On This Page:

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

Summary

On February 29, 2024, the FDA will host 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 Details 

Registration is not necessary. We encourage attendees to submit questions to MedicalDeviceSterilization@fda.hhs.gov, ideally at least one week in advance.

Date: February 29, 2024
Time: 1:00 - 2:00 p.m. ET

Please dial in 15 minutes before the start of the call to allow time to connect.

Please click the link below to join the town hall: https://fda.zoomgov.com/j/1616274024?pwd=Qjh5OXdIWEFRM1hKZlREWlVtYVpFZz09 

Passcode: qGmC$5

Please note: Participants who join the town hall using the Zoom link above should use computer audio (listen through computer speakers and speak through computer microphone/headset).

The dial-in information provided below is for participants who will be joining the town hall by phone only.

• U.S. Callers Dial: 1-833-568-8864 (Toll Free)
• For higher quality, dial a number based on your current location):
  • +1 669 254 5252 US (San Jose)
  • +1 646 828 7666 US (New York)
  • +1 646 964 1167 US (US Spanish Line)
  • +1 415 449 4000 US (US Spanish Line)
  • +1 551 285 1373 US (New Jersey)
  • +1 669 216 1590 US (San Jose)
• International Callers Dial: Please check the international numbers available 
• Webinar ID: 161 627 4024
• Passcode: 632474

Town Hall Materials

Following this town hall, the presentation, printable slides and transcript will be 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) 
• Discussion of 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