Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                eMDR – Electronic Medical Device Reporting

eMDR – Electronic Medical Device Reporting

                        How to Enroll in eMDR Program
          Health Level Seven (HL7) Individual Case Study Report (ICSR)
          FDA Electronic Submissions Gateway (ESG)
          eMDR Help and FAQs
          eMDR System Enhancements
          eMDR System Status Home
          Medical Devices
          Device Advice: Comprehensive Regulatory Assistance
          Postmarket Requirements (Devices)
          Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities
          eMDR – Electronic Medical Device Reporting
          FDA Electronic Submissions Gateway (ESG)eMDR – Electronic Medical Device Reporting FDA Electronic Submissions Gateway (ESG)
  
  	
    Share
    Post
    Linkedin

    Email
    PrinteMDR 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, the FDA Electronic Submissions Gateway (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.

                                                                                  Content current as of:
      03/23/2018
              
              
Regulated Product(s)
		 Medical Devices
			  			     			  			     Radiation-Emitting ProductsTopic(s)
			  Postmarket
				    				       				    				       Electronic Submissions Gateway (ESG)eMDR – Electronic Medical Device Reporting

          
                        How to Enroll in eMDR Program
          Health Level Seven (HL7) Individual Case Study Report (ICSR)
          FDA Electronic Submissions Gateway (ESG)
          eMDR Help and FAQs
          eMDR System Enhancements
          eMDR System Status
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop