CFR section
21 CFR 820.20(b)(2): Management responsibility
PART 820-QUALITY SYSTEM REGULATION · Subpart B-Quality System Requirements
Key facts
| Citation | 21 CFR 820.20(b)(2) |
|---|---|
| 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 |
| Regulation text (excerpt) | (2) Resources. Each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this part. |
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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.