6/7/22 — The FDA is considering this pilot program due to global supply chain constraints and to support sterilization supply chain resiliency. 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.

The FDA 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. Learn more about FDA’s Sterilization Master File Pilot Programs.