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Home » FDA says new lab test combination possible if existing assay EUA is updated for new instrument
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FDA says new lab test combination possible if existing assay EUA is updated for new instrument

Nov. 4, 2020
By Mark McCarty
The U.S. FDA’s stated policy is that it will not review emergency use authorizations (EUAs) for lab-developed tests (LDTs) for the COVID-19 pandemic, but that doesn’t mean labs are completely shut out. The FDA’s Toby Lowe said that a lab that wants to pair an assay that already has an EUA with a new software installation on lab instrumentation can work with the assay developer to update that EUA.
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