The FDA’s Quality Management System Regulation (QMSR) Final Rule, which amends the requirements of the medical device Quality System Regulation (QSR), 21 CFR Part 820, came into effect on February 2, 2026, and represents the most significant update to medical device regulation in over two decades. The amendment, which incorporates by reference ISO 13485:2016, a medical device quality management system (QMS) standard used by regulatory authorities around the world, aligns U.S. medical device quality system expectations with internationally recognized quality management system requirements.