510(k) is on a one-way journey
This article was originally published in Clinica
The FDA‘s January 2011 action plan set the boat afloat. The Institute of Medicine’s (IoM) views last month fixed the rudder. And the NEJM article last week (Curfman and Redberg) got the oars moving in the choppy US device regulatory waters. The US medical device 510(k) approval right now is travelling fast downstream, and its destination looks to be the head of the falls. Will it be seen again? It seems unlikely.