Replies to post #5028 on Grapefruit USA Inc (GPFT)

[kimble1]

i dont know if i spoke to the firm working with I3 because they told me they could not divulge that info (i dont think i was though)

I asked about IDE approval: they said it WAS significant to recieve this
Timeline for approval: it has been long but not completely out of order
If devices that are pending or in process this long still get denied....they said the fact it HAS taken so long is a positive as the FDA would flat decline something that did not have merit

they are not hard to find just google FDA Consultants

Kimble