[Federal Register Volume 60, Number 149 (Thursday, August 3, 1995)]
[Notices]
[Pages 39757-39758]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19089]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 Food and Drug Administration
 [Docket No. 95D-0162]


Marketing of Condom-like Products: Policy Statement; Notice of 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is making generally 
available a policy statement issued on February 23, 1994, directly to 
manufacturers, distributors, and importers of condom products, 
regarding the marketing of condom-like products. The policy statement 
is intended to inform manufacturers, distributors, and importers of 
condoms and condom-like products, including those products labeled or 
packaged as novelty items, that such products are subject to all of the 
regulatory requirements for medical devices. This policy statement 
revises and supersedes the 1989 policy statement regarding the labeling 
of condoms. FDA is making the policy statement generally available at 
this time to help ensure that the policy is known and understood by the 
regulated industry and the public.

DATES: Written comments may be submitted at any time.

ADDRESSES: Submit written requests for single copies of the policy 
statement to the Division of Small Manufacturers Assistance (HFZ-220), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-443-6597 (1-800-638-2041 outside MD). Send two self-addressed 
adhesive labels to assist that office in processing your requests. 
Submit written comments on the policy statement to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857. Requests and comments should 
be identified with the docket number found in brackets in the heading 
of this document. A copy of the policy statement and received comments 
are available for pubic examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices 
and Radiological Health (HFZ-84), Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850, 301-594-4765, ext. 157.

SUPPLEMENTARY INFORMATION: On February 13, 1989, FDA issued a statement 
of policy regarding the marketing of condoms. This policy statement was 
forwarded via certified mail--return receipt requested--to all 
manufacturers, importers, and repackagers of condoms for contraception 
or sexually transmitted disease prevention. Subsequently, FDA 
discovered that some marketers of functional condom-like products may 
have misinterpreted the 1989 policy statement, and were marketing 
functional condoms as novelty items without complying with condom leak 
testing requirements, current good manufacturing practice (CGMP) 
regulations, manufacturer registration, product listing, and premarket 
notification and clearance requirements. Such marketing is in violation 
of the Federal Food, Drug, and Cosmetic Act (the act) and implementing 
regulations. Therefore, to clarify that such products may only be 
legally marketed in compliance with these requirements, FDA issued a 
new policy statement on February 23, 1994.
     Products that are capable of covering the penis with a closely 
fitting membrane and otherwise have the appearance of a condom are 
considered to be medical devices, regardless of their packaging or 
labeling. As such, these products must comply with all the above-
referenced requirements. However, when condom-like products cannot be 
used as condoms, they need not meet the above requirements. For 
example, a product that resembles a condom but which has the closed end 
removed, the sides shredded, or the roll permanently sealed so that it 
is incapable of being unrolled would not be subject to the requirements 
of the act and the regulations. FDA emphasizes that merely labeling the 
products as a novelty does not remove it from the scope of the act or 
in any way exempt it from the requirements applicable to condoms.
     Copies of this final policy statement, along with previous policy 
statements, are available for public examination in the Dockets 
Management Branch (address above).
     Interested persons may, at any time, submit written comments on 
the final policy statement to the Dockets Management Branch (address 
above). Such comments will be considered when determining whether to 
amend the current policy statement. Two copies of any comments are to 
be 

[[Page 39758]]
submitted, except that individuals may submit one copy.

    Dated: June 23, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 95-19089 Filed 8-2-95; 8:45 am]
BILLING CODE 4160-01-F