#097: FDA’s QMSR Is Here: What It Means for Med Device
On February 2, 2026, the U.S. Food and Drug Administration implemented the Quality Management System Regulation (QMSR), replacing the legacy Quality System Regulation (QSR) under 21 CFR Part 820. By incorporating ISO 13485:2016 into federal law and retiring the QSIT inspection framework, the FDA introduced the most significant structural change to U.S. medical device oversight in decades.