2023-07598: Center for Devices and Radiological Health Radiation Sterilization Master File Pilot Program

Summary

The Food and Drug Administration's (FDA, Agency, or we) Center for Devices and Radiological Health (CDRH or Center) is announcing its Radiation Sterilization Master File Pilot Program ("Radiation Pilot Program"). The Radiation Pilot Program is voluntary and intends to allow companies that terminally sterilize single-use medical devices ("sterilization providers") using gamma radiation or ethylene oxide (EO) to submit Master File(s) when making certain changes to sterilization sites, methods, or processes under the specific conditions outlined in this notice. Under this voluntary pilot program, manufacturers of class III devices subject to premarket approval ("PMA holders") who have been granted a right of reference by a sterilization provider may, upon notification from FDA that a manufacturer may do so, include references to Master File(s) accepted into the Radiation Pilot Program in postapproval reports describing the particular changes noted above affecting the sterilization sites, methods, or processes of their class III devices, in lieu of submitting premarket approval application (PMA) supplements for such changes. By helping industry advance alternatives for gamma radiation and EO sterilization of medical devices, the Radiation Pilot Program seeks to help ensure patient access to safe medical devices and, through evaluation of data from pilot participants, provide insights into future regulatory approaches that may help address potential device shortages related to sterilization site, method, or process shifts and facilitate supply chain resiliency.

The agency’s own summary, as published.