Guidance Breakdown: The FDA Updates its GUDID Final Guidance
The update makes minor revisions from the previous 2014 guidance, including the removal of now-unneeded FDA Preferred Terms or codes from the database. We break it down.
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Earlier in December, the FDA issued an updated final guidance on submitting unique device identifiers (UDIs) to the Global Medical Device Nomenclature Database (GUDID).
This updated document, which replaces a June 2014 guidance, includes only minor revisions—most notably removing FDA Preferred Terms (FDA PT or codes) from the database, as these are no longer necessary.
According to the new guidance, the changes “reflect upcoming modifications to the Global Medical Device Nomenclature (GMDN) field in GUDID and other minor clarifications.”
Since April 2019, the GMDN Agency has allowed access to GMDN Terms without a paid membership, making FDA PT codes unnecessary. As a result, the guidance removes references to FDA PT codes and requires GUDID users to use GMDN codes instead.
Another notable update emphasizes a lifecycle approach to maintaining device identifier (DI) records. The guidance states that labelers are responsible for ensuring their DI record information remains accurate and up-to-date throughout the device’s Total Product Lifecycle (TPLC).
The FDA also notes that additional database “enhancements” may be introduced to improve user experience, strengthen validation rules, and incorporate user feedback.
As a brief refresher on the UDI rule, all medical device labels and packaging must include a UDI unless specifically exempt. This requirement also applies to combination products with a device component, convenience kits, in vitro diagnostic (IVD) products, and products derived from human cells and tissues (HCT/Ps) regulated as devices. Standalone software is also subject to this requirement.
A UDI has two parts:
Device Identifier (DI): A mandatory, fixed portion of the UDI that identifies the labeler and the specific version or model of the device.
Production Identifier (PI): A conditional, variable portion of the UDI that can include the lot or batch number, serial number, expiration date, manufacturing date, and, if applicable, a distinct identification code for an HCT/P regulated as a device.
The GUDID database contains only the DI portion, serving as the primary key for accessing device information. Production Identifiers are not submitted to GUDID; instead, the database uses “production identifier flags” to indicate which PI attributes appear on the device label.
The guidance covers key concepts of the GUDID, its modules, and submission requirements. It also includes four appendices:
Appendix A: GUDID packaging information example
Appendix B: GUDID data elements reference table
Appendix C: UDI formats used by FDA-accredited issuing agencies
Appendix D: GUDID attributes mapped to a sample (fictitious) medical device label
Current guidance requirements at a glance
In case you’re not familiar with this new guidance or the older 2014 guidance—or simply want a distilled refresher, below is a quick breakdown of its current details.
Account structure and core concepts
The GUDID is the FDA's repository of key device identification information. Firms must establish a GUDID account identified by their Organization DUNS number, which represents the highest corporate level in the labeler organization. This number may be either the headquarters DUNS or the parent DUNS number for included labelers.
Each organization must designate a single Regulatory Contact who is the primary liaison with the FDA for GUDID matters. Coordinators who manage the account and user access and Labeler Data Entry (LDE) users who handle day-to-day data submission activities support this role. Organizations can also authorize third-party submitters to act on their behalf, though the company retains ultimate responsibility for submission accuracy and compliance.
Device Identifier records and data requirements
At the heart of GUDID are Device Identifier records, which contain the mandatory, fixed portion of the UDI that identifies both the labeler and the specific device version.
Each DI record must include a Primary DI that serves as the main lookup key, at least one GMDN code for device categorization, and all required data attributes specified under 21 CFR 830.310.
Companies may also incorporate optional identifiers, including Secondary DIs from different issuing agencies, Unit of Use DIs for individual devices without direct UDI labeling, Direct Marking DIs for permanently marked devices, and Package DIs for higher-level packaging configurations.
These records progress through distinct states within the system:
They begin as drafts in the web interface, move to an unpublished state once they are complete but pending their future publish date, and finally transition to published status when they become available in the public database.
A critical seven-day grace period follows publication, during which companies can make full edits to the record.
After this period, editing capabilities become limited, though records must be published within 15 days of commercial distribution.
Submission pathways and technical implementation
The FDA provides two primary pathways for submitting GUDID information:
The web interface offers a manual data entry approach well-suited for organizations with lower submission volumes. It provides immediate validation and full editing capabilities, including saving draft records.
For higher-volume submitters, the HL7 SPL XML submission pathway enables automated submission through the FDA Electronic Submissions Gateway. This method requires the completion of testing protocols before production use and must adhere to detailed technical specifications, though it lacks draft record capabilities.
Configuring packages
The GUDID system requires careful attention to package configurations.
Each packaging level must have its unique DI, with the base package (lowest level) DI serving as the Primary DI. Package information inherits base attributes while requiring specific details, including the Package DI number, quantity per package, contained DI Package references, and optional package type descriptors. All values must precisely match device labeling and maintain consistency across FDA submissions.