I'm working on a PMS project that includes analysis of FDA's MAUDE database. A desirable part of the would identify the UDI, or at least the UDI-DI, for the record in MAUDE.
FDA has informed me, "On November 4, 2022, FDA's Center for Devices and Radiological Health (CDRH) announced via email that it had "updated its public adverse event databases to include fields for the Unique Device Identifier – Device Identifier (UDI-DI) and a modified version of the complete Unique Device Identifier (UDI-Public) in the search results. The new fields are now available in the Manufacturer and User Facility Device Experience (MAUDE) database".
The announcement location is https://content.govdelivery.com/accounts/USFDA/bulletins/332541a
Does anybody have information on the "modified version of the complete Unique Device Identifier (UDI-Public)"? How does it differ from the complete UDI?
Has anybody located an instance of the UDI-Public in a MAUDE record?
I infer it is derived from the information a manufacturer is required to submit through eSubmitter, so the manufacturer doesn't need to change the reporting.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
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