MHRA: FDA’s Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices
On November 26, 2024, the FDA published guidance on its transitional enforcement policy for changes in ethylene oxide (EtO) sterilization facilities for Class III medical devices. The policy aims to prevent potential disruptions in the supply chain of sterile medical devices while sterilization facilities adapt to updated Environmental Protection Agency (EPA) requirements.
FDA’s New Guidance on Ethylene Oxide Sterilization
To address changes in EtO sterilization operations, the FDA has introduced a transitional enforcement policy. This policy enables manufacturers of Class III medical devices to proactively secure alternative EtO sterilization facilities without delay. The guidance is intended to mitigate or prevent supply chain interruptions for sterile medical devices.
The policy specifically applies to changes in EtO sterilization facility locations for Class III devices regulated under PMA (Premarket Approval) and HDE (Humanitarian Device Exemption) pathways. It does not cover other changes that could affect device safety or efficacy.
Overview of the Transitional Policy
The FDA has outlined that it will not object to the sterilization of Class III devices at new locations or their distribution before submission of a PMA or HDE supplement for the facility change, provided these changes align with the recommendations in the guidance.
This transitional policy is a response to the potential operational impacts resulting from updated EPA requirements, aiming to ensure continued availability of critical Class III medical devices.
Support for Manufacturers
The transitional enforcement policy provides manufacturers with the flexibility to quickly secure alternative EtO sterilization sites in response to operational changes in existing facilities. This approach is designed to prevent potential shortages of sterile medical devices during the transition to EPA-compliant sterilization processes.
The FDA’s guidance includes key recommendations for assessing new sterilization locations, addressing potential impacts on supply chains, and maintaining compliance with sterilization standards.
Application Process
The FDA encourages manufacturers to voluntarily notify the agency of planned changes in EtO sterilization locations. Notifications should include:
- Details of the new sterilization location.
- Assessment of the potential impact on the supply chain.
- Plans for ensuring compliance with applicable sterilization standards.
This proactive approach helps streamline the transition process and ensures that safety and efficacy standards are upheld.
Guidance and Regulatory Support
The guidance is non-binding and does not replace existing regulations. Instead, it reflects the FDA’s current position on managing changes in EtO sterilization facilities for Class III devices.
The FDA emphasizes that manufacturers should continue to follow all applicable laws and standards while using this transitional enforcement policy as a framework to address immediate sterilization facility changes.
Conclusion
The FDA’s transitional enforcement policy offers essential support for manufacturers of Class III medical devices, enabling them to adapt quickly to changes in EtO sterilization operations without disrupting the supply of sterile medical devices.
This initiative ensures a balance between meeting regulatory requirements and maintaining the availability of critical medical devices.
For more information and to submit notifications, visit the FDA’s guidance page: