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FDA Tweaks 3500A Form For Reporting Adverse Events, Plans September Changes To eMDR System

 
• By Shawn M. Schmitt

An update by the US agency to its MedWatch 3500A adverse event reporting form targets summarized events and patient gender. The FDA is also updating its electronic Medical Device Reporting (eMDR) system to accommodate the changes made to the 3500A, among other revisions.

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An update by the US Food and Drug Administration to its MedWatch 3500A adverse event reporting form targets summarized events and patient gender.

Sec. H1 of the form now includes “new structured data fields” that indicate whether the report is a “summary of multiple events (for example, Voluntary Malfunction Summary Reports),” the FDA...

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