eMDR Troubleshooting
Resolving a Delayed eMDR
After you have submitted the report, the report might be delayed. If this happens, an eMDR Submission Delayed task appears in the My Tasks table for all users in the Regulatory Report Reviewer role.
The FDA system can take up to 48 hours before sending acknowledgement #2 or #3. If you have not received an acknowledgement within that time, send an email to the FDA at
emdr@fda.hhs.gov with the report number. Do not resubmit the eMDR until the submission fails or the FDA instructs you to resubmit the eMDR. After you receive a response from the FDA and decide how to proceed, do the following:
1. Click the eMDR Submission Delayed task in the My Tasks table.
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Instead of navigating to the task page, you can right-click the task in the My Tasks table and select Resolve Delayed Report.
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2. In the Task Action section, click Resolve Delayed Report.
3. Select one of the following:
◦ Wait—This action clears this task and waits another 48 hours, allowing the submission additional time to complete.
◦ Resubmit—This action resends the submission to the FDA. Contact the FDA before selecting this action.
◦ Force to Closed—This action 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—This action treats the submission as a failure, allowing editing of the eMDR with another submission attempt. Contact the FDA before selecting this action.
4. In the Action Reason field, enter the reason for the action.
5. Click Finish. The workflow state of the Regulatory Decision eMDR activity changes, depending on the option that was selected:
◦ Wait—The workflow state changes to In Progress while Windchill Customer Experience Management continues to wait.
◦ Resubmit—The workflow state changes to Submitting while Windchill Customer Experience Management submits the eMDR.
◦ Force to Closed— The workflow state changes to Closed with no further workflow states.
◦ Set as Failed— The workflow state changes to Fail. See the “Resolving an eMDR Submission Failure” section below.
Resolving an eMDR Submission Failure
After you have submitted the report, the report might experience a transmission failure. If this happens, an eMDR Submission Failure task appears in the My Tasks table for all users in the Regulatory Report Creator role.
1. Click the eMDR Submission Failure task in the My Tasks table.
2. In the Task Action section, click Enter Report Details.
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Instead of navigating to the task page, you can right-click the task in the My Tasks table and select Enter Report Details.
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3. In the Submission Errors step, review the reason for the transmission failure.
4. Click Next.
5. Correct the error in the Set Attributes step.
6. If applicable, click Next to enter codes, set attachments, or view product details.
7. Click Finish to move the Regulatory Decision eMDR activity to the Approval workflow state.
