Configuring FDA Gateway Integration (VPS)

Vault Product Surveillance (VPS) includes integrations with the FDA Electronic Submissions Gateway (ESG) for Electronic Medical Device Reporting (eMDR). This integration allows users to send submissions or medicinal product data directly to the FDA from Vault and receive gateway responses.

Note: The configuration information in this article is for adverse event reporting in VPS Vaults. For information on configuring gateways for Regulatory applications, see Configuring Gateway Integration (RIM).

Gateway Profiles

VPS 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 FDA Website.

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

Navigate to Admin > Settings > Gateway Profiles > {Profile}.
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:

Navigate to Admin > Settings > Gateway Profiles.
Click a profile name to open it and then click Edit.
Optional: Edit the Label and Description for the profile.
Enter a Sponsor Email Address to be used in the message header.
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.
Enter the Sponsor ID as provided to the Health Authority. This may be your company’s D-U-N-S number or Routing ID.
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.
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.
Input the Health Authority URL, which is the URL for the FDA gateway system.
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.
Click Save.
Click Set Active.

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

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:

Transmission Profile Field	Description
Name	The name of the profile.
FDA Center	The FDA center to which the event shall be reported. For eMDR adverse event reporting, this value is CDRH.
Submission Type	The type of report information sent. For eMDR adverse event reporting, this value is Adverse_Events.
Routing ID	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.
Gateway Profile	This field references your Gateway Profile. For eMDR, this is the US FDA ESG profile.
Origin	Your organization.
Origin ID	Also known as a D-U-N-S number, this value is obtained during the gateway registration process.
Destination	The organization to which the eMDR transmission will be sent.
Destination ID	The Health Authority ID number of the organization, as determined during gateway account setup.

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.