Replies to post #11841 on Bioelectronics Corp (BIEL)

[MarMaro]

I spoke to Dr.whelan a few days ago and he said that the person that was handling their de novo was away because of a death in the family (if i remember correctly) and would return today....so i doubt they had heard anything yet

[Ryoko]

I can tell you from experience BIEL has received bad news from the FDA in the past and not shared it. I remember that BIEL got a denial last October and the only reason anyone found out about it was that Andy let it slip accidentally.

[fuente]

I don't believe there is. Med devices are not 'approved' as biologics are...they are cleared for certain classifications. So really, if they have heard something it doesn't mean they got rejected, it just means they need to go at it in another way (PMA). That being said, the de novo process has been taking much longer than the 60 days that is identified in the regs.

I wouldn't worry about the delay in that sense.