FDA-21-CFR-820
Quality System Regulation
U.S. federal regulation establishing current good manufacturing practice (cGMP) requirements for medical devices. Covers design controls, production and process controls, corrective and preventive actions (CAPA), and records management.
- Document
- 21 CFR Part 820 (revised 2024)
- URL
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820
- Label
- Regulation
- Keywords
- FDA cGMP medical device manufacturing design controls CAPA production controls quality system US regulation
Domain: Medical · Regulation