Femasys says FDA OKs modular PMA pathway for FemBloc birth control device
FEMY•FDA clears modular PMA pathway for FemBloc
- FDA cleared Femasys to use a modular PMA submission pathway for FemBloc, its investigational non-surgical permanent birth control device.
- The structure allows FDA review of submission modules ahead of final clinical data, potentially speeding the route to a US marketing decision.
- FemBloc is already marketed in Europe and select international markets.
