Faget Quoted on FDA’s Decision to Stop Reviewing COVID-19 Lab Tests

October 7, 2020 BioCentury

Of Counsel Kyle Faget was quoted in a BioCentury article, “FDA to stop reviewing COVID-19 lab tests, raising concerns in Congress,” about the FDA’s announcement that it will no longer review emergency use authorization requests for laboratory developed tests to diagnose COVID-19.

The article cites an Aug. 24 blog post by Faget, who wrote that bringing an LDT to market without securing FDA premarket approval or clearance of, or an emergency use authorization (EUA), comes at a steep cost to clinical laboratories. “Public Health and Emergency Preparedness Act (PREP Act) protection is not available to clinical laboratories opting to use LDTs without FDA premarket review or authorization,” she wrote.

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