Ethylene Oxide Sterilization Facility Changes for Class III Medical Devices During EPA Emissions Standards Transition
This guidance outlines FDA's enforcement discretion policy regarding ethylene oxide (EtO) sterilization facility changes for Class III medical devices during the transition period as facilities work to comply with EPA's new emissions standards. It applies specifically to PMA and HDE holders of Class III devices that are provided sterile and sterilized by EtO, to help prevent and mitigate potential supply chain disruptions.
Recommended Actions
- Submit informal notification to FDA with required information about planned sterilization site change
- Wait for FDA’s determination on enforcement discretion before implementing change
- Complete all process validation activities before distributing devices from new site
- Submit PMA/HDE site change supplement within 120 days of FDA’s enforcement discretion confirmation
- Maintain documentation of all validation activities and site change implementation
- Monitor and report any issues encountered during implementation
- Ensure new sterilization site maintains compliance with quality system requirements
- Be prepared for potential FDA inspection of new sterilization site
- Maintain original sterilization parameters and critical process specifications at new site
- Implement appropriate controls to prevent impact on device safety and effectiveness
Key Considerations
Non-clinical testing
- Process verification and validation testing must be completed prior to device distribution
- Process validation or revalidation protocols and completed reports required for all processes needing validation
Safety
- Methods used in manufacturing must conform to QS regulation requirements (21 CFR Part 820)
- No changes allowed to sterility assurance level (SAL)
- No changes to critical sterilization process parameters
- No changes to release criteria for the sterilization cycle
Other considerations
- Notification to FDA required before implementing sterilization site change
- PMA/HDE supplement must be submitted within 120 days of FDA’s enforcement discretion confirmation
- Site changes must not affect device safety or effectiveness
- New sterilization site must have appropriate quality systems in place
- FDA inspection may be required before or after approval
Relevant Guidances
- Submission Requirements for Terminally Sterilized Medical Devices
- Quality System Information Requirements for Premarket Submissions
- Manufacturing Site Changes for PMA-Approved Medical Devices: When to Submit a Supplement and Documentation Requirements
Related references and norms
- ISO 13485: Medical devices - Quality management systems - Requirements for regulatory purposes
- 21 CFR Part 820: Quality System Regulation
Original guidance
- Ethylene Oxide Sterilization Facility Changes for Class III Medical Devices During EPA Emissions Standards Transition
- HTML / PDF
- Issue date: 2024-11-26
- Last changed date: 2024-11-25
- Status: FINAL
- Official FDA topics: Medical Devices, HUD/HDE, Premarket Approval (PMA)
- ReguVirta summary file ID: a58987f674abdee1881b2446b65a2775
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