Barbara Mikulski actually said...

"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."

"dump it and deal with it."

"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?"

"I think that we need to understand that the first obligation you have is for the safety of patients, not whether or not a company gets the approval in a timely manner."