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