FDA AS2 Connectivity

AS2 connection with FDA

• Set Up an AS2 Station: Configure an AS2 station for your organization in MFT Gateway. This station will handle sending and receiving messages to and from the FDA. Once created, share the station’s partner configuration with the FDA for FDA-side configuration (which usually happens via an FDA support ticket).

• Configure FDA as an AS2 Partner: Create an AS2 partner entry for the FDA in MFT Gateway. Use the connection details provided by FDA to complete this configuration.

• Once FDA has confirmed the connection, send a test file to FDA as instructed by them (usually to the GWTEST center).

Configuring FDA specific HTTP headers

When submitting messages to FDA via AS2, certain custom HTTP headers are essential to ensure that submissions are correctly processed and routed. These headers allow the routing of messages to multiple FDA centers under the same AS2 ID (partner definition).

In MFT Gateway, you can add these custom HTTP headers to your FDA partner setup using the Header Profile functionality in the Manage Partner view under Advance Options. One of these pre-configured profiles can be selected directly in the message compose view when making submissions, automatically adding routing IDs to FDA-bound messages as needed.

Example Headers:

X-Cyclone-Metadata-FdaCenter: Specifies the FDA center for routing
X-Cyclone-Metadata-FdaSubmissionType: Specifies the submission type

Submitting Messages to FDA

The MFT Gateway Message Submission view enables quick FDA submissions with minimal effort. By default, the FDA partner’s pre-configured default header profile is selected, but you can choose any available profile for your configured FDA partner.

To submit, simply select your message sender and message receiver, upload the content, and click Send. MFT Gateway will securely transmit your submission to the FDA over AS2.

You can also automate message delivery using any of the integration methods provided by MFT Gateway.

FDA Submissions list view

After successfully submitting data to FDA via MFT Gateway, a summary of submission details is available in the FDA Submissions List. This view provides essential tracking information, including acknowledgment status, indicating whether acknowledgments have been received successfully or are pending. These acknowledgments play a role in enabling submitters to establish that their submissions were received and are now being acted upon. Usually, FDA acknowledgments may appear in three categories:

Acknowledgment 1 (ACK 1): Receipt Acknowledgment:

The first acknowledgment (ACK1) confirms that the FDA’s ESG has received the submission. For AS2 transmissions, the MDN (Message Disposition Notification) serves as ACK1. The MFT Gateway will receive the ACK1 (MDN) synchronously and will display ACK1 status immediately upon receipt.

Acknowledgment 2 (ACK 2): Validation Acknowledgment:

ACK2 confirms preliminary validation of the submission, verifying correct formatting and compliance with FDA’s basic technical requirements. If errors are found, ACK2 will specify corrections needed. Upon receiving ACK2 (typically as a separate AS2 message), MFT gateway will identify the correlation between the original submission and automatically update the ACK2 information in the FDA submissions view.

Acknowledgment 3 (ACK 3): Center Acknowledgment:

ACK3 is the final acknowledgment confirming successful delivery to the FDA Center, marking the start of the regulatory review process. MFT Gateway automatically updates the corresponding submission with ACK3 information when this AS2 message is received from the FDA with ACK3 information.

In the FDA Submission view, use the Open ACK button to view detailed information for each acknowledgment. Additionally, acknowledgment content can be directly downloaded from the list view without accessing the original AS2 message.

In addition to the acknowledgment status, the FDA Submissions list view provides the following information associated with each submission:

• Message recipient
• AS2 identifier
• Core Identifier
• Report number
• Timestamp

Filtering FDA Submissions

The MFT Gateway enables filtering of FDA submissions by sending station, receiving partner, relative or absolute timestamps, AS2 message identifier, Core Identifier, and Report number for more efficient tracking of each submission.