[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[From the U.S. Government Publishing Office]
21
Food and Drugs
[[Page i]]
PARTS 800 TO 1299
Revised as of April 1, 1996
CONTAINING
A CODIFICATION OF DOCUMENTS
OF GENERAL APPLICABILITY
AND FUTURE EFFECT
AS OF APRIL 1, 1996
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 : 1996
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.......... 617
Table of CFR Titles and Chapters.......................... 619
Alphabetical List of Agencies Appearing in the CFR........ 635
List of CFR Sections Affected............................. 645
[[Page iv]]
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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
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noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie
evidence of the text of the original documents (44 U.S.C. 1510).
HOW TO USE THE CODE OF FEDERAL REGULATIONS
The Code of Federal Regulations is kept up to date by the individual
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To determine whether a Code volume has been amended since its
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Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative
List of Parts Affected,'' which appears in the Reader Aids section of
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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
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instances where the effective date is beyond the cut-off date for the
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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.
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Richard L. Claypoole,
Director,
Office of the Federal Register.
April 1, 1996.
[[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, 1996.
The Table of Exempt Prescription Products to part 1308 appears in
the volume containing part 1300-end.
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, Cheryl E. Sirofchuck 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]]
[GRAPHIC] [TIFF OMITTED] TFRORDR.FRM
[[Page 1]]
H N
TITLE 21--FOOD AND DRUGS
(This book contains Parts 800 to 1299)
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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)
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SUBCHAPTER H--MEDICAL DEVICES
Part Page
800 General..................................... 5
801 Labeling.................................... 13
803 Medical device reporting (effective April
11, 1996)............................... 41
804 Medical device distributor reporting........ 60
805 Cardiac pacemaker registry.................. 65
807 Establishment registration and device
listing for manufacturers and
distributors of devices................. 67
808 Exemptions from Federal preemption of State
and local medical device requirements... 83
809 In vitro diagnostic products for human use.. 92
812 Investigational device exemptions........... 98
813 Investigational exemptions for intraocular
lenses.................................. 111
814 Premarket approval of medical devices....... 132
820 Good manufacturing practice for medical
devices: general........................ 146
821 Medical device tracking requirements........ 155
860 Medical device classification procedures.... 162
861 Procedures for performance standards
development............................. 173
862 Clinical chemistry and clinical toxicology
devices................................. 177
864 Hematology and pathology devices............ 208
866 Immunology and microbiology devices......... 226
868 Anesthesiology devices...................... 260
870 Cardiovascular devices...................... 279
872 Dental devices.............................. 298
874 Ear, nose, and throat devices............... 319
876 Gastroenterology-urology devices............ 329
878 General and plastic surgery devices......... 343
880 General hospital and personal use devices... 354
882 Neurological devices........................ 370
884 Obstetrical and gynecological devices....... 385
[[Page 4]]
886 Opthalmic devices........................... 401
888 Orthopedic devices.......................... 421
890 Physical medicine devices................... 439
892 Radiology devices........................... 454
895 Banned devices.............................. 465
SUBCHAPTER I--MAMMOGRAPHY QUALITY STANDARDS ACT
900 Mammography................................. 471
SUBCHAPTER J--RADIOLOGICAL HEALTH
1000 General..................................... 482
1002 Records and reports......................... 491
1003 Notification of defects or failure to comply 500
1004 Repurchase, repairs, or replacement of
electronic products..................... 503
1005 Importation of electronic products.......... 505
1010 Performance standards for electronic
products: general....................... 509
1020 Performance standards for ionizing radiation
emitting products....................... 514
1030 Performance standards for microwave and
radio frequency emitting products....... 542
1040 Performance standards for light-emitting
products................................ 546
1050 Performance standards for sonic, infrasonic,
and ultrasonic radiation-emitting
products................................ 570
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..................................... 574
1220 Regulations under the Tea Importation Act... 578
1230 Regulations under the Federal Caustic Poison
Act..................................... 586
1240 Control of communicable diseases............ 592
1250 Interstate conveyance sanitation............ 601
1251--1269
[Reserved]
1270 Human tissue intended for transplantation... 611
1271--1299
[Reserved]
SUBCHAPTER H--MEDICAL DEVICES
[[Page 5]]
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: Secs. 201, 304, 501, 502, 505, 506, 507, 515, 519, 521,
601, 602, 701 of the Federal Food, Drug, and Cosmetic Act (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
[[Page 6]]
is the opportunity for the malicious adulteration of these products with
risks both to individuals who unknowingly purchase adulterated products
and with loss of consumer confidence in the security of the packages of
over-the-counter (OTC) health care products. The Food and Drug
Administration has the authority and responsibility under the Federal
Food, Drug, and Cosmetic Act (the act) to establish a uniform national
standard for tamper-resistant packaging of those OTC products vulnerable
to malicious adulteration that will improve the security of OTC
packaging and help assure the safety and effectiveness of the products
contained therein. A contact lens solution or tablet or other dosage
form to be used to make such a solution for retail sale that is not
packaged in a tamper-resistant package and labeled in accordance with
this section is adulterated under section 501 of the act or misbranded
under section 502 of the act, or both.
(b) Requirement for tamper-resistant package. Each manufacturer and
packer who packages for retail sale a product regulated as a medical
device that is a solution intended for use with contact lenses, e.g.,
for cleaning, disinfecting, wetting, lubricating, rinsing, soaking, or
storing contact lenses or tablets or other dosage forms to be used to
make any such solution shall package the product in a tamper-resistant
package, if this product is accessible to the public while held for
sale. A tamper-resistant package is one having an indicator or barrier
to entry which, if breached or missing, can reasonably be expected to
provide visible evidence to consumers that tampering has occurred. To
reduce the likelihood of substitution of a tamper-resistant feature
after tampering, the indicator or barrier to entry is required to be
distinctive by design or by the use of an identifying characteristic
(e.g., a pattern, name, registered trademark, logo, or picture). For
purposes of this section, the term ``distinctive by design'' means the
package cannot be duplicated with commonly available material or through
commonly available processes. A tamper-resistant package may involve an
immediate-container and closure system or secondary-container or carton
system or any combination of systems intended to provide a visual
indication of package integrity. The tamper-resistant feature shall be
designed to and shall remain intact when handled in a reasonable manner
during manufacture, distribution, and retail display.
(c) Labeling. Each retail package of a product covered by this
section is required to bear a statement that is prominently placed so
that consumers are alerted to the tamper-resistant feature of the
package. The labeling statement is also required to be so placed that it
will be unaffected if the tamper-resistant feature of the package is
breached or missing. If the tamper-resistant feature chosen to meet the
requirement in paragraph (b) of this section is one that uses an
identifying characteristic, that characteristic is required to be
referred to in the labeling statement. For example, the labeling
statement on a bottle with a shrink band could say ``For your
protection, this bottle has an imprinted seal around the neck.''
(d) Requests for exemptions from packaging and labeling
requirements. A manufacturer or packer may request an exemption from the
packaging and labeling requirements of this section. A request for an
exemption is required to be submitted in the form of a citizen petition
under Sec. 10.30 of this chapter and should be clearly identified on the
envelope as a ``Request for Exemption from Tamper-resistant Rule.'' A
petition for an exemption from a requirement of this section is required
to contain the same kind of information about the product as is
specified for OTC drugs in Sec. 211.132(d) of this chapter. 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
[[Page 7]]
composition of the closure component in contact with the contents (cap
liner or innerseal) as these features are described in the approved
premarket approval application. Any supplemental premarket approval
application under this paragraph is required to include data sufficient
to show that these changes do not adversely affect the product.
(f) Effective date. Each product subject to this section is required
to comply with the requirements of this section on the dates listed
below except to the extent that a product's manufacturer or packer has
obtained an exemption from a packaging or labeling requirement:
(1) Initial effective date for packaging requirements. (i) The
packaging requirement in paragraph (b) of this section is effective on
February 7, 1983 for each contact lens solution packaged for retail sale
on or after that date, except for the requirement in paragraph (b) of
this section for a distinctive indicator or barrier to entry.
(ii) The packaging requirement in paragraph (b) of this section is
effective on May 5, 1983 for each tablet that is to be used to make a
contact lens solution and that is packaged for retail sale on or after
that date.
(2) Initial effective date for labeling requirements. The
requirement in paragraph (b) of this section that the indicator or
barrier to entry be distinctive by design and the requirement in
paragraph (c) of this section for a labeling statement are effective on
May 5, 1983 for each product subject to this section packaged for retail
sale on or after that date, except that the requirement for a specific
label reference to any identifying characteristic is effective on
February 6, 1984 for each affected product subject to this section
packaged for retail sale on or after that date.
(3) Retail level effective date. The tamper-resistant packaging
requirement of paragraph (b) of this section is effective on February 6,
1984 for each product subject to this section that is held for sale at
retail level on or after that date that was packaged for retail sale
before May 5, 1983. This does not include the requirement in paragraph
(b) of this section that the indicator or barrier to entry be
distinctive by design. Products packaged for retail sale after May 5,
1983, are required to be in compliance with all aspects of the
regulations without regard to the retail level effective date.
[47 FR 50455, Nov. 5, 1982; 48 FR 1706, Jan. 14, 1983, as amended at 48
FR 16666, Apr. 19, 1983; 48 FR 37625, Aug. 19, 1983; 53 FR 11252, Apr.
6, 1988]
Effective Date Note: A document published at 48 FR 41579, Sept. 16,
1983, stayed the effective date of Sec. 800.12(f)(3) until further
notice.
Sec. 800.20 Patient examination gloves and surgeons' gloves; sample plans and test method for leakage defects; adulteration.
(a) Purpose. The prevalence of human immunodeficiency virus (HIV),
which causes acquired immune deficiency syndrome (AIDS), and its risk of
transmission in the health care context, have caused the Food and Drug
Administration (FDA) to look more closely at the quality control of
barrier devices, such as surgeons' gloves and patient examination gloves
(collectively known as medical gloves) to reduce the risk of
transmission of HIV and other blood-borne infectious diseases. The
Centers for Disease Control (CDC) recommend that health care workers
wear medical gloves to reduce the risk of transmission of HIV and other
blood-borne infectious deseases. The CDC recommends that health care
workers wear medical gloves when touching blood or other body fluids,
mucous membranes, or nonintact skin of all patients; when handling items
or surfaces soiled with blood or other body fluids; and when performing
venipuncture and other vascular access procedures. Among other things,
CDC's recommendation that health care providers wear medical gloves
demonstrates the proposition that devices labeled as medical gloves
purport to be and are represented to be effective barriers against the
transmission of blood- and fluid-borne pathogens. Therefore, FDA,
through this regulation, is defining adulteration for patient
examination and surgeons' gloves as a means of assuring safe and
effective devices.
(1) For a description of a patient examination glove, see
Sec. 880.6250. Finger
[[Page 8]]
cots, however, are excluded from the test method and sample plans in
paragraphs (b) and (c) of this section.
(2) For a description of a surgeons' glove, see Sec. 878.4460 of
this chapter.
(b) 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.
Subpart D--Exemptions From Adequate Directions for Use
801.109 Prescription devices.
801.110 Retail exemption for prescription devices.
801.116 Medical devices having commonly known directions.
801.119 In vitro diagnostic products.
801.122 Medical devices for processing, repacking, or manufacturing.
801.125 Medical devices for use in teaching, law enforcement, research,
and analysis.
801.127 Medical devices; expiration of exemptions.
Subpart E--Other Exemptions
801.150 Medical devices; processing, labeling, or repacking.
Subparts F-G--[Reserved]
Subpart H--Special Requirements for Specific Devices
801.403 Specific medical devices; recommended warning and caution
statements.
801.405 Labeling of articles intended for lay use in the repairing and/
or refitting of dentures.
[[Page 14]]
801.408 Pessaries for intracervical and intrauterine use.
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.
801.425 Nonrestricted devices in self-pressurized containers with
chlorofluorocarbon propellants.
801.427 Professional and patient labeling for intrauterine
contraceptive devices.
801.430 User labeling for menstrual tampons.
Authority: Secs. 201, 301, 501, 502, 507, 519, 520, 701, 704 of the
Federal Food, Drug, and Cosmetic Act (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 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.
[[Page 15]]
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, 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.
[[Page 16]]
(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 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)
[[Page 17]]
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 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
[[Page 18]]
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 numerical count is optional. It is sufficient to
distinguish avoirdupois ounce from fluid ounce through association of
terms; for example, ``Net wt. 6 oz'' or ``6 oz net wt.,'' and ``6 fl
oz'' or ``net contents 6 fl oz.''
[[Page 19]]
(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 milliliter ml
quart qt cubic centimeter cc
pint pt yard yd
ounce oz feet or foot ft
pound lb inch in
grain gr meter m
kilogram kg centimeter cm
gram g millimeter mm
milligram mg fluid fl
microgram mcg square sq
liter l weight wt
(m) On packages labeled in terms of linear measure, the declaration
shall be expressed both in terms of inches and, if applicable (1 foot or
more), the largest whole units (yards, yards and feet, feet). The
declaration in terms of the largest whole units shall be in parentheses
following the declaration in terms of inches and any remainder shall be
in terms of inches or common or decimal fractions of the foot or yard;
if applicable, as in the case of adhesive tape, the initial declaration
in linear inches shall be preceded by a statement of the width. Examples
of linear measure are ``86 inches (2 yd 1 ft 2 in)'', ``90 inches (2\1/
2\ yd)'', ``30 inches (2.5 ft)'', ``\3/4\ inch by 36 in (1 yd)'', etc.
(n) On packages labeled in terms of area measure, the declaration
shall be expressed both in terms of square inches and, if applicable (1
square foot or more), the largest whole square unit (square yards,
square yards and square feet, square feet). The declaration in terms of
the largest whole units shall be in parentheses following the
declaration in terms of square inches and any remainder shall be in
terms of square inches or common or decimal fractions of the square foot
or square yard; for example, ``158 sq inches (1 sq ft 14 sq in)''.
(o) Nothing in this section shall prohibit supplemental statements
at locations other than the principal display panel(s) describing in
nondeceptive terms the net quantity of contents, provided that such
supplemental statements of net quantity of contents shall not include
any term qualifying a unit of weight, measure, or count that tends to
exaggerate the amount of the device contained in the package; for
example, ``giant pint'' and ``full quart''. Dual or combination
declarations of net quantity of contents as provided for in paragraphs
(a) and (i) of this section are not regarded as supplemental net
quantity statements and shall be located on the principal display panel.
(p) A separate statement of net quantity of contents in terms of the
metric system of weight or measure is not regarded as a supplemental
statement and an accurate statement of the net quantity of contents in
terms of the metric system of weight or measure may also appear on the
principal display panel or on other panels.
(q) The declaration of net quantity of contents shall express an
accurate statement of the quantity of contents of the package.
Reasonable variations caused by loss or gain of moisture during the
course of good distribution
[[Page 20]]
practice or by unavoidable deviations in good manufacturing practice
will be recognized. Variations from stated quantity of contents shall
not be unreasonably large.
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 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.
[[Page 21]]
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. 801.127 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 inspec-
[[Page 22]]
tion at any reasonable hour to any officer or employee of the Department
who requests them.
(b) An exemption of a shipment or other delivery of a device under
paragraph (a)(1) of this section shall, at the beginning of the act of
removing such shipment or delivery, or any part thereof, from such
establishment, become void ab initio if the device comprising such
shipment, delivery, or part is adulterated or misbranded within the
meaning of the act when so removed.
(c) An exemption of a shipment or other delivery of a device under
paragraph (a)(2) of this section shall become void ab initio with
respect to the person who introduced such shipment or delivery into
interstate commerce upon refusal by such person to make available for
inspection a copy of the agreement, as required by such paragraph
(a)(2).
(d) An exemption of a shipment or other delivery of a device under
paragraph (a)(2) of this section shall expire:
(1) At the beginning of the act of removing such shipment or
delivery, or any part thereof, from such establishment if the device
comprising such shipment, delivery, or part is adulterated or misbranded
within the meaning of the act when so removed; or
(2) Upon refusal by the operator of the establishment where such
device is to be processed, labeled, or repacked, to make available for
inspection a copy of the agreement, as required by such clause.
(e) As it is a common industry practice to manufacture and/or
assemble, package, and fully label a device as sterile at one
establishment and then ship such device in interstate commerce to
another establishment or to a contract sterilizer for sterilization, the
Food and Drug Administration will initiate no regulatory action against
the device as misbranded or adulterated 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. 801.403 Specific medical devices; recommended warning and caution statements.
DENTURE RELINERS, PADS, AND CUSHIONS.
Warning--For temporary use only. Long term use of this product may
lead to faster bone loss, continuing irritation, sores, and tumors. For
Use Only Until A Dentist Can Be Seen.
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.
[[Page 23]]
INFRARED GENERATORS (INCLUDING HEATING PADS).
Warning--Use carefully. May cause serious burns. Do not use over
insensitive skin areas or in the presence of poor circulation. The
unattended use of infrared heat by children or incapacitated persons may
be dangerous.
INSULIN SYRINGES.
Warning--For patients who mix two types of insulin: Do not change:
(a) The order of mixing that the physician has prescribed or (b) the
model and brand of the syringe or needle without first consulting your
physician or pharmacist. Failure to heed this warning can result in
dosage error.
MECHANICAL MASSAGERS AND VIBRATORS.
Warning--This device should not be used over swollen or inflamed
areas or skin eruptions. Do not use in unexplained calf pain. Consult
physician.
STEAM OR TURKISH BATH.
Warning--Elderly persons or those suffering from heart disease or
high blood pressure should not use this device unless directed by
physician.
ULTRAVIOLET GENERATORS.
Warning--Wear protective goggles during use to avoid eye injury.
Serious burns may be caused by exposure in excess of recommended dosage.
Do not use over skin eruptions unless directed by physician.
Sec. 801.405 Labeling of articles intended for lay use in the repairing and/or refitting of dentures.
(a) The American Dental Association and leading dental authorities
have advised the Food and Drug Administration of their concern regarding
the safety of denture reliners, repair kits, pads, cushions, and other
articles marketed and labeled for lay use in the repairing, refitting,
or cushioning of ill-fitting, broken, or irritating dentures. It is the
opinion of dental authorities and the Food and Drug Administration that
to properly repair and properly refit dentures a person must have
professional knowledge and specialized technical skill. Laymen cannot be
expected to maintain the original vertical dimension of occlusion and
the centric relation essential in the proper repairing or refitting of
dentures. The continued wearing of improperly repaired or refitted
dentures may cause acceleration of bone resorption, soft tissue
hyperplasia, and other irreparable damage to the oral cavity. Such
articles designed for lay use should be limited to emergency or
temporary situations pending the services of a licensed dentist.
(b) The Food and Drug Administration therefore regards such articles
as unsafe and misbranded under the Federal Food, Drug, and Cosmetic Act,
unless the labeling:
(1)(i) Limits directions for use for denture repair kits to
emergency repairing pending unavoidable delay in obtaining professional
reconstruction of the denture;
(ii) Limits directions for use for denture reliners, pads, and
cushions to temporary refitting pending unavoidable delay in obtaining
professional reconstruction of the denture;
(2) Contains in a conspicuous manner the word ``emergency''
preceding and modifying each indication-for-use statement for denture
repair kits and the word ``temporary'' preceding and modifying each
indication-for-use statement for reliners, pads, and cushions; and
(3) Includes a conspicuous warning statement to the effect:
(i) For denture repair kits: ``Warning--For emergency repairs only.
Long term use of home-repaired dentures may cause faster bone loss,
continuing irritation, sores, and tumors. This kit for emergency use
only. See Dentist Without Delay.''
(ii) For denture reliners, pads, and cushions: ``Warning--For
temporary use only. Longterm use of this product may lead to faster bone
loss, continuing irritation, sores, and tumors. For Use Only Until a
Dentist Can Be Seen.''
(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:
[[Page 24]]
(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. 801.408 Pessaries for intracervical and intrauterine use.
(a) Because of the limited evidence previously available concerning
the hazards attending the use of intracervical and intrauterine
pessaries, the shipment of such devices within the jurisdiction of the
Federal Food, Drug, and Cosmetic Act with labeling limiting them to sale
only on prescription, has not been subjected to regulatory proceedings.
A recent survey shows that it is now the consensus of medical opinion
among experts qualified by scientific training and experience to
evaluate the safety of such devices that stem-type and wing-type
intercervical and intrauterine pessaries are too dangerous for use under
any form of labeling and serve no useful purpose. This opinion is
particularly applicable to pessaries offered or intended for
contraceptive use. These views do not apply to those pessaries, made
with hollow tubes, intended solely for use when necessary to maintain
drainage from the uterine cavity.
(b) On the basis of this consensus of expert opinion and the
supporting evidence of many known injuries, the Food and Drug
Administration concludes that stem-type and wing-type intracervical and
intrauterine pessaries are dangerous to health, and regardless of their
labeling, may be shown to be misbranded within the meaning of sections
502(f) (1) and (2) and 502(j) of the Federal Food, Drug, and Cosmetic
Act. It is recommended that distributors of these devices remove them
from the interstate market at once. Regulatory action may be instituted
in connection with any such devices found within the jurisdiction of the
act.
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
[[Page 25]]
injuries would be substantially reduced by the use in eyeglasses and
sunglasses of impact-resistant lenses.
(c)(1) To protect the public more adequately from potential eye
injury, eyeglasses and sunglasses must be fitted with impact-resistant
lenses, except in those cases where the physician or optometrist finds
that such lenses will not fulfill the visual requirements of the
particular patient, directs in writing the use of other lenses, and
gives written notification thereof to the patient.
(2) The physician or optometrist shall have the option of ordering
glass lenses, plastic lenses, or laminated glass lenses made impact
resistant by any method; however, all such lenses shall be capable of
withstanding the impact test described in paragraph (d)(2) of this
section.
(3) Each finished impact-resistant glass lens for prescription use
shall be individually tested for impact resistance and shall be capable
of withstanding the impact test described in paragraph (d)(2) of this
section. Raised multifocal lenses shall be impact resistant but need not
be tested beyond initial design testing. Prism segment multifocal, slab-
off prism, lenticular cataract, iseikonic, depressed segment one-piece
multifocal, bioconcave, myodisc and minus lenticular, custom laminate
and cemented assembly lenses shall be impact resistant but 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 deter-
[[Page 26]]
mined 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 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
[[Page 27]]
part per million by volume of air circulating through the device or
causes an accumulation of ozone in excess of 0.05 part per million by
volume of air (when measured under standard conditions at 25 deg. C
(77 deg. F) and 760 millimeters of mercury) in the atmosphere of
enclosed space intended to be occupied by people for extended periods of
time, e.g., houses, apartments, hospitals, and offices. This applies to
any such device, whether portable or permanent or part of any system,
which generates ozone by design or as an inadvertent or incidental
product.
(2) To generate ozone and release it into the atmosphere in
hospitals or other establishments occupied by the ill or infirm.
(3) To generate ozone and release it into the atmosphere and does
not indicate in its labeling the maximum acceptable concentration of
ozone which may be generated (not to exceed 0.05 part per million by
volume of air circulating through the device) as established herein and
the smallest area in 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.
[[Page 28]]
(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 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.
[[Page 29]]
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 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.
[[Page 30]]
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 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
[[Page 31]]
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]
Sec. 801.425 Nonrestricted devices in self-pressurized containers with chlorofluorocarbon propellants.
(a) The label on each package of a nonrestricted device in a self-
pressurized container in which the propellant consists in whole or in
part of a fully halogenated chlorofluoroalkane (chlorofluorocarbon)
shall bear the following warning:
Warning--Contain a chlorofluorocarbon that may harm the public
health and environment by reducing ozone in the upper atmosphere.
(b) The warning required by paragraph (a) of this section shall
appear on an appropriate panel with such prominence and conspicuousness
as to render it likely to be read and understood by ordinary individuals
under normal conditions of purchase. The warning may appear on a firmly
affixed tag, tape, card, sticker or similar overlabeling attached to the
package. The warning shall appear prominent and conspicuously as
compared to other words, statements, designs, or devices and in bold
type on contrasting background, but in no case may the letter be less
than \1/16\ inch in height.
(c) The warning in paragraph (a) of this section is not required and
should not be used for products intended for metered-dose adrenergic
bronchodilators for oral inhalation, and for cytology fixative uses.
(d) The warning required by paragraph (a) of this section is
applicable only to self-pressurized containers that use a
chlorofluorocarbon in whole or in part as a propellant to expel from the
container liquid or solid material different from the propellant.
[42 FR 22034, Apr. 29, 1977]
Sec. 801.427 Professional and patient labeling for intrauterine contraceptive devices.
(a) This section applies to intrauterine devices (IUD's) that are
not subject to new drug requirements under Sec. 310.502 of this chapter.
IUD's subject to this section (device IUD's) include:
(1) IUD's fabricated solely from inactive materials, e.g., inactive
plastics or metals.
(2) IUD's with substances added to improve the physical
characteristics if such substances do not contribute to contraception
through chemical action on or within the body and are not dependent upon
being metabolized for the achievement of the contraceptive purpose.
(3) IUD's that contain a component, such as barium, added
exclusively for the purpose of visualization by x-ray.
(b) The intrauterine contraceptive device (IUD) is a popular method
of contraception used by several million women in the United States.
Although this method of contraception is generally safe and effective,
certain complications and side effects may result from its use. A Food
and Drug Administration review of the labeling of IUD's currently
marketed in the United States reveals that information necessary for the
safe and effective use of these products is not uniformly available to
either the practitioner or the patient. Based on the review of the
labeling and on the recommendations of the Ad Hoc Obstetric-Gynecology
Advisory Committee, the Commissioner has concluded that in the interest
of safe and effective use, and prevention of misleading labeling, there
is a need to establish uniform physician and patient labeling for such
devices.
(1) Labeling accompanying each IUD and directed to the physician
shall be substantially as follows adjusted where appropriate to the
requirements of a particular device IUD:
[[Page 32]]
Description
(to be supplied by manufacturer)
Description shall include the following information:
1. Proprietary or established name of the IUD.
2. Major ingredients or composition.
3. Model.
4. Physical dimensions (size and shape).
5. Description of components in package or system.
6. A statement that the product is sterile.
7. Other characteristics.
Mode of Action or Principles of IUD Design
(to be supplied by the manufacturer)
The manufacturer shall include information on the mode of action or
principles of the IUD's design. At a minimum, the statement should
provide that IUD's seem to interfere in some manner with nidation in the
endometrium, probably through foreign body reaction in the uterus.
Indications and Usage
The labeling may include indications and usages other than those
stated below, provided that an approved premarket approval application
is in effect. (Name of IUD) is indicated for contraception.
Contraindications
IUD's should not be inserted when the following conditions exist:
1. Pregnancy or suspicion of pregnancy.
2. Abnormalities of the uterus resulting in distortion of the
uterine cavity.
3. Acute pelvic inflammatory disease or a history of repeated pelvic
inflammatory disease.
4. Post partum endometritis or infected abortion in the past 3
months.
5. Known or suspected uterine or cervical malignancy including
unresolved, abnormal ``Pap'' smear.
6. Genital bleeding of unknown etiology.
7. Untreated acute cervicitis until infection is controlled.
Warnings
1. Pregnancy--a. Long-term effects. Long-term effects on the
offspring when pregnancy occurs with (name of IUD) in place are unknown.
b. Septic abortion. Reports have indicated an increased incidence of
septic abortion associated in some instances with septicemia, septic
shock, and death in patients becoming pregnant with an IUD in place.
Most of these reports have been associated with the mid-trimester of
pregnancy. In some cases, the initial symptoms have been insidious and
not easily recognized. If pregnancy should occur with an IUD in place,
the IUD should be removed if the string is visible or, if removal proves
to be or would be difficult, termination of the pregnancy should be
considered and offered the patient as an option bearing in mind that the
risks associated with an elective abortion increase with gestational
age.
c. Continuation of pregnancy. If the patient chooses to continue the
pregnancy, she must be warned of the increased risk of spontaneous
abortion and of the increased risk of sepsis, including death if the
pregnancy continues with the IUD in place. The patient must be closely
observed and she must be advised to report all abnormal symptoms, such
as flu-like syndrome, fever, abdominal cramping and pain, bleeding, or
vaginal discharge, immediately because generalized symptoms of
septicemia may be insidious.
2. Ectopic pregnancy. a. A pregnancy that occurs with an IUD in
place is more likely to be ectopic than a pregnancy occurring without an
IUD in place. Accordingly, patients who become pregnant while using the
IUD should be carefully evaluated for the possibility of an ectopic
pregnancy.
b. Special attention should be directed to patients with delayed
menses, slight metrorrhagia and/or unilateral pelvic pain and to those
patients who wish to terminate a pregnancy because of IUD failure to
determine whether ectopic pregnancy has occurred.
3. Pelvic infection. Pelvic infection may occur with the IUD in
place and at times result in the development of tubo-ovarian abscesses
or general peritonitis. Appropriate aerobic and anaerobic
bacteriological studies should be done and antibiotic therapy initiated.
If the infection does not show a marked clinical improvement within 24
to 48 hours, the IUD should be removed and the continuing treatment
reassessed based upon the results of culture and sensitivity tests.
4. Embedment. Partial penetration or lodging of the IUD in the
endometrium can result in difficult removals.
5. Perforation. Partial or total perforation of the uterine wall or
cervix may occur with the use of IUD's. The possibility of performation
must be kept in mind during insertion and at the time of any subsequent
examination. If perforation occurs, the IUD should be removed.
Adhesions, foreign body reactions, and intestinal obstruction may result
if an IUD is left in the peritoneal cavity.
Precautions
1. Patient counseling. Prior to insertion the physician, nurse, or
other trained health professional must provide the patient with the
Patient Brochure. The patient should be given the opportunity to read
the brochure and discuss fully any questions she may have concerning the
IUD as well as other methods of contraception.
[[Page 33]]
2. Patient evaluation and clinical considerations. a. A complete
medical history should be obtained to determine conditions that might
influence the selection of an IUD. Physical examination should include a
pelvic examination, ``Pap'' smear, gonorrhea culture and, if indicated,
appropriate tests for other forms of venereal disease.
b. The uterus should be carefully sounded prior to insertion to
determine the degree of patency of the endocervical canal and the
internal os, and the direction and depth of the uterine cavity. In
occasional cases, severe cervical stenosis may be encountered. Do not
use excessive force to overcome this resistance.
c. The uterus should sound to a depth of 6 to 8 centimeters (cm).
Insertion of an IUD into a uterine cavity measuring less than 6.5 cm by
sounding may increase the incidence of expulsion, bleeding, and pain.
d. The possibility of insertion in the presence of an existing
undetermined pregnancy is reduced if insertion is performed during or
shortly following a menstrual period. The IUD should not be inserted
post partum or postabortion until involution of the uterus is completed.
The incidence of perforation and expulsion is greater if involution is
not completed.
e. IUD's should be used with caution in those patients who have
anemia or a history of menorrhagia or hypermenorrhea. Patients
experiencing menorrhagia and/or metrorrhagia following IUD insertion may
be at risk for the development of hypochromic microcytic anemia. Also,
IUD's should be used with caution in patients receiving anticoagulants
or having a coagulopathy.
f. Syncope, bradycardia, or other neurovascular episodes may occur
during insertion or removal of IUD's, especially in patients with a
previous disposition to these conditions.
g. Patients with valvular or congenital heart disease are more prone
to develop sub-acute bacterial endocarditis than patients who do not
have valvular or congenital heart disease. Use of an IUD in these
patients may represent a potential source of septic emboli.
h. Use of an IUD in those patients with acute cervicitis should be
postponed until proper treatment has cleared up the infection.
i. Since an IUD may be expelled or displaced, patients should be
reexamined and evaluated shortly after the first postinsertion menses,
but definitely within 3 months after insertion. Thereafter annual
examination with appropriate medical and laboratory examination should
be carried out.
j. The patient should be told that some bleeding and cramps may
occur during the first few weeks after insertion, but if these symptoms
continue or are severe she should report them to her physician. She
should be instructed on how to check after each menstrual period to make
certain that the thread still protrudes from the cervix, and she should
be cautioned that there is no contraceptive protection if the IUD is
expelled. She should be cautioned not to pull on the thread and displace
the IUD. If partial expulsion occurs, removal is indicated and a new IUD
may be inserted.
k. The use of medical diathermy (shortwave and microwave) in
patients with metal-containing IUD's may cause heat injury to the
surrounding tissue. Therefore, medical diathermy to the abdominal and
sacral areas should not be used.
Adverse Reactions
These adverse reactions are not listed in any order of frequency or
severity.
Reported adverse reactions include: endometritis, spontaneous
abortion, septic abortion, septicemia, perforation of the uterus and
cervix, embedment, fragmentation of the IUD, pelvic infection,
vaginitis, leukorrhea, cervical erosion, pregnancy, ectopic pregnancy,
difficult removal, complete or partial expultion of the IUD,
intermenstrual spotting, prolongation of menstrual flow, anemia, pain
and cramping, dysmenorrhea, backaches, dyspareunia, neurovascular
episodes including bradycardia and syncope secondary to insertion.
Perforation into the abdomen has been followed by abdominal adhesions,
intestinal penetration, intestinal obstruction, and cystic masses in the
pelvis.
Directions For Use
(to be supplied by manufacturer)
Directions for use shall include the following:
1. Insertion technique.
2. Requirements for replacement and removal, if applicable.
Clinical Studies
Different event rates have been recorded with the use of diffferent
IUD's. Inasmuch as these rates are usually derived from separate studies
conducted by different investigators in several population groups, they
cannot be compared with precision. Furthermore, event rates tend to be
lower as clinical experience is expanded, possibly due to retention in
the clinical study of those patients who accept the treatment regimen
and do not discontinue due to adverse reactions or pregnancy. In
clinical trials conducted by (name of sponsor) with the (name of IUD),
use effectiveness was determined as follows for parous and nulliparous
women, as tabulated by the life table method. (Rates are expressed as
events per 100 women through 12 and 24 months of use.) This experience
is based on (number) women/months of use in-
[[Page 34]]
cluding (number) women who completed 12 months of use and (number) women
who completed 24 months of use.
----------------------------------------------------------------------------------------------------------------
12 mo 24 mo
-------------------------------------------------
Parous Nulliparous Parous Nulliparous
----------------------------------------------------------------------------------------------------------------
Pregnancy..................................................... .......... ........... .......... ...........
Expulsion..................................................... .......... ........... .......... ...........
Medical removal............................................... .......... ........... .......... ...........
Continuation rate............................................. .......... ........... .......... ...........
----------------------------------------------------------------------------------------------------------------
(2) Labeling, in sufficient quantities to be available to patients
who express interest in IUD's shall accompany each IUD (packaged
separately from the sterile packaging), be made available to the
patient, and contain the following information:
Patient Information
This brochure provides information on the use of Intrauterine
Contraceptive Devices (IUD's). There are other birth control methods
that may be suitable. Before deciding which type of birth control method
to use, you should read this brochure and have the opportunity to
discuss fully with your doctor any questions you may have about the IUD
and other methods of contraception.
Preinsertion Information
what you should know about the iud
IUD's are small articles of various sizes and shapes which are
inserted into the uterus (womb). The purpose of the IUD is to prevent
pregnancy.
How the IUD prevents pregnancy is not completely understood. Several
theories have been suggested. IUD's seem to interfere in some manner
with the implantation of the fertilized egg in the lining of the uterine
cavity. The IUD does not prevent ovulation.
The effectiveness of the IUD is measured by the pregnancy rate of
women who use it and the rate of adverse reactions and side effects
requiring removal of the IUD.
Use-Effectiveness
Different pregnancy and adverse reaction rates have been reported
with the use of different IUD's. Because these rates are usually derived
from separate studies conducted by different investigators in several
population groups, they cannot be compared with precision.
In Clinical trials with (name of IUD), ------ patients completed --
---- cycles or months in use. The incidence of unplanned pregnancies was
------ per 100 woman years or ------ women out of 100 became pregnant in
a year while using an IUD. The incidence of adverse reactions requiring
medical removal of the IUD is ------ per 100 woman years or ------ women
out of 100 discontinued using the IUD for medical reasons.
What You Should Tell Your Doctor
Before you have an IUD inserted, you should tell you doctor if you
have ever had, or suspect you have ever had, any of the following
conditions which might make the IUD unsuitable as a method of
contraception for you:
Abnormalities of the uterus (womb).
Allergy to copper.
Anemia.
Bleeding between periods.
Cancer of the uterus (womb) or cervix.
Fainting attacks.
Heart disease.
Heart murmur.
Heavy menstrual flow.
Infection of the uterus (womb) or cervix.
Pelvic infection (pus in fallopian tubes).
Prior IUD use.
Prior uterine surgery.
Recent abortion or miscarriage.
Recent pregnancy.
Severe menstrual cramps.
Suspected or possible pregnancy.
Suspicious or abnormal ``Pap'' smear.
Unexplained genital bleeding.
Vaginal discharge or infection.
Venereal disease.
Adverse Reactions
The following adverse reactions and side effects have been reported
and may occur after the IUD is inserted:
Anemia.
Backache.
Blood poisoning (septicemia).
Bowel obstruction.
Cervical infection.
Complete or partial expulsion.
Cysts on ovaries and tubes.
Delayed menstruation.
Difficult removal.
Embedment.
Fainting at the time of insertion or removal.
Fragmentation of the IUD.
Intermenstrual spotting.
Internal abdominal adhesions.
Pain and cramps.
Painful intercourse.
[[Page 35]]
Pelvic infection.
Perforation of the uterus (womb) or cervix.
Pregnancy.
Pregnancy outside the uterus (womb) (tubal or ovarian).
Prolonged or heavy menstrual flow.
Septic abortion (infected miscarriage) followed in some cases by blood
poisoning (septicemia) which can lead to death.
Spontaneous abortion (miscarriage).
Vaginal discharge and infection.
If you decide on the IUD as your method of birth control, read the
following information and instructions carefully. Please keep this
brochure so that you may refer to it. If you have any questions, consult
your doctor.
Postinsertion Information
description
(to be supplied by manufacturer)
Description shall include the following information.
1. Proprietary or established name of the IUD.
2. Model.
3. Physical dimensions (size and shape).
4. Composition (metal or plastic).
5. Color and number of the tail or threads.
6. Other characteristics.
Directions For Use
1. Checking your IUD. A tail or thread is attached to the IUD so
that you can check to see if it is still in place since the IUD can come
out of the uterus (womb) without your knowing it. This occurs most often
during or right after a menstrual period.
Follow these steps to make sure your IUD is in place:
a. Wash your hands.
b. Assume the squatting position or seat yourself on the toilet.
c. Insert the index or middle finger high in vagina and locate the
cervix (mouth of the uterus (womb)). The cervix feels firm like the tip
of your nose.
d. Feel for the tail or thread of the IUD, which should be in the
cervix high in your vagina.
e. If you can feel the tail or thread it is likely that the IUD is
in place and working. You should not pull on the tail or thread. This
may displace the IUD.
f. After each menstrual period, you should check to make sure the
tail or thread is in place in the cervix. You may check for the tail or
thread more often if you wish.
g. If you think the IUD has come out or has been displaced (i.e.,
you cannot feel the tail or thread or you can feel the IUD itself), use
another birth control method, such as contraceptive vaginal foam, cream,
or jelly, or condoms (rubbers), until you can be checked. (These
alternative methods are not as effective as IUD's.) Call your doctor for
an examination.
h. You should return to see your doctor as soon as possible after
your next menstrual period, after insertion of your IUD, but no later
than 3 months after insertion. This will allow the doctor to make sure
that the IUD is in the correct position.
i. After your first checkup, you should be checked at least once a
year by your doctor.
2. Continuation and removal. While you are wearing the IUD, you may
use tampons and take douches, if this is your usual practice. With some
IUD's, you may wear the IUD until you wish to become pregnant. Check
with your doctor concerning this. You should return to your doctor if
you wish to have the IUD removed.
Side Effects
The following may occur during or after the IUD is inserted:
1. Some bleeding occurs following insertion in most women. Because
of this, your doctor may choose to insert your IUD during or at the end
of your menstrual period. This also reduces the possibility that you are
pregnant at the time of IUD insertion.
2. Bleeding between menstrual periods usually in the form of
spotting, may occur during the first 2 or 3 months after insertion. The
first few menstrual periods after the insertion may be heavier and
longer. If these conditions continue for longer than 2 or 3 months,
consult your doctor.
3. Pain, usually in the form of uterine cramps or low backache, may
occur at the time of insertion and last for a few days. Simple pain
medication usually relieves the cramping.
4. Fainting may occur at the time of insertion or removal of an IUD.
This passes quickly and is not usually serious.
5. The IUD may be expelled during the first two or three menstrual
cycles following insertion. Expulsion increases the risk of an unplanned
pregnancy. Although not as effective as the IUD, the use of a second
contraceptive method, such as a contraceptive vaginal foam, cream, or
jelly, or condoms (rubbers), is recommended.
Warnings
1. Call your doctor for any of the following reasons:
a. Severe or prolonged bleeding. If the flow is heavier and lasts
much longer than your usual menstrual flow, you may need to have the IUD
removed to prevent the development of anemia.
b. Pelvic pain and cramps. This could mean an infection has
developed requiring treatment.
c. Exposure to venereal disease (VD). If exposure to venereal
disease is suspected, report for examination and treatment promptly.
[[Page 36]]
Failure to do so could result in serious pelvic infection because use of
an IUD in itself does not prevent venereal disease.
d. Tail or thread disappearance. If you cannot feel the tail or
thread coming through the cervix, it is possible that the IUD has been
expelled or displaced or that perforation has occurred. If any of these
has occurred you are no longer protected from becoming pregnant. Use
another birth control method, such as contraceptive vaginal foam, cream,
or jelly, or condoms (rubbers), until you can be checked. (These
alternative methods are not as effective as the IUD).
2. Do not undergo medical diathermy (including shortwave or
microwave) treatments to the abdomen or lower back areas if you are
wearing a metal IUD. these treatments may cause heat injury to the
surrounding tissues.
Special Warning About Pregnancy With an IUD in Place
Some women become pregnant while using an IUD. If you miss your
menstrual period, or if you have a scanty flow during your period, or if
you suspect that you might be pregnant, see your doctor right away.
Serious complication of sepsis (severe infection), septic abortion
(infected miscarriage), and death have occurred when a pregnancy
continues with an IUD in place. Most of the occurrences of these serious
complications have been reported in the middle third of pregnancy.
If your doctor confirms that you are pregnant, he should remove the
IUD if the tail is visible. Removal of an IUD in pregnancy decreases the
likelihood of serious complications.
If removal of your IUD proves to be difficult, you and your doctor
should discuss at that time the question of continuing the pregnancy in
view of the serious complications that may occur. In reaching a decision
as to whether or not to have an abortion, it should be remembered that
the risks associated with terminating a pregnancy increase with the
length of time you are pregnant.
(3) Any device IUD that is not labeled as required by this section
and that is either introduced or delivered for introduction into
interstate commerce, or held for sale after shipment in interstate
commerce after November 7, 1977 is misbranded pursuant to section 502 of
the act. However, an IUD in the possession of an independent wholesaler,
a retailer, or a licensed practitioner before November 7, 1977 is not
misbranded if labeling required by paragraph (b)(2) of this section is
furnished to such independent wholesalers, retailers, or licensed
practitioners in sufficient quantities to accompany each device in their
possession.
[42 FR 23780, May 10, 1977; 42 FR 35155, July 8, 1977]
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,
[[Page 37]]
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.
(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
[[Page 38]]
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 39]]
[GRAPHIC] [TIFF OMITTED] TR01FE93.026
[[Page 40]]
[GRAPHIC] [TIFF OMITTED] TR01FE93.027
[[Page 41]]
(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 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]
PART 803--MEDICAL DEVICE REPORTING (Eff. 4-11-96)--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: Secs. 502, 510, 519, 520, 701, 704 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 352, 360, 360i, 360j, 371, 374).
Source: 60 FR 63597, Dec. 11, 1995, unless otherwise noted.
Effective Date Note: At 60 FR 63597, Dec. 11, 1995, part 803 was
revised, effective April 11, 1996. For the convenience of the reader the
superseded text is set forth following the revised text.
Subpart A--General Provisions
Sec. 803.1 Scope.
(a) This part establishes requirements for medical device reporting.
Under this part, device user facilities and manufacturers must report
deaths and serious injuries to which a device has or may have caused or
contributed, and must establish and maintain adverse event files.
Manufacturers are also required to report certain device malfunctions
and submit an annual report to FDA certifying that the correct number of
medical device reports were filed during the previous 12-month period
or, alternatively, that no reports were required during that same time
period. These reports will assist FDA in protecting the public health by
helping to ensure that devices are not adul-
[[Page 42]]
terated 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.
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 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
[[Page 43]]
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 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.
[[Page 44]]
(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 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
[[Page 45]]
(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.
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;
(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
[[Page 46]]
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 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.
[[Page 47]]
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
(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
[[Page 48]]
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
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.
[[Page 49]]
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
(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 re-
[[Page 50]]
ports. 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 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;
[[Page 51]]
(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'');
(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;
[[Page 52]]
(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 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
[[Page 53]]
(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;
(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:
[[Page 54]]
(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 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.
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
[[Page 55]]
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.
All manufacturers, including U.S. agents of foreign manufacturers
required to report under this section, shall submit a certification
report to FDA, on FDA Form 3381, or electronic equivalent as approved
under part 814 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. The
reports shall contain the following information:
(a) Name, address, telephone number, and FDA registration number or
FDA-assigned identification number of the firm and whether the firm is a
manufacturer;
(b) A statement certifying that:
(1) The firm listed in paragraph (a) of this section has filed
reports for all reportable events required under this section during the
previous 12-month period. The firm shall also provide a numerical
summary of MDR reports that it submitted to FDA during the preceding
year; or
(2) The firm listed in paragraph (a) of this section did not receive
reportable events for any devices manufactured by the firm during the
previous 12-month period.
(c) Certification shall be made by the president, chief executive
officer, U.S.-designated agent of a foreign manufacturer, or other
official most directly responsible for the firm's operations; and
(d) Name of the manufacturer and registration numbers submitted
under paragraph (a) of this section shall be the same as those used in
submitting the reports required by Secs. 803.52, 803.53 and 803.55.
Multisite manufacturers who choose to certify centrally must identify
the reporting sites, by registration number or FDA-assigned
identification number and name covered by the certification, and provide
the information required by paragraph (b) of this section for each
reporting site.
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 60 FR 63597, Dec. 11, 1995, part 803 was
revised, effective April 11, 1996. For the convenience of the reader,
the superseded text is set forth below.
[[Page 56]]
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.
Subpart B--Reports and Records
803.24 Reports by manufacturers and importers.
803.31 Complaint files.
803.33 Where to submit a report.
803.36 Exemptions from reporting.
Authority: Secs. 502, 510, 519, 701, 704 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352, 360, 360i, 371, 374).
Source: 49 FR 36348, Sept. 14, 1984, unless otherwise noted.
Subpart A--General Provisions
Sec. 803.1 Scope.
(a) FDA is requiring a device manufacturer or importer to report to
FDA whenever the manufacturer or importer receives or otherwise becomes
aware of information that reasonably suggests that one of its marketed
devices (1) may have caused or contributed to a death or serious injury
or (2) has malfunctioned and that the device or any other device
marketed by the manufacturer or importer would be likely to cause or
contribute to a death or serious injury if the malfunction were to
recur. These reports will 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, a
device importer is required to establish and maintain a complaint file
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.
(b) This part supplements, and does not supersede, other provisions
of this subchapter, including the provisions of Part 820, such as the
requirements under Sec. 820.162 that a manufacturer investigate the
failure of a device or any of its components to meet its performance
specifications and to establish and maintain a written record of the
investigation, including the manufacturer's conclusions and followup,
the requirements under Sec. 820.198 that a manufacturer establish and
maintain a complaint file, and the requirements under Sec. 820.180 that
a manufacturer allow access to, and copying of, these files by any
authorized FDA representative.
(c) References in this part to regulatory sections of the Code of
Federal Regulations are to Chapter I of Title 21, unless otherwise
noted.
Sec. 803.3 Definitions.
(a) FDA means the Food and Drug Administration.
(b) Importer means any person who imports a device into the United
States and is required to register under Part 807.
(c) 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 person 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.
(d) Manufacturer means any person who is required to register under
Part 807, other than a person who initially distributes a device
imported into the United States.
(e) Person includes any individual, partnership, corporation,
association, scientific or academic establishment, Government agency, or
organizational unit thereof, or any other legal entity.
(f) Information that reasonably suggests a conclusion means: (1)
Information (such as professional, scientific, or medical facts or
opinions) from which a reasonable person would reach the conclusion, and
(2) a statement to a manufacturer or importer by a health care
professional (e.g., a doctor of medicine, osteopathy, dental surgery,
podiatry, or chiropractic, or an optometrist, pharmacist, or a
registered nurse, or a hospital administrator), reaching the conclusion.
(g) A remedial action is any recall, repair, modification,
adjustment, relabeling, destruction, inspection (including patient
monitoring), notification, or any other action that is initiated by a
manufacturer or importer in response to information that it receives or
otherwise becomes aware of and that reasonably suggests that one of its
marketed devices (1) may have caused or contributed to a death or
serious injury or (2) has malfunctioned and that the device or any other
device marketed by the manufacturer or importer would be likely to cause
or contribute to a death or serious injury if the malfunction were to
recur.
(h) A serious injury is an injury that (1) is life threatening, (2)
results in permanent impairment of a body function or permanent damage
to body structure, or (3) necessitates medical or surgical intervention
by a health care professional to (i) preclude permanent
[[Page 57]]
impairment of a body function or permanent damage to body structure or
(ii) relieve unanticipated temporary impairment of a body function or
unanticipated temporary damage to body structure. Temporary impairment
of a body function or temporary damage to body structure is
unanticipated if reference to such impairment or damage is not made in
the labeling for the device or, if such reference is made in the
labeling for the device, the manufacturer or importer of the device
determines that such impairment or damage has occurred or is occurring
more frequently or with greater severity than is stated in the labeling
for the device or, if there is not any pertinent statement in the
labeling, than is usual for the device.
(i) Any term defined in section 201 of the Federal Food, Drug, and
Cosmetic Act shall have that meaning, unless otherwise defined in this
part.
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.
(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; and (2) 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.
Subpart B--Reports and Records
Sec. 803.24 Reports by manufacturers and importers.
(a) A manufacturer or importer shall submit to FDA a report
containing the information listed in paragraph (c) of this section
whenever the manufacturer or importer:
(1) Receives or otherwise becomes aware of oral or written
information that reasonably suggests that:
(i) A death or serious injury has occurred and that one of the
manufacturer's or importer's marketed devices may have caused or
contributed to a death or serious injury; or
(ii) One of the manufacturer's or importer's marketed devices has
malfunctioned and that the device or any other device marketed by the
manufacturer or importer would be likely to cause or contribute to a
death or serious injury if the malfunction were to recur.
(2) Receives or otherwise becomes aware of information:
(i) In the medical or scientific literature, whether published or
unpublished, that reasonably suggests that one of its marketed devices
(A) may have caused or contributed to a death or serious injury or (B)
has malfunctioned and that the device or any other device marketed by
the manufacturer or importer would be likely to cause or contribute to a
death or serious injury if the malfunction were to recur; or
(ii) Through its own research, testing, evaluation, servicing, or
maintenance of one of its devices, that reasonably suggests that one of
its marketed devices malfunctions and that the device or any other
device marketed by the manufacturer or importer would be likely to cause
or contribute to a death or serious injury if the malfunction were to
recur.
(b)(1) Whenever a manufacturer or importer receives or otherwise
becomes aware of information that reasonably suggests that one of its
marketed devices may have caused or contributed to a death or serious
injury, the manufacturer or importer shall report to FDA by telephone as
soon as possible, but no later than within 5 calendar days of initial
receipt of the information. The manufacturer or importer shall include
in the telephone report the information listed in paragraph (c) of this
section. The manufacturer or importer shall follow the telephone report
with a written report submitted to FDA within 15 working days of initial
receipt of the information.
(2) Whenever a manufacturer or importer receives or otherwise
becomes aware of information that reasonably suggests that one of its
marketed devices has malfunctioned and that the device or any other
device marketed by the manufacturer or importer would be likely to cause
or contribute to a death or serious injury if the malfunction were to
recur, the manufacturer or importer shall report in writing or by
telephone to FDA as soon as the information listed in paragraph (c) of
this section has been obtained, but in no event later than 15 working
days after initial receipt of the information. The manufacturer or
importer shall follow any report made by telephone with a written report
submitted to FDA within 15 working days of initial receipt of the
information.
(c) A medical device telephone report or written report is required
to:
(1) Identify the device, including its brand name and common or
usual name and, to the extent known, the model, catalog, or other
identification number or code of the device, and the manufacturing lot
or serial number of the device.
(2) Identify the manufacturer or, in the case of an imported device,
identify the importer and the foreign manufacturer;
[[Page 58]]
(3) Identify, by name, address, and telephone number, the individual
making the report to FDA;
(4) Describe, to the extent known, the event giving rise to the
information received by the manufacturer or importer, including (i)
whether any deaths or serious injuries have occurred and (ii) the number
of persons who died or were seriously injured. (If the report is
required under paragraph (a)(2)(i) of this section, the description of
the event shall include a copy of the article.);
(5) Identify, by name and address, the person submitting the
information to the manufacturer or importer;
(6) State whether the manufacturer or importer intends to submit
additional information, and, if so, when such information will be
submitted; and
(7) State whether the reported event has occurred or is occurring
more frequently or with greater severity than is stated in the labeling
for the device or, if there is not any pertinent statement in the
labeling, than is usual for the device, if such information is
available.
(d)(1) A manufacturer or importer shall report to FDA as required
under this part each time it receives or otherwise becomes aware of
information described in paragraph (a) of this section, even if an event
of the same or a similar nature has been reported previously to FDA. A
medical device report is required under paragraph (a) of this section
even if the manufacturer or importer believes that the event that
requires a report is due to user error, the failure to service or
maintain the device properly, the use of the device beyond its labeled
useful life, or any other reason not listed under paragraph (d) (2) or
(3) of this section.
(2) Only one medical device report is required under paragraph (a)
of this section if the manufacturer or importer becomes aware, from more
than one source, of information concerning the same patient and the same
event.
(3) A medical device report is not required if within the time
period specified under paragraph (b) of this section, the manufacturer
or importer determines that:
(i) The information received under paragraph (a)(1)(i) of this
section is erroneous in that a death or serious injury has not occurred;
or
(ii) The information received under paragraph (a)(1)(i) or (ii) of
this section is erroneous in that the device that is the subject of the
information was manufactured or imported by another manufacturer or
importer; or
(iii) Although the manufacturer or importer has received or
otherwise became aware of information that reasonably suggests that a
malfunction has occurred, each of the following applies:
(A) A death or serious injury has not occurred;
(B) The device's labeling sets forth information concerning the
potential for death or the type of serious injury that the malfunction
may cause or contribute to;
(C) The device's labeling describes the malfunction, and the routine
service, repair, or maintenance instructions to correct the malfunction;
(D) The malfunction has occurred or is occurring at or below the
frequency and severity stated in the labeling for the device or, if
there is not any pertinent statement in the labeling, at or below the
frequency and severity that are usual for the device; and
(E) The malfunction does not lead the manufacturer or importer to
undertake a remedial action involving any device other than the device
product in which the malfunction occurred.
(4) FDA may notify a manufacturer or importer, in writing, that
medical device reports of a particular type of event are no longer
required.
(e) If FDA determines that the protection of the public health
requires information in addition to that included in the medical device
report submitted to FDA under paragraph (b) of this section, a
manufacturer or importer shall, upon FDA's request, submit such
additional information. Any request by FDA under this paragraph will be
in writing, state the reason or purpose for which the information is
being requested, and specify a due date for the submission of such
information. Additional items that may be requested include:
(1) Model, catalog, or other identification number or code of the
device.
(2) Manufacturing lot or serial number of the device.
(3) A complete description of the event giving rise to the
information received by the manufacturer or importer, including (i)
whether any deaths or serious injuries have occurred and (ii) the number
of persons who died or were seriously injured. If a complete description
is unavailable, the manufacturer or importer shall explain the reason
for the unavailability of such description.
(4) Any evaluation of the risk of death or serious injury, including
failure analysis, and copies of any laboratory testing or analyses
available to or used by the manufacturer or importer.
(5) Any available evaluation by a practitioner, such as a physician
or dentist, licensed by law to use or order the use of the device, of
the event described in the medical device report.
(6) Any evaluation or other determination available to or used by
the manufacturer or importer as to whether the event described in the
medical device report is or is not attributable to the device and the
basis for such determination.
[[Page 59]]
(7)(i) All the information on the basis of which the manufacturer or
importer determined that the reported event has occurred or is occurring
more frequently or with greater severity than is stated in the labeling
for the device or, if there is not any pertinent statement in the
labeling, than is usual for the device; and
(ii) any evaluation or analysis available to or used by the
manufacturer or importer in making this determination.
(8) If the manufacturer or importer determines that the event
described in the medical device report is attributable to the device, an
outline of the plan for remedial action or, if the manufacturer or
importer determines that a remedial action is unnecessary, the basis for
such determination.
(9) A copy of any proposed remedial action communication and the
names and addresses of recipients of the communication.
(10) Information concerning the device's manufacture, e.g., the
total number manufactured or the number in the same batch, lot, or
equivalent unit of production, the location and date of manufacture, and
the device's expiration date, if any.
(11) Information concerning the device's distribution, e.g., the
location and number of devices in inventory stock and distribution
channels, a list of all consignees, and the dates of distribution.
(f) A report or information submitted by a manufacturer or importer
under this section (and any release by FDA of that report or
information) does not necessarily reflect a conclusion by the
manufacturer, importer, or FDA that the report or information
constitutes an admission that the device caused or contributed to a
death or serious injury or malfunctioned. A manufacturer or importer
need not admit, and may deny, that the report or information submitted
under this section constitutes an admission that the device caused or
contributed to a death or serious injury or malfunctioned.
(Approved by the Office of Management and Budget under control number
0910-0201)
[49 FR 36348, Sept. 14, 1984, as amended at 49 FR 48273, Dec. 12, 1984]
Sec. 803.31 Complaint files.
(a) An importer shall establish a complaint file and maintain a
record of any information, including any written or oral communication,
received by the importer concerning a death, serious injury, or device
malfunction that requires a report under Sec. 803.24. The file also is
required to contain a copy of any medical device report submitted to FDA
under Sec. 803.24(b) and any additional information submitted to FDA
under Sec. 803.24(e).
(b) An importer shall retain copies of records maintained under
paragraph (a) of this section for a period of 2 years from the date that
the medical device report or additional information is submitted to FDA
under Sec. 803.24 (b) or (e), even if the importer has ceased importing
the device that is the subject of the report or the additional
information.
(c) An importer shall maintain the complaint file established under
this section at the importer's principal business establishment. An
importer that also is a manufacturer may maintain the file at the same
location as the manufacturer maintains its complaint file under
Secs. 820.180 and 820.198. An importer shall permit any authorized FDA
employee at all reasonable times to have access to and to copy and
verify the records contained in the complaint file.
(d) A manufacturer shall retain copies of records of any
information, including any written or oral communication, received by
the manufacturer concerning a death, serious injury, or device
malfunction that requires a report under Sec. 803.24. The manufacturer
also shall retain a copy of any medical device report submitted to FDA
under Sec. 803.24(b) and any additional information submitted to FDA
under Sec. 803.24(e). The manufacturer shall retain the records referred
to in this paragraph for a period of 2 years from the date that the
report or additional information is submitted to FDA under Sec. 803.24
(b) or (e) or for a period of time equivalent to the design and expected
life of the device, whichever is greater. The manufacturer may maintain
as part of its complaint file under Sec. 820.198 the records referred to
in this paragraph. The manufacturer shall permit any authorized FDA
employee at all reasonable times to have access to and to copy and
verify the records referred to in this paragraph.
(Approved by the Office of Management and Budget under control number
0910-0201)
[49 FR 36348, Sept. 14, 1984, as amended at 49 FR 48273, Dec. 12, 1984]
Sec. 803.33 Where to submit a report.
(a) Any telephone report required under this part shall be provided
to 301-427-7500.
(b) Any written report or additional information required under this
part shall be submitted to the Product Monitoring Branch (HFZ-351),
Center for Devices and Radiological Health, Food and Drug
Administration, 1390 Piccard Dr., Rockville, MD 20850.
[49 FR 36348, Sept. 14, 1984, as amended at 53 FR 11252, Apr. 6, 1988;
55 FR 11168, Mar. 27, 1990]
Sec. 803.36 Exemptions from reporting.
A manufacturer or importer otherwise subject to this part is exempt
from reporting as required under this part, if the manufacturer or
importer:
(a) Is a practitioner who is licensed by law to prescribe or
administer devices intended for use in humans and who manufactures or
[[Page 60]]
imports devices solely for use in the course of that individual's
professional practice.
(b) Is a person who manufactures or imports devices intended for use
in humans solely for such person's use in research or teaching and not
for sale or under an investigational device exemption granted under part
812 or part 813.
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: Secs. 502, 510, 519, 520, 701, 704 of the Federal Food,
Drug, and Cosmetic Act (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 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 specifica-
[[Page 61]]
tions 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:
(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;
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(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.
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.
[[Page 63]]
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 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;
[[Page 64]]
(10) The name, title, address, telephone number, and signature of
the person who prepared the report.
Sec. 804.30 Annual certification.
Distributors required to report under this section shall submit a
certification report to FDA by the date designated for annual
registration for the firm in Sec. 807.21 of this chapter. This date will
cover the period ending 1 month before the month of the scheduled date
of mailing as indicated in Sec. 807.21(a). The report will contain the
following information:
(a) The name, address, telephone number, and FDA registration number
of the distributor;
(b) A statement certifying that:
(1) The distributor listed in paragraph (a) of this section has
filed reports under this section during the previous 12-month period and
all MDR reportable events have been submitted to FDA and/or to the
appropriate manufacturer. The report will also include the number of
death, serious injury or serious illness reports that were submitted to
FDA, and the number of malfunction reports that were submitted to
manufacturers; or
(2) The distributor listed in paragraph (a) of this section did not
receive any reportable events during the previous 12-month period.
(c) The name, address, title, telephone number, and signature of the
individual making the certification for the firm. This person must be a
responsible person designated by the firm.
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 re-
[[Page 65]]
quirements to ensure the protection of public health and safety. FDA may
also 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: Sec. 1862(h) of the Social Security Act and sec. 2304(d)
of the Deficit Reduction Act (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
[[Page 66]]
pacemaker leads to submit certain information to the registry. If the
physician or the provider of services does not submit the information
according 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.
[[Page 67]]
(f) Identification number (used by PRO's) and name of the operating
physician.
(g) For each device (pulse generator, atrial lead, ventricular lead)
implanted 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 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.
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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: Secs. 301, 501, 502, 510, 513, 515, 519, 520, 701, 704
of the Federal Food, Drug, and Cosmetic Act (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 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 author-
[[Page 69]]
ization 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 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 60 FR 63606, Dec. 11, 1995, Sec. 807.3 was
amended by adding paragraph (r), effective April 11, 1996.
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
[[Page 70]]
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 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 60 FR 63606, Dec. 11, 1995, Sec. 807.20 was
amended by adding paragraph (a)(6), effective April 11, 1996.
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.
[[Page 71]]
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 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]
Effective Date Note: At 60 FR 63606, Dec. 11, 1995, Sec. 807.22 was
amended by revising paragraph (a), effective April 11, 1996. For the
convenience of the reader, the superseded text is set forth below.
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
obtainable upon request from the Center for Devices and Radiological
Health (HFZ-342), Food and Drug Administration, 1390 Piccard Dr.,
Rockville, MD 20850, or from the Food and Drug Administration (FDA)
district offices. Subsequent annual registration shall be accomplished
on form FDA-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 in accordance with the schedule
as described in Sec. 807.21(a). The completed form shall be mailed to
the above-designated address within 30 days after receipt from FDA.
* * * * *
[[Page 72]]
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 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
[[Page 73]]
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).
(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:
[[Page 74]]
(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.
(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]
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.
[[Page 75]]
(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,
(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
[[Page 76]]
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 60 FR 63606, Dec. 11, 1995, Sec. 807.40 was
revised, effective April 11, 1996. For the convenience of the reader,
the superseded text is set forth below.
Sec. 807.40 Establishment registration and device listing for foreign
manufacturers of devices.
(a) Foreign device establishments that export devices into the
United States are requested to register in accordance with the
procedures of subpart B of this part, unless exempt under subpart D of
this part.
(b) Foreign device establishments that export devices into the
United States, whether or not the establishment is registered, shall
comply with the device listing requirements unless exempt from
registration as stated in Sec. 807.65. Those foreign owners or operators
for which there exists joint ownership and control with a domestic
establishment may have the domestic establishment submit listing
information and maintain the historical file. A foreign owner or
operator may authorize a domestic initial distributor to submit listing
information when joint ownership and control does not exist, only if:
(1) The domestic distributor is the sole initial distributor for the
foreign owner or operator's device; and
(2) The foreign owner or operator submits a letter to the Food and
Drug Administration authorizing the initial distributor to list on its
behalf and maintain the historical file.
(c) Except for a device imported or offered for import that has in
effect an approved exemption for investigational use under section
520(g) of the act, a device may not be imported from a foreign device
establishment into the United States unless it is listed at the interval
specified for updating device listing information in Sec. 807.30(b). The
device listing information shall be in the English language.
(d) Foreign device establishments shall submit, as part of the
device listing, the name and address of the establishment and the name
of the individual responsible for submitting device listing information.
Any changes in this information shall be reported to the Food and Drug
Administration at the intervals specified for updating device listing
information in Sec. 807.30(b).
[43 FR 37999, Aug. 25, 1978]
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
[[Page 77]]
devices in the usual course of business as carriers.
(i) Persons who dispense devices to the ultimate consumer or whose
major responsibility is to render a service necessary to provide the
consumer (i.e., patient, physician, layman, etc.) with a device or the
benefits to be derived from the use of a device; for example, a hearing
aid dispenser, optician, clinical laboratory, assembler of diagnostic x-
ray systems, and personnel from a hospital, clinic, dental laboratory,
orthotic or prosthetic retail facility, whose primary responsibility to
the ultimate consumer is to dispense or provide a service through the
use of a previously manufactured device.
[42 FR 42526, Aug. 23, 1977, as amended at 58 FR 46523, Sept. 1, 1993]
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
[[Page 78]]
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 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) 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.
(j) 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.
(k) 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
[[Page 79]]
original premarket notification submission for the Commissioner to make
this determination and that the owner or operator may either submit the
requested data or a new premarket notification containing the requested
information at least 90 days before the owner or operator intends to
market the device, or submit a premarket approval application in
accordance with section 515 of the act. If the additional information is
not submitted within 30 days following the date of the request, the
Commissioner will consider the premarket notification to be withdrawn.
(Information collection requirements in this section were approved by
the Office of Management and Budget (OMB) and assigned OMB control
number 0910-0281)
[42 FR 42526, Aug 23, 1977, as amended at 57 FR 18066, Apr. 28, 1992; 59
FR 64295, Dec. 14, 1994]
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.
[[Page 80]]
If the indication statements are different from those of the legally
marketed device identified in paragraph (a)(3) of this section, the
510(k) summary shall contain an explanation as to why the differences
are not critical to the intended therapeutic, diagnostic, prosthetic, or
surgical use of the device, and why the differences do not affect the
safety and effectiveness of the device when used as labeled; and
(6) If the device has the same technological characteristics (i.e.,
design, material, chemical composition, energy source) as the predicate
device identified in paragraph (a)(3) of this section, a summary of the
technological characteristics of the new device in comparison to those
of the predicate device. If the device has different technological
characteristics from the predicate device, a summary of how the
technological characteristics of the device compare to a legally
marketed device identified in paragraph (a)(3) of this section.
(b) 510(k) summaries for those premarket submissions in which a
determination of substantial equivalence is 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]
[[Page 81]]
Sec. 807.94 Format of a class III certification.
(a) A class III certification submitted as part of a premarket
notification shall state as follows:
I certify, in my capacity as (position held in company), of (company
name), that I have conducted a reasonable search of all information
known or otherwise available about the types and causes of safety or
effectiveness problems that have been reported for the (type of device).
I further certify that I am aware of the types of problems to which the
(type of device) is susceptible and that, to the best of my knowledge,
the following summary of the types and causes of safety or effectiveness
problems about the (type of device) is complete and accurate.
(b) The statement in paragraph (a) of this section should be signed
by the certifier, clearly identified as ``class III certification,'' and
included at the beginning of the section of the premarket notification
submission that sets forth the class III summary.
[59 FR 64296, Dec. 14, 1994]
Sec. 807.95 Confidentiality of information.
(a) The Food and Drug Administration will disclose publicly whether
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 submis-
[[Page 82]]
sion for the device for an additional time when any of the following
occurs:
(1) The Commissioner requests in writing additional information
regarding the device pursuant to Sec. 807.87(h), in which case the
Commissioner will not disclose the existence of the submission until 90
days after the Food and Drug Administration's receipt of a complete
premarket notification submission;
(2) The Commissioner determines that the device intended to be
introduced is a class III device and cannot be marketed without
premarket approval or reclassification, in which case the Commissioner
will not disclose the existence of the submission unless a petition for
reclassification is submitted under section 513(f)(2) of the act and its
existence can be disclosed under Sec. 860.5(d) of this chapter; or
(d) FDA will make a 510(k) summary of the safety and effectiveness
data available to the public within 30 days of the issuance of a
determination that the device is substantially equivalent to another
device. Accordingly, even when a 510(k) submitter has complied 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) 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
[[Page 83]]
source, or other features of the device from those of the predicate
device;
(B) The data submitted establishes that the device is substantially
equivalent to the predicate device and contains information, including
clinical data if deemed necessary by the Commissioner, that demonstrates
that the device is as safe and as effective as a legally marketed
device; and
(C) Does not raise different questions of safety and effectiveness
than the predicate device.
(3) The predicate device has not been removed from the market at the
initiative of the Commissioner of Food and Drugs or has not been
determined to be misbranded or adulterated by a judicial order.
[57 FR 58403, Dec. 10, 1992]
PART 808--EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS--Table of Contents
Subpart A--General Provisions
Sec.
808.1 Scope.
808.3 Definitions.
808.5 Advisory opinions.
Subpart B--Exemption Procedures
808.20 Application.
808.25 Procedures for processing an application.
808.35 Revocation of an exemption.
Subpart C--Listing of Specific State and Local Exemptions
808.53 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.
808.97 Washington.
808.98 West Virginia.
808.101 District of Columbia.
Authority: Secs. 521, 701 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 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 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
[[Page 84]]
(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.
(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.
[[Page 85]]
(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.
(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]
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.
(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
[[Page 86]]
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.
(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 de-
[[Page 87]]
vice 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 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 exemp-
[[Page 88]]
tion 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. 808.53 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,
[[Page 89]]
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, 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.
[[Page 90]]
(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 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
[[Page 91]]
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
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
[[Page 92]]
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. 808.97 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), 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.
Authority: Secs. 301, 501, 502, 505, 507, 512, 513, 514, 518, 519,
520, 701, 702, 704, 801 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331, 351, 352, 355, 357, 360b, 360c, 360d, 360h, 360i, 360j, 371,
372, 374, 381).
[[Page 93]]
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 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
[[Page 94]]
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.
Section 201(k) of the act provides that ``a requirement made by or under
authority of this act that any word, statement, or other information
appear on the label shall not be considered to be complied with unless
such word, statement, or other information also appears on the outside
container or wrapper, if any there be, of the retail package of such
article, or is easily legible through the outside container or
wrapper.''
(1) The proprietary name and established name (common or usual
name), if any.
(2) The intended use or uses of the product.
(3) For a reagent, a declaration of the established name (common or
usual name), if any, and quantity, proportion or concentration of each
reactive ingredient; and for a reagent derived from biological material,
the source and a measure of its activity. The quantity, proportion,
concentration, or activity shall be stated in the system generally used
and recognized by the intended user, e.g., metric, international units,
etc.
(4) A statement of warnings or precautions for users as established
in the regulations contained in 16 CFR Part 1500 and any other warnings
appropriate to the hazard presented by the product; and a statement
``For In Vitro Diagnostic Use'' and any other limiting statements
appropriate to the intended use of the product.
(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, pre-
[[Page 95]]
cipitate, 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 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
appro-
[[Page 96]]
priate 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 specific steps, proper temperatures, wavelengths, etc.
(iv) A statement describing the stability of the final reaction
material to be measured and the time within which it shall be measured
to assure accurate results.
(v) Details of calibration: Identify reference material. Describe
preparation of reference sample(s), use of blanks, preparation of the
standard curve, etc. The description of the range of calibration should
include the highest and the lowest values measurable by the procedure.
(vi) Details of kinds of quality control procedures and materials
required. If there is need for both positive and negative controls, this
should be stated. State what are considered satisfactory limits of
performance.
(9) Results: Explain the procedure for calculating the value of the
unknown. Give an explanation for each component of the formula used for
the calculation of the unknown. Include a sample calculation, step-by-
step, explaining the answer. The values shall be expressed to the
appropriate number of significant figures. If the test provides other
than quantitative results, provide an adequate description of expected
results.
(10) Limitation of the procedure: Include a statement of limitations
of the procedure. State known extrinsic factors or interfering
substances affecting results. If further testing, either more specific
or more sensitive, is indicated in all cases where certain results are
obtained, the need for the additional test shall be stated.
(11) Expected values: State the range(s) of expected values as
obtained with the product from studies of various populations. Indicate
how the range(s) was established and identify the population(s) on which
it was established.
[[Page 97]]
(12) Specific performance characteristics: Include, as appropriate,
information describing such things as accuracy, precision, specificity,
and sensitivity. These shall be related to a generally accepted method
using biological specimens from normal and abnormal populations. Include
a statement summarizing the data upon which the specific performance
characteristics are based.
(13) Bibliography: Include pertinent references keyed to the text.
(14) Name and place of business of manufacturer, packer, or
distributor.
(15) Date of issuance of the last revision of the labeling
identified as such.
(c) A shipment or other delivery of an in vitro diagnostic product
shall be exempt from the requirements of paragraphs (a) and (b) of this
section and from a standard promulgated under part 861 provided that the
following conditions are met:
(1) In the case of a shipment or delivery for an investigation
subject to part 812, if there has been compliance with part 812; or
(2) In the case of a shipment or delivery for an investigation that
is not subject to part 812 (see Sec. 812.2(c)), if the following
conditions are met:
(i) For a product in the laboratory research phase of development,
and not represented as an effective in vitro diagnostic product, all
labeling bears the statement, prominently placed: ``For Research Use
Only. Not for use in diagnostic procedures.''
(ii) For a product being shipped or delivered for product testing
prior to full commercial marketing (for example, for use on specimens
derived from humans to compare the usefulness of the product with other
products or procedures which are in current use or recognized as
useful), all labeling bears the statement, prominently placed: ``For
Investigational Use Only. The performance characteristics of this
product have not been established.''
(d) The labeling of general purpose laboratory reagents (e.g.,
hydrochloric acid) and equipment (e.g., test tubes and pipettes) whose
uses are generally known by persons trained in their use need not bear
the directions for use required by Sec. 809.10 (a) and (b), if their
labeling meets the requirements of this paragraph.
(1) The label of a reagent shall bear the following information:
(i) The proprietary name and established name (common or usual
name), if any, of the reagent.
(ii) A declaration of the established name (common or usual name),
if any, and quantity, proportion or concentration of the reagent
ingredient (e.g., hydrochloric acid: Formula weight 36.46, assay 37.9
percent, specific gravity 1.192 at 60 deg. F); and for a reagent derived
from biological material, the source and where applicable a measure of
its activity. The quantity, proportion, concentration or activity shall
be stated in the system generally used and recognized by the intended
user, e.g., metric, international units, etc.
(iii) A statement of the purity and quality of the reagent,
including a quantitative declaration of any impurities present. The
requirement for this information may be met by a statement of conformity
with a generally recognized and generally available standard which
contains the same information, e.g., those established by the American
Chemical Society, U.S. Pharmacopeia, National Formulary, National
Research Council.
(iv) A statement of warnings or precautions for users as established
in the regulations contained in 16 CFR Part 1500 and any other warnings
appropriate to the hazard presented by the product; and a statement
``For Laboratory Use.''
(v) Appropriate storage instructions adequate to protect the
stability of the product. When applicable, these instructions shall
include such information as conditions of temperature, light, humidity,
and other pertinent factors. The basis for such information shall be
determined by reliable, meaningful, and specific test methods such as
those described in Sec. 211.166 of this chapter.
(vi) A declaration of the net quantity of contents, expressed in
terms of weight or volume, numerical count, or any combination of these
or other terms which accurately reflect the contents of the package. The
use of metric designations is encouraged, wherever appropriate.
[[Page 98]]
(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.
[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]
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]
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.
812.38 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.
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.
Subpart F--[Reserved]
Subpart G--Records and Reports
812.140 Records.
812.145 Inspections.
812.150 Reports.
Authority: Secs. 301, 501, 502, 503, 505, 506, 507, 510, 513-516,
518-520, 701, 702, 704, 721, 801 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 331, 351, 352, 353, 355, 356, 357, 360, 360c-360f, 360h-
360j, 371, 372, 374, 379e, 381); secs. 215, 301, 351, 354-360F of the
Public Health Service Act (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 pur-
[[Page 99]]
suit 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 act and regulations issued thereunder: Misbranding under
section 502, registration, listing, and premarket notification under
section 510, performance standards under section 514, premarket approval
under section 515, a banned device regulation under section 516, records
and reports under section 519, restricted device requirements under
section 520(e), good manufacturing practice requirements under section
520(f) (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]
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 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 diag-
[[Page 100]]
nosis by another, medically established diagnostic product or procedure.
(4) A device undergoing consumer preference testing, testing of a
modification, or testing of a combination of two or more devices in
commercial distribution, if the testing is not for the purpose of
determining safety or effectiveness and does not put subjects at risk.
(5) A device intended solely for veterinary use.
(6) A device shipped solely for research on or with laboratory
animals and labeled in accordance with Sec. 812.5(c).
(7) A custom device as defined in Sec. 812.3(b), unless the device
is being used to determine safety or effectiveness for commercial
distribution.
(8) An intraocular lens. An intraocular lens shall not be used
unless it is subject to an approved IDE under Part 813 or an approved
application for premarket approval under section 515 of the act.
(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]
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.
[[Page 101]]
(h) Investigation means a clinical investigation or research
involving one or more subjects to determine the safety or effectiveness
of a device.
(i) Investigator means an individual who actually conducts a
clinical investigation, i.e., under whose immediate direction the test
article is administered or dispensed to, or used involving, a subject,
or, in the event of an investigation conducted by a team of individuals,
is the responsible leader of that team.
(j) Monitor, when used as a noun, means an individual designated by
a sponsor or contract research organization to oversee the progress of
an investigation. The monitor may be an employee of a sponsor or a
consultant to the sponsor, or an employee of or consultant to a contract
research organization. Monitor, when used as a verb, means to oversee an
investigation.
(k) Noninvasive, when applied to a diagnostic device or procedure,
means one that does not by design or intention: (1) Penetrate or pierce
the skin or mucous membranes of the body, the ocular cavity, or the
urethra, or (2) enter the ear beyond the external auditory canal, the
nose beyond the nares, the mouth beyond the pharynx, the anal canal
beyond the rectum, or the vagina beyond the cervical os. For purposes of
this part, blood sampling that involves simple venipuncture is
considered noninvasive, and the use of surplus samples of body fluids or
tissues that are left over from samples taken for noninvestigational
purposes is also considered noninvasive.
(l) Person includes any individual, partnership, corporation,
association, scientific or academic establishment, Government agency or
organizational unit of a Government agency, and any other legal entity.
(m) Significant risk device means an investigational device that:
(1) Is intended as an implant and presents a potential for serious
risk to the health, safety, or welfare of a subject;
(2) Is purported or represented to be for a use in supporting or
sustaining human life and presents a potential for serious risk to the
health, safety, or welfare of a subject;
(3) Is for a use of substantial importance in diagnosing, curing,
mitigating, or treating disease, or otherwise preventing impairment of
human health and presents a potential for serious risk to the health,
safety, or welfare of a subject; or
(4) Otherwise presents a potential for serious risk to the health,
safety, or welfare of a subject.
(n) Sponsor means a person who initiates, but who does not actually
conduct, the investigation, that is, the investigational device is
administered, dispensed, or used under the immediate direction of
another individual. A person other than an individual that uses one or
more of its own employees to conduct an investigation that it has
initiated is a sponsor, not a sponsor-investigator, and the employees
are investigators.
(o) Sponsor-investigator means an individual who both initiates and
actually conducts, alone or with others, an investigation, that is,
under whose immediate direction the investigational device is
administered, dispensed, or used. The term does not include any person
other than an individual. The obligations of a sponsor-investigator
under this part include those of an investigator and those of a sponsor.
(p) Subject means a human who participates in an investigation,
either as an individual on whom or on whose 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
[[Page 102]]
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: ``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(d) of the act.
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
[[Page 103]]
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]
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
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.
(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. 25.24 or an
environmental assessment under Sec. 25.31.
(10) Copies of all labeling for the device.
(11) Copies of all forms and informational materials to be provided
to subjects to obtain informed consent.
(12) Any other relevant information FDA requests for review of the
application.
(c) Additional information. FDA may request additional information
concerning an investigation or revision in the investigational plan. The
sponsor may treat such a request as a disapproval of the application for
purposes of requesting a hearing under Part 16.
(d) Information previously submitted. Information previously
submitted to the Center for Devices and Radiological Health 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]
[[Page 104]]
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:
(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 regula-
[[Page 105]]
tion 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)).
(b) IRB approval for new facilities. A sponsor shall submit to FDA a
certification of any IRB approval of an investigation or a part of an
investigation not included in the IDE application. If the investigation
is otherwise unchanged, the supplemental application shall consist of an
updating of the information required by Sec. 812.20(b) and (c) and a
description of any modifications in the investigational plan required by
the IRB as a condition of approval. A certification of IRB approval need
not be included in the initial submission of the supplemental
application, and such certification is not a precondition for agency
consideration of the application. Nevertheless, a sponsor may not begin
a part of an investigation at a facility until the IRB has approved the
investigation, FDA has received the certification of IRB approval, and
FDA, under Sec. 812.30(a), has approved the supplemental application
relating to that part of the investigation (see Sec. 56.103(a)).
[50 FR 25909, June 24, 1985; 50 FR 28932, July 17, 1985]
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
[[Page 106]]
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.
(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]
Subpart C--Responsibilities of Sponsors
Sec. 812.40 General responsibilities of sponsors.
Sponsors are responsible for selecting qualified investigators and
providing them with the information they need to conduct the
investigation properly, ensuring proper monitoring of the investigation,
ensuring that IRB review and approval are obtained, submitting an IDE
application to FDA, and ensuring that any reviewing IRB and FDA are
promptly informed of significant new information about an investigation.
Additional responsibilities of sponsors are described in Subparts B and
G.
Sec. 812.42 FDA and IRB approval.
A sponsor shall not begin an investigation or part of an
investigation until an IRB and FDA have both approved the application or
supplemental application relating to the investigation or part of an
investigation.
[46 FR 8957, Jan. 27, 1981]
Sec. 812.43 Selecting investigators and monitors.
(a) Selecting investigators. A sponsor shall select investigators
qualified by training and experience to investigate the device.
(b) Control of device. A sponsor shall ship investigational devices
only to qualified investigators participating in the investigation.
(c) Obtaining agreements. A sponsor shall obtain from each
participating investigator a signed agreement that includes:
(1) The investigator's curriculum vitae.
(2) Where applicable, a statement of the investigator's relevant
experience, including the dates, location, extent, and type of
experience.
(3) If the investigator was involved in an investigation or other
research that was terminated, an explanation of the circumstances that
led to termination.
(4) A statement of the investigator's commitment to:
(i) Conduct the investigation in accordance with the agreement, the
investigational plan, this part and other applicable FDA regulations,
and conditions of approval imposed by the reviewing IRB or FDA;
(ii) Supervise all testing of the device involving human subjects;
and
(iii) Ensure that the requirements for obtaining informed consent
are met.
(d) Selecting monitors. A sponsor shall select monitors qualified by
training and experience to monitor the inves-
[[Page 107]]
tigational study in accordance with this part and other applicable FDA
regulations.
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.
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,
[[Page 108]]
and for the control of devices under investigation. An investigator also
is responsible for ensuring that informed consent is obtained in
accordance with Part 50 of this chapter. Additional responsibilities of
investigators are described in Subpart G.
[45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8957, Jan. 27, 1981]
Sec. 812.110 Specific responsibilities of investigators.
(a) Awaiting approval. An investigator may determine whether
potential subjects would be interested in participating in an
investigation, but shall not request the written informed consent of any
subject to participate, and shall not allow any subject to participate
before obtaining IRB and FDA approval.
(b) Compliance. An investigator shall conduct an investigation in
accordance with the signed agreement with the sponsor, the
investigational plan, this part and other applicable FDA regulations,
and any conditions of approval imposed by an IRB or FDA.
(c) Supervising device use. An investigator shall permit an
investigational device to be used only with subjects under the
investigator's supervision. An investigator shall not supply an
investigational device to any person not authorized under this part to
receive it.
(d) 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.
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. 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.
(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
[[Page 109]]
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:
(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]
Sec. 812.145 Inspections.
(a) Entry and inspection. A sponsor or an investigator who has
authority to grant access shall permit authorized FDA employees, at
reasonable times and in a reasonable manner, to enter and inspect any
establishment where devices are held (including any establishment where
devices are manufactured, processed, packed, installed, used, or
implanted or where records of results from use of devices are kept).
(b) Records inspection. A sponsor, IRB, or investigator, or any
other person acting on behalf of such a person with respect to an
investigation, shall permit authorized FDA employees, at reasonable
times and in a reasonable manner, to inspect and copy all records
relating to an investigation.
(c) Records identifying subjects. An investigator shall permit
authorized FDA employees to inspect and copy records that identify
subjects, upon notice that FDA has reason to suspect that adequate
informed consent was not obtained, or that reports required to be
submitted by the investigator to the sponsor or IRB have not been
submitted or are incomplete, inaccurate, false, or misleading.
Sec. 812.150 Reports.
(a) Investigator reports. An investigator shall prepare and submit
the following complete, accurate, and timely reports:
(1) Unanticipated adverse device effects. An investigator shall
submit to the sponsor and to the reviewing IRB a report of any
unanticipated adverse device effect occurring during an investigation as
soon as possible, but in no event later than 10 working days after the
investigator first learns of the effect.
(2) Withdrawal of IRB approval. An investigator shall report to the
sponsor, within 5 working days, a withdrawal of approval by the
reviewing IRB of the investigator's part of an investigation.
(3) Progress. An investigator shall submit progress reports on the
inves-
[[Page 110]]
tigation 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, the sponsor shall also submit
progress reports to FDA.
(6) Recall and device disposition. A sponsor shall notify FDA and
all reviewing IRB's of any request that an investigator return, repair,
or otherwise dispose of any units of a device. Such notice shall occur
within 30 working days after the request is made and shall state why the
request was made.
(7) Final report. In the case of a significant risk device, the
sponsor shall notify FDA within 30 working days of the completion or
termination of the investigation and shall submit a final report to FDA
and all reviewing the IRB's and participating investigators within 6
months after completion or termination. In the case of a device that is
not a significant risk device, the sponsor shall submit a final report
to all reviewing IRB's within 6 months after termination or completion.
(8) Informed consent. A sponsor shall submit to FDA a copy of any
report by an investigator under paragraph (a)(5) of this section of use
of a device without obtaining informed consent, within 5 working days of
receipt of notice of such use.
(9) Significant risk device determinations. If an IRB determines
that a device is a significant risk device, and the sponsor had proposed
that the IRB consider the device not to be a significant risk device,
the sponsor shall submit to FDA a report of the IRB's determination
within 5 working days after
[[Page 111]]
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]
PART 813--INVESTIGATIONAL EXEMPTIONS FOR INTRAOCULAR LENSES--Table of Contents
Subpart A--General Provisions
Sec.
813.1 Scope.
813.2 Applicability.
813.3 Definitions.
813.5 General qualifications for an exemption.
813.10 Petitions for waiver of requirements.
813.12 Information previously submitted.
813.19 Requirements applicable to importers and exporters of
intraocular lenses.
Subpart B--Applications for Exemption for Investigational Studies
Involving Human Subjects
813.20 Application.
813.25 Investigational plan.
813.27 Report of prior experience with the lens.
813.30 Food and Drug Administration review of and action on an
application.
813.35 Withdrawal of an exemption.
813.38 Confidentiality of data and information in an application.
813.39 Supplemental applications and submissions concerning
applications.
Subpart C--Sponsor Responsibilities in Investigational Studies of
Intraocular Lenses
813.40 General.
813.42 Review of the investigational study by the Food and Drug
Administration and the institutional review committee.
813.43 Selection of investigators.
813.45 Control over the intraocular lens.
813.46 Monitoring the investigational study.
813.47 Submitting information to investigators.
813.50 Promotion and sale of intraocular lenses.
Subpart D--Institutional Review Committee
813.60 Requirement of institutional review committee.
813.62 Membership of an institutional review committee.
813.65 Procedures for review and monitoring of investigational studies
by an institutional review committee.
813.66 Procedures and criteria for review of investigational studies by
an institutional review committee.
813.70 Review by institution.
813.79 Actions where review by an institutional review committee is
inadequate.
Subpart E--Investigator Responsibilities in Investigational Studies of
Intraocular Lenses
813.100 General.
813.101 Review of investigational study by the Food and Drug
Administration.
813.103 Review of investigational study by institutional review
committee.
813.105 Conformity to investigational plan.
813.107 Control over intraocular lenses.
813.119 Disqualification of a clinical investigator.
Subpart F--[Reserved]
Subpart G--Inspections, Reports, and Records
813.150 Inspections.
813.153 Reports.
813.155 Records.
Subpart H--Investigational Studies That Do Not Involve Human Subjects
813.160 Condtions of exemption.
813.170 Termination of exemption.
Authority: Secs. 301, 501, 502, 520, 701, 704, 801 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 331, 351, 352, 360j, 371, 374,
381).
Source: 42 FR 58889, Nov. 11, 1977, unless otherwise noted.
Subpart A--General Provisions
Sec. 813.1 Scope.
(a) General. This part provides that intraocular lenses may be
exempted from any of the requirements of the act enumerated in paragraph
(b) of this section that would otherwise be applicable to the device, to
permit investigational studies of the device by experts who are
qualified by scientific training and experience to investigate the
safety and effectiveness of the lenses. This part implements sections
520(g) and 520(1) of the act with respect to intraocular lenses.
[[Page 112]]
(b) Effect of exemption. (1) In general, intraocular lenses are
exempted from provisions of the following sections of the act and
regulations thereunder when an application for exemption applicable to
the lenses is in effect under this part: Misbranding under section 502,
registration and premarket notification under section 510, performance
standards under section 514, premarket approval under section 515,
records and reports under section 519, restricted devices under section
520(e), good manufacturing practices under section 520(f), and color
additives under section 721.
(2) Intraocular lenses shall not be extempted from a provision of
the act listed in paragraph (b)(1) of this section where the
Commissioner indicates that the lens is not exempt from such a provision
in an order of disapproval, approval, or approval with modifications
under Sec. 813.30.
[42 FR 58889, Nov. 11, 1977, as amended at 59 FR 14366, Mar. 28, 1994]
Sec. 813.2 Applicability.
This part applies to all implantations of intraocular lenses in
humans unless a premarket approval application has been approved for
these lenses under section 515 of the act.
Sec. 813.3 Definitions.
(a) Intraocular lens means a lens intended to replace surgically the
natural lens of the human eye. An intraocular lens is, for purposes of
this part, synonymous with ``investigational device,'' lens, or lenses.
(b) Investigational device means a device that is used in an
investigational study involving human subjects, where the study is for
the purpose of determining if the device is safe or effective.
(c) Investigational plan means a plan or protocol for using an
investigational device in an investigational study. See Sec. 813.25 for
requirements applicable to an investigational plan.
(d) Investigational study means a study involving human subjects
when the study is for the purpose of determining if an investigational
device is safe or effective and includes any implantation in a human of
an intraocular lens for which there is no approved application for
premarket approval under section 515 of the act.
(e) Investigator means an individual who actually conducts an
investigational study, i.e., under whose immediate direction the
investigational device is administered or dispensed to, or used
involving, a subject.
(f) Monitor, when used as a noun, means an individual selected by a
sponsor or contract research organization to oversee the progress of an
investigational study. The monitor may be a full-time employee of a
sponsor or contract research organization or a consultant to the sponsor
or contract research organization. (Monitor, when used as a verb, means
the act of reviewing the progress of an investigational study.)
(g) Sponsor means a person who initiates an investigational study,
but who does not actually conduct the study (i.e., the investigational
device is administered or dispensed to, or used involving, a subject
under the immediate direction of another individual). A person other
than an individual, e.g., corporation or government agency, that uses
one or more of its own employees to conduct an investigational study
that it has initiated is considered to be a sponsor (not a sponsor-
investigator), and the employees are considered to be investigators.
(h) Sponsor-investigator means an individual who both initiates and
actually conducts, alone or with others, an investigational study (i.e.,
under whose immediate direction the investigational device is
administered or dispensed to, or used involving, a subject). The term
does not include any person other than an individual. Any sponsor-
investigator shall carry out the responsibilities under this part of a
sponsor and of an investigator.
(i) Institution means a person (other than an individual) who
engages in the conduct of research on human subjects or in the delivery
of medical services to human subjects as a primary activity or as an
adjunct to providing residential or custodial care to human beings. The
term includes a hospital, retirement home, prison, university, or device
manufacturer. Facility as used in section 520(g) of the act is deemed to
by synonymous with the term institution for purposes of this part.
[[Page 113]]
(j) Subject means an individual who is or becomes a paticipant in an
investigational study, either as a recipient of the investigational
device or as a control. A subject may be either a nonpatient volunteer
or a patient on whom the intraocular lens might have a therapeutic
effect.
(k) Person includes an individual, partnership, corporation,
association, scientific establishment, government agency, and any other
legal entity.
(l) Institutional review committee means a committee (appointed by
an institution to review and monitor investigations in which human
subjects participate) whose major responsibility is the protection of
human subjects from risk to their health, safety, or dignity in
accordance with the current professional standards and the requirements
of this part. Such a committee may be known as an institutional review
board or by other names.
Sec. 813.5 General qualifications for an exemption.
A shipment of an intraocular lens is exempt from any or all the
otherwise applicable requirements of the act enumerated in
Sec. 813.1(b)(1) if all the following conditions are met:
(a) The label of the device bears the following: the name and place
of business of the manufacturer, packer, or distributor in accordance
with Sec. 801.1 of this chapter; the quantity of contents; the sterility
shelf life of the lens; and the statement, ``Caution--investigational
device. Limited by Federal (or United States) law to investigational
use''.
(b) The labeling of the intraocular lens is not false or misleading
in any particular.
(c)(1) An application for investigational device exemption covering
that shipment was submitted by the sponsor under Subpart B of this part,
and the requisite time has elapsed following the date of receipt of the
application by the Food and Drug Administration to permit the
investigational study to begin under Sec. 813.30(b).
(2) The Commissioner has not disapproved the application or
withdrawn the exemption.
(3) Each shipment of the intraocular lens is made in accordance with
the commitments in the application and any conditions imposed in the
Commissioner's approval of the application.
(4) The sponsor has complied with the requirements of Subparts B, C,
and G of this part, any institutional review committee that is to review
and approve the investigational study for which shipment is made has
complied with the requirements of Subparts D and G of this part, and the
investigator(s) to which the shipment is to be made has complied with
the requirements of Subparts E and G of this part and with the
requirements for informed consent contained in Part 50 of this chapter.
(d) If the shipment is to be imported into or exported from the
United States, the requirements of Sec. 813.19 have been met.
[42 FR 58889, Nov. 11, 1977, as amended at 47 FR 46079, Oct. 15, 1982]
Sec. 813.10 Petitions for waiver of requirements.
(a) Any person subject to any requirement under this part may
petition the Commissioner for a waiver of such requirement. Such a
petition shall be submitted in accordance with Sec. 10.30 of this
chapter and shall set forth the basis for the petitioner's belief that
compliance with the requirement is not necessary to achieve the
objectives of this part and, where appropriate, any alternative means to
achieve the objective of the requirement from which the waiver is
sought.
(b) The Commissioner may, at his discretion, grant a petition for a
waiver submitted under this section if he finds that compliance with the
requirement from which the waiver is sought is not necessary to achieve
the objectives of this part and, where appropriate, that the proposed
alternative means will achieve the objective of the requirement from
which the waiver is sought.
(c) The person who submits a petition under this section continues
to be subject to the requirement from which the waiver is sought unless
and until the Commissioner grants the petition.
[[Page 114]]
Sec. 813.12 Information previously submitted.
Wherever this part requires the submission to the Food and Drug
Administration of information or data that previously had been submitted
in accordance with this part or other parts of this chapter, the
information or data need not be resubmitted but may be incorporated by
reference.
Sec. 813.19 Requirements applicable to importers and exporters of intraocular lenses.
(a) Any person who imports or offers for importation into the United
States an intraocular lens shall assure that all the following
requirements are met:
(1) The labeling of such lens complies with Sec. 813.5 (a) and (b).
(2) The importer of such shipment is an agent in the United States
of the foreign exporter or is the ultimate consignee, and the foreign
exporter or the ultimate consignee has, prior to such shipment,
completed and submitted to the Food and Drug Administration an
application for an investigational device exemption in accordance with
Sec. 813.20 and acts as the sponsor of the investigational study to
assure compliance with the procedures, conditions, and requirements of
this part.
(3) The requisite time has elapsed after the date of receipt of the
application by the Food and Drug Administration to permit the
investigational study to begin under Sec. 813.30(b).
(4) The Commissioner has not disapproved the application or
withdrawn the exemption.
(b) Any person who exports an intraocular lens from the United
States to a foreign country shall comply with all the following
requirements:
(1) The lens shall conform to the specifications of the foreign
purchaser.
(2) The lens shall comply with the laws of the country to which it
is being exported.
(3) The label on the outside of the shipping package shall indicate
that the lens is intended for export.
(4) The lens shall not be sold or offered for sale in domestic
commerce.
(5) The person shall obtain the approval of the exportation of the
lens from the country to which it is intended for export.
(6) The person shall request and obtain from the Commissioner a
determination that the exportation of the device is not contrary to the
public health and safety and has the approval of the country to which it
is intended for export.
Subpart B--Applications for Exemption for Investigational Studies
Involving Human Subjects
Sec. 813.20 Application.
(a) The sponsor of an investigational study shall submit to the Food
and Drug Administration a completed application for an investigational
device exemption that has been signed by the sponsor or an authorized
representative of the sponsor. Three copies of the application and any
material required to accompany the application, bound and contained in
volumes of reasonable size, shall be sent by registered mail or hand
delivered to the Center for Devices and Radiological Health Document
Mail Center (HFZ-401), Food and Drug Administration, 1390 Piccard Dr.,
Rockville, MD 20850. Any subsequent reports, correspondence concerning
an application, and supplemental application submitted under Sec. 813.39
also shall be submitted in triplicate by registered mail or hand
delivered to this address. The outside wrapper of any application or
supplemental application should include the statement ``Application (or
Supplemental Application) for Investigational Device Exemption'' and the
outside wrapper of any reports or correspondence should include the
statement, ``Regarding an Investigational Device Exemption''.
(b) An application for an investigational device exemption for an
intraocular lens shall include the following information:
(1) A brief statement of its intended use(s) and how it is to be
administered.
(2) A description of all components, ingredients, and properties and
a description of the principle of operation of the device and any
anticipated changes in the device that may occur in the course of the
study in enough detail so that a scientist or physician familiar with
the general type of lens can make a knowledgeable judgment about
[[Page 115]]
the anticipated safety and effectiveness of the lens in the proposed
investigational study.
(3) A description of those methods, facilities, and controls, used
for the manufacture, processing, packing, and storage of the device in
enough detail so that a person generally informed in that area can make
a knowledgeable judgment about the safety and effectiveness of the
device in the proposed investigational study.
(4) A statement of the location(s) of the study and whether an
institutional review committee(s) is to monitor the study at such
location(s).
(5) A report of prior investigations of the device that meets the
requirements of Sec. 813.27 and a summary of the investigational plan.
(6)(i) A statement from the sponsor that an investigational plan
that meets the requirements of Sec. 813.25 and a report of prior
investigations of the device that meets the requirements of Sec. 813.27
have been submitted to and approved by the institutional review
committee, or (ii) if no institutional review committee exists and one
cannot be formed, a statement from the head of the institution that such
a committee cannot be formed, and copies of the investigational plan and
the report of prior investigations.
(7) A statement from any institutional review committee (where a
committee is to monitor the study), signed by the chairman, that the
committee has approved the investigational plan and has reviewed the
report of prior investigations of the lens, that the committee will
review the study periodically at intervals appropriate to the degree of
risk but not to exceed 1 year, and that it will review reports of
unexpected adverse effects on a timely basis for the purpose of
determining if the study should be continued.
(8) A copy of all informational materials to be given to subjects,
including all form(s) to be used to obtain informed consent of human
subjects as required by Part 50 of this chapter (this material may be
appended to the investigational plan or the summary of the
investigational plan).
(9) A copy of all informational material, including labels and other
labeling, which is to be supplied to investigators as required by
Sec. 813.47(a).
(10) A description of the scientific training and experience that
the sponsor considers appropriate to qualify individuals as suitable
experts to investigate the safety and effectiveness of the intraocular
lens. (See Sec. 813.43(a).)
(11) A copy of the agreement signed by investigators who will be
participating, to comply with Subparts E and G of this part and Part 50
of this chapter as required by Sec. 813.43(b).
(12) The name and a summary of the training and experience of the
individual who is to monitor the progress of the study for the sponsor
as required by Subpart C.
(13) A statement as to whether any institutional review committee
has ever disapproved any investigational study of the device and the
reasons for such disapproval.
(14) A statement that the sponsor will comply with each of the
requirements of Subparts C and G of this part.
(15) A statement by a sponsor notifying FDA if he intends to charge
investigators and subjects for the device.
(16) A statement by the sponsor of his reasons for any request for a
waiver of the requirement of Sec. 813.30(a) that a study shall not begin
before the expiration of 30 days after the Food and Drug Administration
has received an application meeting the requirements of this subpart, if
such waiver is requested.
(17) A claim for categorical exclusion under Sec. 25.24 of this
chapter or an environmental assessment under Sec. 25.31 of this chapter.
(18) Any other information relevant to review of the application
required by the Food and Drug Administration to be submitted. The
sponsor may refuse to provide the information requested under paragraph
(b)(18) of this section and treat FDA's request as a final disapproval
for purposes of requesting a regulatory hearing under Sec. 813.30. If a
sponsor fails to respond to a request for information within the time
prescribed in a request, FDA may treat the application as withdrawn.
[42 FR 58889, Nov. 11, 1977, as amended at 47 FR 46079, Oct. 15, 1982;
50 FR 16669, Apr. 26, 1985; 53 FR 11253, Apr. 6, 1988; 55 FR 11169, Mar.
27, 1990]
[[Page 116]]
Sec. 813.25 Investigational plan.
(a) The investigational plan for the investigational study of an
intraocular lens shall include the following:
(1) A statement of the intended use of the lens;
(2) A general outline of the plan and any anticipated or forseeable
changes or variations in the plan that may be made based on experience
gained in the study;
(3) A description of what results are expected from the
investigational study;
(4) A justification for beginning the study, taking into account
prior experience with the intraocular lens;
(5) the expected duration of the investigational study;
(6) Identification of the investigator or investigators, the
facilities where the study will occur, and any institutional review
committees that will supervise the study;
(7) The patient population in which the lens will be used (in terms
of age, sex, and condition) and the size of each population;
(8) A justification for using such patient population and of the
size of each population;
(9) The sponsor's plan for monitoring the study in accordance with
Sec. 813.46;
(10) A description of records to be maintained, and the reports to
be made, by the investigator(s) and the sponsor to assure compliance
with the plan and enable the progress of the investigation and the
safety and effectiveness of the lenses to be reviewed by the sponsor,
any institutional review committee, and the Food and Drug
Administration;
(11) The plan for obtaining informed consent from subjects and
copies of all informational materials to be given to subjects, including
all forms and materials to be used in obtaining such consent; and
(12) A description of the scientific training and experience the
sponsor considers appropriate to qualify individuals as suitable experts
to investigate the safety and effectiveness of the intraocular lens.
(See Sec. 813.43(a)).
(b) The procedures and conditions in the investigational plan may
vary depending on the following:
(1) The scope and duration of the investigational study;
(2) The number of human subjects who are to be involved in the
study;
(3) The need to permit changes to be made in the device during the
study conducted in accordance with the plan; and
(4) The purpose of the study, e.g., whether the study is designed
for developing data to obtain approval for the commercial distribution
of the device.
(c) When an investigational study is to develop data to obtain
approval for commercial distribution of the device, the Food and Drug
Administration will not ordinarily regard an investigational plan as
capable of providing data that will support an application for such
approval unless it provides for more than one independent qualified
investigator.
(d) The investigational plan may provide for additional animal tests
to be made during the investigational study.
[42 FR 58889, Nov. 11, 1977; 43 FR 1940, Jan. 13, 1978]
Sec. 813.27 Report of prior experience with the lens.
(a) A report of prior investigations with the lens shall be
submitted to an institutional review committee and to the Food and Drug
Administration.
(b) The report of prior investigations of a lens shall include:
(1) A bibliography of any publications relevant to the
investigational study and copies of significant publications both
adverse and supporting.
(2) Any other unpublished information available to the sponsor, both
adverse and supporting, information relating to preclinical
investigations of the lens, including appropriate tests in animals and
tests in vitro, and prior clinical investigations of the device or
clinical experience with the device from commercial marketing, whether
in the United States or in foreign countries, in sufficient detail so
that a scientist or physician familiar with the general type of lens can
make a knowledgeable judgment about the anticipated safety and
effectiveness of the device in the proposed investigational study.
[[Page 117]]
(c) Prior investigations of a lens shall not be considered adequate
to justify an investigational study involving human subjects unless the
conditions of the prior investigations of the lens are comparable to the
conditions of the proposed investigational study.
Sec. 813.30 Food and Drug Administration review of and action on an application.
(a) Upon receipt of an application for an investigational device
exemption submitted in accordance with this subpart, the Food and Drug
Administration will notify the sponsor of the date of such receipt and
inform the sponsor that the investigational study may not be begun until
30 days after the date of the agency's receipt of the application,
unless the agency has decided to waive the 30-day time requirement and
so informs the sponsor.
(b) An application for an investigational device exemption shall be
deemed to be approved on the 30th day after the Food and Drug
Administration received the application unless, on or before such day,
the Commissioner finds that the application does not meet the
requirements of this part and by order disapproves the application,
stating his reasons therefor, or finds the application deficient and
requests additional information or suggests revisions, or approves the
application with modifications. If the Commissioner requests additional
information or suggests revisions, the sponsor may treat the application
as disapproved for purposes of requesting a regulatory hearing under
Part 16 of this chapter.
(c) The Commissioner may by order disapprove an application if he
makes any of the following findings:
(1) The application contains an untrue statement of a material fact
or omits material information required by Sec. 813.20.
(2) The report of prior investigations of the intraocular lens is
inadequate to support a conclusion that it is reasonably safe to begin
or continue the proposed investigational study.
(3) There is reason to believe that the lens may be unsafe or
ineffective when used for the purpose or in the manner for which it is
to be investigated.
(4) The investigational plan described in the application is not a
reasonable plan, in whole or in part, for a scientific investigation to
determine whether the investigational device is safe or effective.
(5) The methods, facilities, and controls used for the
manufacturing, processing, packing, storage, or implantation of the lens
do not assure adequately the safety and effectiveness of the lens.
(6) The sponsor's proposed use of the lens is not intended solely
for an investigational study, since it is being or is to be sold or
otherwise commercially distributed in a manner not justified by the
requirements of the investigational study and not permitted by this
part.
(7) The proposed investigational study on which the application is
submitted does not conform to procedures, conditions, or requirements
prescribed in this part.
(8) The proposed investigational study subjects human subjects to
undue risks. In assessing risks, the Commissioner shall consider, among
other things, the factors prescribed in Sec. 813.66(f).
(d) The Commissioner shall notify the sponsor of an approval,
disapproval, or approval with modifications of an application. The
notification shall contain the order of the approval, disapproval, or
approval with modifications and a complete statement of the reasons for
the order. An order that is a notification of disapproval or approval
with modifications shall advise the sponsor that he has recourse to an
opportunity for a regulatory hearing pursuant to Part 16 of this
chapter.
(e) The Commissioner may in his discretion decide not to disapprove
an application for which there are grounds for disapproval if he
concludes that risks do not outweigh the benefits to subjects.
Sec. 813.35 Withdrawal of an exemption.
(a) The Commissioner may by order withdraw an exemption granted
under this part if he makes any of the following findings:
(1) The application for such exemption or any subsequent report
contains
[[Page 118]]
an untrue statement of material fact or omits material information
required by Secs. 813.20, 813.39, or Subpart C of this part.
(2) The report of prior investigations of the device is inadequate
to support a conclusion that it is reasonably safe to continue the
investigational study involving human subjects.
(3) There is reason to believe that the investigational device may
be unsafe or ineffective when used for the purposes or in the manner for
which it is investigated.
(4) The investigational plan described in the application is not a
reasonable plan, in whole or in part, for a scientific investigation to
determine whether the investigational device is safe or effective.
(5) The methods, facilities, and controls used for the
manufacturing, processing, packing, storage, or installation of the
investigational device do not adequately assure its safety and
effectiveness.
(6) The investigational study is not being conducted in accordance
with the investigational plan submitted to the Food and Drug
Administration or the institutional review committee; or any change in,
or deviation from, the investigational plan was not approved as required
by Sec. 813.39 and Sec. 813.105.
(7) The sponsor's use of the investigational device is not solely
for an investigational study since it is being or is to be sold or
otherwise commercially distributed in a manner not justified by the
requirements of the investigational study and not permitted by this
part.
(8) The sponsor has failed to submit an application for premarket
approval of the device when requested to do so by the Food and Drug
Administration pursuant to Sec. 813.46(d).
(9) The investigational study does not conform to procedures,
conditions, or requirements prescribed under this part.
(10) The investigational study subjects human subjects to undue
risks. In assessing risks, the Commissioner shall consider, among other
things, the factors prescribed in Sec. 813.66(f).
(11) The process of review or monitoring undertaken by the
institutional review committee that is monitoring the study is
inadequate.
(b) The Commissioner may in his discretion decide not to disapprove
an application for which there are grounds for disapproval if he
concludes that the risks do not outweigh the benefits to subjects.
(c) An order under this section shall include a complete statement
of the reasons for the Commissioner's action. Such order shall be issued
only after the sponsor has been afforded an opportunity for a regulatory
hearing pursuant to Part 16 of the chapter, except that the order may be
issued before providing an opportunity for such hearing if the
Commissioner determines that the continuation of testing under the
exemption with respect to which the order is to be issued will result in
an unreasonable risk to the public health or safety.
(d) An exemption that has been withdrawn under section may be
reinstated if the sponsor satisfies the Commissioner that the grounds
for withdrawal no longer apply.
[42 FR 58889, Nov. 11, 1977; 43 FR 1940, Jan. 13, 1978]
Sec. 813.38 Confidentiality of data and information in an application.
(a) The existence of an application for an investigational device
exemption will not be disclosed by the Food and Drug Administration
unless it has previously been publicly disclosed or acknowledged.
(b) The availability for public dislosure of all data and
information in the Food and Drug Administration file concerning the
application shall be handled in accordance with the provisions
established in Sec. 814.9.
(c) Notwithstanding the provisions of Sec. 814.9 of this chapter,
the Food and Drug Administration shall disclose upon request to an
individual in whom an intraocular lens has been used a copy of any
adverse reaction report relating to such use.
[42 FR 58889, Nov. 11, 1977, as amended at 53 FR 11253, Apr. 6, 1988]
[[Page 119]]
Sec. 813.39 Supplemental applications and submissions concerning applications.
(a) Except as provided in paragraphs (b), (c), and (d) of this
section, information contained in an application submitted under
Sec. 813.20 may be updated by means of a report to the Food and Drug
Administration under Sec. 813.153.
(b)(1) Whenever the sponsor or any investigator participating in an
investigational study wishes to implement a change in, or deviation
from, the investigational plan submitted to the Food and Drug
Administration under Sec. 813.20 that may affect the validity of the
study or the rights or safety of the human subjects under the criteria
in paragraph (b)(3) of this section, the sponsor shall submit to the
Food and Drug Administration a supplemental application describing the
proposed change or deviation and the justification therefor. Except as
provided in paragraph (b)(2) of this section, the sponsor shall submit
the supplemental application before the change or deviation is
implemented, shall obtain the prior review and approval of any
institutional review committee pursuant to Secs. 813.42(d) and 813.105,
shall attach to such supplemental application a copy of the approval of
such change or deviation by such committee, and shall not permit the
change or deviation to be implemented unless and until the supplemental
application is approved or deemed approved under Sec. 813.30(b), except
as described in paragraph (b)(2) of this section.
(2) When a change or deviation is necessary to eliminate or reduce
an apparent immediate hazard to the safety of a human subject who is
already participating in the investigational study, the sponsor is not
required to comply with the prior approval requirements of paragraph
(b)(1) of this section. The sponsor shall instead notify the Food and
Drug Administration and any institutional review committee not notified
by the investigator of the change or deviation and the justification
therefor as soon as possible but in no event later than 5 days after he
learns of such change or deviation.
(3) The following changes in, or deviations from, an investigational
plan illustrate some of the situations in which prior review and
approval are required under paragraph (a) of this section:
(i) A significant change in the method of administration or use of
the lens.
(ii) A significant change in the number of subjects participating in
the study at one time or cumulatively.
(iii) The use of subjects with medical conditions unrelated to, but
possibly affecting, the scope or validity of the study.
(iv) The use of human subjects who require special consideration or
protection and who are not listed specifically in the plan, e.g.,
children, mentally disabled individuals, or prisioners.
(v) The administration of concomitant or concurrent therapy where it
is likely that an interaction with the lens might occur.
(c) The sponsor shall submit to the Food and Drug Administration the
signed statements required under Sec. 813.43(b) for any additional
investigators and, as required by Sec. 813.42(d), the statement signed
by the chairman of any institutional review committee that is added to
an investigational study after submission of an application for an
investigational device exemption under Sec. 813.20 (b). Any such
additional statement shall be submitted before an investigator may begin
participation in the investigational study.
(d) The sponsor shall submit to the Food and Drug Administration any
additional informational materials to be given to subjects, including
forms, or revisions in informational materials or forms, to be used by
investigators to obtain informed consent of human subjects and any
additional informational materials, or revision in such informational
materials, supplied to investigators, which had not been submitted in an
application under Sec. 813.20(b) (8) and (9) or any subsequent reports
to the Food and Drug Administration. The sponsor shall submit such forms
or materials to the Food and Drug Administration at the same time that
they are provided to investigators.
[42 FR 58893, Nov. 11, 1977; 43 FR 1940, Jan. 13, 1978]
[[Page 120]]
Subpart C--Sponsor Responsibilities in Investigational Studies of
Intraocular Lenses
Sec. 813.40 General.
The requirements of this subpart are applicable to sponsors of
investigational studies, including sponsor-investigators.
Sec. 813.42 Review of the investigational study by the Food and Drug Administration and the institutional review committee.
(a) The sponsor shall submit for review and approval by the Food and
Drug Administration an application for an investigational device
exemption in accordance with Subpart B of this part before any human
subjects are allowed to participate in the investigational study.
(b) The sponsor shall not permit any human subjects to participate
in the study until the study has been approved by an institutional
review committee and the application for exemption is approved by the
Food and Drug Administration.
(c) The sponsor shall assure that the institutional review committee
and the Food and Drug Administration are provided all the information on
the proposed investigational study and the lens that they will need to
review, approve, and monitor the study.
(d) The sponsor shall obtain from the institutional review committee
a statement, signed by the chairman, that the committee has approved the
investigational plan and has reviewed the report of prior investigations
of the lens and that the committee will monitor the investigation in
accordance with Subpart D of this part.
(e) The sponsor shall not implement a change in or deviate from the
investigational plan, or permit a change or deviation to be implemented,
unless there has been compliance with the requirements of Secs. 813.39
and 813.105.