Medical Devices; Quality System Regulation Amendments (Proposed Rule) Preliminary Regulatory Impact Analysis

FDA requires current Good Manufacturing Practices (CGMP) under the Quality System regulation (QSR) (21 CFR part 820) to ensure the required methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices intended for human use. FDA proposes to converge the QSR with the quality management system requirements used by other regulatory authorities from other jurisdictions by amending current 21 CFR part 820 (Part 820) through incorporating by reference the International Organization for Standardization (ISO) requirements for medical devices under ISO 13485 (2016 edition). FDA is also proposing conforming edits to 21 CFR Part 4 to clarify medical device requirements for combination products, and to connect and align 21 CFR Part 4 with ISO 13485 and the proposed rule. The benefit of the proposed rule is estimated in terms of reduction of compliance effort, and consequently cost savings, for medical device establishments that currently comply with both standards (primary estimate is $533 million annualized over 10 years at 7 percent). The costs of the rule include initial training of personnel, and information technology and documentation update for the medical device industry and the FDA (primary estimate is $7 million annualized over 10 years at 7 percent).

Regulatory Impact Analysis

Medical Devices; Quality System Regulation Amendments (PDF- 807KB)

Federal Register: 87 FR 10119, February 23, 2022

Docket: FDA-2021-N-0507