FDA Launches One-Day Inspectional Assessments Pilot
The FDA has launched a pilot program introducing one-day inspectional assessments across medical products, biologics, clinical research, and food sectors to support more targeted and efficient oversight.
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.