Orrin Hatch actually said...

"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."

"I've had extensive experience with the FDA, and they don't miss much."

"I'm really glad you did what you did, and I'm glad you've had that result."

"One thing that I think needs to be made clear is that everybody here wants to see people who are injured be fairly compensated when they suffer injuries resulting from another person's negligence."