The U.S. Food and Drug Administration (FDA) has recently updated its list of medical devices that have received market authorization under its Breakthrough Devices Program.
With the recent update, the FDA has now granted a total of 1176 Breakthrough Device designations, as well as 160 marketing authorizations. Medical devices reviewed by the FDA’s Center for Devices and Radiological Health (CDRH) constitute the majority of designations and market authorizations under the Program, with 1157 designations and 156 market authorizations.
More than 20 different categories of medical devices are currently categorized as Breakthrough Devices on the FDA list. Devices intended for cardiovascular, neurological, or orthopedic uses top the list, accounting for nearly 600 of the total number of listed devices.
Initially launched in 2016 under the federal 21st Century Cures Act, the Breakthrough Devices Program provides medical device manufacturers with an expedited path for premarket approvals, 510(k) clearances, and De Novo marketing authorizations. The goal of the Program is to provide healthcare providers and patients with more timely access to innovative medical devices for diagnosing or treating life-threatening or debilitating health conditions.
More information about the FDA’s updated authorization list for its Breakthrough Devices Program is available at https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program?utm_medium=email&utm_source=govdelivery#metrics.