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Creating Supplemental or Follow-Up Regulatory Reports

Often, it is necessary to follow-up an initial report with a follow-up report that provides supplementary information to the regulatory agency.

When you run a supplemental or follow-up report, the report should contain the initial report number and any corrected or new data.

CAUTION:  Regulatory report records cannot be deleted.

This task is a step in Process of Regulatory Reporting.

To create a follow-up or supplemental regulatory report

1. Navigate to Product Issues screen, then the Product Issue List view.
2. In the Product Issue List, drill down on a product issue.
3. Click the Regulatory Reports tab.
4. In the Regulatory Reports list, create a new record and complete the necessary fields.

   When the regulatory report is created:

   • The following fields are copied from the product issue: PI # and SR #
   • The following fields are set with a default value: Status is set to In Progress, Owner is set to Creator of the record.
5. Set the Report Type field to 3500A Supplemental or MDV Follow-up.
6. Click Populate Report.

   The Populate Report button only copies the initial report number to the supplemental report. (No other fields are copied.) You can configure the application to copy additional fields such as Mfg Narrative and Corrected Data to the supplemental report. Review the LS Medical Product Issue Populate Report Workflow for an example of a similar configuration.

7. If you are a device manufacturer preparing a 3500A Supplemental report, make sure to check a Follow-Up Type in the Investigation view.
8. After creating a follow-up or supplemental regulatory report, you can view it, submit it, reopen it in the same way as a initial report:
   • Running 3500A and MDV Reports
   • Generating Regulatory Report Numbers and Submitting Reports
   • Reopening a Regulatory Report