11/16/2011
https://congress.gov...
"Instead of strengthening our device laws, Republican members have proposed radical changes to our device laws that could further imperil patients."
"We need to ask why unsafe devices have gotten onto the market and harmed so many patients."
"I don't think devices are something that we shouldn't take seriously as we do drugs. They both must meet a safety and efficacy standard."
"It is pretty irrational because there is a different standard for drugs and devices."