How to Simplify Medical Device Reporting Set-Up

What is a Medical Device Report?

Medical Device Reports (MDRs) are publicly accessible documents resulting from an event that manufacturers or importers become aware of and that reasonably suggests one of their marketed devices may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. While these outcomes are what all Medical Device manufacturers strive to mitigate, these events do occur. Rook Quality Systems is here to help you ensure you report these events in a timely & compliant manner by providing some insight into the set-up process and tips on how to streamline reporting.

ESG Account Generation

The FDA Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions. The FDA ESG enables the secure submission of premarket and postmarket regulatory information for review. To submit MDRs electronically, you will need to set up a Web Trader Account and then submit test data that is successfully processed through the ESG before you receive a production account to use for your MDR submissions. Here is the process for beginning to file eMDRs:

1. Request a Web Trader Account from the ESG
2. Submit a Letter of Non-Repudiation to FDA
   • Also submit a letter of Authorization if a consultant will be submitting MDRs on your behalf
3. Obtain a personal digital certificate
4. Submit test data.
   • Compile the test data using the FDA eSubmitter software
5. Receive a production account from the ESG
6. Use the production account to send your actual eMDRs to FDA.

How do I know if my submission of an electronic MDR was successful?

FDA’s system will automatically route three separate electronic acknowledgments to the user’s ESG account. These acknowledgements indicate the stage of processing that the eMDR has reached:

1. Acknowledgement 1, also known as the Receipt or MDN (Message Disposition Notification) acknowledgment, indicates that the ESG received the eMDR(s).
2. Acknowledgement 2 indicates that CDRH received the eMDR(s).
3. Acknowledgement 3 indicates the pass or failure status of the eMDR(s) into CDRH’s adverse event database–that is, whether the eMDR was successfully loaded into the database.

If there are no errors, the FDA anticipates that the three acknowledgement letters will be generated the same day or within 24 hours of the submission.

MDR Setup Helpful Tips

1. Remember or securely store the file directory location of where your personal digital certificate is stored. In the instance that it gets disconnected from your Gateway account, save yourself some stress of trying to find it again.
2. Remember to securely store your personal digital certificate password; this is used right before submission, and it is probably different than your login password. If you do not know this password, you will have to create a new certificate.
3. When in doubt or having issues, reach out to their help desk team at ESGHelpDesk@fda.hhs.gov. Their responses are timely and effective.
4. Save your Acknowledgements as records from your Submission.
5. In the eSubmitter software, you can duplicate reports easily by opening the report you want to duplicate; then go to File -> Save As and rename the report. This will save you time by not having to input repetitive information for the next report.
6. Look to RookQS to help support your entire MDR process, from account generation to consistent submission!