The FDA is determined to step up the pace of coronavirus testing in the US to cope with the recent coronavirus outbreak, and it's willing to greenlight technology at an early stage to make that happen. The regulator said it will allow new diagnostic tech to be used to test for COVID-19 before an Emergency Use Authorization request has gone through a review. This will only apply to validated methods from labs that are certified to handle "high-complexity" tests in line with key requirements, the FDA said, and doesn't amount to lowering standards -- this is only to ensure there's "wide availability" of testing options.
from Yahoo Tech https://ift.tt/2vqwaOQ
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