The FDA considers an EtO 510(k) sterilization change to streamline approval processes

Dec. 20, 2021
The U.S. Food and Drug Administration (FDA) developed the Sterilization Master File Pilot Programs to help ensure patients have access to safe medical devices and encourage new, innovative ways to sterilize medical devices that reduce the potential impact of EtO on the environment and on the public health.510(k) Holders and Contract Sterilizers.

The FDA is considering an additional Sterilization Master File Pilot Program for sterilization changes to 510(k) cleared medical devices for sterilization providers with an Established Category B or Novel Sterilization Method as described in the FDA guidance Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.

The 510(k) Sterilization Change Master File Pilot Program under consideration would be open to all current 510(k) holders and is intended 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. Medical device manufacturers can reference the Master File rather than submitting a new 510(k) for the sterilization change.

The pilot program under consideration would not be limited to the sterilization Innovation Challenge participants (Identify New Sterilization Methods and Technologies or Reduce Ethylene Oxide Emissions). The FDA encourages Innovation Challenge participants to consider participation in the potential pilot program because they may benefit from it in the future as a part of their Innovation Challenge interactions. The pilot program may be an impactful endpoint for Innovation Challenge participants with Established Category B or Novel Sterilization Methods.

FDA release