What Is 21 CFR Part 820?
Title 21 of the Code of Federal Regulations (CFR), Part 820, commonly known as the Quality System Regulation (QSR), is the FDA's framework governing how medical devices must be designed, manufactured, packaged, labeled, stored, and distributed in the United States.
Key Subparts of QSR
The regulation covers a broad range of manufacturing controls:
- Design Controls (Subpart C) – Structured development process from concept to validation
- Document Controls (Subpart D) – Controlled, current, and accessible documentation
- Production and Process Controls (Subpart G) – Validated manufacturing processes
- Corrective and Preventive Action (Subpart J) – Systematic problem identification and resolution
- Records (Subpart M) – Complete device history records (DHRs)
How QSR Aligns with ISO 13485
The FDA has harmonized much of its QSR framework with ISO 13485, making dual compliance more achievable for manufacturers serving both US and international markets.
Working with a QSR-Compliant Partner
Choosing a contract manufacturer with a mature QSR-compliant quality system protects your regulatory standing and ensures every product delivered is traceable, documented, and audit-ready.
