Does this mean the end of the Condom Wars, finally?

FDA: Condoms Work

[Federal Register: November 10, 2008 (Volume 73, Number 218)]
[Rules and Regulations]
[Page 66522-66539]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10no08-12]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. FDA-2004-N-0511] (formerly Docket No. 2004N-0556)

RIN 0910-AF21
Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA) is amending the classification regulation for condoms to designate a special control for male condoms made of natural rubber latex (latex). The special control for the device is the guidance document entitled ``Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300.'' The FDA will publish a notice in the Federal Register announcing the availability of the special control guidance document no later than the effective date of this final rule.

DATES: Effective Date: This rule is effective January 9, 2009. Compliance Dates: Premarket notification submissions (510(k)s) for latex condoms filed on or after the effective date of this rule are expected to comply with the requirement of special controls at the time that the 510(k) is submitted. Latex condoms cleared for marketing on or after the effective date of the rule but submitted in 510(k)s filed before the effective date of the rule are expected to comply with the requirement of special controls on or before March 10, 2009. Latex condoms legally marketed before the effective date of this rule are expected to comply with the requirement of special controls December 10, 2009. Specific information on how the rule will be implemented can be found in section II.B of this document.

FOR FURTHER INFORMATION CONTACT: Colin M. Pollard, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1180.

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Notice Highlight:

FDA concludes that the scientific evidence today continues to fully support the overall effectiveness of latex condoms in reducing the risk of transmission of common STIs. That evidence supports the conclusions that correct and consistent use of latex condoms reduces the risk of transmission of HIV/AIDS and other STIs such as gonorrhea that are sexually transmitted solely by contact with the head of the penis (via genital fluids). Also, the evidence available today provides even more support than was available at the time of publication of the proposed rule for the conclusion that latex condoms are effective in reducing the risk of transmission of other STIs, such as genital herpes and HPV, that can be transmitted not only by contact with the head of the penis, the area covered by a latex condom, but also by contact with infected skin outside the area covered by the latex condom.