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.
IMDRF Publishes 2026 Playbook for Medical Device Regulatory Reliance Programs
IMDRF releases its 2026 Playbook for Medical Device Regulatory Reliance Programs, outlining work-sharing, recognition and abridged pathways.