I think its the same as before. From my research

I think its the same as before. From my research (a decade or so ago?), diagnostic tests don't require FDA approval, but the problem is that few will use a test without FDA approval -- and this is in a 'normal' situation.

With this pandemic and given the failures of tests that have already been allowed to go to market, I think anything sponsored by the government will require FDA approval.

So....in short, YES. But I'm just guessing.