GUDID is the U.S. publicly accessible database that contains the device identifier portion of UDIs along with attributes like brand name, version/model, sterilization, MR safety, and more. Labelers submit DI records through the GUDID web interface or via HL7 SPL files, and FDA publishes the data in AccessGUDID, run with the National Library of Medicine. Records include device identifiers, labeler, product codes, sizes, MR safety status and whether the device contains latex. Data must be kept current, and changes to certain attributes require a new DI. GUDID does not hold production identifiers such as lot or serial numbers.

Why it matters

Labelers submit GUDID records via FDA's portal or HL7 SPL. Data quality directly affects EHR ingestion, recall lookups, and supply chain integrity.

Common pitfalls

•Failing to accurately link UDI-DI to correct device attributes can lead to submission rejection and compliance issues.
•Incorrectly submitting data, especially regarding device characteristics, can impair the utility of GUDID for post-market surveillance.
•Not understanding the distinction between device identifier (DI) and production identifier (PI) can result in improper data entry.
•Ignoring the ongoing maintenance requirements for GUDID records can lead to outdated information and non-compliance.
•Assuming GUDID is a global database and not recognizing it as specific to the US FDA’s regulatory framework often causes confusion.

Sources

GUDID · FDA
FDA Recalls - Medical Devices · FDA
EUDAMED Public Site · European Commission

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Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
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