Info Collection Extension for Device PMAs

Federal Register notice: FDA is seeking comments on an information collection extension entitled “Premarket Approval of Medical Devices” (OMB Control Number 0910-0231). Premarket approval application (PMA) requirements assist in the agency’s scientific and regulatory review to ensure the safety and effectiveness of Class 3 devices. PMA requirements apply differently to preamendments devices, postamendments devices, and transitional Class 3 devices. The Food and Drug Administration Modernization Act of 1997 provided that PMA supplements were required for all device changes that affect safety and effectiveness unless such changes are modifications to manufacturing procedures or method of manufacture. That type of manufacturing change requires a 30-day notice, or where FDA finds such notice inadequate, a 135-day PMA supplement. To view the notice, click here.