CFR section
21 CFR 801.45(a): Devices that must be directly marked with a unique device identifier
PART 801-LABELING · Subpart B-Labeling Requirements for Unique Device Identification
Key facts
| Citation | 21 CFR 801.45(a) |
|---|---|
| Section | Devices that must be directly marked with 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. A device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. |
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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.