On Friday, the U.S. Food and Drug Administration issued the proposed order, Obstetrical and Gynecological Devices: Reclassification of Single-Use Female Condom, To Be Renamed Single-Use Internal Condom.”  The order proposes to reclassify the single-use female condom a Class II medical device (on par with male condoms) as well as recommending changing the name from “female” to “internal” and including an indication for anal sex.  These are changes that the National Female Condom Coalition (of which NCSD is a member) has been advocating for several years!!

There are now 60 days to provide comments on the proposed rule to ensure that it become reality.  Comments must be submitted by February 2, 2018. Comments can be submitted electronically here.  If this proposed order is finalized, it is expected to reduce the regulatory burden on industry, as single-use internal condoms will no longer require premarket approval (PMA).