>>>Well, next Friday is the 90 day deadline, per the recent 510(k) submission by BIEL. If the clearance doesn't come through by then, IMO, it's not going to happen. Ya know, this just might be last last hurrah for BIEL, IMO.<<<
Oh, here we go with the FDA timelines again. Please, we have been through this before and the conclusion was that the USA FDA could care less about a timeline. Timelines don't mean a darn thing to them. They work at their own pace (SLOW) and never give a definitive date when they will make a decision. They are a government agency, thus they answer to NO ONE. Guidelines are not fact or carved in stone. Let's just hope that they have enough to not delay too long and we will get a answer that will FINALLY make us smile. Still, not holding my breath the way this has been going.
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