Replies to post #47728 on Grapefruit USA Inc (GPFT)

[BuyOnDips]

INCORRECT THE FDA APPROVED IDE USE! Please read the link below. This could be how Dean was allowed to demo the DVIS? Only those that signed the NDA know what was in it.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm051345.htm

Also read the letter I received from the FDA. They laid it out very clearly IMO.If Dean has not complied with the FDA guidelines they will request the Federal Marshal to confiscate any equipment used outside of their authorization. The rules and consequences are very clear, if you take the time to research and read them. The FDA has a plethora of information on their guidelines.

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=60367647


Has anyone considered that the DVIS machine that is off site? could be doing IDE at this time, generating images to be submitted to the FDA for comparison?

[cl1021]

Hi Kimble - I see where you're going with this but I respectfully disagree. The radiation emitted doesn't have to be confirmed by an outside agency for a demo. It is completely possible to take area readings while the DViS is running. You take these readings at various distances to figure exactly where the exposure is at background levels. If onlookers stay at that distance they shouldn't receive any exposure. You can verify this with SRPDs or by using a geiger counter during the demo.

That said, this all has to be documented: what type of meters where used, what are their cal dates, etc...

As an example - most rad licenses will require the licensee to prove they are not exposing the general public. We submit maps of all our buildings with geiger counter readings noted inside and outside the buildings. We also do these surveys with radiation both in use and in storage so we can prove that we aren't exposing the general public. IMGG could have done the same thing on a smaller scale for the OH. But if they have no documentation? THAT would be the problem, not the demo itself.

If the folks at IMGG can prove via documentation that exposure levels were at background for the OH attendees then they haven't done anything wrong or exposed anyone. The state and IMGG should both be able to provide an attendee with this info.

I would be in total agreement with you IF IMGG was trying to use the DViS on the OH attendees.