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FDA provides path for authorization of at-home COVID-19 tests

FDA provides path for authorization of at-home COVID-19 tests

Business
March 16 (UPI) -- The Food and Drug Administration on Tuesday introduced a path for manufacturers to receive emergency authorization for take-home COVID-19 tests. The agency issued a supplemental template that would allow point-of-care or at-home tests to be authorized for over-the-counter use without validating how they perform on people without systems. Advertisement "We believe this effort will pave the way for further expanding the availability of tests authorized for screening asymptomatic individuals, help bolster existing and new testing programs and increase consumer access to testing," FDA medical device director Jeffrey Shuren said in a statement. The template will allow developers to seek emergency use authorization for kits that will allow businesses to conduct COVID-19 screen...