Replies to post #48233 on Grapefruit USA Inc (GPFT)

[Uncle Snook]

Your FACTS are correct. There is no trouble with the SEC. I have confirmed this myself. Anything you hear otherwise is not FACT. Long and strong my friend.

[KingKong_Guru]

I want to see in post FDA meeting PR:

As per FDA.
1) NO PMA or De-novo.
2) 510K and no human clinical studies required.
3) No cadaver study required (Preferred , but no the red flag).
4) FDA accepts imaging protocol proposal. Performance data comparison using phantom is sufficient. (Load)
5) FDA agree on predicate device selection for equivalence determination. (Load)


KkG