The QMSR amends 21 CFR Part 820 so that device manufacturers follow ISO 13485 requirements for their quality system, with a small number of FDA-specific additions. This aligns US requirements with international practice, which makes it easier to run a single system for several markets. FDA's inspections now follow an updated compliance program built around the QMSR.
Why it matters for labeling
FDA kept its own section on device labeling and packaging controls (820.45) because it judged ISO 13485's labeling coverage insufficient. It requires manufacturers to inspect labeling for accuracy before release, and to document that release. So verifying labels before they ship is a specific, inspectable requirement, alongside the document control expectations in ISO 13485.
Common mistakes
- Assuming the old QSR wording still applies
- Label inspection that isn't documented
- Document control that doesn't show which version was approved and released
- Treating labeling as outside design and production change control
Sources
Related reading
GUIDE
Medical Device Labeling Requirements: FDA, EU MDR, UDI, and IFU Explained
EU MDR, FDA, UDI, IFU, and ISO 15223-1 requirements for medical device labels — what teams need to verify before every release.
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ARTICLE
Device Recalls and Labeling Errors: What FDA Data Shows
Many device recalls blamed on "packaging" trace back to label and IFU text. What FDA recall classes mean, and what the new QMSR requires before labels ship.
Read the article →