10/06/2010
https://www.congress.gov...
"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..."
"But, under Riegel, if there is--if they can say, 'My gosh, we'll never have to give those documents up.'"
"I don't care how small they are, they'd better meet the most stringent standards of safety and efficacy."
"We are going to make sure."