21 CFR Part 820 (FDA Quality System Regulation)

21 CFR Part 820 is the United States Food and Drug Administration’s Quality System Regulation (QSR) governing the methods used in, and facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices. The FDA published a 2024 final rule to harmonize the QSR with ISO 13485:2016, renaming it the Quality Management System Regulation (QMSR), with effect from February 2, 2026.

Scope

Part 820 covers management responsibility, quality audit, personnel, design controls (§820.30), document and record controls, purchasing, identification and traceability, production and process controls, acceptance activities, nonconforming product, corrective and preventive action (§820.100), labeling, handling and storage, distribution, installation, servicing, and statistical techniques. It is enforceable by FDA inspection and underpins 510(k), De Novo, and PMA submissions.

Relationships (see sidebar)

• Normative for the QMS capability, Design Controls, CAPA, and the DHF / DMR / DHR medical-device records.
• Harmonized with ISO 13485 under the QMSR transition.

Steward

US Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH).