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Icologiq Knowledge · Regulation

FDA Quality Management System Regulation

The FDA medical device quality system regulation that incorporates ISO 13485:2016 by reference and governs quality system requirements for applicable device manufacturers.

QMSR

Also known as:  

FDA QMSR, 21 CFR Part 820

At a glance

Definition

The FDA Quality Management System Regulation aligns the U.S. medical-device quality-system framework more closely with ISO 13485:2016 while retaining FDA-specific requirements. The amended Part 820 became effective on 2 February 2026. Organizations should use current FDA materials when determining applicability and detailed obligations.

Why it matters

QMSR is timely and commercially valuable for MedTech prospects with U.S. market exposure and demonstrates that Icologiq’s knowledge layer is maintained against current regulatory changes.

MED-004

The FDA medical device quality system regulation that incorporates ISO 13485:2016 by reference and governs quality system requirements for applicable device manufacturers.

The FDA Quality Management System Regulation aligns the U.S. medical-device quality-system framework more closely with ISO 13485:2016 while retaining FDA-specific requirements. The amended Part 820 became effective on 2 February 2026. Organizations should use current FDA materials when determining applicability and detailed obligations.
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