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Home » Stenzel says FDA will no longer review LDTs under EUA for COVID-19 pandemic
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Stenzel says FDA will no longer review LDTs under EUA for COVID-19 pandemic

Oct. 7, 2020
By Mark McCarty
The U.S. FDA will no longer review lab-developed tests (LDTs) for the SARS-CoV-2 virus under the emergency use authorization (EUA) program, a change that will eliminate any prospect of immunity from liability for these tests. The FDA’s Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health, announced the news on the weekly COVID-19 testing town hall, but the change was simultaneously unveiled in the FDA’s Q&A for testing.
BioWorld MedTech Regulatory Coronavirus U.S. FDA

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