BioCentury
ARTICLE | Politics, Policy & Law

FDA to stop reviewing COVID-19 lab tests, raising concerns in Congress 

As agency drops voluntary reviews of LDT EUAs, lawmakers worry about accuracy of tests

October 7, 2020 8:24 PM UTC

In a move that raises concerns about the accuracy of tests, as well as liability protections for laboratories, FDA announced Wednesday that it will no longer review emergency use authorization requests for laboratory-developed tests to diagnose COVID-19.

The announcement precludes even voluntary regulatory oversight over tests that are critical links in the chain of pandemic public health response. ...



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