United States (FDA)
21 CFR Part 830: Unique Device Identification
Part 830 sets up the US unique device identification system. It defines what a UDI is, who assigns it, how issuing agencies are accredited, and what labelers must submit to FDA's Global Unique Device Identification Database (GUDID). UDI also runs through the QMS, from labeling controls to the records named in the QMSR.
At a Glance
- Regulation
- 21 CFR Part 830
- Subject
- Unique Device Identification
- Group
- United States (FDA)
- Industries
- 6 industry guides reference it
A plain-language summary, not legal advice. Always read the current official text.
What It Covers
A UDI identifies a device through distribution and use. It has two parts: a device identifier (DI), which identifies the labeler and the specific version or model, and a production identifier (PI), which carries production information such as lot or serial number, expiration date or manufacturing date when that information appears on the label. UDIs are issued under systems run by FDA-accredited issuing agencies, and Part 830 sets out how those agencies are accredited.
The labeler, generally the firm that causes a label to be applied to a device or modifies the label, is responsible for assigning UDIs and submitting device identifier information to GUDID. The GUDID record must be kept current when relevant device information changes, and a change to the device that requires a new version or model calls for a new DI. Part 830 includes exceptions and alternatives, and the labeling requirements for placing the UDI on labels and packages sit alongside it in Part 801.
Under the QMSR, 820.35 names UDI among the record content FDA expects, and Compliance Program 7382.850 lists UDI among the other applicable FDA requirements reviewed during QMS inspections. In practice, investigators check that the UDI on the label, the device history and the GUDID entry all agree, and that labeling controls prevent the wrong UDI from reaching a package.
Who It Applies To
- Labelers of devices marketed in the United States, domestic and foreign
- Manufacturers, relabelers and repackagers whose activities make them the labeler
- Firms changing device versions, models or packaging configurations that may require new device identifiers
- Device makers using exceptions or alternatives under the rule, who need documentation to support them
What Auditors Check
UDI on Labels and Packages
Whether UDIs appear where required in both human-readable and machine-readable form, at the right packaging levels.
GUDID Data Accuracy
Whether GUDID records match the labeled device and were updated when device information changed.
New DI Decisions
Whether design, labeling or packaging changes were assessed for the need for a new device identifier as part of change control.
UDI in Device Records
Whether device records capture the UDI as expected under 820.35, so units can be traced through production and distribution.
Labeling Controls
Whether labeling and packaging controls under 820.45 prevent UDI mix-ups, including checks before labels are released for use.
Related Services
QMSR Transition
Bringing a QSR-era or ISO 13485 quality system in line with FDA's QMSR, which is now in effect.
FDA Inspection Readiness (CP 7382.850)
FDA device inspection preparation built around Compliance Program 7382.850 and its risk-based approach.
AI-Assisted QMS Gap Assessment
An AI-assisted first pass over the QMS documents you already have, with every result reviewed by an advisor.
Industry Guides That Reference 21 CFR Part 830
Questions
Who is responsible for UDI compliance?
The labeler, generally the firm that causes the label to be applied or modifies it, is responsible for assigning UDIs and submitting data to GUDID. For contract manufacturing and private label arrangements, who holds that role depends on the arrangement, so it should be agreed and documented.
When do we need a new device identifier?
A new DI is needed when a change creates a new version or model of the device, and some packaging and labeling changes have the same effect. Build the DI question into change control so it is answered for every relevant change.
How does UDI show up in an FDA inspection now?
Compliance Program 7382.850 lists UDI among the other applicable FDA requirements, and the QMSR names UDI in 820.35 records. Investigators can check labels, device records and GUDID entries for agreement, and look at labeling controls under 820.45.
21 CFR Part 830
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