[Federal Register: December 14, 2004 (Volume 69, Number 239)]
[Notices]
[Page 74529-74532]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14de04-88]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0515]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Labeling Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on medical device labeling
regulations.
DATES: Submit written or electronic comments on the collection of
information by February 14, 2005.
ADDRESSES: Submit electronic comments on the collection of information
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on
the collection of information to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane
Rockville, MD 20857, 301-827-1223.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Medical Device Labeling Regulations--21 CFR Parts 800, 801, and 809
(OMB Control No. 0910-0485)--Extension
Section 502 of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 352), among other things, establishes requirements for the
label or labeling of a medical device so that it is not misbranded and
subject to regulatory action. Certain provisions of section 502 of the
act require that manufacturers, importers, and distributors of medical
devices disclose information about themselves or their devices on the
labels or labeling of the devices. Section 502(b) of the act requires
that, if the device is in a package, the label must contain the name
and place of business of the manufacturer, packer, or distributor and
an accurate statement of the quantity of the contents. Section 502(f)
of the act provides that the labeling of a device must contain adequate
directions for use. FDA may grant an exemption from the adequate
directions for use requirement, if FDA determines that adequate
directions for use are not necessary for the protection of the public
health.
FDA regulations in parts 800, 801, and 809 (21 CFR parts 800, 801,
and 809) require manufacturers, importers, and distributors of medical
devices to disclose to health professionals and consumers specific
information about themselves or their devices on the label or labeling
of their devices. FDA issued these regulations under the authority of
sections 201, 301, 502, and 701 of the act (21 U.S.C. 321, 331, 352,
and 371). Most of the regulations in parts 800, 801, and 809 derive
from the requirements of section 502 of the act, which provides, in
part, that a device shall be misbranded if, among other things, its
label or labeling fails to bear certain required information concerning
the device, is false or misleading in any particular way, or fails to
contain adequate directions for use.
Section 800.12 requires that packages of contact lens cleaning
solutions include a tamper-resistant feature to prevent malicious
adulteration. Sections 800.10(a)(3) and 800.12(c) require that the
label of contact lens cleaning solutions contain a prominent statement
alerting consumers to the tamper-resistant feature.
Section 800.10(b)(2) requires that the labeling of liquid
ophthalmic preparations packed in multiple-dose containers include
information as to duration of use and necessary warnings to afford
adequate protection from contamination during use.
Section 801.1 requires that the label of a device in package form
contain the name and place of business of the manufacturer, packer, or
distributor.
Section 801.5 requires that the labeling of devices include
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''. Where necessary, the labeling should include: (1) Statements of
all conditions, purposes, or uses for which the device is intended,
unless the device is a prescription device subject to the requirements
of Sec. 801.109; (2) quantity of dose; (3) frequency of administration
or application; (4) duration of administration or application; (5) time
of administration, e.g. in relation to meals, onset of symptoms, etc.;
(6) route of method or application; and (7) preparation for use.
Section 801.61 requires that the principal display panel of an
over-the-counter (OTC) device in package form must include a statement
of the identity of the device. The statement of the identity of the
device must include the common name of the device followed by an
accurate statement of the principal intended actions of the device.
Section 801.62 requires that the label of an OTC device in package
form must include a declaration of the net quantity of contents. The
label must express the net quantity in terms of weight, measure,
numerical count, or a combination of numerical count and weight,
measure, or size.
Section 801.109 establishes labeling requirements for prescription
devices. A prescription device is defined as a device which, because of
its potential for harmful effect, the method of its use,
[[Page 74530]]
or the collateral measures necessary to its use, is not safe except
under the supervision of a practitioner licensed by law to use the
device and, therefore, for which adequate directions for use by a
layperson cannot be developed.
The label of the device must include: (1) The statement ``Caution:
Federal law restricts this device to sale by or on the order of a `----
--------'''. The blank is to be filled in by a term such as
``physician,'' ``dentist,'' or other appropriate term; and (2) the
method of its application or use.
Labeling must include information for use, including indications,
effects, routes, methods, 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.
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.
Section 801.110 establishes a labeling requirement for a
prescription device delivered to the ultimate purchaser or user upon
the prescription of a licensed practitioner. The device must be
accompanied by labeling bearing the name and address of the licensed
practitioner and the directions for use and cautionary statements, if
any, contained in the order.
Section 801.405 establishes labeling requirements for articles
intended for lay use in repairing and refitting dentures. The labeling
must: (1) Limit directions for use for denture repair kits to emergency
repair pending unavoidable delay in obtaining professional
reconstruction of the denture; (2) limit directions for use for denture
reliners, pads, and cushions to temporary refitting pending unavoidable
delay in obtaining professional reconstruction of the denture; and (3)
contain 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.
Section 801.410(f) requires that results of impact tests and
description of the test method and apparatus be kept for a period of 3
years.
Section 801.410(f) is designed to protect the eyeglass wearer from
potential eye injury resulting from shattering of ordinary eyeglass
lenses and requires that eyeglasses and sunglasses be fitted with
impact-resistant lenses. 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. According to the Vision Council of
America, 60 percent of the population, or 161 million Americans, wear
prescription eyewear; 81 percent have eyeglasses, 3 percent have
contact lenses only and 16 percent have both eyeglasses and contact
lenses.
Section 801.420(c) requires that the manufacturers or distributors
of hearing aids develop a User Instructional Brochure, which
accompanies the device and is provided to the prospective user by the
dispenser of the hearing aid. The brochure must contain detailed
information on the use and maintenance of the hearing aid.
Section 801.421(b) requires the hearing aid dispenser to provide
the prospective user a copy of the User Instructional Brochure and an
opportunity to review the comments with him/her orally or in the
predominant method of communication used during the sale.
Section 801.421(c) requires the hearing aid dispenser to provide,
upon request, to the prospective purchaser of any hearing aid (s)he
dispenses, a copy of the User Instructional Brochure or the name and
address of the manufacturer or distributor from whom the brochure may
be obtained.
Section 801.421(d) requires the hearing aid dispenser to retain
copies of all physician statements or any waivers of medical evaluation
for 3 years from the time of dispensing.
Section 801.435 requires condom manufacturers to include an
expiration date in the labeling of the condom. The manufacturer must
support the expiration date by data from quality control tests
demonstrating physical and mechanical integrity of three random lots of
the same product which were stored under accelerated and real time
conditions.
Section 809.10(a) provides that a label for an in vitro diagnostic
product must contain the following information:
1. The proprietary and established name;
2. The intended use or uses of the product;
3. For a reagent, a declaration of the established name, if any,
and the quantity, proportion, and concentration of each reactive
ingredient;
4. A statement of warnings and precautions for users;
5. For a reagent, appropriate storage instructions;
6. For a reagent, a means by which the user may be assured that the
product meets the appropriate standards of identity, strength, quality,
and purity;
7. For a reagent, a declaration of the net quantity of contents;
8. Name and place of business of the manufacturer, packer, and
distributor; and
9. A lot or control number.
Section 809.10(b) provides that the labeling (package insert)
accompanying the device must contain the following:
1. Proprietary name and established name, if any;
2. The intended use or uses;
3. A summary and explanation of the test;
4. The chemical, physical, physiological, or biological principles
of the procedure;
5. Information about the reagents;
6. Information about the instruments;
7. Information about the specimen collection and preparation for
analysis;
8. Information about the procedure;
9. Information about the results;
10. Information about the limitations of the procedure;
11. Expected values;
12. Specific performance characteristics;
13. A bibliography of pertinent references; and
14. Date of issuance of the last revision of the labeling.
Section 809.10(d) provides that the labeling for general purpose
laboratory reagents may be exempt from the labeling requirements in
Sec. 809.10(a) and (b), if the labeling contains the following:
1. The proprietary name and established name of the reagent;
2. The established name and the quantity, proportion, and
concentration of the reagent ingredient;
3. A statement of the purity and quality of the reagent;
4. A statement of warnings and precautions for users;
5. Appropriate storage instructions;
6. A declaration of the net quantity of contents;
7. Name and place of business of the manufacturer, packer, or
distributor; and
8. A lot or control number.
Section 809.10(e) requires manufacturers of analyte specific
reagents to include the following in the labeling:
1. The proprietary name and established name, if any, of the
reagent;
2. A declaration of established name, if any, and quantity,
proportion or concentration of the reagent ingredient;
[[Page 74531]]
3. A statement of the purity and quality of the reagent;
4. A statement of warnings or precautions for users;
5. Appropriate storage instructions;
6. A declaration of the net quantity of contents;
7. Name and place of business of the manufacturer, packer, or
distributor;
8. A lot or control number; and
9. The statement, ``For analyte specific reagent use only.
Analytical and performance characteristics are not established.''
Section 809.10(f) requires that the labeling for OTC test sample
collection systems for drugs of abuse testing bear the following
information in a language appropriate for the intended users:
1. Adequate instructions for specimen collection and handling;
2. An identification system to ensure that specimens are not mixed
up or otherwise misidentified at the laboratory;
3. The intended use or uses of the product;
4. A statement that confirmatory testing will be conducted on all
samples that initially test positive;
5. A statement of warnings or precautions for users;
6. Adequate instructions on how to obtain test results from a
person who can explain their meaning, including the probability of
false positive and false negative results, as well as how to contact a
trained health professional if additional information on interpretation
of test results or followup counseling is desired; and
7. Name and place of business of the manufacturer, packer, or
distributor.
Section 809.30(d) requires that manufacturers of analyte specific
reagents (ASRs) assure that advertising and promotional materials for
ASRs:
1. Include the identity and purity of the ASR and the identity of
the analyte; and
2. Do not include any statement regarding analytical or clinical
performance.
These estimates are based on FDA's registration and listing
database for medical device establishments, agency communications with
industry, and FDA's knowledge of and experience with device labeling.
We have not estimated a burden for those requirements where the
information to be disclosed is information that has been supplied by
FDA. Also, we have not estimated a burden for that information that is
disclosed to third parties as a usual and customary part of a medical
device manufacturer, distributor, or importer's normal business
activities. We do not include any burden for time that is spent
designing labels to improve the format or presentation.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency per Total Annual Hours per
21 CFR Section Respondents Response Responses Response Total Hours
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800.10(a)(3) and 4 10 40 1 40
800.12(c)
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800.10(b)(2) 4 10 40 40 1,600
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801.1 20,000 3.5 70,000 0.1 7,000
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801.5 2,000 3.5 7,000 22.35 156,450
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801.61 1,000 3.5 3,500 1 3,500
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801.62 200 5 1,000 1 1,000
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801.109 18,000 3.5 63,000 17.77 1,119,510
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801.110 10,000 50 500,000 0.25 125,000
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801.405(b) 40 1 40 4 160
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801.420(c) 40 5 200 40 8,000
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801.421(b) 10,000 160 1,600,000 0.30 480,000
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801.421(c) 10,000 5 50,000 0.17 8,500
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801.435 45 1 45 96 4,320
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809.10(a) and (b) 1,700 6 10,200 80 816,000
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809.10(d) 300 2 600 40 24,000
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809.10(e) 300 25 7,500 1 7,500
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809.10(f) 20 1 20 100 2,000
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809.30(d) 300 25 7,500 1 7,500
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Total Burden Hours 2,772,080
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 74532]]
Table 2.--Estimated Annual Recordkeeping Burden\1\
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No. of Annual Frequency per Total Annual
21 CFR Section Recordkeepers Recordkeeping Records Hours per Record Total Hours
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801.410(f) 30 769,000 23,070,000 641 19,225
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801.421(d) 9,900 162 1,600,000 0.25 400,000
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Total Hours 419,225
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 6, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-27333 Filed 12-13-04; 8:45 am]
BILLING CODE 4160-01-S