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adrian taylor

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adrian taylor

Re: art2426 post# 31781

Tuesday, 11/09/2010 10:53:04 AM

Tuesday, November 09, 2010 10:53:04 AM

Post# of 59551
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
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