OFFICIAL SOURCES · ORGANISED BY TASK
FDA links for UDI, GUDID, ESG NextGen and eMDR
Find the right FDA guide for data preparation, accounts, submission or feedback.
This directory links to official FDA sources and the National Library of Medicine’s public AccessGUDID service. It distinguishes three tasks: device data for GUDID, technical gateway access and incident reporting through eMDR. This takes you to the appropriate procedure rather than instructions for a different submission type.
To understand the context first, start with FDA UDI and GUDID. Implementation support is described on the linked Europe IT service pages.
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1. Requirements and data preparation
FDA UDI Basics
An introduction to labelling, the labeler role and UDI terminology. Useful before mapping requirements to individual fields.
UDI Compliance Policies and Compliance Dates
Guidance by device type and requirement. Consider current policies rather than using a historical deadline table in isolation.
Prepare for GUDID
Prepare your organisation, data and responsibilities. Includes FDA context on DUNS numbers and possible third-party submitters.
GUDID overview and data reference
Starting point for the database and its linked Data Elements Reference Table. Use the current reference when mapping device data.
A related Europe IT tool: FDA GUDID Excel template. The template is a separate product, not a file issued by the FDA.
2. GUDID accounts, testing and public searches
Request a GUDID account
The official starting point for a new GUDID account. Prepare the requested company and role information.
GUDID Production — login
Existing direct access to the production GUDID application. Check the actual environment you are logged into before making changes.
GUDID Pre-Production — test access
Existing direct test access. Processing in the test environment does not replace a production submission.
AccessGUDID — search public device data
Search, retrieval and public data services. Do not confuse this with the submission access for labelers.
If a direct login fails, start with the official GUDID submission guide and clarify access or responsibilities with the Help Desk. Do not use a test environment as a substitute for a required production submission.
3. GUDID files and ESG NextGen
Submit Data to GUDID
Guidance for the web application and HL7 SPL route, linking data preparation to the appropriate submission process.
UDI rules, guidance and technical resources
Official entry point for documents and training. Check purpose and version before applying requirements in your mapping.
Select FDA documents and training materials
ESG NextGen — starting point and USP login
The current gateway starting point. The Unified Submission Portal replaces the former WebTrader interface. A GUDID account and gateway setup are different tasks.
ESG NextGen User Guides
Technical user guides for the selected gateway method. Authority support for a technology does not mean every Europe IT installation uses every option.
For software and implementation: Global Submission Portal · GUDI in SAP · UDI data submission.
4. eMDR — electronic incident reporting
Case reports use different documentation from GUDID device data. In particular, do not confuse HL7 ICSR with the GUDID format HL7 SPL.
FDA eMDR — overview
Official explanation of electronic Medical Device Reporting.
eMDR onboarding
Setup and testing for the chosen workflow. The applicable onboarding also matters when using third-party software.
HL7 ICSR and eMDR Implementation Package
Starting point for technical case-report documentation. Check the applicable package version for implementation.
eMDR FAQ
Questions about submissions, feedback and follow-up processing.
eMDR System Enhancements
Announced and implemented changes, for planning updates to mapping, validation rules and software.
Europe IT solution: eMDR submission with Excel, conversion and ACK evaluation.
5. Which support team is responsible?
| Your issue | Official contact |
|---|---|
| UDI/GUDID questions | FDA UDI Help Desk — for account communication, the FDA lists GUDIDsupport@fda.hhs.gov. |
| ESG NextGen / gateway | ESG NextGen support – ESGNGSupport@fda.hhs.gov. |
| Missing eMDR feedback or errors in responses | eMDR troubleshooting and contact information — distinguishes gateway, centre and eMDR issues. |
| GUDID outage or changed behaviour | GUDID System Status and GUDID Enhancements and Fixes. |
Have the affected application, test/production environment, time, reference and error message ready. Passwords and access keys do not belong in a support description. Send sensitive case information only through the designated channel.
Place other authority sources in the right context
The NANDO search previously listed here concerns European notified bodies and is not an FDA onboarding step. For European authority sources, use the EUDAMED resource directory. For DUNS preparation, the FDA starting point linked above leads to relevant guidance; an old UPIK/Bisnode link is not presented as a current FDA requirement.
From guidance to implementation
Know your objective but need help with source data, mapping or transfer? Europe IT helps you distinguish technical tasks from responsibility for the data content.
Discuss your FDA process with Europe IT · FDA overview
This selection provides orientation. Authority sources are not certification or endorsement of Europe IT products.
