Thursday, October 11, 2012
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, consists of 4 main steps: 1) Receipt; 2) Acknowledgement; 3) Routing; and 4) Notification.
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.
To become a registered user of the FDA ESG, several steps must be completed in sequence. First, an organization is required to apply for a test account and, once approved, test submissions are sent to the FDA test system to ensure accuracy and compliance with FDA standards. Once test account requirements have been satisfied, a production account request is submitted, allowing an organization to begin electronically submitting data to the FDA. In addition to the above outlined requirements, additional preparations include a letter of repudiation (to comply with Federal Regulations), a digital certificate for use with AS2 along with a thorough understanding of submission guidelines and FDA ESG processing.
Once an FDA ESG process is automated, the organization will realize significant business benefits. Decreased compliance risk and increased cost savings realized by implementing systems to create, submit and audit the eMDR process will be a significant improvement over manual systems offered by regulatory bodies in place today.