Femasys Inc. received FDA approval for a modular premarket approval (PMA) submission for its FemBloc permanent birth control device. This allows the company to submit application sections for rolling regulatory review while the pivotal FINALE clinical trial continues.
The modular PMA pathway aims to expedite the final U.S. approval process. It enables the FDA to review key components before the submission of final clinical data.
FemBloc is a non-surgical, in-office solution. The device is already approved for marketing in Europe and other international markets.