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# Device EtO Sterilization Transitional Enforcement Policy
- URL: https://www.fdaweb.com/device-eto-sterilization-transitional-enforcement-policy/
- Published: 2024-11-25T12:00:00.000Z
- Updated: 2026-09-14T14:47:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158251

FDA has issued a [final guidance](https://www.fda.gov/media/183833/download?ref=fdaweb.com) entitled “Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class 3 Devices.” The document articulates the agency’s stance on expected EtO changes pursuant to new Environmental Protection Agency (EPA) requirements.

The guidance provides recommendations for manufacturers whose devices are sterilized by EtO, and that might be affected by potential, actual, or temporary stop or reduction in operations at a sterilization facility, to implement certain types of sterilization site changes. The following actions are available under the enforcement policy:

- PMA and Humanitarian Device Exemption holders of approved Class 3 devices sterilized by EtO may make certain sterilization facility changes prior to approval of a supplement during the transition period.
- FDA is permitted to work proactively with manufacturers, developers, and other agencies to explore effective, efficient, and innovative solutions that will help maintain a strong supply of medical devices.
- Expedited sterilization site changes to reduce the impact of potential, actual, or temporary operation reductions at sterilization facilities.