HHS reinstates FDA review of lab-developed COVID-19 tests

HHS is withdrawing a 2020 policy that limited the FDA's review process of certain lab tests, including some COVID-19 tests, the agency said Nov. 15.

The policy was originally put in place to help labs meet increased need, but the FDA said it also allowed some poorly performing tests to slip through.

The agency now generally expects new COVID-19 tests, including lab-developed tests, to have either an emergency use authorization or traditional marketing authorization prior to clinical use. Tests without emergency authorization already in use will also need to submit an EUA request, the agency said.

EUA review efforts will be focused on tests that can be manufactured in high volumes, such as at-home and point-of-care diagnostic tests, and those that will expand testing capacity and accessibility, such as high-volume lab-based tests.

The FDA also issued an umbrella EUA for serial testing with certain lab-developed molecular diagnostic tests that will be used at schools, workplaces and other community groups, the agency said.

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