Replies to post #25664 on Grapefruit USA Inc (GPFT)

[Frank39]

BennyJ

What I see regarding FDA’s performance is an average elapsed time to approval. If there are many 510K devices whose “Substantial Equivalence” is so obvious that they pass through the 510K process quickly they can offset devices whose approval takes a very long time without affecting the average. If I am thinking correctly, it would suggest that the DVIS approval could take much longer and still not affect the FDA’s average time to approval.

Any thoughts on this BennyJ? In addition, do you know of any data that shows the longest times to approval for devices?

Thanks for your research,

Frank39