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  4. Webinar - Breakthrough Devices Program Updated Final Guidance - 11/14/2023
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Webcast | Virtual

Event Title
Webinar - Breakthrough Devices Program Updated Final Guidance
November 14, 2023

Date:
November 14, 2023
Time:
1:00 p.m. - 2:00 p.m. ET

Summary

On November 14, 2023, the U.S. Food and Drug Administration (FDA) held 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: 

  • Discussed the updates made to the final guidance.
  • Shared how the program can help advance health equity.
  • Answered questions about the updated final guidance.

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 Materials

The presentation, printable slides, and transcript are available at CDRH Learn under “How to Study and Market Your Device," sub-section "Clinical Studies/Investigational Device Exemption (IDE).”

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.

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