> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Pilot Program on Radiation Sterilization Master Files
- URL: https://www.fdaweb.com/pilot-program-on-radiation-sterilization-master-files/
- Published: 2023-04-12T12:00:00.000Z
- Updated: 2026-09-14T18:25:24.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154193

*Federal Register* notice: CDRH has announced its Radiation Sterilization Master File Pilot Program, a voluntary program intended to allow companies that terminally sterilize single-use medical devices using gamma radiation or ethylene oxide to submit Master Files when making certain changes to sterilization sites, methods, or processes under the specific conditions outlined in the notice. Under the program, Class 3 device makers who have been granted a right of reference by a sterilization provider may include references to Master Files accepted into the pilot in postapproval reports describing particular changes affecting the sterilization in lieu of submitting PMA supplements. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-04-12/pdf/2023-07598.pdf?ref=fdaweb.com).