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Re: West Coast Snapper post# 51570

Wednesday, 12/16/2015 10:07:32 AM

Wednesday, December 16, 2015 10:07:32 AM

Post# of 178138
Yes you're right. New rules because they deemed radiogel not comparable to any prior device.

So yes the fda has officially considered it different than any prior product so more testing is needed.

Not that the testing is gauranteed for anything because the fda's confidence is very low for radiogel by reading the last denail.

FDA says flat out:

"We do not believe that the benefits of your device outweigh the risks. "
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