Draft Guidance - Special Control for Latex Condoms with and without Spermicidal Lubricant

FDA is proposing some regulatory changes relating to condoms and their classification and labeling. Changes proposed include, amending the identification sections of the classification regulations for condoms with and without spermicidal lubricant to change the wording “venereal disease” to “sexually transmitted diseases”. FDA is also proposing to add classification sections to each of the regulations, segregating the subset of condoms in each classification that are made of latex. Finally, FDA is proposing to designate a special controls guidance document with labeling recommendations for latex condoms.

Condoms have been classified as Class II device and hence require mandatory performance standards. However, because of various complexities, FDA hadn’t announced any performance standards for condoms or most other Class II devices. However, after the passage of the Safe Medical Devices Act of 1990, FDA has the authority to enact special controls through which Class II devices can be regulated.

FDA has, after an extensive study come up with Special Controls for Condoms that when followed would provide adequate safety and effectiveness information for consumers to make an informed choice.

The labeling recommendations in the draft special controls guidance are intended to provide information to users of latex condoms with and without spermicidal lubricant. FDA through this guidance is recommending that manufacturers to inform users about the extent of protection provided by condoms against unintended pregnancies and also against various types of sexually transmitted diseases (STDs). In addition the labeling should mention about possible risks associated with exposure to N-9 contained in the spermicidal lubricant of some condoms.

This draft guidance is neither final nor is it in effect at this time. FDA is welcoming written or electronic comments till February 13, 2006.

For more information, please review the following documents:

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-22610.pdf and

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-22611.pdf

If any questions on the report or comments please email us at info@mdiconsultants.com.

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