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At Our Bodies Our Blog: Female Condom Gets FDA Approval

March 12, 2009

Female Condom Receives FDA Approval – the post includes links to our previous coverage of the device as well. I still have some issues with this, because my understanding is that the FC2 was approved as “substantially equivalent” to the previously approved FC1 female condom. However, the material was changed, and research comparing the two focused on breakage and similar technical issues, rather than actual efficacy in STI/pregnancy prevention. I’m wondering why/if/how you can make a substantial equivalence argument when the material has been changed, so I’m looking forward to seeing the FDA’s documents on the approval.

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