# Configuring FDA Gateway Integration (Product Surveillance)

Product Surveillance includes integrations with the FDA Electronic Submissions Gateway (ESG) for Electronic Medical Device Reporting (eMDR). This integration allows users to send <a href="/en/gr/66495/">submissions</a> or medicinal product data directly to the FDA from Vault and receive gateway responses.


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      <p><strong>Note</strong>: The configuration information in this article is for adverse event reporting in Product Surveillance Vaults. For information on configuring gateways for Regulatory applications, see <a class="external-link " href="https://regulatory.veevavault.help/en/gr/49062" target="_blank" rel="noopener">Configuring Gateway Integration (RIM)<i class="fa fa-external-link" aria-hidden="true"></i></a>.</p>
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## Gateway Profiles

Product Surveillance comes provisioned with the _US FDA ESG_ (`us_fda_esg__v`) gateway profile in an inactive state. In order for users to send adverse event reporting data through this gateway, you must configure and activate its profile within Vault. Gateway profiles have a specific Vault URL that users must register when setting up an account at the FDA.

### Copying the Vault AS2 URL

You must create an account with the FDA before configuring a Vault gateway profile. You can find the steps to create an FDA account on the <a class="external-link " href="https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/CreateanESGAccount/ucm425405.htm" target="_blank" rel="noopener">FDA Website<i class="fa fa-external-link" aria-hidden="true"></i></a>.

As part of the account setup, the FDA will require the **Vault AS2 URL**. To obtain the URL:

  1. Navigate to **Admin > Settings > Gateway Profiles > {Profile}**.
  2. Click the **Copy URL** button to copy the **Vault AS2 URL**.

Once you obtain the necessary certificates from the FDA, you can configure a gateway profile.

### Configuring a Gateway Profile

To configure an FDA gateway profile:

  1. Navigate to **Admin** > **Settings** > **Gateway Profiles**.
  2. Click a profile name to open it and then click **Edit**.
  3. Optional: Edit the **Label** and **Description** for the profile.
  4. Enter a **Sponsor Email Address** to be used in the message header.
  5. Click the **Choose** button next to **Sponsor Certificate** to upload a corresponding digital certificate with the PKCS12 (\*.pfx or \*.p12) format. The FDA gateway system requires digital certificates to verify the digital signature of a document received from a specific source. Input the **Sponsor Certificate Password**. You cannot activate a profile without uploading a certificate.
  6. Enter the **Sponsor ID** as provided to the Health Authority. This may be your company's D-U-N-S number or Routing ID.
  7. Click the **Choose** button next to **Health Authority Certificate** to upload a corresponding digital public certificate for the FDA gateway system. This would have been received from the FDA during account setup. The format of this file can be PKCS7 (\*.p7b or \*.p7c), DER (\*.cer, \*.der) and PEM (\*.cer, \*.crt, \*.pem). The FDA system requires a digital certificate to verify the digital signature of a document received from a specific source.
  8. Edit the **Health Authority ID** for the profile. This should be the same value used by the FDA gateway system and provided by the Health Authority during account setup.
  9. Input the **Health Authority URL**, which is the URL for the FDA gateway system.
  10. Optional: Select the **Gateway User Required** checkbox to use a separate Vault account to manage the gateway profile and then select a **Gateway User**. Vault sends all submission notification messages to this account. Note that this field is required for some connections.
  11. Click **Save**.
  12. Click **Set Active**.

Note that you can only activate the profile after you've populated all fields and uploaded the appropriate Health Authority Certificate.

### Configuring Certificate-Only Authentication

If enabled by an Admin, the **FDA eMDR Gateway Certification Only Authentication** feature allows users to authenticate acknowledgements from the FDA gateway using the digital certificate only, rather than a certificate and the Vault user ID and password. Once this feature is enabled, the Vault URL in the FDA gateway profile is updated to support certificate-only authentication. However, Vault continues to process the new or old URL until the FDA confirms that they have received and applied your new gateway profile information.

To update your gateway profile to support certificate-only authentication:

1. Navigate to **Admin > Settings > Product Surveillance**.
2. Select **FDA eMDR Gateway Certification Only Authentication** to enable this functionality.
3. Navigate to **Admin > Settings > Gateway Profiles > Profile Configuration**.
4. Click the **Copy URL** button to copy the **Vault URL**.
5. Send the updated URL to the FDA via email.

## Creating Transmission Profiles

_Transmission Profile_ object records, referenced from _Country Report Type_ records, contain additional information beyond what is stored in the _Gateway Profile_. Vault uses data from these records to generate the adverse event report XML file with complete information and to indicate to the gateway which type of information you are sending. Define values for the following _Transmission Profile_ fields:

<table class="wbord">
  <tr>
    <td>
      <p>
        <strong>Transmission Profile Field</strong>
      </p>
    </td>
    <td>
      <p>
        <strong>Description</strong>
      </p>
    </td>
  </tr>
  <tr>
    <td>
      <p>
        <em>Name</em>
      </p>
    </td>
    <td>
      <p>
        The name of the profile.
      </p>
    </td>
  </tr>
  <tr>
    <td>
      <p>
        <em>FDA Center</em>
      </p>
    </td>
    <td>
      <p>
        The FDA center to which the event shall be reported. For eMDR adverse event reporting, this value is <em>CDRH</em>.
      </p>
    </td>
  </tr>
  <tr>
    <td>
      <p>
        <em>Submission Type</em>
      </p>
    </td>
    <td>
      <p>
        The type of report information sent. For eMDR adverse event reporting, this value is <em>Adverse_Events</em>.
      </p>
    </td>
  </tr>
  <tr>
    <td>
      <p>
        <em>Routing ID</em>
      </p>
    </td>
    <td>
      <p>
        Also known as a CFN number, this ID is acquired when registering for the FDA ESG. This field value is transferred to the XML file when transmitted.
      </p>
    </td>
  </tr>
  <tr>
    <td>
      <p>
        <em>Gateway Profile</em>
      </p>
    </td>
    <td>
      <p>
        This field references your <em>Gateway Profile</em>. For eMDR, this is the <em>US FDA ESG</em> profile.
      </p>
    </td>
  </tr>
  <tr>
    <td>
      <p>
        <em>Origin</em>
      </p>
    </td>
    <td>
      <p>
        Your organization.
      </p>
    </td>
  </tr>
  <tr>
    <td>
      <p>
        <em>Origin ID</em>
      </p>
    </td>
    <td>
      <p>
        Also known as a D-U-N-S number, this value is obtained during the gateway registration process.
      </p>
    </td>
  </tr>
  <tr>
    <td>
      <p>
        <em>Destination</em>
      </p>
    </td>
    <td>
      <p>
        The organization to which the eMDR transmission will be sent.
      </p>
    </td>
  </tr>
  <tr>
    <td>
      <p>
        <em>Destination ID</em>
      </p>
    </td>
    <td>
      <p>
        The Health Authority ID number of the organization, as determined during gateway account setup.
      </p>
    </td>
  </tr>
</table>

## Submission to the US FDA Gateway

Sending an eMDR XML document through the FDA ESG is part of the _Transmission_ object lifecycle and occurs when the _Transmission_ record enters the standard _Sending_ state. The **VPS: Submit to Gateway** action, when used on an _Adverse Event Report_ record, performs this process automatically.