The advisory committee voted 15-0 that the product is approvable with the condition that the FC2 Female Condom’s instructions for use continue to follow use instructions for the FC Female Condom (FC1 Female Condom) and appropriately identify the study that was performed to establish the comparable safety and effectiveness of FC2 with FC1.
The FDA is not bound by the committee’s recommendation, but it takes its advice into consideration when reviewing obstetric and gynecologic devices.
Mary Leeper, The Female Health Company’s (FHC’s) senior strategic advisor, said: “We are very pleased with today’s outcome and look forward to working with the FDA as it continues to review our application for the FC2 Female Condom. We believe that FHC’s second-generation female condom can strengthen the fight against AIDS by expanding affordable access to a woman-initiated HIV prevention method.”