CFR section
21 CFR 820.120(b): Device labeling
PART 820-QUALITY SYSTEM REGULATION · Subpart K-Labeling and Packaging Control
Key facts
| Citation | 21 CFR 820.120(b) |
|---|---|
| Section | Device labeling |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart K-Labeling and Packaging Control |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs, Food/Cosmetics, General |
| Regulation text (excerpt) | (b) Labeling inspection. Labeling shall not be released for storage or use until a designated individual(s) has examined the labeling for accuracy including, where applicable, the correct unique device identifier (UDI) or universal product code (UPC), expiration date, control number, storage instructions, handling instructions, and any additional processing instructions. The release, including the date and signature of the individual(s) performing the examination, shall be documented in the DHR. |
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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.