FDA QMSRQuality Management System Regulation
The Quality Management System Regulation (QMSR) is FDA's current quality system rule for medical device manufacturers in 21 CFR Part 820. Effective 2 February 2026, it incorporates ISO 13485:2016 by reference and adds a small set of FDA-specific requirements.
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01What QMSR is
QMSR is the name FDA uses for 21 CFR Part 820 as amended by its February 2024 final rule. Instead of writing its own detailed quality system text, FDA now requires device manufacturers to meet the applicable clauses of ISO 13485:2016, which the rule incorporates by reference, plus the FDA-specific provisions that remain in Part 820.
The amended rule took effect on 2 February 2026. The former Quality System Regulation (QSR) sections — including the old Device History Record section, 820.184, and the old CAPA section, 820.100 — are not current requirements. Older annual printings of the CFR still show the legacy text, so check the edition date before quoting a section.
02Who it applies to
Part 820 applies to manufacturers of finished medical devices intended for human use that are sold in the United States, with the exemptions the rule describes. It is a U.S. requirement; selling elsewhere brings separate rules such as the EU MDR, and ISO 13485 certification by a notified body or registrar is a different thing from FDA compliance.
| Layer | Where it comes from | Binding? |
|---|---|---|
| ISO 13485:2016 clauses | Incorporated by reference through 21 CFR 820.10 | Yes, as applicable, for U.S. device manufacturers in scope |
| FDA-specific provisions | 21 CFR 820.1, 820.3, 820.7, 820.10, 820.35, 820.45 | Yes |
| Other FDA device rules | Complaint/MDR reporting, UDI, corrections and removals, Part 11 where electronic records apply | Yes, under their own parts |
| ISO 13485 certificate | A third-party audit result | Not an FDA determination |
03What FDA added on top of ISO 13485
The amended text keeps several FDA-specific points. Section 820.3 aligns definitions with the FD&C Act and FDA terminology where they differ from the standard. Section 820.10 requires a documented quality management system that meets the applicable ISO 13485 requirements and links to other FDA regulations. Section 820.35 adds record requirements — for example, what complaint and servicing records must contain. Section 820.45 sets device labeling and packaging controls, including inspection of labeling before release.
04Worked example: a production record after the change
A contract manufacturer of single-use surgical kits used to cite 820.184 in its SOP for the Device History Record. Under QMSR it rewrites the SOP to cite ISO 13485:2016 production and traceability expectations (as incorporated through 820.10) and the relevant 820.35 and 820.45 record and labeling provisions. The record content barely changes: lot or batch identity, quantities made and released, acceptance records, labels used and the UDI. What changes is the cited basis and the terminology auditors expect to see.
- Update procedure citations; do not leave 820.184 or 820.100 as the cited requirement.
- Keep U.S. labeling inspection steps from 820.45 explicit.
- Confirm that complaint and servicing records hold the information 820.35 requires.
05Common failure modes and checks
- Treating an ISO 13485 certificate as proof of QMSR compliance — FDA inspects against Part 820 and does not rely on the certificate.
- Quoting legacy QSR sections as current requirements in procedures, training or supplier agreements.
- Assuming the incorporated standard replaced other FDA device obligations such as reporting or UDI rules.
- Updating the quality manual but not the forms and electronic records people actually fill in.
A useful check: pick three live records (one production, one complaint, one labeling release) and trace each field back to a current clause or Part 820 section.
06Where V5 fits
V5 records production steps, lots, quality events, CAPA and complaint investigations with electronic signatures and an audit history, and produces device production records (eDHR). That can hold the evidence your QMSR procedures call for. It does not interpret the regulation for you: your quality system, procedures, clause mapping, validation for intended use and every release decision remain with your people.
Frequently asked questions
Q.When did QMSR take effect?+
2 February 2026, under the final rule published 2 February 2024 (89 FR 7496).
Q.Does QMSR replace ISO 13485?+
No. It incorporates ISO 13485:2016 by reference into 21 CFR Part 820 and adds FDA-specific requirements.
Q.Is 21 CFR 820.184 still a requirement?+
No. The legacy Device History Record section was removed by the amendment; production record expectations now come from the incorporated standard and the remaining Part 820 provisions.
Q.Does an ISO 13485 certificate show QMSR compliance?+
No. A certificate is a third-party audit result; FDA assesses compliance with Part 820 itself.
Q.Was the full ISO 13485 text reviewed for this page?+
No. It is a paid standard; this page relies on the published rule and FDA material.
Primary sources
Further reading
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