Replies to post #161432 on Vivos Inc (RDGL)

[SC8]

Again, the device is only under review for human trials when RDGL submits an IDE application. To date RDGL has not submitted an application. Therefore, the device is not under any review whatsoever from FDA.

FDA review and comment on RDGL submission of components to a possible IDE application down the road is not a review of the device for human trials. It is FDA making helpful suggestions towards a possible IDE application.

The RDGL Twitter statement "Our (PRnT) device is currently undergoing review with the @US_FDA." is false. If it were true, the device would have either already been rejected or approved for human trials, as the review consideration period is only 30 days, not 20 months and counting.

Point is there's nothing for FDA to consider decision wise until RDGL submits the IDE application. Only then will the device be under FDA review and for a period not to exceed 30 days.