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.
FDA Announces New eMDR System Enhancements: What Medical Device Manufacturers Should Know
The FDA has announced new eMDR system enhancements, including AEMS integration updates, country code validation changes, and IMDRF adverse event code updates impacting medical device manufacturers.
FDA Updates Coding Resources for Medical Device Reports: Key Changes from IMDRF 2025 Maintenance
FDA updates MDR adverse event codes under IMDRF 2025. Key changes may impact manufacturer reporting, vigilance systems, and data consistency.