[Emergo, UL] FDA ESG NextGen Now Open for Test Submissions

The U.S. Food and Drug Administration (FDA) has opened the test submission phase of the new Electronic Submission Gateway NextGen system (ESG NextGen) in preparation for the official launch at 9:00 a.m. ET on April 14, 2025. The testing phase will conclude after April 11, and the existing (legacy ESG) system will be disabled at midnight Eastern time (ET) on April 12. No submissions can be made in the intervening period.

The rise of electronic submissions

Mandatory electronic Medical Device Reporting (eMDR) via ESG has contributed substantially to the growth in submissions to the Center for Devices and Radiological Health (CDRH) in particular over the past 10 years.

 

 

FDA ESG NextGen Now Open for Test Submissions | Emergo by UL

FDA ESG NextGen Now Open for Test Submissions