Radiation Sterilization Update for PMA Holders

On June 7, 2022, the FDA announced it was considering a master file pilot program for premarket approval (PMA) holders whose approved devices are sterilized using radiation, including gamma radiation. The FDA is considering this pilot program due to global supply chain constraints and to support sterilization supply chain resiliency. If implemented, this program would help medical device manufacturers advance alternative ways to sterilize their approved medical devices, including changing radiation sources, in a least burdensome regulatory approach. 

Note:

• This pilot program would not include 510(k)-cleared devices where the following advice will be of interest: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
• When deciding when to submit a 510(k) for a change to an existing product this advice is useful When to Submit a 510(k) for a Change to an Existing Device,