FDA Considering Radiation Sterilization Master File Pilot

FDA says it is considering a master file pilot program for PMA holders whose approved devices are sterilized using radiation, including gamma radiation. An agency notice says the agency is considering such a pilot program due to global supply chain constraints and to support sterilization supply chain resiliency.

“If implemented,” the notice says, “this program would help medical device manufacturers advance alternative ways to sterilize their approved medical devices, including changing radiation sources, in a least burdensome approach.”

FDA says it is working actively with sterilization experts, medical device manufacturers, and other government agencies to advance alternative ways to sterilize medical devices, including using lower levels of currently used sterilizing agents and using new sterilizing agents or alternatives, while maintaining device safety and effectiveness.