FDA Gateway System Updates: The Continuing Evolution of eMDR Submissions
Bernard Jee, Product Manager, Pilgrim Quality Solutions, an IQVIA company
The U.S. Food and Drug Administration (FDA) announced, on June 8, 2017, that updates and changes are being made to its Electronic Submission Gateway (ESG) system for electronic medical device reporting (eMDR). If you are not subscribed to the FDA listserv, this information may not be readily available unless you visit the FDA Gateway website to see the full list of the planned updates.
In the interim, there are key updates that will impact various components of the submissions process.
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