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Recent eMDR Change By FDA Asks Adverse Event Reporters About Third-Party Servicers

 
• By Shawn M. Schmitt

The addition of the question “Was this device serviced by a third party servicer?” to adverse event reports filed through the US FDA’s electronic Medical Device Reporting system could prove helpful for the agency and device makers, experts tell Medtech Insight. Industry has long complained about poor work performed by servicers – and loudly groused that they’re not regulated.

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A change made by the US Food and Drug Administration to its MedWatch program that asks adverse event reporters whether a third party serviced a malfunctioning medical device flew under the radar of many in industry for nearly a year.

The FDA in late 2019 added to its MedWatch 3500A paper reporting form the question: “Was this device serviced...

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