No PMA here. Worst case scenario 90 days for a 510K. But, with the circumstances this should go much much faster. This is the whole point of the meeting with the FDA. If I were the FDA, I will grant them clearance at the door steps along with a medal of excellence.
It isn't clear if you need to submit a 501K for a new indication of use if the device itself hasn't been changed
BIEL had some good lawyers before who were able to dig their heals in over allowing OTC clearance even though the category didn't specify that. So may be they can get or may already have got some form of agreement to the process.
I keep wondering about the single SKU packaging - that had to be cleared by FDA I would think. It doesn't specify knee and foot as far as I recall, so may be the indication of use only applies to marketing material used to sell a cleared device and so we just require permission to market by letter referencing prior 501K
I had hoped the company would have explained things better.
as far as I am concerned if we do get an announcement of being cleared for general pain indication quickly I will be surprised and very happy. If we are told they ave to submit a new form and wait a few weeks I will not be surprised as that's what I am expecting
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