FDA Quality Management System Regulation (QMSR)
What is FDA Quality Management System Regulation (QMSR)?
The new 21 CFR Part 820 (Quality Management System Regulation, QMSR) was published as a Final Rule on 31 January 2024 (89 FR 7496) and applies from 2 FEBRUARY 2026. It HARMONISES the FDA medical device quality system requirements with ISO 13485:2016 by INCORPORATING THAT STANDARD BY REFERENCE under §820.7 + retaining a small number of FDA-specific additions (§820.15 clarifications + §820.35 record controls including audit trail + UDI + reporting + §820.45 device labelling + packaging controls). It comprises 13 controls organised across 7 domains, and applies in the United States.
How FDA Quality Management System Regulation (QMSR) maps to other frameworks
All 13 controls, each one mapped to the equivalent requirement in other standards, with the evidence that carries across and the mappings that were judged and rejected shown alongside. No account needed to look.
See the control mappings →The 7 domains FDA Quality Management System Regulation (QMSR) groups its controls into
Where FDA Quality Management System Regulation (QMSR) overlaps with the standards you already hold
What FDA Quality Management System Regulation (QMSR) means in your sector
What FDA Quality Management System Regulation (QMSR) means for your job
Questions people ask about FDA Quality Management System Regulation (QMSR)
What is FDA Quality Management System Regulation?
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Query FDA Quality Management System Regulation (QMSR) programmatically
FDA Quality Management System Regulation (QMSR), its 13 controls and every mapping into other standards are available over a REST endpoint and an MCP server, so an agent can read them directly. The free tier is 10 calls a day and needs no signup.
FDA Quality Management System Regulation (QMSR) API reference and MCP config →What FDA Quality Management System Regulation (QMSR) requires, control by control
Each page carries the requirement text for one FDA Quality Management System Regulation (QMSR) control and what an assessor expects to see as evidence.
- QMSR-820-10 Requirements for a Quality Management System - ISO 13485:2016 Sections 4-8 incorporation (§820.10)
- QMSR-820-15 Clarification of concepts (§820.15)
- QMSR-820-35 Control of records - record retention, audit trail, UDI, medical-device reporting (§820.35)
- QMSR-820-45 Device labelling and packaging controls (§820.45)
- QMSR-COORD-ISO13485-MDR-IVDR-PART11 Coordination with ISO 13485:2016, EU MDR/IVDR, FDA Part 11, Cybersecurity Guidance
- QMSR-ISO13485-SEC5 Management responsibility (ISO 13485:2016 Section 5 - incorporated via §820.10)
- QMSR-ISO13485-SEC6 Resource management (ISO 13485:2016 Section 6 - incorporated via §820.10)
- QMSR-ISO13485-SEC8 Measurement, analysis and improvement (ISO 13485:2016 Section 8)
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