John Shimkus actually said...

The reality is, I was at a breakfast this morning and someone was asking for additional Federal money, only $21 million.

Do you agree that the Institute of Medicine study on the 510(k) process was widely rejected? Yes or no.

Why is that not working here? Why isn't there a signal being sent to manufacturers, hey, there is a demand that is not being filled.

I think focusing on the risk-based approach in the recent reports is right on.