21 CFR Part 820 - FDA QMSR
21 CFR Part 820 is the FDA Quality Management System Regulation (QMSR) that establishes the current Good Manufacturing Practice (CGMP) requirements for medical device manufacturers.
21 CFR Part 820 (QMSR): Medical Device CGMP and ISO 13485:2016
21 CFR Part 820 is the FDA regulation that sets the current Good Manufacturing Practice (CGMP) requirements for medical devices. As of February 2, 2026, it is known as the Quality Management System Regulation (QMSR) and is built directly on ISO 13485:2016. This page explains what 21 CFR Part 820 now requires, how the QMSR differs from the former Quality System Regulation (QSR), and where each old subpart’s requirements now live in ISO 13485:2016.
Any company that manufactures medical devices in the United States — or makes devices abroad for sale in the U.S. market — must meet these CGMP requirements by operating a quality management system that keeps products safe, effective, and consistently within specification. The FDA verifies compliance through facility inspections conducted against 21 CFR Part 820, and any shortcomings are documented on an FDA 483 observation form.
What Is the QMSR, and How Is It Different from the QSR?
A major regulatory change took effect on February 2, 2026: the FDA’s former Quality System Regulation (QSR) was succeeded by the Quality Management System Regulation (QMSR). The most consequential part of this update is that 21 CFR Part 820 now adopts ISO 13485:2016 directly, by reference. Where the regulation once contained its own detailed quality system rules that merely paralleled the international standard, it now relies on ISO 13485:2016 itself — supplemented by a set of FDA-specific provisions — to define the device CGMP requirements.
What this means in practice:
- The citation hasn’t changed, but the substance has. You still reference 21 CFR Part 820, but its requirements now flow from ISO 13485:2016 rather than the previous lettered subparts.
- Conforming to ISO 13485:2016 is necessary but not sufficient. The FDA pairs the standard with extra obligations of its own, covering areas such as labeling and packaging, unique device identification (UDI), and specific record and management expectations.
- Holding an ISO 13485:2016 certificate will not shield you from FDA inspection. There has never been an FDA “GMP certificate,” and neither registration nor third-party certification may be portrayed as FDA approval or endorsement.
- Inspections themselves have been updated. Alongside the rule change, the FDA discontinued its older Quality System Inspection Technique (QSIT) in favor of a revised inspection program built around the QMSR.
QSR to QMSR: How the Old Subparts Map to ISO 13485:2016
With the QMSR in force, most of the old Part 820 subparts are now marked “reserved,” and the underlying obligations are now addressed in ISO 13485:2016. Use this QSR-to-ISO 13485:2016 cross-reference to see where each former subpart’s requirements are now located.
| Former QSR subpart | Now under ISO 13485:2016 |
|---|---|
| Subpart A — General Provisions | Clauses 1–3 (Scope, references, terms) and FDA additions in §820.10 / §820.15 |
| Subpart B — Quality System Requirements | Clauses 4 & 5 (QMS and management responsibility) |
| Subpart C — Design Controls | Clause 7.3 (Design and development) |
| Subpart D — Document Controls | Clause 4.2 (Documentation requirements) |
| Subpart E — Purchasing Controls | Clause 7.4 (Purchasing) |
| Subpart F — Identification and Traceability | Clauses 7.5.8 & 7.5.9 (Identification; Traceability) |
| Subpart G — Production and Process Controls | Clauses 6 & 7.5 (Resources; Production and service provision) |
| Subpart H — Acceptance Activities Clauses 7.4.3 & 8.2 (Verification of purchased product; Monitoring and measurement) | Clauses 7.4.3 & 8.2 (Verification of purchased product; Monitoring and measurement) |
| Subpart I — Nonconforming Product | Clause 8.3 (Control of nonconforming product) |
| Subpart J — Corrective and Preventive Action | Clause 8.5 (Improvement — corrective and preventive action) |
| Subpart K — Labeling and Packaging Control | Clause 7.5.1 plus FDA-specific labeling/UDI requirements |
| Subpart L — Handling, Storage, Distribution, Installation | Clauses 7.5.5, 7.5.3 & 7.5.4 (Preservation; Installation; Servicing) |
| Subpart M — Records | Clause 4.2.5 (Control of records) |
| Subpart N — Servicing | Clause 7.5.4 (Servicing activities) |
| Subpart O — Statistical Techniques | Clause 8.2.6 / 8.4 (Monitoring & measurement; Analysis of data) |
How LMG Helps with QMSR Compliance
- Planning your QSR-to-QMSR transition and running a gap analysis against ISO 13485:2016
- Developing quality management system documentation and procedures
- Advising on facility design and environmental controls
- Carrying out internal audits and supporting implementation
- Preparing you for FDA inspections and assisting with 483 responses afterward
To discuss support for your QMSR transition or ongoing compliance, please contact us with your project details for an approximate budget quote.
Frequently Asked Questions
Is 21 CFR Part 820 still valid under the QMSR?
Does the QMSR mean medical device manufacturers must follow ISO 13485:2016?
Effectively, yes. Compliance with ISO 13485:2016 is now the foundation of the FDA’s device CGMP requirements, along with additional FDA-specific provisions on labeling, UDI, records, and management responsibilities that the standard alone does not cover.
Will ISO 13485:2016 certification make me exempt from FDA inspection?
No. Certification does not replace or exempt you from FDA inspection. The FDA retains full authority to inspect device establishments, and there is no FDA “GMP certificate.” Certification should never be presented as FDA approval or endorsement.
When did the QMSR take effect?
The FDA published the QMSR final rule on February 2, 2024, with a two-year transition period. It became effective on February 2, 2026.
Is there still an FDA certificate for GMP compliance?
No. The FDA does not issue a GMP or QMSR certificate. Compliance is demonstrated through your quality management system and verified by FDA inspection, not by a certificate.
Need Help with 21 CFR 820 Compliance?
LMG provides GMP consulting for 21 CFR 820 — gap assessment, document controls, CAPA.
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