Unique Device Identification
The FDA regulation establishing the unique device identification system: how a UDI is constructed (a device identifier plus production identifiers), the FDA-accredited issuing agencies whose systems labelers use, and the submission of device data to the Global Unique Device Identification Database (GUDID). Together with the labelling requirements in 21 CFR Part 801, it is the US device-identification regime — the device-world analogue of pharmaceutical serialization.
What this does not cover
stated in the document's own scope- Governs UDI construction, issuing agencies, and GUDID data; the requirement that a device label bear the UDI is in 21 CFR Part 801, not Part 830.
- A device-identification regime: prescription-drug tracing under the DSCSA is a separate statutory system with different data flows.
- Covers identification and the GUDID record; adverse-event reporting (Part 803) and corrections-and-removals reporting (Part 806) are separate postmarket obligations that reference the identified device.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
21 CFR Part 830 establishes the unique device identification system — the device-world counterpart of pharmaceutical serialization. It defines how a UDI is constructed: a device identifier (DI) that names the specific version or model and labeler, plus production identifiers (PI) carrying lot, serial number, expiration date, or manufacture date where the label bears them. UDIs are issued under systems operated by FDA-accredited issuing agencies, and the part prescribes accreditation of those agencies, the circumstances in which FDA itself may act as one, and the submission and maintenance of device data in the Global Unique Device Identification Database (GUDID). The companion obligation — that device labels and packages actually bear the UDI — lives in the labeling regulations of 21 CFR Part 801.
Scope & applicability
Labelers of medical devices distributed in the United States — typically the manufacturer or repackager. Part 830 governs UDI construction, issuing agencies, and GUDID data; the obligation to bear a UDI on the label sits in 21 CFR Part 801.
Legal basis & how it acquires force
A regulation issued under the FD&C Act pursuant to section 519(f), which directed FDA to establish a unique device identification system. The UDI final rule of 24 September 2013 created Part 830 and the related labeling requirements, with compliance dates phased by device class over the following years. Part 830 sits in subchapter H (medical devices) and operates with Part 801 (labeling) and Part 820/QMSR record expectations.
Document structure
| Part | Covers |
|---|---|
| Subpart A — General provisions | Scope, definitions, and the applicability of the UDI requirements |
| Subpart B — Requirements for a unique device identifier | Composition of the UDI: device identifier plus production identifiers, and when identifiers change or are retired |
| Subpart C — FDA accreditation of an issuing agency | How organizations are accredited to operate UDI issuance systems, and their obligations |
| Subpart D — FDA as an issuing agency | The circumstances and terms under which FDA acts as an issuing agency itself |
| Subpart E — Global Unique Device Identification Database | Electronic submission of device data to GUDID and keeping it current |
Key requirements
- UDIs composed of a device identifier (DI) and, where applicable, production identifiers (lot, serial, expiry, manufacture date)
- UDIs issued under a system operated by an FDA-accredited issuing agency
- Device data submitted to GUDID and kept current
- The device identifier retired/replaced when the device version or model changes
Implementation tips
- The accredited issuing agencies operate the identifier systems (GS1 GTIN-based identifiers are the most widely used), so UDI programmes usually reuse the same GS1 infrastructure as pharma serialization
- Treat GUDID as a regulated data product: attribute changes flow from change control, and stale GUDID records against current labelling are an easy inconsistency to create
Revision notes
Established by the UDI final rule of 24 September 2013, with compliance dates phased by device class in the years following.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
Part 830 defines the regulatory system and delegates identifier syntax to accredited issuing agencies — in practice dominated by GS1, whose GTIN-based identifiers serve the same role in EU FMD and DSCSA serialization, so device and pharma identification share one technical infrastructure. Internationally it parallels the UDI obligations the EU built into the MDR and IVDR with their EUDAMED UDI module; the IMDRF UDI guidance supplied the common conceptual frame both regimes drew on.
21 CFR Part 830: frequently asked questions
Quick answers to common questions about 21 CFR Part 830.
What are the parts of a UDI?
A device identifier (DI) — the fixed portion identifying the labeler and the specific version or model — and production identifiers (PI), the variable portion carrying whichever of lot, serial number, expiration date, or manufacture date appear on the label.
Who issues UDIs?
Labelers obtain UDIs under a system operated by an FDA-accredited issuing agency; Part 830 also provides for FDA to act as an issuing agency. GS1 is the most widely used accredited agency, which is why GTIN-based UDIs dominate in practice.
What is GUDID?
The Global Unique Device Identification Database — FDA's public database of device identification data. Subpart E requires labelers to submit the prescribed device data electronically for each device required to bear a UDI, and to keep the records current.
Does Part 830 require the UDI to appear on the device label?
No — that obligation sits in the labeling regulations at 21 CFR Part 801. Part 830 defines what a UDI is, who may issue one, and the GUDID data submission that accompanies it.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.