https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/ethylene-oxide-sterilization-medical-devices?utm_campaign=2020-3-20%20Update%20on%20the%20Ethylene%20Oxide%20Sterilization%20Master%20File%20Pilot%20Program&utm_medium=email&utm_source=Eloqua

Update on the Ethylene Oxide Sterilization Master File Pilot Program

Today, as part of our ongoing efforts to expedite approvals of certain changes to ethylene oxide sterilization processes & facilities, the FDA is announcing its first Master File acceptance into the FDA Ethylene Oxide Sterilization Master File Pilot Program.

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This acceptance comes at an especially critical time for the FDA to continue our important work to mitigate ethylene oxide sterilized device shortages.  The FDA believes the Ethylene Oxide Sterilization Master File Pilot Program should result in sterilization facilities using a greatly reduced amount of ethylene oxide while still providing robust patient safeguards. The FDA will continue in its efforts to reduce over-reliance on ethylene oxide for medical device sterilization and will provide updates on future Master File acceptances. Questions? If you have questions or need to report a medical device shortage or supply issue, email Deviceshortages@fda.hhs.gov.