The federal government seems at times determined to make a blogger’s job easier, and recent events do little to dissuade one of that view.
Following are a couple of developments of interest to device makers, but we can’t be sure what’s real and what’s just more smoke and mirrors.
Is corporate tax reform kaput?
As we noted recently, Secretary of Commerce Penny Pritzker said in public that the administration wants revenue-neutral tax reform, but President Obama said little about taxes in the State of the Union address other than that he sees a need to boost taxes on the well-off in order to pay for free junior college and other things.
The President’s silence on the issue doesn’t mean corporate tax reform is DOA, but Pritzker was the first in this administration to say anything favorable toward revenue neutrality. Trust me when I say the GOP will not go for corporate tax reform that is revenue enhancing.
Nothing against Secretary Pritzker, but until I hear it from the horse’s mouth…
Taking the initiative or taking an initiative over?
One model of leadership is said to consist of finding a parade and jumping in front. At first glance, that seems to be the case with the President’s Personalized Medicine Initiative, which entirely ignores the fact that the House of Representatives has been working on just this for quite some time now in the guise of the 21st Century Cures initiative.
There’s another model of leadership that’s more or less prevalent in both the public and private sectors. It’s called, “take the credit for the work of others and pretend the idea was entirely yours.” I hear it’s great for morale and should go a long way toward easing tensions between 1600 Pennsylvania Ave. and Capitol Hill.
New questions of usability?
Just when you think you’ve heard it all, you read another FDA product development guidance. FDA’s draft guidance for “wellness devices,” states that the classification of such an offering may depend on whether the device presents “novel questions of usability.” That’s odd because the guidance seems to suggest at the outset that unless the intended use indicates a moderate degree of risk, these devices are presumed to be class I devices.
So how does a developer document that the wellness device does not present novel questions of usability? I don’t know. Human factors engineering? Studies of the article’s use in real-life settings?
I started my review of this draft guidance thinking it was a way to get some really basic mobile medical apps to market, but this question about novel questions suggests FDA is bound and determined to snare them all in its class II (or higher) regulatory tentacles. Shocking, no?