10/23/2013
https://congress.gov...
"No, this doesn't codify our policy. It takes out from our authority the ability to assure the safety and effectiveness of devices that we currently regulate, including some high-risk devices."
"I am also concerned about what the impact would be of giving this broad set of software a new definition and excluding it from the device definition."
"I have several concerns about this bill starting with the timing."
"I question whether it makes sense to enshrine in statute something that may not work for an ever-evolving industry."