Grapefruit USA Inc (GPFT)

[kinlaw]

Actually, if you are that confused and not sure who to believe then you might want to take a look at the FDA site yourself and try to figure out the process.

90 days is the typical "review period" of a 510K process. These 90 days are only counted while the FDA is reviewing the app. The 90 day review clock stops once the FDA responds for more information and starts again once they have received it and has notified the company of the receipt of the info. For additional information, as in the 2nd or more additional information request from the FDA, a 60 day review is needed by the FDA. We are now getting into that 60 day window from the last submission.