Submitting Device Identification to Regulatory Authority Through AS2 Gateway

You can submit device identification objects to FDA or any other regulatory authority through AS2 gateway. AS2 gateway helps in efficiently managing submissions and acknowledgments between the Device Identification app and the regulatory authority.

Important: This app uses electronic signatures to provide an audit trail for certain approvals, as is often required in highly-regulated industries. You cannot delete or modify the personal data contained in the electronic signatures. You should carefully review your use cases associated with electronic signatures to ensure that the specific business requirements associated with them are being met, while still adhering to good personal data management practices.

Required access roles:

  • App-specific: Regulatory Lead
  • Baseline: Leader

Before you begin:
  • You must be a Regulatory Lead or a Leader.
  • The selected objects must be in the Approved state.
  • In the Device Information page, the value of Automatic submission to Authority must be set to Yes for automatic submission and No for manual submission.
  • A device classification for country need to be added in the DIPreferences setting.
    Note: The user assigned with the Administrator role can modify the DIPreference.xml file present at the <Server_Install_dir>\Apps\DeviceIdentification\<RELEASE_NAME>\Modules\ENODEIDBase\AppInstall\Programs location, add the required device classification for the country. For more information, see Page Object for Grace Period.

The ESIGN (one-step validation) is enabled and the 'This approval requires an electronic signature' page is appeared if,

  • The context object has the route and the value is specified to true for the Requires ESign attribute of the context route object.
  • The context object does not have the route,
    • The global E-Signature value is configured as ‘Required for approval tasks’ or ‘Specified in route template’.
    • The global E-Signature value is configured as ‘Not required for approval tasks’, the 'This approval requires an electronic signature' page is not appeared.

The 3DEXPERIENCE Platform - Access Control page is appeared if,

  • All the selected objects have the route and the value is specified to true for the Requires ESign attribute of the context route.
  • All the selected business objects do not have route and global E-Signature value is configured as ‘Required for approval tasks’ or ‘Specified in route template’.
  • Some of selected objects have route and some do not have the route, the 3DEXPERIENCE Platform - Access Control page is appeared.
    • If the value is specified to true for the ‘Requires ESign’ attribute for any route object.
    • If the value is specified false to the ‘Requires ESIGN’ attribute for all the route objects. Also the global E-Signature value is configured as ‘Required for approval tasks’ or ‘Specified in route template’.

  1. Go to the Device Identification home page or the Device Identification list page.

    For details, see Device Identification Home Page or Device Identification List.

  2. Select the required device identification object.

    If you are selecting more than one device identification object, the DUNS number of the selected objects must be the same.

  3. From the page toolbar, select Actions > Publish To Authority.
    The Submission Information panel appears.
  4. Enter the following details.
    Column Name Description
    Comments Type the comments or any additional information. This is optional.
    DUNS Number Type the DUNS number of the labeler.
    Labeler Organization The submitter type of DI and cannot be edited. If Authorized Representative is assigned, the Labeler Organization is set to Third-Party. Otherwise it is set to Labeler.
  5. Click Done.
    The "This approval requires an electronic signature page" appears.
  6. Enter your user name and password in the User Name and Password dialog boxes respectively in the 3DEXPERIENCE section. Also select the check box that confirms that your electronic signature is the equivalent to your hand written signature.
  7. Click Validate.
    The 3DEXPERIENCE Platform - Access Control page appears.
  8. Enter the code that is received on the configured device.
  9. Click Validate.

    The submission file is created only for USA and attached to the DI object and the DI object is moved to the Submitted state. For all other countries and region, the DI object is moved to Published state and the submission file is not created.

If the Automatic submission to Authority is set to Yes, the submission file is sent to the regulatory authority. When the acknowledgment files for submission are received from the regulatory authority, the device identification object is moved to the Published state and the values of Core Id, Status, and Response are updated in the Device Information page.

If the Automatic submission to Authority is set to No, you must download the submission file from the Content page and send it manually to the regulatory authority. After submission, you can check in the acknowledgment files by following the given procedure.

  1. From the Content category, click the ACKs tab.
  2. Click Check-in ACKs from the page tool bar.
  3. In Checkin Dialog, select and upload the acknowledgment files.
When the acknowledgment files are uploaded, the values of Message Id, Core Id, Status, and Response are updated.