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# QMSR

Quality Management System Regulation

Definition

FDA's updated quality system rule that harmonizes 21 CFR 820 with ISO 13485:2016. Takes effect February 2, 2026, replacing the legacy QSR.

More in FDA

[524B](/glossary/524b)[RTA](/glossary/rta)[eSTAR](/glossary/estar)[TPLC](/glossary/tplc)[PMA](/glossary/pma)[510(k)](/glossary/510k)

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