CFR section
21 CFR 820.181(a): Device master record
PART 820-QUALITY SYSTEM REGULATION · Subpart M-Records
Key facts
| Citation | 21 CFR 820.181(a) |
|---|---|
| Section | Device master record |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart M-Records |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs, General |
| Regulation text (excerpt) | (a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications; |
At a glance
- 100–999 Inspections citing this section
- 10–99 Warning letters citing this section
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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.