CFR section
21 CFR 820.181(c): Device master record
PART 820-QUALITY SYSTEM REGULATION · Subpart M-Records
Key facts
| Citation | 21 CFR 820.181(c) |
|---|---|
| Section | Device master record |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart M-Records |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Biologics, Devices, Drugs |
| Regulation text (excerpt) | (c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used; |
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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.