FDA QMSR compliance date — 21 CFR Part 820 aligned with ISO 13485
Key Date
2026-02-02 — FDA QMSR compliance date — 21 CFR Part 820 aligned with ISO 13485
2 February 2026 was the mandatory compliance date for FDA's updated Quality Management System Regulation (QMSR), which amended 21 CFR Part 820 to incorporate ISO 13485:2016 by reference. The QMSR replaced the prior Quality System Regulation (QSR).
Manufacturers supplying medical devices in the United States must now operate under a QMS that satisfies the QMSR. Key actions that should already be complete:
- Gap analysis of your existing QMS against QMSR requirements (particularly FDA-specific obligations not covered by ISO 13485).
- Update to QMS documentation (procedures, SOPs, design controls, complaint handling) to reflect QMSR structure.
- Ensure design history files, device master records, and device history records align with the QMSR/ISO 13485 equivalents.
If your organisation has not yet completed QMSR transition, treat this as a critical compliance gap requiring immediate remediation. FDA inspections from 2 February 2026 onward assess compliance against the QMSR.
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