05/03/2011
https://www.congress.gov...
"Well, the ultimate goal is to get the very best devices we can to really help people like Mr. Mulvihill, like Mr. Roman, in ways that they've got to be helped."
"I think sometimes they do good things, other times they don't do what they should be doing."
"Manufacturers who commit fraud on the FDA are not immune from lawsuits."
"They could penalize the company. They could seize the offending illegal products."