Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300

Class II Special Controls Guidance
Document: Labeling for Natural Rubber
Latex Condoms Classified Under 21 CFR
884.5300
Document issued on December 23, 2008.
The draft of this document was issued November 14, 2005.
OMB control number: 0910-0633
Expiration date: December 31, 2011
See additional PRA statement in section VIII of this guidance.

For questions regarding this document, contact Paul F. Tilton 301-796-5484 or by email
at [email protected].
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Ob/Gyn, Gastroenterology and Urology Devices Branch
Division of Enforcement A
Office of Compliance
Preface
Public Comment

Written comments and suggestions may be submitted at any time for Agency
consideration to the Division of Dockets Management, Food and Drug Administration,
5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. Alternatively,
electronic comments may be submitted to Regulations.gov1. When submitting comments,
please refer to Docket No. FDA-2004-D-0375. Comments may not be acted upon by the
Agency until the document is next revised or updated.
Additional Copies

Additional copies are available from the Internet. You may also send an e-mail request to
[email protected] to receive an electronic copy of the guidance or send a fax request
to 301-847-8149 to receive a hard copy. Please use the document number (1688) to
identify the guidance you are requesting.

Table of Contents
I.
II.
III.
IV.
V.
VI.
VII.
VIII.

Introduction
Background
Other Labeling Requirements
Scope
Issues Requiring Special Controls
Labeling Recommendations
Examples of Condom Labeling that Follow the Recommendations in the
Guidance
Paperwork Reduction Act of 1995

Guidance for Industry and FDA Staff
Class II Special Controls Guidance Document: Labeling for Natural
Rubber Latex Condoms Classified Under 21 CFR 884.5300
I. Introduction
The Food and Drug Administration (FDA) has developed this guidance as a special
controls guidance for male condoms made from natural rubber latex without spermicidal
lubricant (latex condoms).1 This guidance is issued in conjunction with a Federal Register
notice announcing the amendment of 21 CFR 884.5300, an existing classification for
condoms, from class II (performance standards) to class II (special controls). The
amended classification designates this guidance document as the special control for latex
condoms.
Latex condoms that are the subject of premarket notification submissions (510(k)s) filed
on or after January 9, 2009, the effective date of the final rule designating this as a special
control, are expected to comply with the requirement of special controls immediately
upon the rule taking effect. Therefore, a firm submitting a 510(k) for a latex condom on
or after the effective date of the rule must address the issues of safety and effectiveness
identified in this special controls guidance, either by following the recommendations of
this guidance or by some other means that provides equivalent assurances of safety and
effectiveness.
Latex condoms that are the subject of a 510(k) that is pending on the effective date of the
final rule but are subsequently cleared are expected to comply with the requirement of
special controls and address the issues of safety and effectiveness identified in this
special controls guidance, either by following the recommendations in this guidance or
by some other means that provides equivalent assurances of safety and effectiveness, on
or before March 10, 2009.
Latex condoms that were legally marketed prior to the effective date of the final rule are
expected to comply with the requirement of special controls and address the issues of
safety and effectiveness identified in this special controls guidance, either by following

the recommendations in this guidance or by some other means that provides equivalent
assurances of safety and effectiveness, on or before December 10, 2009.
If you want to discuss an alternative means of satisfying the requirement of special
controls for latex condoms, you may contact the FDA staff responsible for implementing
this guidance. If you cannot identify the appropriate FDA staff, call the appropriate
number listed on the title page of this guidance.
The Least Burdensome Approach

In developing this guidance, we carefully considered the relevant statutory criteria for
agency decision-making. We also considered the burden that may be incurred in your
attempt to comply with the guidance and address the issues we have identified. We
believe that we have considered the least burdensome approach to resolving the issues
presented in the guidance document. If, however, you believe that there is a less
burdensome way to address the issues, you should follow the procedures outlined in the
“A Suggested Approach to Resolving Least Burdensome Issues2” document.
II. Background
FDA believes that special controls, when combined with the general controls, will be
sufficient to provide a reasonable assurance of the safety and effectiveness of latex
condoms. Thus, a manufacturer who intends to market a device of this type must
(1) conform to the general controls of the Federal Food, Drug, and Cosmetic Act (the
Act), including the 510(k) requirements described in 21 CFR Part 807, Subpart E, and the
Quality Systems Regulation (21 CFR Part 820); and (2) address the specific issues
requiring special controls associated with these devices as identified in this guidance,
either in the user labeling as recommended here or in some other way that provides
equivalent assurances of safety and effectiveness.
This special controls guidance document provides the classification and product code for
latex condoms (refer to Section IV). In addition, other sections of this guidance document
list the issues requiring special controls identified by FDA and describe labeling
measures that, if followed by manufacturers, will generally address the issues requiring
special controls associated with this device.
The labeling recommendations in this guidance document reflect an extensive review on
the part of the Agency, in consultation with the National Institutes for Health (NIH) and
the Centers for Disease Control and Prevention (CDC), of the available medical literature
on the safety and effectiveness of latex condoms intended to prevent pregnancy and
sexually transmitted infections (STIs). In addition, the Agency considered other relevant
information related to the barrier properties of latex condoms and the various routes of
transmission of STIs, as well as public comments on the draft of this guidance, issued
November 14, 2005 (70 FR 69156).
III. Other Labeling Requirements

While this guidance document provides examples of labeling recommended to meet the
requirement of special controls for latex condoms under 21 CFR 884.5300(b)(2), there
are also other specific labeling requirements for latex condoms contained in the following
two regulations:



user labeling for latex condoms (21 CFR 801.435), and
user labeling for devices that contain natural rubber (21 CFR 801.437).

Additionally, condom manufacturers must ensure that their devices meet the general
labeling requirements for medical devices described in 21 CFR Part 801.
Labeling requirements for latex condoms include the following:
A. Expiration date (21 CFR 801.435)

The retail and primary condom package (individual foil packet) must include an
expiration date that is no later than five years from the date of product packaging. This
expiration date must be supported by shelf life data developed by the condom
manufacturer. For details, please see 21 CFR 801.435, “User labeling for latex
condoms.” This regulation addresses the risk of condom deterioration due to product
aging.
B. Caution regarding natural rubber latex and allergic reactions (21 CFR 801.437)

Latex condoms, and all other devices composed of, or containing, natural rubber latex
that contacts humans, are required to bear the following statement in bold print:
Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic
Reactions.
This statement must appear on all device labels, and other labeling, and must also appear
on the principal display panel of the device packaging, the outside package, container or
wrapper, and the immediate device package, container, or wrapper. For details, please see
21 CFR 801.437, “User labeling for devices that contain natural rubber." This labeling
requirement is necessary because devices composed of, or containing, natural rubber
latex, pose a significant health risk to some individuals.
C. General labeling requirements

All devices, including latex condoms, are subject to the general labeling provisions
described in 21 CFR Part 801, Subpart A. Additionally, latex condoms are over-thecounter (OTC) devices, and are therefore subject to the requirements for OTC devices
described in 21 CFR Part 801, Subpart C. You should familiarize yourself with these
labeling requirements. This special controls guidance is consistent with these
requirements and, in fact, some of the labeling terminology used in this guidance is
described by these regulations.

Latex condoms must also include adequate directions for use to avoid being misbranded
(section 502(f) of the Act, 21 U.S.C. 352(f); 21 CFR 801.5). Adequate directions for use
help ensure that the condom will be used correctly. (Section VI.3., includes an example
of acceptable directions for use of latex condoms.)
FDA has included examples of labeling that incorporate the requirements of the Act and
regulations and the recommendations made in this special controls guidance document in
Section VII, below.
IV. Scope
The scope of this special controls guidance document is limited to male condoms made
from natural rubber latex without spermicidal lubricant (latex condoms). Latex condoms
are described in 21 CFR 884.5300 as follows:
A condom is a sheath which completely covers the penis with a closely fitting membrane.
The condom is used for contraceptive and for prophylactic purposes (preventing
transmission of sexually transmitted infections). The device may also be used to collect
semen to aid in the diagnosis of infertility.
Latex condoms are the subset of these condoms made of natural rubber latex and are
assigned the product code HIS. (See 21 CFR 884.5300(b)(2).)
Exclusions from the Scope of this Guidance:

This guidance has not been established as a special control for male condoms with
spermicidal lubricant (21 CFR 884.5310). Likewise, this guidance has not been
established as a special control for male condoms made of natural membrane (skin) or
synthetic materials that are classified under 21 CFR 884.5300(b)(1). Because male
condoms with spermicidal lubricant, natural membrane condoms, and synthetic condoms
differ in some respects from latex condoms without spermicidal lubricant, this special
control guidance does not address these products.
V. Issues Requiring Special Controls
FDA has identified the following issues requiring special controls associated with the use
of latex condoms, which can be mitigated by the labeling recommended in the special
controls guidance. The recommended mitigation measures (labeling) are intended to
provide information to users about the extent of protection provided by latex condoms to
help prevent pregnancy and help prevent the spread of various types of STIs. The
labeling provides important information for condom users to assist them in determining
whether latex condoms are appropriate for their needs, as well as instructions for optimal
use.
Table 1 includes risks associated with sexual intercourse, i.e., unintended pregnancy and
STI transmission, that latex condoms are intended to prevent. This special controls

guidance document addresses how manufacturers can label their latex condoms to help
assure that they will be safe and effective for these intended uses, which are of significant
personal and public health concern. Labeling for latex condoms should follow the
mitigation measures suggested in Table 1. All the labeling recommendations are
discussed in more detail in Section VI.
A. Issues Requiring Special Controls and Recommended Mitigation Measures for Latex Condoms

Table 1. Identified Issues and Recommended Mitigation Measures
Identified issues*
Recommended mitigation measures
1. Risk of Unintended Pregnancy Labeling should indicate that latex condoms are
intended to prevent pregnancy. Labeling should
indicate that condom use does not eliminate the risk of
pregnancy and also indicate the importance of correct
and consistent use.
Labeling should indicate that consumers should consult
a health care provider if they have questions about birth
control options, particularly because of health reasons
for avoiding pregnancy.
Labeling should include information comparing the
percentage of women experiencing unintended
pregnancy during one year of use of latex condoms
with rates experienced during one year of use of other
contraceptive methods available in the U.S., including
drugs, devices, and methods of permanent sterilization
. The information should address, at minimum, typical
use rates.
Labeling should indicate that latex condoms are
2. Risk of Transmission of
Sexually Transmitted Infections intended to prevent HIV/AIDS and other STIs.
(STIs)
Labeling should indicate that condom use does not
eliminate the risk of STIs and also indicate the
importance of correct and consistent use.
 Condoms reduce the
overall risk of STI
transmission (including Labeling should indicate that latex condoms reduce the
transmission of
risk of transmission of STIs by providing a barrier
HIV/AIDS and other
against the source of the infection.
STIs).
 Degree of protection
Labeling should indicate that condoms are most
against different types of effective against STIs such as HIV/AIDS and
STIs varies.
gonorrhea that are spread by contact with the head of
the penis.
Labeling should indicate condoms are less effective

against STIs such as Human Papillomavirus (HPV) and
herpes that can also be spread by contact with infected
skin that is not covered by the condom.
Labeling should indicate that consumers who believe
they have an STI should contact a health care provider.
Labeling should indicate that for more information on
latex condoms or STIs, consumers should contact a
health care provider or public health agency.
3. Incorrect or inconsistent use Labeling should include adequate directions for use
diminishing the effectiveness of and precautions about incorrect or inconsistent use.
latex condoms against the risks
of unintended pregnancy and STI
transmission.
* Additional risks of (1) product deterioration due to aging and (2) allergic reactions to
latex have been specifically addressed in labeling regulations that are discussed in
Section III of this guidance.
VI. Labeling Recommendations
This section provides guidance on the labeling of latex condoms grouped according to the
issues identified in Table 1 of Section V of this document. Generally, there are three
different levels of packaging for latex condoms:




the retail package (includes the principal display panel)
the primary condom package (individual foil packet)
the package insert.

The recommendations in this section indicate the level(s) of packaging where the labeling
should appear and provide examples of labeling statements that adequately address the
issues identified in Table 1. Example statements appear in the guidance in italics to make
them easier to identify, but FDA is not recommending italic font be used in actual
labeling.
Labeling Recommendations for Latex Condoms
1. Unintended Pregnancy

1a. The principal display panel, the primary condom package (individual foil packet) and
the package insert should identify contraception as one of the principal intended actions
of the latex condom (along with preventing transmission of HIV/AIDS and other STIs, as
described in section VI.2a.)2 The following is an example of an acceptable statement
addressing both intended actions:

“Latex condoms are intended to prevent pregnancy, HIV/AIDS, and other sexually
transmitted infections.”
1b. The back of the retail package should contain a box entitled Important Information.
The first statements in this box should indicate that latex condom use does not completely
eliminate the risk of pregnancy and highlight the importance of correct and consistent
use. (These statements should also include the information described in Section VI.2b of
this guidance.) The following is an example of such statements:
“Latex condoms do not completely eliminate the risks of pregnancy and sexually
transmitted infections (STIs).
To get the most protection from a latex condom, use one correctly every time you have
sex. Please see directions for use inside the package.”
1c. The package insert should include a statement that consumers should consult a health
care provider if they have questions about birth control options, particularly because of
health reasons for avoiding pregnancy. The following is an example of such a statement:
"If you have questions about birth control options, particularly because of health reasons
for avoiding pregnancy, consult a health care provider."
The package insert should also contain contraceptive effectiveness information
comparing the percentage of women experiencing unintended pregnancy during one year
of use of latex condoms with rates experienced during one year of use of other
contraceptive options available in the U.S. including drugs, devices, and methods of
permanent sterilization . This information should at minimum include typical use rates.
This information is intended to enable contraceptive users to compare alternatives and
make appropriate choices. We recommend that you develop your contraceptive
effectiveness information from Hatcher, Trussell, et al. (Hatcher RA, Trussell J, Nelson
AL, Cates W, Stewart FH, Kowal D. Contraceptive Technology: Nineteenth Revised
Edition. New York NY: Ardent Media, 2007), or its updates.
2. Sexually Transmitted Infections (STIs)
Condoms reduce the overall risk of STI transmission (including transmission of HIV/AIDS and other
STIs):

2a. The principal display panel, the primary condom package (individual foil packet), and
the package insert should identify preventing transmission of HIV/AIDS and of other
STIs as a principal intended action of the latex condom (along with preventing
pregnancy, as described in section VI.1a).3 The following is an example of a statement
addressing both uses.
“Latex condoms are intended to prevent pregnancy, HIV/AIDS, and other sexually
transmitted infections.”

2b. The back of the retail package should have a box entitled Important Information. The
first statements in this box should indicate that latex condom use does not completely
eliminate the risk of STIs and highlight the importance of correct and consistent use.
(These statements should also include the information described in Section VI.1b of this
guidance.) The following is an example of such statements:
“Latex condoms do not completely eliminate the risks of pregnancy and sexually
transmitted infections (STIs).
To get the most protection from a latex condom, use one correctly every time you have
sex. Please see directions for use inside the package.”
Degree of protection against different types of STIs varies:

STIs can be transmitted in various ways, including transmission to or from the head of
the penis and transmission by contact with infected skin not covered by the condom. The
degree of protection provided by latex condoms depends on whether the condom
provides a barrier against the source of the infection.
2c. To reflect this, the Important Informationbox on the back of the retail package should
contain the following information. The first statement, after the statements addressing the
information discussed in sections VI.1b and 2b should state that there are many STIs, and
address the differential effectiveness of condoms for various STIs. This message should
also refer consumers to the location in the labeling of additional information on STI
protection. Another statement should suggest that consumers who believe they have an
STI should contact a health care provider and that for more information on latex condoms
or STIs, consumers should contact a health care provider or public health agency.
The following is an example of an acceptable set of statements addressing 1b, 2b, and 2c:
Important Information






Latex condoms do not completely eliminate the risks of pregnancy and sexually
transmitted infections (STIs).
To get the most protection from a latex condom, use one correctly every time you
have sex. Please see directions for use inside the package.
There are many STIs. A latex condom can reduce the risk of STI transmission to
or from the head of the penis. However, some STIs can also be spread by other
sexual contact. For additional information on STI protection, please read the
information inside the package.
If you believe you have an STI, contact a health care provider. For more
information on condoms or STIs, contact a health care provider or public health
agency.

2d. The package insert of latex condoms should contain a section stating that latex
condoms reduce the risk of STIs by providing a barrier against the source of infection.
The section should also explain that latex condoms are most effective against STIs, such
as HIV infection (AIDS) and gonorrhea, that are spread by contact with the head of the
penis. The section should also explain that condoms are less effective against STIs, such
as HPV and herpes, that can also be spread by contact with infected skin not covered by
the condom. The following is an example of an acceptable statement:
“Degree of STI Protection
Latex condoms reduce the risk of transmitting STIs by providing a barrier against the
source of the infection.



Latex condoms are most effective against STIs such as HIV infection (AIDS) and
gonorrhea that are spread by contact with the head of the penis.
Latex condoms are less effective against STIs such as Human Papillomavirus
(HPV) and herpes. These STIs can also be spread by contact with infected skin
that is not covered by the condom.”

2e. The package insert should also refer consumers to health care providers if they
believe they have an STI. The following is an example of an acceptable statement:
“If you believe you have an STI, contact a health care provider.”
2f. The package insert should notify the consumer that for additional information on latex
condoms and STIs a health care provider or public health agency should be contacted.
The following is an example of an acceptable statement:
“For more information on latex condoms or STIs, contact a health care provider or a
public health agency.”
3. Incorrect or Inconsistent Use

Latex condoms must include adequate directions for use to avoid being misbranded
(section 502(f) of the Act, 21 U.S.C. 352(f); 21 CFR 801.5). Adequate directions for use
will also help address the issue of incorrect or inconsistent use. Precautions should also
address this issue. We provide examples of appropriate directions for use and precautions
for latex condoms below. Manufacturers may have additional directions for use,
precautions, or other information that they believe is necessary for proper use of their
products. Such additional information is acceptable as long as it does not conflict with or
detract from the statements recommended in this guidance (or equivalent statements) or
any other applicable requirements (see Section III).
3a. Directions for Use:

The following set of statements is an example of acceptable directions for use for latex
condoms:4
Latex condoms are intended to prevent pregnancy, HIV/AIDS, and other sexually
transmitted infections.
1. Use a new condom for each act of sex.
2. Tear open the package carefully. Do not use fingernails, teeth, or anything that
can damage the condom.
3. Before any sexual contact, place the condom on the head of the erect penis with
the rolled side out.
o Lesions, pre-ejaculate secretions, semen, vaginal secretions and blood can
all transmit infectious organisms.
4. Unroll or pull the condom all the way to the base of the erect penis. If the condom
doesn’t unroll easily, it may be on backwards, damaged or too old. Throw it away
and start over with a new condom.
5. Immediately after ejaculation, hold the rim of the condom in place and withdraw
the penis while it is still erect.
o Avoid spilling semen.
6. Dispose of a used condom by wrapping it in tissue and throwing it into the trash.
Wash your hands with soap and water.
Pictorial representations of each direction for use are recommended. Line art attracts and
keeps a reader’s interest and is often remembered longer than words. Properly chosen
and placed illustrations re-emphasize the text, make it more meaningful, and reduce the
burden of details in the text. Graphics should:







be simple and clearly drawn, without clutter, unneeded background, or extraneous
detail
be placed next to corresponding text
use cues such as circles or arrows to point out key information
be clearly labeled
be easy to understand
be recognizable to the audience

3b. Precautions

The following set of statements is an example of acceptable precautions regarding
condom use:


Do not reuse latex condoms.



Store latex condoms in a cool, dry place (below 100ºF) and avoid exposure to
direct sunlight.



If the rubber material is sticky or brittle or obviously damaged, do not use the
condom.



If the color is uneven or changed, do not use the condom.



Make sure there is adequate lubrication. If you add lubricant, use a water-based
lubricant. [Manufacturers may identify one or more examples.] DO NOT USE
OIL-BASED LUBRICANTS, such as those made with petroleum jelly (e.g.,
Vaseline ®), mineral oil, vegetable oil, or cold cream, as these may damage the
condom.

VII. Examples of Condom Labeling that Follow the Recommendations in the
Guidance
Label statements appearing in italics are those recommended in Section VI of the current
guidance. Other label statements, discussed in Section III of this guidance, appear in
regular font. This difference in font styles is used only to identify the labeling
recommended by this guidance as a special control. FDA is not recommending italic font
for the actual label statements provided by manufacturers.
In recognition of the variety of ways that manufacturers may configure their labeling to
satisfy their statutory and regulatory labeling obligations as well as incorporate the
recommendations of this guidance, this section does not include a full mock-up of a
package insert, but gives only selected examples of recommended language. Please
consult the body of this guidance, 21 CFR Part 801, and the Act, for other information on
the full content of labeling.
Front panels of condom retail package:

Latex condoms are intended to prevent pregnancy, HIV/AIDS, and other sexually
transmitted infections.
Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic
Reactions.
When used correctly every time you have sex, latex condoms help prevent pregnancy and
reduce the risk of transmitting HIV/AIDS, and other sexually transmitted infections.5
XYZ Brand Latex Condoms
# (net quantity) Latex Condom
Rear panel of condom retail package

Important Information







Latex condoms do not completely eliminate the risks of pregnancy and sexually
transmitted infections (STIs).
To get the most protection from a latex condom, use one correctly every time you
have sex. Please see directions for use inside the package.
There are many STIs. A latex condom can reduce the risk of STI transmission to
or from the head of the penis. However, some STIs can also be spread by other
sexual contact. For additional information on STI protection, please read the
information inside the package.
If you believe you have an STI, contact a health care provider. For more
information on condoms or STIs, contact a health care provider or public health
agency.

Distributed by XYZ Corporation
Rockville, Maryland

EXP. Date: Jan 20XX

Primary condom package (individual foil packet):

Front of packet
One XYZ Brand Latex Condom
Latex condoms are intended to prevent
pregnancy, HIV/AIDS, and other sexually
transmitted infections.
Caution: This Product Contains Natural
Rubber Latex Which May Cause
Allergic Reactions.

Back of packet
Before using, please see directions for use
inside the package.

Distributed by XYZ Corporation
Rockville, Maryland
EXP Date: Jan 20XX

Examples of information to be included in package insert:

Directions for Use
Latex condoms are intended to prevent pregnancy, HIV/AIDS, and other sexually
transmitted infections.
1. Use a new condom for each act of sex.
2. Tear open the package carefully. Do not use fingernails, teeth, or anything that
can damage the condom.
3. Before any sexual contact, place the condom on the head of the erect penis with
the rolled side out.
o Lesions, pre-ejaculate secretions, semen, vaginal secretions and blood can
all transmit infectious organisms.

4. Unroll or pull the condom all the way to the base of the erect penis. If the condom
doesn’t unroll easily, it may be on backwards, damaged or too old. Throw it away
and start over with a new condom.
5. Immediately after ejaculation, hold the rim of the condom in place and withdraw
the penis while it is still erect.
o Avoid spilling semen.
6. Dispose of a used condom by wrapping it in tissue and throwing it into the trash.
Wash your hands with soap and water.

Package insert (cont.)

Precautions:






Do not reuse latex condoms.
Store latex condoms in a cool, dry place (below 100ºF) and avoid exposure to
direct sunlight.
If the rubber material is sticky or brittle or obviously damaged, do not use the
condom.
If the color is uneven or changed, do not use the condom.
Make sure there is adequate lubrication. If you add lubricant, use a water-based
lubricant. [Manufacturers may identify one or more examples.] DO NOT USE
OIL-BASED LUBRICANTS, such as those made with petroleum jelly (e.g.,
Vaseline®), mineral oil, vegetable oil, or cold cream, as these may damage the
condom.

Degree of STI Protection
Latex condoms reduce the risk of transmitting STIs by providing a barrier against the
source of the infection.



Latex condoms are most effective against STIs such as HIV infection (AIDS) and
gonorrhea that are spread by contact with the head of the penis.
Latex condoms are less effective against STIs such as Human Papillomavirus
(HPV) and herpes. These STIs can also be spread by contact with infected skin
that is not covered by the condom.

If you believe you have an STI, contact a health care provider. For more information on
latex condoms or STIs, contact a health care provider or a public health agency.

VIII. Paperwork Reduction Act of 1995

This guidance contains information collection provisions that are subject to review by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520).
The time required to complete this information collection is estimated to average 12
hours per response, including the time to review instructions, search existing data
sources, gather the data needed, and complete and review the information collection.
Send comments regarding this burden estimate or suggestions for reducing this burden to:
Paul Tilton,
Center for Devices and Radiological Health (HFZ-332),
Food and Drug Administration,
2094 Gaither Road,
Rockville, MD 20850.
This guidance also refers to previously approved collections of information found in FDA
regulations. The collections of information in 21 CFR part 807, subpart E, have been
approved under OMB control number 0910-0120; the collections of information in 21
CFR part 820 have been approved under OMB control number 0910-0073; the
collections of information in 21 CFR part 801, including those in 21 CFR 801.435,
referenced in the guidance, have been approved under OMB control number 0910-0485.
The latex allergy caution required by 21 CFR 801.437 and referenced in the guidance
does not constitute a "collection of information" under the PRA. Rather, it is a "public
disclosure of information originally supplied by the Federal government to the recipient
for the purpose of disclosure to the public." (5 CFR 1320.3(c)(2)).
An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number. The
OMB control number for this information collection is 0910-0633 (expires December 31,
2011).
1

As discussed in section IV of this guidance, male condoms made of natural rubber latex
with spermicidal lubricant (21 CFR 884.5310), which includes lubricant that contains
nonoxynol-9 (N-9), are not within the scope of this guidance.
2

In the package insert, this statement may be included in the directions for use, to satisfy
the requirements of 21 CFR 801.5(a).
3

In the package insert, this statement may be included in the directions for use, to satisfy
the requirements of 21 CFR 801.5(a).
4

Adequate directions for use must contain a statement of indications for use. (21 CFR
801.5(a)). As indicated in the example below, the statement recommended under sections
1a and 2a may be incorporated into the instructions for use to fulfill this requirement.

5

You may add this statement to the “top shelf” of the condom retail package (the front
panels also include the hanger and main box front).
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