Monday, May 19, 2014 1:36:07 PM
In probably two months, the FDA will announce the rule change is final.
Not much doing before then.
After rule is final, then BIEL can submit 510k.
Then they should get clearance a couple months after that.
Maybe by years end the products get OTC clearance in USA.
In the meantime, hope for increasing sales quarter over quarter.
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