The possibilities for mobile health technologies are promising and exciting and there are so many functions that mobile health applications can be designed for...
I appreciate that we have the opportunity today to discuss the SOFTWARE Act.
As you know, Representative Blackburn has introduced a bill, H.R. 3303, that would create an entirely new regulatory framework for medical s...
I am not convinced there is a problem that needs to be fixed here.
I think that is the concern.
But we think at the present time, this is just simply premature.
opening statement
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 cu...
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 de...
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.