Pilot Program Could Help Streamline FDA Approvals of Changes in Ethylene Oxide Sterilization

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Pilot Program Could Help Streamline FDA Approvals of Changes in Ethylene Oxide Sterilization

Class III Device Manufacturers, Sponsors Could File Post-Approval Reports Rather than PMA Supplements

Dennis Tosh

November 26, 2019 at 05:19 PM EST

The FDA’s Center for Devices and Radiological Health (CDRH) is setting up a pilot program that could make it easier for some medical device manufacturers to obtain agency approval of certain changes to the ethylene oxide (EtO) sterilization of their products. The agency launched the pilot program Nov. 25. Also that day, the FDA announced other actions that it is taking to hel... Read More

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Pilot Program Could Help Streamline FDA Approvals of Changes in Ethylene Oxide Sterilization

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Pilot Program Could Help Streamline FDA Approvals of Changes in Ethylene Oxide Sterilization

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