Replies to post #7377 on Grapefruit USA Inc (GPFT)

[goldcoastoh]

joe, that post pertains to a PMA (pre-market approval), which is only applicable to a class 3 device, we are a class 2... class 2's have predicates and such applications are based on being substantially equivalent to their listed predicates. class 3 devices do not have predicates and thus need to apply with clinical data (trials) to support said application... but, both processes then are obviously evaluated by the FDA...