Radiation sterilization change master file pilot program under consideration

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FDA - Center for Devices and Radiological Health

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The FDA is Considering a Radiation Sterilization Change Master File Pilot Program  

The U.S. Food and Drug Administration (FDA) is considering a master file pilot program for premarket approval (PMA) holders whose approved devices are sterilized using radiation, including gamma radiation.

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.

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Sterilization for Medical Devices

The FDA recently launched a 510(k) Sterility Change Master File Pilot Program intended to help with changes to a cleared medical device’s sterilization method from a fixed chamber ethylene oxide (EtO) sterilization cycle to the sterilization method described in the Master File.

Supply Chain for Medical Devices

The FDA will hold a Virtual Public Workshop from June 7-9, 2022 on Building Medical Device Supply Chain Resilience: A Healthcare and Public Health Ecosystem-Wide Collaboration to discuss ways to foster resiliency in the medical device supply chain and to seek input on the new Resilient Supply Chain Program (RSCP).


If you have questions about the radiation sterility change master file pilot program under consideration, please contact cdrh-innovation-sterilization@fda.hhs.gov. For questions about the existing EtO Sterilization Master File Pilot Program for Premarket Approval holders, contact the Division of Industry and Consumer Education.