Quality Management System Regulation
FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference.
Definition
Issued in 2024 and effective in 2026, the Quality Management System Regulation amends 21 CFR Part 820 to incorporate ISO 13485:2016 by reference, with additional FDA-specific requirements for records, labeling, and complaint reporting.What this means in practice
QMSR aligns U.S. quality system expectations with international practice while retaining FDA-specific requirements around records access, labeling, unique device identification, complaint files, and servicing. Effective February 2, 2026, QMSR replaces the previous 21 CFR Part 820 QSR structure. Manufacturers must reconcile procedures, terminology (device master record vs medical device file), and records strategies before the effective date, and update supplier agreements and training programs to reflect the ISO 13485:2016 vocabulary.Examples
- A Class II manufacturer remapping its QSR-based procedures (DMR, DHF, DHR) to the ISO 13485 medical device file structure while retaining FDA-required records access clauses.
- A software-only SaMD company adopting ISO 13485:2016 as the QMS backbone with QMSR overlays for UDI and complaint file requirements.
- •Assuming ISO 13485 conformance alone is sufficient under QMSR. FDA retains specific provisions for records access, labeling, UDI, complaint files, and servicing.
- •Waiting until 2026 to start the transition. Auditors expect evidence of a planned, documented harmonization effort well before the effective date.
- •Retiring QSR terminology (DMR/DHF/DHR) without a cross-reference matrix, which breaks traceability across legacy records.
- •Ignoring supplier agreements. Many quality agreements reference 21 CFR Part 820 clauses that no longer exist under QMSR.
Frequently asked questions
Cross-references
Governs
Things this term applies rules or requirements to.
Uses
Concepts or artefacts this term builds on.
Replaces
Supersedes an older term, regulation, or standard.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsFDA's current good manufacturing practice (cGMP) requirements for medical devices.
Systematic process to investigate and resolve quality issues and prevent recurrence.
Structured process governing the design of medical devices.
International standard for medical device quality management systems.
QMS Foundations
· From this learning pathProcess for receiving, evaluating, and responding to device complaints.
Compilation of records describing the design history of a finished device.
Notice of inspectional observations issued at the conclusion of an FDA inspection.
Confirming design outputs meet inputs (V) and that devices meet user needs (V).
Primary references
3 sources- 1
QMSR Final Rule (Federal Register)UncheckedFederal Registerfederalregister.gov
- 2
FDA QMSR Final Rule PageUncheckedFDAfda.gov
- 3
MDIC Case for QualityVerifiedMDICmdic.org
Inline markers like [1] jump to the matching reference above.