CDRH Announces Radiation Sterilization Pilot Program

CDRH Announces Radiation Sterilization Pilot Program     On the heels of the EPA’s announcement of two new proposed rules to reduce ethylene oxide (EtO) emissions, Jeff Shuren, M.D., J.D., director of the FDA CDRH, announced a radiation sterilization master file pilot program for medical devices. The program is designed to help companies advance alternative and …

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