Replies to post #46463 on Grapefruit USA Inc (GPFT)

[mr_sano]

HOmer you guys need to read the AI and NSE letters front to back. IF you believe DVIS is a diagnostic device then you can kiss the 510K good bye. The FDA clearly states it believes a diagnostic capability to be a new intended use as the predicate does not function in this manner. Simply put you are making the FDA case for them and the case for PMA.