CFR section
21 CFR 830.300(a): Devices subject to device identification data submission requirements
PART 830-UNIQUE DEVICE IDENTIFICATION · Subpart E-Global Unique Device Identification Database
Key facts
| Citation | 21 CFR 830.300(a) |
|---|---|
| Section | Devices subject to device identification data submission requirements |
| Part | PART 830-UNIQUE DEVICE IDENTIFICATION |
| Subpart | Subpart E-Global Unique Device Identification Database |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | (a) In general. The labeler of a device must provide the information required by this subpart for each version or model required to bear a unique device identifier (UDI). |
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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.