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On August 14, 2023, the U.S. Food and Drug Administration (FDA) will update the fields released in the public AccessGUDID Database and the openFDA Unique Device Identifier endpoint to include Global Medical Device Nomenclature (GMDN) Term Codes along with the status of the GMDN Term Code, Active or Obsolete. If a labeler submitted an FDA Preferred Term (FDA PT) Code to meet their GMDN Code data entry requirement, the equivalent GMDN Code will now also be released publicly. This latest update is intended to provide end users with enhanced search and retrieval capabilities for GUDID data.
To prepare for this upcoming release, the FDA is reminding labelers to review their GUDID records to assure their GMDN Term Code or FDA PT Code assignment is correct, and the code is active, NOT obsolete, consistent with labelers’ obligation to update the information they have submitted to GUDID in 21 CFR 830.330(b). The FDA expects labelers to complete their updates within the timelines specified in the regulations and by the end of July 2023 to assure accurate information is released in GUDID and openFDA.
Resources are available on the GMDN website to help labelers identify alternatives to obsolete term codes.
Questions?
If you have questions or need further assisstance, please contact the FDA UDI Help Desk.
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