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Today, the U.S. Food and Drug Administration (FDA) updated the Breakthrough Devices Program website to update the device designations data and the marketing authorizations list with information from January 1 to March 31, 2023. During this time the FDA:
- granted 32 Breakthrough Device designations, and
- authorized five Breakthrough Devices for marketing.
The Breakthrough Devices Program is intended to provide patients and health care providers with timely access to certain medical devices. Breakthrough Devices must meet the FDA’s rigorous standards for device safety and effectiveness in order to be authorized for marketing. The Breakthrough Devices Program reflects our commitment to device innovation and protecting the public health.
Through the program, manufacturers can interact with FDA 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. From launch of the Breakthrough Devices Program through March 31, 2023, in total, the FDA:
- granted 794 Breakthrough Device designations, and
- authorized 67 Breakthrough Devices for marketing.
Questions?
If you have questions about the Breakthrough Devices Program, contact the Division of Industry and Consumer Education.
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