Over the last few years, the FDA has looked into ways to allow certain device manufacturers to move away from ethylene oxide (EtO) sterilization practices, citing environmental concerns, even as alternative sterilization methods faced other challenges. In late 2019, the agency launched a pilot to allow certain manufacturers with devices under Pre-Market Approval (PMA) to use a streamlined process to reduce their reliance on EtO. Now, CDRH is expanding the pilot to other types of sterilization changes to reduce reliance on both EtO and the other main sterilization method: gamma radiation.
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