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Update FSCA (create new version)

Once an FSCA is submitted, it can be updated through the creation of a new version.

Note

Due to the inter-dependence between FSCA and FSN reports, the available options when updating an FSCA can vary.

Here is a cheat sheet of all possible updates depending on the FSCA's state and FSN variations:

FSCA_cheat_sheet.png

  1. Having accessed the relevant FSCA on the default Report Primary Details screen via Search & view Vigilance items, click on Create new version at the top right corner:Search & View Vigilance & Post-Market Surveillance reports

    FSCA_create_new_version.png

  2. Click on Complete action in the pop-up window, to confirm the initiation of a new FSCA version:

    FSCA_update_confirm.png

    The applicable FSCA sections will become accessible for updates.

  3. Modify the relevant fields selecting the appropriate sections from the list on the left, for example:

    FSCA_update_example.png

    Important

    Under the Device information section you can see any FSNs linked to the current FSCA:

    FSN_linked_in_Device_info_FSCA.png

  4. When you have made all necessary updates, click on the Submit button at the top right corner:

    FSCA_submit_new_version.png

  5. Click on Complete action in the pop-up window to finalise the action:

    FSCA_complete_action.png

    The system will save the new version, and the current version number will also be visible under the report’s reference number:

    FSCA_updated_version_ref.png

    The newly created version is shown in the Action history overview section:

    FSCA_report_history_new_version.png

    Note

    When creating a new FSCA version, CAs and NBs will receive a notification:

    FSCA_new_version_notif.png