Grapefruit USA Inc (GPFT)

[adrian taylor]

FDA scientists oppose the use of the 510-K process for radiation emitting devices, saying the devices needed to undergo actual testing to prove their safety. "Central to the scientists complaints is an FDA pathway to approval that allows speedy clearance if a device appears comparable to others already on the market". I wouldn't doubt for a second that the DViS is already under a PMA process. Dean, am I right?