Obstetrics and Gynecology Devices Panel - December 11, 2008
The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee met on December 11, 2008 in Gaithersburg, MD.
The panel discussed the pre-market approval application (PMA P080002) from Female Health Company ( Chicago, IL) for the FC2 Female Condom. The proposed Indication for Use is “The FC2 Female Condom when used correctly and consistently, helps to prevent HIV/AIDS, other sexually transmitted infections (STIs) and unintended pregnancy.”
The FC2 Female Condom is composed of a nitrile sheath, nitrile outer ring, and a polyurethane inner ring. The sponsor developed FC2 to replace their currently marketed female condom (FC1), made of polyurethane.
The pivotal clinical study supporting the PMA compared FC1 to FC2 with respect to the four female condom failure modes (breakage, invagination, slippage, and misdirection). The study was a multi-center, cross-over, randomized trial conducted in South Africa. This study is based on user reports (coital logs) and follow-up interviews. FDA’s review of this study noted several methodological concerns, including concerns about how the user report data was obtained. No clinical studies have been submitted to show FC2 effectiveness for pregnancy or STI risk reduction.
The panel was asked to address whether the data from the failure modes study conducted in South Africa would be sufficient to support the PMA for FC2.
There were 15 presenters during the Open Public Hearing representing issues of women’s health and global initiatives.
The panel critically evaluated the pivotal study and voted unanimously (14-0) to recommend approval of the PMA for the FC2 Female Condom, subject to one condition. The condition was for device labeling to be revised to accurately reflect the extent of the evidence comparing FC1 and FC2. Specifically, the clinical outcomes (i.e., pregnancy and sexually transmitted infections) had not been studied on FC2.
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