1.1 Setting up a WebTrader Account with the FDA Electronic Submissions Gateway (ESG)

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

1.2 Apply for DUNS

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.

1.3 Draft the SPL document

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

1.4 Sending the submission through ESG