Electronic Medical Device Reporting
When an adverse event happens, there is no time for delay—U.S. FDA requires swift action and accurate reporting. As of 2014, all medical device manufacturers and importers must submit adverse event reports in a specific electronic format (eMDR). Registrar Corp can assist you with eMDR submissions to assure compliance with FDA reporting regulations.
Submitting eMDRs
FDA offers two methods for submitting eMDRs: the eSubmitter web interface or AS2 Gateway. Both options are available to all reporters.
- eSubmitter application
- Users must download and install FDA eSubmitter software and create an electronic zip file for submission. Often used by low-volume reporters.
- AS2 Gateway
- Users must develop or purchase an AS2 submission system that can generate Health Level Seven (HL7) Individual Case Safety Report (ICSR) standard XML files for submission. Often used by high-volume reporters.
Once the submission file has been created, it can be uploaded to FDA’s secure Electronic Submissions Gateway (ESG) portal.
How we can help.
Registrar Corp’s team of regulatory specialists will help you navigate the process of adverse event report submission. As part of our service, we offer report submission in eMDR format to the ESG portal so they can be accurately processed and reviewed by FDA.
Registrar Corp assists quickly and efficiently with eMDR.
Take the first step and complete the form to get started.