U.S. flag An official website of the United States government
  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

As of August 14, 2015, the FDA published a Final Rule: Medical Device Reporting; Electronic Submission Requirements requiring manufacturers and importers to submit their device MDR reports 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 and transition to electronic reporting.

Low Volume vs. High Volume Submitters

eMDR and Electronic Submissions Gateway (ESG), 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.

Reporting Process

Low-volume submitters report a new MDR electronically by using eSubmitter to create a MedWatch 3500A electronic submission zip file and then logging into the WebTrader internet site to submit the file.

High-volume submitters use their own AS2 gateway software systems to submit MDRs electronically.

Which method should I choose?

Submitters are free to choose whichever submission method best meets their needs. The low-volume submission method typically requires more manual action to file each report, but the high-volume submission method typically requires more effort to stand-up. The testing process is also much more intensive for high-volume submitters. While low-volume submitters use eSubmitter, which is supplied by the FDA, high-volume systems generate the files using their own system. Multiple test submissions can be used to validate that a high-volume system is generating the correct file. Once a reporter has decided which submission method to pursue, they should view the corresponding page to begin the enrollment process:

Back to Top