FDA 21 CFR Part 820 (QSR)

What FDA 21 CFR Part 820 (QSR) requires

FDA 21 CFR Part 820 is the Quality System Regulation (QSR) governing the manufacture and design of medical devices in the United States. It requires medical device manufacturers to establish a quality system to ensure that their products consistently meet applicable requirements and specifications.

Pillar: Medical & Healthcare · Authority: US Food and Drug Administration (FDA) · Version: 1.1.0 · Last updated: 2026-04-09

Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820

SHA-256 integrity: 67348728c50605e364d9e60cd06999e4cb9c9bf8a17476ca7c28907e412d66cf

Primary Citations — 6 traced to source

• 21 CFR 820.30 - Design controls: Mandates procedures to control the design of the device to ensure specified design requirements are met, including software lifecycle and risk analysis.
• 21 CFR 820.100 - Corrective and preventive action (CAPA): Requires procedures for analyzing quality data to identify existing and potential causes of nonconforming product or quality problems.

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