That's not correct. You always do safety and efficacy analysis, but with a 501(k) you don't have to stage clinical trials as you would with a PMA. The bar is

That's not correct. You always do safety and efficacy analysis, but with a 501(k) you don't have to stage clinical trials as you would with a PMA. The bar is certainly lower than a PMA, but it isn't laughable. This is a difficult trade off. If everything went through a PMA as currently defined, we would have a tiny fraction of the devices that we do today, and they would cost orders of magnitude more. The FDA is trying to balance access to beneficial technology with risk, and it isn't an easy line to draw.