CFR section
21 CFR 820.120(a): Device labeling
PART 820-QUALITY SYSTEM REGULATION · Subpart K-Labeling and Packaging Control
Key facts
| Citation | 21 CFR 820.120(a) |
|---|---|
| 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 | Biologics, Devices |
| Regulation text (excerpt) | (a) Label integrity. Labels shall be printed and applied so as to remain legible and affixed during the customary conditions of processing, storage, handling, distribution, and where appropriate use. |
At a glance
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- 1–9 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.