• Summary
• Background
• Webinar Details
• Webinar Materials

Summary

On November 14, 2023, the U.S. Food and Drug Administration (FDA) will host a webinar for the medical device industry and other interested stakeholders to discuss the updated final guidance: Breakthrough Devices Program.
During the webinar, the FDA will: 

• Discuss the updates made to the final guidance.
• Share how the program can help advance health equity.
• Answer questions about the updated final guidance.

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Background

The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization.

The FDA issued updates to the final guidance on the Breakthrough Devices Program to: 

• Clarify how the program may apply to certain medical devices that promote health equity.
• Clarify considerations in designating devices, including eligible devices that may support innovation of new and existing technologies that address health inequities
• Clarify that the program may be available for certain non-addictive medical products to treat pain or addiction.
• Clarify how the FDA discloses the Breakthrough status of designated devices once they receive marketing authorization.

Webinar Details

Registration is not necessary.

Date: November 14, 2023
Time: 1-2 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 webinar: https://fda.zoomgov.com/j/1601919917?pwd=aEZnMG1BcVdnaENDYzJBQ3NBU1Z4UT09 

Passcode: t0Y6?C

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

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

• U.S. Callers Dial:  833-568-8864 (Toll Free)
  • For higher quality, dial a number based on your current location:
    • +1 669 254 5252 US (San Jose)
    • +1 646 964 1167 US (US Spanish Line)
    • +1 646 828 7666 US (New York)
    • +1 551 285 1373 US (New Jersey)
    • +1 669 216 1590 US (San Jose)
    • +1 415 449 4000 US (US Spanish Line)
• International Callers Dial: Please check the international numbers available
• Webinar ID: 160 191 9917
• Passcode: 846759

Webinar Materials

After the webinar, the presentation, printable slides, and transcript will be available at CDRH Learn.

If you have questions about this guidance document, please contact CDRH’s Breakthrough Devices Program at BreakthroughDevicesProgram@fda.hhs.gov. If you have questions about this webinar, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.