 
Today, the U.S. Food and Drug Administration (FDA) issued an update to the final guidance: Breakthrough Devices Program. The updates align with the actions outlined in the FDA’s Center for Devices and Radiological Health (CDRH) Strategic Priorities to Advance Health Equity by supporting innovation of new and existing technologies that address health inequities.
The final guidance updates:
- Clarify how the Breakthrough Devices 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 Breakthrough Devices 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.
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 has also updated the Breakthrough Devices Program website to update the device designations data and the marketing authorizations list with information from April 1 to June 30, 2023.
Upcoming webinar on this guidance
On Tuesday, November 14, 2023, at 1 p.m. ET the FDA will host a webinar for the medical device industry and others interested in learning more about the updated final guidance.
Questions?
If you have questions about this final guidance, contact the Division of Industry and Consumer Education.
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