FDA ESG Support

Order a FDA ESG Digital Certificate

From the FDA ESG website

“The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions. The FDA ESG enables the secure submission of regulatory information for review.

The FDA ESG is the central transmission point for sending information electronically to the FDA. Within that context, the FDA ESG is a conduit along which submissions travel to reach their final destination. It does not open or review submissions; it automatically routes them to the proper FDA Center or Office.”

“FDA forms (e.g., 1571, 356h) and documents require a signature. The FDA’s General Counsel (GC) has said that the FDA must be able to determine the origin of a submission in order to implement fully electronic submissions. The PKI (x.509 version 3 class I) Certificate employed by the ESG allows the FDA to determine the origin of the submission through the use of a public/private key exchange.”

Intesi Group digital certificates are approved by FDA for electronic submissions through ESG.

Important

The digital certificate is personal and cannot be shared with other persons within your company

The email address provided for the digital certificate issuance should be for an individual and not a group email

The email address should be connected to your company. FDA does not accept Gmail or yahoo accounts

Once the FDA ESG digital certificate is issued, you will receive by separate emails:

The certificate in two formats – one to be installed on your computer and one to be sent directly to FDA for configuring your account

The password for the private key of your digital certificate. This password will be used for certificate installation and for sending encrypted submissions to FDA

FDA ESG Digital Certificate

Il certificato digitale ha un alto livello di sicurezza, legato al nome e l’indirizzo e-mail della persona. I certificati digitali di Intesi Group sono stati dichiarati conformi da FDA e consentono agli utenti di inviare i propri dati tramite ESG.

Common Error

“Message signed with certificate that is not configured on the sender.”

In order to send successfully a submission to the FDA ESG, you should have registered previously your digital certificate with FDA. This error means that your digital certificate is not stored in your WebTrader account and your signature cannot be verified.

To fix this error, please follow the steps below:

  1. Email the public key (.p7b file that you have received by email from Intesi Group) to ESGHelpDesk@fda.hhs.gov providing the following information:
    a. Primary account holder’s name
    b. Electronic Submissions Gateway Account name
  2. A confirmation email from ESGHelpDesk@fda.hhs.gov, will be received, notifying the account holder that the new public key has been uploaded. You may now send submissions via the Electronic Submissions Gateway using the newly exported private key (.pfx).

Useful information

Create an ESG Account
Setting up a WebTrader Account with the FDA ESG Checklist
Setting up an AS2 Account with the FDA Checklist
Sending a WebTrader Test Submission

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