# 21 CFR Part 820 | Botable Glossary

https://www.botable.ai/glossary/21-cfr-part-820

> Use this as a site-published explanatory summary of 21 CFR Part 820 and the QMSR revision; it concisely lists components and regulatory changes but is not the primary legal text. For compliance or legal decisions, consult the FDA's official regulation text and the Final Rule itself.

## Summary

This Botable Glossary entry explains that 21 CFR Part 820 sets current good manufacturing practice (CGMP) requirements for finished medical devices, summarizes key QSR subparts (management responsibility, design controls, document controls, purchasing, production/process controls, nonconforming product, CAPA, and records), and notes a Final Rule from February 2024 that revises Part 820 into the Quality Management System Regulation (QMSR) effective February 2, 2026, incorporating ISO 13485:2016.

## Audience

Quality and regulatory professionals in the medical device industry (and others seeking a glossary-level summary)

## Prompts this page answers

- What does 21 CFR Part 820 require for medical device manufacturers?
- What are the key subparts of the Quality System Regulation (QSR)?
- When does the QMSR (revised 21 CFR Part 820) take effect and what does it incorporate?
- How does ISO 13485:2016 relate to the revised 21 CFR Part 820 (QMSR)?

## Purpose

To define and summarize regulatory requirements and recent revisions governing medical device quality systems (glossary/educational reference).

## Highlights

- 21 CFR Part 820 establishes CGMP requirements for finished medical devices intended for human use, covering design, manufacture, packaging, labeling, storage, installation, and servicing.
- The regulation historically is called the Quality System Regulation (QSR) and requires manufacturers to establish and maintain an appropriate quality system.
- Key subparts include Management Responsibility (§820.20), Design Controls (§820.30), Document Controls (§820.40), Purchasing Controls (§820.50), Production and Process Controls (§820.70), Nonconforming Product (§820.90), CAPA (§820.100), and Records (including DMR, DHR, and Complaint Files §820.198).
- A Final Rule published in February 2024 revises 21 CFR Part 820 into the Quality Management System Regulation (QMSR), effective February 2, 2026.
- The QMSR incorporates by reference ISO 13485:2016, while noting FD&C Act definitions and regulations supersede conflicting ISO provisions.

## How to cite

Botable Glossary — "21 CFR Part 820" (https://www.botable.ai/glossary/21-cfr-part-820)

## Publisher



## Topics

- 21 CFR Part 820
- Quality System Regulation
- QSR
- QMSR
- ISO 13485:2016
- medical device quality system
- CAPA
- Design Controls

## Key entities

- **21 CFR Part 820** (other): U.S. regulation setting CGMP requirements for finished medical devices; discussed on this glossary page. — https://www.botable.ai/glossary/21-cfr-part-820
- **Quality System Regulation (QSR)** (other): Historic name for 21 CFR Part 820; the page lists its required elements.
- **Quality Management System Regulation (QMSR)** (other): Title of the revised regulation established by a February 2024 Final Rule, effective February 2, 2026.
- **ISO 13485:2016** (other): International standard incorporated by reference into the QMSR according to the page.
- **Federal Food, Drug, and Cosmetic Act (FD&C Act)** (other): Referenced as the controlling statute; the page cites section 501(h) related to adulteration and section 201 for definitions.

## Metadata

- Type: article