What the QMSR Adds to ISO 13485:2016
21 CFR Part 820 has required a quality system that complies with ISO 13485:2016 since February 2, 2026. The part adds a short set of FDA-specific requirements.
21 CFR 820.7 incorporates ISO 13485:2016 by reference. Under 21 CFR 820.10(a), a manufacturer must document a quality management system that complies with the applicable requirements of the standard. Under 21 CFR 820.10(e), failure to comply with an applicable requirement makes a device adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act.
| Part 820 | What it adds | ISO clause |
|---|---|---|
| 21 CFR 820.10(b)(1) | A system to assign unique device identification under part 830. | 7.5.8 |
| 21 CFR 820.10(b)(2) | Traceability procedures under part 821, if applicable. | 7.5.9.1 |
| 21 CFR 820.10(b)(3) | Notification to the FDA of complaints that meet the reporting criteria of part 803. | 8.2.3 |
| 21 CFR 820.10(b)(4) | Advisory notices handled under part 806. | 7.2.3, 8.2.3, 8.3.3 |
| 21 CFR 820.10(c) | Design and development, clause 7.3, required for class II, class III, and listed class I devices. | 7.3 |
| 21 CFR 820.10(d) | Traceability for implantable devices (clause 7.5.9.2), required for devices that support or sustain life when failure under proper use can reasonably be expected to cause significant injury. | 7.5.9.2 |
| 21 CFR 820.35 | Required content for complaint, servicing, and unique device identifier records. | 4.2.5, 8.2.2, 7.5.4 |
| 21 CFR 820.45 | Procedures for labeling and packaging integrity, with an accuracy examination before release. | 7.5.1 |
Part 820 now has six sections with text: 820.1, 820.3, 820.7, 820.10, 820.35, and 820.45. Sections 820.20 through 820.30 are reserved. A procedure, training record, or audit checklist that cites the older numbering, such as 21 CFR 820.100 for corrective and preventive action, cites a section that no longer exists.
Sixteen of the 27 device warning letters issued on or after February 2, 2026 and posted through October 20, 2026 allege a quality-system violation. Eleven of the sixteen cite a section of Part 820. Six cite ISO 13485 clauses. One of those also cites a section. Two letters cite no section of the CFR at all. One of them is the Linemaster letter.
Which of your procedures still cite a section of Part 820 that no longer exists?
Sources: 21 CFR Part 820 on the eCFR (read October 21, 2026) and the FDA’s warning letters issued on or after February 2, 2026 and posted through October 20, 2026.