QMSR
The Quality Management System Regulation is FDA's requirement for how a medical device manufacturer runs its quality system. It amends 21 CFR Part 820 and incorporates the international standard ISO 13485:2016 by reference. It came into force on 2 February 2026, replacing the way the former Quality System Regulation was written while keeping most of what it required.
21 CFR 820; 89 FR 7496, published 2 February 2024
At a glance
| In force since | 2 February 2026. |
|---|---|
| Where it lives | 21 CFR Part 820, now titled "Quality Management System Regulation". |
| What it incorporates | ISO 13485:2016 by reference, plus Clause 3 of ISO 9000:2015 for definitions. |
| What happened to the old text | Subparts C through O of the former Quality System Regulation have been removed and reserved. Part 820 is now Subpart A (general) and Subpart B (supplemental). |
| Does it apply to foreign manufacturers? | Yes. Part 820 applies to any finished device imported or offered for import into the United States. |
| Does ISO 13485 certification satisfy it? | No. See below. |
| Consequence of non-compliance | Failure to comply renders a device adulterated under section 501(h) of the FD&C Act. |
| How FDA inspects now | FDA stopped using the Quality System Inspection Technique on 2 February 2026 and uses Compliance Program 7382.850. |
What is different from the QSR
The change with the most operational consequence: the records exemption at the former 21 CFR 820.180(c) is gone. Under the QSR, FDA could not review management review records, internal quality audit reports and supplier audit reports during an inspection. Under QMSR it can.
FDA states this plainly: the exceptions that existed in the QS regulation at 820.180(c) are not maintained in the QMSR.
The other changes:
- Risk management is now explicitly required, as part of the ISO 13485 framework.
- Definitions now flow from ISO 13485 and ISO 9000 Clause 3, rather than from FDA's own definitions section.
- The inspection method changed. FDA retired the Quality System Inspection Technique on the effective date.
- Part 820 was restructured and renamed, with most subparts removed and replaced by the incorporated standard.
FDA states that the rulemaking does not fundamentally alter the requirements for a quality system that existed previously. A manufacturer with a genuinely functioning ISO 13485 system has most of what QMSR asks for. What it may not have is the FDA-specific supplemental requirements in Subpart B, and a readiness to hand over records the QSR used to protect.
Questions people ask
We are certified to ISO 13485. What else do we need?
The supplemental requirements in Subpart B of Part 820, and compliance with the other FDA regulations an ISO audit does not cover: Part 803 adverse event reporting, Part 806 corrections and removals, Part 821 tracking, and Part 830 UDI. You also need to be ready for FDA to inspect the records the former 820.180(c) exemption used to shield.
Does QMSR apply to us if we manufacture outside the United States?
Yes. Part 820 applies to any finished device imported or offered for import into the United States. A device that appears to be adulterated is subject to refusal of admission at the border.
Will FDA inspect us the way an ISO auditor does?
No. FDA states its inspections will not follow the MDSAP audit plan or procedures. FDA uses its own compliance program.
Do we need to buy a copy of ISO 13485?
The standard is incorporated by reference, which means the regulation gives it legal force but FDA does not reproduce its text. Access to the standard is a practical necessity for compliance.
What happens if we do not comply?
Failure to comply with any applicable requirement of Part 820 renders a device adulterated under section 501(h) of the FD&C Act.