The US Food and Drug Administration (FDA) may allow medical device manufacturers to modify their radiation sterilization processes to prevent supply shortages. The agency is considering a pilot program to allow lower radiation levels for sterilization for premarket approved (PMA) products, though it would not apply to 510(k) devices. The pilot would include gamma radiation sterilization.
On 7 June, FDA said it was considering a master file pilot program for PMA device manufacturers who sterilize their products using radiation.
“The FDA is considering this pilot program due to global supply chain constraints and to support sterilization supply chain resiliency,” the agency said. “If implemented, this program would help medical device manufacturers advance alternative ways to sterilize their approved medical devices, including changing radiation sources, in a least burdensome regulatory approach.”…
