12/12/2012
https://congress.gov...
"Do you believe that the clinical trial standards laid out by FDA in the premarket approval process are rigorous enough to prove safety and effectiveness of class III devices?"
"Do you believe that the current postmarket surveillance requirements are adequate?"
"Do you believe that the device manufacturers have met their responsibility to conduct rigorous postmarket surveillance to ensure the safety of their devices?"
"Absent compelling national security related concern, have you heard of a Federal agency not answering a congressional request for information?"