eMDR - Electronic Medical Device Reporting

The FDA final rule on Electronic Medical Device Reporting - eMDR published February 13, 2014, requires manufacturers and importers to submit MDRs to the FDA in electronic format. ThinSpring's EMDR service supports the submission of individual and bulk eMDR reports to the FDA. Time is of the essence depending on the type of safety issue being reported about the device. The clock starts as soon as you are notified of the issue. As soon as you securely upload the FDA 3500A form, we begin processing the eMDR submission. We convert the PDF form to the FDA required Individual Case Report Form - ICSR using eXtensible Markup Language - XML electronic file format. If any required information is missing, we contact you to resolve then submit the file via our AS2 Electronic Submission Gateway (ESG) server connected to the FDA. ThinSpring tracks the three acknowledgment messages expected from the FDA following the submission, providing completion verification.