13831, Apr. 5, 1989]



                      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.
[53 FR 5078, Feb. 1, 1989]



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.
[55 FR 48443, Nov. 20, 1990]



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.

[[Page 466]]

    (b) Classification. Class I.
[55 FR 48444, Nov. 20, 1990]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 59 FR 63015, Dec. 7, 1994]
[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. 892.1200  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.
[55 FR 48444, Nov. 20, 1990]



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.
[55 FR 48444, Nov. 20, 1990]



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

[[Page 467]]

and display equipment, patient and equipment supports, radionuclide 
anatomical markers, component parts, and accessories.
    (b) Classification. Class I.
[55 FR 48444, Nov. 20, 1990]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter only 
when the device is labeled with weight limit, is used with planar 
scanning only, and is not for diagnostic X-ray use.
[55 FR 48444, Nov. 20, 1990, as amended at 59 FR 63015, Dec. 7, 1994]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989]



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.
[55 FR 48444, Nov. 20, 1990]



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.

[[Page 468]]

    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989]



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 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.



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.



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

[[Page 469]]

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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48444, Nov. 20, 1990, as amended at 59 FR 63015, Dec. 7, 1994]



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 generic type of device may include signal analysis 
and display equipment, patient and equipment supports, component parts, 
and accessories.
    (b) Classification. Class II.



Sec. 892.1660  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.



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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996]



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. 892.1720  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.

[[Page 470]]



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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996]



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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996]



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807.



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.

[[Page 471]]

    (b) Classification. Class II.



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.



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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996]



Sec. 892.1890  Radiographic film illuminator.

    (a) Identification. A radiographic film illuminator is a device 
containing a visible light source covered with a translucent front that 
is intended to be used to view medical radiographs.
    (b) Classification. Class I.
[55 FR 48444, Nov. 20, 1990]



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.
[55 FR 48444, Nov. 20, 1990]



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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807. The device is exempt 
from the current good manufacturing practice regulations 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. 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807. The device is exempt 
from the current good manufacturing practice regulations 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. 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807. The device is exempt 
from the current good manufacturing practice regulations in part 820, 
with the exception of Sec. 820.180, with respect to general requirements 
concerning records, and

[[Page 472]]

Sec. 820.198, with respect to complaint files.



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 light and intended for 
medical purposes to expose radiographic film.
    (b) Classification. Class I.



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.
[55 FR 48444, Nov. 20, 1990]



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.



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 a 
product development protocol (PDP) is required. The effective date of 
the requirement for premarket approval has not been established. See 
Sec. 892.3.
[60 FR 36639, July 18, 1995]



                        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.



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.



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 surface of the body for radiation therapy. This generic 
type of device may include patient and equipment supports, component 
parts, treatment

[[Page 473]]

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. 892.5730  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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 59 FR 63015, Dec. 7, 1994]



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.



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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996]



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.

[[Page 474]]



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. If the device's labeling specifies the 
lead equivalence, it is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter.
[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996]



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.

    Authority:  21 U.S.C. 352, 360f, 360h, 360i, 371.

    Source:  44 FR 29221, May 18, 1979, unless otherwise noted.



                      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

[[Page 475]]

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 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;

[[Page 476]]

    (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 
Dockets Management Branch, Food and Drug Administration.

The notice will afford all interested persons an opportunity to submit 
written comments and request an informal hearing, as defined in section 
201(y) of the act, before the Food and Drug Administration within 30 
days after the date of publication of the proposed regulation. If a 
request for an informal hearing is granted, the hearing will be 
conducted as a regulatory hearing under the applicable provisions of 
part 16 of this chapter. All nonconfidential information upon which the 
proposed finding is based, including the recommendations of the panel, 
will be available for public review in the office of the Dockets 
Management Branch, 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 
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]



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

[[Page 477]]

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 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,

[[Page 478]]

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 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.
    (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,

[[Page 479]]

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]



                  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]



PART 897--CIGARETTES AND SMOKELESS TOBACCO--Table of Contents






                      Subpart A--General Provisions

Sec.
897.1  Scope.
897.2  Purpose.
897.3  Definitions.

Subpart B--Prohibition of Sale and Distribution to Persons Younger Than 
                             18 Years of Age

897.10  General responsibilities of manufacturers, distributors, and 
          retailers.
897.12  Additional responsibilities of manufacturers.
897.14  Additional responsibilities of retailers.
897.16  Conditions of manufacture, sale, and distribution.

                            Subpart C--Labels

897.24  Established names for cigarettes and smokeless tobacco.
897.25  Statement of intended use and age restriction.

                   Subpart D--Labeling and Advertising

897.30  Scope of permissible forms of labeling and advertising.
897.32  Format and content requirements for labeling and advertising.
897.34  Sale and distribution of nontobacco items and services, gifts, 
          and sponsorship of events.

    Authority:  21 U.S.C. 352, 360, 360h, 360i, 360j, 371, 374, 393.

    Source:  61 FR 44615, Aug. 28, 1996, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 897.1  Scope.

    (a) This part sets out the restrictions under the Federal Food, 
Drug, and Cosmetic Act (the act) on the sale, distribution, and use of 
cigarettes and smokeless tobacco that contain nicotine.
    (b) The failure to comply with any applicable provision in this part 
in the sale, distribution, and use of cigarettes and smokeless tobacco 
renders the product misbranded under the 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.

[[Page 480]]



Sec. 897.2  Purpose.

    The purpose of this part is to establish restrictions on the sale, 
distribution, and use of cigarettes and smokeless tobacco 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.



Sec. 897.3  Definitions.

    (a) Cigarette means any product which contains nicotine, is intended 
to be burned under ordinary conditions of use, and consists of:
    (1) Any roll of tobacco wrapped in paper or in any substance not 
containing tobacco; or
    (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 (a)(1) of 
this section.
    (b) Cigarette tobacco means any product that consists of loose 
tobacco that contains or delivers nicotine and is intended for use by 
consumers in a cigarette. Unless otherwise stated, the requirements 
pertaining to cigarettes shall also apply to cigarette tobacco.
    (c) Distributor means any person who furthers the distribution of 
cigarettes or smokeless tobacco, 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.
    (d) Manufacturer means any person, including any repacker and/or 
relabeler, who manufactures, fabricates, assembles, processes, or labels 
a finished cigarette or smokeless tobacco product.
    (e) Nicotine means the chemical substance named 3-(1-Methyl-2-
pyrrolidinyl)pyridine or C10H14N2, 
including any salt or complex of nicotine.
    (f) Package means a pack, box, carton, or container of any kind in 
which cigarettes or smokeless tobacco are offered for sale, sold, or 
otherwise distributed to consumers.
    (g) Point of sale means any location at which a consumer can 
purchase or otherwise obtain cigarettes or smokeless tobacco for 
personal consumption.
    (h) Retailer means any person who sells cigarettes or smokeless 
tobacco to individuals for personal consumption, or who operates a 
facility where vending machines or self-service displays are permitted 
under this part.
    (i) Smokeless tobacco means any product that consists of cut, 
ground, powdered, or leaf tobacco that contains nicotine and that is 
intended to be placed in the oral cavity.



Subpart B--Prohibition of Sale and Distribution to Persons Younger Than 
                             18 Years of Age



Sec. 897.10  General responsibilities of manufacturers, distributors, and retailers.

    Each manufacturer, distributor, and retailer is responsible for 
ensuring that the cigarettes or smokeless tobacco it manufactures, 
labels, advertises, packages, distributes, sells, or otherwise holds for 
sale comply with all applicable requirements under this part.



Sec. 897.12  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. 897.14  Additional responsibilities of retailers.

    In addition to the other requirements under this part, each retailer 
is responsible for ensuring that all sales of cigarettes or smokeless 
tobacco to any person comply with the following requirements:
    (a) No retailer may sell cigarettes or smokeless tobacco to any 
person younger than 18 years of age;
    (b)(1) Except as otherwise provided in Sec. 897.16(c)(2)(i) and in 
paragraph (b)(2) of this section, each retailer shall 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;

[[Page 481]]

    (2) No such verification is required for any person over the age of 
26;
    (c) Except as otherwise provided in Sec. 897.16(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);
    (d) 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. 897.16(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
    (e) Each retailer shall 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.



Sec. 897.16  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) Free samples. No manufacturer, distributor, or retailer may 
distribute or cause to be distributed any free samples of cigarettes or 
smokeless tobacco.
    (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 subparts C and D of this 
part, and other applicable requirements.



                            Subpart C--Labels



Sec. 897.24  Established names for cigarettes and smokeless tobacco.

    Each cigarette or smokeless tobacco package shall bear, as provided 
in section 502 of the act, the following established name: 
``Cigarettes'', ``Cigarette Tobacco'', ``Loose Leaf Chewing Tobacco'', 
``Plug Chewing Tobacco'', ``Twist Chewing Tobacco'', ``Moist Snuff'', or 
``Dry Snuff'', whichever name is appropriate.



Sec. 897.25  Statement of intended use and age restriction.

    Each cigarette or smokeless tobacco package, that is offered for 
sale, sold, or otherwise distributed shall bear the following statement: 
``Nicotine-Delivery Device for Persons 18 or Older''.



                   Subpart D--Labeling and Advertising



Sec. 897.30  Scope of permissible forms of labeling and advertising.

    (a)(1) A manufacturer, distributor, or retailer may, in accordance 
with this

[[Page 482]]

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 Division of Drug Marketing, 
Advertising, and Communications, 5600 Fishers Lane (HFD-40), rm. 17B-20, 
Rockville, MD 20857.
    (b) No outdoor advertising for cigarettes or smokeless tobacco, 
including billboards, posters, or placards, may be placed within 1,000 
feet of the perimeter of any public playground or playground area in a 
public park (e.g., a public park with equipment such as swings and 
seesaws, baseball diamonds, or basketball courts), elementary school, or 
secondary school.
    (c) This subpart D does not apply to cigarette or smokeless tobacco 
package labels.



Sec. 897.32  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.
    (c) Each manufacturer, distributor, and retailer advertising or 
causing to be advertised, disseminating or causing to be disseminated, 
advertising permitted under this subpart D, shall include, as provided 
in section 502 of the act, the product's established name and a 
statement of its intended use as follows: ``Cigarettes--A Nicotine-
Delivery Device for Persons 18 or Older'', ``Cigarette Tobacco--A 
Nicotine-Delivery Device for Persons 18 or Older'', or ``Loose Leaf 
Chewing Tobacco'', ``Plug Chewing Tobacco'', ``Twist Chewing Tobacco'', 
``Moist Snuff'' or ``Dry Snuff'', whichever is appropriate for the 
product, followed by the words ``A Nicotine-Delivery Device for Persons 
18 or Older''.



Sec. 897.34  Sale and distribution of nontobacco items and services, gifts, and sponsorship of events.

    (a) No manufacturer and no distributor of imported cigarettes or 
smokeless

[[Page 483]]

tobacco may market, license, distribute, sell, or cause to be marketed, 
licensed, distributed, or sold any item (other than cigarettes or 
smokeless tobacco) 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 then cigarettes or smokeless tobacco) 
to any 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.

    Effective Date Note:  At 61 FR 44617, Aug. 28, 1996, in Sec. 897.34, 
paragraph (c) was added, effective Feb. 28, 1998. At 61 FR 47550, Sept. 
9, 1996, the effective date was corrected to Aug. 28, 1998.



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:

[[Page 484]]



                          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.             
----------------------------------------------------------------------------------------------------------------

    (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 clearance for information 
collection.

[[Page 485]]



             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 accrediting body.
900.4  Responsibilities of accrediting bodies.
900.5  Evaluation.
900.6  Withdrawal of approval.
900.7  Hearings.

             Subpart B--Quality Standards and Certification

900.10  Applicability.
900.11  Requirements for certification.
900.12  Quality standards.
900.13  Revocation of accreditation and accrediting body approval.
900.14  Hearings regarding certification decisions.
900.18  Alternative requirements for MQSA quality standards.

    Authority:  21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b.

    Effective Date Note: At 62 FR 55976, Oct. 28, 1997, part 900 was 
revised; and at 62 FR 60614, Nov. 10, 1997, it was republished and 
corrected, effective Apr. 28, 1999, with excepted provisions effective 
Oct. 28, 2002. For the convenience of the user, revised and corrected 
part 900 follows the text of this part.



                        Subpart A--Accreditation

    Source:  58 FR 67562, Dec. 21, 1993, unless otherwise noted.



Sec. 900.1  Scope.

    The regulations set forth in this part implement 42 U.S.C. 263b(b) 
through (f). The intent of subpart A of this part is to establish 
application procedures for accrediting bodies and to establish 
requirements and standards for such bodies to ensure that all 
mammography facilities in the United States are adequately and 
consistently evaluated for compliance with quality standards for 
mammography. The intent of subpart B of this part is to establish 
procedures for facility certification and to establish quality standards 
for mammography facilities to assure safe, reliable, and accurate 
mammography on a nationwide level.



Sec. 900.2  Definitions.

    The following definitions apply to subparts A and B of this part:
    (a) Accrediting body or body means an entity that has been approved 
by FDA under 42 U.S.C. 263b(e)(1)(A) to accredit mammography facilities.
    (b) Certificate means the certificate described in 42 U.S.C. 
263b(b)(1).
    (c) Certification means the state of approval of a facility by FDA 
to provide screening and diagnostic mammography services.
    (d) Clinical image means a mammogram.
    (e) Facility means a hospital, outpatient department, clinic, 
radiology practice, or mobile unit, office of a physician, or other 
facility that conducts breast cancer screening mammography activities or 
conducts diagnostic mammography activities, including the following: The 
operation of equipment to produce a mammogram, processing of film, 
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.
    (f) Interpreting physician means a physician who interprets 
mammograms made during screening or diagnostic mammography procedures 
and who meets the requirements of Sec. 900.12(a)(1).
    (g) Mammogram means a radiographic image produced through 
mammography.
    (h) Mammography means radiography of the breast.
    (i) Medical physicist means a person meeting the qualifications for 
a medical physicist set forth in Sec. 900.12(a)(3).
    (j) Patient means any individual who undergoes clinical evaluation 
in a mammography facility, regardless of whether the person is referred 
by a physician or is self-referred.
    (k) Phantom means a test object used to simulate radiographic 
characteristics of compressed breast tissue and

[[Page 486]]

containing components that radiographically model aspects of breast 
disease and cancer.
    (l) Phantom image means a radiographic image of a phantom.
    (m) Provisional certificate means the provisional certificate 
described in 42 U.S.C. 263b(c)(2).
    (n) Radiographic equipment means x-ray equipment used for the 
production of static x-ray images.
    (o) Radiological 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 in 
Sec. 900.12(a)(2).
    (p) Qualified practicing physician means a physician meeting the 
requirements of an interpreting physician as specified under 
Sec. 900.12(a)(1).
    (q) Survey means an on-site physics consultation and evaluation of a 
facility performed by a medical physicist.
    (r) Diagnostic mammography means mammography performed on a patient 
with: clinical signs, symptoms, physical findings suggestive of breast 
cancer; an abnormal or questionable screening mammogram; a history of 
breast cancer with breast conservation surgery regardless of absence of 
clinical breast signs, symptoms, or physical findings; or, augmented 
breasts regardless of absence of clinical breast signs, symptoms, or 
physical findings. Diagnostic mammography is also called problem-solving 
mammography or consultative mammography. This definition excludes 
mammography performed during invasive interventions for localization or 
biopsy procedures. The definition further excludes mammography performed 
as part of a scientific study to evaluate an experimental mammography 
device conducted in accordance with FDA's investigational device 
exemption regulations in part 812 of this chapter.
    (s) Screening mammography means mammography performed on an 
asymptomatic patient to detect the presence of breast cancer at an early 
stage. This definition excludes mammography performed as part of a 
scientific study to evaluate an experimental mammography device 
conducted in accordance with FDA's investigational device exemption 
regulations in part 812 of this chapter.
[58 FR 67562, Dec. 21, 1993; 59 FR 6899, Feb. 14, 1994, as amended at 59 
FR 49812, Sept. 30, 1994]



Sec. 900.3  Application for approval as an accrediting body.

    (a) Eligibility. Private nonprofit organizations or State agencies 
capable of meeting the requirements of this subpart A may apply for 
approval as accrediting bodies.
    (b) Application. One copy of an application for approval as an 
accrediting body shall be submitted to the Center for Devices and 
Radiological Health (HFZ-200), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, and should be marked ATTENTION: 
Mammography Program. Applications for approval as an accrediting body 
should include the following information:
    (1) Name, address, and phone number of body and evidence of 
nonprofit status (i.e., of fulfilling Internal Revenue Service 
requirements as a nonprofit organization) if the body is not a State 
agency;
    (2) Standards the body agrees to impose on facilities pursuant to 42 
U.S.C. 263b(e)(3);
    (3) Methods for performing clinical image review as required in 42 
U.S.C. 263b(e)(1)(B)(i)(I);
    (4) Methods for monitoring and evaluation of annual surveys of 
facilities by medical physicists as required in 42 U.S.C. 
263b(e)(1)(B)(v);
    (5) Methods for performing on-site inspections of facilities as 
required in 42 U.S.C. 263b(e)(4);
    (6) Fee schedules, with supporting cost data; and
    (7) Satisfactory assurances that the body will comply with the 
requirements of Sec. 900.4.
    (c) Ruling on application. FDA will approve an accrediting body if 
FDA determines upon review of the application that the body 
substantially meets (or will substantially meet when it begins to 
evaluate facilities) the requirements of this subpart, and the body's 
standards are substantially the same as the quality standards published

[[Page 487]]

under subpart B of this part in accordance with 42 U.S.C. 263b(f). If 
the applicant fails to substantially meet the requirements set forth in 
this subpart A, or if the applicant's standards are determined not to be 
substantially the same as the quality standards published under subpart 
B of this part, or if FDA determines that the applicant has not provided 
satisfactory assurances that it is capable of meeting the requirements 
established in this subpart A, FDA will notify the applicant of any 
problems it has identified with the application and request that the 
applicant resolve such problems within 90 days of receipt of notice. If 
the problems are substantially resolved to the satisfaction of FDA 
within the 90-day time period, the body will be approved as an 
accrediting body. If the problems are not substantially resolved to the 
satisfaction of FDA within the 90-day time period, the application for 
approval as an accrediting body will be rejected and the applicant so 
notified. A rejected application that has been modified so as to render 
it satisfactory is subject to resubmission at any time.



Sec. 900.4  Responsibilities of accrediting bodies.

    (a) Facility standards. The accrediting body shall require that each 
facility it accredits meet standards for the performance of quality 
mammography that are substantially the same as those promulgated in 
subpart B of this part under 42 U.S.C. 263b(f). The requirements set 
forth by the body for accreditation of a facility shall address, at a 
minimum, the following aspects of performing quality mammography:
    (1) Physician training, experience, certification, and continuing 
education;
    (2) Technologist training, experience, certification, and continuing 
education;
    (3) Medical physicist training, experience, certification, and 
continuing education;
    (4) X-ray equipment characteristics, including a requirement that 
the x-ray equipment be specifically designed for mammography;
    (5) Quality assurance and quality control programs for ensuring that 
quality mammography is practiced by the facility;
    (6) Phantom image quality testing and objective criteria to be used 
for passing the image quality test;
    (7) Maximum radiation dose for a single view for specific imaging 
systems;
    (8) Information update provisions that require accredited facilities 
to update at least annually the information listed in this section that 
they have provided the accrediting body; and
    (9) Medical recordkeeping and patient notification requirements.
    (b) Clinical image review. The accrediting body shall review 
clinical images from each facility accredited by the body at least once 
every 3 years and shall also review a random sample of clinical images 
from each facility accredited by the body in each 3-year period 
beginning October 1, 1994. These clinical image reviews shall be 
conducted by a qualified practicing physician not associated with the 
facility. The clinical image reviews shall ensure that quality clinical 
images are produced in the facility on a routine basis, as measured by 
proper breast positioning and compression and overall image quality. Any 
qualified practicing physicians who conduct clinical image quality 
reviews shall not have a financial interest in the facilities they 
review for the accrediting body, nor shall such physicians have any 
other interest that would constitute an apparent or real conflict of 
interest, other than receiving a service fee from the accrediting body 
itself related solely to the work performed in conducting the clinical 
review.
    (c) Fees. Fees charged to facilities for accreditation shall be 
reasonable. FDA will usually find fees to be reasonable if they are 
limited to recovering costs to the accrediting body, including overhead 
incurred proportionately in accrediting a given facility. Accrediting 
bodies may adjust fees annually for inflation in accordance with the 
Consumer Price Index (CPI).
    (d) Reports of physics survey. (1) The accrediting body shall 
require every facility applying for accreditation to submit to the 
accrediting body, with its accreditation application, a report of a 
survey by a medical physicist to assess the facility's compliance with

[[Page 488]]

the accrediting body's standards established under paragraph (a) of this 
section. The accrediting body shall require that every facility it 
accredits undergo an annual survey by a medical physicist to assure 
continued facility compliance with applicable standards and to provide 
continued oversight of the facility's quality assurance program. The 
accrediting body shall require that the results of this survey be 
transmitted to the accrediting body, together with quality control 
records and any other information the body may require, as a part of the 
annual report about the facility.
    (2) The accrediting body shall review the report of the annual 
physicist's survey, the quality control records of the facility, and 
other information that may come to its attention to determine if all the 
accrediting body's standards are being met by the facility. If the 
results of the survey or other information create doubt as to the 
quality of clinical images produced by the facility, then the 
accrediting body shall investigate by examination of recent clinical 
images from that facility to verify that the images meet the evaluation 
criteria of the accrediting body. If the accrediting body determines 
that the images are not of sufficient quality, the body shall determine 
necessary corrective measures to be taken by the facility, establish a 
schedule for implementation of such measures, and notify the facility 
that it must implement these measures within the specified schedule in 
order to retain accreditation. The accrediting body shall verify that 
the appropriate and necessary steps are taken by the facility within the 
schedule specified and that all accrediting body standards are being 
substantially met or will be substantially met. However, the 
responsibility for compliance remains with the facility.
    (e) On-site inspections. On an annual basis, in accordance with 
methods specified in the accrediting body's application for approval, 
the accrediting body shall make on-site visits to a sufficient number of 
facilities accredited by the body to assess overall compliance with the 
accrediting body standards and the quality of performance of 
mammography. The accrediting body shall prepare and submit one copy of a 
report of the findings of each of these visits to FDA at the address 
specified in Sec. 900.3(b). The facility may be given advance notice at 
the discretion of the accrediting body.
    (f) Complaints. The accrediting body shall require all facilities it 
accredits to publish an address where complaints can be filed with the 
accrediting body, shall investigate such complaints within 90 days of 
receipt, and shall maintain records of all of such complaints for a 
period of 3 years from the time of completion of the investigation. 
Complaint records shall include a summary of the complaint and of the 
results of the accrediting body's investigation.
    (g) Reporting and recordkeeping. All reporting requirements listed 
in this section shall be fulfilled by the accrediting body by sending 
reports to FDA at the address specified in Sec. 900.3(b). Reports 
required within 48 hours may be made by phone initially but must be 
followed by a written notification within 5 days. The accrediting body 
shall:
    (1) Comply with any reporting and recordkeeping requirements 
specified in paragraphs (a) through (f) of this section;
    (2) submit to FDA the names of any facilities for which the 
accrediting body denies, suspends, or revokes accreditation, and the 
basis for the action, within 48 hours of the action;
    (3) obtain FDA authorization for any change the accrediting body 
proposes to make in the standards of the body under Sec. 900.3(c);
    (4) collect the information required by 42 U.S.C. 263b(d) for each 
facility accredited by the body and submit it to FDA within 5 days of 
the date of accreditation;
    (5) accept applications containing the information required in 42 
U.S.C. 263b(c)(2) for provisional certificates and in Sec. 900.11(b)(2) 
for extensions of provisional certificates, on behalf of FDA and notify 
FDA within 5 working days of the successful completion of the initial 
application; and
    (6) provide to FDA any information requested by FDA about any 
particular facility accredited by the body within 5 days of receipt of 
the request.

[[Page 489]]



Sec. 900.5  Evaluation.

    FDA will evaluate annually the performance of each approved 
accrediting body by:
    (a) Inspecting a sample of the facilities accredited by the body and 
evaluating the reports of inspections to ascertain whether the 
facilities accredited by the accrediting body are in compliance with the 
standards promulgated by the agency in subpart B of this part, and
    (b) Evaluating a sample of the body's clinical image and phantom 
image reviews, evaluating the body's speed and efficiency in accrediting 
facilities, evaluating the body's ability to file reports within 
deadlines, and reviewing the body's records and recordkeeping processes.



Sec. 900.6  Withdrawal of approval.

    If FDA determines, through the evaluation activities of Sec. 900.5 
or through other information that comes to the attention of the agency, 
that an accrediting body is not in substantial compliance with this 
subpart, FDA shall initiate enforcement actions as follows:
    (a) Major deficiencies. If FDA determines that the accrediting body 
has major deficiencies in performance, such as commission of fraud, or 
material false statements, or failure to perform a major accreditation 
function satisfactorily, or significant noncompliance with the 
requirements of this subpart A, FDA will withdraw its approval of that 
accrediting body and notify such body of the grounds on which the 
approval was withdrawn.
    (b) Minor deficiencies. If FDA determines that the accrediting body 
has minor deficiencies in the performance of an accreditation function, 
including minor failure to comply with this subpart A, FDA will notify 
the body that it has 90 days to submit to FDA a plan of corrective 
action addressing the problems specified by FDA. This plan must include 
a summary of planned corrective actions and a schedule for their 
implementation.
    (1) If the corrective action plan is received within the 90-day time 
period specified and is satisfactory to FDA, FDA will notify the body 
that it is on probationary approval status until further notice. This 
probationary status will 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 schedule, and the corrective actions taken have 
substantially eliminated all identified problems. When such 
determination of restoration of satisfactory performance is made, FDA 
will restore the body to full approval status.
    (2) If the body does not submit a satisfactory corrective action 
plan within the designated 90-day time period or does not implement an 
FDA-approved corrective action plan within the time interval specified 
in the corrective action plan (as amended, with FDA approval, if 
necessary) FDA will withdraw approval of the body as an accrediting 
body. In cases of withdrawal of approval of accrediting bodies, if FDA 
finds that there are satisfactory assurances that the unacceptable 
performance of the accrediting body has been substantially resolved, on 
application by the accrediting body, FDA may reinstate the approval of 
the accrediting body, unless there have been fraud or material false 
statements.



Sec. 900.7  Hearings.

    Opportunities to challenge final adverse actions taken by FDA 
regarding approval of accrediting bodies, withdrawal of approval of 
accrediting bodies, or rejection of a proposed fee shall be communicated 
through notices of opportunity for informal hearings in accordance with 
part 16 of this chapter.



             Subpart B--Quality Standards and Certification

    Source:  58 FR 67570, Dec. 21, 1993, unless otherwise noted.



Sec. 900.10  Applicability.

    The provisions of this subpart are applicable to all facilities 
under the regulatory jurisdiction of the United States that provide 
screening and/or diagnostic mammography services, with the exception of 
facilities of the Department of Veterans Affairs.

[[Page 490]]



Sec. 900.11  Requirements for certification.

    (a) General. After October 1, 1994, a certificate issued by FDA will 
be required for lawful operation of all facilities. In order to obtain a 
certificate from FDA, facilities are required to meet the quality 
standards in Sec. 900.12 and to be accredited by an accrediting body 
approved by FDA. On request from a facility, FDA will provide such 
facility with a current list of approved accrediting bodies. Any request 
for such list shall include the name and address of the facility and 
must be sent to the address provided in Sec. 900.3(b).
    (b) Application--(1) Certificates. When applying for accreditation 
to an approved accrediting body, a facility shall submit to such 
accrediting body the information required in 42 U.S.C. 263b(d)(1). If 
and when the facility becomes accredited, information required for 
certification of the facility shall be forwarded to FDA by the 
accrediting body, in accordance with Sec. 900.4(g)(4).
    (2) Provisional certificates. Facilities that have not obtained a 
certificate by October 1, 1994, but have applied for accreditation to an 
approved accrediting body by then are eligible to receive a provisional 
certificate. To receive a provisional certificate, a facility shall 
submit the information required in 42 U.S.C. 263b(c)(2) to an approved 
accrediting body. New facilities may also submit such information 
directly to FDA. If and when the accrediting body determines that such 
application is sufficiently complete for review purposes, this fact 
shall be communicated to FDA by the accrediting body in accordance with 
Sec. 900.4(g)(5). To apply for a 90-day extension to a provisional 
certificate, a facility shall submit to the accrediting body a statement 
of what the facility is doing to obtain certification and evidence that 
a significant adverse impact on the regional availability of mammography 
would result if such facility did not obtain an extension. Such 
information shall be forwarded to FDA by the accrediting body in 
accordance with Sec. 900.4(g)(5).
    (c) Issuance and renewal of certificates--(1) Certificates. FDA will 
issue a certificate to a facility within 30 days of receipt of 
notification from an approved accrediting body of the accreditation of 
such facility. The initial certificate for a facility shall remain in 
effect until 30 days after the date of expiration of the facility's 
existing accreditation unless certification and/or accreditation of the 
facility is revoked prior to such deadline. FDA will issue a renewed 
certificate to a previously certified facility within 30 days of receipt 
of notification from an approved accrediting body of renewal of the 
accreditation of such facility. A renewed certificate shall be effective 
for a period of 3 years from the date of issuance, unless certification 
and/or accreditation of the facility is revoked prior to such deadline.
    (2) Provisional certificates. FDA will issue a provisional 
certificate to a facility within 10 days of receipt of notification from 
an approved accrediting body of satisfaction of the requirements of 
paragraph (b)(2) of this section. A provisional certificate shall be 
effective for 6 months from the date of issuance. FDA will issue a 90-
day extension for a provisional certificate within 10 days of receipt 
from the accrediting body of the information required in paragraph 
(b)(2) of this section, provided that FDA determines that the statutory 
prerequisites for the extension as set forth in section 354(c)(2) of the 
Public Health Service Act have been met. No renewal of a provisional 
certificate beyond the 90-day extension can occur.



Sec. 900.12  Quality standards.

    The following requirements establish the minimum quality standards 
that must be met by a facility to be eligible for certification to 
provide screening and/or diagnostic mammography services:
    (a) Personnel. The following requirements apply to personnel 
involved in any aspect of mammography, including the production, 
processing, and interpretation of mammograms and related quality 
assurance activities. Lists of personnel certifying bodies approved by 
FDA and referenced in this section may be obtained by submitting to FDA 
at the address specified in Sec. 900.3(b) a request containing the 
information needed and the name and address of the facility.

[[Page 491]]

    (1) Interpreting physician. Interpreting physicians shall meet the 
following requirements:
    (i) Be licensed to practice medicine in the State or facility in 
which they are practicing; and
    (ii) Have the following training:
    (A) Be certified by one of the bodies approved by FDA to certify 
interpreting physicians; or
    (B) Have had at least 2 months of documented full-time training in 
the interpretation of mammograms, including instruction in radiation 
physics, radiation effects, and radiation protection; and
    (C) Have 40 hours of documented continuing medical education in 
mammography. Time spent in residency specifically devoted to mammography 
will be accepted, if documented in writing by the radiologist; and
    (iii) Have the following initial experience:
    (A) Have read and interpreted the mammograms from the examinations 
of at least 240 patients in the 6 months preceding application; or
    (B) Read and interpret mammograms as specified in paragraph 
(a)(1)(iii)(A) of this section under the direct supervision of a fully 
qualified interpreting physician; and
    (iv) Have the following continuing experience:
    (A) Continue to read and interpret mammograms from the examination 
of an average of at least 40 patients per month over 24 months; and
    (B) Continue to participate in education programs, either by 
teaching or completing an average of at least five continuing medical 
education credits in mammography per year.
    (2) Radiological technologist. Radiological technologists shall meet 
the following requirements:
    (i) Have a license to perform radiographic procedures in the State 
or facility where they are practicing; or
    (ii) Have certification by one of the bodies approved by FDA to 
certify radiologic technologists; and
    (iii) For those radiological technologists associated with 
facilities applying for accreditation before October 1, 1996:
    (A) Have undergone training specific to mammography, either through 
a training curriculum or special mammography course, and accumulate at 
least an average of five continuing education units per year related to 
mammography; or
    (B) Have 1 year of experience in the performance of mammography and 
by October 1, 1996, meet the training requirements of paragraph 
(a)(2)(iii)(A) of this section; and
    (iv) For those radiological technologists associated with facilities 
applying for accreditation on and after October 1, 1996, meet the 
requirements of paragraph (a)(2)(i) or (a)(2)(ii) of this section and 
undergo specific training in mammography through documented curriculum 
and on-the-job training under the direct supervision of experienced 
mammographers; and
    (v) Participate in formal continuing education programs and 
accumulate an average of at least five continuing education units in 
mammography per year.
    (3) Medical physicist. Medical physicists shall meet the following 
requirements:
    (i) Have a license or approval by a State to conduct evaluations of 
mammography equipment and procedures as required under the Public Health 
Service Act; or
    (ii) Have certification in an accepted specialty area by one of the 
bodies approved by FDA to certify medical physicists; or
    (iii) For those medical physicists associated with facilities 
applying for accreditation before October 27, 1997, meet the following 
criteria:
    (A) Have a masters, or higher, degree in physics, radiological 
physics, applied physics, biophysics, health physics, medical physics, 
engineering, radiation science, or in public health with a bachelor's 
degree in the physical sciences; and
    (B) Have 1 year of training in medical physics specific to 
diagnostic radiological physics; and
    (C) Have 2 years of experience in conducting performance evaluation 
of mammography equipment; and
    (iv) Participate in continuing education programs related to 
mammography, either by teaching or completing an average of at least 
five continuing education units per year.

[[Page 492]]

    (b) Equipment--(1) Radiographic equipment designed for conventional 
radiographic procedures that have been modified or equipped with special 
attachments for mammography shall not be used for mammography.
    (2) Radiographic equipment used for mammography shall:
    (i) Be certified pursuant to Sec. 1010.2 of this chapter as meeting 
the applicable requirements of Secs. 1020.30 and 1020.31 of this chapter 
in effect at the date of manufacture;
    (ii) Be specifically designed for mammography;
    (iii) Incorporate a breast compression device; and
    (iv) Have the provision for operating with a removable grid, except 
for xeromammography systems.
    (c) Dose. The average glandular dose delivered during a single 
cranio-caudal view of an accepted phantom simulating a 4.5 centimeter 
thick, compressed breast consisting of 50 percent glandular and 50 
percent adipose tissue, shall not exceed 3.0 milliGray (0.3 rad) per 
exposure for screen-film mammography procedures and 4.0 milliGray (0.4 
rad) per exposure for xeromammography procedures. The dose shall be 
determined at least annually under the technique factors and conditions 
that are used to produce the phantom images submitted for accreditation.
    (d) Quality assurance--(1) Equipment. Each facility shall establish 
and maintain a quality assurance program to assure the adequate 
performance of the radiographic equipment and other equipment and 
materials used in conjunction with such equipment sufficient to assure 
the reliability and clarity of its mammograms. The program shall also 
require periodic monitoring of the dose delivered by the facility's 
examination procedures to ensure that it does not exceed the limit 
specified in paragraph (c) of this section and is appropriate for the 
image receptor used. Such quality assurance program shall:
    (i) For film-screen systems, be substantially the same as that 
described in the 1992 or 1994 edition of ``Mammography Quality Control: 
Radiologist's Manual, Radiologic Technologist's Manual, and Medical 
Physicist's Manual,'' prepared by the American College of Radiology, 
Committee on Quality Assurance in Mammography, which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
may be obtained from the American College of Radiology, Mammography 
Accreditation Program, 1891 Preston White Dr., Reston, VA 22091-5431; 
and may be inspected at the Center for Devices and Radiological Health, 
Division of Mammography and Radiation Programs (HFZ-200), 5600 Fishers 
Lane, Rockville, MD 20857; or may be examined at the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (ii) For systems with alternate image receptor modalities, be 
substantially the same as the quality assurance program recommended by 
the image receptor manufacturer, which, if followed, will allow a 
facility to maintain high image quality; and
    (iii) For all image receptors, provide for the maintenance of log 
books documenting compliance with the applicable requirements in 
paragraph (d)(1) of this section and recording corrective actions taken.
    (2) Phantom images. Each facility shall establish and maintain a 
program to assess the performance of the mammography system through the 
evaluation of radiographic images obtained with a phantom. The phantom 
must be of a type approved or accepted by the American College of 
Radiology or of an equivalent type accepted by FDA. The phantom images 
must score at least the minimum required by the accrediting body.
    (3) Clinical images. Each facility shall establish and maintain a 
clinical image quality control program, including:
    (i) Monitoring of mammograms repeated due to poor image quality; and
    (ii) Maintenance of records, analysis of results, and a description 
of any remedial action taken on the basis of such monitoring.
    (4) Clinical image interpretation. Each facility shall establish a 
system for reviewing outcome data from all mammography performed, 
including followup on the disposition of positive mammograms and 
correlation of surgical biopsy results with mammogram reports.

[[Page 493]]

    (5) Surveys. As a part of its overall quality assurance program, 
each facility shall have a medical physicist establish, monitor, and 
direct the procedures required by paragraphs (d)(1), (d)(2), and (d)(3) 
of this section and perform a survey of the facility to assure that it 
meets the quality control and equipment standards as specified in 
paragraph (b)(2) of this section. Such surveys shall be performed at 
least annually, and reports of such surveys shall be prepared and 
transmitted to the accrediting body in accordance with Sec. 900.4(d)(1). 
Each such report shall be retained by the facility until such time as 
the next annual survey is satisfactorily completed.
    (e) Medical records. (1) Each facility shall maintain mammograms and 
associated records in a permanent medical record of the patient as 
follows:
    (i) 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 longer if mandated by State or local law; or
    (ii) Until requested by the patient to permanently transfer the 
records to a medical institution, or to a physician of the patient, or 
to the patient herself, and the records are so transferred.
    (2) Each facility shall prepare a written report of the results of 
any mammography examination. Such report shall be completed as soon as 
reasonably possible and shall:
    (i) Be signed by the interpreting physician; and
    (ii) Be provided to the patient's physicians (if any); or
    (A) If the patient's physician is not available or if the patient 
does not have a physician, the report shall be sent directly to the 
patient; and
    (B) If such report is sent to the patient, it shall include a 
summary written in language easily understood by a lay person; and
    (iii) Be maintained in the patient's record in accordance with 
paragraph (e)(1) of this section.
[58 FR 67570, Dec. 21, 1993; 59 FR 6899, Feb. 14, 1994, as amended at 59 
FR 49812, Sept. 30, 1994]



Sec. 900.13  Revocation of accreditation and accrediting body approval.

    (a) Accreditation. If a facility's accreditation is revoked by an 
accrediting body, the facility's certificate shall remain in effect 
until such time as determined by the agency on a case-by-case basis 
after an investigation into the reasons for the revocation. If FDA 
determines that the revocation was justified by violations of applicable 
quality standards, FDA will revoke or suspend the facility's certificate 
and/or require the submission and implementation of a corrective action 
plan, whichever action will protect the public health in the least 
burdensome way.
    (b) Accrediting body approval. If the approval of an accrediting 
body is revoked by FDA, the certificates of the facilities accredited by 
such body shall remain in effect for a period of 1 year after the date 
of such revocation subject to FDA's determination that the facility 
continues to perform quality mammography. By the end of a year following 
revocation of approval of a facility's accrediting body, the facility 
must obtain accreditation by another accrediting body.



Sec. 900.14  Hearings regarding certification decisions.

    Opportunities to challenge final adverse actions taken by FDA 
regarding denials of certification or suspension or revocations of 
certification of facilities will be communicated through notices of 
opportunity for informal hearings in accordance with part 16 of this 
chapter.



Sec. 900.18  Alternative requirements for MQSA quality standards.

    (a) Criteria for approval of alternative standards. Upon application 
by a qualified party as defined under paragraph (b) of this section, the 
Director, Division of Mammography Quality and Radiation Programs (the 
Director), may approve an alternative to a quality standard under 
Sec. 900.12, when the Director 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 amending the 
standard, or

[[Page 494]]

    (ii) Offers an expected benefit to public health which is so great 
that the time required for the processing of an amendment to the 
standard would present an unjustifiable risk to public health, and
    (3) The granting of the alternative is in keeping with the purposes 
of the Mammography Quality Standards Act of 1992.
    (b) Applicants for alternatives. (1) Mammography facilities and 
accreditation bodies may apply for alternatives to the quality standards 
of Sec. 900.12.
    (2) State governments that are not accrediting 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), (c), and 
(d).
    (c) Application 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 Director, Division of Mammography Quality 
and Radiation Programs, Center for Devices and Radiological Health (HFZ-
240), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857. 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 it is 
believed necessary to propose 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 
assure 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) The Director 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 written notice will 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 will also 
include the effective date and the termination date of the approval, 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 will be assigned an identifying number.
    (2) Notice of an approved request for an alternative standard or any 
amendment or extension thereof will be placed in the public docket file 
in the office of the Dockets Management Branch and may also be in the 
form of a notice published in the Federal Register. The notice will 
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 approval of the 
alternative standard.
    (3) Summaries of approved alternative standards, including 
information on their nature and number, will 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 will be available for 
public disclosure in the Dockets Management Branch, 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;

[[Page 495]]

    (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 assure equal or greater quality of production, 
processing, or interpretation of mammograms than the original standard.
    (f) Applicability of the alternative standards. 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, except that when an alternative standard is approved for a 
manufacturer of equipment, any facility using that equipment will also 
be covered by the alternative standard. Other entities interested in 
similar or identical approvals must file their own application by 
following the provisions of Sec. 900.18(c).
    (g) Withdrawal of approval of alternative standards. The Director 
shall amend or withdraw approval of an alternative standard whenever the 
Director determines that this action is necessary to protect the public 
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 the Director determines that such 
action is necessary to prevent an imminent health hazard.
[59 FR 49812, Sept. 30, 1994]

    Effective Date Note: At 62 FR 55976, Oct. 28, 1997, part 900 was 
revised; and at 62 FR 60614, Nov. 10, 1997, it was republished and 
corrected, effective Apr. 28, 1999, with excepted provisions effective 
Oct. 28, 2002. For the convenience of the user, revised and corrected 
part 900 is set forth as follows:



PART 900--MAMMOGRAPHY

                        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.

    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 and B 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.

[[Page 496]]

    (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 than 300 kiloelectronvolts (keV), 1 Gy = 100 radian (rad) 
= 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 
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.
    (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.

[[Page 497]]

    (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 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.

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

[[Page 498]]

of Mammography Quality and Radiation Programs (DMQRP), Center for 
Devices and Radiology Health (HFZ-240), Food and Drug Administration, 
1350 Piccard Dr., Rockville, MD 20850, marked Attn: Mammography 
Standards 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;
    (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).

[[Page 499]]

    (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, 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]

    Effective Date Note:  At 62 FR 60614, Nov. 10, 1997, 
Sec. 900.3(c)(4) was corrected by inserting a comma after ``July 28, 
1998'', effective Apr. 28, 1999.

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

[[Page 500]]

    (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 financial 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, 
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.

[[Page 501]]

    (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.
    (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 
clinical image reviewers.
    (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) Clinical image reviewers. Accreditation bodies shall ensure that 
all of their clinical image reviewers:
    (i) Meet the interpreting physician requirements specified in 
Sec. 900.12(a)(1);
    (ii) Are trained and evaluated in the clinical image review process, 
for the types of clinical images to be evaluated by a clinical image 
reviewer, by the accreditation body before designation as clinical image 
reviewers 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 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 clinical image reviewer 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.

[[Page 502]]

    (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 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.

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    (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 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;

[[Page 504]]

    (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 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.

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 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

[[Page 505]]

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.

Secs. 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 facility must meet the requirements of 42 U.S.C. 
263b(c)(2) 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

[[Page 506]]

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.

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 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.

[[Page 507]]

 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 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 
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.

[[Page 508]]

    (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 October 28, 1997, 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 MQSA inspection or the last day of the calendar 
quarter 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
    (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 paragraph 
(a)(3)(i) or (a)(3)(ii) of this section were completed or of October 28, 
1997, 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 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 on a specific unit within a 
period of 60 days can be counted towards the total mammography unit 
survey 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.

[[Page 509]]

    (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 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 Secs. 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 
Secs. 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) Beam limitation and light fields.  (i) All systems shall have 
beam-limiting devices that allow the useful beam to extend to or beyond 
the chest wall edge of the image receptor.
    (ii) 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 those smaller than the full size of the 
image receptor (for ``spot compression'') may be provided. Such 
compression paddles

[[Page 510]]

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;
    (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 patient.  Each 
facility shall maintain a system to ensure that the results of each 
mammographic examination are communicated to the patient in a timely 
manner. If

[[Page 511]]

assessments are ``Suspicious'' or ``Highly suggestive of malignancy'' 
and the patient has not named a health care provider, the facility shall 
make reasonable attempts to ensure that the results are communicated to 
the patient as soon as possible.
    (i) As soon as possible, but no later than 30 days from the date of 
the mammography examination, 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, in addition to a written 
notification of results in lay terms.
    (ii) Each facility that accepts patients who do not have a primary 
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)(3)(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 or on behalf of, by 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 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

[[Page 512]]

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 employee qualifications to meet assigned quality 
assurance tasks, mammography technique and procedures, quality control 
(including monitoring data, problems detected by analysis of that data, 
corrective actions, and the effectiveness of the corrective actions), 
safety, and protection 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 examinations are performed 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.
    (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 209 
newtons (47 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.

[[Page 513]]

    (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 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/millimeters 
(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 useful X-ray beam to extend to or beyond the edges of the image 
receptor but by no more than 2 percent of the SID at the chest wall 
side.

[[Page 514]]

    (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 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 the component of the mammography system that failed the 
test, if the failed test was that described in paragraphs (e)(1), 
(e)(2), (e)(4)(ii), (e)(4)(iii), (e)(5)(i), (e)(5)(iii), (e)(5)(v), 
(e)(5)(vi), (e)(6), or (e)(7) of this section;
    (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.

[[Page 515]]

    (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 dissembled 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.
    (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) Reviewing 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, notifying other interpreting physicians of 
their results and the facility aggregate results. If followup actions 
are taken, the reviewing 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

[[Page 516]]

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 any activity related to the provision of 
mammography at a facility may present a serious risk to human health 
such that patient notification is necessary, the facility shall notify 
patients or their designees, their physicians, or the public of action 
that may be taken to minimize the effects of the risk. 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]

    Effective Date Note: At 62 FR 60614, Nov. 10, 1997, Sec. 900.12 was 
corrected as follows:
    1. Effective Apr. 28, 1999: the introductory text of (a)(2)(iv) was 
corrected by inserting a comma after ``October 28, 1997''; (b)(6)(ii) 
was corrected by changing the word ``valve'' to read ``value''; 
(e)(5)(iii) and (e)(5)(x)(A) were corrected by changing ``October 28, 
1999'' to read ``October 28, 2002''; (e)(1)(ii), (iii), (e)(2)(ii), 
(e)(5)(ii), and (e)(12) were corrected by changing the ``+'' to read 
``''; and (h) was corrected by changing the word 
``compliant'' to read ``complaint''.
    2. Effective Oct. 28, 2002: in paragraphs (b)(8)(i), (e)(4)(iii)(B), 
and (e)(5)(i)(B) ``October 28, 1999'' was corrected to read ``October 
28, 2002''.

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:
    (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

[[Page 517]]

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.

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 DMQRP within 60 days 
of the accreditation body's adverse appeals decision, at the following 
address: Division of Mammography Quality and Radiation Programs (HFZ-
240), Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850, Attn: Facility 
Accreditation Review Committee.
    (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.

[[Page 518]]

    (6) A facility cannot perform mammography services while an adverse 
accreditation decision is being appealed.

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 Director, Division of Mammography Quality 
and Radiation Programs (HFZ-240), Center for Devices and Radiological 
Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 
20850. 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 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 Dockets Management Branch 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.

[[Page 519]]

    (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 Dockets Management Branch, 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]

    Effective Date Note: At 62 FR 60614, Nov. 10, 1997, 
Sec. 900.18(a)(1) was corrected by changing the word ``assuing'' to read 
``assuring'', effective Apr. 28, 1999.

[[Page 520]]



                    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.

             Subpart C--Radiation Protection Recommendations

1000.50  Recommendation for the use of specific area gonad shielding on 
          patients during medical diagnostic x-ray procedures.
1000.55  Recommendation for quality assurance programs in diagnostic 
          radiology facilities.
1000.60  Recommendation on administratively required dental x-ray 
          examinations.

    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 event or series 
of 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 521]]

[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 522]]

    (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) Phototherapy product means any ultraviolet lamp, or product 
containing such lamp, that is intended for irradiation of any part of 
the living human body by light in the wavelength range of 200 to 400 
nanometers, in order to perform a therapeutic function.
    (t) 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.
    (u) 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]



           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.

[[Page 523]]

Sonic:
    Electronic oscillators.
    Sound amplification equipment.
Ultrasonic:
    Cauterizers.
    Cell and tissue disintegrators.
    Cleaners.
    Diagnostic and nondestructive testing equipment.
    Ranging and detection equipment.



             Subpart C--Radiation Protection Recommendations



Sec. 1000.50  Recommendation for the use of specific area gonad shielding on patients during medical diagnostic x-ray procedures.

    Specific area gonad shielding covers an area slightly larger than 
the region of the gonads. It may therefore be used without interfering 
with the objectives of the examination to protect the germinal tissue of 
patients from radiation exposure that may cause genetic mutations during 
many medical x-ray procedures in which the gonads lie within or are in 
close proximity to the x-ray field. Such shielding should be provided 
when the following conditions exist:
    (a) The gonads will lie within the primary x-ray field, or within 
close proximity (about 5 centimeters), despite proper beam limitation. 
Except as provided in paragraph (b) or (c) of this section:
    (1) Specific area testicular shielding should always be used during 
those examinations in which the testes usually are in the primary x-ray 
field, such as examinations of the pelvis, hip, and upper femur;
    (2) Specific area testicular shielding may also be warranted during 
other examinations of the abdominal region in which the testes may lie 
within or in close proximity to the primary x-ray field, depending upon 
the size of the patient and the examination techniques and equipment 
employed. Some examples of these are: Abdominal, lumbar spine and 
lumbosacral spine examinations, intravenous pyelograms, and abdominal 
scout film for barium enemas and upper GI series. Each x-ray facility 
should evaluate its procedures, techniques, and equipment and compile a 
list of such examinations for which specific area testicular shielding 
should be routinely considered for use. As a basis for judgment, 
specific area testicular shielding should be considered for all 
examinations of male patients in which the pubic symphysis will be 
visualized on the film;
    (3) Specific area gonad shielding should never be used as a 
substitute for careful patient positioning, the use of correct technique 
factors and film processing, or proper beam limitation (confinement of 
the x-ray field to the area of diagnostic interest), because this could 
result in unnecessary doses to other sensitive tissues and could 
adversely affect the quality of the radiograph; and
    (4) Specific area gonad shielding should provide attenuation of x-
rays at least equivalent to that afforded by 0.25 millimeter of lead.
    (b) The clinical objectives of the examination will not be 
compromised.
    (1) Specific area testicular shielding usually does not obscure 
needed information except in a few cases such as oblique views of the 
hip, retrograde urethrograms and voiding cystourethrograms, 
visualization of the rectum and, occasionally, the pubic symphysis. 
Consequently, specific area testicular shielding should be considered 
for use in the majority of x-ray examinations of male patients in which 
the testes will lie within the primary beam or within 5 centimeters of 
its edge. It is not always possible to position shields on male patients 
so that no bone is obscured. Therefore, if all bone structure of the 
pelvic area must be visualized for a particular patient, the use of 
shielding should be carefully evaluated. The decision concerning the 
applicability of shielding for an individual patient is dependent upon 
consideration of the patient's unique anthropometric characteristics and 
the diagnostic information needs of the examination.
    (2) The use of specific area ovarian shielding is frequently 
impractical at present because the exact location of the ovaries is 
difficult to estimate, and the shield may obscure visualization of 
portions of adjacent structures such as the spine, ureters, and small 
and large bowels. However, it may be possible for

[[Page 524]]

practitioners to use specific area ovarian shielding during selected 
views in some examinations.
    (c) The patient has a reasonable reproductive potential.
    (1) Specific area shielding need not be used on patients who cannot 
or are not likely to have children in the future.
    (2) The following table of statistical data regarding the average 
number of children expected by potential parents in various age 
categories during their remaining lifetimes is provided for x-ray 
facilities that wish to use it as a basis for judging reproductive 
potential:

  Expected Number of Future Children Versus Age of Potential Parent \1\ 
------------------------------------------------------------------------
                                                        Male     Female 
                         Age                           parent    parent 
------------------------------------------------------------------------
Fetus...............................................       2.6       2.6
0 to 4..............................................       2.6       2.5
5 to 9..............................................       2.7       2.5
10 to 14............................................       2.7       2.6
15 to 19............................................       2.7       2.6
20 to 24............................................       2.6       2.2
25 to 29............................................       2.0       1.4
30 to 34............................................       1.1        .6
35 to 39............................................        .5        .2
40 to 44............................................        .2       .04
45 to 49............................................       .07         0
50 to 54............................................       .03         0
55 to 64............................................       .01         0
Over 65.............................................         0         0
------------------------------------------------------------------------
\1\ Derived from data published by the National Center for Health       
  Statistics, ``Final Natality Statistics 1970,'' HRA 74-1120, vol. 22, 
  No. 12, Mar. 20, 1974.                                                

[41 FR 30328, July 23, 1976; 41 FR 31812, July 30, 1976]



Sec. 1000.55  Recommendation for quality assurance programs in diagnostic radiology facilities.

    (a) Applicability. Quality assurance programs as described in 
paragraph (c) of this section are recommended for all diagnostic 
radiology facilities.
    (b) Definitions. As used in this section, the following definitions 
apply:
    (1) Diagnostic radiology facility means any facility in which an x-
ray system(s) is used in any procedure that involves irradiation of any 
part of the human body for the purpose of diagnosis or visualization. 
Offices of individual physicians, dentists, podiatrists, and 
chiropractors, as well as mobile laboratories, clinics, and hospitals 
are all examples of diagnostic radiology facilities.
    (2) Quality assurance means the planned and systematic actions that 
provide adequate confidence that a diagnostic x-ray facility will 
produce consistently high quality images with minimum exposure of the 
patients and healing arts personnel. The determination of what 
constitutes high quality will be made by the facility producing the 
images. Quality assurance actions include both ``quality control'' 
techniques and ``quality administration'' procedures.
    (3) Quality assurance program means an organized entity designed to 
provide ``quality assurance'' for a diagnostic radiology facility. The 
nature and extent of this program will vary with the size and type of 
the facility, the type of examinations conducted, and other factors.
    (4) Quality control techniques are those techniques used in the 
monitoring (or testing) and maintenance of the components of an x-ray 
system. The quality control techniques thus are concerned directly with 
the equipment.
    (5) Quality administration procedures are those management actions 
intended to guarantee that monitoring techniques are properly performed 
and evaluated and that necessary corrective measures are taken in 
response to monitoring results. These procedures provide the 
organizational framework for the quality assurance program.
    (6) X-ray system means an assemblage of components for the 
controlled production of diagnostic images with 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. Other components that function with the system, such as 
image receptors, image processors, view boxes, and darkrooms, are also 
parts of the system.
    (c) Elements. A quality assurance program should contain the 
elements listed in paragraphs (c)(1) through (10) of this section. The 
extent to which each element of the quality assurance program is 
implemented should be determined by an analysis of the facility's 
objectives and resources conducted by its qualified staff or by 
qualified outside consultants. The extent of implementation should be 
determined on the

[[Page 525]]

basis of whether the expected benefits in radiation exposure reduction, 
improved image quality, and/or financial savings will compensate for the 
resources required for the program.
    (1) Responsibility. (i) Responsibility and authority for the overall 
quality assurance program as well as for monitoring, evaluation, and 
corrective measures should be specified and recorded in a quality 
assurance manual.
    (ii) The owner or practitioner in charge of the facility has primary 
responsibility for implementing and maintaining the quality assurance 
program.
    (iii) Staff technologists will generally be delegated a basic 
quality assurance role by the practitioner in charge. Responsibility for 
specific quality control monitoring and maintenance techniques or 
quality administration procedures may be assigned, provided that the 
staff technologists are qualified by training or experience for these 
duties. The staff technologists should also be responsible for 
identifying problems or potential problems requiring actions beyond the 
level of their training. They should bring these problems to the 
attention of the practitioner in charge, or his or her representative, 
so that assistance in solving the problems may be obtained from inside 
or outside the facility.
    (iv) In facilities where they are available, physicists, supervisory 
technologists, or quality control technologists should have a major role 
in the quality assurance program. Such specialized personnel may be 
assigned responsibility for day-to-day administration of the program, 
may carry out monitoring duties beyond the level of training of the 
staff technologist or, if desired by the facility, may relieve the staff 
technologists of some or all of their basic monitoring duties. Staff 
service engineers may also be assigned responsibility for certain 
preventive or corrective maintenance actions.
    (v) Responsibility for certain quality control techniques and 
corrective measures may be assigned to personnel qualified by training 
or experience, such as consultants or industrial representatives, from 
outside of the facility, provided there is a written agreement clearly 
specifying these services.
    (vi) In large facilities, responsibility for long-range planning of 
quality assurance goals and activities should be assigned to a quality 
assurance committee as described in paragraph (c)(9) of this section.
    (2) Purchase specifications. Before purchasing new equipment, the 
staff of the diagnostic radiology facility should determine the desired 
performance specifications for the equipment. Initially, these 
specifications may be stated in terms of the desired performance of the 
equipment, or prospective vendors may be informed solely of the 
functions the equipment should be able to perform and asked to provide 
the performance specifications of items from their equipment line that 
can perform these functions. In either case, the responses of the 
prospective vendors should serve as the basis for negotiations to 
establish the final purchase specifications, taking into account the 
state of the art and balancing the need for the specified performance 
levels with the cost of the equipment to meet them. The final purchase 
specifications should be in writing and should include performance 
specifications. The availability of experienced service personnel should 
also be taken into consideration in making the final purchase decisions. 
Any understandings with respect to service personnel should be 
incorporated into the purchase specifications. After the equipment is 
installed, the facility should conduct a testing program, as defined in 
its purchase specifications, to ensure that the equipment meets the 
agreed upon specifications, including applicable Federal and State 
regulatory requirements. The equipment should not be formally accepted 
until any necessary corrections have been made by the vendor. The 
purchase specifications and the records of the acceptance testing should 
be retained throughout the life of the equipment for comparison with 
monitoring results in order to assess continued acceptability of 
performance.
    (3) Monitoring and maintenance. A routine quality control monitoring 
and maintenance system incorporating state-of-the-art procedures should 
be established and conducted on a regular schedule. The purpose of 
monitoring is

[[Page 526]]

to permit evaluation of the performance of the facility's x-ray 
system(s) in terms of the standards for image quality established by the 
facility (as described in paragraph (c)(4) of this section) and 
compliance with applicable Federal and State regulatory requirements. 
The maintenance program should include corrective maintenance to 
eliminate problems revealed by monitoring or other means before they 
have a serious deleterious impact on patient care. To the extent 
permitted by the training of the facility staff, the maintenance program 
should also include preventive maintenance, which could prevent 
unexpected breakdowns of equipment and disruption of departmental 
routine.
    (i) The parameters to be monitored in a facility should be 
determined by that facility on the basis of an analysis of expected 
benefits and cost. Such factors as the size and resources of the 
facility, the type of examinations conducted, and the quality assurance 
problems that have occurred in that or similar facilities should be 
taken into account in establishing the monitoring system. The monitoring 
frequency should also be based upon need and can be different for 
different parameters.
    (ii) Although the parameters to be monitored will vary somewhat from 
facility to facility, every diagnostic radiology facility should 
consider monitoring the following five key components of the x-ray 
system:
    (a) Film processing.
    (b) Basic performance characteristics of the x-ray unit.
    (c) Cassettes and grids.
    (d) View boxes.
    (e) Darkroom.
    (iii) Examples of parameters of the above-named components and of 
more specialized equipment that may be monitored are as follows:
    (a) For film processing:

An index of speed.
An index of contrast.
Base plus fog.
Solution temperatures.
Film artifact identification.

    (b) For basic performance characteristics of the x-ray unit:
    (1) For fluoroscopic x-ray units:

Table-top exposure rates.
Centering alignment.
Collimation.
kVp accuracy and reproducibility.
mA accuracy and reproducibility.
Exposure time accuracy and reproducibility.
Reproducibility of x-ray output.
Focal spot size consistency.
Half-value layer.
Representative entrance skin exposures.

    (2) For image-intensified systems:

Resolution.
Focusing.
Distortion.
Glare.
Low contrast performance.
Physical alignment of camera and collimating lens.

    (3) For radiographic x-ray units:

Reproducibility of x-ray output.
Linearity and reproducibility of mA stations.
Reproducibility and accuracy of timer stations.
Reproducibility and accuracy of kVp stations.
Accuracy of source-to-film distance indicators.
Light/x-ray field congruence.
Half-value layer.
Focal spot size consistency.
Representative entrance skin exposures.

    (4) For automatic exposure control devices:

Reproducibility.
kVp compensation.
Field sensitivity matching.
Minimum response time.
Backup timer verification.

    (c) For cassettes and grids:
    (1) For cassettes:

Film/screen contact.
Screen condition.
Light leaks.
Artifact identification.

    (2) For grids:

Alignment and focal distance.
Artifact identification.

    (d) For view boxes:

Consistency of light output with time.
Consistency of light output from one box to another.
View box surface conditions.

    (e) For darkrooms:

Darkroom integrity.
Safe light conditions.

    (f) For specialized equipment:
    (1) For tomographic systems:

Accuracy of depth and cut indicator.

[[Page 527]]

Thickness of cut plane.
Exposure angle.
Completeness of tomographic motion.
Flatness of tomographic field.
Resolution.
Continuity of exposure.
Flatness of cassette.
Representative entrance skin exposures.

    (2) For computerized tomography:

Precision (noise).
Contrast scale.
High and low contrast resolution.
Alignment.
Representative entrance skin exposures.

    (iv) The maintenance program should include both preventive and 
corrective aspects.
    (a) Preventive maintenance. Preventive maintenance should be 
performed on a regularly scheduled basis with the goal of preventing 
breakdowns due to equipment failing without warning signs detectable by 
monitoring. Such actions have been found cost effective if 
responsibility is assigned to facility staff members. Possible 
preventive maintenance procedures are visual inspection of the 
mechanical and electrical characteristics of the x-ray system (covering 
such things as checking conditions of cables, watching the tomographic 
unit for smoothness of motion, assuring cleanliness with respect to 
spilling of contaminants in the examination room or the darkroom, and 
listening for unusual noises in the moving parts of the system), 
following the manufacturer's recommended procedures for cleaning and 
maintenance of the equipment, and regular inspection and replacement of 
switches and parts that routinely wear out or fail. The procedures 
included would depend upon the background of the staff members 
available. Obviously, a large facility with its own service engineers 
can do more than an individual practitioner's office.
    (b) Corrective maintenance. For maximum effectiveness, the quality 
assurance program should make provision, as described in paragraph 
(c)(5) of this section, for ascertaining whether potential problems are 
developing. If potential or actual problems are detected, corrective 
maintenance should be carried out to eliminate them before they cause a 
major impact on patient care.
    (4) Standards for image quality. Standards of acceptable image 
quality should be established. Ideally, these should be objective, e.g., 
acceptability limits for the variations of parameter values, but they 
may be subjective, e.g., the opinions of professional personnel, in 
cases where adequate objective standards cannot be defined. These 
standards should be routinely reviewed and redefined as needed, as 
described in paragraph (c)(10) of this section.
    (5) Evaluation. The facility's quality assurance program should 
include means for two levels of evaluation.
    (i) On the first level, the results of the monitoring procedures 
should be used to evaluate the performance of the x-ray system(s) to 
determine whether corrective actions are needed to adjust the equipment 
so that the image quality consistently meets the standards for image 
quality. This evaluation should include analysis of trends in the 
monitoring data as well as the use of the data to determine the need for 
corrective actions on a day-by-day basis. Comparison of monitoring data 
with the purchase specifications and acceptance testing results for the 
equipment in question is also useful.
    (ii) On the second level, the facility quality assurance program 
should also include means for evaluating the effectiveness of the 
program itself. Possible means include ongoing studies of the retake 
rate and the causes of the repeated radiographs, examination of 
equipment repair and replacement costs, subjective evaluation of the 
radiographs being produced, occurrence and reasons for complaints by 
radiologists, and analysis of trends in the results of monitoring 
procedures such as sensitometric studies. Of these, ongoing studies of 
the retake rate (reject rate) and its causes are often the most useful 
and may also provide information of value in the first level of 
evaluation. Such studies can be used to evaluate potential for 
improvement, to make corrections, and to determine whether the 
corrective actions were effective. The number of rejects should be 
recorded daily or weekly, depending on the facility's analysis of its 
needs. Ideally, the reasons for the rejection

[[Page 528]]

should also be determined and recorded. Should determining these reasons 
be impossible on a regular basis with the available staff, the analysis 
should be done for a 2-week period after major changes have occurred in 
diagnostic procedures or the x-ray system and at least semi-annually.
    (6) Records. The program should include provisions for the keeping 
of records on the results of the monitoring techniques, any difficulties 
detected, the corrective measures applied to these difficulties, and the 
effectiveness of these measures. The extent and form of these records 
should be determined by the facility on the basis of its needs. The 
facility should view these records as a tool for maintaining an 
effective quality assurance program and not view the data in them as an 
end in itself but rather as a beginning. For example, the records should 
be made available to vendors to help them provide better service. More 
importantly, the data should be the basis for the evaluation and the 
reviews suggested in paragraphs (c)(5) and (10) of this section.
    (7) Manual. A quality assurance manual should be written in a format 
permitting convenient revision as needed and should be made readily 
available to all personnel. The content of the manual should be 
determined by the facility staff, but the following items are suggested 
as providing essential information:
    (i) A list of the individuals responsible for monitoring and 
maintenance techniques.
    (ii) A list of the parameters to be monitored and the frequency of 
monitoring.
    (iii) A description of the standards, criteria of quality, or limits 
of acceptability that have been established for each of the parameters 
monitored.
    (iv) A brief description of the procedures to be used for monitoring 
each parameter.
    (v) A description of procedures to be followed when difficulties are 
detected to call these difficulties to the attention of those 
responsible for correcting them.
    (vi) A list of the publications in which detailed instructions for 
monitoring and maintenance procedures can be found. Copies of these 
publications should also be readily available to the entire staff, but 
they should be separate from the manual. (Publications providing these 
instructions can usually be obtained from FDA or private sources, 
although the facility may wish to make some modifications to meet its 
needs more effectively.)
    (vii) A list of the records, with sample forms, that the facility 
staff has decided should be kept. The facility staff should also 
determine and note in the manual the length of time each type of record 
should be kept before discarding.
    (viii) A copy of each set of purchase specifications developed for 
new equipment and the results of the acceptance testing for that 
equipment.
    (8) Training. The program should include provisions for appropriate 
training for all personnel with quality assurance responsibilities. This 
should include both training provided before the quality assurance 
responsibilities are assumed and continuing education to keep the 
personnel up-to-date. Practical experience with the techniques conducted 
under the supervision of experienced instructors, either in the facility 
or in a special program, is the most desirable type of training. The use 
of self-teaching materials can be an adequate substitute for supervised 
instruction, especially in continuing education programs, if supervised 
instruction is not available.
    (9) Committee. A facility whose size would make it impractical for 
all staff members to meet for planning purposes should consider the 
establishment of a quality assurance committee whose primary function 
would be to maintain lines of communication among all groups with 
quality assurance and/or image production or interpretation 
responsibilities. For maximum communication, all departments of the 
facility with x-ray equipment should be represented. The committee may 
also be assigned policy-making duties such as some or all of the 
following:

Assign quality assurance responsibilities; maintain acceptable standards 
of quality; periodically review program effectiveness, etc. 
Alternatively, the

[[Page 529]]

duties of this committee could be assigned to an already-existing 
committee such as the Radiation Safety Committee. In smaller facilities, 
all staff members should participate in the committee's tasks. The 
Quality Assurance Committee should report directly to the head of the 
radiology department, or, in facilities where more than one department 
operates x-ray equipment, to the chief medical officer of the facility. 
The committee should meet on a regular basis.
    (10) Review. The facility's quality assurance program should be 
reviewed by the Quality Assurance Committee and/or the practitioner in 
charge to determine whether its effectiveness could be improved. Items 
suggested for inclusion in the review include:
    (i) The reports of the monitoring and maintenance techniques to 
ensure that they are being performed on schedule and effectively. These 
reports should be reviewed at least quarterly.
    (ii) The monitoring and maintenance techniques and their schedules 
to ensure that they continue to be appropriate and in step with the 
latest developments in quality assurance. They should be made current at 
least annually.
    (iii) The standards for image quality to ensure that they are 
consistent with the state-of-the-art and the needs and resources of the 
facility. These standards should be evaluated at least annually.
    (iv) The results of the evaluations of the effectiveness of the 
quality assurance actions to determine whether changes need to be made. 
This determination should be made at least annually.
    (v) The quality assurance manual should also be reviewed at least 
annually to determine whether revision is needed.
[44 FR 71737, Dec. 11, 1979]



Sec. 1000.60  Recommendation on administratively required dental x-ray examinations.

    (a) The Food and Drug Administration recommends that dental x-ray 
examinations be performed only after careful consideration of the dental 
or other health needs of the patient, that is, when the patient's 
dentist or physician judges them to be necessary for diagnosis, 
treatment, or prevention of disease. Administratively required dental x-
ray examinations are those required by a remote third party for reasons 
not related to the patient's immediate dental needs. These x-ray 
examinations are usually a source of unnecessary radiation exposure to 
the patient. Because any unnecessary radiation exposure should be 
avoided, third parties should not require dental x-ray examinations 
unless they can demonstrate that such examinations provide a direct 
clinical benefit to the patient, and the patient's dentist or physician 
agrees with that assessment.
    (b) Some examples of administrative x-ray examinations that should 
not be required by third parties are those intended solely:
    (1) To monitor insurance claims or detect fraud;
    (2) To satisfy a prerequisite for reimbursement;
    (3) To provide training or experience;
    (4) To certify qualifications or competence.
    (c) This recommendation is not intended to preclude dental x-ray 
examinations ordered by the attending practitioner, based on the 
patient's history or physical examination, or those performed on 
selected populations shown to have significant yields of previously 
undiagnosed disease. This recommendation is also not intended to 
preclude the administrative use by third parties of dental radiographs 
that are taken on the order of the patient's dentist or physician as a 
necessary part of the patient's clinical care.
[45 FR 40978, June 17, 1980]



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.

[[Page 530]]

    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 1of 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.

                                                 Table 1.--Record and Reporting Requirements By Product                                                 
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Manufacturer                                                                   Dealer &  
------------------------------------------------------------------------------------------------------------------------------------------  Distributor 
                                                                                                                                          --------------
                                                 Supplemental     Abbreviated                                             Distribution      Distribution
          Products            Product reports    reports Sec.     reports Sec.    Annual reports   Test records Sec.      records Sec.        records   
                               Sec.  1002.10       1002.11          1002.12       Sec.  1002.13       1002.30(a)1          1002.30(b)2      1002.40 and 
                                                                                                                                              1002.41   
--------------------------------------------------------------------------------------------------------------------------------------------------------
DIAGNOSTIC X-RAY3 (1020.30,   ...............  ...............  ...............  ...............  ...................  ..................  .............
 1020.31, 1020.32, 1020.33)                                                                                                                             
Computed tomography           X                X                ...............  X                X                    X                   X            
X-ray system4                 X                X                ...............  X                X                    X                   X            
Tube housing assembly         X                X                ...............  X                X                    X                   .............
X-ray control                 X                X                ...............  X                X                    X                   X            

[[Page 531]]

                                                                                                                                                        
X-ray high voltage generator  X                X                ...............  X                X                    X                   X            
X-ray table or cradle         ...............  ...............  X                ...............  X                    X                   X            
X-ray film changer            ...............  ...............  X                ...............  X                    X                   .............
Vertical cassette holders     ...............  ...............  X                ...............  X                    X                   X            
 mounted in a fixed location                                                                                                                            
 and cassette holders with                                                                                                                              
 front panels                                                                                                                                           
Beam-limiting devices         X                X                ...............  X                X                    X                   X            
Spot-film devices and image   X                X                ...............  X                X                    X                   X            
 intensifiers manufactured                                                                                                                              
 after April 26, 1977                                                                                                                                   
Cephalometric devices         ...............  ...............  X                ...............  X                    X                   .............
 manufactured after February                                                                                                                            
 25, 1978                                                                                                                                               
Image receptor support        ...............  ...............  X                ...............  X                    X                   X            
 devices for mammographic X-                                                                                                                            
 ray systems manufactured                                                                                                                               
 after September 5, 1978                                                                                                                                
CABINET X RAY (Sec.           ...............  ...............  ...............  ...............  ...................  ..................  .............
 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 DIAGNOSTIC X-RAY                                                                                                                            
Medical                       ...............  ...............  X                X                X                    X                   .............
Analytical                    ...............  ...............  X                X                X                    X                   .............
Industrial                    ...............  ...............  X                X                X                    X                   .............
TELEVISION PRODUCTS (Sec.     ...............  ...............  ...............  ...............  ...................  ..................  .............
 1020.10)                                                                                                                                               
25 kilovolt (kV) and 0.1      ...............  ...............  X                X6               ...................  ..................  .............
 milliroentgen per hour (mR/                                                                                                                            
 hr IRLC5,6                                                                                                                                             
25kV and 0.1mR/hr IRLC5       X                X                ...............  X                ...................  ..................  .............
0.1mR/hr IRLC5                X                X                ...............  X                X                    X                   .............
MICROWAVE/RF                  ...............  ...............  ...............  ...............  ...................  ..................  .............
MW ovens (Sec.  1030.10)      X                X                ...............  X                X                    X                   .............
MW diathermy                  ...............  ...............  X                ...............  ...................  ..................  .............
MW heating, drying, security  ...............  ...............  X                ...............  ...................  ..................  .............
 systems                                                                                                                                                
RF sealers, electromagnetic   ...............  ...............  X                ...............  ...................  ..................  .............
 induction and heating                                                                                                                                  
 equipment, dielectric                                                                                                                                  
 heaters (2-500 megahertz)                                                                                                                              
OPTICAL                       ...............  ...............  ...............  ...............  ...................  ..................  .............
Phototherapy products         X                X                ...............  ...............  ...................  ..................  .............
Laser products (Secs.         ...............  ...............  ...............  ...............  ...................  ..................  .............
 1040.10, 1040.11)                                                                                                                                      
Class I lasers and products   X                ...............  ...............  X                X                    ..................  .............
 containing such lasers7                                                                                                                                
Class I laser products        X                ...............  ...............  X                X                    X                   .............
 containing class IIa, II,                                                                                                                              
 IIIa, lasers7                                                                                                                                          
Class IIa, II, IIIa lasers    X                X                ...............  X                X                    X                   X            
 and products other than                                                                                                                                
 class I products containing                                                                                                                            
 such lasers7                                                                                                                                           
Class IIIb and IV lasers and  X                X                ...............  X                X                    X                   X            
 products containing such                                                                                                                               
 lasers7                                                                                                                                                
Sunlamp products (Sec.        ...............  ...............  ...............  ...............  ...................  ..................  .............
 1040.20)                                                                                                                                               
Lamps only                    X                ...............  ...............  ...............  ...................  ..................  .............
Sunlamp products              X                X                ...............  X                X                    X                   X            

[[Page 532]]

                                                                                                                                                        
Mercury vapor lamps (Sec.     ...............  ...............  ...............  ...............  ...................  ..................  .............
 1040.30)                                                                                                                                               
T lamps                       X                X                ...............  X                ...................  ..................  .............
R lamps                       ...............  ...............  X                ...............  ...................  ..................  .............
ACOUSTIC                      ...............  ...............  ...............  ...............  ...................  ..................  .............
Ultrasonic therapy (1050.10)  X                X                ...............  X                X                    X                   X            
Diagnostic ultrasound         ...............  ...............  X                ...............  ...................  ..................  .............
Medical ultrasound other      X                X                ...............  ...............  ...................  ..................  .............
 than therapy or diagnostic                                                                                                                             
Nonmedical ultrasound         ...............  ...............  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 Secs.  1002.31 and 1002.42, if applicable.                                                                                  
\3\Report of Assembly (Form FDA 2579) is required for diagnostic x-ray components; see 21 CFR 1020.30(d)(1) through (d)(3).                             
\4\Systems records and reports are required if a manufacturer exercises the option and certifies the system as permitted in 21 CFR 1020.30(c).          
\5\Determined using the isoexposure rate limit curve (IRLC) under phase III test conditions (1020.10(c)(3)(iii)).                                       
\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.     

[60 FR 48382, Sept. 19, 1995; 61 FR 13423, Mar. 27, 1996]



Sec. 1002.2  [Reserved]



Sec. 1002.3  Notification to user of performance and technical data.

    As authorized by Sec. 5.90 of this chapter, the Director and Deputy 
Director of the Center for Devices and Radiological Health 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.
[60 FR 48385, Sept. 19, 1995; 61 FR 13424, Mar. 27, 1996]



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 Center for Devices and Radiological Health, Electronic 
Product Reports, Office of Compliance (HFZ-307), 2098 Gaither Rd., 
Rockville, MD 20850.
    (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.

[[Page 533]]

    (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]



    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 aproduct 
report as set forth in table 1 of Sec. 1002.1 shall submit a product 
report to the Center for Devices and Radiological Health, Electronic 
Product Reports, Office of Compliance (HFZ-307), 2098 Gaither Rd., 
Rockville, MD 20850, 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.

[[Page 534]]

    (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.



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.
    (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.
    (c) New models of a model family that do not involve changes in 
radiation emission or requirements of a performance standard do not 
require supplemental reports prior to introduction into commerce. These 
model numbers should be reported in quarterly updates to the annual 
report.



  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, immediately 
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 addressed to the Director, Center for 
Devices and Radiological Health, 5600 Fishers Lane, Rockville, MD 20857, 
and the reports and their envelopes shall be distinctly marked ``Report 
on Sec. 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;

[[Page 535]]

    (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 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. If a manufacturer is required to report to the Director under 
paragraph (a) of this section and is not required to report under part 
803, the manufacturer shall report in accordance with paragraph (a) of 
this section. 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.
[38 FR 28625, Oct. 15, 1973, as amended at 49 FR 36351, Sept. 14, 1984; 
53 FR 11254, Apr. 6, 1988; 60 FR 48386, Sept. 19, 1995]



                    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 paragraph (c) of 
Sec. 1002.61 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]



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

[[Page 536]]

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:
    (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 359 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]



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 359 of the Act.



       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;

[[Page 537]]

    (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 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 Office of Compliance (HFZ-307), Center for Devices and 
Radiological Health, 2098 Gaither Rd., Rockville, MD 20850.
    (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]



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:  42 U.S.C. 263b-263n.

    Source:  38 FR 28628, Oct. 15, 1973, unless otherwise noted.

[[Page 538]]



                      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 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:

[[Page 539]]

    (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 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

[[Page 540]]

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:
    (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

[[Page 541]]

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.
    (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:  42 U.S.C. 263b-263n.

    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.

[[Page 542]]

    (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 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;

[[Page 543]]

    (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 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:  42 U.S.C. 263d, 263h.

    Source:  38 FR 28630, Oct. 15, 1973, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 1005.1  Applicability.

    (a) The provisions of Secs. 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 has the rights of a 
consignee under the provisions of sections 483, 484, and 485 of the 
Tariff Act of 1930, as amended (19 U.S.C. 1483, 1484, 1485).



Sec. 1005.3  Importation of noncomplying goods prohibited.

    The importation of any electronic product for which standards have 
been prescribed under section 358 of the Act (42 U.S.C. 263f) 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 358(h) of the Act (42 U.S.C. 263f(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 Secs. 1005.21 and 1005.22.

[[Page 544]]



                    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 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 the Radiation Control for Health and Safety Act of 1968. 
Billing for reimbursement shall be made by the owner or consignee to the 
Center for Devices and Radiological Health, 5600 Fishers Lane, 
Rockville, MD 20857. 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.
[38 FR 28630, Oct. 15, 1973, as amended at 53 FR 11254, Apr. 6, 1988]



              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.

[[Page 545]]



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 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 home station, as provided by law;
    (c) Service fees: (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 266 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 (sec. 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 266 percent of the hourly rate of regular pay of a grade 
GS-12/4 employee.
    (3) The rate per hour equal to 266 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:

------------------------------------------------------------------------
                                                                  Hours 
------------------------------------------------------------------------
Gross number of working hours in 52 40-hour weeks.............     2,080
Less:                                                                   
  Nine legal public holidays--New Years Day, Washington's               
   Birthday, Memorial Day, Independence Day, Labor Day,                 
   Columbus Day, Veterans Day, Thanksgiving Day, and Christmas          
   Day........................................................        72
  Annual Leave--26 days.......................................       208
  Sick Leave--13 days.........................................       104
                                                               ---------
      Total...................................................       384
                                                               =========
      Net number of working hours.............................     1,696
                                                               =========
Gross number of working hours in 52 40-hour weeks.............     2,080

[[Page 546]]

                                                                        
Working hour equivalent of Government contributions for                 
 employee retirement, life insurance, and health benefits               
 computed at 8\1/2\% of annual rate of pay of employee........       176
                                                               ---------
Equivalent annual working hours...............................     2,256
Support required to equal to 1 man-year.......................     2,256
                                                               ---------
Equivalent gross annual working hours charged to Food and Drug          
 appropriation................................................     4,512
                                                                        
------------------------------------------------------------------------

    Note: Ratio of equivalent gross annual number of working hours 
charged to Food and Drug appropriation to net number of annual working 
hours (4512/1696)=266 pct.

    (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]



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 360(d) of the Radiation Control for Health and 
Safety Act of 1968 (42 U.S.C. 263h(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) The designation shall be addressed to the Center for Devices and 
Radiological Health, 5600 Fishers Lane, Rockville, MD 20857. It shall be 
in writing and dated; all signatures shall be in ink. The designation 
shall 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 shall 
disclose the manufacturer's full legal name and the name(s) under which 
he conducts his business, if applicable, his principal place of 
business, and mailing address. If any of the products of the 
manufacturer do not bear his legal name, the designation shall identify 
the marks, trade names, or other designations of origin which these 
products bear. The designation shall 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 shall 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 360(d) of the Radiation Control for Health and 
Safety Act of 1968 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 360(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]



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.

[[Page 547]]

                  Subpart B--Alternate Test Procedures

1010.13  Special test procedures.

              Subpart C--Exportation of Electronic Products

1010.20  Electronic products intended for export.

    Authority:  21 U.S.C. 351, 352, 360, 360e-360j, 371, 381; 42 U.S.C. 
263b-263n.

    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 358 of the Radiation Control for Health and Safety Act of 1968 
(42 U.S.C. 263f) 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.
[40 FR 32257, July 31, 1975]



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.
[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]



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:

[[Page 548]]

    (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:

          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]



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 the 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. Applications for variances or for 
amendments or extensions thereof shall be submitted in an original and 
two copies to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
    (1) The application for variance shall include the following 
information:
    (i) A description of the product and its intended use.
    (ii) An explanation of how compliance with the applicable standard 
would restrict or be inappropriate for this intended use.
    (iii) A description of the manner in which it is proposed to deviate 
from the requirements of the applicable standard.
    (iv) A description of the advantages to be derived from such 
deviation.
    (v) An explanation of how alternate or suitable means of radiation 
protection will be provided.
    (vi) The period of time it is desired that the variance be in 
effect, and, if appropriate, the number of units the applicant wishes to 
manufacture.
    (vii) In the case of prototype or experimental equipment, the 
proposed location of each unit.
    (viii) Such other information required by regulation or by the 
Director, Center for Devices and Radiological Health, to evaluate and 
act on the application.

[[Page 549]]

    (ix) With respect to each nonclinical laboratory study contained in 
the application, either a statement that the study was conducted in 
compliance with the good laboratory practice regulations 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.
    (x) [Reserved]
    (xi) If the electronic product is used in a clinical investigation 
involving human subjects, is subject to the requirements for 
institutional review set forth in part 56 of this chapter, and is 
subject to the requirements for informed consent set forth in part 50 of 
this chapter, the investigation shall be conducted in compliance with 
such requirements.
    (2) The application for amendment or extension of a 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 Dockets Management Branch, except for information regarded 
as confidential under section 360A(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;
    (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]



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

[[Page 550]]

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 Divices 
and Radiological Health if it desires to be notified of the approval, 
amendment, or withdrawal of the exemption.
    (c) Application for exemption. An original and two copies of any 
application for exemption, or for amendment or extension thereof, shall 
be submitted to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. For 
an exemption pursuant to the criteria prescribed in paragraph (a)(1) of 
this section, the application shall include the information prescribed 
in paragraphs (c)(1) through (13) of this section. For an exemption 
pursuant to the criteria prescribed in paragraph (a)(2) of this section, 
the application shall include the information prescribed in paragraphs 
(c)(3) through (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 Dockets 
Management Branch 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 above, 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.
    (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

[[Page 551]]

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 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

[[Page 552]]

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]



                  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, 360gg-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 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.
    (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.

[[Page 553]]

    (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.



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 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

[[Page 554]]

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.
    (C) Spot-film devices and image intensifiers manufactured after 
April 26, 1977.
    (D) Cephalometric devices manufactured after February 25, 1978.
    (E) Image receptor support devices for mammographic x-ray systems 
manufactured after September 5, 1978.
    (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 Secs. 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);

[[Page 555]]

    (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 Secs. 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.
    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 by 20 centimeters by 3.8 centimeters.
    Automatic exposure control 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.
    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.
    Cantilevered tabletop means a tabletop designed such that the 
unsupported portion can be extended at least 100 centimeters 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] TR01FE93.030


[[Page 556]]


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.
    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.
    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 by 
ionizing radiation to matter of mass dm.
    Equipment means x-ray equipment.
    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.
    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 imaging assembly means a subsystem in which x-ray 
photons produce a fluoroscopic image. It includes the image receptor(s) 
such as the image intensifier and spot-film device, electrical 
interlocks, if any, and structural material providing linkage between 
the image receptor and diagnostic source assembly.
    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 
exposure rate 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, 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 means, for mammographic systems, that part of 
the system designed to support the image receptor in a horizontal plane 
during a mammographic examination.
    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

[[Page 557]]

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 
continuous tube current for 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
[GRAPHIC] [TIFF OMITTED] TC01AP93.002

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.
    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.
    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 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 Sec. 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 Secs. 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.
    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 permanent form of an image resulting 
from x-ray photons (e.g., film, videotape).
    Scan means the complete process of collecting x-ray transmission 
data for the production of a tomogram. Data

[[Page 558]]

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.
    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.
    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 an image intensifier for the purpose of 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 milliamperes-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;
    (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 
exposure rate is

[[Page 559]]

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 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 subsystem means any combination of two or more components of 
an x-ray system for which there are requirements specified in this 
section and Secs. 1020.31 and 1020.32.
    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, image 
intensifier, 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 Secs. 1020.30 through 1020.33 shall certify that each of their 
products meet all applicable requirements when installed 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 of the 
Office of Compliance and Surveillance of the 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 Secs. 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 
Secs. 1020.31, 1020.32, or 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 Secs. 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 Secs. 1020.30 through 1020.33. All assembler 
reports must be on a form prescribed by and available from the Director, 
Center for Devices and Radiological Health, 5600 Fishers Lane, 
Rockville, MD 20857. Completed reports must be submitted to the 
Director, 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 that have been identified as 
such to the Center for Devices and Radiological Health in the report 
required under Sec. 1002.10 of this chapter;

[[Page 560]]

    (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) 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

    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 Secs. 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 pursuant to 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.
    (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 pursuant to 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 Secs. 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

[[Page 561]]

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, 
he shall provide necessary information 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 Secs. 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 Secs. 1020.31, 1020.32, and 1020.33.
    (2) Tube housing assemblies. For each tube housing assembly, there 
shall be provided:
    (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 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

[[Page 562]]

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.
    (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 and operating instructions 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 
2.58 x 10-5 coulombs per kilogram (C/kg) (100 milliroentgens 
(mR)) 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 centimeters with no linear dimension greater than 
20 centimeters.
    (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 5.16 x 10-7 C/kg (2 mR) in 1 
hour at 5 centimeters 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 centimeters with no linear dimension 
greater than 20 centimeters.
    (m) Beam quality--(1) Half-value layer. The half-value layer (HVL) 
of the useful beam for a given x-ray tube potential shall not be less 
than the appropriate value shown in table I under ``Specified dental 
systems,'' for any dental x-ray system designed for use with intraoral 
image receptors and manufactured after December 1, 1980; and under 
``Other x-ray systems,'' for all other x-ray systems subject to this 
section. If it is necessary to determine such HVL at an x-ray tube 
potential which is not listed in table I, linear interpolation or 
extrapolation may be made. Positive means \2\ shall be provided to 
insure that at least the minimum filtration needed to achieve the above 
beam quality requirements is in the useful beam during each exposure.
---------------------------------------------------------------------------


    \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 
interlock with the kilovoltage selector which will prevent x-ray 
emission if the minimum required filtration is not in place.

                                 Table I                                
------------------------------------------------------------------------
        X-ray tube voltage (kilovolt peak)               Minimum HVL    
---------------------------------------------------    (millimeters of  
                                                          aluminum)     
                                          Measured ---------------------
        Designed operating range         operating  Specified   Other X-
                                         potential    dental      ray   
                                                     systems    systems 
------------------------------------------------------------------------
Below 51...............................         30        1.5        0.3
                                                40        1.5        0.4

[[Page 563]]

                                                                        
                                                50        1.5        0.5
51 to 70...............................         51        1.5        1.2
                                                60        1.5        1.3
                                                70        1.5        1.5
Above 70...............................         71        2.1        2.1
                                                80        2.3        2.3
                                                90        2.5        2.5
                                               100        2.7        2.7
                                               110        3.0        3.0
                                               120        3.2        3.2
                                               130        3.5        3.5
                                               140        3.8        3.8
                                               150        4.1        4.1
------------------------------------------------------------------------

    (2) 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 II, 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 a HVL of 2.7 
millimeters of aluminum. 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 II                                
------------------------------------------------------------------------
                                                             Aluminum   
                          Item                              equivalent  
                                                           (millimeters)
------------------------------------------------------------------------
Front panel(s) of cassette holder (total of all)........             1.0
Front panel(s) of film changer (total of all)...........             1.0
Cradle..................................................             2.0
Tabletop, stationary, without articulated joint(s)......             1.0
Tabletop, movable, without articulated joint(s)                         
 (including stationary subtop)..........................             1.5
Tabletop, with radiolucent panel having one articulated                 
 joint..................................................             1.5
Tabletop, with radiolucent panel having two or more                     
 articulated joints.....................................             2.0
Tabletop, cantilevered..................................             2.0
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 sections 358(a)(5) or 
360B(b) of the Public Health Service 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, Sec. 1020.32, or Sec. 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, and provided the modification of the x-ray 
system does not result in a failure to comply with Sec. 1020.31, 
Sec. 1020.32, or Sec. 1020.33.
[58 FR 26396, May 3, 1993, as amended at 59 FR 26403, May 19, 1994]



Sec. 1020.31  Radiographic equipment.

    The provisions of this section apply to equipment for the recording 
of images, except equipment involving use

[[Page 564]]

of an image intensifier or computed tomography x-ray systems 
manufactured on or after November 28, 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. 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:
    (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 milliamperes-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 
(kW's) 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 
radiation exposures 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

[[Page 565]]

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 exposure to the indicated milliampere-
seconds product (C/kg/mAs (or mR/mAs)) obtained at any two consecutive 
tube current settings shall not differ by more than 0.10 times their 
sum. This is: 
|X1-X2|0.10(X1+X2)
; where X1 and X2 are the average C/kg/mAs (or mR/
mAs) values obtained at each of two consecutive tube current settings or 
at two settings differing by no more than a factor of 2 where the tube 
current selection is continuous.
    (2) Equipment having selection of x-ray tube current-exposure time 
product (mAs). For equipment manufactured after May 3, 1994 the average 
ratios of exposure to the indicated milliampere-seconds product (C/kg/
mAs (or mR/mAs)) obtained at any two consecutive mAs selector settings 
shall not differ by more than 0.10 times their sum. This is: 
|X1-X2|0.10(X1+X2)
; where X1 and X2 are the average C/kg/mAs (or mR/
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 may include any two focal spot sizes except 
where one is equal to or less than 0.45 millimeters and the other is 
greater than 0.45 millimeters. 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 
or special attachments for mammography 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 shall be equal to or 
less than 5 centimeters.
    (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 centimeters or at the maximum SID, whichever is 
less. The average illuminance shall be based upon 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 centimeters 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 
millimeters from the edge of the light field toward the center of the 
field; and I2 is the illuminance 3 millimeters from the edge 
of the light field away from the center of the field. Compliance shall 
be determined with a measuring aperture of 1 millimeter.

[[Page 566]]

    (e) Field indication and alignment on stationary general purpose x-
ray equipment. Except when spot-film devices or special attachments for 
mammography 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 SID's 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 SID's and image 
receptor dimensions in common clinical use (such as SID's of 100, 150, 
and 200 centimeters and/or 36, 40, 48, and 72 inches and nominal image 
receptor dimensions of 13, 18, 24, 30, 35, 40, and 43 centimeters 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 be provided with means to limit the x-
ray beam such that:
    (i) If the minimum source-to-skin distance (SSD) is 18 centimeters 
or more, the x-ray field at the minimum SSD shall be containable in a 
circle having a diameter of no more than 7 centimeters; and
    (ii) If the minimum SSD is less than 18 centimeters, the x-ray field 
at the minimum SSD shall be containable in a circle having a diameter of 
no more than 6 centimeters.
    (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 or provided with special attachments for 
mammography. Radiographic systems designed only for mammography and 
general purpose radiographic systems, when special attachments for 
mammography are in service, 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 
which 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. In addition, each image receptor support intended for 
installation on a system designed only 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)

[[Page 567]]

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 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 
centimeters;
    (iii) The x-ray beam axis is within 3 degrees of 
vertical and the SID is 90 centimeters to 130 centimeters inclusive; or 
the x-ray beam axis is within 3 degrees of horizontal and 
the SID is 90 centimeters to 205 centimeters 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 centimeters shall be equal to or 
less than 5 centimeters. 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 SID's and image receptor sizes. A key

[[Page 568]]

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 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 centimeters; 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 
centimeters by 5 centimeters.
    (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 centimeters if operable above 50 kVp; or
    (ii) Ten centimeters 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 centimeters.
    (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

[[Page 569]]

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) 8.6 x 10-9 C/kg (0.03 mR) in 1 minute at 5 
centimeters 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 centimeters, with no linear dimension greater than 
20 centimeters; and
    (2) 2.58 x 10-5 C/kg (100 mR) in 1 hour at 100 
centimeters 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 exposure 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 centimeters with no linear dimension greater 
than 20 centimeters.
    (m) Transmission limit for image receptor supporting devices used 
for mammography. For x-ray systems manufactured after September 5, 1978, 
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 exposure 5 centimeters from any accessible 
surface beyond the plane of the image receptor supporting device does 
not exceed 2.58 x 10-8 C/kg (0.1 mR) for each activation of 
the tube. Exposure shall be measured with the system operated at the 
minimum SID for which it is designed. Compliance shall be determined at 
the maximum rated peak tube potential for the system and at the maximum 
rated product of the tube current and exposure time (mAs) for that peak 
tube potential. Compliance shall be determined by measurements averaged 
over an area of 100 square centimeters with no linear dimension greater 
than 20 centimeters.
[58 FR 26401, May 3, 1993; 58 FR 31067, May 28, 1993]



Sec. 1020.32  Fluoroscopic equipment.

    The provisions of this section apply to equipment for fluoroscopy 
and for the recording of images through an image intensifier 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 exposure rate due to transmission through the barrier 
with the attenuation block in the useful beam combined with radiation 
from the image intensifier if provided, shall not exceed 
3.34 x 10-3 percent of the entrance exposure rate, at a 
distance of 10 centimeters 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, 
pursuant to Sec. 1020.30(h)(1)(i), precautions concerning the importance 
of remote control operation.
    (2) Measuring compliance. The entrance exposure rate shall be 
measured in accordance with paragraph (d) of this section. The exposure 
rate due to transmission through the primary barrier combined with 
radiation from the image intensifier shall be determined by measurements 
averaged over an area of 100 square centimeters with no linear dimension 
greater than 20 centimeters. If the source is below the tabletop, the 
measurement shall be made with the input surface of the

[[Page 570]]

fluoroscopic imaging assembly positioned 30 centimeters 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 centimeters. 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 centimeters from the point of measurement of entrance 
exposure rate and between this point and the input surface of the 
fluoroscopic imaging assembly.
    (b) Field limitation--(1) Nonimage-intensified fluoroscopy. (i) The 
x-ray field produced by nonimage-intensified fluoroscopic equipment 
shall not extend beyond the entire visible area of the image receptor. 
Means shall be provided for stepless adjustment of the field size. The 
minimum field size, at the greatest SID, shall be containable in a 
square of 5 centimeters by 5 centimeters.
    (ii) For 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 paragraph (b)(1)(i) of this section shall be determined with the 
beam axis indicated to be perpendicular to the plane of the image 
receptor.
    (2) Image-intensified fluoroscopy. (i) For image-intensified 
fluoroscopic equipment other than radiation therapy simulation systems, 
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) 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.
    (iii) For equipment manufactured after February 25, 1978, when the 
angle between 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. Compliance with paragraph (b)(2)(i) 
of this section shall be determined with the beam axis indicated to be 
perpendicular to the plane of the image receptor.
    (iv) Means shall be provided to permit further limitation of the 
field. 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 centimeters 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 centimeters 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 centimeters 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 centimeters by 5 centimeters.
    (3) 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 
fluoroscopic images, 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.

[[Page 571]]

    (d) Entrance exposure rates. For fluoroscopic equipment manufactured 
before May 19, 1995, the following requirements apply:
    (1) Equipment with automatic exposure rate control (AERC). 
Fluoroscopic equipment that is provided with AERC shall not be operable 
at any combination of tube potential and current that will result in an 
exposure rate in excess of 2.58x10-3 coulomb per kilogram (C/
kg) per minute (10 roentgens per minute (10 R/min)) at the point where 
the center of the useful beam enters the patient, except:
    (i) During recording of fluoroscopic images, or
    (ii) When an optional high-level control is provided. When so 
provided, the equipment shall not be operable at any combination of tube 
potential and current that will result in an exposure rate in excess of 
1.29x10-3 C/kg per minute (5 R/min) at the point where the 
center of the useful beam enters the patient, 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) Equipment without AERC (manual mode). Fluoroscopic equipment 
that is not provided with AERC shall not be operable at any combination 
of tube potential and current that will result in an exposure rate in 
excess of 1.29x10-3 C/kg per minute (5 R/min) at the point 
where the center of the useful beam enters the patient, except:
    (i) During recording of fluoroscopic images, or
    (ii) When an optional 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.
    (3) Equipment with both an AERC mode and a manual mode. Fluoroscopic 
equipment that is 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 exposure rate in excess of 2.58x10-3 
C/kg per minute (10 R/min) in either mode at the point where the center 
of the useful beam enters the patient except:
    (i) During recording of fluoroscopic images, or
    (ii) When the mode or modes have an optional high-level control, in 
which case that mode or modes shall not be operable at any combination 
of tube potential and current that will result in an exposure rate in 
excess of 1.29x10-3 C/kg per minute (5 R/min) at the point 
where the center of the useful beam enters the patient, 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 is being employed.
    (4) 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 exposure rate shall 
be measured at 1 centimeter above the tabletop or cradle.
    (ii) If the source is above the x-ray table, the exposure rate shall 
be measured at 30 centimeters 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 exposure rate shall be 
measured at 30 centimeters 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 centimeters from the input surface of the imaging assembly.
    (iv) In a lateral type of fluoroscope, the exposure rate shall be 
measured at a point 15 centimeters 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

[[Page 572]]

source, with the end of the beam-limiting device or spacer no closer 
than 15 centimeters to the centerline of the x-ray table.
    (5) Exemptions. Fluoroscopic radiation therapy simulation systems 
are exempt from the requirements set forth in paragraph (d) of this 
section.
    (e) Entrance exposure rate limits. For fluoroscopic equipment 
manufactured on and after May 19, 1995, the following requirements 
apply:
    (1) Fluoroscopic equipment operable at any combination of tube 
potential and current that results in an exposure rate greater than 
1.29x10-3 C/kg per minute (5 R/min) at the point where the 
center of the useful beam enters the patient shall be equipped with 
AERC. Provision for manual selection of technique factors may be 
provided.
    (2) Fluoroscopic equipment shall not be operable at any combination 
of tube potential and current that will result in an exposure rate in 
excess of 2.58x10-3 C/kg per minute (10 R/min) at the point 
where the center of the useful beam enters the patient except:
    (i) During the recording of images from an x-ray image-intensifier 
tube using photographic film or a video camera when the x-ray source is 
operated in a pulsed mode.
    (ii) When an optional high-level control is activated. When the 
high-level control is activated, the equipment shall not be operable at 
any combination of tube potential and current that will result in an 
exposure rate in excess of 5.16x10-3 C/kg per minute (20 R/
min) at the point where the center of the useful beam enters the 
patient. Special means of activation of high-level controls shall be 
required. The high-level control shall only be operable 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 (e) of this 
section shall be determined as follows:
    (i) If the source is below the x-ray table, the exposure rate shall 
be measured at 1 centimeter above the tabletop or cradle.
    (ii) If the source is above the x-ray table, the exposure rate shall 
be measured at 30 centimeters 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 exposure rate shall be 
measured at 30 centimeters 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 centimeters from the input surface of the fluoroscopic imaging 
assembly.
    (iv) In a lateral type of fluoroscope, the exposure rate shall be 
measured at a point 15 centimeters 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 centimeters to the 
centerline of the x-ray table.
    (4) Exemptions. Fluoroscopic radiation therapy simulation systems 
are exempt from the requirements set forth in paragraph (e) of this 
section.
    (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. Means shall be provided to limit the 
source-skin distance to not less than 38 centimeters on stationary 
fluoroscopes and to not less than 30 centimeters on mobile and portable 
fluoroscopes. In addition, for image-intensified 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 centimeters. When provided, the manufacturer must set forth 
precautions with

[[Page 573]]

respect to the optional means of spacing, in addition to other 
information as required in Sec. 1020.30(h).
    (h) Fluoroscopic timer. Means shall be provided to preset the 
cumulative on-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 fluoroscopist shall indicate the completion of any 
preset cumulative on-time. Such signal shall continue to sound while x-
rays are produced until the timing device is reset. 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.
    (i) Mobile and portable fluoroscopes. In addition to the foregoing 
requirements of this section, mobile and portable fluoroscopes shall 
provide intensified imaging.
[58 FR 26404, May 3, 1993, as amended at 59 FR 26404, May 19, 1994]



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:
w=Linear attenuation coefficient of water.
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 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

[[Page 574]]

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.
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 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.

[[Page 575]]

    (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 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.

[[Page 576]]

    (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.
    (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

[[Page 577]]

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 rays with a 
shutter, the radiation emitted may not exceed 100 milliroentgens 
(2.58 x 10-5 coulomb/kilogram) in 1 hour at any point 5 
centimeters outside the external surface of the housing of the scanning 
mechanism when the shutter is closed. Compliance shall be determined by 
measurements averaged over an area of 100 square centimeters with no 
linear dimensions greater than 20 centimeters.
    (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).

(The information collection requirements in paragraphs (c), (d), (g), 
and (j) were approved by the Office of Management and Budget under 
control number 0910-0025)

[49 FR 34712, Aug. 31, 1984; 49 37381, Sept. 24, 1984, as amended at 49 
FR 47388, Dec. 4, 1984; 56 FR 36098, Aug. 1, 1991]



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 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

[[Page 578]]

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.
    (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

[[Page 579]]

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 
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.

[[Page 580]]

    (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 Secs. 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, 371, 381; 42 U.S.C. 
263b-263n.



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

[[Page 581]]

the microwave oven, including doors, 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 582]]

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 
275plus-minus15 milliliters of tap water initially at 
20plus-minus5  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 583]]


    (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), (2), and (3) of this section under 
the adverse condition of use addressed by such precautionary 
statement(s). An original and two copies of applications shall be 
submitted to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. 
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 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]



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 584]]


    Authority:  21 U.S.C. 351, 352, 360, 360e-360j, 371, 381; 42 U.S.C. 
263b-263n.



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). The registration and listing shall 
include the name and address of the manufacturer and shall be submitted 
to the Director, Office of Compliance (HFZ-300), Center for Devices and 
Radiological Health, 5600 Fishers Lane, Rockville, MD 20857.
    (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 585]]

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 
106 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 
1.0X106 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 586]]

    (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 587]]

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 588]]

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[GRAPHIC] [TIFF OMITTED] TR01FE93.032


[[Page 590]]


[GRAPHIC] [TIFF OMITTED] TR01FE93.033


[[Page 591]]


[GRAPHIC] [TIFF OMITTED] TR01FE93.034


[[Page 592]]


[GRAPHIC] [TIFF OMITTED] TR01FE93.035


[[Page 593]]


[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 594]]

    (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 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 595]]

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 596]]

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, Office of Compliance (HFZ-300), 
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 
Secs. 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 597]]

    (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

[[Page 598]]

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''.
[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

[[Page 599]]

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.
    (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

[[Page 600]]

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.
    (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, Office of Compliance (HFZ-
300), 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

[[Page 601]]

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 clsssification of the product, the following warning 
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 Secs. 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]



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

[[Page 602]]

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 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/
cm2).
    (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/(cm2/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.

[[Page 603]]

    (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.
    (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 an 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 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (d) Label requirements. In addition to the labeling requirements in 
part 801 and the certification and identification requirements of 
Secs. 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

[[Page 604]]

sequential exposures and maximum exposure time(s) in minutes.
    (v) A statement of the time it may take before the expected results 
appear.
    (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, Office of Compliance (HFZ-300), 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), alernate 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 Secs. 1010.2(b) and 1010.3(a), the 
manfacturer 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, Office of Compliance (HFZ-300), 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

[[Page 605]]

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.
    (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.

(The information collection requirements contained in paragraphs (d) and 
(e) were approved by the Office of Management and Budget under control 
number 0910-0195)

[50 FR 36550, Sept. 6, 1985]



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

[[Page 606]]

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 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 Secs. 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 
25plus-minus5  deg.C.

[[Page 607]]

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).
    (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]



PART 1050--PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS--Table of Contents




    Authority:  21 U.S.C. 351, 352, 360, 360e-360j, 371, 381; 42 U.S.C. 
263b-263n.



Sec. 1050.10  Ultrasonic therapy products.

    (a) Applicability. The provisions of this section are applicable as 
specified herein to any ultrasonic therapy product for use in physical 
therapy manufactured on or after February 17, 1979.
    (b) Definitions. The following definitions apply to words and 
phrases used in this section:
    (1) Amplitude modulated waveform means a waveform in which the ratio 
of the temporal-maximum pressure amplitude spatially averaged over the 
effective radiating surface to the root-mean-square pressure amplitude 
spatially averaged over the effective radiating surface is greater than 
1.05.
    (2) Applicator means that portion of a fully assembled ultrasonic 
therapy product that is designed to emit ultrasonic radiation and which 
includes one or more ultrasonic transducers and any associated housing.
    (3) Beam cross-section means the surface in any plane consisting of 
the points at which the intensity is greater than 5 percent of the 
spatial-maximum intensity in that plane.
    (4) Beam nonuniformity ratio means the ratio of the temporal-average 
spatial-maximum intensity to the temporal-average effective intensity.
    (5) Centroid of a surface means the point whose coordinates are the 
mean values of the coordinates of the points of the surface.
    (6) Collimating applicator means an applicator that does not meet 
the definition of a focusing applicator as specified in paragraph 
(b)(15) of this section and for which the ratio of the area of at least 
one beam cross-section, whose centroid is 12 centimeters from the 
centroid of the effective radiating surface, to the area of the 
effective radiating surface is less than two.
    (7) Continuous-wave waveform means a waveform in which the ratio of 
the temporal-maximum pressure amplitude spatially averaged over the 
effective radiating surface to the root-mean-square pressure amplitude 
spatially averaged over the effective radiating surface is less than or 
equal to 1.05.
    (8) Diverging applicator means an applicator that does not meet the 
definition of a collimating applicator or a focusing applicator as 
specified in paragraphs (b) (6) and (15) of this section.
    (9) Effective intensity means the ratio of the ultrasonic power to 
the focal area for a focusing applicator. For all other applicators, the 
effective intensity is the ratio of the ultrasonic power to the 
effective radiating area. Effective intensity is expressed in watts per 
square centimeter (W cm-2).
    (10) Effective radiating area means the area consisting of all 
points of the effective radiating surface at which the intensity is 5 
percent or more of the maximum intensity at the effective radiating 
surface, expressed in square centimeters (cm2).
    (11) Effective radiating surface means the surface consisting of all 
points 5 millimeters from the applicator face.
    (12) Focal area means the area of the focal surface, expressed in 
square centimeters (cm2).
    (13) Focal length means the distance between the centroids of the 
effective radiating surface and the focal surface, for a focusing 
applicator, expressed in centimeters (cm).
    (14) Focal surface means the beam cross-section with smallest area 
of a focusing applicator.
    (15) Focusing applicator means an applicator in which the ratio of 
the area of the beam cross-section with the smallest area to the 
effective radiating area is less than one-half.

[[Page 608]]

    (16) Generator means that portion of a fully assembled ultrasonic 
therapy product that supplies electrical energy to the applicator. The 
generator may include, but is not limited to, a power supply, ultrasonic 
frequency oscillator, service controls, operation controls, and a 
cabinet to house these components.
    (17) Maximum beam nonuniformity ratio means the maximum value of the 
beam nonuniformity ratio characteristic of a model of an ultrasonic 
therapy product.
    (18) Operation control means any control used during operation of an 
ultrasonic therapy product that affects the ultrasonic radiation emitted 
by the applicator.
    (19) Pressure amplitude means the instantaneous value of the 
modulating waveform, and is p1(t) in the expression for a 
pressure wave, p(t)=p1(t) p2(t), where p(t) is the 
instantaneous pressure, p1(t) is the modulating envelope, and 
p2(t) is the relative amplitude of the carrier wave 
normalized to a peak height of one. All are periodic functions of time, 
t, at any point in space. The period of p1(t) is greater than 
the period of p2(t).
    (20) Pulse duration means a time interval, expressed in seconds, 
beginning at the first time the pressure amplitude exceeds the minimum 
pressure amplitude plus 10 percent of the difference between the maximum 
and minimum pressure amplitudes, and ending at the last time the 
pressure amplitude returns to this value.
    (21) Pulse repetition rate means the repetition frequency of the 
waveform modulating the ultrasonic carrier wave expressed in pulses per 
second (pps).
    (22) Service control means any control provided for the purpose of 
adjustment that is not used during operation and can affect the 
ultrasonic radiation emitted by the applicator, or can alter the 
calibration or accuracy of an indicator or operation control.
    (23) Ultrasonic frequency means the frequency of the ultrasonic 
radiation carrier wave, expressed in Hertz (Hz), kilohertz (kHz), or 
megahertz (MHz).
    (24) Ultrasonic power means the total power emitted in the form of 
ultrasonic radiation by the applicator averaged over each cycle of the 
ultrasonic radiation carrier wave, expressed in watts.
    (25) Ultrasonic therapy product means:
    (i) Any device intended to generate and emit ultrasonic radiation 
for therapeutic purposes at ultrasonic frequencies above 16 kilohertz 
(kHz); or
    (ii) Any generator or applicator designed or specifically designated 
for use in a device as specified in paragraph (b)(25)(i) of this 
section.
    (26) Ultrasonic transducer means a device used to convert electrical 
energy of ultrasonic frequency into ultrasonic radiation or vice versa.
    (c) Performance requirements. The requirements of this paragraph are 
applicable to each ultrasonic therapy product as defined in paragraph 
(b)(25) of this section when the generator and applicator are designated 
or intended for use together, or to each generator when the 
applicator(s) intended for use with the generator does not contain 
controls that affect the functioning of the generator.
    (1) Ultrasonic power and intensity--(i) Continuous-wave waveform 
operation. A means shall be incorporated to indicate the magnitudes of 
the temporal-average ultrasonic power and the temporal-average effective 
intensity when emission is of continuous-wave waveform. The error in the 
indication of the temporal-average ultrasonic power shall not exceed 
plus-minus20 percent for all emissions greater than 10 
percent of the maximum emission.
    (ii) Amplitude-modulated waveform operation. A means shall be 
incorpor-ated to indicate the magnitudes of the temporal-maximum 
ultrasonic power and the temporal-maximum effective intensity when the 
emission is of amplitude-modulated waveform. The sum of the errors in 
the indications of the temporal-maximum ultrasonic power and the ratio 
of the temporal-maximum effective intensity to the temporal-average 
effective intensity specified in paragraph (d)(3)(ii) of this section 
shall not exceed plus-minus20 percent for all emissions 
greater than 10 percent of the maximum emission.
    (2) Treatment time. A means shall be incorporated to enable the 
duration of emission of ultrasonic radiation for treatment to be preset 
and such means shall terminate emission at the end of

[[Page 609]]

the preset time. Means shall also be incorporated to enable termination 
of emission at any time. Means shall be incorporated to indicate the 
magnitude of the duration of emission (expressed in minutes) to within 
0.5 minute of the preset duration of emission for setting less than 5 
minutes, to within 10 percent of the preset duration of emission for 
settings of from 5 minutes to 10 minutes, and to within 1 minute of the 
preset duration of emission for settings greater than 10 minutes.
    (3) Pulse duration and repetition rate. A means shall be 
incorporated for indicating the magnitudes of pulse duration and pulse 
repetition rate of the emitted ultrasonic radiation, if there are 
operation controls for varying these quantities.
    (4) Ultrasonic frequency. A means shall be incorporated for 
indicating the magnitude of the ultrasonic frequency of the emitted 
ultrasonic radiation, if there is an operation control for varying this 
quantity.
    (5) Visual indicator. A means shall be incorporated to provide a 
clear, distinct, and readily understood visual indicator when and only 
when electrical energy of appropriate ultrasonic frequency is being 
applied to the ultrasonic transducer(s).
    (d) Labeling requirements. In addition to the labeling requirements 
in part 801 and the requirements of Secs. 1010.2 and 1010.3 of this 
chapter, each ultrasonic therapy product shall be subject to the 
applicable labeling requirements of this paragraph.
    (1) Operation controls. Each operation control shall be clearly 
labeled identifying the function controlled and, where appropriate, the 
units of measure of that function. If a separate control and indicator 
are associated with the same function, then labeling the appropriate 
units of measure of that function is required for the indicator but not 
for the control.
    (2) Service controls. Each service control that is accessible 
without displacement or removal of any part of the ultrasonic therapy 
product shall be clearly labeled identifying the function controlled and 
shall include the phrase ``for service adjustment only.''
    (3) Generators. (i) Each generator shall bear a label that states: 
The brand name, model designation, and unique serial number or other 
unique identification so that it is individually identifiable; 
ultrasonic frequency (unless there is an operation control for varying 
this quantity); and type of waveform (continuous wave or amplitude 
modulated).
    (ii) Generators employing amplitude-modulated waveforms shall also 
bear a label that provides the following information: Pulse duration and 
pulse repetition rate (unless there are operation controls for varying 
these quantities), an illustration of the amplitude-modulated waveform, 
and the ratio of the temporal-maximum effective intensity to the 
temporal-average effective intensity. (If this ratio is a function of 
any operation control setting, then the range of the ratio shall be 
specified, and the waveform illustration shall be provided for the 
maximum value of this ratio.)
    (4) Applicators. Each applicator shall bear a label that provides 
the following information:
    (i) The brand name, model designation, and unique serial number or 
other unique identification so the applicator is individually 
identifiable;
    (ii) A designation of the generator(s) for which the applicator is 
intended; and
    (iii) The ultrasonic frequency, effective radiating area, maximum 
beam nonuniformity ratio, type of applicator (focusing, collimating, 
diverging), and for a focusing applicator the focal length and focal 
area.
    (5) Label specification. Labels required by this paragraph shall be 
permanently affixed to or inscribed on the ultrasonic therapy product; 
they shall be legible and clearly visible. If the size, configuration, 
or design of the ultrasonic therapy product would preclude compliance 
with the requirements of this paragraph, the Director, Center for 
Devices and Radiological Health, may approve alternate means of 
providing such labels).
    (e) Tests for determination of compliance--(1) Tests for 
certification. Tests on which certification pursuant to Sec. 1010.2 of 
this chapter is based shall account for all measurement errors and 
uncertainties. Such tests shall also account

[[Page 610]]

for increases in emission and degradation in radiation safety that occur 
with age.
    (2) Test conditions. Except as provided in Sec. 1010.13 of this 
chapter, tests for compliance with each of the applicable requirements 
of this section shall be made:
    (i) For all possible combinations of adjustments of the controls 
listed in the operation instructions.
    (ii) With the ultrasonic radiation emitted into the equivalent of an 
infinite medium of distilled, degassed water at 30  deg.C for 
measurements concerning the ultrasonic radiation.
    (iii) With line voltage variations in the range of 
plus-minus10 percent of the rated value specified by the 
manufacturer.
    (3) Measurement parameters. Measurements for determination of the 
spatial distribution of the ultrasonic radiation field shall be made 
with a detector having dimensions of less than one wavelength in water 
or an equivalent measurement technique.
    (f) Informational requirements--(1) Servicing information. The 
manufacturer of an ultrasonic therapy product shall provide or cause to 
be provided 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 operations, service, and 
calibration, including a description of those controls and procedures 
that could be used to increase radiation emission levels, and a schedule 
of maintenance necessary to keep equipment in compliance with this 
section. The instructions shall include adequate safety precautions that 
may be necessary regarding ultrasonic radiation exposure.
    (2) User information. The manufacturer of an ultrasonic therapy 
product shall provide as an integral part of any user instruction or 
operation manual that is regularly supplied with the product, or, if not 
so supplied, shall cause to be provided with each ultrasonic therapy 
product, and to others upon request, at a cost not to exceed the cost of 
preparation and distribution:
    (i) Adequate instructions concerning assembly, operation, safe use, 
any safety procedures and precautions that may be necessary regarding 
the use of ultrasonic radiation, and a schedule of maintenance necessary 
to keep the equipment in compliance with this section. The operation 
instructions shall include a discussion of all operation controls, and 
shall describe the effect of each control.
    (ii) Adequate description of the spatial distribution of the 
ultrasonic radiation field and the orientation of the field with respect 
to the applicator. This will include a textual discussion with diagrams, 
plots, or photographs representative of the beam pattern. If there is 
more than one ultrasonic transducer in an applicator and their positions 
are not fixed relative of each other, then the description must specify 
the spatial distribution of the ultrasonic radiation field emitted by 
each ultrasonic transducer and present adequate examples of the 
combination field of the ultrasonic tranducers with regard to safe use. 
The description of the ultrasonic radiation field shall state that such 
description applies under conditions specified in paragraph (e)(2)(ii) 
of this section.
    (iii) Adequate description, as appropriate to the product, of the 
uncertainties in magnitude expressed in terms of percentage error, of 
the ultrasonic frequency effective radiating area, and, where 
applicable, the ratio of the temporal-maximum effective intensity to the 
temporal-average effective intensity, pulse duration, pulse repetition 
rate, focal area, and focal length. The errors in indications specified 
in paragraphs (c)(1) and (c)(2) of this section shall be stated in the 
instruction manual.
    (iv) A listing of 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 exposure to ultrasonic 
energy.''
[43 FR 7166, Feb. 17, 1978, as amended at 45 FR 16483, Mar. 14, 1980; 53 
FR 11255, Apr. 6, 1988]

[[Page 611]]



                        SUBCHAPTER K  [RESERVED]





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.

    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.

    Source:  38 FR 32104, Nov. 20, 1973, unless otherwise noted.



                      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.

[[Page 612]]

    (e) Sweetened condensed milk. Sweetened condensed milk conforms to 
the definition and standard of identity for 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 Secs. 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 613]]



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 Secs. 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 Secs. 1210.12, 1230.13, and also by Secs. 1210.11, 1210.14, as 
applicable. The necessary inspections and examinations upon which the 
reports are based

[[Page 614]]

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, 
Secs. 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, 
Secs. 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 1220--REGULATIONS UNDER THE TEA IMPORTATION ACT--Table of Contents




                      Subpart A--General Provisions

Sec.
1220.5  Importation of inferior goods prohibited.

[[Page 615]]

1220.6  Importation without appraisement.
1220.7  Bonding of tea for consumption.
1220.8  Tea packages and contents shall constitute a unit.
1220.9  Duties of supervising tea examiner.

                     Subpart B--Shipment and Storage

1220.10  Teas destined for interior ports.
1220.15  Warehouses for storage of tea.
1220.16  Method of storing in warehouse.
1220.17  Removal of tea from warehouse.

                     Subpart C--Customs Requirements

1220.20  Examination of packages.
1220.21  Tea blended, mixed and repacked for export.
1220.22  Unclaimed teas.

                     Subpart D--Sampling Procedures

1220.30  Taking of samples at ports where tea examiner is stationed.
1220.31  Taking of samples at ports where there is no tea examiner.
1220.32  Result of examination; form of report.
1220.33  Chop list.
1220.34  Surplus samples.
1220.37  Exemption of sample packages from examination.
1220.38  Tea brought in by passengers.

                  Subpart E--Establishment of Standards

1220.40  Tea standards.
1220.41  Effective date of tea standards.
1220.42  To whom standards will be furnished.
1220.43  Disposition of obsolete standards.

                     Subpart F--Individual Standards

1220.50  Macao or Canton congou and brick tea standards.
1220.51  Teas imitating China green teas.
1220.52  Powchong Formosa oolong teas.

        Subpart G--Inspection, Testing, and Grounds for Rejection

1220.60  Instructions to examiners.
1220.61  Testing of teas.
1220.62  Testing quality of infused leaf.
1220.63  Test for paraffin and similar substances.
1220.64  Tests for impurities.
1220.65  Tea dust.
1220.66  Tolerance for fine tea particles.
1220.67  Tea inferior to the standard in any requisite is justly 
          rejected.

        Subpart H--Administrative Procedures Based on Examination

1220.70  Action based on result of examination.
1220.71  Procedure for protest against findings.
1220.72  Procedure by importer for review.
1220.73  Rejected tea.
1220.74  Exportation of rejected tea.
1220.75  Reimportation of exported teas forbidden.
1220.76  Destruction of condemned tea.

    Authority:  21 U.S.C. 41-50; 19 U.S.C. 1311.

    Cross Reference: For U.S. Customs Service regulations governing 
importation of tea, see 19 CFR 12.33.

    Source:  38 FR 32107, Nov. 20, 1973, unless otherwise noted.

    Effective Date Note: At 63 FR 12997, Mar. 17, 1998, part 1220 was 
removed, effective Apr. 17, 1998.



                      Subpart A--General Provisions



Sec. 1220.5  Importation of inferior goods prohibited.

    The importation of any merchandise as tea which is inferior in 
purity, quality, and fitness for consumption to the standards fixed and 
established by the Secretary of Health and Human Services, in accordance 
with section 3 of the Tea Importation Act (29 Stat. 605; 21 U.S.C. 43), 
is prohibited.



Sec. 1220.6  Importation without appraisement.

    Importations of tea may be entered for consumption, for transit to 
foreign countries, or for immediate transportation without appraisement. 
All entries must be on the regular forms, and the regular serial 
numbers, for both bonds and entries should be used.



Sec. 1220.7  Bonding of tea for consumption.

    Tea entered for consumption must be stored as provided in 
Sec. 1220.15, pending examination, and bond must be taken by the 
District Director of Customs, as provided in section 4 of the Tea 
Importation Act (29 Stat. 605; 21 U.S.C. 44), on Customs Form No. 7551 
or 7553. This bond shall be canceled upon the issuance of a permit for 
release, as the consumption entry bond includes provisions for the 
redelivery, the exportation, the destruction, and the holding of the 
merchandise for customs examination.

[[Page 616]]



Sec. 1220.8  Tea packages and contents shall constitute a unit.

    Tea packages and contents shall be treated as a unit, and no 
separation of tea from its covering can be allowed, for either 
exportation or destruction, except under the two following conditions:
    (a) In cases of importations of tea containing an excessive quantity 
of dust and siftings, the tea may be sifted and admitted to entry if 
found up to the standard, and the dust and siftings may also be admitted 
if found up to the standard or, if no standard exists, if found up to 
the respective leaf standard. If not up to the standard, or respective 
leaf standard when no standard exists, the dust and siftings must be 
exported or destroyed under Government supervision.
    (b) If, by reason of damage, a tea otherwise equal in quality to the 
standard has been rejected, the damaged portion may be removed and 
exported or destroyed under custom's supervision, and the sound 
remainder resubmitted for examination and admitted to entry if found up 
to the standard.



Sec. 1220.9  Duties of supervising tea examiner.

    (a) The supervising tea examiner is charged with the immediate 
supervision of all matters relating to the enforcement of the Tea 
Importation Act, and particularly the securing of uniformity in the 
treatment of imported teas at all the points of examination. He is also 
to perform such duties in connection with tea under the Federal Food, 
Drug, and Cosmetic Act as may be assigned to him.
    (b) For the purpose of securing uniformity in the treatment of teas 
each tea examiner will send to the supervising tea examiner one-half 
pound samples of the teas rejected by him, also such other samples of 
teas as the supervising tea examiner may direct. To each sample a label 
(T. I. S. Cat. No. 2) shall be affixed.
    (c) The examiner of tea at each port where a qualified tea examiner 
is stationed shall prepare and forward to the supervising tea examiner 
and to the chairman of the United States Board of Tea Appeals, as soon 
as practicable after the close of each month, a report (T. I. S. Cat. 
No. 3), showing details as to every shipment of tea examined by the tea 
examiner. This information the tea examiner should compile from his 
report of ``Teas Imported and Examined'' (T. I. S. Cat. No. 4) which 
should always be kept up to date.



                     Subpart B--Shipment and Storage



Sec. 1220.10  Teas destined for interior ports.

    Imported teas entered at an exterior port destined for immediate 
transportation to an interior port shall be forwarded without detention.



Sec. 1220.15  Warehouses for storage of tea.

    (a) Warehouses for the storage of tea will be designated by the 
District Director of Customs and the proprietor thereof will be required 
to give a bond in the form prescribed (Customs Form No. 3581). Teas not 
stored in such designated warehouses will be placed in general order 
store or in public store pending examination and release on proper 
permit. In the absence of proper storage facilities at customhouses, 
teas may be retained in locked cars as constructive warehouses, under 
proper supervision, pending examination.
    (b) The importer's premises may be designated as warehouses for the 
storage of tea on the filing of the bond provided for by the regulations 
in this part, but whenever, in the discretion of the District Director 
of Customs, it shall be considered desirable, a storekeeper shall be 
assigned to the supervision of such premises at the importer's expense 
while the teas shall remain under bond therein.



Sec. 1220.16  Method of storing in warehouse.

    (a) When tea under examination is stored in any warehouse it must be 
so placed as to be separate from other merchandise and so as to allow 
convenient supervision by customs officers and officers of the 
Department of Health and Human Services. At ports where there are no 
bonded warehouses, class 2 or 3, the chief customs officer of the port 
will, when necessary, procure suitable premises for the temporary 
storage of any tea reaching his port.

[[Page 617]]

The repacking of tea in warehouse for export purposes is not allowed.
    (b) All expenses of storage, cartage, and labor must be paid by the 
importer.



Sec. 1220.17  Removal of tea from warehouse.

    No tea shall be delivered to the importer or removed from warehouse 
for any purpose before the examination required by the Tea Importation 
Act.



                     Subpart C--Customs Requirements



Sec. 1220.20  Examination of packages.

    Chief officers of customs may order such an examination of packages 
containing tea as will satisfy them that no dutiable goods are packed 
therein. For this purpose the customary designation should be made of 
packages for examination in public store.



Sec. 1220.21  Tea blended, mixed and repacked for export.

    Tea importers desiring to import teas into the United States to be 
blended, mixed, and repacked for export can do so by bonding a warehouse 
under the provisions of section 311 of the Tariff Act of 1930 (46 Stat. 
691; 19 U.S.C. 1311), upon compliance with Secs. 19.13 to 19.15, 
inclusive, of the Customs Regulation of 1943 (19 CFR 19.13-19.15), 
giving bond on Customs Form No. 3583. All teas placed in bonded 
manufacturing warehouses must be exported.

    Cross Reference: For customs regulations governing manufacturing 
warehouses, see 19 CFR 19.13-19.16.



Sec. 1220.22  Unclaimed teas.

    Unclaimed teas should be taken possession of by District Directors 
of Customs the same as other unclaimed goods and placed in ``general 
order'', but not sold at the expiration of the year unless declared fit 
for consumption by a designated tea examiner.

    Cross Reference: For U.S. Customs Service regulations governing 
disposition of merchandise unclaimed or in warehouse beyond the time 
fixed by law, see 19 CFR part 127.



                     Subpart D--Sampling Procedures



Sec. 1220.30  Taking of samples at ports where tea examiner is stationed.

    The examination of teas at ports where a duly qualified tea examiner 
is stationed shall be made by means of samples drawn by the sampler from 
packages designated by the tea examiner. The importer, when his teas are 
ready for sampling, shall submit in duplicate to the tea examiner a chop 
list and release permit (T.I.S. Cat. No. 1) of the several lines 
included in the invoice, and the tea examiner shall select for 
examination packages representing the different lines.



Sec. 1220.31  Taking of samples at ports where there is no tea examiner.

    (a) In case an entry of imported tea shall be made at a port or 
subport where no tea examiner is stationed the importer should prepare 
the chop list and release permit (T. I. S. Cat. No. 1) in triplicate and 
forward them to the chief officer of the customs at the port of entry.
    (b) Samples shall be obtained by such officers, together with the 
original and one copy of the chop list and release permit (T. I. S. Cat. 
No. 1), and shall be forwarded to the nearest qualified tea examiner for 
his report and return. Samples sent for the purpose of examination from 
ports of importation to ports where tea examiners are located shall be 
packed in clean tin cans, free from odor, fitted with tight covers, and 
of a capacity to hold about 4 ounces avoirdupois of tea. Each can shall 
be properly labeled (T. I. S. Cat. No. 5).



Sec. 1220.32  Result of examination; form of report.

    (a) The examination and report upon such samples shall be made in 
accordance with the provisions of section 7 of the Tea Importation Act 
(29 Stat. 606; 21 U.S.C. 46), and the result of this examination shall 
be noted on the invoice by the tea examiner before he returns the 
invoice to the collector of customs. The tea examiner at the same time 
should make his returns on the original copy of the chop list and 
release permit (T. I. S. Cat. No. 1), which, after being duly signed by 
him, should be

[[Page 618]]

forwarded by him to the importer or consignee.
    (b) In case the tea coverings are dutiable and appraised at a value 
or rate higher than the entered value or rate, the tea examiner shall 
follow the same procedure as above, except that the chop list and 
release permit shall be returned to the District Director of Customs for 
such action as he sees fit to take.
    (c) In case a partial release is desired the importer shall furnish 
an additional chop list and release permit (T. I. S. Cat. No. 1) of the 
goods that he desires, the original chop list and release permit being 
retained by the tea examiner until action on all the teas in the entry 
has been taken.



Sec. 1220.33  Chop list.

    (a) In all cases the importer shall indicate on the chop list and 
release permit where the goods are to be sampled, whether on the dock or 
in warehouse. If the consular invoice has not been received the importer 
may prepare an additional copy of the chop list and release permit as a 
pro forma invoice, marking across the face thereof ``Pro Forma 
Invoice.''
    (b) Importers may print their chop list and release permit forms, 
provided they conform strictly with the official form (T.I.S. Cat. No. 
1). Otherwise, they can be obtained free from the United States tea 
examiner at ports where tea examiners are stationed, or from the chief 
officer of customs at ports, or subports, where no tea examiners are 
stationed.



Sec. 1220.34  Surplus samples.

    (a) Surplus samples drawn from importations for purposes of 
examination, and which represent pure tea as declared by the examiner, 
shall be returned to the importer after examination is completed, if so 
requested by the importer, but if no request is made for the return of 
samples they shall be disposed of as provided in Sec. 1220.43 for unused 
standard samples.
    (b) Surplus samples representing tea which has been finally rejected 
should be destroyed, or, after being denatured, should be sold for 
manufacturing purposes under the Tea Importation Act (35 Stat. 163; 21 
U.S.C. 41).



Sec. 1220.37  Exemption of sample packages from examination.

    Where tea is put up in packages of not over 2 pounds in weight, 
imported by mail, express, or otherwise from the country of production, 
and the fact is established that the packages are samples for 
distribution, or for use in soliciting orders and not for sale, no 
examination should be made under the Tea Importation Act (29 Stat. 604; 
21 U.S.C. 41-50), and they may be delivered at once to the importer.



Sec. 1220.38  Tea brought in by passengers.

    Packages of tea not exceeding 5 pounds in weight brought by 
passengers may be delivered without examination under the Tea 
Importation Act (29 Stat. 604; 21 U.S.C. 41-50).



                  Subpart E--Establishment of Standards



Sec.  1220.40  Tea standards.

    (a) Samples for standards of the following teas, prepared, 
identified, and submitted by the Board of Tea Experts on February 28, 
1995, are hereby fixed and established as the standards of purity, 
quality, and fitness for consumption under the Tea Importation Act for 
the year beginning May 1, 1995, and ending April 30, 1996:
    (1) Black Tea (for all teas except those from the People's Republic 
of China (China), Taiwan (Formosa), Iran, Japan, Russia, Turkey, and 
Argentina).
    (2) Black Tea (for Argentina teas).
    (3) Black Tea (for teas from the People's Republic of China (China), 
Taiwan (Formosa), Iran, Japan, Russia, and Turkey).
    (4) Green Tea (of all origins).
    (5) Formosa Oolong.
    (6) Canton Oolong (for all Canton types from the People's Republic 
of China (China) and Taiwan (Formosa)).
    (7) Scented Black Tea.
    (8) Spiced Tea.

These standards apply to tea shipped from abroad on or after May 1, 
1995.

[[Page 619]]

    (b) The Board of Tea Experts shall prepare duplicate samples of the 
standards for teas.
[38 FR 32107, Nov. 20, 1973, as amended at 55 FR 34797, Aug. 24, 1990; 
60 FR 29987, June 7, 1995]



Sec. 1220.41  Effective date of tea standards.

    The standards prepared and submitted to the Secretary of Health and 
Human Services by the Board of Tea Experts, appointed by him on or 
before February 15 of each year, shall be fixed and established as 
standards under the act and shall be in effect from the 1st day of May 
of each year until April 30, inclusive, of the following year, except 
that tea shipped from abroad prior to May 1 of any year shall be 
governed by the standards in effect at the time of shipment. Such 
standards for each year will be published in the Federal Register.



Sec. 1220.42  To whom standards will be furnished.

    (a) A quantity of tea of the approved standards will be repacked in 
half-pound tin containers by competent tea packers under the constant 
supervision of an officer of the Food and Drug Administration and full 
sets will be furnished the Board of Tea Appeals, the supervising tea 
examiner, and the examiners of tea at all the tea examining stations.
    (b) Standards will be furnished to actual importers and regular tea 
brokers on application to the supervising tea examiner, at the actual 
cost of the same.



Sec. 1220.43  Disposition of obsolete standards.

    After standard samples have served their purpose and new season 
samples have been submitted, the old samples may be included in 
quarterly sales of unclaimed goods, and the proceeds paid into the 
Treasury, after deducting expenses of advertisement and sale, the 
designation on the packages showing such teas to have been used as 
Government standards to be obliterated before delivery to purchaser.



                     Subpart F--Individual Standards



Sec. 1220.50  Macao or Canton congou and brick tea standards.

    Macao or Canton congou and brick tea should be compared with the 
standard for China congou. The mustiness or damaged flavor exhibited in 
certain Canton teas would be just cause for rejection.



Sec. 1220.51  Teas imitating China green teas.

    Whenever Japans, Ceylons, Indias, or any other teas are made up to 
imitate the green teas of China, they are to be examined in comparison 
with the China green standards.



Sec. 1220.52  Powchong Formosa oolong teas.

    All Powchong (scented) Formosa oolong teas should be examined in 
comparison with the Formosa standard.



        Subpart G--Inspection, Testing, and Grounds for Rejection



Sec. 1220.60  Instructions to examiners.

    (a) Examiners are instructed not to pass upon samples representing 
importations of tea imported separately from the importation; neither 
shall they give nonofficial opinions concerning samples.
    (b) The examination of tea in comparison with the standards under 
this act shall be made according to the usages and customs of the tea 
trade, including the testing of an infusion in boiling water and, if 
necessary, chemical analysis; and examiners are advised, inasmuch as 
they must not under the law admit any tea inferior to the standards in 
purity, quality, and fitness for consumption, to employ the present 
methods of determining the presence of artificial coloring and other 
impurities. (See Sec. 1220.64.)



Sec. 1220.61  Testing of teas.

    (a) In comparing with standards, examiners are to test all the teas 
for quality, for impurity consisting of artificial coloring or facing 
matter, and other impurity, and for quality of infused leaf. Quality 
shall be ascertained by drawing, according to the custom of

[[Page 620]]

the tea trade, with the weight of a silver half dime to the cup. The 
quality must be equal to standard, but the flavor may be that of a 
different district, as long as it is equally fit for consumption. As an 
illustration, a Teenkai may be equal to a Moyune, but a distinctly smoky 
or rank Fychow or Wenchow of sour character is not considered equal to 
the first two mentioned.
    (b) Tea dust, fannings, siftings, and offgrades, including broken 
tea (BT), broken mix (BM), and Bohea when so marked and for which there 
is no specific standard, should be tested for quality, purity, and 
fitness for consumption in comparison with their respective leaf 
standards.



Sec. 1220.62  Testing quality of infused leaf.

    In order to test the quality of the infused leaf in comparison with 
the standard, a second drawing should be made of double weight. Before 
pouring off the water, examine for an excess of ``floaters'' (woody 
stems which remain floating after the leaf is thoroughly infused) to 
determine whether they are in sufficient quantity to reduce the quality 
of the infusion below that of the standard. After pouring off the water 
the infused leaf should be taken out so as to exhibit the lower side 
which rested against the cup. Should the mass show a larger quantity of 
exhausted or decayed leaf than the standard, it affords sufficient 
evidence to be judged inferior in quality and consequently to be 
rejected.



Sec. 1220.63  Test for paraffin and similar substances.

    If the examiner suspects the presence of paraffin or any similar 
substance, he should make the following test in comparison with the 
standard: Spread the tea between two sheets of unglazed white paper. 
Place thereon a hot iron. The greasy substance, if any, will appear on 
the paper, and if not equal to the standard the tea would justly be 
rejected.



Sec. 1220.64  Tests for impurities.

    (a) To examine for impurities the following tests may be used in 
comparison with the standard:
    (1) Read test, with additions and modifications, and the cup test, 
doubleweight. Place 2 ounces of tea in a sieve 5 or 6 inches in 
diameter, having 60 meshes to the inch and provided with a top. Sift a 
small quantity of the dust onto a semiglazed white paper about 8 by 10 
inches. The amount of dust placed on the paper should be approximately 1 
grain. To get the requisite amount of dust it is sometimes necessary to 
rub the leaf gently against the bottom of the sieve, but this must not 
be done until the sieve has been well shaken over the test paper. Pour 
the dust thus collected from the paper into the scales, weigh out 1 
grain, and return this quantity to the same paper, distributing it well 
over the surface of the paper. Then place the paper on a plain, firm 
surface, preferably glass or marble, and crush the dust by pushing over 
it, with considerable pressure, a flat steel spatula about 5 inches 
long. Do this repeatedly until the tea dust is ground almost to a powder 
and the particles of coloring matter or other impurities, if any, are 
spread or streaked on the paper, so as to become more apparent. Brush 
off the loose dust and examine the paper by means of a simple lens 
magnifying 7\1/2\ diameters. In distinguishing these particles and 
streaks bright light is essential.
    (2) The crushed leaf in either black or green tea appears in such 
quantity that there is no chance of mistaking the leaf for artificial 
coloring, facing material, or other impurities.
    (3) The test is performed in comparison with the standard, and, if 
the tea is clearly equal to the standard with respect to artificial 
coloring, facing matter, or other impurities, the operation need not be 
repeated. If particles of artificial coloring, facing, or other 
impurities are found in the sample under comparison with the standard 
repeat this operation a sufficient number of times to be sure whether or 
not the tea contains impurities in excess of the standard.
    (4) Repeat the operation, using semiglazed black paper instead of 
the white paper. This black-paper test shows the presence of facing and 
other impurities, such as talc, gypsum, barium sulfate, clay, and 
kaolin.

[[Page 621]]

    (5) If the tea under examination is found, by the foregoing tests, 
to contain more impurities than the standard, draw samples from packages 
representing at least 5 percent of the line in question, and subject 
each sample to the tests to ascertain whether or not the majority 
contain impurities in excess of the standard.
    (6) The foregoing tests may be applied to tea of all varieties.
    (b) Should the examination of the sample by the cup test, double-
weight, for scum, sediment, etc., or the Read test, or both, disclose 
the presence of more impurities than the standard, a pound sample should 
be sent to the nearest district of the Food and Drug Administration and 
an analysis made in comparison with the standard to determine whether it 
contains more impurities than the standard. If the tea in question is 
found to contain more impurities than the standard, it would properly be 
rejected as not being equal to the standard in purity.
    (c) All extraneous substances are impurities, and the presence of 
any may be detected in any way found efficient.



Sec. 1220.65  Tea dust.

    Tea dust or broken leaf mixed with other teas or separate, made to 
imitate gunpowder or other teas, with the use of paste or gum, or any 
other substance, would justly be rejected.



Sec. 1220.66  Tolerance for fine tea particles.

    Except for teas listed under Sec. 1220.61(b), the amount by weight 
of fine tea particles that will pass through a wire sieve having 30 
openings per linear inch in either direction and made of wire with a 
diameter of 0.01 inch, must not exceed 4 percent. Before condemning any 
tea for fine particles in excess of 4 percent, examiners shall sieve at 
least 4 representative samples, each taken from a different package in a 
shipment containing four or more packages, or where a lesser number of 
packages is involved, examiners shall sieve a representative sample from 
each package.



Sec. 1220.67  Tea inferior to the standard in any requisite is justly rejected.

    Should a tea prove on examination to be inferior to the standard in 
any one of the requisites--namely, quality, quality of infused leaf, or 
purity--it would justly be rejected, notwithstanding the fact that it 
may be superior to the standards in some of the qualifications. No 
consideration shall be given to the appearance or so-called style of the 
dry leaf.



        Subpart H--Administrative Procedures Based on Examination



Sec. 1220.70  Action based on result of examination.

    (a) If, after examination, the tea is found not be prohibited under 
the act, a release permit shall at once be granted to the importer, 
declaring that the tea is not within the prohibition of the Tea 
Importation Act; but if, on examination, such tea, or merchandise 
described as tea, is found in the opinion of the examiner, to come 
within the prohibitions of the law and of the regulations in this part, 
the importer shall be immediately notified (T.I.S. Cat. No. 6), and the 
tea, or merchandise described as tea, so returned, shall not be released 
by the customhouse authorities, unless on a re-examination called for by 
the importer the return of the examiner shall be found erroneous. Should 
a portion only of the invoice be passed by the examiner as correct, a 
permit of delivery shall be granted for that portion and the remainder 
held as provided in section 6 of the act (29 Stat. 606; 21 U.S.C. 47).
    (b) In all cases of rejections by examiners, the importers should be 
notified of the reason for rejection; that is, whether it be on the 
ground of quality, character of infused leaf, dust, or admixture with 
foreign substance.



Sec. 1220.71  Procedure for protest against findings.

    In case the collector of customs, importer, or consignee shall 
protest against the finding of the examiner, the matter in dispute shall 
be referred for decision to the United States Board

[[Page 622]]

of Tea Appeals, designated by the Secretary of Health and Human 
Services, and if such board shall, after due examination, find the tea 
in question to be equal in purity, quality, and fitness for consumption, 
as compared with the proper standards, a permit shall be issued by the 
District Director of Customs for its release and delivery to the 
importer; but if, upon such final re-examination by such board, the tea 
shall be found to be inferior in purity, quality, and fitness for 
consumption, as compared with the said standards, the importer or 
consignee shall give a bond, unless he has previously done so, with 
security satisfactory to the District Director of Customs, to export 
said tea out of the limits of the United States within a period of 6 
months after such final re-examination; and if the same shall not have 
been exported within the time specified, the District Director of 
Customs, at the expiration of that time, shall cause the same to be 
destroyed.



Sec. 1220.72  Procedure by importer for review.

    (a) If the importer desires teas rejected by the examiner to be 
reviewed by the United States Board of Tea Appeals, as provided in 
section 6 of the said act, he shall, within 30 days after he has been 
notified of such return, file a written application with the collector 
in the form T.I.S. Cat. No. 20. The District Director of Customs will 
thereupon forward such application to the United States Board of Tea 
Appeals, designated by the Secretary of Health and Human Services for 
review of the matter in dispute, and the proceedings shall be according 
to section 8 of the act.
    (b) The re-examination of the tea samples must be restricted to the 
samples put up and sealed by the examiner at ports where qualified tea 
examiners are stationed, or by the chief officer of the customs, if 
there is no qualified tea examiner so stationed, in the presence of the 
importer or consignee, if he so desires. In either case the samples 
should be transmitted to the United States Board of Tea Appeals by the 
tea examiner, together with a copy of the finding of the examiner, 
setting forth the cause of condemnation.
    (c) These samples for re-examination should weigh at least 1 pound, 
and should be put up in tins securely labeled (T.I.S. Cat. No. 21) and 
well wiped and seasoned. Half of such samples shall be utilized for the 
examination by the Board of Tea Appeals and for return to the port of 
entry with the decision, as heretofore, and the remaining half pound, if 
the tea be rejected by said board, shall be distributed among the 
various examiners for their information and guidance.
    (d) Teas rejected by team examiners and rejections affirmed by the 
United States Board of Tea Appeals cannot be re-examined.



Sec. 1220.73  Rejected tea.

    Rejected tea can only be released or withdrawn for exportation, for 
transportation and exportation, or for manufacturing purposes under the 
Tea Importation Act (35 Stat. 163; 21 U.S.C. 41), as the case may be.



Sec. 1220.74  Exportation of rejected teas.

    (a) Teas to be exported for the reason that they are within the 
prohibition of the statute will be entered for exportation on Customs 
Form No. 7515, and bond on Customs Form No. 7557 shall be given for 
their exportation in a penal sum equal to double the value of the tea, 
provided consumption entry bond (Form No. 7551 or Form No. 7553) was not 
previously given.
    (b) Whenever a bond is given to export any condemned tea in 
pursuance of the act, it will be canceled upon the filing of an outward 
bill of lading and a duly authenticated certificate of clearance from 
the customs officer supervising the lading thereof, as in the case of 
rejected foods and drugs (T.D. 28841), and all accrued charges must be 
paid before issuance of permit for exportation.
    (c) At interior ports the export entry shall be made for 
transportation and immediate exportation in bond.



Sec. 1220.75  Reimportation of exported teas forbidden.

    (a) No imported teas which have been rejected by an examiner, or by 
the United States Board of Tea Appeals, and exported under the 
provisions of this act, shall be reimported into the

[[Page 623]]

United States under the penalty of forfeiture for a violation of this 
prohibition.
    (b) Customs officers will make seizure of any tea so imported.



Sec. 1220.76  Destruction of condemned tea.

    Whenever condemned tea is to be destroyed it must be conveyed to 
some suitable place, and proper means, to be prescribed by the examiner, 
must be used for its effectual destruction, which shall be effected in 
the presence of an officer of customs, detailed by the District Director 
of Customs for the purpose. Before the tea is destroyed a particular 
description or statement of the same must be prepared containing the 
name of the importer or owner, the date of importation, the name of the 
vessel, and the place from which imported, with the character and 
quantity of the tea and the invoice value. The fact of its destruction 
must be certified on said statement by the officer detailed as 
aforesaid, which statement must be filed in the customhouse.



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.

                           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

[[Page 624]]

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:
[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

[[Page 625]]

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) (Secs. 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:

    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 (Secs. 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 Secs. 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

[[Page 626]]

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 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

[[Page 627]]

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, 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

[[Page 628]]

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 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.

[[Page 629]]

    (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 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.

              Subpart C--Restrictions on Travel of Persons

1240.40  All communicable diseases.
1240.45  Report of disease.
1240.50  Certain communicable diseases; special requirements.
1240.54  Apprehension and detention of persons with specific diseases.
1240.55  Responsibility with respect to minors, wards, and patients.
1240.57  Members of military and naval forces.

   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.
1240.70  Lather brushes.
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

[[Page 630]]

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.
    (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.

[[Page 631]]

    (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:
    (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

[[Page 632]]

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]



              Subpart C--Restrictions on Travel of Persons



Sec. 1240.40  All communicable diseases.

    A person who has a communicable disease in the communicable period 
shall not travel from one State or possession to another without a 
permit from the health officer of the State, possession, or locality of 
destination, if such permit is required under the law applicable to the 
place of destination. Stop-overs other than those necessary for 
transportation connections shall be considered as places of destination.



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.



Sec. 1240.50  Certain communicable diseases; special requirements.

    The following provisions are applicable with respect to any person 
who is in the communicable period of cholera, plague, smallpox, typhus 
or yellow fever, or who, having been exposed to any such disease, is in 
the incubation period thereof:
    (a) Requirements relating to travelers. (1) No such person shall 
travel from one State or possession to another, or on a conveyance 
engaged in interstate traffic, without a written permit of the Surgeon 
General or his authorized representative.
    (2) Application for a permit may be made directly to the Surgeon 
General or to his representative authorized to issue permits.
    (3) Upon receipt of an application, the Surgeon General or his 
authorized representative shall, taking into consideration the risk of 
introduction, transmission, or spread of the disease from one State or 
possession to another, reject it, or issue a permit which may be 
conditioned upon compliance with such precautionary measures as he shall 
prescribe.
    (4) A person to whom a permit has been issued shall retain it in his 
possession throughout the course of his authorized travel and comply 
with all conditions prescribed therein, including presentation of the 
permit to the operators of conveyances as required by its terms.
    (b) Requirements relating to operation of conveyances. (1) The 
operator of any conveyance engaged in interstate traffic shall not 
knowingly (i) accept for transportation any person who fails to present 
a permit as required by paragraph (a) of this section, or (ii) transport 
any person in violation of conditions prescribed in his permit.
    (2) Whenever a person subject to the provisions of this section is 
transported on a conveyance engaged in interstate traffic, the operator 
thereof shall take such measures to prevent the spread of the disease, 
including submission of the conveyance to inspection, disinfection and 
the like, as an officer of the Public Health Service designated by the 
Surgeon General for such purposes deems reasonably necessary and 
directs.



Sec. 1240.54  Apprehension and detention of persons with specific diseases.

    Regulations prescribed in parts 1240 and 1250 are not applicable to 
the apprehension, detention, or conditional release of individuals 
except for the purpose of preventing the introduction, transmission, or 
spread of the following diseases: Anthrax, chancroid, cholera, dengue, 
diphtheria, granuloma inguinale, infectious encephalitis, favus, 
gonorrhea, leprosy, lymphogranuloma venereum, meningococcus meningitis, 
plague, poliomyelitis, psittacosis, relapsing fever, ringworm of the 
scalp, scarlet fever, streptococcic sore throat, smallpox, syphilis, 
trachoma, tuberculosis, typhoid fever, typhus, and yellow fever.

[[Page 633]]



Sec. 1240.55  Responsibility with respect to minors, wards, and patients.

    A parent, guardian, physican, nurse, or other such person shall not 
transport, or procure or furnish transportation for any minor child or 
ward, patient or other such person who is in the communicable period of 
a communicable disease, except in accordance with provisions of this 
subpart.



Sec. 1240.57  Members of military and naval forces.

    The provisions of Secs. 1240.40, 1240.45, 1240.50, 1240.55 and 
1240.57 shall not apply to members of the military or naval forces, and 
medical care or hospital beneficiaries of the Army, Navy, Veterans' 
Administration, or Public Health Service, when traveling under competent 
orders: Provided, That in the case of persons otherwise subject to the 
provisions of Sec. 1240.50 the authority authorizing the travel requires 
precautions to prevent the possible transmission of infection to others 
during the travel period.



   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, 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.                   

[[Page 634]]

                                                                        
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) Destruction of turtles or turtle eggs; criminal penalties. (1) 
Any viable turtle eggs or live turtles with a carapace length of less 
than 4 inches which are held for sale or offered for any other type of 
commercial or public distribution shall be subject to destruction in a 
humane manner by or under the supervision of an officer or employee of 
the Food and Drug Administration in accordance with the following 
procedures:
    (i) Any District Office of the Food and Drug Administration, upon 
detecting viable turtle eggs or live turtles with a carapace length of 
less than 4 inches which are held for sale or offered for any other type 
of commercial or public distribution, shall serve upon the person in 
whose possession such turtles or turtle eggs are found a written demand 
that such turtles or turtle eggs be destroyed in a humane manner under 
the supervision of said District Office, within 10 working days from the 
date of promulgation of the demand. The demand shall recite with 
particularity the facts which justify the demand. After service of the 
demand, the person in possession of the turtles or turtle eggs shall not 
sell, distribute, or otherwise dispose of any of the turtles or turtle 
eggs except to destroy them under the supervision of the District 
Office, unless and until the Director of the Center for Food Safety and 
Applied Nutrition withdraws the demand for destruction after an appeal 
pursuant to paragraph (c)(1)(ii) of this section.
    (ii) The person on whom the demand for destruction is served may 
either comply with the demand or, within 10 working days from the date 
of its promulgation, appeal the demand for destruction to the Director 
of the Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204. The demand for 
destruction may also be appealed within the same period of 10 working 
days by any other person having a pecuniary interest in such turtles or 
turtle eggs. In the event of such an appeal, the Center Director shall 
provide an opportunity for hearing by written notice to the appellant(s) 
specifying a time and place for the hearing, to be held within 14 days 
from the date of the notice but not within less than 7 days unless by 
agreement with the appellant(s).
    (iii) Appearance by any appellant at the hearing may be by mail or 
in person, with or without counsel. The hearing shall be conducted by 
the Center Director or his designee, and a written summary of the 
proceedings shall be prepared by the person presiding. Any appellant 
shall have the right to hear and to question the evidence on which the 
demand for destruction is based, including the right to cross-examine 
witnesses, and he may present oral or written evidence in response to 
the demand.
    (iv) If, based on the evidence presented at the hearing, the Center 
Director finds that the turtles or turtle

[[Page 635]]

eggs were held for sale or offered for any other type of commercial or 
public distribution in violation of this section, he shall affirm the 
demand that they be destroyed under the supervision of an officer or 
employee of the Food and Drug Administration; otherwise, the Center 
Director shall issue a written notice that the prior demand by the 
District Office is withdrawn. If the Center Director affirms the demand 
for destruction he shall order that the destruction be accomplished in a 
humane manner within 10 working days from the date of the promulgation 
of his decision. The Center Director's decision shall be accompanied by 
a statement of the reasons for the decision. The decision of the Center 
Director shall constitute final agency action, reviewable in the courts.
    (v) If there is no appeal to the Director of the Center for Food 
Safety and Applied Nutrition from the demand by the Food and Drug 
Administration District Office and the person in possession of the 
turtles or turtle eggs fails to destroy them within 10 working days, or 
if the demand is affirmed by the Director of the Center for Food Safety 
and Applied Nutrition after an appeal and the person in possession of 
the turtles or turtle eggs fails to destroy them within 10 working days, 
the District Office shall designate an officer or employee to destroy 
the turtles or turtle eggs. It shall be unlawful to prevent or to 
attempt to prevent such destruction of turtles or turtle eggs by the 
officer or employee designated by the District Office. Such destruction 
will be stayed if so ordered by a court pursuant to an action for review 
in the courts as provided in paragraph (c)(1)(iv) of this section.
    (2) Any person who violates any provision of this section, including 
but not limited to any person who sells, offers for sale, or offers for 
any other type of commercial or public distribution viable turtle eggs 
or live turtles with a carapace length of less than 4 inches, or who 
refuses to comply with a valid final demand for destruction of turtles 
or turtle eggs (either an unappealed demand by an FDA District Office or 
a demand which has been affirmed by the Director of the Center for Food 
Safety and Applied Nutrition pursuant to appeal), or who fails to comply 
with the requirement in such a demand that the manner of destruction be 
humane, shall be subject to a fine of not more than $1,000 or 
imprisonment for not more than 1 year, or both, for each violation, in 
accordance with section 368 of the Public Health Service Act (42 U.S.C. 
271).
    (d) 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.''
    (4) Marine turtles excluded from this regulation under the 
provisions of paragraph (a) of this section and eggs of such turtles.
    (e) 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 
Dockets Management Branch, Food and Drug Administration, rm. 1-23, 12420 
Parklawn Dr., Rockville, MD 20857.
[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]



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.

[[Page 636]]

    (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. 1240.70  Lather brushes.

    (a) General requirements. A person shall not transport, or offer for 
transportation by the owner or operator of a conveyance, nor shall the 
owner or operator of a conveyance knowingly transport for another 
person, in interstate traffic lather brushes made from animal hair or 
bristles unless such brushes have been manufactured in the United 
States, its territories, or possessions in compliance with the 
provisions of paragraphs (b), (c), (d), (e), and (f) of this section.
    (b) Treatment. The hair or bristles used in such brushes, if other 
than badger hair, shall be subjected to sterilization or to a treatment 
found by the Surgeon General, upon application of an interested person 
and the submission by such person of supporting data, to be effective to 
destroy anthrax spores in the hair or bristles to be treated. Badger 
hair shall be subject to the requirement of sterilization or other 
treatment only if the Surgeon General finds, and so notifies the 
manufacturer, that the hair was secured from areas, or has been stored 
or handled under circumstances, likely to render it an agent in the 
spread of communicable diseases from one State or possession to another.
    (c) Sterilization. Sterilization shall consist of:
    (1) Exposure to steam under pressure in an autoclave at a minimum 
temperature of 120  deg.C (248  deg.F) for 15 minutes for bristles and 
20 minutes for hair; or
    (2) Exposure to streaming steam in an autoclave (not under pressure) 
at 100  deg.C (212  deg.F) for 30 minutes for bristles and 40 minutes 
for hair.

In either case, the steam temperature shall be measured in the exhaust 
line at its exit from the autoclave by an indicating thermometer found 
by the Surgeon General to give reasonable assurance of accuracy, and by 
a recording thermometer adjusted to read no higher at any time than the 
indicating thermometer. The time of exposure shall be measured from the 
moment at which the indicating thermometer reaches the specified 
sterilization temperature. Recording thermometer charts for each 
sterilization shall be kept readily available. The hair or bristles 
shall be sterilized in tied or wrapped bundles not exceeding 2\1/2\ 
inches in diameter and 5 inches in length, or in untied and unwrapped 
lots not exceeding 2\1/2\ inches in depth. The bundle or lots shall be 
placed on racks or trays in single layers, with the racks or trays 
separated from each other sufficiently to assure free circulation of the 
steam and the exposure of all the hair or bristles to such steam. If the 
hair or bristles are placed in the autoclave in wrapped bundles, the 
ends of the bundles shall be left open.
    (d) Handling and storage. Hair or bristles which have been treated, 
by sterilization or otherwise, shall be marked with the date of 
treatment, the method used, and name and location of the establishment 
at which treatment occurred, and shall be so handled and stored as to 
prevent their contamination or recontamination with anthrax spores.
    (e) Identifying marks. Lather brushes shall be marked permanently 
with the name of the manufacturer or with an identifying mark of the 
manufacturer registered with the Surgeon General.

[[Page 637]]

    (f) Inspection. Persons engaged in processing or other handling of 
hair or bristles for use in lather brushes manufactured for 
transportation in interstate traffic and persons engaged in 
manufacturing such lather brushes from hair or bristles shall permit 
authorized representatives of the Surgeon General to make at any 
reasonable time such inspection of the plants or other places, including 
the equipment, operations, and products thereof, at which such 
manufacturing, processing or handling is carried on as may be necessary 
in the judgment of such representatives to determine compliance with the 
provisions of this section.
[40 FR 5620, Feb. 6, 1975, as amended at 54 FR 24900, June 12, 1989]



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 thereat 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 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

[[Page 638]]

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.
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

[[Page 639]]

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.
    (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.

[[Page 640]]



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.
    (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]

[[Page 641]]



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.



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.

[[Page 642]]

    (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 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

[[Page 643]]

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, 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, 200 C St. SW., Washington, DC 20204, 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

[[Page 644]]

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.
    (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, 200 C St., SW., Washington, DC 20204, 
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 Dockets Management Branch, rm. 1-23, 12420 Parklawn 
Dr., Rockville, MD 20857.
    (iii) After notice to the railroad company and opportunity for 
hearing in accordance with part 16 of this chapter, a

[[Page 645]]

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]

    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]



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.

[[Page 646]]



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.



       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

[[Page 647]]

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 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.

[[Page 648]]



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 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 1251-1269  [RESERVED]






PART 1270--HUMAN TISSUE INTENDED FOR TRANSPLANTATION--Table of Contents






                      Subpart A--General Provisions

Sec.
1270.1  Scope.
1270.3  Definitions.

                 Subpart B--Donor Screening and Testing

1270.21  Determination of donor suitability for human tissue intended 
          for transplantation.

                    Subpart C--Procedures and Records

1270.31  Written procedures.
1270.33  Records, general requirements.
1270.35  Specific records.

             Subpart D--Inspection of Tissue Establishments

1270.41  Inspections.
1270.42  Human tissue offered for import.
1270.43  Retention, recall, and destruction of human tissue.


    Authority:  42 U.S.C. 216, 243, 264, 271.

    Source: 62 FR 40444, July 29, 1997, unless otherwise noted.

[[Page 649]]



                      Subpart A--General Provisions



Sec. 1270.1  Scope.

    (a) The regulations in this part apply to human tissue and to 
establishments or persons engaged in the recovery, screening, testing, 
processing, storage, or distribution of human tissue.
    (b) Regulations in this chapter as they apply to drugs, biologics, 
devices, or other FDA-regulated commodities do not apply to human 
tissue, except as specified in this part.
    (c) Regulations in this chapter do not apply to autologous human 
tissue.
    (d) Regulations in this chapter do not apply to hospitals or other 
clinical facilities that receive and store human tissue only for 
transplantation within the same facility.



Sec. 1270.3  Definitions.

    (a) Act for the purpose of this part means the Public Health Service 
Act, section 361 (42 U.S.C. 264).
    (b) Blood component means any part of a single-donor unit of blood 
separated by physical or mechanical means.
    (c) Colloid means a protein or polysaccharide solution that can be 
used to increase or maintain osmotic (oncotic) pressure in the 
intravascular compartment such as albumin, dextran, hetastarch; or 
certain blood components, such as plasma and platelets.
    (d) Contract services are those functions pertaining to the 
recovery, screening, testing, processing, storage, or distribution of 
human tissue that another establishment agrees to perform for a tissue 
establishment.
    (e) Crystalloid means a balanced salt and/or glucose solution used 
for electrolyte replacement or to increase intravascular volume such as 
saline, Ringer's lactate solution, or 5 percent dextrose in water.
    (f) Distribution includes any transfer or shipment of human tissue 
(including importation or exportation), whether or not such transfer or 
shipment is entirely intrastate and whether or not possession of the 
tissue is taken.
    (g) Donor means a human being, living or dead, who is the source of 
tissue for transplantation.
    (h) Donor medical history interview means a documented dialogue with 
an individual or individuals who would be knowledgeable of the donor's 
relevant medical history and social behavior; such as the donor if 
living, the next of kin, the nearest available relative, a member of the 
donor's household, other individual with an affinity relationship, and/
or the primary treating physician. The relevant social history includes 
questions to elicit whether or not the donor met certain descriptions or 
engaged in certain activities or behaviors considered to place such an 
individual at increased risk for HIV and hepatitis.
    (i) Establishment means any facility under one management including 
all locations, that engages in the recovery, screening, testing, 
processing, storage, or distribution of human tissue intended for 
transplantation.
    (j) Human tissue means any tissue derived from a human body, which:
    (1) Is intended for transplantation to another human for the 
diagnosis, cure, mitigation, treatment, or prevention of any condition 
or disease;
    (2) Is recovered, processed, stored, or distributed by methods that 
do not change tissue function or characteristics;
    (3) Is not currently regulated as a human drug, biological product, 
or medical device;
    (4) Excludes kidney, liver, heart, lung, pancreas, or any other 
vascularized human organ; and
    (5) Excludes semen or other reproductive tissue, human milk, and 
bone marrow.
    (k) Importer of record means the person, establishment or their 
representative responsible for making entry of imported goods in 
accordance with all laws affecting such importation.
    (l) Legislative consent means relating to any of the laws of the 
various States that allow the medical examiner or coroner to procure 
corneal tissue in the absence of consent of the donor's next-of-kin.
    (m) Person includes an individual, partnership, corporation, 
association, or other legal entity.
    (n) Physical assessment means a limited autopsy or recent antemortem 
or postmortem physical examination of the donor to assess for any signs 
of HIV

[[Page 650]]

and hepatitis infection or signs suggestive of any risk factor for such 
infections.
    (o) 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.
    (p) Processing means any activity performed on tissue, other than 
tissue recovery, including preparation, preservation for storage, and/or 
removal from storage to assure the quality and/or sterility of human 
tissue. Processing includes steps to inactivate and remove adventitious 
agents.
    (q) Quarantine means the identification of human tissue as not 
suitable for transplantation, including human tissue that has not yet 
been characterized as being suitable for transplantation. Quarantine 
includes the storage of such tissue in an area clearly identified for 
such use, or other procedures, such as automated designation, for 
prevention of release of such tissue for transplantation.
    (r) Reconstituted blood means the extracorporeal resuspension of a 
blood unit labeled as ``Red Blood Cells'' by the addition of colloids 
and/or crystalloids to produce a hematocrit in the normal range.
    (s) Recovery means the obtaining from a donor of tissue that is 
intended for use in human transplantation.
    (t) Relevant medical records means a collection of documents 
including a donor medical history interview, a physical assessment of 
the donor, laboratory test results, medical records, existing coroner 
and autopsy reports, or information obtained from any source or records 
which may pertain to donor suitability regarding high risk behaviors, 
clinical signs and symptoms for HIV and hepatitis, and treatments 
related to medical conditions suggestive of such risk.
    (u) Responsible person means a person who is authorized to perform 
designated functions for which he or she is trained and qualified.
    (v) Storage means holding tissue.
    (w) Summary of records means a condensed version of the required 
testing and screening records that contains the identity of the testing 
laboratory, the listing and interpretation of all required infectious 
disease tests, and a listing of the documents reviewed as part of the 
relevant medical records, and the name of the person or establishment 
determining the suitability of the human tissue for transplantation.
    (x) Vascularized means containing the original blood vessels which 
are intended to carry blood after transplantation.



                 Subpart B--Donor Screening and Testing



Sec. 1270.21  Determination of donor suitability for human tissue-intended for transplantation.

    (a) Donor specimens shall be tested for the following communicable 
viruses, using Food and Drug Administration (FDA) licensed donor 
screening tests in accordance with manufacturers' instructions:
    (1) Human immunodeficiency virus, Type 1 (e.g., FDA licensed 
screening test for anti-HIV-1);
    (2) Human immunodeficiency virus, Type 2 (e.g., FDA licensed 
screening test for anti-HIV-2);
    (3) Hepatitis B (e.g., FDA licensed screening test for HBsAg); and
    (4) Hepatitis C (e.g., FDA licensed screening test for anti-HCV).
    (b) In the case of a neonate, the mother's specimen is acceptable 
for testing.
    (c) Such infectious disease testing shall be performed by a 
laboratory certified under the Clinical Laboratories Improvement 
Amendments of 1988 (CLIA).
    (d) Human tissue shall be accompanied by records indicating that the 
donor's specimen has been tested and found negative using FDA licensed 
screening tests for HIV-1, HIV-2, hepatitis B, and hepatitis C. FDA 
licensed screening tests labeled for cadaveric specimens must be used 
when available.
    (e) Human tissue for transplantation shall be accompanied by a 
summary of records or copies of the original records of the donor's 
relevant medical records as defined in Sec. 1270.3(t) which documents 
freedom from risk factors for and clinical evidence of hepatitis B, 
hepatitis C, or HIV infection. There

[[Page 651]]

shall be a responsible person designated and identified in the original 
record and summary of records as having made the determination that the 
human tissue is suitable for transplantation.
    (f) Determination by the responsible person that a donor of human 
tissue intended for transplantation is suitable shall include 
ascertainment of the donor's identity, and accurately recorded relevant 
medical records (as defined in Sec. 1270.3(t)) which documents freedom 
from risk factors for and clinical evidence of hepatitis B, hepatitis C, 
and HIV infection.
    (g) For corneal tissue procured under legislative consent where a 
donor medical history screening interview has not occurred, a physical 
assessment of the donor is required and other available information 
shall be reviewed. The corneal tissue shall be accompanied by the 
summary of records documenting that the corneal tissue was determined to 
be suitable for transplantation in the absence of the donor medical 
history interview. Corneal tissue procured under legislative consent 
shall be documented as such in the summary of records.
    (h) Human tissue shall be determined to be not suitable for 
transplantation if from:
    (1) A donor whose specimen has tested repeatedly reactive on a 
screening test for HIV, hepatitis B, or hepatitis C;
    (2) A donor where blood loss is known or suspected to have occurred 
and transfusion/infusion of more than 2,000 milliliters (mL) of blood 
(i.e., whole blood, reconstituted blood, or red blood cells), or 
colloids within 48 hours; or more than 2,000 mL of crystalloids within 1 
hour; or any combination thereof prior to the collection of a blood 
specimen from the tissue donor for testing, unless:
    (i) A pretransfusion or preinfusion blood specimen from the tissue 
donor is available for infectious disease testing; or
    (ii) An algorithm is utilized that evaluates the volumes 
administered in the 48 hours prior to collecting the blood specimen from 
the tissue donor to ensure that there has not been plasma dilution 
sufficient to affect test results; or
    (3) A donor who is 12 years of age or less and has been transfused 
or infused at all, unless:
    (i) A pretransfusion or preinfusion blood specimen from the tissue 
donor is available for infectious disease testing; or
    (ii) An algorithm is utilized that evaluates the volumes 
administered in the 48 hours prior to collecting the blood specimen from 
the tissue donor to ensure that there has not been plasma dilution 
sufficient to affect test results.



                    Subpart C--Procedures and Records



Sec. 1270.31  Written procedures.

    (a) There shall be written procedures prepared and followed for all 
significant steps in the infectious disease testing process under 
Sec. 1270.21 which shall conform to the manufacturers' instructions for 
use contained in the package inserts for the required tests. These 
procedures shall be readily available to the personnel in the area where 
the procedures are performed unless impractical. Any deviation from the 
written procedures shall be recorded and justified.
    (b) There shall be written procedures prepared and followed for all 
significant steps for obtaining, reviewing, and assessing the relevant 
medical records of the donor as provided in Sec. 1270.21. Such 
procedures shall be readily available to personnel who may perform the 
procedures. Any deviation from the written procedures shall be recorded 
and justified.
    (c) There shall be written procedures prepared and followed for 
designating and identifying quarantined tissue.
    (d) There shall be written procedures prepared, validated, and 
followed for prevention of infectious disease contamination or cross-
contamination by tissue during processing.
    (e) In conformity with this section, any facility may use current 
standard written procedures such as those in a technical manual prepared 
by another organization, provided the procedures are consistent with and 
at least as

[[Page 652]]

stringent as the requirements of this part.



Sec. 1270.33  Records, general requirements.

    (a) Records shall be maintained concurrently with the performance of 
each significant step required in this part in the performance of 
infectious disease screening and testing of donors of human tissue. All 
records shall be accurate, indelible, and legible. The records shall 
identify the person performing the work, the dates of the various 
entries, and shall be as detailed as necessary to provide a complete 
history of the work performed and to relate the records to the 
particular tissue involved.
    (b) All human tissue shall be quarantined until the following 
criteria for donor suitability are satisfied:
    (1) All infectious disease testing under Sec. 1270.21 has been 
completed, reviewed by the responsible person, and found to be negative; 
or
    (2) Donor screening has been completed, reviewed by the responsible 
person, and determined to assure freedom from risk factors for and 
clinical evidence of HIV infection, hepatitis B, and hepatitis C.
    (c) All human tissue processed or shipped prior to determination of 
donor suitability must be under quarantine, accompanied by records 
assuring identification of the donor and indicating that the tissue has 
not been determined to be suitable for transplantation.
    (d) All human tissue determined to be suitable for transplantation 
must be accompanied by a summary of records, or copies of such original 
records, documenting that all infectious disease testing and screening 
under Sec. 1270.21 has been completed, reviewed by the responsible 
person, and found to be negative, and that the tissue has been 
determined to be suitable for transplantation.
    (e) Human tissue shall be quarantined until the tissue is either 
determined to be suitable for transplantation or appropriate disposition 
is accomplished.
    (f) All persons or establishments that generate records used in 
determining the suitability of the donor shall retain such records and 
make them available for authorized inspection or upon request by FDA. 
The person(s) or establishment(s) making the determination regarding the 
suitability of the donor shall retain all records, or true copies of 
such records required under Sec. 1270.21, including all testing and 
screening records, and shall make them available for authorized 
inspection or upon request from FDA. Records that can be retrieved from 
another location by electronic means meet the requirements of this 
paragraph.
    (g) Records required under this part may be retained electronically, 
or as original paper records, or as true copies such as photocopies, 
microfiche, or microfilm, in which case suitable reader and photocopying 
equipment shall be readily available.
    (h) Records shall be retained at least 10 years beyond the date of 
transplantation if known, distribution, disposition, or expiration, of 
the tissue, whichever is latest.



Sec. 1270.35  Specific records.

    Records shall be maintained that include, but are not limited to:
    (a) Documentation of results and interpretation of all required 
infectious disease tests;
    (b) Information on the identity and relevant medical records of the 
donor, as required by Sec. 1270.21(e) in English or, if in another 
language translated to English and accompanied by a statement of 
authenticity by the translator which specifically identifies the 
translated document;
    (c) Documentation of the receipt and/or distribution of human 
tissue; and
    (d) Documentation of the destruction or other disposition of human 
tissue.



             Subpart D--Inspection of Tissue Establishments



Sec. 1270.41  Inspections.

    (a) An establishment covered by these regulations in this part, 
including any location performing contract services, shall permit an 
authorized inspector of the Food and Drug Administration (FDA) to make 
at any reasonable time and in a reasonable manner such inspection of the 
establishment,

[[Page 653]]

its facilities, equipment, processes, products, and records as may be 
necessary to determine compliance with the provisions of this part. Such 
inspections may be made with or without notice and will ordinarily be 
made during regular business hours.
    (b) The frequency of inspection will be at the agency's discretion.
    (c) The inspector shall call upon a responsible person of the 
establishment and may question the personnel of the establishment as the 
inspector deems necessary.
    (d) The inspector may review and copy any records required to be 
kept pursuant to part 1270.
    (e) The public disclosure of records containing the name or other 
positive identification of donors or recipients of human tissue will be 
handled in accordance with FDA's procedures on disclosure of information 
as set forth in 21 CFR part 20 of this chapter.



Sec. 1270.42  Human tissue offered for import.

    (a) When human tissue is offered for entry, the importer of record 
must notify the director of the district of the Food and Drug 
Administration having jurisdiction over the port of entry through which 
the tissue 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.
    (b) Human tissue offered for import must be quarantined until the 
human tissue is released by FDA.



Sec. 1270.43  Retention, recall, and destruction of human tissue.

    (a) Upon a finding that human tissue may be in violation of the 
regulations in this part, an authorized Food and Drug Administration 
(FDA) representative may:
    (1) Serve upon the person who distributed the tissue a written order 
that the tissue be recalled and/or destroyed, as appropriate, and upon 
persons in possession of the tissue that the tissue shall be retained 
until it is recalled by the distributor, destroyed, or disposed of as 
agreed by FDA, or the safety of the tissue is confirmed; and/or
    (2) Take possession of and/or destroy the violative tissue.
    (b) The written order will ordinarily provide that the human tissue 
be recalled and/or destroyed within 5 working days from the date of 
receipt of the order and will state with particularity the facts that 
justify the order.
    (c) After receipt of an order under this part, the person in 
possession of the human tissue shall not distribute or dispose of the 
tissue in any manner except to recall and/or destroy the tissue 
consistent with the provisions of the order, under the supervision of an 
authorized official of FDA.
    (d) In lieu of paragraphs (b) and (c) of this section, other 
arrangements for assuring the proper disposition of the tissue may be 
agreed upon by the person receiving the written order and an authorized 
official of FDA. Such arrangements may include providing FDA with 
records or other written information that adequately assure that the 
tissue has been recovered, screened, tested, processed, stored, and 
distributed in conformance with part 1270.
    (e) Within 5 working days of receipt of a written order for 
retention, recall, and/or destruction of tissue (or within 5 working 
days of the agency's possession of such tissue), the recipient of the 
written order or prior possessor of such tissue shall request a hearing 
on the matter in accordance with part 16 of this chapter. The order for 
destruction will be held in abeyance pending resolution of the hearing 
request.



PARTS 1271-1299  [RESERVED]



[[Page 655]]


                              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.
  Material Approved for Incorporation by Reference
  Table of CFR Titles and Chapters
  Alphabetical List of Agencies Appearing in the CFR
  List of CFR Sections Affected

[[Page 657]]

            Material Approved for Incorporation by Reference

                      (Revised as of April 1, 1998)

  The Director of the Federal Register has approved under 5 U.S.C. 
552(a) and 1 CFR part 51 the incorporation by reference of the following 
publications. This list contains only those incorporations by reference 
effective as of the revision date of this volume. Incorporations by 
reference found within a regulation are effective upon the effective 
date of that regulation. For more information on incorporation by 
reference, see the preliminary pages of this volume.


21 CFR (PARTS 800 TO 1299)

FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
                                                                  21 CFR


American College of Radiology, Committee on Quality Assurance in 
Mammography, Mammography Accreditation Program

  1891 Preston White Dr., Reston, VA 22091-5431
Mammography Quality Control: Radiologist's Manual,             900.12(d)
  Radiologic Technologists's Manual, Medical 
  Physicist's Manual, 1992 edition.
Mammography Quality Control Manual, 1994 edition..             900.12(d)


American Society for Testing and Materials

  100 Barr Harbor Drive, West Conshohocken, PA 
  19428-2959, Telephone (610) 832-9585, FAX (610) 
  832-9555
ASTM D 412-68 Standard Method of Tension Testing                 801.410
  of Vulcanized Rubber.
ASTM D 1415-68 Test for International Hardness of                801.410
  Vulcanized Rubber.
ASTM D 3492-83 Standard Specification for Rubber           801.430(f)(2)
  Contraceptives (Condoms).


American National Standards Institute

  11 West 42nd Street, New York, NY 10036 
  Telephone: (212) 642-4900
ANSI C81.10-1976 Specifications for Electric Lamp             1040.20(c)
  Bases and Holders-Screw Shall Types.
ANSI S3.22-1987 Specification of Hearing Aid               801.420(c)(4)
  Characteristics (ASA 70-1987).



[[Page 659]]



                    Table of CFR Titles and Chapters




                     (Revised as of March 31, 1998)

                      Title 1--General Provisions

         I  Administrative Committee of the Federal Register 
                (Parts 1--49)
        II  Office of the Federal Register (Parts 50--299)
        IV  Miscellaneous Agencies (Parts 400--500)

                          Title 2--[Reserved]

                        Title 3--The President

         I  Executive Office of the President (Parts 100--199)

                           Title 4--Accounts

         I  General Accounting Office (Parts 1--99)
        II  Federal Claims Collection Standards (General 
                Accounting Office--Department of Justice) (Parts 
                100--299)

                   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  Advisory Committee on Federal Pay (Parts 1400--1499)
         V  The International Organizations Employees Loyalty 
                Board (Parts 1500--1599)
        VI  Federal Retirement Thrift Investment Board (Parts 
                1600--1699)
       VII  Advisory Commission on Intergovernmental Relations 
                (Parts 1700--1799)
      VIII  Office of Special Counsel (Parts 1800--1899)
        IX  Appalachian Regional Commission (Parts 1900--1999)
        XI  Armed Forces Retirement Home (Part 2100)
       XIV  Federal Labor Relations Authority, General Counsel of 
                the Federal Labor Relations Authority and Federal 
                Service Impasses Panel (Parts 2400--2499)
        XV  Office of Administration, Executive Office of the 
                President (Parts 2500--2599)
       XVI  Office of Government Ethics (Parts 2600--2699)
       XXI  Department of the Treasury (Parts 3100--3199)
      XXII  Federal Deposit Insurance Corporation (Part 3201)
     XXIII  Department of Energy (Part 3301)

[[Page 660]]

      XXIV  Federal Energy Regulatory Commission (Part 3401)
       XXV  Department of the Interior (Part 3501)
      XXVI  Department of Defense (Part 3601)
    XXVIII  Department of Justice (Part 3801)
      XXIX  Federal Communications Commission (Parts 3900--3999)
       XXX  Farm Credit System Insurance Corporation (Parts 4000--
                4099)
      XXXI  Farm Credit Administration (Parts 4100--4199)
    XXXIII  Overseas Private Investment Corporation (Part 4301)
      XXXV  Office of Personnel Management (Part 4501)
        XL  Interstate Commerce Commission (Part 5001)
       XLI  Commodity Futures Trading Commission (Part 5101)
      XLII  Department of Labor (Part 5201)
     XLIII  National Science Foundation (Part 5301)
       XLV  Department of Health and Human Services (Part 5501)
      XLVI  Postal Rate Commission (Part 5601)
     XLVII  Federal Trade Commission (Part 5701)
    XLVIII  Nuclear Regulatory Commission (Part 5801)
         L  Department of Transportation (Part 6001)
       LII  Export-Import Bank of the United States (Part 6201)
      LIII  Department of Education (Parts 6300--6399)
       LIV  Environmental Protection Agency (Part 6401)
      LVII  General Services Administration (Part 6701)
     LVIII  Board of Governors of the Federal Reserve System (Part 
                6801)
       LIX  National Aeronautics and Space Administration (Part 
                6901)
        LX  United States Postal Service (Part 7001)
       LXI  National Labor Relations Board (Part 7101)
      LXII  Equal Employment Opportunity Commission (Part 7201)
     LXIII  Inter-American Foundation (Part 7301)
       LXV  Department of Housing and Urban Development (Part 
                7501)
      LXVI  National Archives and Records Administration (Part 
                7601)
      LXIX  Tennessee Valley Authority (Part 7901)
      LXXI  Consumer Product Safety Commission (Part 8101)
     LXXIV  Federal Mine Safety and Health Review Commission (Part 
                8401)
     LXXVI  Federal Retirement Thrift Investment Board (Part 8601)
    LXXVII  Office of Management and Budget (Part 8701)

                          Title 6--[Reserved]

                         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)

[[Page 661]]

        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)
      VIII  Grain Inspection, Packers and Stockyards 
                Administration (Federal Grain Inspection Service), 
                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)
      XIII  Northeast Dairy Compact Commission (Parts 1300--1399)
       XIV  Commodity Credit Corporation, Department of 
                Agriculture (Parts 1400--1499)
        XV  Foreign Agricultural Service, Department of 
                Agriculture (Parts 1500--1599)
       XVI  Rural Telephone Bank, Department of Agriculture (Parts 
                1600--1699)
      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)
      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, 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  [Reserved]
    XXXIII  Office of Transportation, Department of Agriculture 
                (Parts 3300--3399)
     XXXIV  Cooperative State Research, Education, and Extension 
                Service, Department of Agriculture (Parts 3400--
                3499)

[[Page 662]]

      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]
      XLII  Rural Business-Cooperative Service and Rural Utilities 
                Service, Department of Agriculture (Parts 4200--
                4299)

                    Title 8--Aliens and Nationality

         I  Immigration and Naturalization Service, Department of 
                Justice (Parts 1--499)

                 Title 9--Animals and Animal Products

         I  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 1--199)
        II  Grain Inspection, Packers and Stockyards 
                Administration (Packers and Stockyards Programs), 
                Department of Agriculture (Parts 200--299)
       III  Food Safety and Inspection Service, Meat and Poultry 
                Inspection, 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)
        XI  United States Enrichment Corporation (Parts 1100--
                1199)
      XVII  Defense Nuclear Facilities Safety Board (Parts 1700--
                1799)

                      Title 11--Federal Elections

         I  Federal Election Commission (Parts 1--9099)

                      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  Office of Thrift Supervision, Department of the 
                Treasury (Parts 500--599)
        VI  Farm Credit Administration (Parts 600--699)
       VII  National Credit Union Administration (Parts 700--799)

[[Page 663]]

      VIII  Federal Financing Bank (Parts 800--899)
        IX  Federal Housing Finance Board (Parts 900--999)
        XI  Federal Financial Institutions Examination Council 
                (Parts 1100--1199)
       XIV  Farm Credit System Insurance Corporation (Parts 1400--
                1499)
        XV  Thrift Depositor Protection Oversight Board (Parts 
                1500--1599)
      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)

                    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--499)
         V  National Aeronautics and Space Administration (Parts 
                1200--1299)

                 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 Export Administration, Department of 
                Commerce (Parts 700--799)
      VIII  Bureau of Economic Analysis, Department of Commerce 
                (Parts 800--899)
        IX  National Oceanic and Atmospheric Administration, 
                Department of Commerce (Parts 900--999)
        XI  Technology Administration, Department of Commerce 
                (Parts 1100--1199)
      XIII  East-West Foreign Trade Board (Parts 1300--1399)
       XIV  Minority Business Development Agency (Parts 1400--
                1499)

[[Page 664]]

            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)

                    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  United States Customs Service, Department of the 
                Treasury (Parts 1--199)
        II  United States International Trade Commission (Parts 
                200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)

                     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  Employment Standards Administration, 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)

[[Page 665]]

        IX  Office of the Assistant Secretary for Veterans' 
                Employment and Training, 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, International 
                Development Cooperation Agency (Parts 200--299)
       III  Peace Corps (Parts 300--399)
        IV  International Joint Commission, United States and 
                Canada (Parts 400--499)
         V  United States Information Agency (Parts 500--599)
        VI  United States Arms Control and Disarmament Agency 
                (Parts 600--699)
       VII  Overseas Private Investment Corporation, International 
                Development Cooperation Agency (Parts 700--799)
        IX  Foreign Service Grievance Board Regulations (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  Board for International Broadcasting (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)

                          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)

[[Page 666]]

                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)
         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 and Section 202 Direct Loan Program) 
                (Parts 800--899)
        IX  Office of Assistant Secretary for Public and Indian 
                Housing, Department of Housing and Urban 
                Development (Parts 900--999)
         X  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Interstate Land Sales 
                Registration Program) (Parts 1700--1799)
       XII  Office of Inspector General, Department of Housing and 
                Urban Development (Parts 2000--2099)
        XX  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 3200--3899)
       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--799)
         V  Bureau of Indian Affairs, Department of the Interior, 
                and Indian Health Service, Department of Health 
                and Human Services (Part 900)
        VI  Office of the Assistant Secretary-Indian Affairs, 
                Department of the Interior (Part 1001)

[[Page 667]]

       VII  Office of the Special Trustee for American Indians, 
                Department of the Interior (Part 1200--1299)

                      Title 26--Internal Revenue

         I  Internal Revenue Service, Department of the Treasury 
                (Parts 1--799)

           Title 27--Alcohol, Tobacco Products and Firearms

         I  Bureau of Alcohol, Tobacco and Firearms, Department of 
                the Treasury (Parts 1--299)

                   Title 28--Judicial Administration

         I  Department of Justice (Parts 0--199)
       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)

                            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  Pension and Welfare Benefits 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)

[[Page 668]]

                      Title 30--Mineral Resources

         I  Mine Safety and Health Administration, Department of 
                Labor (Parts 1--199)
        II  Minerals Management Service, Department of the 
                Interior (Parts 200--299)
       III  Board of Surface Mining and Reclamation Appeals, 
                Department of the Interior (Parts 300--399)
        IV  Geological Survey, Department of the Interior (Parts 
                400--499)
        VI  Bureau of Mines, Department of the Interior (Parts 
                600--699)
       VII  Office of Surface Mining Reclamation and Enforcement, 
                Department of the Interior (Parts 700--999)

                 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
         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 International Investment, Department of the 
                Treasury (Parts 800--899)

                      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  Defense Logistics Agency (Parts 1200--1299)
       XVI  Selective Service System (Parts 1600--1699)
       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)
      XXIX  Presidential Commission on the Assignment of Women in 
                the Armed Forces (Part 2900)

[[Page 669]]

               Title 33--Navigation and Navigable Waters

         I  Coast Guard, Department of Transportation (Parts 1--
                199)
        II  Corps of Engineers, Department of the Army (Parts 
                200--399)
        IV  Saint Lawrence Seaway Development Corporation, 
                Department of Transportation (Parts 400--499)

                          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 Vocational and Adult Education, Department 
                of Education (Parts 400--499)
         V  Office of Bilingual Education and Minority Languages 
                Affairs, Department of Education (Parts 500--599)
        VI  Office of Postsecondary Education, Department of 
                Education (Parts 600--699)
       VII  Office of Educational Research and Improvement, 
                Department of Education (Parts 700--799)
        XI  National Institute for Literacy (Parts 1100-1199)
            Subtitle C--Regulations Relating to Education
       XII  National Council on Disability (Parts 1200--1299)

                        Title 35--Panama Canal

         I  Panama Canal Regulations (Parts 1--299)

             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)
       VII  Library of Congress (Parts 700--799)
      VIII  Advisory Council on Historic Preservation (Parts 800--
                899)
        IX  Pennsylvania Avenue Development Corporation (Parts 
                900--999)
        XI  Architectural and Transportation Barriers Compliance 
                Board (Parts 1100--1199)
       XII  National Archives and Records Administration (Parts 
                1200--1299)
       XIV  Assassination Records Review Board (Parts 1400-1499)

[[Page 670]]

             Title 37--Patents, Trademarks, and Copyrights

         I  Patent and Trademark Office, Department of Commerce 
                (Parts 1--199)
        II  Copyright Office, Library of Congress (Parts 200--299)
        IV  Assistant Secretary for Technology Policy, Department 
                of Commerce (Parts 400--499)
         V  Under Secretary for Technology, Department of Commerce 
                (Parts 500--599)

           Title 38--Pensions, Bonuses, and Veterans' Relief

         I  Department of Veterans Affairs (Parts 0--99)

                       Title 39--Postal Service

         I  United States Postal Service (Parts 1--999)
       III  Postal Rate Commission (Parts 3000--3099)

                  Title 40--Protection of Environment

         I  Environmental Protection Agency (Parts 1--799)
         V  Council on Environmental Quality (Parts 1500--1599)

          Title 41--Public Contracts and Property Management

            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, Department of Labor 
                (Parts 61-1--61-999)
            Subtitle C--Federal Property Management Regulations 
                System
       101  Federal Property Management Regulations (Parts 101-1--
                101-99)
       105  General Services Administration (Parts 105-1--105-999)
       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)
            Subtitle D--Other Provisions Relating to Property 
                Management [Reserved]
            Subtitle E--Federal Information Resources Management 
                Regulations System
       201  Federal Information Resources Management Regulation 
                (Parts 201-1--201-99) [Reserved]
            Subtitle F--Federal Travel Regulation System
       301  Travel Allowances (Parts 301-1--301-99)
       302  Relocation Allowances (Parts 302-1--302-99)

[[Page 671]]

       303  Payment of Expenses Connected with the Death of 
                Certain Employees (Parts 303-1--303-2)
       304  Payment from a Non-Federal Source for Travel Expenses 
                (Parts 304-1--304-99)

                        Title 42--Public Health

         I  Public Health Service, Department of Health and Human 
                Services (Parts 1--199)
        IV  Health Care Financing Administration, Department of 
                Health and Human Services (Parts 400--499)
         V  Office of Inspector General-Health Care, Department of 
                Health and Human Services (Parts 1000--1999)

                   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 200--499)
        II  Bureau of Land Management, Department of the Interior 
                (Parts 1000--9999)
       III  Utah Reclamation Mitigation and Conservation 
                Commission (Parts 10000--10005)

             Title 44--Emergency Management and Assistance

         I  Federal Emergency Management Agency (Parts 0--399)
        IV  Department of Commerce and Department of 
                Transportation (Parts 400--499)

                       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)

[[Page 672]]

         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  Office of Human Development Services, 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 on Fine Arts (Parts 2100--2199)
      XXII  Christopher Columbus Quincentenary Jubilee Commission 
                (Parts 2200--2299)
     XXIII  Arctic Research Commission (Part 2301)
      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 Transportation (Parts 1--
                199)
        II  Maritime Administration, Department of Transportation 
                (Parts 200--399)
        IV  Federal Maritime Commission (Parts 500--599)

                      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)

           Title 48--Federal Acquisition Regulations System

         1  Federal Acquisition Regulation (Parts 1--99)
         2  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  United States 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)

[[Page 673]]

        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  United States Information Agency (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)
        34  Department of Education Acquisition Regulation (Parts 
                3400--3499)
        35  Panama Canal Commission (Parts 3500--3599)
        44  Federal Emergency Management Agency (Parts 4400--4499)
        51  Department of the Army Acquisition Regulations (Parts 
                5100--5199)
        52  Department of the Navy Acquisition Regulations (Parts 
                5200--5299)
        53  Department of the Air Force Federal Acquisition 
                Regulation Supplement (Parts 5300--5399)
        54  Defense Logistics Agency, Department of Defense (Part 
                5452)
        57  African Development Foundation (Parts 5700--5799)
        61  General Services Administration Board of Contract 
                Appeals (Parts 6100--6199)
        63  Department of Transportation Board of Contract Appeals 
                (Parts 6300--6399)
        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  Research and Special Programs Administration, 
                Department of Transportation (Parts 100--199)
        II  Federal Railroad Administration, Department of 
                Transportation (Parts 200--299)

[[Page 674]]

       III  Federal Highway Administration, Department of 
                Transportation (Parts 300--399)
        IV  Coast Guard, Department of Transportation (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, Department of 
                Transportation (Parts 1000--1399)

                   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)
        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)

                      CFR Index and Finding Aids

            Subject/Agency Index
            List of Agency Prepared Indexes
            Parallel Tables of Statutory Authorities and Rules
            List of CFR Titles, Chapters, Subchapters, and Parts
            Alphabetical List of Agencies Appearing in the CFR



[[Page 675]]





           Alphabetical List of Agencies Appearing in the CFR




                     (Revised as of March 31, 1998)

                                                  CFR Title, Subtitle or 
                     Agency                               Chapter

ACTION                                            45, XII
Administrative Committee of the Federal Register  1, I
Advanced Research Projects Agency                 32, I
Advisory Commission on Intergovernmental          5, VII
     Relations
Advisory Committee on Federal Pay                 5, IV
Advisory Council on Historic Preservation         36, VIII
African Development Foundation                    22, XV
  Federal Acquisition Regulation                  48, 57
Agency for International Development, United      22, II
     States
  Federal Acquisition Regulation                  48, 7
Agricultural Marketing Service                    7, I, IX, X, XI
Agricultural Research Service                     7, V
Agriculture Department
  Agricultural Marketing Service                  7, I, IX, X, XI
  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
  Cooperative State Research, Education, and      7, XXXIV
       Extension Service
  Economic Research Service                       7, XXXVII
  Energy, Office of                               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 Consumer Service                       7, II
  Food Safety and Inspection Service              9, III
  Foreign Agricultural Service                    7, XV
  Forest Service                                  36, II
  Grain Inspection, Packers and Stockyards        7, VIII; 9, II
       Administration
  Information Resources Management, Office of     7, XXVII
  Inspector General, Office of                    7, XXVI
  National Agricultural Library                   7, XLI
  National Agricultural Statistics Service        7, XXXVI
  Natural Resources Conservation Service          7, VI
  Operations, Office of                           7, XXVIII
  Rural Business-Cooperative Service              7, XVIII, XLII
  Rural Development Administration                7, XLII
  Rural Housing Service                           7, XVIII, XXXV
  Rural Telephone Bank                            7, XVI
  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                              32, VII
  Federal Acquisition Regulation Supplement       48, 53
Alaska Natural Gas Transportation System, Office  10, XV
     of the Federal Inspector
Alcohol, Tobacco and Firearms, Bureau of          27, I
AMTRAK                                            49, VII
American Battle Monuments Commission              36, IV
American Indians, Office of the Special Trustee   25, VII

[[Page 676]]

Animal and Plant Health Inspection Service        7, III; 9, I
Appalachian Regional Commission                   5, IX
Architectural and Transportation Barriers         36, XI
     Compliance Board
Arctic Research Commission                        45, XXIII
Armed Forces Retirement Home                      5, XI
Arms Control and Disarmament Agency, United       22, VI
     States
Army Department                                   32, V
  Engineers, Corps of                             33, II; 36, III
  Federal Acquisition Regulation                  48, 51
Assassination Records Review Board                36, XIV
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
Board for International Broadcasting              22, XIII
Census Bureau                                     15, I
Central Intelligence Agency                       32, XIX
Chief Financial Officer, Office of                7, XXX
Child Support Enforcement, Office of              45, III
Children and Families, Administration for         45, II, III, IV, X
Christopher Columbus Quincentenary Jubilee        45, XXII
     Commission
Civil Rights, Commission on                       45, VII
Civil Rights, Office for                          34, I
Coast Guard                                       33, I; 46, I; 49, IV
Commerce Department                               44, IV
  Census Bureau                                   15, I`
  Economic Affairs, Under Secretary               37, V
  Economic Analysis, Bureau of                    15, VIII
  Economic Development Administration             13, III
  Emergency Management and Assistance             44, IV
  Export Administration, Bureau of                15, VII
  Federal Acquisition Regulation                  48, 13
  Fishery Conservation and Management             50, VI
  Foreign-Trade Zones Board                       15, IV
  International Trade Administration              15, III; 19, III
  National Institute of Standards and Technology  15, II
  National Marine Fisheries Service               50, II, IV
  National Oceanic and Atmospheric                15, IX; 50, II, III, IV, 
       Administration                             VI
  National Telecommunications and Information     15, XXIII; 47, III
       Administration
  National Weather Service                        15, IX
  Patent and Trademark Office                     37, I
  Productivity, Technology and Innovation,        37, IV
       Assistant Secretary for
  Secretary of Commerce, Office of                15, Subtitle A
  Technology, Under Secretary for                 37, V
  Technology Administration                       15, XI
  Technology Policy, Assistant Secretary for      37, IV
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 Product Safety Commission                5, LXXI; 16, II
Cooperative State Research, Education, and        7, XXXIV
     Extension Service
Copyright Office                                  37, II
Cost Accounting Standards Board                   48, 99
Council on Environmental Quality                  40, V
Customs Service, United States                    19, I
Defense Contract Audit Agency                     32, I
Defense Department                                5, XXVI; 32, Subtitle A
  Advanced Research Projects Agency               32, I
  Air Force Department                            32, VII

[[Page 677]]

  Army Department                                 32, V; 33, II; 36, III, 
                                                  48, 51
  Defense Intelligence Agency                     32, I
  Defense Logistics Agency                        32, I, XII; 48, 54
  Engineers, Corps of                             33, II; 36, III
  Federal Acquisition Regulation                  48, 2
  National Imagery and Mapping Agency             32, I
  Navy Department                                 32, VI; 48, 52
  Secretary of Defense, Office of                 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
Drug Enforcement Administration                   21, II
East-West Foreign Trade Board                     15, XIII
Economic Affairs, Under Secretary                 37, V
Economic Analysis, Bureau of                      15, VIII
Economic Development Administration               13, III
Economic Research Service                         7, XXXVII
Education, Department of                          5, LIII
  Bilingual Education and Minority Languages      34, V
       Affairs, Office 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
  Vocational and Adult Education, Office of       34, IV
Educational Research and Improvement, Office of   34, VII
Elementary and Secondary Education, Office of     34, II
Employees' Compensation Appeals Board             20, IV
Employees Loyalty Board                           5, V
Employment and Training Administration            20, V
Employment Standards Administration               20, VI
Endangered Species Committee                      50, IV
Energy, Department of                             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
Enrichment Corporation, United States             10, XI
Environmental Protection Agency                   5, LIV; 40, I
  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
  Administration, Office of                       5, XV
  Environmental Quality, Council on               40, V
  Management and Budget, Office of                25, III, LXXVII; 48, 99
  National Drug Control Policy, Office of         21, III
  National Security Council                       32, XXI; 47, 2
  Presidential Documents                          3
  Science and Technology Policy, Office of        32, XXIV; 47, II
  Trade Representative, Office of the United      15, XX
       States
Export Administration, Bureau of                  15, VII
Export-Import Bank of the United States           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

[[Page 678]]

Federal Acquisition Regulation                    48, 1
Federal Aviation Administration                   14, I
  Commercial Space Transportation                 14, III
Federal Claims Collection Standards               4, II
Federal Communications Commission                 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                       11, I
Federal Emergency Management Agency               44, I
  Federal Acquisition Regulation                  48, 44
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; 49, III
Federal Home Loan Mortgage Corporation            1, IV
Federal Housing Enterprise Oversight Office       12, XVII
Federal Housing Finance Board                     12, IX
Federal Inspector for the Alaska Natural Gas      10, XV
     Transportation System, Office of
Federal Labor Relations Authority, and General    5, XIV; 22, XIV
     Counsel of the Federal Labor Relations 
     Authority
Federal Law Enforcement Training Center           31, VII
Federal Maritime Commission                       46, IV
Federal Mediation and Conciliation Service        29, XII
Federal Mine Safety and Health Review Commission  5, LXXIV; 29, XXVII
Federal Pay, Advisory Committee on                5, IV
Federal Prison Industries, Inc.                   28, III
Federal Procurement Policy Office                 48, 99
Federal Property Management Regulations           41, 101
Federal Property Management Regulations System    41, Subtitle C
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
Fine Arts, Commission on                          45, XXI
Fiscal Service                                    31, II
Fish and Wildlife Service, United States          50, I, IV
Fishery Conservation and Management               50, VI
Food and Drug Administration                      21, I
Food and Consumer 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 Accounting Office                         4, I, II
General Services Administration                   5, LVII
  Contract Appeals, Board of                      48, 61
  Federal Acquisition Regulation                  48, 5
  Federal Property Management Regulations System  41, 101, 105
  Federal Travel Regulation System                41, Subtitle F
  Payment From a Non-Federal Source for Travel    41, 304
       Expenses
  Payment of Expenses Connected With the Death    41, 303
     of Certain Employees
[[Page 679]]

  Relocation Allowances                           41, 302
  Travel Allowances                               41, 301
Geological Survey                                 30, IV
Government Ethics, Office of                      5, XVI
Government National Mortgage Association          24, III
Grain Inspection, Packers and Stockyards          7, VIII; 9, II
     Administration
Great Lakes Pilotage                              46, III
Harry S. Truman Scholarship Foundation            45, XVIII
Health and Human Services, Department of          5, XLV; 45, Subtitle A
  Child Support Enforcement, Office of            45, III
  Children and Families, Administration for       45, II, III, IV, X
  Community Services, Office of                   45, X
  Family Assistance, Office of                    45, II
  Federal Acquisition Regulation                  48, 3
  Food and Drug Administration                    21, I
  Health Care Financing Administration            42, IV
  Human Development Services, Office of           45, XIII
  Indian Health Service                           25, V
  Inspector General (Health Care), Office of      42, V
  Public Health Service                           42, I
  Refugee Resettlement, Office of                 45, IV
Health Care Financing Administration              42, IV
Housing and Urban Development, Department of      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
  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
Human Development Services, Office of             45, XIII
Immigration and Naturalization Service            8, I
Independent Counsel, Office of                    28, VII
Indian Affairs, Bureau of                         25, I, V
Indian Affairs, Office of the Assistant           25, VI
     Secretary
Indian Arts and Crafts Board                      25, II
Indian Health Service                             25, V
Information Agency, United States                 22, V
  Federal Acquisition Regulation                  48, 19
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
Institute of Peace, United States                 22, XVII
Inter-American Foundation                         5, LXIII; 22, X
Intergovernmental Relations, Advisory Commission  5, VII
     on
Interior Department
  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
  Minerals Management Service                     30, II

[[Page 680]]

  Mines, Bureau of                                30, VI
  National Indian Gaming Commission               25, III
  National Park Service                           36, I
  Reclamation, Bureau of                          43, I
  Secretary of the Interior, Office of            43, Subtitle A
  Surface Mining and Reclamation Appeals, Board   30, III
       of
  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, United States        22, II; 48, 7
       Agency for
  Overseas Private Investment Corporation         5, XXXIII; 22, VII
International Fishing and Related Activities      50, III
International Investment, Office of               31, VIII
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
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                                5, XXVIII; 28, I
  Drug Enforcement Administration                 21, II
  Federal Acquisition Regulation                  48, 28
  Federal Claims Collection Standards             4, II
  Federal Prison Industries, Inc.                 28, III
  Foreign Claims Settlement Commission of the     45, V
       United States
  Immigration and Naturalization Service          8, I
  Offices of Independent Counsel                  28, VI
  Prisons, Bureau of                              28, V
  Property Management Regulations                 41, 128
Labor Department                                  5, XLII
  Benefits Review Board                           20, VII
  Employees' Compensation Appeals Board           20, IV
  Employment and Training Administration          20, V
  Employment Standards Administration             20, VI
  Federal Acquisition Regulation                  48, 29
  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
  Pension and Welfare Benefits Administration     29, XXV
  Public Contracts                                41, 50
  Secretary of Labor, Office of                   29, Subtitle A
  Veterans' Employment and Training, Office of    41, 61; 20, IX
       the Assistant Secretary for
  Wage and Hour Division                          29, V
  Workers' Compensation Programs, Office of       20, I
Labor-Management Standards, Office of             29, II, IV
Land Management, Bureau of                        43, II
Legal Services Corporation                        45, XVI
Library of Congress                               36, VII
  Copyright Office                                37, II
Management and Budget, Office of                  5, III, LXXVII; 48, 99
Marine Mammal Commission                          50, V
Maritime Administration                           46, II
Merit Systems Protection Board                    5, II
Micronesian Status Negotiations, Office for       32, XXVII
Mine Safety and Health Administration             30, I
Minerals Management Service                       30, II

[[Page 681]]

Mines, Bureau of                                  30, VI
Minority Business Development Agency              15, XIV
Miscellaneous Agencies                            1, IV
Monetary Offices                                  31, I
National Aeronautics and Space Administration     5, LIX; 14, V
  Federal Acquisition Regulation                  48, 18
National Agricultural Library                     7, XLI
National Agricultural Statistics Service          7, XXXVI
National Archives and Records Administration      5, LXVI; 36, XII
  Information Security Oversight Office           32, XX
National Bureau of Standards                      15, II
National Capital Planning Commission              1, IV
National Commission for Employment Policy         1, IV
National Commission on Libraries and Information  45, XVII
     Science
National and Community Service, Corporation for   45, XXV
National Council on Disability                    34, XII
National Credit Union Administration              12, VII
National Drug Control Policy, Office of           21, III
National Foundation on the Arts and the           45, XI
     Humanities
National Highway Traffic Safety Administration    23, II, III; 49, V
National Imagery and Mapping Agency               32, I
National Indian Gaming Commission                 25, III
National Institute for Literacy                   34, XI
National Institute of Standards and Technology    15, II
National Labor Relations Board                    5, LXI; 29, I
National Marine Fisheries Service                 50, II, IV
National Mediation Board                          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                       5, XLIII; 45, VI
  Federal Acquisition Regulation                  48, 25
National Security Council                         32, XXI
National Security Council and Office of Science   47, II
     and Technology Policy
National Telecommunications and Information       15, XXIII; 47, III
     Administration
National Transportation Safety Board              49, VIII
National Weather Service                          15, IX
Natural Resources Conservation Service            7, VI
Navajo and Hopi Indian Relocation, Office of      25, IV
Navy Department                                   32, VI
  Federal Acquisition Regulation                  48, 52
Neighborhood Reinvestment Corporation             24, XXV
Northeast Dairy Compact Commission                7, XIII
Nuclear Regulatory Commission                     5, XLVIII; 10, I
  Federal Acquisition Regulation                  48, 20
Occupational Safety and Health Administration     29, XVII
Occupational Safety and Health Review Commission  29, XX
Offices of Independent Counsel                    28, VI
Operations Office                                 7, XXVIII
Overseas Private Investment Corporation           5, XXXIII; 22, VII
Panama Canal Commission                           48, 35
Panama Canal Regulations                          35, I
Patent and Trademark Office                       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                                       22, III
Pennsylvania Avenue Development Corporation       36, IX
Pension and Welfare Benefits Administration       29, XXV
Pension Benefit Guaranty Corporation              29, XL
Personnel Management, Office of                   5, I, XXXV; 45, VIII
  Federal Acquisition Regulation                  48, 17
  Federal Employees Group Life Insurance Federal  48, 21
     Acquisition Regulation
[[Page 682]]

  Federal Employees Health Benefits Acquisition   48, 16
       Regulation
Postal Rate 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 Commission on the Assignment of      32, XXIX
     Women in the Armed Forces
Presidential Documents                            3
Prisons, Bureau of                                28, V
Productivity, Technology and Innovation,          37, IV
     Assistant Secretary
Public Contracts, Department of Labor             41, 50
Public and Indian Housing, Office of Assistant    24, IX
     Secretary for
Public Health Service                             42, I
Railroad Retirement Board                         20, II
Reclamation, Bureau of                            43, I
Refugee Resettlement, Office of                   45, IV
Regional Action Planning Commissions              13, V
Relocation Allowances                             41, 302
Research and Special Programs Administration      49, I
Rural Business-Cooperative Service                7, XVIII, XLII
Rural Development Administration                  7, XLII
Rural Housing Service                             7, XVIII, XXXV
Rural Telephone Bank                              7, XVI
Rural Utilities Service                           7, XVII, XVIII, XLII
Saint Lawrence Seaway Development Corporation     33, IV
Science and Technology Policy, Office of          32, XXIV
Science and Technology Policy, Office of, and     47, II
     National Security Council
Secret Service                                    31, IV
Securities and Exchange Commission                17, II
Selective Service System                          32, XVI
Small Business Administration                     13, I
Smithsonian Institution                           36, V
Social Security Administration                    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                                  22, I
  Federal Acquisition Regulation                  48, 6
Surface Mining and Reclamation Appeals, Board of  30, III
Surface Mining Reclamation and Enforcement,       30, VII
     Office of
Surface Transportation Board                      49, X
Susquehanna River Basin Commission                18, VIII
Technology Administration                         15, XI
Technology Policy, Assistant Secretary for        37, IV
Technology, Under Secretary for                   37, V
Tennessee Valley Authority                        5, LXIX; 18, XIII
Thrift Depositor Protection Oversight Board       12, XV
Thrift Supervision Office, Department of the      12, V
     Treasury
Trade Representative, United States, Office of    15, XX
Transportation, Department of                     5, L
  Coast Guard                                     33, I; 46, I; 49, IV
  Commercial Space Transportation                 14, III
  Contract Appeals, Board of                      48, 63
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 12
  Federal Aviation Administration                 14, I
  Federal Highway Administration                  23, I, II; 49, III
  Federal Railroad Administration                 49, II
  Federal Transit Administration                  49, VI
  Maritime Administration                         46, II
  National Highway Traffic Safety Administration  23, II, III; 49, V
  Research and Special Programs Administration    49, I
  Saint Lawrence Seaway Development Corporation   33, IV
  Secretary of Transportation, Office of          14, II; 49, Subtitle A
  Surface Transportation Board                    49, X

[[Page 683]]

Transportation, Office of                         7, XXXIII
Travel Allowances                                 41, 301
Treasury Department                               5, XXI; 17, IV
  Alcohol, Tobacco and Firearms, Bureau of        27, I
  Community Development Financial Institutions    12, XVIII
       Fund
  Comptroller of the Currency                     12, I
  Customs Service, United States                  19, I
  Engraving and Printing, Bureau of               31, VI
  Federal Acquisition Regulation                  48, 10
  Federal Law Enforcement Training Center         31, VII
  Fiscal Service                                  31, II
  Foreign Assets Control, Office of               31, V
  Internal Revenue Service                        26, I
  International Investment, Office of             31, VIII
  Monetary Offices                                31, I
  Secret Service                                  31, IV
  Secretary of the Treasury, Office of            31, Subtitle A
  Thrift Supervision, Office of                   12, V
Truman, Harry S. Scholarship Foundation           45, XVIII
United States and Canada, International Joint     22, IV
     Commission
United States and Mexico, International Boundary  22, XI
     and Water Commission, United States Section
United States Enrichment Corporation              10, XI
Utah Reclamation Mitigation and Conservation      43, III
     Commission
Veterans Affairs Department                       38, I
  Federal Acquisition Regulation                  48, 8
Veterans' Employment and Training, Office of the  41, 61; 20, IX
     Assistant Secretary for
Vice President of the United States, Office of    32, XXVIII
Vocational and Adult Education, Office of         34, IV
Wage and Hour Division                            29, V
Water Resources Council                           18, VI
Workers' Compensation Programs, Office of         20, I
World Agricultural Outlook Board                  7, XXXVIII

[[Page 685]]



List of CFR Sections Affected



All changes in this volume of the Code of Federal Regulations which were 
made by documents published in the Federal Register since January 1, 
1986, 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 and parts as well as 
sections for revisions.
For the period before January 1, 1986, see the ``List of CFR Sections 
Affected'', 1949-1963, 1964-1972, and 1973-1985, published in seven 
separate volumes.

                                  1986

21 CFR
                                                                   51 FR
                                                                    Page
Chapter I
Mandatory compliance date 1-1-89...................................34085
807  Authority citation revised....................................33032
807.31  (c) revised................................................33033
814  Added.........................................................26364
    Technical correction...........................................34589
    Authority citation revised.....................................43344
814.15  (b) heading correctly revised..............................40415
    Amended (OMB number)...........................................43344
814.20  (b)(3)(v) introductory text corrected......................40415
    Amended (OMB number)...........................................43344
814.39  Amended (OMB number).......................................43344
814.82  Amended (OMB number).......................................43344
814.84  Amended (OMB number).......................................43344
868  Authority citation revised....................................40388
868.5795  Added....................................................40388
868.5800  Added....................................................40389
874  Added.........................................................40389
882  Authority citation revised....................................12101
882.5830  (c) added................................................12101
    Technical correction...........................................15883
884  Authority citation revised.............................16649, 39845
884.1600  (c) added................................................39845
884.5360  (d) added................................................16649

                                  1987

21 CFR
                                                                   52 FR
                                                                    Page
Chapter I
805  Added.........................................................27763
862  Added.........................................................16122
862.1385  (a) corrected............................................29468
862.3750  (b) corrected............................................48623
864  Authority citation revised; section authority citations 
        removed....................................................17732
864.1  Revised.....................................................17732
864.3  Added.......................................................17732
864.5220  (c) added................................................17733
864.5680  (c) added................................................17733
864.7250  (c) added................................................17733
864.7300  (c) added................................................17733
864.9205  (c) added................................................17733
864.9245  (c) added................................................17733
866  Authority citation revised; section authority citations 
        removed....................................................17733
866.1  Revised.....................................................17733
866.3  Added.......................................................17733
    (b) and (c) corrected..........................................22577
866.2420  (c) added................................................17734
866.3290  (c) added................................................17734
866.3305  (c) added................................................17734
866.3510  (c) added................................................17734
866.6010  (c) added................................................17734
868  Authority citation revised; section authority citations 
        removed....................................................17734
868.1  Revised.....................................................17734
868.3  Added.......................................................17734
868.1120  (c) added................................................17735
    (c) corrected..................................................22577

[[Page 686]]

868.1150  (c) added................................................17735
868.1170  (c) added................................................17735
868.1200  (c) added................................................17735
868.2450  (c) added................................................17735
868.2500  (c) added................................................17735
868.5400  (c) added................................................17735
868.5610  (c) added................................................17735
870  Authority citation revised; section authority citations 
        removed....................................................17735
870.1  Revised.....................................................17735
870.3  Added.......................................................17735
870.1025  (c) added................................................17736
870.1350  (c) added................................................17736
870.1360  (c) added................................................17736
870.3300  (c) added................................................17736
870.3375  (c) added................................................17736
870.3450  (c) added................................................17736
870.3535  (c) added................................................17736
870.3545  (c) added................................................17736
870.3600  (c) added................................................17736
870.3610  (c) added................................................17736
870.3620  (c) added................................................17736
870.3680  (c) added................................................17736
870.3700  (c) added................................................17736
870.3710  (c) added................................................17736
870.3800  (c) added................................................17736
870.3850  (c) added................................................17736
870.3925  (c) added................................................17737
    (c) revised; eff. 12-9-87......................................18163
    (c) corrected..................................................23137
870.4230  (c) added................................................17737
870.4260  (c) added................................................17737
870.4320  (c) added................................................17737
870.4350  (c) added................................................17737
870.4360  (c) added................................................17737
870.5200  (c) added................................................17737
870.5225  (c) added................................................17737
870.5300  (c) added................................................17737
870.5550  (c) added................................................17737
872  Added.........................................................30097
872.3680  (a) corrected............................................34456
872.6080  (a), (b), and (c) corrected..............................49250
874.9  Added.......................................................32111
874.1100  Correctly designated.....................................18495
    (b) revised....................................................32111
874.3540  (b) revised..............................................32111
874.4420  (b) revised..............................................32111
874.5800  (b) revised..............................................32111
876  Authority citation revised; section authority citations 
        removed....................................................17737
876.1  Revised.....................................................17737
    (d) corrected..................................................22577
876.3  Added.......................................................17737
876.3350  (c) added................................................17738
876.3630  (c) added................................................17738
876.3750  (c) added................................................17738
876.4480  (c) added................................................17738
876.5220  (c) added................................................17738
876.5270  (c) added................................................17738
876.5280  (c) added................................................17738
876.5540  (c) added................................................17738
876.5860  (c) added................................................17738
876.5870  (c) added................................................17738
876.5955  (c) added................................................17738
880  Authority citation revised; section authority citations 
        removed....................................................17738
880.1  Revised.....................................................17738
880.3  Added.......................................................17738
880.5130  (c) added................................................17739
880.5760  (c) added................................................17739
882  Authority citation revised; section authority citations 
        removed....................................................17739
882.1  Revised.....................................................17739
882.3  Added.......................................................17739
882.1790  (c) added................................................17739
882.1825  (c) added................................................17740
882.5150  (c) added................................................17740
882.5800  (c) added................................................17740
882.5840  (c) added................................................17740
882.5850  (c) added................................................17740
882.5860  (c) added................................................17740
882.5940  (c) added................................................17740
882.5950  (c) added................................................17740
884  Authority citation revised; section authority citations 
        removed....................................................17740
884.1  Revised.....................................................17740
884.3  Added.......................................................17740
884.1060  (c) added................................................17741
884.1100  (c) added................................................17741
884.1185  (c) added................................................17741
884.2050  (c) added................................................17741
884.2620  (c) added................................................17741
884.2685  (c) added................................................17741
884.4100  (c) added................................................17741
884.4150  (c) added................................................17741
884.4250  (c) added................................................17741
884.4270  (c) added................................................17741
884.5050  (c) added................................................17741
884.5225  (c) added................................................17741
884.5380  (c) added................................................17741
    (c) revised....................................................36883
    Technical correction...........................................38171
884.5940  (c) added................................................17741
886  Added.........................................................33355

[[Page 687]]

888  Added.........................................................33702
    Technical correction...........................................36863
890  Authority citation revised; section authority citations 
        removed....................................................17741
890.1  Revised.....................................................17741
890.3  Added.......................................................17741
890.3610  (c) added................................................17742
890.3890  (c) added................................................17742
    (c) corrected..................................................22577
890.5275  (c) added................................................17742
890.5290  (c) added................................................17742
890.5300  (c) added................................................17742
890.5525  (c) added................................................17742
890.5860  (c) added................................................17742
1240  Authority citation revised...................................29514
1240.61  Added.....................................................29514

                                  1988

21 CFR
                                                                   53 FR
                                                                    Page
Chapter I
Uniform compliance date 1-1-91.....................................44861
800  Authority citation revised; section authority citations 
        removed....................................................11252
800.12  Second (c) removed.........................................11252
803.33  (b) amended................................................11252
807.22  (a) amended................................................11252
807.35  (b) amended................................................11252
807.37  (a) and (b)(2) amended.....................................11252
807.90  (a) amended................................................11252
807.95  (c)(1) amended.............................................11252
808.87  (a) amended................................................11252
808.98  (a) revised................................................35314
809.5  (a)(1), (2), (3), and (4) and (b) amended...................11252
812.2  (e) amended.................................................11252
812.19  Amended....................................................11252
812.20  (b)(9) and (d) amended.....................................11252
812.38  (d) amended................................................11253
813.20  (a) amended................................................11253
813.38  (b) and (c) amended........................................11253
813.119  (e)(2) amended............................................11253
813.160  (a) introductory text amended.............................11253
820.1  (d) amended.................................................11253
820.3  (f) amended.................................................11253
860.7  (g)(4) amended..............................................11253
860.123  (b)(1) amended............................................11253
861.32  (b) and (c)(5) amended.....................................11253
862.9  Added.......................................................21448
862.1190  (b) corrected............................................11645
    (b) revised....................................................21449
862.1210  (b) revised..............................................21449
862.1255  (b) revised..............................................21449
862.1290  (b) revised..............................................21449
862.1295  (b) corrected............................................11645
862.1305  (b) revised..............................................21449
862.1320  (b) revised..............................................21449
862.1365  (b) revised..............................................21449
862.1380  (b) revised..............................................21449
862.1420  (b) revised..............................................21449
862.1470  (b) revised..............................................21449
862.1490  (b) revised..............................................21449
862.1515  (b) revised..............................................21449
862.1565  (b) revised..............................................21449
862.1575  (b) revised..............................................21449
862.1640  (b) revised..............................................21449
862.1670  (b) revised..............................................21449
862.1680  (b) corrected............................................11645
862.1695  Redundant printing correctly removed.....................11645
862.1700  Redundant printing correctly removed.....................11645
862.1705  Redundant printing correctly removed.....................11645
862.1720  (b) corrected............................................11645
    (b) revised....................................................21449
862.1815  (b) revised..............................................21449
862.2100  (b) revised..............................................21449
862.3750  (b) revised..............................................21450
862.3850  (b) revised..............................................21450
    Technical correction...........................................25050
864.9050  (a) amended..............................................11253
864.9160  (a) amended..............................................11253
866  Technical correction..........................................16837
866.5240  (a) amended..............................................11253
866.5890  (a) amended..............................................11253
876  Technical correction..........................................16837
876.5830  (a) amended..............................................11253
878  Added.........................................................23872
882.5840  (c) revised..............................................48621
884.2980  Added.....................................................1566
    Technical correction............................................5080
884.2982  Added.....................................................1566
    Technical correction............................................5080
886.9  Added.......................................................35603
886.1040  (b) revised..............................................35603
886.1140  (b) revised..............................................35603
886.1150  (b) revised..............................................35603
    (b) corrected..................................................40825
886.1170  (b) revised..............................................35603
886.1190  (b) revised..............................................35603
886.1200  (b) revised..............................................35604
886.1270  (b) revised..............................................35604
886.1320  (b) revised..............................................35604
886.1330  (b) revised..............................................35604

[[Page 688]]

886.1350  (b) revised..............................................35604
886.1375  (b) revised..............................................35604
886.1380  (b) revised..............................................35604
886.1390  (b) revised..............................................35604
886.1395  (b) revised..............................................35604
886.1400  (b) revised..............................................35604
886.1410  (b) revised..............................................35604
886.1415  (b) revised..............................................35604
886.1420  (b) revised..............................................35604
886.1460  (b) revised..............................................35605
886.1500  (b) revised..............................................35605
886.1605  (b) revised..............................................35605
886.1650  (b) revised..............................................35605
886.1655  (b) revised..............................................35605
886.1660  (b) revised..............................................35605
886.1665  (b) revised..............................................35605
886.1700  (b) revised..............................................35605
886.1770  (b) revised..............................................35605
886.1790  (b) revised..............................................35605
    (b) corrected..................................................40825
886.1800  (b) revised..............................................35605
886.1810  (b) revised..............................................35605
886.1840  (b) revised..............................................35605
    Heading corrected..............................................40825
886.1860  (b) revised..............................................35606
886.1870  (b) revised..............................................35606
886.1880  (b) revised..............................................35606
886.1905  (b) revised..............................................35606
886.1910  (b) revised..............................................35606
886.4230  (b) revised..............................................35606
886.4335  (b) revised..............................................35606
886.4350  (b) revised..............................................35606
886.4360  (b) revised..............................................35606
886.4392  Added....................................................38947
886.4445  (b) revised..............................................35606
886.4570  (b) revised..............................................35606
886.4770  (b) revised..............................................35606
886.4855  (b) revised..............................................35606
886.5120  (b) revised..............................................35607
886.5420  (b) revised..............................................35607
886.5540  (b) revised..............................................35607
886.5600  (b) revised..............................................35607
886.5800  (b) revised..............................................35607
886.5810  (b) revised..............................................35607
886.5840  (b) revised..............................................35607
886.5844  (b) revised..............................................35607
886.5870  (b) revised..............................................35607
886.5910  (b) revised..............................................35607
886.5915  (b) revised..............................................35607
888.9  Added.......................................................52953
888.4200  (b) revised..............................................52953
888.4210  (b) revised..............................................52953
888.4220  (b) revised..............................................52954
888.4230  (b) revised..............................................52954
888.5890  (b) revised..............................................52954
888.5940  (b) revised..............................................52954
888.5980  (b) revised..............................................52954
892  Added..........................................................1567
    Technical correction............................................5080
895  Technical correction..........................................16837
895.21  (d)(1) amended.............................................11254
1002  Technical correction.........................................16837
1002.7  Nomenclature change........................................11254
1002.10  Introductory text amended.................................11254
1002.20  (a) and (b) introductory text and (5) amended.............11254
1002.31  (c) amended...............................................11254
1002.41  (a)(1) amended............................................11254
1002.50  (a) introductory text and (b) amended.....................11254
1002.51  Amended...................................................11254
1005.11  Amended...................................................11254
1005.25  (b) and (c) amended.......................................11254
1010  Authority citation revised...................................52683
1010.2  (c) and (d) amended........................................11254
1010.3  (a)(1) and (2)(i), (b), and (c) amended....................11254
1010.4  (a) introductory text, (b)(1)(viii), (c)(1) and (3) 
        amended....................................................11254
    (a) revised; (c)(2) removed; (c)(3) and (4) redesignated as 
(c)(2) and (3).....................................................52683
1010.5  (a) introductory text, (b), (c)(12), and (e)(1) and (2) 
        amended....................................................11254
1010.13  Amended...................................................11254
1020.30  (c) and (d) introductory text and (3)(ii) amended.........11254
1020.32  (a)(1) amended............................................11254
1030  Authority citation revised...................................11254
1030.10  (c)(4)(iv), (5)(iv), and (6)(iii), (iv) introductory text 
        and (d) amended............................................11254
1040.30  (c)(1)(ii) amended........................................11254
1050  Authority citation revised...................................11255
1050.10  (d)(5) amended............................................11255

                                  1989

21 CFR
                                                                   54 FR
                                                                    Page
Chapter I
800  Authority citation revised....................................39640

[[Page 689]]

801  Authority citation revised; sectional authority citations 
        removed....................................................39640
801.420  (c)(4) amended; eff. 6-19-90..............................52396
801.430  (e) and (f) redesignated as (g) and (h); (b), (d) 
        introductory text, (2), (3) and (4), new (g), and new (h) 
        revised; new (e) and new (f) added.........................43771
803  Authority citation revised....................................39640
805  Authority citation revised....................................39640
807  Authority citation revised; sectional authority citations 
        removed....................................................39640
808  Authority citation revised....................................39640
809  Authority citation revised; sectional authority citations 
        removed....................................................39640
812  Authority citation revised; sectional authority citations 
        removed....................................................39640
813  Authority citation revised; sectional authority citations 
        removed....................................................39641
814  Authority citation revised....................................39641
820  Authority citation revised....................................39641
860  Authority citation revised....................................39641
861  Authority citation revised....................................39641
861.26  Authority citation removed.................................39641
862  Authority citation revised....................................39641
862.1113  Added....................................................30206
864  Authority citation revised....................................39641
864.9  Added.......................................................25043
    Effective date added...........................................26958
864.1850  (b) revised..............................................25044
    Effective date added...........................................26958
864.2220  (b) revised..............................................25044
    Effective date added...........................................26958
864.2240  (b) revised..............................................25044
    Effective date added...........................................26958
864.2260  (b) revised..............................................25044
    Effective date added...........................................26958
864.2360  (b) revised..............................................25044
    Effective date added...........................................26958
864.2800  (b) revised..............................................25044
    Effective date added...........................................26958
864.2875  (b) revised..............................................25044
    Effective date added...........................................26958
864.3010  (b) revised..............................................25044
    Effective date added...........................................26958
864.3250  (b) revised..............................................25044
    Effective date added...........................................26958
    Revised........................................................47206
864.3300  (b) revised..............................................25044
    Effective date added...........................................26958
864.3400  (b) revised..............................................25044
    Effective date added...........................................26958
864.3600  (b) revised..............................................25044
    Effective date added...........................................26958
864.3800  (b) revised..............................................25044
    Effective date added...........................................26958
864.3875  (b) revised..............................................25045
    Effective date added...........................................26958
864.4010  (b) revised..............................................25045
    Effective date added...........................................26958
864.4400  (b) revised..............................................25045
    Effective date added...........................................26958
864.5800  (b) revised..............................................25045
    Effective date added...........................................26958
864.5850  (b) revised..............................................25045
    Effective date added...........................................26958
864.6150  (b) revised..............................................25045
    Effective date added...........................................26958
864.6160  (b) revised..............................................25045
    Effective date added...........................................26958
864.6600  (b) revised..............................................25045
    Effective date added...........................................26958
864.6700  (b) revised..............................................25045
    Effective date added...........................................26958
864.8200  (b) revised..............................................25045
    Effective date added...........................................26958
864.8540  (b) revised..............................................25045
    Effective date added...........................................26958
866  Authority citation revised....................................39641
866.9  Added.......................................................25045
    Effective date added...........................................26958
866.2050  (b) revised..............................................25045
    Effective date added...........................................26958
866.2170  (b) revised..............................................25045
    Effective date added...........................................26958
866.2300  (b) revised..............................................25046
    Effective date added...........................................26958
866.2320  (b) revised..............................................25046
    Effective date added...........................................26958
866.2330  (b) revised..............................................25046
    Effective date added...........................................26958
866.2350  (b) revised..............................................25046
    Effective date added...........................................26958

[[Page 690]]

866.2360  (b) revised..............................................25046
    Effective date added...........................................26958
866.2450  (b) revised..............................................25046
    Effective date added...........................................26958
866.2480  (b) revised..............................................25046
    Effective date added...........................................26958
866.2500  (b) revised..............................................25046
    Effective date added...........................................26958
866.2560  (b) revised..............................................25046
    Effective date added...........................................26958
866.2580  (b) revised..............................................25046
    Effective date added...........................................26958
866.3010  (b) revised..............................................25046
    Effective date added...........................................26958
866.3020  (b) revised..............................................25046
    Effective date added...........................................26958
866.3035  (b) revised..............................................25046
    Effective date added...........................................26958
866.3065  (b) revised..............................................25046
    Effective date added...........................................26958
866.3125  (b) revised..............................................25046
    Effective date added...........................................26958
866.3205  (b) revised..............................................25046
    Effective date added...........................................26958
866.3250  (b) revised..............................................25046
    Effective date added...........................................26958
866.3255  (b) revised..............................................25046
    Effective date added...........................................26958
866.3270  (b) revised..............................................25046
    Effective date added...........................................26958
866.3330  (b) revised..............................................25047
    Effective date added...........................................26958
866.3340  (b) revised..............................................25047
    Effective date added...........................................26958
866.3400  (b) revised..............................................25047
    Effective date added...........................................26958
866.3410  (b) revised..............................................25047
    Effective date added...........................................26958
866.3470  (b) revised..............................................25047
    Effective date added...........................................26958
866.3490  (b) revised..............................................25047
    Effective date added...........................................26958
866.3520  (b) revised..............................................25047
    Effective date added...........................................26958
866.3630  (b) revised..............................................25047
    Effective date added...........................................26958
866.3700  (b) revised..............................................25047
    Effective date added...........................................26958
866.4500  (b) revised..............................................25047
    Effective date added...........................................26958
866.4520  (b) revised..............................................25047
    Effective date added...........................................26958
866.4540  (b) revised..............................................25047
    Effective date added...........................................26958
866.4600  (b) revised..............................................25047
    Effective date added...........................................26958
866.4830  (b) revised..............................................25047
    Effective date added...........................................26958
866.4900  (b) revised..............................................25047
    Effective date added...........................................26958
866.5800  (b) revised..............................................25047
    Effective date added...........................................26958
868  Authority citation revised....................................39641
868.9  Added.......................................................25047
    Effective date added...........................................26958
868.1030  (b) revised..............................................25048
    Effective date added...........................................26958
868.1930  (b) revised..............................................25048
    Effective date added...........................................26958
868.1965  (b) revised..............................................25048
    Effective date added...........................................26958
868.2480  Added....................................................27160
868.5220  (b) revised..............................................25048
    Effective date added...........................................26958
868.5280  (b) revised..............................................25048
    Effective date added...........................................26958
868.5365  (b) revised..............................................25048
    Effective date added...........................................26958
868.5420  (b) revised..............................................25048
    Effective date added...........................................26958
868.5560  (b) revised..............................................25048
    Effective date added...........................................26958
868.5760  (b) revised..............................................25048
    Effective date added...........................................26958
868.6100  (b) revised..............................................25048
    Effective date added...........................................26958
868.6175  (b) revised..............................................25048
    Effective date added...........................................26958
868.6225  (b) revised..............................................25048
    Effective date added...........................................26958
868.6700  (b) revised..............................................25049
    Effective date added...........................................26958
870  Authority citation revised....................................39641
870.9  Added.......................................................25049
    Effective date added...........................................26958
870.3730  (b) revised..............................................25049
    Effective date added...........................................26958
870.4200  (b) revised..............................................25049
    Effective date added...........................................26958
870.4500  (b) revised..............................................25049
    Effective date added...........................................26958
872  Authority citation revised....................................39641
872.9  Added.......................................................13829
872.1730  (b) revised..............................................13830
872.1905  (b) revised..............................................13830
872.3080  (b) revised..............................................13830
872.3110  (b) revised..............................................13830

[[Page 691]]

872.3140  (b) revised..............................................13830
872.3150  (b) revised..............................................13830
872.3220  (b) revised..............................................13830
872.3830  (b) revised..............................................13830
872.3840  (b) revised..............................................13830
872.3850  (b) revised..............................................13830
872.4565  (b) revised..............................................13830
872.6010  (b) revised..............................................13830
872.6050  (b) revised..............................................13830
872.6200  (b) revised..............................................13830
872.6290  (b) revised..............................................13831
872.6390  (b) revised..............................................13831
872.6570  (b) revised..............................................13831
872.6650  (b) revised..............................................13831
872.6670  (b) revised..............................................13831
872.6855  (b) revised..............................................13831
872.6870  (b) revised..............................................13831
872.6880  (b) revised..............................................13831
874  Authority citation revised....................................39641
876  Authority citation revised....................................39641
876.9  Added.......................................................25049
    Effective date added...........................................26958
876.4370  (b)(2) revised...........................................25049
    Effective date added...........................................26958
876.4530  (b) revised..............................................25049
    Effective date added...........................................26958
876.4560  (b) revised..............................................25049
    Effective date added...........................................26958
876.4730  (b) revised..............................................25049
    Effective date added...........................................26958
876.4890  (b)(2) revised...........................................25050
    Effective date added...........................................26958
876.5030  (b) revised..............................................25050
    Effective date added...........................................26958
876.5820  (b)(2) revised...........................................25050
    Effective date added...........................................26958
876.5900  (b) revised..............................................25050
    Effective date added...........................................26958
876.5920  (b) revised..............................................25050
    Effective date added...........................................26958
878  Authority citation revised....................................39641
878.9  Added.......................................................13827
    (b) corrected................................................16438-T
878.1800  (b) revised..............................................13827
878.3250  (b) revised..............................................13827
878.3910  (b) revised..............................................13827
878.3925  (b) revised..............................................13827
878.4160  (b) revised..............................................13827
878.4800  (b) revised..............................................13827
878.4830  Added....................................................50738
878.4950  (b) revised..............................................13828
878.5900  (b) revised..............................................13828
880  Authority citation revised....................................39641
880.9  Added.......................................................25050
    Effective date added...........................................26958
880.5110  (b) revised..............................................25050
    Effective date added...........................................26958
880.5120  (b) revised..............................................25050
    Effective date added...........................................26958
880.5510  (b) revised..............................................25050
    Effective date added...........................................26958
880.6150  (b) revised..............................................25050
    Effective date added...........................................26958
880.6175  Removed..................................................47206
880.6250  (b) revised; eff. 4-13-89.................................1604
    Technical correction............................................6804
880.6280  (b) revised..............................................25050
    Effective date added...........................................26958
880.6970  (b) revised..............................................25050
    Effective date added...........................................26958
882  Authority citation revised....................................39641
882.9  Added.......................................................25051
    Effective date added...........................................26958
882.1200  (b) revised..............................................25051
    Effective date added...........................................26958
882.1500  (b) revised..............................................25051
    Effective date added...........................................26958
882.1525  (b) revised..............................................25051
    Effective date added...........................................26958
882.1700  (b) revised..............................................25051
    Effective date added...........................................26958
882.1750  (b) revised..............................................25051
    Effective date added...........................................26958
882.4215  (b) revised..............................................25051
    Effective date added...........................................26958
882.4650  (b) revised..............................................25051
    Effective date added...........................................26958
884  Authority citation revised....................................39641
884.9  Added.......................................................25051
    Effective date added...........................................26958
884.2900  (b) revised..............................................25052
    Effective date added...........................................26958
884.4520  (b) revised..............................................25052
    Effective date added...........................................26958
884.5920  (b) revised..............................................25052
    Effective date added...........................................26958
886  Authority citation revised....................................39641
888  Authority citation revised....................................39641
888.3353  Added....................................................48239
    (a) corrected..................................................51342
890  Authority citation revised....................................39641

[[Page 692]]

890.9  Added.......................................................25052
    Effective date added...........................................26958
890.3700  (b) revised..............................................25052
    Effective date added...........................................26958
890.5125  (b) revised..............................................25052
    Effective date added...........................................26958
892  Authority citation corrected...................................6804
    Authority citation revised.....................................39641
892.9  Added.......................................................13831
892.1000  Added.....................................................5078
892.1370  (b) revised..............................................13832
892.1380  (b) revised..............................................13832
892.1400  (b) revised..............................................13832
892.1420  (b) revised..............................................13832
895  Authority citation revised....................................39641
895.101  Authority citation removed................................39641
1000  Authority citation revised...................................39642
1000.50  Authority citation removed................................39641
1002  Authority citation revised; sectional authority citations 
        removed....................................................39642
1003  Authority citation revised; sectional authority citations 
        removed....................................................39642
1004  Authority citation revised...................................39642
1005  Authority citation revised; sectional authority citations 
        removed....................................................39642
1010  Authority citation revised; sectional authority citations 
        removed....................................................39642
1020  Authority citation revised...................................39642
1020.33  Authority citation removed................................39642
1030  Authority citation revised...................................39642
1040  Authority citation revised...................................39642
1040.30  Authority citation removed................................39642
1050  Authority citation revised...................................39642
1210  Authority citation revised...................................39642
1220  Authority citation revised...................................39642
1220.40  Authority citation removed................................39642
1230  Authority citation revised...................................39642
1240  Cross-references revised.....................................24900
    Authority citation revised.....................................39642
1240.10  (f) amended...............................................24900
1240.62  (c)(1)(i) through (v) and (2) amended.....................24900
1240.70  (a) revised...............................................24900
1250  Cross-references revised.....................................24900
    Authority citation revised.....................................39642
1250.51  (d), (f)(1), (2), (3) introductory text, and (4)(i) and 
        (iii) amended..............................................24900

                                  1990

21 CFR
                                                                   55 FR
                                                                    Page
Chapter I
800.20  Added......................................................51256
801  Policy statement...............................................7491
    Technical correction...........................................10347
801.420  Technical correction........................................548
801.430  (f)(2) amended; (f)(2) figure 1 revised...................17600
803.33  (b) amended................................................11168
807.22  (a) amended................................................11169
807.37  (a) and (b)(2) amended.....................................11169
807.90  (a) revised................................................11169
812.19  Amended....................................................11169
813.20  (a) amended................................................11169
814.20  (h) amended................................................11169
820.1  (d) amended.................................................11169
860.123  (b)(1) amended............................................11169
864.5220  (b) and (c) revised......................................23511
872.3100  Added....................................................48439
872.3530  Added....................................................48439
872.4200  Added....................................................48439
872.4620  Added....................................................48439
872.6250  Added....................................................48439
872.6475  Added....................................................48439
872.6510  Added....................................................48439
872.6640  Added....................................................48439
872.6710  Added....................................................48439
872.6865  Added....................................................48440
874.1070  Added....................................................48440
874.1800  Added....................................................48440
874.4750  Added....................................................48440
874.4770  Added....................................................48440
874.5300  Added....................................................48440
874.5550  Added....................................................48440
878.4635  Added....................................................48440
878.4700  Added....................................................48440
878.4820  Added....................................................48440
878.4960  Added....................................................48440
884.2980  (a) added................................................48440

[[Page 693]]

884.2982  (a) revised..............................................48441
886.1050  Added....................................................48441
886.1070  Added....................................................48441
886.1090  Added....................................................48441
886.1120  Added....................................................48441
886.1140  Revised..................................................48441
886.1160  Added....................................................48441
886.1250  Revised..................................................48441
886.1290  Added....................................................48441
886.1300  Added....................................................48441
886.1340  Added....................................................48441
886.1350  Revised..................................................48441
886.1425  Added....................................................48442
886.1430  Added....................................................48442
886.1435  Added....................................................48442
886.1450  Added....................................................48442
886.1605  Revised..................................................48442
886.1680  Added....................................................48442
886.1690  Added....................................................48442
886.1700  Revised..................................................48442
886.1780  Revised..................................................48442
    (a) corrected..................................................51799
886.1810  Revised..................................................48442
886.1860  Revised..................................................48442
886.1870  Revised..................................................48442
886.1910  Revised..................................................48442
    (a) corrected..................................................51799
886.1940  Added....................................................48443
886.1945  Revised..................................................48443
886.4070  Revised..................................................48443
    (a) corrected..................................................51799
886.4250  Revised..................................................48443
886.4335  Revised..................................................48443
886.4370  Revised..................................................48443
886.4855  Revised..................................................48443
886.5820  Added....................................................48443
886.5900  Revised..................................................48443
886.5915  Revised..................................................48443
888.1500  Added....................................................48443
888.5960  Added....................................................48443
892.1100  Added....................................................48443
892.1110  Added....................................................48444
892.1130  Added....................................................48444
892.1300  Added....................................................48444
892.1320  Added....................................................48444
892.1330  Added....................................................48444
892.1350  Added....................................................48444
892.1410  Added....................................................48444
892.1640  Added....................................................48444
892.1890  Added....................................................48444
892.1900  Added....................................................48444
892.1970  Added....................................................48444
1220.40  (a) revised...............................................33671
    Correctly designated...........................................34797

                                  1991

21 CFR
                                                                   56 FR
                                                                    Page
Chapter I
801  Policy statement corrected.....................................2677
812  Clarification.................................................29177
    Regulation at 29177 corrected..................................32241
    Extension of applicability.....................................35815
878  Technical corrections.........................................36871
878.3540  (c) revised..............................................14627
878.4493  Added....................................................47151
878.5000  Added....................................................24685
878.5010  Added....................................................24685
878.5020  Added....................................................24685
1020  Authority citation revised...................................36098
1020.33  (f)(2)(ii) removed; (f)(2)(iii) redesignated as 
        (f)(2)(ii).................................................36098
1220.40  (a) revised...............................................50250

                                  1992

21 CFR
                                                                   57 FR
                                                                    Page
Chapter I
807.3  (n) through (q) added; interim..............................18066
    Regulation at 57 FR 18066 stayed...............................23059
807.87  (h) redesignated as (k); new (h), (i) and (j) added; 
        interim....................................................18066
    Regulation at 57 FR 18066 stayed...............................23059
    (i)(2) corrected...............................................29354
807.92  Added; interim.............................................18066
    Regulation at 57 FR 18066 stayed...............................23059
807.93  Added; interim.............................................18067
    Regulation at 57 FR 18067 stayed...............................23059
807.94  Added; interim.............................................18067
    Regulation at 57 FR 18067 stayed...............................23059
807.95  (c)(3) removed; (d) redesignated as (e); new (d) added; 
        interim....................................................18067
    Regulation at 57 FR 18067 stayed...............................23059
807.100  Added.....................................................58403
812  Extension of applicability.............................12875, 29001
814.44  (a) revised................................................58403
821  Added.........................................................22967
860.3  (c)(1) amended; (c)(2) and (3) revised......................58403

[[Page 694]]

860.84  (a) amended................................................58404
860.120  (c) amended...............................................58404
860.130  (e) and (f) amended; (c) through (f) redesignated as (d) 
        through (g); new (c) added.................................58404
860.134  Heading, (a) introductory text, and (b)(3) revised........58404
861  Authority citation revised....................................58404
861.1  (a) and (b) revised.........................................58404
861.20  Revised....................................................58404
861.22  Removed....................................................58405
861.24  (a) introductory text and (b) revised......................58405
861.26  Removed....................................................58405
861.28  Removed....................................................58405
861.30  Revised....................................................58405
861.32  Removed....................................................58405
861.36  (c) amended................................................58405
861.38  (b)(2) revised.............................................58405
895.20  Amended....................................................58405
895.21  (b), (d)(4) and (8) revised................................58405
895.30  (c) and (d) amended........................................58405
1220.40  (a) revised...............................................38771
1240.3  (i) through (p) redesignated as (k) through (r); new (i) 
        and new (j) added..........................................57344
1240.61  (a) revised...............................................57344

                                  1993

21 CFR
                                                                   58 FR
                                                                    Page
Chapter I
804  Opportunity for comment.......................................46514
    Added..........................................................46519
807  Opportunity for comment.......................................46514
    Heading and authority citation revised.........................46522
807.3  (d)(2) and (g) revised; (e)(3) and (4) amended; (e)(5) 
        added......................................................46522
807.20  (a)(4) revised; (c) and (d) added..........................46522
807.21  Revised....................................................46522
807.22  (a) and (c) revised........................................46522
807.25  (b) revised................................................46523
807.65  (e) revised; (g) removed...................................46523
821  Opportunity for comment.......................................43442
    Revised........................................................43447
    Authority citation revised.....................................43455
    Regulation at 58 FR 43447 and 43455 comment period extended....48599
    Technical correction...........................................52440
821.20  (b)(1) table and (c) table amended.........................43455
864.5680  (b) revised; (c) removed.................................51571
874.4490  Revised..................................................29534
878  Authority citation revised....................................57558
878.5030  Added....................................................57558
888.3358  Added.....................................................3228
890.3450  Removed..................................................29535
900 (Subchapter I)  Added; interim.................................67562
900.10--900.14 (Subpart B)  Added; interim.........................67570
1020  Authority citation revised...................................26396
1020.30  Revised; eff. in part 5-3-94..............................26396
1020.31  Revised; eff. in part 5-3-94..............................26401
    (c)(2) corrected...............................................31067
1020.32  Revised...................................................26404
1220.40  (a) revised...............................................64137
1270  Added; interim...............................................65520

                                  1994

21 CFR
                                                                   59 FR
                                                                    Page
Chapter I
Nomenclature changes...............................................14366
807.3  (n) amended; (o) and (q) revised............................64295
807.87  (i)(2) and (j) amended.....................................64295
807.92  (a) introductory text, (3) through (6) and (b) amended; 
        (d) added..................................................64295
807.93  Revised....................................................64295
807.94  Revised....................................................64296
807.95  (d) revised................................................64296
808.20  (b) amended................................................14365
812  Notice of applicability.......................................52078
821.2  (b) introductory text amended...............................31138
821.20  (c)  table corrected.......................................15052
864.5350  (b) revised..............................................63007
864.7660  (b) revised..............................................63007
864.7675  (b) revised..............................................63007
864.7900  (b) revised..............................................63007
864.8500  (b) revised..............................................63007
866.5170  (b) revised..............................................63007
866.5220  (b) revised..............................................63007

[[Page 695]]

866.5230  (b) revised..............................................63007
866.5360  (b) revised..............................................63007
866.5370  (b) revised..............................................63007
866.5540  (b) revised..............................................63007
866.5700  (b) revised..............................................63007
868.5340  (b) revised..............................................63007
868.5350  (b) revised..............................................63007
870.1875  (a)(2) revised...........................................63007
872.1500  (b) revised..............................................63007
872.1820  (b) revised..............................................63008
872.3100  (b) amended..............................................63008
872.3130  (b) revised..............................................63008
872.3165  (b) revised..............................................63008
872.3240  (b) revised..............................................63008
872.3285  (b) revised..............................................63008
872.3330  (b) revised..............................................63008
872.3350  (b) revised..............................................63008
872.3360  (b) revised..............................................63008
872.3410  (b) revised..............................................63008
872.3450  (b) revised..............................................63008
872.3490  (b) revised..............................................63008
872.3520  (b) revised..............................................63008
872.3530  (b) revised..............................................63008
872.3580  (b) revised..............................................63008
872.3670  (b) revised..............................................63008
872.3900  (b) revised..............................................63008
872.3910  (b) revised..............................................63008
872.3940  Added....................................................65478
872.3950  Added....................................................65478
872.3960  Added....................................................65478
872.3970  Added....................................................65478
872.4130  (b) revised..............................................63008
872.4535  (b) revised..............................................63008
872.4620  (b) revised..............................................63008
872.4730  (b) revised..............................................63008
872.5410  (b) revised..............................................63009
872.5525  (b) revised..............................................63009
872.5550  (b)(1) revised...........................................63009
872.6030  (b) revised..............................................63009
872.6140  (b) revised..............................................63009
872.6250  (b) revised..............................................63009
872.6300  (b) revised..............................................63009
872.6475  (b) revised..............................................63009
872.6510  (b) revised..............................................63009
872.6640  (b) revised..............................................63009
872.6865  (b) revised..............................................63009
872.6890  (b) revised..............................................63009
874.3375  (b) revised..............................................63009
874.4750  (b) revised..............................................63009
874.5220  (b) revised..............................................63009
874.5800  (b) revised..............................................63009
876.5970  (b) revised..............................................63010
878.1800  (b) revised..............................................63010
878.3750  (b) revised..............................................63010
878.3800  (b) revised..............................................63010
878.3900  (b) revised..............................................63010
878.4100  (b) revised..............................................63010
878.4380  (b) revised..............................................63010
878.4440  (b) revised..............................................63010
878.4470  (b) revised..............................................63010
878.4635  (b) revised..............................................63010
878.4660  (b) revised..............................................63010
878.4700  (b) revised..............................................63010
878.4730  (b) revised..............................................63010
878.4800  (b) revised..............................................63010
878.4930  (b) revised..............................................63010
878.4950  (b) revised..............................................63010
878.5900  (b) revised..............................................63010
880.2400  (b) revised..............................................63010
880.2720  (b)(1) revised...........................................63011
880.5180  (b) revised..............................................63011
880.5210  (b) revised..............................................63011
880.5240  (b) revised..............................................63011
880.5630  (b) revised..............................................63011
880.5740  (b) revised..............................................63011
880.5780  (b)(2) revised...........................................63011
880.5950  (b) revised..............................................63011
880.6060  (b) revised..............................................63011
880.6150  (b) revised..............................................63011
880.6190  (b) revised..............................................63011
880.6900  (b) revised..............................................63011
882.1430  (b) revised..............................................63011
882.1700  (b) revised..............................................63011
882.1925  (b) revised..............................................63011
882.4030  (b) revised..............................................63011
882.4125  (b) revised..............................................63012
882.4190  (b) revised..............................................63012
882.4200  (b) revised..............................................63012
882.4215  (b) revised..............................................63012
882.4440  (b) revised..............................................63012
882.4500  (b) revised..............................................63012
882.4525  (b) revised..............................................63012
882.4535  (b) revised..............................................63012
882.4600  (b) revised..............................................63012
882.4900  (b) revised..............................................63012
884.5320  Added....................................................67187
886.1040  (b) revised..............................................63012
886.1050  (b) revised..............................................63012
886.1070  (b) revised..............................................63012
886.1090  (b) revised..............................................63012
886.1140  (b) revised..............................................63012
886.1160  (b) revised..............................................63012
886.1250  (b) revised..............................................63012
886.1290  (b) revised..............................................63012
886.1340  (b) revised..............................................63012
886.1350  (b) revised..............................................63012
886.1425  (b) revised..............................................63013
886.1430  (b) revised..............................................63013
886.1435  (b) revised..............................................63013
886.1450  (b) revised..............................................63013

[[Page 696]]

886.1660  (b) revised..............................................63013
886.1680  (b) revised..............................................63013
886.1690  (b) revised..............................................63013
886.1700  (b) revised..............................................63013
886.1810  (b) revised..............................................63013
886.1860  (b) revised..............................................63013
886.1870  (b) revised..............................................63013
886.1910  (b) revised..............................................63013
886.1945  (b) revised..............................................63013
886.4250  (b) revised..............................................63013
886.4350  (b) revised..............................................63013
886.4360  (b) revised..............................................63013
886.4570  (b) revised..............................................63013
886.4750  (b) revised..............................................63014
886.4855  (b) revised..............................................63014
886.5820  (b) revised..............................................63014
886.5840  (b) revised..............................................63014
886.5842  (b) revised..............................................63014
886.5844  (b) revised..............................................63014
886.5900  (b) revised..............................................63014
886.5915  (b) revised..............................................63014
886.5916  (b) and (c) revised; eff. 4-4-94.........................10284
886.5925  (b) and (c) revised; eff. 4-4-94.........................10284
888.4200  (b) revised..............................................63014
888.4210  (b) revised..............................................63014
888.4230  (b) revised..............................................63014
888.4540  (b) revised..............................................63014
888.5940  (b) revised..............................................63014
890.1175  (b) revised..............................................63014
890.3100  (b) revised..............................................63014
890.3750  (b) revised..............................................63014
890.3920  (b) revised..............................................63014
890.3940  (b) revised..............................................63015
890.5765  (b) revised..............................................63015
892.1130  (b) revised..............................................63015
892.1350  (b) revised..............................................63015
892.1640  (b) revised..............................................63015
892.5740  (b) revised..............................................63015
900  Workshop......................................................53586
    Technical correction...........................................60051
900.2  (f) corrected................................................6899
    (e) revised; (r) and (s) added; interim........................49812
900.12  (d)(1) corrected............................................6899
    (d)(1)(i) revised; interim.....................................49812
900.18  Added; interim.............................................49812
1010.4  (b) introductory text amended..............................14365
1010.5  (c) introductory text amended..............................14365
1020.30  (b) amended...............................................26403
1020.32  (d) revised; (e) through (h) redesignated as (f) through 
        (i); new (e) added.........................................26404
1030.10  (c)(6)(iv) amended........................................14365
1220.40  (a) revised...............................................35253
1240.62  (e) amended...............................................14366
1250.51  (f)(4)(ii) amended........................................14366
1270  Workshop.....................................................29950

                                  1995

21 CFR
                                                                   60 FR
                                                                    Page
Chapter I
803  Revised; eff. 4-11-96.........................................63597
807.3  (r) added; eff. 4-11-96.....................................63606
807.20  (a)(6) added; eff. 4-11-96.................................63606
807.22  (a) revised; eff. 4-11-96..................................63606
807.40  Revised; eff. 4-11-96......................................63606
862.2310  (b) revised..............................................38899
862.2320  (b) revised..............................................38900
862.2485  (b) revised..............................................38900
862.2720  (b) revised..............................................38900
862.2800  (b) revised..............................................38900
862.2920  (b) revised..............................................38900
866  Compliance date extension.....................................54942
866.2560  (b) revised..............................................38482
872.3740  (b) revised..............................................38900
872.3810  (b) revised..............................................38900
872.6100  (b) revised..............................................38900
876  Authority citation revised....................................17216
876.3750  (c) revised..............................................17216
882.5800  (c) revised..............................................43969
886.4350  (b) corrected............................................15872
892.1990  Added....................................................36639
900  Technical correction...........................................3451
1000  Authority citation revised...................................48380
1000.3  Revised....................................................48380
1002  Authority citation revised...................................48382
1002.1  Revised....................................................48382
1002.2  Removed....................................................48385
1002.3  Revised....................................................48385
1002.7  Introductory text and (b) amended; (c) added...............48385
1002.10--1002.13 (Subpart B)  Revised..............................48386
1002.20  (c) amended...............................................48386
1002.30  (a) introductory text amended; (a)(5) added...............48386
1002.31  (c) amended...............................................48386
1002.40  (a) revised...............................................48386
1002.50  Revised...................................................48387
1002.61 (Subpart G)  Removed.......................................48387
1220.40  (a) revised...............................................29987

[[Page 697]]

1240.3  (r) revised; (s), (t) and (u) added; eff. 12-18-97.........65201
1240.60  Heading revised; existing text designated as (a) and 
        amended; (b), (c) and (d) added; eff. 12-18-97.............65202
1270  Workshop.....................................................27406

                                  1996

21 CFR
                                                                   61 FR
                                                                    Page
Chapter I
801.63  Added; interim.............................................20101
801.126  Added; eff. 8-28-97.......................................44615
801.403  Removed...................................................37683
801.408  Removed...................................................37683
801.425  Removed; interim..........................................20101
801.427  Removed...................................................37683
801.433  Added; interim............................................20101
803  Regulation at 60 FR 63597 eff. date delayed to 7-31-96........16043
803.3  (n)(4) stayed...............................................38347
803.19  (f) and (g) added; eff. 8-28-97............................44615
803.55  (b)(9) and (10) stayed.....................................39869
803.57  Stayed.....................................................38347
803.58  Stayed.....................................................38347
804.25  (c) added; eff. 8-28-97....................................44615
804.30  Removed....................................................38347
807  Technical correction..........................................47550
807.3  Regulation at 60 FR 63606 eff. date delayed to 7-31-96......16043
    (r) stayed.....................................................38347
807.20  Regulation at 60 FR 63606 eff. date delayed to 7-31-96.....16043
    (a)(6) stayed..................................................38347
807.22  Regulation at 60 FR 63606 eff. date delayed to 7-31-96.....16043
807.40  Regulation at 60 FR 63606 eff. date delayed to 7-31-96.....16043
    Stayed.........................................................38347
807.65  (j) added; eff. 8-28-97....................................44615
808  Authority citation revised....................................52654
808.1  (d)(10) added; eff. 6-1-97..................................52654
810  Added; eff. 5-19-97...........................................59018
812  Authority citation revised....................................52654
812.1  (a) amended; eff. 6-1-97....................................52654
812.20  (a)(1) revised; (a)(4) added...............................51530
812.35  (a) amended................................................51531
812.38  (b)(4) added...............................................51531
812.47  Added......................................................51531
812.140  (a)(3) introductory text revised; (a)(3)(i) amended.......57280
814  Authority citation revised....................................51531
814.3  (k) and (l) added...........................................15190
    (m) and (n) added..............................................33244
814.9  (d) redesignated as (d)(1); (d)(2) added....................51531
814.47  Added......................................................15190
814.100--814.126 (Subpart H)  Added................................33244
814.102  Stayed....................................................55741
814.104  Stayed....................................................55741
814.106  Stayed....................................................55741
814.108  Stayed....................................................55741
814.110  (a) stayed................................................55741
814.112  (b) stayed................................................55741
814.116  (b) stayed................................................55741
814.118  (d) stayed................................................55741
814.120  (b) stayed................................................55741
814.124  (b) stayed................................................55741
814.126  (b)(1) stayed.............................................55741
820  Technical correction..........................................47550
    Revised; eff. 6-1-97...........................................52654
820.1  (f) added; eff. 8-28-97.....................................44615
862.2230  (b) revised...............................................1119
866.2160  (b) revised...............................................1119
866.3720  (b) revised...............................................1119
866.5520  (b) revised...............................................1119
866.5530  (b) revised...............................................1119
866.5860  (b) revised...............................................1119
868.1100  (b) revised...............................................1119
868.1575  (b) revised...............................................1119
868.1870  (b) revised...............................................1119
868.1975  (b) revised...............................................1119
868.2300  (b) revised...............................................1119
868.2320  (b) revised...............................................1119
868.2340  (b) revised...............................................1119
868.2350  (b) revised...............................................1119
868.2610  (b) revised...............................................1119
868.2620  (b) revised...............................................1119
868.2700  (b) revised...............................................1119
868.2875  (b) revised...............................................1119
868.2885  (b) revised...............................................1119
868.2900  (b) revised...............................................1120
868.5100  (b) revised...............................................1120
868.5110  (b) revised...............................................1120
868.5240  (b) revised...............................................1120
868.5300  (b) revised...............................................1120
868.5310  (b) revised...............................................1120
868.5320  (b) revised...............................................1120
868.5375  (b) revised...............................................1120

[[Page 698]]

868.5400  (c) revised..............................................50706
868.5460  (b) revised...............................................1120
868.5530  (b) revised...............................................1120
868.5540  (b) revised...............................................1120
868.5550  (b) revised...............................................1120
868.5570  (b) revised...............................................1120
868.5580  (b) revised...............................................1120
868.5590  (b) revised...............................................1120
868.5600  (b) revised...............................................1120
868.5770  (b) revised...............................................1120
868.5780  (b) revised...............................................1120
868.5790  (b) revised...............................................1120
868.5810  (b) revised...............................................1120
868.5820  (b) revised...............................................1120
868.5860  (b) revised...............................................1120
868.5975  (b) revised...............................................1120
868.5995  (b) revised...............................................1120
868.6400  (b) revised...............................................1121
868.6820  (b) revised...............................................1121
868.6885  (b) revised...............................................1121
870.1350  (c) revised..............................................50706
870.1360  (c) revised..............................................50706
870.2390  (b) revised...............................................1121
870.2600  (b) revised...............................................1121
870.2620  (b) revised...............................................1121
870.2640  (b) revised...............................................1121
870.2810  (b) revised...............................................1121
870.3650  (b) revised...............................................1121
870.3670  (b) revised...............................................1121
870.3690  (b) revised...............................................1121
870.3850  (c) revised..............................................50706
870.3935  (b) revised...............................................1121
870.3945  (b) revised...............................................1121
870.5300  (c) revised..............................................50706
872.1840  (b) revised...............................................1121
872.1850  (b) revised...............................................1121
872.3400  (c) revised..............................................50706
872.3420  (c) revised..............................................50707
872.3480  (c) revised..............................................50707
872.3500  (c) revised..............................................50707
872.3560  (c) revised..............................................50707
872.3820  (c) revised..............................................50707
872.4630  (b) revised...............................................1121
872.6390  (b) revised...............................................1121
874.1060  (b) revised...............................................1121
874.1080  (b) revised...............................................1121
874.4140  (b) revised...............................................1122
874.4175  (b) revised...............................................1122
874.4350  (b) revised...............................................1122
874.4770  (b) revised...............................................1122
876  Authority citation revised..............................1122, 50707
876.1075  (b) revised...............................................1122
876.1400  (b) revised...............................................1122
876.1500  (b) revised...............................................1122
876.1800  (b) revised...............................................1122
876.4590  (b) revised...............................................1122
876.4890  (b) revised...............................................1122
876.5090  (b) revised...............................................1122
876.5130  (b) revised...............................................1122
876.5220  (c) revised..............................................50707
876.5270  (c) revised..............................................50707
876.5450  (b) revised...............................................1122
876.5520  (b) revised...............................................1122
876.5540  (b)(3) revised; (b)(4) added..............................1122
878.4450  (b) revised...............................................1123
878.4810  (b) revised...............................................1123
878.5350  (b) revised...............................................1123
878.5910  (b) revised...............................................1123
880.2720  (b) revised...............................................1123
880.2900  (b) revised...............................................1123
880.5560  (b) revised...............................................1123
880.5580  Added....................................................64617
880.5760  (c) revised..............................................50708
880.6320  (b) revised...............................................1123
880.6760  Revised; eff. 9-3-96......................................8439
882.1410  (b) revised...............................................1123
882.1825  (c) revised..............................................50708
882.4325  (b) revised...............................................1123
882.5150  (c) revised..............................................50708
882.5850  (c) revised..............................................50708
884.1550  Revised...................................................1123
884.1640  (b) revised...............................................1123
884.1690  (b) revised...............................................1123
884.1700  (b) revised...............................................1124
884.1720  (b) revised...............................................1124
884.1730  (b) revised...............................................1124
884.2620  (c) revised..............................................50708
884.2685  (c) revised..............................................50708
884.4250  (c) revised..............................................50708
884.4270  (c) revised..............................................50708
884.4530  (b) revised...............................................1124
884.5050  (c) revised..............................................50709
884.5150  (b) revised...............................................1124
884.5225  (c) revised..............................................50709
884.5425  (b) revised..............................................67714
884.5435  (b) revised..............................................67714
884.5900  (b) revised...............................................1124
886.1405  (b) revised...............................................1124
886.1750  (b) revised...............................................1124
886.1760  (b) revised...............................................1124
886.3200  Revised...................................................1124
888.1100  (b) revised...............................................1124
888.3000  (b) revised...............................................1124
888.3120  (c) revised..............................................50709
888.3180  (c) revised..............................................50709
888.3200  (c) revised..............................................50709
888.3210  (c) revised..............................................50709
888.3220  (c) revised..............................................50709

[[Page 699]]

888.3300  (c) revised..............................................50709
888.3310  (c) revised..............................................50710
888.3370  (c) revised..............................................50710
888.3380  (c) revised..............................................50710
888.3480  (c) revised..............................................50710
888.3540  (c) revised..............................................50710
888.3550  (c) revised..............................................50710
888.3570  (c) revised..............................................50710
888.3580  (c) revised..............................................50711
888.3640  (c) revised..............................................50711
888.3680  (c) revised..............................................50711
888.3790  (c) revised..............................................50711
888.5960  (b) revised...............................................1125
890.1575  (b) revised...............................................1125
890.1600  (b) revised...............................................1125
890.1615  (b) revised...............................................1125
890.3175  (b) revised...............................................1125
890.3610  (c) revised..............................................50711
890.3760  (b) revised...............................................1125
890.3910  Revised; eff. 9-3-96......................................8439
890.5380  (b) revised...............................................1125
890.5410  (b) revised...............................................1125
890.5660  (b) revised...............................................1125
890.5925  (b) revised...............................................1125
890.5940  (b) revised...............................................1125
890.5950  (b) revised...............................................1125
890.5975  (b) revised...............................................1125
892.1700  (b) revised...............................................1125
892.1760  (b) revised...............................................1125
892.1770  (b) revised...............................................1125
892.1830  (b) revised...............................................1125
892.1880  (b) revised...............................................1125
892.5780  (b) revised...............................................1125
892.6500  (b) revised...............................................1125
897  Added; eff. 8-28-97...........................................44615
897.14  Eff. in part 2-28-97.......................................44616
897.34  Eff. in part 2-28-98.......................................44617
    Regulation at 61 FR 44617 eff. date corrected to 8-28-98.......47550
1000.3  Figure 1 correctly revised.................................13422
1002.1  Table 1 correctly revised..................................13423
1002.3  Corrected..................................................13424
1240  Meetings......................................................9100
1250.51  (d) amended...............................................14481

                                  1997

21 CFR
                                                                   62 FR
                                                                    Page
Chapter I
800  Authority citation revised....................................51519
801  Authority citation revised....................................51519
801.435  Added.....................................................50501
801.437  Added; eff. 9-30-98.......................................51029
803  Authority citation revised....................................51519
803.1  (a) revised; eff. 5-19-97...................................13306
803.57  Revised; eff. 5-19-97......................................13306
804  Authority citation revised....................................51519
804.30  Added; eff. 5-19-97........................................13306
805  Authority citation revised....................................51519
806  Added.........................................................27191
    Authority citation revised.....................................51519
806.10  Regulation at 62 FR 27191 stayed...........................67274
806.20  Regulation at 62 FR 27191 stayed...........................67274
807  Authority citation revised....................................51519
808  Authority citation revised....................................51519
808.51  Added......................................................63274
808.52  Added......................................................63274
808.94  Added......................................................63274
809  Authority citation revised....................................51520
809.10  (a) amended; (e) added; eff. 11-23-98......................62259
809.30  Added; eff. 11-23-98.......................................62259
810  Authority citation revised....................................51520
812  Authority citation revised.............................26229, 51520
    Meeting........................................................46198
    Technical correction...........................................47760
812.2  (c)(8) removed...............................................4165
    (c) introductory text revised; eff. 5-13-97....................12096
812.18  (b) revised................................................26229
812.20  (b)(9) revised.............................................40600
812.36  Added......................................................48947
812.119  Added; eff. 5-13-97.......................................12096
812.150  (b)(5) revised............................................48948
813  Removed........................................................4165
814  Meeting.......................................................46198
    Technical correction...........................................47760
    Authority citation revised.....................................51520
814.20  (b)(11) revised............................................40600
814.102  Reinstated................................................38026
814.104  Reinstated................................................38026
814.106  Reinstated................................................38026
814.108  Reinstated................................................38026
814.110  (a) reinstated............................................38026
814.112  (b) reinstated............................................38026
814.116  (b) reinstated............................................38026

[[Page 700]]

814.118  (d) reinstated............................................38026
814.120  (b) reinstated............................................38026
814.124  (b) reinstated............................................38026
814.126  (b)(1) reinstated.........................................38026
820  Authority citation revised....................................51520
821  Authority citation revised....................................51520
860  Authority citation revised....................................51520
861  Authority citation revised....................................51520
862  Authority citation revised....................................51520
864  Authority citation revised....................................51520
864.4010  (a) revised; eff. 11-23-98...............................62260
864.4020  Added; eff. 11-23-98.....................................62260
866  Authority citation revised....................................51520
866.6010  Revised..................................................66005
868  Authority citation revised....................................51520
870  Authority citation revised....................................51520
872  Authority citation revised....................................51520
872.6730  (c) revised...............................................2902
    (c) amended....................................................31512
874  Authority citation revised....................................51520
876  Authority citation revised....................................51520
878  Authority citation revised....................................51520
880  Authority citation revised....................................51520
880.5130  Revised..................................................33350
882  Authority citation revised....................................51520
882.5800  (c) revised..............................................30457
884  Authority citation revised....................................51520
886  Authority citation revised....................................51520
886.5918  Revised..................................................30987
886.5928  Revised..................................................30988
886.5933  Removed..................................................30988
888  Authority citation revised....................................51520
890  Authority citation revised....................................51520
892  Authority citation revised....................................51520
895  Authority citation revised....................................51520
897  Authority citation revised....................................51520
898  Added.........................................................25497
    Authority citation revised.....................................51521
898.14  Stayed.....................................................25498
900  Authority citation revised....................................51521
    Revised; eff. in part 4-28-99..................................55976
    (c)(4) corrected...............................................60614
900.12  (b)(8)(i), (e)(4)(iii)(B) and (5)(i)(B) revised; eff. 10-
        28-02......................................................55984
    (a)(2)(iv), (b)(6)(ii), (8)(i), (e)(1)(ii), (iii), (2)(ii), 
(4)(iii)(B), (5)(i)(B), (ii), (iii), (x)(A), (12) and (h) heading 
corrected; effective date corrected in part........................60614
900.18  (a)(1) corrected...........................................60614
1000  Authority citation revised...................................51521
1002  Authority citation revised...................................51521
1003  Authority citation revised...................................51521
1004  Authority citation revised...................................51521
1005  Authority citation revised...................................51521
1010  Authority citation revised...................................51521
1020  Authority citation revised...................................51521
1030  Authority citation revised...................................51521
1040  Authority citation revised...................................51521
1050  Authority citation revised...................................51521
1210  Authority citation revised...................................51521
1220  Authority citation revised...................................51521
1230  Authority citation revised...................................51521
1240  Authority citation revised...................................51521
1250  Authority citation revised...................................51521
1270  Revised......................................................40444
    Authority citation revised.....................................51521

[[Page 701]]

                                  1998

   (Regulations published from January 1, 1998, through April 1, 1998)

21 CFR
                                                                   63 FR
                                                                    Page
807.31  (d)(3) added; eff. 2-2-99...................................5253
807.87  (i), (j) and (k) redesignated as (j), (k) and (l); new (i) 
        added; eff. 2-2-99..........................................5253
807.100  (a)(4) redesignated as (a)(5); new (a)(4) added; eff. 2-
        2-99........................................................5253
812.43  (c)(5) added; eff. 2-2-99...................................5253
812.110  (d) redesignated as (e); new (d) added; eff. 2-2-99........5253
812.140  (b)(3) revised; eff. 2-2-99................................5253
814.20  (b)(12) redesignated as (b)(13); new (b)(12) added; eff. 
        2-2-99......................................................5253
814.42  (e)(5) added; eff. 2-2-99...................................5254
814.44  (d) revised.................................................4572
814.45  (d) revised.................................................4572
814.112  (a)(4) added; eff. 2-2-99..................................5254
820  Meeting........................................................3465
860.123  (a)(10) added; eff. 2-2-99.................................5254
878.5040  Added.....................................................7705
1220  Removed; eff. 4-17-98........................................12996