Ethylene Oxide Sterilization Facility Changes for Class III Medical Devices During EPA Emissions Standards Transition

What You Need to Know? 👇

What is the scope of FDA’s transitional enforcement policy for ethylene oxide sterilization facility changes?

This policy applies only to Class III devices (PMA or HDE approved) that are provided sterile, single-use, and sterilized with ethylene oxide. It does not cover Class I/II devices, combination products, reusable devices, or devices sterilized by other methods.

When should manufacturers notify FDA about potential EtO sterilization facility changes?

Manufacturers should notify FDA when they become aware of potential, actual, or temporary stops or reductions in operations at EtO sterilization facilities that may require changing sterilization sites to prevent supply chain disruptions.

How long does FDA’s enforcement discretion policy remain in effect?

FDA anticipates this enforcement discretion will likely no longer be appropriate after three years from the guidance issuance date (November 2024), and expects to decline requests after that timeframe unless circumstances change.

What information must be included in the notification to FDA?

Required information includes device/trade name, PMA/HDE number, sponsor details, reason for notification, current and proposed sterilization sites with FEI numbers, implementation date, and a signed statement of affirmation confirming no other changes.

What happens after FDA receives a sterilization site change notification?

FDA reviews each notification case-by-case and issues correspondence indicating whether enforcement discretion is appropriate. If approved, manufacturers must submit a PMA/HDE site change supplement within 120 calendar days of FDA’s correspondence.

Does this policy eliminate the need for PMA site change supplements?

No, this policy provides temporary enforcement discretion while manufacturers prepare required PMA 180-day or HDE 75-day site change supplements. The supplements must still be submitted and approved for permanent authorization of the site change.

---

What You Need to Do 👇

Recommended Actions

1. Submit informal notification to FDA with required information about planned sterilization site change
2. Wait for FDA’s determination on enforcement discretion before implementing change
3. Complete all process validation activities before distributing devices from new site
4. Submit PMA/HDE site change supplement within 120 days of FDA’s enforcement discretion confirmation
5. Maintain documentation of all validation activities and site change implementation
6. Monitor and report any issues encountered during implementation
7. Ensure new sterilization site maintains compliance with quality system requirements
8. Be prepared for potential FDA inspection of new sterilization site
9. Maintain original sterilization parameters and critical process specifications at new site
10. 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 ID: a58987f674abdee1881b2446b65a2775