Resolving Individual Delayed FDA UDI Submissions
After you have submitted the UDI, it might be delayed. If this happens, a UDISubmission Delayed task appears in the My Tasks table.
To resolve a delayed UDI submission, follow these steps:
1. Right-click the UDISubmission Delayed task and select Resolve Delayed Submission.
2. In the FDA UDI Transmission Delayed or Transmission Failure window, from the Delayed Action list, select one of the following:
◦ Wait—Clears this task and waits another four hours, allowing the submission additional time to complete.
◦ Resubmit—Sends the submission to the FDA again. Contact the FDA before selecting this action.
◦ Force to Closed—Forces the workflow to the Closed state. This action assumes that the submission was successful, but no successful acknowledgement was received. Contact the FDA before selecting this action.
◦ Set as Failed—Treats the submission as a failure, allowing editing of the UDI with another submission attempt. Contact the FDA before selecting this action.
3. In the Delayed Comment field, enter a comment explaining the action.
4. Click Finish.
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The FDA system can take up to four hours before sending acknowledgement #2 or #3. If you do not receive a response after that time, send an email to the FDA at guidsupport@fda.hhs.gov with the Primary Device Identifier. Do not resubmit the UDI until the submission fails or the FDA instructs you to do so. |
