FDA opens door to rapid, at-home testing for COVID
Post# of 11803
(Total Views: 689)
Posted On: 07/30/2020 9:19:42 AM
FDA opens door to rapid, at-home testing for COVID-19 — if companies don't find the rules too burdensome.
True and typical of the FDA. Bow to political pressure for an at-home testing alternative and then make the rules to get there so burdensome that the average developer or the typical pro kits companies with kits under development or in use can't be adapted for at-home use because of the rules.
I read the FDA guidance last night cover to cover (see below) and it appears to me to almost be a knock-off of the FDA Blood Glucose guidance from 2016 (implemented in 2018) with added difficulties for molecular methods. I am not sure how a molecular method can work in an at-home setting anyway, but I am sure at least one genius on the iHub message board can tell us all how.
In any event, the FDA EUA template for at-home use appears to be very closely related to the 510K guidance and as the author says -- "if companies do not find the rules too burdensome."
Is $800K and 120 days too burdensome? I would think that the Yahoo posters will flip out over this. But is November really so bad?
True and typical of the FDA. Bow to political pressure for an at-home testing alternative and then make the rules to get there so burdensome that the average developer or the typical pro kits companies with kits under development or in use can't be adapted for at-home use because of the rules.
I read the FDA guidance last night cover to cover (see below) and it appears to me to almost be a knock-off of the FDA Blood Glucose guidance from 2016 (implemented in 2018) with added difficulties for molecular methods. I am not sure how a molecular method can work in an at-home setting anyway, but I am sure at least one genius on the iHub message board can tell us all how.
In any event, the FDA EUA template for at-home use appears to be very closely related to the 510K guidance and as the author says -- "if companies do not find the rules too burdensome."
Is $800K and 120 days too burdensome? I would think that the Yahoo posters will flip out over this. But is November really so bad?
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