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CATEGORY: QUALITY SYSTEMS
QMSR (Quality Management System Regulation)
The updated FDA regulation (effective 2026) that replaces the Quality System Regulation (21 CFR 820) by incorporating ISO 13485:2016 by reference. QMSR eliminates redundancy between FDA QSR and ISO 13485.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
FDA’s Quality Management System Regulation (QMSR) modernizes device quality system requirements, aligning more closely with ISO 13485 while retaining FDA inspection authority.
PROCESS / STEPS
- Gap-assess current QSR procedures vs QMSR/ISO 13485 expectations.
- Update SOPs, training, and internal audits.
- Prepare inspection readiness under the new framework.
- Monitor FDA transition timelines and enforcement communications.
EXAMPLES
- Manufacturers already certified to ISO 13485 still need FDA-specific processes (e.g., certain reporting interfaces).
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to QMSR (Quality Management System Regulation) across 27 authorities in real time.
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