Sunday, October 04, 2015 12:35:21 PM
BIEL's ActiPatch for general pain and ALLAY for debilitating menstrual pains and cramping will dramatically change pain treatment in America, a paradigm tsunami like shift from pill popping to safety in treating mild, medium and severe chronic or occasional pain from old injuries and wounds, twists, spasms from tricky backs, recreation, sports and just life.
FDA now gets it big time, beefed up its devices division, published its Proposed Order in the Federal Register in Feb 2014, "on its own initiative" and, "based on new information" (about BIEL's and others devices and the science and therapeutic value of them) and has been diligently, cautiously and prudently revising its Proposed Order, using the public and industry comments it requested, into its Final Order to reclassify BIEL category products to Class II from Class III.
FDA invited companies in the BIEL product space to submit new 510(k)'s during the time it is revising the Final Order. How do I know this to be true? I have the correspondence in my possession. Good thing for shareholders is that BIEL provides the treatment in miniaturized products, safe, efficacious and cost-effective and is the company providing many hundreds of Boots in the UK with OTC pain management products, owned by Walgreens, Boots is the beacon we Americans will follow. The result? Less harmful side-effects and deaths caused by chemical analgesics.
The bad news? It takes time and thousands of hours of hard work for FDA to produce a Final Order. I'll take the good news with the bad every day, because when the Final Order is published, it will be done properly. Although time consuming and often frustrating, the tsunami of BIEL helping the American people manage pain better and saving lives is coming - soon.
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