On This Page:

• Summary
• Background
• Town Hall Materials
• Previous Medical Device Sterilization Town Halls
• Future Medical Device Sterilization Town Halls

Summary

On February 29, 2024, the FDA held the fourth in a series of medical device sterilization town halls to understand:

• Leveraging the, “When to Submit a 510(k) for a Change to an Existing Device,” guidance (also known as the “Mods“ guidance) and the, “Modifications to Devices Subject to Premarket Approval (PMA) – The PMA Supplement Decision-Making Process,” guidance.
• Use of Device Master Files (MAFs) for sterility review and what it means to use MAFs, the Sterility MAF Pilot Programs, and the difference between the MAF Pilots as compared to traditional MAFs.

Background

Sterilization is a critical step in the manufacturing process for certain medical devices. Sterilization of medical devices helps prevent serious infections. Inadequate sterilization can lead to life-threatening infections. 

Medical devices are sterilized in a variety of ways including using moist heat (steam), dry heat, radiation, ethylene oxide (EtO) gas, vaporized hydrogen peroxide, and other sterilization methods (for example, chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide).

EtO is the most commonly used method to sterilize medical devices in the United States, and it is widely used by medical device manufacturers and contract sterilizers worldwide. Other existing sterilization modalities cannot currently replace the use of EtO for many devices. While some novel technologies hold promise, innovative alternative sterilization methods are still in early phases of research and development.

The FDA is committed to reducing reliance on EtO sterilization use while ensuring the integrity of the supply chain so that patients and providers have continued access to the sterile devices they need. To meet this goal, FDA continues to take a multipronged approach, including regulatory flexibilities, supply chain analysis and mitigation, collaboration, innovation, and communication, including this regular series of town halls.

Learn more about sterilization of medical devices.

Town Hall Materials

The presentation, printable slides and transcript are available on CDRH Learn under "Specialty Technical Topics," sub-section "Sterility.” 

For comments or questions related to this town hall or this series, please email us at MedicalDeviceSterilization@fda.hhs.gov. 

If you have general questions about this town hall or this series, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.

Previous Medical Device Sterilization Town Halls

Watch previous town halls and access related materials on CDRH Learn under "Specialty Technical Topics," sub-section "Sterility.” 

• Overview of Sterilization Landscape and Role of Ethylene Oxide (January 10, 2024)
• FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) (January 26, 2024) 
• Premarket Submission Expectations and Additional Considerations for Sterility Review (February 7, 2024)

Future Medical Device Sterilization Town Halls

• March 21, 2024, 12-1 pm ET. Tentative topics: Using Standards in Premarket Submissions and the FDA Standards Program

For a complete list of previous and future sterilization town hall event information, visit Medical Device Sterilization Town Hall Series.