As of February 2, 2026, the FDA has officially replaced the old Quality System Regulation (21 CFR 820) with the new Quality Management System Regulation (QMSR). This historic alignment with ISO 13485:2016 streamlines global compliance for medical device manufacturers. This article explores the core changes, the additional FDA-specific requirements, and how this "single audit" reality reduces costs and accelerates market access for international firms.

The FDA updates its real-world evidence policy for medical devices by removing the routine requirement for identifiable patient data. This change expands the regulatory use of de-identified databases and reshapes evidence strategies for medical device manufacturers seeking FDA clearance or approval.