Replies to post #1631 on Bioelectronics Corp (BIEL)

[J-Rhino]

What retail store can I purchase one from? Thanks in advance.

[IZZYBOY]

Hi there Janice... Let me just get this skin out of the way and I will inform you about FDA approval.

Firstly the FDA does not approve any device or drug. The FDA issues a market clearance. That means the FDA, after reviewing application and data, may permit the company to market its product according to a stated "indication for use" and market stipulation.

In Biel's case it was permitted to market (6-7 years ago) it's product under the extremely narrow indication of "reduction of edema following blepharoplasty" and with the stipulation that it only be used on the order of a medical professional.

That means that it is illegal for the company to market the product in the US, to anyone, for anything but that express use. Essentially they can market to healthcare professionals as a reducer of swelling after eyelid surgery ONLY.

Despite the messiah's contention that securing a pain relief indicaion for OTC distribution "is not an issue", it requires legitimate clinical documentation that the product is equivalent to the predicate device cited and poses no risk. It is an issue, and could be a barrier. It will take considerable time, may require specific clinical trials and at the end of the day may be rejected.