FDA UDI & GUDID Submission Guide

UDI labeling, GUDID and authorization are different controls

A Unique Device Identifier supports device identification and traceability. GUDID holds identification information submitted by the responsible labeler. Neither a GUDID record nor a UDI grants FDA marketing authorization or replaces establishment registration and listing.

Determine whether you are the labeler, what device and packaging levels are involved, and whether an exception or current compliance policy applies. Do not assume every Class I device has identical GUDID duties or that a relabeler is exempt because another company manufactured the product. Use the FDA UDI framework for scope and current policy.

Device identifier versus production identifier

The device identifier, or DI, identifies the labeler and a specific device version or model. A production identifier, or PI, can convey variable production information such as lot, serial number or expiry where applicable. FDA states that GUDID contains the DI and indicators describing PI content; the database does not receive individual PI values for every manufactured unit.

Build a model and packaging hierarchy connecting the assigned identifiers, label artwork and master data. Assess direct marking for devices intended for repeated use and reprocessing where applicable, and apply the relevant exceptions instead of extending a packaging rule to every device.

GUDID preparation and submission workflow

1. Assign a regulatory owner and data owner; document the labeler decision and device scope.
2. Establish identifiers through an FDA-accredited issuing agency and reconcile each DI with the controlled model list.
3. Review FDA's account preparation instructions and request a GUDID account, with appropriate coordinator and user access.
4. Select a submission method. FDA provides GUDID web entry and HL7 Structured Product Labeling submission options through its current submission instructions.
5. Validate required attributes against the final label, device version, product code, packaging and other source records. Resolve errors before publication.
6. Verify the published record and retain submission evidence, ownership and change-control instructions.

Maintain the record as the device changes

A changed model, packaging configuration or identifying attribute may require a new DI or another record action. Assess the issuing-agency rules and FDA requirements before overwriting master data. Keep discontinued models and record corrections traceable, and distinguish corrections from changes to the marketed product.

Connect the workflow to labeling review and QMSR document control. The release checklist should reconcile physical labels, human-readable and machine-readable UDI, database attributes and the device authorized for sale. Pure Global can help define responsibility and review the evidence and data gaps before submission.