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- FDA Updates LDT Policy for COVID-19 Tests
On November 15, the Department of Health and Human Services announced it withdrew a Trump Administration policy limiting the Food and Drug Administration’s (FDA) review of laboratory-developed tests (LDTs) for COVID-19.
The FDA now generally expects newly offered COVID-19 tests, including LDTs, to have an emergency use authorization (EUA), or traditional marketing authorization such as a granted De Novo or cleared 510(k), prior to clinical use, the agency said.
For more information, read the guidance document from the FDA. Additional frequently asked questions regarding testing for SARS-CoV-2 is also available from the FDA.