21 CFR Part 830 — Unique Device Identification (UDI)
21 CFR Part 830 implements FD&C Act § 519(f) and establishes the Unique Device Identification (UDI) system. It requires device labels to bear a unique identifier and mandates submission of device information to the GUDID database.
Structure of Part 830
| Subpart | Content |
|---|---|
| Subpart A (§§ 830.1–830.10) | General provisions, definitions |
| Subpart B (§§ 830.20–830.50) | Labelling requirements — when UDI is required, format, content |
| Subpart C (§§ 830.100–830.310) | GUDID — submission requirements |
| Subpart D (§§ 830.330–830.360) | UDI issuing agency accreditation |
Key provisions
§ 830.3 — Definitions
| Term | Definition |
|---|---|
| UDI | A unique numeric or alphanumeric code that consists of a DI and a PI |
| Device Identifier (DI) | The mandatory, fixed portion identifying the specific version or model |
| Production Identifier (PI) | The conditional, variable portion containing lot/batch/serial/dates |
| Labeller | The entity whose name appears on the device label as the manufacturer, packer, or distributor |
§ 830.20 — Labelling requirements
Device labels must include the UDI in:
- Plain text (human-readable)
- AIDC (automatic identification and data capture — barcode or 2D matrix)
The UDI must be placed on the label of each device and, for higher-level packaging, on the packaging label of each higher level.
§ 830.50 — Direct marking
Reusable devices intended for more than one use that are intended to be processed before each use must have the UDI directly marked on the device itself in addition to the label.
§§ 830.100–830.310 — GUDID submissions
The labeller must submit the following information for each Primary DI to GUDID:
- Brand name, model number, device description
- Company name and DUNS number
- Device class and 510(k)/PMA/De Novo reference
- Sterilisation method, shelf life, latex content
- MRI safety status
- Whether the device is implantable, life-sustaining, or life-supporting
- Whether it is a single-use device