FDA ESG NextGen Now Open for Test Submissions

By Amelia Boldrick and Elizabeth Pugh

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.

Source: FDA Submission Statistics

Features of ESG NextGen

The legacy and NextGen ESG systems both facilitate the secure transfer of a variety of pre and post-market regulatory submissions to the FDA. However, ESG NextGen has a number of advantages over its predecessor. Notable among these are cloud-based architecture, an identity, credential, and access management framework, and a new application programming interface (API) service that allows for integration with user software for automated submissions to the FDA.

Although Applicability Statement 2 (AS2) submission is considered a legacy technology largely replaced by API, NextGen will continue to support legacy AS2 ESG account users. The new Unified Submission Portal (USP) is a web-based interface that replaces the legacy WebTrader portal and the location where API users can receive their credentials.

Recall notifications post-reorganization

Due to the reorganization within the FDA (effective October 1, 2024), the Office of Regulatory Affairs is now called the Office of Inspections and Investigations (OII) in order to better convey its role as the frontline of the FDA. The OII recall coordinators manage recalls and should be contacted at the email address listed in the FDA table according to the manufacturer or U.S. agent location.

The contact information in the correction and removal fillable form (Form FDA 5072) has not yet been updated. However, any emails sent to the previous contacts will generate an automated response containing the new contact information.  

Concluding remarks

As a reminder, Emergo by UL has an ESG NextGen account and can submit eMDRs on behalf of our clients, if authorized. We are available to assist with recall notifications to the FDA. Please contact the vigilance team at EmergoVigilance@ul.com for additional details regarding this service.