FDA Finalizes Risk-Based Guidance on Human Factors Information in Medical Device Submissions
The FDA has published its final guidance on Human Factors information in medical device submissions, introducing a new risk-based framework and three Human Factors Submission Categories. Learn what manufacturers need to know.
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.