CFR section
21 CFR 820.20(e): Management responsibility
PART 820-QUALITY SYSTEM REGULATION · Subpart B-Quality System Requirements
Key facts
| Citation | 21 CFR 820.20(e) |
|---|---|
| Section | Management responsibility |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart B-Quality System Requirements |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Biologics, Devices, Drugs, Food/Cosmetics, General, Other_Regulations |
| Regulation text (excerpt) | (e) Quality system procedures. Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate. |
At a glance
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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.