Data Export to GUDID

COSMO Unique Device Identification supports the upload of UDI data to the FDA GUDID database. The connection to the GUDID is not a machine-to-machine connection, but a manual upload based on a generated XML data set.

To create XML files for one or more UDI-DIs, open a list of released FDA UDI-DIs.

1. Select the records you need and then choose the Create GUDID export file action.
2. Confirm the dialog by choosing the Yes button.
3. A zipped export folder will be downloaded to the Downloads folder on your computer. The folder contains one subfolder per UDI-DI named according to the name of the UDI-DI Item No., Variant Code and Submission Version No. Within this folder, another subfolder with the spl name has been created, which contains the actual XML file. This folder structure was defined by the FDA.
4. To upload the file, follow the instructions for using the GUDID database.

Note

The Create GUDID export file action is only active if the selected UDI-DI has the Released status.

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