Electronic Submissions Gateway Next Generation (ESG NextGen)
Announcement: ESG NextGen FDA CDRH Delayed Processing
The Center for Devices and Radiological Health (CDRH) submissions experienced a delay in processing. Due to this, there was a delay in receiving acknowledgment (ACK3) messages for CDRH submission types: Adverse Events and Electronic Submissions.
The delayed processing started the evening of March 27, 2026.
The delayed processing was resolved on March 30, 2026, at 9:48 AM ET.
CDRH anticipates that ACK3 messages should be received within 24 hours.
Please do not resubmit unless directed by CDRH to do so.
Getting Started with ESG NextGen
The Getting Started with ESG NextGen section provides users with the tools needed to start utilizing ESG NextGen. User guides and training videos are available within this section.
To log in, use the ‘Industry USP Login’ link above to get started in the Unified Submission Portal (USP). In compliance with FDA security policy and NIST standards, ESG accounts will automatically be deactivated if inactive for 60 days. Please log in within 60 days to avoid deactivation.
What is ESG NextGen?
The Food and Drug Administration (FDA) Electronic Submissions Gateway Next Generation (ESG NextGen) is the FDA’s modernized platform for securely receiving and processing electronic regulatory submissions with improved architecture that supports greatly expanding submission bandwidth and storage. ESG NextGen provides a high-performance gateway for FDA and its global partners, allowing the seamless submission of regulatory documents and enabling the FDA to streamline review processes. ESG NextGen functions as a unified solution, serving as a single-entry point for the secure submission, receipt, acknowledgment, routing, and notification of all regulatory submissions to the FDA.
- Unified Submission Portal (USP): The ESG NextGen USP is a user-friendly web-based platform which replaces the legacy WebTrader user interface. The USP provides the ability to submit regulatory information to the FDA and track the status through Center receipt.
- API Integration: ESG NextGen’s suite of APIs enables programmatic submissions, allowing organizations to integrate submission processes directly into their internal systems. This option supports the automation of submission workflows and real-time status tracking through Center receipt of the submission.
- Applicability Statement 2 (AS2): A system-to-system connection for an automated data exchange between the FDA and its partners.
Where Do Submissions Go?
ESG NextGen acts as a secure conduit for all electronic submissions to the FDA. Each submission is automatically routed to the appropriate FDA Center or Office based on user selections chosen during the submission process. ESG NextGen itself does not open or review submissions but serves as a secure and efficient channel for ensuring regulatory information reaches its destination.
Contact Us
For ESG NextGen related questions: ESGNGSupport@fda.hhs.gov✉️