Sending an electronic Medical Device Reporting (eMDR) XML payload to the FDA is part of the adverse event reporting process. Vault’s integrations with the FDA Electronic Submissions Gateway (ESG) allow you to transmit directly from an Adverse Event Report record to the FDA.
In order to send an eMDR XML payload directly to the FDA, your Admin must first set up a gateway profile and provide you with a Vault AS2 URL to create an AS2 account at the FDA. This ensures the FDA can successfully receive electronic submissions. To learn about creating an AS2 account, view the FDA website.
Note: This feature is only available on Quality Vault Product Surveillance (VPS) Vaults.
How Gateway Integration Works
Gateway integration enables you to gather information and transmit adverse event reports to the ESG directly from your Vault. Vault validates the required information when generating the XML document. After transfer, Vault adds responses from the ESG, known as acknowledgments, as Transmission Messages related to the Transmission record, allowing you to track and manage acknowledgments from the FDA within Vault.
About the FDA Electronic Submissions Gateway
The ESG is provided by the FDA to allow for the transmission of electronic regulatory submissions. It enables the secure submission of reporting content for review and is the central receipt point for sending information electronically to the FDA.
Note: If your password on the Vault account used by the FDA to authenticate expires, you’ll need to contact the FDA to update the password. If you don’t update your password, incoming requests from the FDA will fail authentication.
Sending Submissions to a Gateway
You can submit to a gateway with the VPS: Submit to Gateway action on an Adverse Event Report record.
To submit to the FDA gateway from an Adverse Event Report record:
- From Business Admin or a custom object tab, navigate to the individual Adverse Event Report record.
- From the Actions menu, select the VPS: Submit to Gateway action.
FDA Acknowledgment Responses
When sending a submission to the FDA ESG, Vault receives responses as acknowledgments and adds them as Transmission Messages to the Transmission record. Each acknowledgment has a prefix of the date and time it was received, as well as the transfer ID. For example,
2017-11-25 18:12:23 ci1433968485346.681040@fdsul08646_te2.txt.
Note that you receive multiple acknowledgments from the FDA which may contain information about an issue that occurred during processing. Depending on the contents of the acknowledgments, we recommend reviewing the FDA eMDR FAQ, contacting the FDA, or contacting Veeva Support.
The FDA ESG delivers three (3) different acknowledgments to the account from which the submission was sent:
When the FDA receives a submission, the ESG validates the signature to ensure it was signed by a valid certificate. Once the signature is validated, the FDA sends a Message Delivery Notification (MDN) back to the user. This is considered the first acknowledgment and confirms that the submission was delivered.
The first acknowledgment contains a Message ID and a timestamp showing when the submission was received. The Message ID uniquely identifies each submission and can be used to track and correlate a submission to its Center’s acknowledgment.
If signature validation is successful, the submission is unpackaged and restored to its original structure. The ESG generates and sends Acknowledgment 2 (Ack2) when unpackaging is complete. Ack2 also contains a timestamp and a Core ID, which the ESG uses to track a submission. Note that if unpackaging is unsuccessful, Ack2 will contain an error. The ESG only processes successfully unpackaged submissions.
In some cases, Centers may generate and send Acknowledgment 3 (Ack3) with validation results. Ack3 notifies you if the submission was successfully processed. The Ack3 may also include a Technical Rejection Notification that states why the submission was unsuccessful.