1. Home
  2. Medical Devices
  3. Device Advice: Comprehensive Regulatory Assistance
  4. Postmarket Requirements (Devices)
  5. Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities
  6. eMDR – Electronic Medical Device Reporting
  7. How to Enroll in eMDR Program
  1. eMDR – Electronic Medical Device Reporting

How to Enroll in eMDR Program

Update: April 13, 2026

As of April 14, 2025, the ESG NextGen Unified Submission Portal (USP) replaced the legacy WebTrader user interface. This user-friendly web-based platform provides the ability to submit regulatory information to the FDA and track the status through Center receipt. 

As of August 14, 2015, the FDA published a Final Rule: Medical Device Reporting; Electronic Submission Requirements requiring manufacturers and importers to submit their medical device reports (MDRs) electronically to CDRH. Electronic reporting is also available to user facilities, but the rule permits user facilities to continue to submit written reports to the FDA.

This page provides detailed instructions for enrolling in the eMDR program to comply with the Final Rule. Submitters should read the information below carefully to transition to electronic reporting.

Low Volume vs. High Volume Submitters

eMDR and the Electronic Submissions Gateway NextGen (ESG NextGen), an Agency-wide solution for accepting electronic regulatory submissions, support two different submission methods, which are commonly referred to as low-volume and high-volume. Each method has its own unique submission process, testing requirements, and account enrollment process. These differences are outlined below.

The first step of enrolling in the eMDR program is to decide which method of submission to use. Both options are open to all submitters.

Low-volume submitters report a new MDR electronically by using the FDA eSubmitter tool to create a MedWatch 3500A electronic submission file and then logging into the Unified Submission Portal (USP) from the ESG NextGen website to submit the file.

In the context of ESG NextGen, USP is a web-based interface which serves as the primary platform for preparing, submitting, and managing electronic regulatory submissions to the FDA. The USP is also where industry users who will be submitting through Application Program Interface (API), will receive their API credentials. ESG NextGen also provides submission methods via API and Applicability Statement 2 (AS2).

High-volume submitters use their own software to create the electronic MDR submission file according to the FDA-published XML specification and submit it through one of two communication protocols:

  1. AS2 (Applicability Statement 2): a server-to-server Internet communications protocol for Electronic Data Interchange (EDI) that was used by the legacy ESG and is still supported by ESG NextGen (although the configuration has changed from the legacy system).
  2. API (Application Programming Interface): a more modern software interface used by many Web applications that utilizes various “endpoints” and is entirely request-driven.

Refer to the Table below for additional comparison of the submission methods.

Submission 
Method

Software 
Source

Submission 
Protocol

Testing 
Process

Advantages

Low-Volume

Provided by FDA (eSubmitter)    
 		Web through USP    
 		Test submissions are recommended but not required    
 

Utilizes free FDA-supplied software and doesn’t require test submissions at stand-up. But requires each MDR to be manually entered and submitted.

High-Volume

Maintained by the submitter firm    
 		AS2 or API    
 		Test submissions are required to verify submission file content    
 		Allows for rapid submission of MDRs by extracting information directly from the reporter’s database. But requires firms to conduct testing on stand-up and perform yearly maintenance for eMDR changes.
 

Once a reporter has decided which submission method to pursue, they should view the corresponding section below to begin the enrollment process:

This section outlines the enrollment process for new low-volume submitters. Each individual submitter should complete steps to comply with the Final Rule, even if other individuals in the same firm are already enrolled.

Note: This process applies only to submitters who use eSubmitter. If your firm uses non-FDA software to generate an eMDR submission file, enroll for eMDR using the high-volume enrollment process.

Step 1: Obtain a USP account and complete ESG NextGen registration.

  • Visit the Electronic Submissions Gateway Next Generation (ESG Next Gen) webpage and begin the process outlined there.
  • The first step is to create a new USP account with your email and password.
  • Then you will complete the first login wizard by submitting a letter of non-repudiation and providing details like your company name and user type.
  • You will receive an email from ESG NextGen when your full registration is complete. 
  • If you have already created an ESG NextGen USP account, please use the credentials created during account registration to log in to your account.

Step 2: Prepare your submission file.

  • Download the eSubmitter application and install it on your computer. You may see a screen requesting you register eSubmitter. However, registration is not required.
  • Once you have eSubmitter installed, open the application and select Create New Submission > CDRH: MedWatch Form 3500A.
  • Fill out the form as completely as possible to describe the adverse event you are reporting. If you are enrolling to comply with the Final Rule before any adverse event has taken place, you may create a test report by describing a fictional adverse event.

The eSubmitter site includes a quick guide, installation instructions, and tutorial videos that are common to all submission types. When filling out the 3500A form in eSubmitter, it may be helpful to refer to the MedWatch 3500A instructions for more details about each MDR field. Here are a few more helpful tips for first-time users of the eSubmitter 3500A form:

  • When you fill out the report number, choose "MFR Report Number" or “Importer Report Number” (depending on your firm) in the drop-down box and include your firm’s Central File Number (CFN) or Firm Establishment Identifier (FEI) in the first part of the report number. If you have a 7-digit CFN, do not choose FEI and do not add three leading zeroes to the CFN number to make a 10-digit number.
  • In the second part of the report number, use the current year.
  • For the third part of the report number, use a five-digit number that is the next consecutive sequence number for the reports filed by your firm in this year. If you are creating a test report, please use a sequence number that has never been used for any previous MDR report (a sequence number with a high leading digit such as "70001" is best).
  • When you have finished filling out the 3500A form in eSubmitter, click the Package Files button in the toolbar. In the dialog that appears, click Next > Next > Package Submission Files. This will generate a .zip file on your computer. This .zip file is the submission file that you will send to eMDR in the next step.

Note: The eSubmitter .zip file contains both the HL7 ICSR XML for the report, as well as a Portable Document Format (PDF) copy of the report. Windows Explorer has an issue with .zip files produced by eSubmitter, but you should be able to extract these files using third-party tools such as WinZip or 7-zip. Low-volume submitters may want to save the PDF for their records. High-volume submitters may want to use the XML as a reference while developing their software.

ESG NextGen USP users are able to perform Test and Production submission uploads within the same user interface.

Now that your eMDR submission zip file is complete, continue to Step 3A if you created a test report to send to eMDR Test. Or continue to Step 3B if you created a production MDR to send to eMDR.

Step 3A: Send your test MDR submission to eMDR Test.

To send a test report to eMDR Test, log into the USP and perform the following steps:

  • Select “Test Submission” from the left navigation menu.
  • If you are an Agent or Consultant, you will need to choose or input the Authorizing Company and Company for the submission.
  • If it is your first submission, you will be prompted to download and install FileCatalyst Transfer Agent before continuing.
  • Select the submission file from your computer’s local file system in the FileCatalyst Transfer Agent window and click “Add Files”, then click “Upload Queue”. Wait for the transfer to complete before clicking “Next”.
  • Choose “CDRH” for Receiving Center.
  • Choose “Adverse Events” for Submission Type.
  • You may enter notes for your own records in the “Notes on Submission” field.
  • Electronically sign the submission by drawing your signature in the signature field.
  • Click “Submit” to complete the upload.

Continue to Step 4 to verify that your test submission was accepted by eMDR Test.

Step 3B: Send your production MDR submission to eMDR.

To send a production report to eMDR, log into the USP and perform the following steps:

  • Select “New Production Submission” from the left navigation menu.
  • If you are an Agent or Consultant, you will need to choose or input the Authorizing Company and Company for the submission.
  • If it is your first submission, you will be prompted to download and install FileCatalyst Transfer Agent before continuing.
  • Select the submission file from your computer’s local file system in the FileCatalyst Transfer Agent window and click “Add Files”, then click “Upload Queue”. Wait for the transfer to complete before clicking “Next”.
  • Choose “CDRH” for Receiving Center.
  • Choose “Adverse Events” for Submission Type.
  • You may enter notes for your own records in the “Notes on Submission” field.
  • Electronically sign the submission by drawing your signature in the signature field.
  • Click “Submit” to complete the upload.

Continue to Step 4 to verify that your production submission was accepted by eMDR.

Step 4: Verify your submission was accepted.

  • In the USP, select “Submission History” from the left navigation menu. This page displays your submissions uploaded in the last 30 days. Acknowledgements (ACKs) are also sent to users by ESG NextGen as part of the processing of the submission through ESG NextGen. USP submissions (test and production) will receive ACK messages by email. 
  • Note that the default filter does not include test submissions, so if you sent a test report to eMDR Test in Step 3A, make sure to change the filter for “Test Submission” in the top-right corner of the page to “Include” and click “Search” to refresh the list below.
  • Click on the core ID for your submission from Step 3A or 3B to open a new tab with additional details.
  • Click on the “Status History” tab to see a list of Acknowledgment (Ack) files for your submission.
  • Click on Ack3, which is an HTML file, to view it in your browser. This Ack file (as well as Ack3, the XML file) are created by eMDR after processing your submission. If Ack3 and Ack4 are not displayed in the list, please wait 5-10 minutes and check again.
  • When you open Ack3, verify that the “Summary” row says “Passed: 1, Failed: 0”, and that the “Report Number” row includes the MDR Report Number you entered in eSubmitter and “passed”. This indicates that your submission was accepted by eMDR.
  • The “Environment” row indicates whether your submission was processed by eMDR Test (“TEST”) if you correctly followed the instructions in Step 3A or the production eMDR system (“PRODUCTION”) if you correctly followed the instructions in Step 3B.
  • If Ack3 contains an error message and says that "Passed: 0, Failed: 1", reopen your submission in eSubmitter and correct any outstanding issues in the error message. Repeat Step 2 and Step 3A or 3B with the updated report information in eSubmitter. If you cannot resolve the error, view the eMDR Troubleshooting and Contacts webpage for tips. The most common Ack3 failure is caused by using an inactive or incorrect CFN or FEI in the MDR Report Number field in eSubmitter.

If your Ack3 indicates that your submission passed, you have completed the enrollment process for eMDR. The next time you have an MDR to submit to eMDR, follow Steps 2, 3B, and 4 to complete your electronic MDR submission to eMDR production.

For technical issues or general submission inquiries, please contact ESG NextGen Support at: ESGNGSupport@fda.hhs.gov.

This section outlines the enrollment process for new high-volume submitters.

Note: If your firm uses non-FDA software to generate the eMDR submission file before submitting through USP, follow this enrollment process so that your XML generation software can be verified by CDRH.

Step 1: Acquire submission software.

  • High-volume submitters should first decide whether to develop their own system for submission to eMDR or purchase an existing solution. There are several relevant third-party software vendors, but the FDA cannot endorse a specific vendor or product.
  • For firms that decide to develop their own systems, the eMDR Implementation Package describes the submission file content expected by eMDR.
  • Submitters will also need to determine whether they will use AS2 or API as the protocol to communicate with ESG NextGen. The User Guides describe the transport-layer configuration needed for server-to-server communication with the ESG NextGen.

Step 2: Obtain a USP account and complete ESG NextGen registration.

  • Visit the User Guides webpage and begin the process outlined there.
  • The first step is to create a new USP account with your email and password.
  • Then you will complete the first login wizard by submitting a letter of non-repudiation and providing details like your company name. You must choose “Power User” for access to the API Management module of USP.
  • You will receive an email from ESG NextGen when your full registration is complete.

Step 3: Configure system communication with ESG NextGen.

  • Log into the USP and select “API Management” from the left navigation menu.
  • Click “Generate” to obtain your Client ID and Secret Key.
  • Configure your eMDR submission system using either the AS2 or API guides published by the ESG NextGen.
  • Use “CDRH” for Center and “Adverse_Events” for the Submission Type.

Note: Once this step is complete, the ESG NextGen will allow you to send submissions to eMDR production. However, CDRH requests that all new high-volume submitters (and firms who make changes to their eMDR submission systems) complete the remaining steps below to ensure that the electronic MDR content from their system is complete and correct before commencing with production MDR submission.

Step 4: Submit high-volume test submissions.

Configure your system to submit to eMDR Test. Note that eMDR Test is always available for firms who are developing high-volume systems or software updates to test against. It may experience weekend downtime, similar to the production eMDR system. No approval is required to make test submissions to this system during development and deployment of your submission software.

Conduct internal testing and validation for your system using eMDR Test until your firm is confident that your software is ready for production. You may request the eMDR-generated PDFs for your test submissions from the eMDR Helpdesk by emailing eMDR@fda.hhs.gov to verify that the values you sent in the XML were parsed correctly by eMDR. Note that you must receive and process Ack3 or Ack4 per the instructions in the eMDR Implementation Package to ensure that your MDRs “passed” validation and were accepted by eMDR Test.

Once you are confident that your system is ready for production, make the following final test submissions to eMDR Test:

  1. A complete initial MDR (fill every report field, including the attachment) for your firm type (Manufacturer, Importer, or User Facility). If your firm will submit more than one type of report, send a complete initial MDR for each type.
  2. A complete supplemental MDR (fill every report field) for each of the firm types for which you submitted an initial MDR.

PDFs from eMDR Test submissions are only stored for two weeks, so you may not be able to use older submissions from your earlier testing.

Step 5: Request high-volume eMDR approval.

Once you have made each of the submissions, send an email to the eMDR helpdesk at eMDR@fda.hhs.gov containing the following information:

  1. The report number for each of the final test submissions
  2. The core ID for each of the final test submissions
  3. A PDF, image, or other human-readable representation of each of the final submissions generated by your system
  4. If you purchased your system from a third-party software vendor, please include the name of the software, version number, and developer company name.
  5. If you are installing a new instance of the submission software that is already used for production eMDR submissions by another division of your firm, include the name of the firm and the email address from their ESG NextGen account used for high-volume submissions.

The eMDR team will manually review your test submissions and notify you to resubmit if there are any discrepancies. Once all concerns have been addressed, you will receive an email from the eMDR Helpdesk instructing you to begin production submissions to eMDR. Before beginning production submissions to eMDR, make sure that you change your system configuration to send production submissions instead of test submissions.

Additional Resources

Back to Top