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Center for Devices and Radiological Health Radiation Sterilization Master File Pilot Program

FDA - 2023-04-12

FDA announces voluntary Radiation Sterilization Master File Pilot Program allowing medical device manufacturers to use master files for sterilization process changes instead of premarket approval supplements, aimed at supporting device supply chain resilience.

Signal typeregulatory_update
Strategic importancemedium
MaterialsGamma radiation, Ethylene oxide

Primary source: https://www.federalregister.gov/documents/2023/04/12/2023-07598/center-for-devices-and-radiological-health-radiation-sterilization-master-file-pilot-program

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