Grapefruit USA Inc (GPFT)

[DAK424]

The intended use is determined by the applicant, not by subsequent third party use. If FDA believes that a device that is the subject of a 510(k) premarket notification is likely to be used off-label and that a particular use may present health risks, FDA can mandate a warning against that use. FDA cannot, however, reject a 510(k) because of anticipated off-label use.

This was posted by Chemic76Spirit (Message # 7733). There is no further complex technological validation to be performed by the FDA. Clarification of the "intended use statement" is the last piece of the puzzle and the fact that there has been no word from the FDA means that they have already decided to approve the device. Jan 12th is the approximate 60 day deadline, but don't be surprised to see it come sooner.

If anyone doubts this then please, sell your shares now and move on. For those of us who understand the incredible impact this device will have on the medical industry (not to mention transportation, manufacturing, etc.), we will stay to reap the rewards.