Calyx RIM for Registrations

Add an Indications/Intended Use PDS Project

Using the Global Project Planning (GPP) wizard, you can add indications and intended use to the PDS for a product.

The following conditions apply to this function:

  • The list of available indications/intended use options will include all indications/intended use options that are not currently included in the PDS with Pending or Approved status.
  • You cannot use this function to assign indications or intended use to veterinary product families.
Note: The procedure below is a continuation of the Update Product Detail Sets project in the GPP wizard. The procedure presented in Creating an Update Product Detail Set Project must be initiated first.

To add indications and intended use from the Select Action page of the GPP wizard:

  1. Select Add Indications/Intended Use on the Select Action page.
  2. Click Next.
    The Select Indications/Intended Use page opens.
  3. Select one or more indications/intended uses.
    The only ones available to select are those associated with the product families selected for the project.
  4. Click Next.
    The Perform Another PDS Action page opens.
  5. On the Perform Another PDS Action page, do one of the following:
    • Click Yes to return to the Select Action page to perform another update PDS action.
    • Click No and proceed to the Summary page of the GPP wizard. Go to step 6.
  6. On the Summary page, do one of the following:
    • Select the project link on the Summary page to review the new project you created.
    • Click Finish.
    You are returned to the view from which you invoked the GPP wizard. Upon completion, the selected indications/intended uses are assigned a Pending Add status in the PDS tree and a Pending status on the Indication/Intended Use Detail Attributes pages. Also, the selected indications/intended uses are associated with the Product Family if they were not previously associated.
  7. To view the project after closing the GPP wizard, click Home > Projects.
  8. Click the link for the project you just created to open the Project Attributes page.
  9. Navigate to the PDS to view the newly added detail.