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Today, the U.S. Food and Drug Administration (FDA) has updated the Breakthrough Device designations data, which includes the number of breakthrough devices that have received marketing authorizations.
From the launch of the Breakthrough Devices Program through June 30, 2026, the FDA has granted a total of 1,320 Breakthrough Device designations. Of those designations, the Center for Devices and Radiological Health granted 1,299 and the Center for Biologics Evaluation and Research granted 21.
The agency has also granted 210 marketing authorizations for breakthrough devices since the launch of the Breakthrough Devices Program, including 25 authorizations granted in the first half of 2026.
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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