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U.S. Department of Health and Human Services

For Consumers

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Proposed Guidance for Condom Labeling

The Food and Drug Administration (FDA) recently published information about proposed changes in the way condoms are to be regulated, and draft guidelines for condom labeling.

FDA sets regulatory controls on medical devices. The least restrictive level is general controls. General controls can include good manufacturing practices/quality system regulation, registration and listing, adverse event reporting, and the prohibitions on adulteration and misbranding.

Another level of control is known as special controls. The way a device is labeled can be considered part of special controls.

FDA believes that special controls (in this case special labeling), when combined with general controls, will be sufficient to provide a reasonable assurance of the safety and effectiveness of latex condoms, with or without spermicidal lubricant.

FDA is proposing to amend the classification regulations to designate a special control for natural rubber latex (latex) condoms, with and without spermicidal lubricant. New guidelines (below) specify the kind of labeling that will be considered sufficient and appropriate for the products.

Three separate documents were published on November 14, 2005 to support these proposed changes:

1. Proposed Rule - Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom With Spermicidal Lubricant

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-22611.htm
This document explains the regulatory structure for devices of this class.

2. Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-22610.htm 
A Notice of Availability of the Guidance, which includes a very good overview of the regulatory history of condoms.

3. Draft Guidance - Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex

http://www.fda.gov/cdrh/comp/guidance/1548.html 
The draft guidance, which explains the specific labeling requirements considered to be special controls, including labeling recommendations intended to help address issues related to nonoxynol-9 (N-9), used as a spermicide in the lubricant of some latex condoms.

The labeling recommendations in the draft guidance reflect an extensive review by FDA, in consultation with the National Institutes for Health (NIH) and the Centers for Disease Control and Prevention (CDC), of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 condoms intended to prevent pregnancy and provide protection against sexually transmitted diseases (STDs). In addition, the Agency considered other relevant information related to the barrier properties of latex condoms and the various routes of transmission of STDs.

Interested parties are encouraged to comment on the proposals. Instructions for submitting comments are provided within the linked documents.

Richard Klein
HIV/AIDS Program Director
Office of Special Health Issues
Food and Drug Administration