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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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EPA Announces Proposed Rules To Reduce Ethylene Oxide Exposure On April 11, the Environmental Protection Agency (EPA) proposed new health protections to reduce exposure to Ethylene Oxide (EtO). These include a proposed rule regulating ethylene oxide (EtO) sterilizers of medical technology and other commercial uses through the National Emission Standards for Hazardous Air Pollutants …
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