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Regulatory News | 26 September 2018 | By Michael Mezher
Editor's note: This article has been updated to clarify that Veru's FC2 Female Condom is available directly from the company without a prescription.
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 or can be purchased directly from the company by consumers and government and non-profit healthcare agencies.
“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.
The devices, regulated under product code MBU, will be subject to premarket notification and special controls including clinical performance testing, viral penetration testing and nonclinical performance testing.
Device makers must also demonstrate that the devices are biocompatible, maintain their performance characteristics throughout their shelf-life and bear adequate labeling.
In addition to reclassifying the devices, FDA is renaming the devices as “single-use internal condom” and renaming reusable female condoms regulated under product code OBY to “multiple-use female condoms” to further distinguish the two product types.
FDA says it is ordering the reclassification on its own initiative after reviewing new information that was not available when the agency granted premarket approval to the first single-use female condom.