Industry leaders across the medical device landscape began to weigh in on proposed changes to the 510(K) premarket notification program Wednesday, with most expressing relief over the recommendations proposed by the Centers for Devices and Radiological Health.
“The proposals are more benign than many had feared. No radical change to the current process appears likely. ” Leerink Swann analyst Rick Wise wrote in an email to investors. “The concern here is that an already tougher and more demanding FDA might deploy new rules in a way that could make the approval process overall more transparent but also more burdensome.”