FDA QMSR: A Complete Guide to the New Quality Management System Regulation
The FDA Quality Management System Regulation (QMSR) represents the most significant change to medical device quality system requirements in the United States in decades. Effective February 2, 2026, the QMSR replaces the legacy Quality System Regulation (QSR) under 21 CFR Part 820 by incorporating ISO 13485:2016 by reference. What Is the QMSR? The QMSR is the FDA’s effort to…