Glossary · USA: FDA device and drug rules
Quality Management System Regulation (QMSR, 21 CFR Part 820)
Also known as: QMSR, 21 CFR 820, FDA Quality Management System Regulation
The Quality Management System Regulation (QMSR) is the amended FDA regulation at 21 CFR Part 820 that sets quality system requirements for medical device manufacturers in the USA. Effective February 2, 2026, it incorporates ISO 13485:2016 by reference, adds FDA-specific requirements, and replaces the former Quality System Regulation (QSR).
- USA
- Standards
In one sentence
The FDA QMSR (21 CFR Part 820) incorporates ISO 13485:2016 by reference for device makers; effective February 2, 2026, it replaced the former QSR.
Example
A US maker of infusion pumps already certified to ISO 13485:2016 maps its procedures to the QMSR, adds the FDA-specific requirements that remain in Part 820, and updates internal references from QSR sections to ISO 13485 clauses.
How it applies
- ISO 13485 by reference: The core quality management requirements are those of ISO 13485:2016, which becomes part of the regulation. Part 820 keeps its own definitions and additional requirements where FDA considered ISO 13485 insufficient for US law.
- Links to other FDA rules: The QMSR works together with other device regulations, such as medical device reporting, corrections and removals, and UDI under 21 CFR Part 830. Electronic records remain subject to 21 CFR Part 11.
- Risk management: Because ISO 13485 requires risk-based decisions throughout the quality system, ISO 14971 becomes more directly relevant to FDA inspections.
- Certification: An ISO 13485 certificate does not replace FDA inspection, and FDA does not issue ISO 13485 certificates.
- Technical documentation: Quality manual, procedures and records follow ISO 13485 structure and terms. Check the final rule for each FDA-specific addition and cite QMSR requirements, not the former QSR sections, in procedures and design files.
QMSR vs. the former QSR
The QSR, adopted in 1996, was FDA's own quality system text, with terms such as design history file and device master record. The QMSR replaces most of it with ISO 13485:2016, so one quality system can serve the FDA, the EU MDR and IVDR, and other markets that rely on ISO 13485. The substance of design controls, CAPA and production controls continues; the structure and terminology change.