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Adverse Events Stack Up At FDA; 2016 Warning Letter Data Show Troubles With MDRs, Complaints

 
• By Shawn M. Schmitt

The US agency is inundated with adverse events through its Medical Device Reporting system with more than 1.4 million sent to FDA in 2015. Yet several industry experts – including from Eli Lilly and Implant Direct (Danaher) – say the industry overall may be underreporting adverse events, while some firms are overreporting. Preliminary 2016 warning letter data compiled by Medtech Insight also pinpoint problems with MDRs and complaint handling. Meanwhile, quality officials debate what makes a good complaint handling system, and tell what FDA expects from manufacturers. Plus: check out Medtech Insight's new FDA Warning Letters Data Tracker.

Serious businessman with red umbrella under huge wave of documents

Problems with a bevy of specific devices, better adverse event reporting by manufacturers, and enhanced industry and public awareness about what's reportable to FDA when a product fails are three possible reasons why the number of Medical Device Reports (MDRs) swelled to an all-time high of more than 1.4 million last year, the US agency says.

Yet several industry experts – including from Eli Lilly and Implant Direct (Danaher) – say not only is there underreporting going on, but adverse events are overreported in many cases,...

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