Maternal, Adolescent and Child Health, Department of Obstetrics and Gynaecology, University of the Witwatersrand, Overport 4091, South Africa.
Contraception. 2011 Apr;83(4):316-21. doi: 10.1016/j.contraception.2010.07.022. Epub 2010 Sep 15.
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.
女用避孕套（FCs）与男用避孕套一样，可以预防非意愿妊娠和大多数性传播感染，包括艾滋病毒。1993 年，Female Health Company 生产的第一个 FC 获得了美国食品和药物管理局（USFDA）的批准。自 2000 年以来，已经有几种不同类型的 FC 可供使用或正在开发中，以降低成本和/或提高可接受性。尽管功能相似，但新型 FC 在设计和材料上往往有所不同。USFDA 将 FC 归类为 III 类医疗器械，其监管流程比男用避孕套更为复杂。再加上缺乏国际标准来验证新设备的质量，这阻碍了新产品获得监管批准并进入市场。我们回顾了 FC 现有的监管途径、为 FC 专门制定标准方面取得的进展以及现有的或正在开发的 FC，包括它们在获得批准方面的现状。
