Female condom technology: new products and regulatory issues.

摘要

Like male condoms, female condoms (FCs) provide protection against unplanned pregnancy and most sexually transmitted infections including HIV. The first FC made by the Female Health Company was approved by the US Food and Drug Administration (USFDA) in 1993. Since 2000, several different types of FCs have become available or are in development to lower the cost and/or improve acceptability. Although similar in function, new FCs often differ in design and materials. Classified as Class III medical devices by the USFDA, FCs have a regulatory process that is more complex than that for male condoms. This, coupled with the lack of an international standard to verify the quality of new devices, has hindered new products gaining regulatory approvals and entering the market. We review the existing regulatory pathway for FCs, the progress made in developing standards specifically for FCs and the FCs available now or in development, including their current status regarding approval.