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FDA schedules ob/gyn panel

This article was originally published in The Gray Sheet

Executive Summary

Female Health's PMA for the FC2 second generation female condom will go before FDA's Obstetrics and Gynecology Devices advisory panel May 16, the agency announces March 27 in the Federal Register. The firm's first-generation FC is the only product for women approved by FDA that provides dual protection against unintended pregnancy and sexually transmitted diseases, according to Female Health. The second-generation device is made of nitrile while the FC is made of polyurethane

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