1 EDI Source, Inc. is proud to announce the addition of the Food and Drug Administration as a new trading partner option for our clients.
This partnership, which is extremely information intensive, will provide information management by leveraging information technology to facilitate the electronic submission of data by industries regulated by the FDA.
This electronic submission solution is known as the FDA Electronic Submissions Gateway, or FDA ESG.
The FDA ESG is a centralized communications point for receiving regulatory information securely, and in turn, distributing data received agency wide within the FDA. The FDA ESG, acting as an electronic conduit for electronic submissions.
This consists of 4 main steps:
Submission types for Adverse Event Reporting include Electronic Medical Device Reports (eMDR) which once submitted, generate three return acknowledgements from the FDA. These three acknowledgements must all be received back with a status of successful to be considered accepted by the FDA. If any of the acknowledgements are returned with a status of failed, the original eMDR must be corrected and resubmitted within thirty days to remain compliant with FDA regulations.