03/16/2015
https://congress.gov...
"H.R. 3202, the Novel Device Regulatory Relief Act, appears to be intended to streamline the de novo process for FDA approval of medical devices."
"I mean, I as a politician get that from both ends, you know, 'Why aren't you moving quickly?' On the other hand, everything has to be safe."
"I have been interested in how to fix it for a long time. In fact, when I was the chairman of the subcommittee, we held a hearing in 2009. Quite frankly, both before and after that hearing, I was of th..."
"I think it is unfortunate that after 5 years, I think we should be closer on implementation on what I consider a very critical component."