Device Expert: FDA De Novo Rule Provides Clarity For Industry

A medical device industry expert told Inside Health Policy he expects a new proposed rule published by FDA on the de novo pathway will go a long way towards clarifying the process for device manufacturers, helping FDA reach the performance goals laid out by Congress and helping the agency achieve its goals of modernizing the 510(k) premarket notification process. De novo is reserved for new, low- to moderate-risk devices for which there are no existing predicate devices for comparison...