Replies to post #8918 on Grapefruit USA Inc (GPFT)

[IMGGorBust]

Re: Vibration

During the CC, Dean explained that one of the follow-up inquiries from the FDA was whether Imaging3 had conducted a certain type of structural integrity analysis, which identifies issues related to vibration (in terms of the rate of speed and rotation of the device). Dean explained very clearly that Imaging3 had indeed already conducted the very analysis about which the FDA was inquiring, and that the DViS passed that test with flying colors. Responding to that item will take 0 time because the data already exists, and in fact, had been provided to the previous FDA review team.

This is a non-issue.