HHS again permits FDA review of LDTs, updates EUA policy for laboratory developed tests

On November 15, the U.S. Department of Health and Human Services (HHS) withdrew a controversial Trump-era HHS Policy Change that effectively prevented the Food and Drug Administration (FDA) from reviewing laboratory-developed tests (LDTs) developed by high complexity clinical laboratories, including LDTs for diagnosis of COVID-19. In the statement announcing this change, HHS Secretary Xavier Becerra said that the withdrawal is intended to help “ensure that COVID-19 tests are accurate, reliable, and available.”

Also last week, FDA updated its emergency use authorization (EUA) policies for COVID-19 tests. In the updated policy, FDA expects newly offered COVID-19 tests, including LDTs, to have an EUA, or traditional marketing authorization such as a granted De Novo or cleared 510(k) Notice, prior to clinical use.

 

For now, FDA says it will prioritize its EUA reviews for:

  • tests performed at home or at the point of care that are manufactured in high volume;
  • high-volume lab tests that use techniques such as specimen pooling or testing for multiple respiratory viruses to expand test capacity;
  • high-volume antibody tests that can measure the number of antibodies or neutralizing antibodies in patient samples; and
  • tests supported by a government stakeholder, such as BARDA or NIH’s Rapid Acceleration of Diagnostics.

 

FDA will also prioritize tests (LDTs and in vitro diagnostics, generally) where the sponsor says they have sufficient instrument and kit production capacity, or sufficient assay and collection kit production capacity for high volume and especially home-based tests, the agency said.

 

FDA also issued an umbrella emergency use authorization (EUA) pathway for molecular LDTs that are used for serial testing in settings, such as workplaces or schools; this new document will help those tests reach users more efficiently, the agency said.

 

In a statement announcing the actions, FDA’s Center for Devices and Radiological Health (CDRH) Director Jeff Shuren said, “The FDA remains committed to helping to increase the availability of tests that will have the biggest impact on the nation’s ongoing COVID-19 testing needs, such as at-home and point-of-care diagnostic tests that can be produced in high volumes.”

 

 

Authored by Randy Prebula, Blake Wilson, Brooke Bumpers, Susan Tiedy-Stevenson, and Erkang Ai

 

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