Resolving Failed FDA UDI Submissions

Zusätzliche Funktionen > Windchill Quality Management Solutions > Unique Device Identification > Working with Unique Device Identification > Resolving Failed FDA UDI Submissions

After you have submitted the UDI, it might experience a transmission failure. If this happens, a UDISubmission Failure task appears in the My Tasks table. To resolve a failed UDI submission, follow these steps:

1. Right-click the UDISubmission Failure task and select Resolve Failed Submission.

2. In the Edit UDI Submission window, review the errors in the Transmission Errors step.

If you have manually set a delayed UDI submission to the Failed state, errors are not present in this step.

3. Click Next.

4. Edit the necessary information in the Set Attributes and Table Data steps to correct the errors.

5. Click Finish. If the errors have been corrected, the item moves to the Approval state.

The UDI must be reapproved before it is submitted to the FDA.