FDA Update

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

This new rules for the MDR reporting requirements. It will now include the UDI number.

The U.S. Food and Drug Administration (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 visit the Unique Device Identification System website.

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

For more information on the Unique Device Identifier, please email us at: [email protected] and ref: Unique Device Identifier (UDI-DI) AND (UDI-Public).