09/06/2017
https://www.congress.gov...
"I was the prime sponsor of that legislation with former Senator Biden."
"I want to thank Senator Harkin for chairing this hearing in the absence of our esteemed chairman of the committee."
"I don't think any of us want somebody to be hurt by a medical device, and to not be compensated if it's truly the fault of the company."
"A supplemental PMA, which is required for any change of any kind, is required to be approved by FDA, using the same standards of safety and effectiveness as the original PMA."