CFR section
21 CFR 801.20(a): Label to bear a unique device identifier
PART 801-LABELING · Subpart B-Labeling Requirements for Unique Device Identification
Key facts
| Citation | 21 CFR 801.20(a) |
|---|---|
| Section | Label to bear a unique device identifier |
| Part | PART 801-LABELING |
| Subpart | Subpart B-Labeling Requirements for Unique Device Identification |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | (a) In general. (1) The label of every medical device shall bear a unique device identifier (UDI) that meets the requirements of this subpart and part 830 of this chapter. (2) Every device package shall bear a UDI that meets the requirements of this subpart and part 830 of this chapter. |
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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.