Quality Management System Regulation (QMSR) — 21 CFR Part 820
The FDA quality-system regulation for finished medical devices. As of 2 February 2026 the former Quality System Regulation (QSR) was amended to the Quality Management System Regulation (QMSR), which incorporates ISO 13485:2016 by reference as the core quality-management-system requirement, with device-specific US additions retained.
What this does not cover
stated in the document's own scope- Covers finished medical devices; drugs are governed by 21 CFR Parts 210–211 and biologics add Parts 600–680.
- Sets the quality system for design and manufacture, not device market clearance or approval — that is decided through the 510(k), De Novo, or PMA pathways.
- Governs quality-system controls, not post-market adverse-event reporting, which is the separate subject of the Medical Device Reporting rule at 21 CFR Part 803.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
21 CFR Part 820 is the quality-system requirement for finished medical devices in the United States — the framework governing the methods, facilities, and controls used in their design, manufacture, packaging, labelling, storage, installation, and servicing. Historically known as the Quality System Regulation (QSR), it requires a manufacturer to establish and maintain a quality system that includes management responsibility, design controls, document and record controls, purchasing and supplier controls, production and process controls, corrective and preventive action (CAPA), and handling of nonconforming product. It applies to devices intended for human use and scales with device risk and complexity.
Scope & applicability
All manufacturers of finished medical devices intended for commercial distribution in the United States, regardless of the location of the manufacturing facility.
Legal basis & how it acquires force
Part 820 is a binding regulation in Title 21 CFR, issued under the Federal Food, Drug, and Cosmetic Act — principally §520(f), which authorises good manufacturing practice requirements for devices, alongside §501, §502, §510, and §513. In 2024 FDA finalised the Quality Management System Regulation (QMSR) rule, which amends Part 820 to incorporate ISO 13485:2016 by reference; the amended Part 820 takes effect on 2 February 2026, replacing much of the former QSR text while keeping device-specific US additions.
Document structure
| Part | Covers |
|---|---|
| §820.1 Scope | Application to finished devices and the incorporation of ISO 13485:2016 by reference as the quality-management-system requirement |
| §820.3 Definitions | Terms, and how the FD&C Act definitions reconcile with the ISO 13485 vocabulary the rule adopts |
| §820.10 Requirements | The obligation to establish and maintain a QMS conforming to ISO 13485, together with the supplementary device-specific requirements |
| §820.35 Control of records | US-specific record additions layered on ISO 13485, including unique device identification (UDI) and complaint/servicing records |
| §820.45 Device labelling and packaging controls | The device-specific labelling and packaging controls retained on top of the ISO base |
| Incorporated ISO 13485:2016 (clauses 4–8) | The operational requirements — QMS, management responsibility, resources, product realisation (incl. design controls), measurement and improvement (incl. CAPA) — supplied by the referenced standard |
Key requirements
- Design controls including DHF, design input/output, design review, verification and validation
- CAPA subsystem with procedures for identifying, investigating, and correcting quality problems
- Purchasing controls — supplier qualification and ongoing oversight
- Production and process controls including process validation
- Device History Record (DHR) for each batch or production run
- Management with executive responsibility and quality planning
Implementation tips
- Design history file (DHF) must be initiated at the beginning of design development — retrofitting is extremely difficult
- Risk management per ISO 14971 is not explicitly required but expected by FDA inspectors
- Post-market surveillance integration with CAPA is expected — document the linkage
Revision notes
The QSR was amended to the Quality Management System Regulation (QMSR): the final rule was published 2 February 2024 and took effect 2 February 2026, incorporating ISO 13485:2016 by reference and replacing the requirements the QSR spelled out directly. FDA inspections moved to Compliance Program 7382.850, retiring the QSIT-based 7382.845.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
Under the 2024 QMSR final rule the amended Part 820 incorporates ISO 13485:2016 by reference, harmonising the US device quality system with the international standard used across the EU, Canada, Japan, and Australia. It interlocks with the Medical Device Single Audit Program (MDSAP), through which a single audit against ISO 13485 can satisfy several regulators, and it sits alongside the device reporting duties of 21 CFR Part 803. Device-specific US elements, such as certain labelling and record requirements, are retained on top of the ISO base.
21 CFR Part 820: frequently asked questions
Quick answers to common questions about 21 CFR Part 820.
What is the QMSR and when does it take effect?
The Quality Management System Regulation is the 2024 final rule that amends 21 CFR Part 820 to incorporate ISO 13485:2016 by reference. The amended Part 820 takes effect on 2 February 2026.
Does Part 820 apply to drugs?
No. Part 820 applies to finished medical devices. Drug manufacturing is governed by 21 CFR Parts 210 and 211, and biological products add the Part 600-series requirements.
What is the statutory basis for Part 820?
The Federal Food, Drug, and Cosmetic Act, principally §520(f), which authorises FDA to prescribe good manufacturing practice requirements for medical devices.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.