Quality System Regulation / QMSR
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A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
The Quality System Regulation and its successor, the Quality Management System Regulation (QMSR), are FDA’s device quality-system requirements. QMSR replaces the legacy 21 CFR Part 820 framework effective February 2, 2026 by incorporating ISO 13485:2016 by reference, harmonizing FDA’s device quality expectations with the standard most other major device markets already require.
For decades, US device manufacturers operated under 21 CFR Part 820, which was closely aligned with but not identical to ISO 13485. The QMSR final rule closes that gap by adopting ISO 13485:2016 directly, with a small set of FDA-specific additions and clarifications retained in the amended Part 820 — for example, on recordkeeping, complaint files, and definitions FDA needed to preserve.
The practical effect for manufacturers already certified to ISO 13485 for EU MDR purposes is a single quality management system that can largely satisfy both FDA and EU requirements simultaneously, reducing the historical burden of maintaining two closely related but separately documented systems — though terminology, such as “medical device file” versus DMR, still requires a crosswalk.
- —QMSR is FDA’s successor to the 21 CFR Part 820 Quality System Regulation
- —Effective February 2, 2026; incorporates ISO 13485:2016 by reference
- —Retains a small set of FDA-specific additions within the amended Part 820
- —Lets manufacturers largely run one QMS for both FDA and EU MDR compliance
21 CFR Part 820 (Quality System Regulation, superseded); FDA QMSR final rule (effective February 2, 2026), incorporating ISO 13485:2016 by reference
Frequently asked questions
What is Quality System Regulation / QMSR?
The Quality System Regulation and its successor, the Quality Management System Regulation (QMSR), are FDA’s device quality-system requirements. QMSR replaces the legacy 21 CFR Part 820 framework effective February 2, 2026 by incorporating ISO 13485:2016 by reference, harmonizing FDA’s device quality expectations with the standard most other major device markets already require.
Which regulations cover Quality System Regulation / QMSR?
21 CFR Part 820 (Quality System Regulation, superseded); FDA QMSR final rule (effective February 2, 2026), incorporating ISO 13485:2016 by reference