Which CFR Part corresponds to Quality and system regulations?

Which CFR Part corresponds to Quality and system regulations?

• A. 21 CFR Part 210
• B. 21 CFR Part 211
• C. 21 CFR Part 820
• D. 21 CFR Part 50

Answer: (C)

Quality and system regulation for medical devices are defined in the device Quality System Regulation. It requires a complete quality management system with elements like design controls, document and change control, production and process controls, CAPA, supplier controls, labeling, and postmarket surveillance. This is distinct from drug manufacturing regulations (Parts 210 and 211) and from protections for human subjects in research (Part 50). Because the question asks which CFR Part covers quality and system requirements for devices, the appropriate Part is the device Quality System Regulation.

Quality and system regulation for medical devices are defined in the device Quality System Regulation. It requires a complete quality management system with elements like design controls, document and change control, production and process controls, CAPA, supplier controls, labeling, and postmarket surveillance. This is distinct from drug manufacturing regulations (Parts 210 and 211) and from protections for human subjects in research (Part 50). Because the question asks which CFR Part covers quality and system requirements for devices, the appropriate Part is the device Quality System Regulation.