01/12/2009
https://www.congress.gov...
"You're saying that a device manufacturer, like this Medtronic defibrillator, when it went through the whole premarket approval and everything, and it was approved, later on they made a change to it, b..."
"Do I want safe products? Absolutely. For me, the question is who decides."
"The FDA does not have subpoena power, does it?"
"To me, that choice is clear. We need safe products and we need innovation, and the best way to achieve both goals is not through litigation created by this bill, but through a strong, well-funded FDA."