02/05/2014
https://www.congress.gov...
"I don't care how small they are, they'd better meet the most stringent standards of safety and efficacy."
"But, under Riegel, if there is--if they can say, 'My gosh, we'll never have to give those documents up.'"
"I happen to be for innovation, I happen to be for new devices, I happen to think that these are good things, but I also believe in holding people accountable unto the strictest standards of safety and..."
"I must also say, regardless of the difference between drugs and devices, we're getting new drugs on the market all the time, and they are not preempted from tort claims."