Bioelectronics Corp (BIEL)

[uksausage]

I think on the same lines as you - there is no reason not to approve it, however the system seems to have got confused and I am sure they (FDA and BIEL) are now trying to sort things out.

You are right - the product works, (proven in science information and studies presented to FDA and available bielcorp.com web site.)
The product is safe (again from science "bench tests" etc
The product has no side effects from studies

However the initial 50K applications that came back NSE meant the FDA say there is nothing like it on the market please submit a DeNovo application to create a new category of product.

After 2 years in the sausage machine it comes back saying - "Actually we classify this product as such and such so no need to have a new category, and you initially are class 2 until you submit another 501K."

BIEL then IMHO quite rightly goes ballistic. The FDA have contradicted themselves and wasted years of BIEL's time.

I am sure this summer there has been a lot if debate as to how the FDA can get out of this easily.

If they create a new category as the DeNovo process should conclude they have to make it tight enough so not every PEMF device goes OTC immediately and also explain their initial decision on Allay.

If they got it wrong first time (2010) they should be expediting the original application to give OTC clearance, but their process doesn't allow that.

As I posted before had Andy gone - wider RecoveryRx applications, then Actipatch OTC then Allay OTC he might have had a smoother ride,