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Home » FDA eyes radiation sterilization pilot to foster sterilization alternatives
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FDA eyes radiation sterilization pilot to foster sterilization alternatives

June 7, 2022
By Mark McCarty
The U.S. FDA’s device center continues to promote alternatives to ethylene oxide (EtO) as a medical device sterilant, with the latest development involving radiation as a sterilizing technology. The agency said it may open a new master file program for radiation that follows an existing program that is agnostic as to sterilization method, and which may speed the adoption of alternative sterilization methods in the years ahead. The FDA’s Center for Devices and Radiological Health recently announced a pilot program for alternatives to EtO sterilization that would eliminate a significant number of regulatory filings.
BioWorld MedTech Regulatory U.S. FDA

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