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Adverse Event Codes From IMDRF Now Used By FDA’s eMDR System

 
• By Shawn M. Schmitt

The US FDA has updated its electronic Medical Device Reporting system to accept adverse event codes devised by the International Medical Device Regulators Forum. The agency is urging reporters using an AS2 submission account to “update their systems as soon as possible.”

FDA entrance sign 2016

In a long-planned update, the US Food and Drug Administration’s electronic Medical Device Reporting (eMDR) system now accepts adverse event codes devised by the International Medical Device Regulators Forum (IMDRF).

The change affects Secs. F10 and H6 of the FDA’s MedWatch 3500A adverse event reporting form, “Adverse Event Problem.” User facilities and importers report event codes under Sec. F10, while...

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