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

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.