Replies to post #31781 on Grapefruit USA Inc (GPFT)

[adrian taylor]

The FDA has the LEGAL right to demand CLINICAL TRIALS as part of the 510K acceptance process. You must apply to the FDA and receive an IDE before you can LEGALLY start the required clinical trials. Dean Janes did apply and did receive an IDE from the FDA however he never performed the trials.http://medicaldeviceschool.com/fda%20clinical%20trials.html