1. Request a WebTrader account
Provide the following information:
Submission Method: (WebTrader)
Attach a Letter of Non Repudiation
2. Preparatory activities
Send a hard copy Letter of Non-Repudiation to the FDA.
Obtain a personal digital certificate
3. Register Your Test Account
4. Setup your machine/PC for ESG
5. Send Test Submissions
6. Production Account Approval
The Data Universal Numbering System, abbreviated as DUNS or D-U-N-S, is a proprietary system developed and managed by Dun & Bradstreet (D&B) that assigns a unique numeric identifier, referred to as a "DUNS number" to a single business entity.
1. Establishment Registration Using XForms
The Establishment registration XForms is used to create an SPL (Structured Product Labeling) file for establishment registration. A registrant includes all of their establishments in one Establishment registration SPL file.
2. Self-Identification Submission
Submitters should enter the required information into the eSubmitter tool