GREY:TSTIF - Post by User
Comment by
binjo222on May 27, 2017 6:46pm
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Post# 26292607
RE:RE:Rumbles gamble and he lost
RE:RE:Rumbles gamble and he lostelgin & metalsguy, I share your frustration. But RR doesn't hold all the cards in a joint submission. I would rather they do it 'right' instead of do it 'fast.' The FDA probes every detail. I remember getting the original FDA clearance, which ultimately came through with the new product code, but there was a lot of back & forth with FDA in the process. When the joint submission does get the clearance to say this one flexible scope can be sterilized, that sets the stage for all flexible scopes to be cleared for sterilization. That will be the game changer. Like you I wish the submission was in, but I don't want the FDA bouncing it back half a dozen times for more data.