QMSR
The Quality Management System Regulation (21 CFR Part 820 revision) issued by the FDA for medical device manufacturers. The version taking effect in February 2026 incorporates ISO 13485:2016 directly into U.S. federal regulation, requiring full traceability of requirements, risks, testing, and changes throughout the software development lifecycle.
Timeline (last 90 days)
The FDA's Quality Management System Regulation (QMSR) officially takes effect on February 2, 2026.
QMSR incorporates ISO 13485:2016 into the device quality framework, harmonizing the United States with international medical device quality standards.
QMSR is a revised version of 21 CFR Part 820 and is FDA's quality management framework for medical device manufacturers.
All Facts (3)
The FDA's Quality Management System Regulation (QMSR) officially takes effect on February 2, 2026.
50%UnverifiedQMSR incorporates ISO 13485:2016 into the device quality framework, harmonizing the United States with international medical device quality standards.
50%UnverifiedQMSR is a revised version of 21 CFR Part 820 and is FDA's quality management framework for medical device manufacturers.
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