Medical Devices: Unique Device Identification and GUDID

A labeler generally causes a device label to be applied or modified for commercial distribution without further replacement or modification. Depending on the activity, this can include a manufacturer, repackager, relabeler or other organization. Merely adding distributor contact details has a specific treatment. Assign responsibility using the regulatory definition rather than a purchasing department’s informal terminology. FDA UDI basics.

The device identifier identifies the labeler and the particular device version or model. The production identifier is conditional and relates to information such as lot, serial number or expiration date when that information appears on the label. The two parts should be distinguished in label design, data management and the evidence retained for a distributed configuration. FDA format explanation.

Part 830 addresses the UDI system, issuing-agency framework and labeler responsibilities. Device identifiers must be assigned and maintained consistently with applicable requirements. The internal device master data should connect identifiers to the version or model and any relevant changes. A company-created inventory code does not automatically satisfy the UDI framework. Part 830.

UDI labeling requirements and exceptions are addressed in Part 801. Some reusable devices intended to be reprocessed before each use also require direct marking, subject to the relevant provisions. Evaluate the device, package levels and any exception or alternative separately. A general claim that a product is reusable does not settle the complete labeling analysis. FDA requirements overview.

GUDID contains the device identifier and associated identifying information, not individual production-identifier values for every manufactured unit. FDA’s December 2024 guidance explains data submission and updates, including changes to nomenclature information. A public GUDID entry identifies a device record; it does not establish FDA clearance, approval or a clinical performance conclusion. FDA GUDID guidance.

Determine the labeler, identify applicable exceptions, establish identifiers through an appropriate issuing system and reconcile packaging with GUDID data. Changes to a version or model require assessment of identifier and record consequences. Keep evidence supporting exceptions or granted alternatives with the labeling decision, and verify the actual record rather than relying only on successful submission. Regulatory responsibilities.