Friday, February 21, 2014 3:58:17 PM
the FDA have re-categorized all these types of equipment to class II with special conditions.
Each device manufacturer now has to re-submit a n application to be classified as SWT equipment and hence ear class II categorization.
It is a major change by the FDA.
Can BIEL now sell OTC - no
Will they be able to when they submit their paper work - almost certainly yes.
How long will that take? may be 6-12 months unless there is a fast track system after this reclassification.
but it opens them up to buy out IMHO.
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