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56 Breakthrough Devices Have Received Marketing Authorization

The U.S. Food and Drug Administration (FDA) updated the list of Breakthrough Devices that have been authorized for marketing. The list includes 56 Breakthrough Devices that the FDA has authorized for marketing. Online metrics also show the number of granted Breakthrough Device designations by fiscal year and by clinical panel, which totals 728 as of September 30, 2022.

The Breakthrough Devices Program provides patients and health care providers with timely access to medical devices by speeding up their development, assessment, and review, while preserving the statutory standards consistent with the FDA’s mission to protect and promote public health.

Questions?

If you have questions about the Breakthrough Devices Program, contact the Division of Industry and Consumer Education.