> The catch phrase they use is "safety and efficacy". FDA doesn't really care if your device works as well / better / etc. The market will decide that. FDA cares that you don't injure people more than necessary / more than the predicate device does.
That's just safety.
> FDA doesn't really care if your device works as well / better / etc.
This is the "efficacy" part of "safety and efficacy".
That's just safety.
> FDA doesn't really care if your device works as well / better / etc.
This is the "efficacy" part of "safety and efficacy".