Medical Innovation Exchange

medical device sterilization

FDA CDRH Takes Additional Steps To Advance Innovation in Medical Device Sterilization

FDA CDRH Takes Additional Steps To Advance Innovation in Medical Device Sterilization     In response to safety concerns and proposed regulatory action related to industrial use of ethylene oxide (EtO), the FDA Center for Devices and Radiological Health (CDRH) is taking additional steps to advance innovation in medical device sterilization. CDRH has updated its Recognized …

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FDA CDRH Takes Additional Steps To Advance Innovation in Medical Device Sterilization

FDA CDRH Takes Additional Steps To Advance Innovation in Medical Device Sterilization     In response to safety concerns and proposed regulatory action related to industrial use of ethylene oxide (EtO), the FDA Center for Devices and Radiological Health (CDRH) is taking additional steps to advance innovation in medical device sterilization. CDRH has updated its Recognized …

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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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