21 CFR Part 820

21 CFR Part 820 sets forth the current good manufacturing practice (CGMP) requirements for finished medical devices intended for human use. These requirements govern the methods, facilities, and controls used for the entire device lifecycle, including design, manufacture, packaging, labeling, storage, installation, and servicing. The overall intent is to assure that finished devices will be safe and effective and comply with the Federal Food, Drug, and Cosmetic Act (the act). Failure to comply with any applicable provision in this part renders a device adulterated under section 501(h) of the act, subjecting the device and responsible person to regulatory action

Key Components of 21 CFR Part 820 (The Quality System Regulation/QSR)

Historically, this regulation was known as the Quality System Regulation (QSR). It establishes requirements for manufacturers to "establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured".

The structure of the traditional 21 CFR Part 820 includes several subparts detailing various mandatory quality management elements, such as:

Management Responsibility (§ 820.20): Requires management with executive responsibility to establish quality policy and organizational structure.• Design Controls (Subpart C, § 820.30): Procedures to control the design of Class II, Class III, and specific Class I devices, ensuring specified design requirements are met. This includes requirements for Design Review, Design Verification, and maintaining the Design History File (DHF).

Document Controls (Subpart D, § 820.40): Procedures for approving, distributing, and preventing the unintended use of obsolete documents.

Purchasing Controls (Subpart E, § 820.50): Procedures for evaluating and selecting suppliers and defining control over purchased products and services.

Production and Process Controls (Subpart G, § 820.70): Ensures processes conform to specifications, including requirements for documenting changes, monitoring process parameters, and process validation.

Nonconforming Product (Subpart I, § 820.90): Procedures to control nonconforming product, including identification, documentation, evaluation, segregation, and disposition.

Corrective and Preventive Action (CAPA) (Subpart J, § 820.100): Requires medical device manufacturers to implement documented CAPA procedures for identifying, investigating, and preventing existing and potential nonconformities.

Records (Subpart M): Requires documentation such as the Device Master Record (DMR) and Device History Record (DHR). This also specifies requirements for Complaint Files (§ 820.198).

The Recent Revision (QMSR)

21 CFR Part 820 is undergoing a significant revision, established via a Final Rule in February 2024, which will take effect on February 2, 2026. The revised regulation is titled the Quality Management System Regulation (QMSR) and aims to harmonize the U.S. requirements with international quality management system requirements.

Key characteristics of the QMSR (§ 820.10) include:

Incorporation by Reference: The QMSR incorporates by reference the International Standard ISO 13485:2016 (Medical devices - Quality management systems – Requirements for regulatory purposes).

Superseding Definitions: Definitions laid out in the Federal Food, Drug, and Cosmetic Act (FD&C Act, Section 201) will apply and supersede correlating terms defined in ISO 13485 or ISO 9000 (e.g., the definitions of device and labeling). Where ISO 13485 clauses conflict with the FD&C Act or its implementing regulations, the latter will control.

Scope Retention: The QMSR generally retains the scope and some definitions from the 1996 version of Part 820.

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