>>Policy & Regulation

Condom Approved In US With Anal Sex Indication Through FDA Process Encouraging More Proposals

24 Feb 2022

With approval, FDA created regulatory classification allowing subsequent devices of same type with same intended use may go through 510(k) pathway, allowing devices to obtain clearance by demonstrating substantial equivalence to a predicate device.

A condom with labeling to help reduce transmission of sexually transmitted infections during anal intercourse has been approved for the first time in the US through a regulatory pathway likely to spur additional proposals for additional condoms to have the indication.

The Food and Drug Administration has authorized Global Protection Corp.’s One brand natural rubber latex condom to use the labeling,...