Question 1

FDA’s New Guidance on Ethylene Oxide Sterilization

Accepted Answer

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.

Question 2

Overview of the Transitional Policy

Accepted Answer

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.

Question 3

Support for Manufacturers

Accepted Answer

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.

Question 4

Application Process

Accepted Answer

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.

Question 5

Guidance and Regulatory Support

Accepted Answer

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.

Question 6

<h2>Conclusion</h2>

Accepted Answer

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: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/transitional-enforcement-policy-ethylene-oxide-sterilization-facility-changes-class-iii-devices

News

MHRA: FDA’s Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices

Artificial Intelligence in Medical Devices Questionnaire published by TEAM-NB

MDR Regulator at MEDICA 2024

New EU guidelines for medical device supply continuity – MDR & IVDR

Team-NB’s perspective on MDR and IVDR implementation

Changes in MDCG guidance – borderline products: medical devices & medicinal products

Changes in Code of Conduct for Notified Bodies according to MDR and IVDR – harmonization of activities in the EU

European Commission published Notified Body list of standard fees for MDR and IVDR related services

The US FDA updated the list of AI/ML-Enabled Medical Devices, authorizing 950 devices