Pilot Program Could Help Streamline Transitions Away From Ethylene Oxide Sterilization for Devices

Sponsors Could Avoid the Need To Resubmit 510(k)s, Relying Instead on Internal Device Master Files
Dennis Tosh
May 25, 2022 at 01:45 PM EST
The FDA May 19 launched a pilot program to encourage “new, innovative ways” to sterilize medical devices to reduce the potential environmental impact of ethylene oxide (EtO) sterilization processes and facilities. The program could help device sponsors change to more environmentally friendly sterilization methods without the need to provide additional premarket submissions to ... Read More

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