Being a regulatory body for medical devices, the FDA gets thousands of adverse events reports. To get a better handle on the reports, they needed a system that would help collect, review, and analyze this information. To that end, the FDA introduced an electronic medical device reporting system that allows medical device manufacturers and importers to file adverse medical device events reports electronically.
What is FDA Electronic Medical Device Reporting (FDA eMDR)?
The FDA established the MedWatch information program in 1993 to help collect data on adverse events from consumers and healthcare professionals. FDA eMDR refers to an electronic-Medical Device Report consisting of electronic versions of the MedWatch form, also known as Form FDA 3500A, to be submitted to the FDA. Medical device companies must fill out the appropriate MedWatch forms with different categories of information in case of an adverse event before submitting.
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