10/23/2013
https://congress.gov...
"A strong and well-functioning FDA requiring industry to comply with robust statutory standards for clearance."
"We believe that any steps necessary to address the situation can be taken without changing the current robust statutory standards for clearance and approval of medical devices."
"in order to do that, they need resources."
"The medical technology industry has long recognized that a strong and well-functioning FDA is vital to maintaining America's preeminence in the medical technology innovation."