FDA Proposes Exciting Changes to the Female Condom

Dec 11, 2017 | Kim Rodgers

On Worlds AIDS Day (December 1), the U.S. Food and Drug Administration (FDA) announced that it proposes to not only reclassify the female condom from a Class III to a Class II medical device, but to also de-gender the device through renaming it the “single-use internal condom.”

The proposed order also calls for expanding the indication of internal condoms to include anal sex. Since the internal condom came on the market more than 20 years ago, people of all genders have used it both vaginally and anally to reduce transmission of HIV and STIs. The FDA’s proposals demonstrate a recognition of the unique role internal condoms can play in enabling receptive partners of all genders to protect themselves and their partners.

The National Female Condom Coalition (NFCC) thanked the FDA for releasing proposals that align with the substantial body of scientific evidence demonstrating the safety and efficacy of these products as well as people’s sexual health needs.

Advocates have until Friday, Feb. 2, 2018 to submit comments to the FDA outlining support for this reclassification, renaming and expanded use indication. Please stay tuned to the NFCC for resources to support development and submission of your own comments, as well as opportunities to endorse comments that will be submitted.


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About Kim Rodgers

Kim Rodgers is the Communications Manager at NACCHO.

More posts by Kim Rodgers

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