Earlier this week, an Institute of Medicine’s Committee released its report on the Public Health Effectiveness of the FDA 510(k) Clearance Process. The report offers a variety of recommendations and suggested reforms for FDA’s 510(k) premarket notification pathway, describing the device clearance process as badly flawed.

Readers of MassTortDefense know how the regulatory clearance process has impacted preemption of state law product liability claims, and the significant medical device litigation we have covered here.