FDA Transitional Enforcement Guidance for Ethylene Oxide Sterilization Facility Changes for Class III Devices

On November 26, 2024, the U.S. Food and Drug Administration (FDA) issued guidance titled “Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices.” 

The guidance was developed to address potential disruptions in the supply of Class III medical devices sterilized using ethylene oxide (EtO). These disruptions may arise from new environmental regulations or operational challenges leading to changes in sterilization facilities. The FDA offers a streamlined process for manufacturers to manage sterilization site changes quickly, ensuring that critical medical devices remain available to patients.

Historical Context 

Ethylene oxide is a highly effective sterilant used in sterilizing numerous medical devices, particularly Class III devices, due to its effectiveness and compatibility with various materials. Recent Environmental Protection Agency (EPA) regulations have imposed stricter standards on EtO emissions. 

In April 2024, the EPA amended its National Emission Standards for Hazardous Air Pollutants (NESHAP), introducing new standards for previously unregulated EtO emissions. These updates have required some sterilization facilities to modify or suspend operations, potentially causing disruptions in the sterilization of medical devices.

Key Objectives of the Guidance

The FDA’s guidance outlines its flexible and proactive approach to managing the regulatory landscape for EtO sterilization site changes. Key objectives include:

1. Encouraging Proactive Manufacturer Engagement: Manufacturers are urged to notify the FDA of planned sterilization site changes and provide detailed information, including the device name, PMA number, current and proposed sterilization sites, reasons for the change, and any alterations to the sterilization process.
2. Exercising Enforcement Discretion: The FDA may allow manufacturers to distribute devices sterilized at new locations before submitting a Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) site change supplement, provided they adhere to specific recommendations.
3. Streamlining Regulatory Compliance: The FDA will review PMA or HDE supplements to ensure that site changes comply with applicable regulations, enabling a smoother transition to new sterilization sites.

Scope and Limitations

The policy applies specifically to:

• PMA and HDE holders of approved Class III devices sterilized with EtO.

Exclusions:

• Combination products.
• Devices sterilized by methods other than EtO.
• Changes involving a shift from EtO to a different sterilization method.
• Other manufacturing site changes that affect the safety or effectiveness of the device.

What Does the FDA Expect From Manufacturers?

Below is a concise summary of the FDA’s requirements for all manufacturers within the scope of the new guidance:

Notify the FDA

Manufacturers anticipating a site change must submit a notification with:

• The device name and regulatory status (PMA/HDE number).
• Details about the current and proposed sterilization sites.
• Reasons for the site change (e.g., regulatory compliance or capacity issues).
• A summary of any modifications to the sterilization process.

Exercise Enforcement Discretion

Once notified, the FDA may allow manufacturers to distribute devices sterilized at the new site before approval of a PMA or HDE site change supplement.

This enforcement discretion is granted only if the sterilization site changes comply with the recommendations in the guidance.

Submit a Site Change Supplement

Manufacturers must follow up with a complete PMA or HDE site change supplement to formally document the new sterilization location.

The FDA will review this submission to ensure the changes meet regulatory and safety standards.

Why is This Policy Important?

This transitional enforcement policy provides clarity and flexibility to manufacturers, fostering collaboration with the FDA to ensure uninterrupted access to sterile medical devices. It underscores the agency’s dedication to safeguarding public health while adapting to evolving sterilization and regulatory landscapes.

Supply Chain Stability

By offering this transitional enforcement discretion, the FDA helps avoid supply chain disruptions that could lead to shortages of critical medical devices.

Streamlined Process

The alternative regulatory approach allows manufacturers to act quickly while ensuring they remain compliant with safety regulations.

Public Health Protection

Ensuring continued access to sterilized medical devices is vital for patients who rely on these life-saving technologies.

Conclusion

This FDA guidance represents a critical step in addressing the challenges posed by recent EtO sterilization facility changes. Manufacturers are encouraged to familiarize themselves with the policy and work closely with the FDA to navigate sterilization site changes efficiently, ensuring the continued availability of life-saving Class III medical devices.