FDA Mulls Master File Pilot For Makers Of PMA-Approved Devices Sterilized Using Radiation

Makers of PMA-approved devices that are sterilized using radiation – including gamma radiation – might be wooed soon by the US Food and Drug Administration for a potential pilot program that would look at alternative ways to sterilize such products.

The pilot under consideration, which hasn’t been given a name, would allow a PMA-holder to submit updated master files to the agency if the manufacturer switches sterilization methods.