Bioelectronics Corp (BIEL)

[srinsocal]

Thanks pittts, the Answer is Right in Your Post

“Any commercial distribution of this device prior to approval of a PMA, or the effective date of any order by the Food and Drug Administration re-classifying this device into class I or II, would be a violation of the Act.”

BIEL's products are, as of 10/13/2015, a FDA class 2 Device. Therefor, per the warning letter, BIEL is no longer in violation of any FDA regulations.

How can the FDA hold any grudge against BIEL if their own warning letter and reclassification has exonerated them from wrong doing??