The FDA is Considering a New 510(k) Sterilization Change Master File Pilot Program

U.S. Food and Drug Administration sent this bulletin at 12/17/2021 09:22 AM EST

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FDA - Center for Devices and Radiological Health

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The FDA is Considering a 510(k) Sterilization Change Master File Pilot Program  

Medical device syringe that was sterilized using ethylene oxide

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 considering an additional Sterilization Master File Pilot Program for sterilization changes to 510(k) cleared medical devices. The existing pilot program is limited to devices with approved Premarket Approval applications.

The FDA designed the Sterilization Master File Pilot Program to help ensure patients have access to safe medical devices and to encourage new, innovative ways to sterilize medical devices that reduce the potential impact of EtO on the environment and on the public health.

The addition of a 510(k) Sterilization Change Master File Pilot Program would:

  • Allow contract sterilizers or 510(k) holderswith an Established Category B or Novel Sterilization Method to submit a Master File.
  • Enable other device manufacturers to reference Master Files to facilitate changes to a cleared medical device’s sterilization method from a fixed chamber EtO sterilization cycle to the sterilization methoddescribed in the Master File.

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Questions?

If you have questions about the 510(k) Sterility Change Master File Pilot Program under consideration, please contact cdrh-innovation-sterilization@fda.hhs.gov. For questions about the existing EtO Sterilization Master File Pilot Program for Premarket Approval holders, contact the Division of Industry and Consumer Education.