Complaints that FDA’s busiest pathway to market for medical devices is anything but straight piled up in 2014.
By Jim Dickinson
Looking back, 2014 will be remembered as the year when FDA’s busiest medical device route to market, the 510(k) “substantially equivalent” process, came under unprecedented challenge amid calls for structural change and even general abandonment.
There is dissatisfaction with the 510(k) status quo both within FDA (if unexpressed) and throughout industry and patient activist communities.
Kicking off the argument in January was a petition from the Minneapolis-based DuVal & Associates law firm on behalf of the Minnesota Medical Device Alliance and the medical device industry generally asking FDA to...