QMSR is the FDA’s Quality Management System Regulation. It took effect on 2 February 2026, replacing the previous Quality System Regulation.
What it did
QMSR amends 21 CFR Part 820 and incorporates ISO 13485:2016 by reference. In other words, the substance of the US regulation for medical device quality systems is now the international standard, rather than a parallel American framework.
On the same date, FDA transitioned to inspection process 7382.850 to match. Technical amendments followed on 4 December 2025.
The relationship people get backwards
It is common to hear that device manufacturers need ISO 13485 “and also” a QMSR alignment plan, as though they are two separate obligations. They are not. ISO 13485 conformance is the substance of the regulation now.
But certification is still not required
FDA requires compliance with the incorporated requirements. It does not require an ISO 13485 certificate. Many manufacturers certify anyway — for customers, for notified bodies, for markets outside the US — but that is a commercial decision, not a regulatory one.
Where conflicts arise between ISO 13485 and US law, the Federal Food, Drug and Cosmetic Act controls.
What changed in practice
For a manufacturer already certified to ISO 13485, less than expected. For one running a QSR-shaped system that never adopted the standard, the gap is real — particularly around risk management, which is far more central to ISO 13485 than it was to the old regulation.