NYSDA Publications

FDA Updates Medical/Dental Device Adverse Events Database

Per the notice below, the United States Food and Drug Administration (FDA) has updated its medical/dental device adverse events database.

FDA Updates Fields Available in the Manufacturer and User Facility Device Experience (MAUDE) Database and openFDA

The FDA 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 and the openFDA Device Adverse Event endpoint.  This latest update is intended to ensure adverse event information in the databases is searchable.

 

 

To learn more information about the UDI, go to the Unique Device Identification System website.

Questions?

Contact the Division of Industry and Consumer Education for any questions or concerns about specifications and enhancements.

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