Replies to post #47569 on Vivos Inc (RDGL)

[Chief Slapaho]

You'll have to ask the FDA. My DD has determined that no human trials are needed for this round for a de novo device resubmission. Period. Call them yourself.

In any case, logic dictates that if they didn't ask for human trials previously for the same submission ... twice now ... they won't be asking for it the 3rd go round. It's bullshit to state otherwise.

[TickTalker]

The statement stands on it's own but when the goggles are on it is very hard to see it clearly, I know.