March 11, 2009

Female Condom Receives FDA Approval

The Female Health Company is announcing [PDF] today that the FDA has approved the company’s FC2 Female Condom for preventing pregnancy, HIV/AIDS, and other sexually transmitted infections.

The company notes that the approval will “enable the United States Agency for International Development (USAID) to procure FC2 for distribution to global HIV/AIDS programs,” and that changes in the material and manufacturing as compared to their original female condom should make the product more affordable. The device has been available in other countries since 2006, but FDA approval apparently means that it can now be purchased for U.S.-funded prevention programs worldwide.

Although the approval documents are not yet available on the FDA website, they should be available here sometime in the near future for examination.

The FDA’s Obstetrics and Gynecology Devices Panel reviewed and recommended approval of the product last December. For further discussion of this and other female condom prototypes, see our recent guest post from Audacia Ray of the International Women’s Health Coalition.

One Response to “Female Condom Receives FDA Approval”

  1. e. rampart Says:

    President Obama’s new White House Council on Women must take this up as a critical tool to prevent the spread of HIV/AIDS among women – particularly minority women in the south (

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