Breakthrough Devices Program announces additional marketing authorizations

The FDA increases the number of market-authorized Breakthrough Devices.

If your email program has trouble displaying this email, view as a webpage. More than 50 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 now includes more than 50 Breakthrough Devices that the FDA has authorized for marketing. Online metrics show the number of granted Breakthrough Device designations by fiscal year and by clinical panel. 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. Read More Questions? If you have questions about the Breakthrough Devices Program, contact the Division of Industry and Consumer Education.

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