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# Device Sterilization Enforcement Discretion Guide
- URL: https://www.fdaweb.com/device-sterilization-enforcement-discretion-guide/
- Published: 2024-11-26T12:00:00.000Z
- Updated: 2026-09-14T14:48:08.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158260

*Federal Register* notice: FDA is making available a final guidance entitled “Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class 3 Devices.” The document provides recommendations for Class 3 devices sterilized by ethylene oxide whose products are affected by the potential, actual, or temporary stop or reduction of operations at a sterilization facility. It specifically addresses when a manufacturer wants FDA to consider whether the exercise of enforcement discretion relating to the implementation of certain types of sterilization site changes is appropriate. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-11-26/pdf/2024-27661.pdf?ref=fdaweb.com).