FDA Updates Breakthrough Devices Program Information and 2026 Designation Data
FDA’s Breakthrough Devices Program provides expedited interaction and prioritized review for eligible medical devices intended to treat or diagnose life-threatening or irreversibly debilitating diseases or conditions.
FDA Reports 1,284 Devices Granted Breakthrough Device Designation as of March 2026
The FDA has reported 1,284 Breakthrough Device designations and 198 market-authorised Breakthrough Devices as of March 2026. Learn what this means for medical device manufacturers and U.S. market access strategies.