QMSR — Quality Management System Regulation Transition from QSR (21 CFR Part 820)
FDA finalised the Quality Management System Regulation (QMSR) amending 21 CFR Part 820 to align with ISO 13485:2016. The rule, effective February 2026 (with a compliance date of February 2026 after a two-year transition), replaces the former Quality System Regulation (QSR) with an approach that incorporates ISO 13485 by reference — meaning manufacturers complying with ISO 13485 will generally satisfy FDA QSR obligations for the incorporated provisions.
Key changes from the prior QSR:
- ISO 13485:2016 is incorporated by reference for the bulk of QMS requirements.
- FDA-specific requirements (complaint files, MDR reportability linkages, corrections and removals) remain as explicit regulatory obligations.
- Design history files, device master records, and device history records map to ISO 13485 equivalents.
- MDSAP-participating manufacturers benefit most directly, as their ISO 13485-based audits now align closely with QMSR requirements.
📅 Effective / published: Finalised 2024; compliance date February 2026
Manufacturers currently compliant with ISO 13485:2016 should conduct a gap analysis against the QMSR to identify FDA-specific requirements not covered by ISO 13485 — particularly MDR reporting linkages, corrections and removals (21 CFR Part 806), and unique US labelling requirements. Update your QMS documentation to reflect the QMSR structure before the compliance date.
View official source (FDA — QMSR) ↗