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rawman

07/06/20 9:48 PM

#88039 RE: shalley #88038

I hope they get FDA approval.


Here is a quick primer in FDA Emergency Use Authorization 101. An Emergency Use Authorization or EUA is NOT the stated "FDA Approval". An EUA simply allows a company to distribute a product during an emergency, but when the emergency is over, the product can no longer be sold.

Using the proper terminology in the COVID-19 test kit discussion can add clarity to the situation. An EUA grant is NOT like going through a full FDA product approval review! In this case the FDA is waiting on DECN to deliver certified test results that meet the FDA's efficacy standards. The "WAIT" has been going on since mid-March and will continue, probably ad infinitum!