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FDA Withdraws Exceptions for Laboratory-Developed COVID-19 Tests

For compliance, laboratory staff

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The Food & Drug Administration (FDA) has reversed the prior administration’s policy on pre-market review exception for COVID-19 laboratory-developed tests that allowed the tests to be offered prior to or without FDA authorization.  

The agency will now regulate these tests and require an emergency use authorization (EUA) or traditional marketing authorization. The FDA also updated its policies on the types of tests it intends to focus its review of emergency use authorization requests to:   

  • At-home and point-of-care (POC) diagnostic tests for use with or without a prescription and that can be manufactured in high volumes 
  • Certain high-volume, lab-based molecular diagnostic tests (and home collection kits for use with such tests) that expand testing capacity or accessibility such as through pooling of specimens to increase throughput, testing specimens collected at home and shipped to the lab, screening asymptomatic individuals or detecting multiple different respiratory viruses at once 
  • Certain lab-based and POC high-volume antibody tests that can measure the amount of antibodies (fully quantitative antibody tests) or the amount of neutralizing antibodies 
  • Tests for which the request is from, or supported by, a U.S. government stakeholder, such as the Biomedical Advanced Research and Development Authority or the National Institutes of Health’s Rapid Acceleration of Diagnostics.