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# FDA Sets Device Radiation Sterilization File Pilot
- URL: https://www.fdaweb.com/fda-sets-device-radiation-sterilization-file-pilot/
- Published: 2023-04-11T12:00:00.000Z
- Updated: 2026-09-14T18:24:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154190

FDA has announced a voluntary Radiation Sterilization Master File Pilot Program to help companies advance alternative and innovative ways to sterilize approved medical devices, including changing radiation sources, in a least burdensome regulatory approach. A [notice](https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the [pilot](https://www.federalregister.gov/public-inspection/2023-07598/center-for-devices-and-radiological-health-radiation-sterilization-master-file-pilot-program?ref=fdaweb.com) will be open to nine companies that sterilize single-use, PMA-approved medical devices using gamma radiation or ethylene oxide and intend to submit master files when making certain changes to sterilization sites, sterilization methods, or other processes, under specific conditions outlined in the notice.