On the recordFebruary 14, 2012
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 the opinion that the 510(k) process was broken, so I am glad that FDA has focused its attention on resources and how to improve it.
Source
congress.gov




