There have been comments about the new FDA accurac
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Posted On: 10/19/2017 9:49:28 AM
There have been comments about the new FDA accuracy guidelines, will all of the GEN family products meet those specs on the existing meters they are designed for?
The new FDA guidelines are for new products. FDA doesn't have Congress authority to retroactively regulate products. But the EU does and they are.
Just trying to understand what 6% of overall meters which products are going to capture. The last statement about 28M meters worldwide seems to be the relevant number and determining how much of that share is captured by each GEN product. The 28M won't be a static number as evidenced by many projections, but that overall share can only be split up so many ways. I think we would all be ecstatic if DECN can capture even 3% of that market in the next 2-3 yrs.
DECN should choose their partner wisely. 3% marketshare is Nipro sized, and to me that would be a failure.
The new FDA guidelines are for new products. FDA doesn't have Congress authority to retroactively regulate products. But the EU does and they are.
Just trying to understand what 6% of overall meters which products are going to capture. The last statement about 28M meters worldwide seems to be the relevant number and determining how much of that share is captured by each GEN product. The 28M won't be a static number as evidenced by many projections, but that overall share can only be split up so many ways. I think we would all be ecstatic if DECN can capture even 3% of that market in the next 2-3 yrs.
DECN should choose their partner wisely. 3% marketshare is Nipro sized, and to me that would be a failure.
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