21 CFR Part 820 — Quality System / QMSR
21 CFR Part 820 is the Quality Management System Regulation (QMSR) — the FDA regulation requiring medical device manufacturers to establish and maintain a quality management system. The QMSR final rule, published February 2, 2024, amended Part 820 to incorporate ISO 13485:2016 by reference, effective February 2, 2026.
Structure of Part 820 (QMSR)
| Section | Content |
|---|---|
| § 820.1 | Scope — who must comply |
| § 820.3 | Definitions |
| § 820.10–820.30 | Management responsibility; quality planning; design controls |
| § 820.50 | Purchasing controls |
| § 820.70–820.86 | Production and process controls; acceptance activities |
| § 820.90 | Nonconforming product |
| § 820.100 | Corrective and preventive action (CAPA) |
| § 820.120–820.130 | Labelling and packaging controls |
| § 820.140–820.160 | Handling, storage, distribution, installation |
| § 820.170 | Servicing |
| § 820.180–820.198 | Records — general, DHR, DMR, complaint files |
ISO 13485:2016 incorporation
The QMSR incorporates ISO 13485:2016 by reference with specific US additions. Manufacturers with a conforming ISO 13485:2016 QMS will substantially satisfy QMSR — but must also address US-specific requirements including:
- MDR-integrated complaint handling (§ 820.198)
- Design History File (DHF) records
- CAPA linkage to FDA-specific data sources
- Distribution records (§ 820.160) capturing initial consignee
Who must comply (§ 820.1)
- Manufacturers of finished medical devices distributed in the USA
- Class II and III device manufacturers must comply with all sections
- Class I manufacturers are exempt from some provisions but must still comply with CAPA (§ 820.100), complaint handling (§ 820.198), and quality records (§ 820.180)
Key QMSR requirements
Design controls (§ 820.30)
Mandatory for Class II and III devices — requires documented design planning, inputs, outputs, review, verification, validation, transfer, and change control. Output is the Design History File (DHF).
CAPA (§ 820.100)
Systematic processes for identifying and eliminating the root cause of actual and potential nonconformities. Must be driven by analysis of MDRs, complaints, nonconforming product data, and audit results.
Complaint files (§ 820.198)
All complaints must be reviewed and evaluated for MDR reportability. A formal complaint file must be maintained for each complaint, including the investigation and disposition.