Setting Up a Gateway Account with the FDA

Additional Windchill Capabilities > Windchill Quality Solutions > Unique Device Identification > Installing Unique Device Identification > Enabling Your System for UDI Data Entry > Setting Up a Gateway Account with the FDA

For additional instructions, see the “FDA ESG Web Interface Electronic Submissions” section of the ESG website at http://www.fda.gov/esg.

1. Send an email to esgprep@fda.hhs.gov requesting a test AS2 account.

2. The FDA provides you with a URL, user id, and password for the AS2 registration wizard. Follow the AS2 registration wizard to complete the registration process.

After you successfully set up a test account, the FDA sends an email to the address you provided during registration. This email indicates approval as a transaction partner and authorization to send a test submission.

3. Send a test submission to make sure that the submission process is working.