1. User's Guide
  2. Transmit and Monitor Reports
  3. Schedule Reports
  4. Follow-Up eMDR Reports

Follow-Up eMDR Reports

If an eMDR report is manually scheduled or automatically scheduled for the same reporting Destination, system either schedules Initial or Follow-up report based on the same logic (product license ID and status of previously scheduled report) that is currently existing for Device reports.

If the case was previously submitted to a Reporting Destination as MedWatch Device report and if the same reporting destination is configured for sending eMDR report:

  1. System schedules the next eMDR as a follow-up report and displays the follow-up numbering in the Case Form ' Regulatory Reports ' Seq field by considering the previously reported MedWatch device report.
  2. System uses the same report number (F.2 or G.9) that was used in MedWatch Device report in eMDR for the data element ufimporterrepnumber(F2) or mfrreportnumber (G9).
  3. Follow-up number that is populated in (F7 uffollowupnumber or G7 gfollowupnumber) shall be incremented from (F7 or G7) of the previously submitted MedWatch Device report by considering the internal common profile switch Allow generation of Report.

Example : If F/p 1 report was submitted as 0000555-2014-00011 to CDRH in MedWatch format and the next follow-up report in eMDR format, then Mfr Report # shall be populated as 0000555-2014-00011 and F/p number as 2.

If the previous report was sent by eMDR and the subsequent report is being sent as MedWatch Device to the same destination, the system shall maintain the report numbering (F2 or G9) same as of previously submitted eMDR.

  1. System schedules a follow-up report by populating Follow-up' in the Case Form Regulatory Reports' Seq column.
  2. System uses the same report number (F2 or G9) from the previously submitted eMDR report in the F2 or G9 of MedWatch Device report.
  3. Follow-up number that is populated in (F7 or G7) is incremented from (F7 uffollowupnumber or G7 gfollowupnumber) of the previously submitted eMDR report by considering the internal common profile switch Allow generation of Report.
  4. The MedWatch Device scheduled after the eMDR report does not respect the Common Profile Switch "Data to print on follow up MedWatch Device form "and system displays a warning message during manual scheduling of report as Delta data will not be printed MedWatch Device form for this Device license as it was previously submitted as an eMDR. In case automatic scheduling, this warning message is logged against the report without impacting report scheduling or generation.

Example: If F/p 1 report was submitted as 0000555-2014-00011 to CDRH in eMDR format and the next follow-up report in eMDR report fails due to some reason and company decides to send them in MedWatch device format, then MedWatch report shall print Mfr Report # as 0000555-2014-00011 and F/p number as 2

System includes complete data in follow-up eMDR as the other E2B (R3) reports.

Note:

Common Profile Switch Data to print on follow up MedWatch Device form does not have any impact on eMDR follow-ups.

Downgrade report is scheduled automatically if the F/UP version does not satisfy the Regulatory Reporting Rules defined for eMDR for a case that was previously submitted in eMDR.

Follow-up eMDR is scheduled automatically if the Significant F/UP version is marked as Amendment for a case that was previously submitted in eMDR (existing functionality for non E2B (R3) reports).

Nullification reports are not scheduled for eMDR.

Parent topic: Schedule Reports