03/03/2010
https://www.congress.gov...
"If you're going to criticize FDA for approval, criticize us for bill approval."
"But this issue of totally replacing the 510(k) gives us pause, and I think one of the reasons it gives us pause is the looming question of who would design the new system?"
"dump it and deal with it."
"We're facing a joint committee report. If the joint committee fails to act, or we fail to adopt the joint committee recommendation, we will go to a sequester."