[Federal Register Volume 69, Number 239 (Tuesday, December 14, 2004)]
[Notices]
[Pages 74529-74532]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-27333]



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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://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;

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    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.


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                                                   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