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Today, the U.S. Food and Drug Administration’s (FDA) updated the Breakthrough Devices Program webpage to update the device designations data and the marketing authorizations list. From launch of the Breakthrough Devices Program through December 31, 2023, in total, the FDA:
- granted 933 Breakthrough Devices designations, and
- authorized 95 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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