FDA: Get Ready, the World is Getting Ready to Change

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Jeff Mazik, Vice President, Life Science Solutions, AssurX

Jeff Mazik, Vice President, Life Science Solutions, AssurX

This headline statement was shared by Michael Fauntleroy, FDA’s ESG Program Manager, during last week’s RAPS 2013 conference. It was in relation to his opinion that all FDA submissions in the future will require to be electronic. Mr. Fauntleroy also states that all adverse events for medical devices will require submitters to use the agency’s ESG (Electronic Submissions Gateway) by 2015. Furthermore, he expects that all adverse events for individualized commercial products submissions to be mandated by 2017.

However, the industry is already utilizing the technology as Mr. Fauntleroy noted: already this year the ESG has received over 4.5 million transactions in total, with over 1.1 million to the CDRH.

It is obvious that the ESG is FDA’s “go to” technology for its connection to the world when it comes to incoming submissions, their acknowledgements, and routing for processing. We have seen this focus on the ESG in numerous other ways recently. As announced by the FDA two weeks ago, the UDI (Unique Device Identifier) database termed “GUDID” will be populated via submissions that are handled through the ESG. Furthermore, as reported last week by Mr. Fauntleroy, a partnership between FDA and Canada Health utilizes the ESG to help standardize the submission process for both countries, and routes submissions accordingly. This allows medical device companies to send their submissions to one location (with the same set of requirements, and typically no additional programming for the submitter) and the submissions route to the desired country’s health organization for acknowledgement and processing.

 

eMDR

AssurX eMDR Process

AssurX worked in close coordination with the FDA over the years as we developed our AssurX eMDR solution that utilizes the FDA’s ESG for electronic submissions. In fact, Mr. Fauntleroy noted how prevalent AssurX customers are in utilizing this technology as he continues to see more and more AssurX accounts requesting access and others actively utilizing the ESG with their eMDR submissions. We are truly happy that the solution we have provided to our customers has been used and accepted so favorably by the industry. We look forward to the continued use of our software with the ESG technology for other regulatory submission needs in the future.

Click here for more information in AssurX’s turnkey eMDR solution which communicates directly with FDA’s Electronic Submissions Gateway

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FDA: Get Ready, the World is Getting Ready to Change
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FDA: Get Ready, the World is Getting Ready to Change
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This headline statement was shared by Michael Fauntleroy, FDA’s ESG Program Manager, during last week’s RAPS 2013 conference. It was in relation to his opinion that all FDA submissions in the future will require to be electronic. Mr. Fauntleroy also states that all adverse events for medical devices will require submitters to use the agency’s ESG (Electronic Submissions Gateway) by 2015.
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AssurX
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