Grapefruit USA Inc (GPFT)

[KingKong_Guru]

Good video on 510k processing at CDRH...

www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/ucm070201.htm

In this page look for (Windows Media Video).

As we know , from last 3-4 weeks dean didn't hear anything from reviewer ..it used to be very frequent communication between Dean and reviewer otherwise ...

This mean , reviewer has completed his review ..made the decision and sent the application to division direction/ big bosses for final review .

Now as per video once big boss (director ) accepts reviewer decision , he signs the application send it to administrative prepossessing .

Bib boss decision and administrative processing itself might take 2-3 week time.

I am pretty sure that reviewer has made the final decision and DVIS file is either with CDRH director or administrative team.

We may hear tomorrow ..who knows.. ($5)

LongLoaded,
KingKong_Guru