FDA's guidance is very measured and risk-based.

I think it is fair to say that we all want to encourage continued innovation, but it is also important that we shepherd these emerging technologies...

But we think at the present time, this is just simply premature.

I think that is the concern.

As you know, Representative Blackburn has introduced a bill, H.R. 3303, that would create an entirely new regulatory framework for medical software.

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 question whether it makes sense to enshrine in statute something that may not work for an ever-evolving industry.

I have no doubt that the sponsors of the bill had no intention of exempting such apps from oversight.

I have several concerns about this bill starting with the timing.

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 am not convinced there is a problem that needs to be fixed here.

I appreciate that we have the opportunity today to discuss the SOFTWARE Act.