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Re: docmts2 post# 18566

Wednesday, 06/23/2010 11:20:11 AM

Wednesday, June 23, 2010 11:20:11 AM

Post# of 59551
Not hostile, I just don't want to see people be misled. You put it out there like it was a fact, that this Advisory Comittee, made up almost entirely of non-FDA employees, somehow had a role in reviewing and approving 510(k) applications, and so there was no way would get Approval for a couple more months. It wasn't put out as a question but as a fact. I wanted to quelch that as soon as possible. Also, it was the middle of the night when I first read it and I was exhausted. Sorry if it came off harsh, but your post was misleading (obviously unintentionally so) and I wanted to make sure the facts about how the FDA operate were put out there quickly and definitively.