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For Consumers

FDA approval of the FC2 Female Condom

On March 9, 2009, the Food and Drug Administration approved a medical device Premarket Approval Application (PMA) for the FC2 Female Condom. Indicated for preventing pregnancy, HIV/AIDS, and other sexually transmitted infections (STIs), the FC2 consists of a thin, flexible, nitrile polymer (synthetic latex) sheath, open at one end. There is an outer ring at the open end, and (though not attached to the condom) an inner ring inside the sheath that aids in insertion.

The FC2 is a new version of the original Female Condom (FC), which was aprroved by FDA in 1993. FC2 is less costly than the original product because of changes in materials and the manufacturing process,

Like male condoms, female condoms are sold without a prescription. The FC2 and FC are designed and intended to be used only once.

The FC and FC2 are manufactured by the Female Health Company, of Chicago, IL.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

Page Last Updated: 08/13/2014
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