CFR section
21 CFR 820.20(b)(3): Management responsibility
PART 820-QUALITY SYSTEM REGULATION · Subpart B-Quality System Requirements
Key facts
| Citation | 21 CFR 820.20(b)(3) |
|---|---|
| Section | Management responsibility |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart B-Quality System Requirements |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs, General, Other_Regulations |
| Regulation text (excerpt) | (3) Management representative. Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for: (i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and (ii) Reporting on the performance of the quality system to management with executive responsibility for review. |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.