USA – FDA Reduces Regulatory Burden for Female Condoms

The US Food and Drug Administration (FDA) on Wednesday issued a final order lowering the regulatory burden for device makers looking to market single-use female condoms by reclassifying the devices from Class III to Class II.

Currently, only a single line of female condoms, Veru’s FC2 Female Condom, is sold in the US and is dispensed by prescription only.

“By reducing the regulatory burden for approval, the FDA intends to encourage more manufacturers to bring single-use internal condoms to market in the United States,” FDA writes.

The order, which was first proposed last December, will take effect on 29 October 2018 and comes after years of campaigning by women’s health advocates who viewed the more stringent classification as a barrier to access…