In January 2024, the US Food and Drug Administration (FDA) published a final rule amending the Quality Systems (QS) regulation for medical devices. The rule entered into force on 2 February 2026, formally revising part 820 of Title 21 of the Code of Federal Regulations (21 CFR 820), now referred to as the Quality Management System Regulation (QMSR).
The QMSR represents a significant update to US current good manufacturing practice (CGMP) requirements, reflecting the FDA’s objective to further align its quality system framework with internationally recognised practice.
Incorporation of ISO 13485:2016
The new QMSR incorporates by reference ISO 13485:2016, the international quality management system benchmark establishing requirements for manufacturers engaged in one or more phases of a medical device lifecycle.
While the previous regulation was generally aligned with ISO 13485, the revised framework strengthens regulatory harmonisation and modernises the US quality system approach.
To this end, the QMSR introduces supplementary provisions that clarify regulatory expectations and key concepts used in ISO 13485. These additions ensure that the application of the standard remains consistent with existing FDA requirements, with US implementing regulations prevailing in the event of any conflict.
The additional provisions address, in particular:
- Quality management system (QMS) requirements across the full product lifecycle;
- Control of records;
- Device labelling and packaging controls;
- The adoption of specific terms and definitions through reference to ISO 9000:2015.
The FDA has also updated its device inspection processes to support enforcement of the new QMSR framework.
Impact on manufacturers
Manufacturers of finished medical devices intended for the US market must now ensure that their QMS is compliant with the QMSR.
For companies operating globally, the transition is expected to facilitate greater consistency across jurisdictions and reduce duplication of quality system requirements.
Contact the MDlaw Team here or at mdlaw@obelis.net for support on QMSR compliance.
References:
eCFR. (2026). Title 21, Chapter I, Subchapter H, Part 820 – Quality Management System Regulation. Retrieved on 13/02/2026.
FDA, Department of Health and Human Services Food and Drug Administration. (2024). Medical Devices; Quality System Regulation Amendments. Retrieved on 13/02/2026.
FDA. (2026). Quality Management System Regulation – Frequently Asked Questions. Retrieved on 13/02/2026.
FDA. (2026). Quality Management System Regulation (QMSR). Retrieved on 13/02/2026.
ISO. (2016). ISO 9000:2015 – Quality management systems — Fundamentals and vocabulary. Retrieved on 13/02/2026
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