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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 March 31, 2026, the FDA has granted a total of 1,284 Breakthrough Device designations. Of those, the Center for Devices and Radiological Health granted 1,264 designations and the Center for Biologics Evaluation and Research granted 20 designations.
The agency has also granted 198 marketing authorizations for breakthrough devices since the launch of the Breakthrough Devices Program.
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 FDA 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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