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# Device Sterilization Master File Pilot
- URL: https://www.fdaweb.com/device-sterilization-master-file-pilot/
- Published: 2019-11-26T12:00:00.000Z
- Updated: 2026-09-14T15:54:31.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145588

*Federal Register* notice: CDRH has announced an Ethylene Oxide Sterilization Master File Pilot Program that will allow sterilization providers that sterilize single-use medical devices using fixed chamber ethylene oxide (EtO) to submit a master file when making certain changes between sterilization sites or when making certain changes to sterilization processes that utilize reduced EtO concentrations. Under the pilot, Class 3 devices that are affected by such changes may, upon FDA’s permission, reference the master file in a postapproval report in lieu of submitting a PMA supplement. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-11-26/pdf/2019-25631.pdf?ref=fdaweb.com).