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Posted On: 07/27/2017 3:01:03 PM
Post# of 11803
Quote:
Oh and by the way, and keep this under wraps, but the FDA is fighting for a new standard +/- 12% mg/dl 97% of the time, and +/- 14% mg/dl 99% of the time. This split precision standard would eliminate 95% of the products currently on the market, making small improvements to existing commercial products impossible. It would be back to the drawing boards for them. The DECN GenPrecis is expected to be +/- 9% mg/dl 97% of the time. That would make the new FDA standards obsolete before they are implemented. That is why I have said, there will be many partners asking for exclusive arrangements for GenPrecis, but really only one natural home for it.
Will the new FDA standard make Genultimate, Genchoice, Gencambre, Genaccord also obsolete?
And what about the iso 15197:2015 in the EU?
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