About Device Identification Submission to Regulatory Authority Through AS2 Gateway

You can submit device identification objects to FDA or any other regulatory authority through AS2 Gateway. For this, there must be communication between the Device Identification app, AS2 Gateway, and the regulatory authority. AS2 Gateway helps to efficiently manage submissions and acknowledgments between the app and the regulatory authority. The AS2 Gateway server supports multiple ENOVIA servers.

The Device Identification (DI) app sends a unique file with the extension tar.gz to AS2 Gateway. AS2 Gateway immediately sends acknowledgment (ACK) to DI to indicate that the file has been received. When DI receives the acknowledgment, the DI object gets promoted to the Submitted state and the Message ID of the DI gets updated.

AS2 Gateway sends the tar.gz file to the regulatory authority (FDA) for approval. After processing the files, the regulatory authority sends acknowledgments back to the gateway. The gateway receives the acknowledgments and processes it. DI requests AS2 Gateway for the acknowledgments that the regulatory authority has sent and the gateway sends the acknowledgments to DI.

You can see the checked-in acknowledgments under the ACKs tab in the Content category of the DI page. If there is a successful response from the regulatory authority, the DI object is promoted to the Published state. If the submission is a failure, the DI object is demoted to the Review state, and the Regulatory Response field in the DI page is updated with a reason for failure.

If ACK1 has any processing error at the regulatory authority, the DI object gets demoted to the Review state and the Regulatory Response field on the DI is updated as unexpected processing error and the Submit Status is changed to Fail.