FDA Announces New Environmental and Public Health Initiative To Streamline EtO Sterilization Methods

As a part of the U.S. Food and Drug Administration’s (FDA) ongoing effort to streamline certain changes to ethylene oxide (EtO) sterilization processes and facilities, the FDA is announcing a 510(k) Sterility Change Master File Pilot Program. This new pilot program is for sterilization changes to 510(k) cleared medical devices.

The 510(k) Sterility Change Master File Pilot Program:

• Encourages new, innovative ways to sterilize medical devices that reduce the potential impact of EtO on the environment and on public health,
• Allows, generally, contract sterilizers or 510(k) holders with an Established Category B or Novel Sterilization Method to submit a Master File, and
• Enables other device manufacturers to reference Master Files to help with changes to a cleared medical device’s sterilization method from a fixed chamber EtO sterilization cycle to the sterilization method described in the Master File.

Questions?

If you have questions about the new 510(k) Sterility Change Master File Pilot Program, policy please contact mdi at: [email protected] and ref: 510(k) Sterility Change Master File Pilot Program.