Drekab, Having one's technology listed on the F
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Posted On: 01/09/2017 2:50:22 PM
Drekab,
Having one's technology listed on the FDA website is a requirement prior to marketing. I see that NanoLogix technology is 510K exempt and can be marketed along with their BNP and petri plates. The update states that they have to perform a time and sensitivity study prior to marketing. That is what we "Docs" would have to see in addition to the published paper from October to show that researchers other than the original personnel listed on that paper had confirmed the capabilities of the N-Assay. You don't have the developers confirm their own results, it has to be researchers who weren't involved with the development.
Scott
USUHS
Class of been there, done that
Having one's technology listed on the FDA website is a requirement prior to marketing. I see that NanoLogix technology is 510K exempt and can be marketed along with their BNP and petri plates. The update states that they have to perform a time and sensitivity study prior to marketing. That is what we "Docs" would have to see in addition to the published paper from October to show that researchers other than the original personnel listed on that paper had confirmed the capabilities of the N-Assay. You don't have the developers confirm their own results, it has to be researchers who weren't involved with the development.
Scott
USUHS
Class of been there, done that
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