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Today, the U.S. Food and Drug Administration (FDA) updated our Breakthrough Device designations data as well as the number of breakthrough devices that have received marketing authorizations.
From the launch of the Breakthrough Devices Program through September 30, 2024, the FDA has:
- granted 1,041 devices Breakthrough Device designation.
- 1,029 from the Center for Devices and Radiological Health (CDRH)
- 12 from the Center for Biologics Evaluation and Research (CBER)
- authorized 128 Breakthrough Devices for marketing.
The Breakthrough Devices Program is intended to provide patients and health care providers with timely access to certain medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. Through the program, manufacturers can interact with the FDA’s experts to receive feedback on device development, receive help navigating the path to the FDA’s marketing authorization, and obtain prioritized review on regulatory submissions.
Questions?
If you have questions about the Breakthrough Devices Program, contact BreakthroughDevicesProgram@fda.hhs.gov.
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