Quality Management System Regulation (QMSR)

The FDA Quality Management System Regulation (QMSR), codified at 21 CFR Part 820, is the FDA's updated quality management system (QMS) framework governing the design, manufacture, packaging, labeling, storage, installation, and servicing of medical devices intended for commercial distribution in the United States. The QMSR replaced the former Quality System Regulation (QSR) and took effect on February 2, 2026.

QMSR aligns FDA’s QMS requirements more closely with ISO 13485:2016, the internationally recognized standard for medical device quality management systems, and incorporates Clause 3 of ISO 9000:2015 for terms and definitions. ISO 13485 certification by itself does not establish FDA compliance: manufacturers must also meet the FDA-specific provisions retained in 21 CFR Part 820 and other applicable requirements. QMSR applies to manufacturers of finished devices and device accessories, including contract manufacturers, subject to the regulation's exemptions. See our QMSR compliance overview and the FDA's official QMSR guidance.

When does FDA QMSR come into effect?

FDA QMSR is in effect as of February 2, 2026.

What is ISO 9000:2015 Clause 3?

Clause 3 of ISO 9000:2015 contains the terms and definitions used across quality-management-system standards. QMSR incorporates this vocabulary alongside ISO 13485:2016. The incorporated standard is ISO 9000:2015—not Clause 3 of ISO 9001:2015.

What does “Incorporation by Reference” (IBR) mean?

"Incorporation by reference" means that ISO 13485:2016 is legally adopted as part of the FDA regulations (21 CFR Part 820) without being rewritten verbatim. ISO 13485:2016 and Clause 3 of ISO 9000:2015 are now the foundational standards for QMS compliance for medical devices in the US, though US-specific requirements also apply.