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Andersen Sterilizers & Andersen Scientific First Awardee in FDA's 510(k) Ethylene Oxide Sterility Change Master File Pilot Program | Business

HAW RIVER, N.C. (BUSINESS WIRE) Aug 8, 2023 ....

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FDA Roundup: June 30, 2023

/PRNewswire/ Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA s Center. ....

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FDA Roundup: June 30, 2023

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. ....

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Medical Device Makers See Progress in EO Sterilization

Photo credit: okrasiuk – adobe.stock.com
Medical device manufacturers and contract sterilizers are working with regulators to reduce ethylene oxide (EO) emissions and develop alternative sterilization methods, while assuring product availability.
Public and governmental alarm about the use of ethylene oxide (EO) for sterilization of medical devices is driving device manufacturers, contract sterilizers, and other stakeholders to double down on developing sterilization processes that reduce or eliminate the use of EO.
“Ethylene Oxide Sterilization: An FDA & EPA Update,” presented during 2020 Virtual Engineering Week by Mac McKeen, fellow, regulatory science, at Boston Scientific, presents the regulatory lay of the land, as well as strategies for reducing reliance on EO. Watch the full 30-minute presentation in this video. ....

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