FDA > CDRH > eMDR > FDA Electronic Submissions Gateway (ESG)

FDA Electronic Submissions Gateway (ESG)

eMDR uses the FDA Electronic Submissions Gateway (ESG), an agency-wide entry point for all electronic submissions, to receive electronic MDRs. The FDA ESG (also referred to as the ESG or the Gateway):

• Enables the FDA to process regulatory submissions automatically
  
• Functions as a single point of entry for the receipt and processing of all electronic submissions in a secure
  environment that complies with secure messaging standards
  
• Serves as a conduit, or “highway,” along which submissions travel to reach their final FDA destination
  
• Automatically routes submissions to the appropriate FDA Center or Office.

The electronic submission process through the ESG encompasses the receipt, acknowledgment of receipt (to the sender), routing, and notification (to a receiving FDA Center or Office) of the delivery of an electronic submission. For more information, please visit, www.fda.gov/esg/. If you have any questions regarding the registration process or the Gateway in general, please contact the help desk as indicated on the ESG website.

Updated December 18, 2007