Edition 2026-11 · Free sample page · 01-qmsr/qmsr-at-a-glance.md
21 CFR Part 820 at a glance
The regulation's name, dates, incorporation of ISO 13485 by reference, the six retained sections and the three changes that matter.
See the pack
USD 129 per person, one edition
About this page
- Type
- Concept page
- Source
- Summarises public material (regulation, guidance or an official site)
- Edition
- Edition 2026-11
- Primary source
- www.ecfr.gov
- Sources
-
eCFR, 21 CFR Part 820
Federal Register, 89 FR 7496 - Tags
- qmsr, overview, start-here
- Status
- Stable
- Licence
- Individual licence, Edition 2026-11; see LICENSE.md
Front matter, as shipped
---
type: "concept"
title: "QMSR at a glance"
description: "The regulation's name, dates, incorporation of ISO 13485 by reference, the six retained sections and the three changes that matter."
source: "public"
date: "2026-11"
edition: "2026-11"
licence: "Individual licence, Edition 2026-11; see LICENSE.md"
resource: "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820"
sources:
- {id: "ecfr-820", resource: "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820", title: "eCFR, 21 CFR Part 820"}
- {id: "fr-final-rule", resource: "https://www.federalregister.gov/citation/89-FR-7496", title: "Federal Register, 89 FR 7496"}
tags: ["qmsr", "overview", "start-here"]
status: "stable"
---
Free sample of the QMSR Knowledge Pack, Edition 2026-11, published here by Koala Tea with Neel LLC. Reading this page needs no licence; the download and the full pack are licensed per person.
| Name | Quality Management System Regulation (QMSR), 21 CFR Part 820 |
| Published | 2 February 2024, as the final rule Medical Devices; Quality System Regulation Amendments (89 FR 7496) |
| In effect | 2 February 2026 |
| Incorporates by reference (21 CFR 820.7) | ISO 13485:2016(E), Medical devices - Quality management systems - Requirements for regulatory purposes, third edition, 1 March 2016 (for 820.1, 820.3, 820.10, 820.35 and 820.45); ISO 9000:2015(E), Quality management systems - Fundamentals and vocabulary, clause 3, Terms and definitions (for 820.3) |
| Replaces | the Quality System Regulation of 1996; its numbered sections are reserved and appear in this pack only as labelled cross-references |
| Inspected under | FDA Compliance Program 7382.850, Inspection of Medical Device Manufacturers, effective the same day (the program as a PDF; see 02-fda-inspections) |
| Consequence of non-compliance | a device is adulterated under section 501(h) of the FD&C Act (21 CFR 820.10(e)) |
How the regulation is built now
| Section | What it does |
|---|---|
| 21 CFR 820.1 Scope | Who is covered (manufacturers of finished devices for human use, including contract sterilizers, installers, relabelers, remanufacturers, repackers, specification developers and initial distributors of foreign entities), who is not (component manufacturers, blood establishments), how HCT/Ps regulated as devices are treated, that the FD&C Act and its other regulations control over any conflicting clause of the incorporated standard, refusal of imports, and exemptions and variances. |
| 21 CFR 820.3 Definitions | Imports the definitions of ISO 13485 and clause 3 of ISO 9000, adds six terms the standards do not define, and makes the FD&C Act's definitions and five further terms supersede the standards' correlating terms. See definitions-precedence.md (full pack). |
| 21 CFR 820.7 Incorporation by reference | Names the two incorporated documents and their editions and says where they can be inspected or bought. |
| 21 CFR 820.10 Requirements for a quality management system | The operative requirement: document a QMS that complies with ISO 13485 and the rest of Part 820; link four clauses to other FDA regulations (UDI, tracking, medical device reporting, corrections and removals); apply ISO 13485 clause 7.3 (Design and development) to class II, class III and listed class I devices; apply ISO 13485 clause 7.5.9.2 (Particular requirements for implantable medical devices) to life-supporting and life-sustaining devices; adulteration on non-compliance. |
| 21 CFR 820.35 Control of records | Record contents FDA adds on top of ISO 13485 clause 4.2.5 (Control of records): complaint records, servicing records, UDI per device or batch, confidentiality marking. See fda-supplements.md (full pack). |
| 21 CFR 820.45 Device labeling and packaging controls | Labeling and packaging controls FDA adds on top of ISO 13485 clause 7.5.1 (Control of production and service provision): procedures, examination before release, documented release, mix-up prevention. See fda-supplements.md (full pack). |
All other section numbers of Part 820 are reserved. The crosswalk shows where each former section's subject now lives.
Three things that changed
- The requirements live in the standard. Instead of restating quality-system requirements, the regulation requires a QMS that complies with ISO 13485:2016 (21 CFR 820.10(a)). The standard's text is copyrighted and is not reproduced here or in the regulation; a manufacturer needs its own copy.
- FDA kept what the standard does not cover. The retained sections carry the FDA-specific requirements: UDI, device tracking, medical device reporting and corrections and removals linked to named clauses (21 CFR 820.10(b)); the design and development applicability rule (820.10(c)); traceability for life-supporting devices (820.10(d)); complaint and servicing record contents (820.35); labeling and packaging controls (820.45).
- Definitions follow the Act. Where the FD&C Act or 21 CFR 820.3 defines a term, that definition supersedes the standard's; the standard's "organization" is read as "manufacturer" and "safety and performance" as "safety and effectiveness" (21 CFR 820.3(b)).
Where to read it
- Current text of 21 CFR Part 820 on eCFR
- Final rule, 89 FR 7496, 2 February 2024 (Federal Register)
- FDA's QMSR page
- Compliance Program 7382.850, current edition (PDF)
- Compliance Program Manual (index of all compliance programs)
QMSR Knowledge Pack, Edition 2026-11. Professional reference material, not legal or regulatory advice. Licensed per person; see LICENSE.md.
Want the notice when the next edition is published? Join the newsletter at https://www.qms.coach
Free sample of the QMSR Knowledge Pack, Edition 2026-11, published here by Koala Tea with Neel LLC. Reading this page needs no licence; the download and the full pack are licensed per person. Seller: Koala Tea with Neel LLC; questions to tiwarineelank@gmail.com.