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FDA To Review Smaller Number Of Emergency Use Requests For COVID-19 Tests

  • The FDA said it will now review only a small number of emergency use authorization (EUA) requests for COVID-19 diagnostic tests.

  • The agency encourages developers of all test types interested in marketing authorization to pursue authorization through the de novo classification or 510(k) clearance premarket review pathways.

  • It said companies seeking EUA for their COVID tests would have to apply for the agency's traditional premarket review process.

  • Also ReadNo More Free COVID-19 At-Home Tests, Federal Government Says

  • "Taking into account the current status of manufacturing capacity and consumer access...shifting to traditional premarket review would best meet the public health needs at the current stage of the COVID-19 public health emergency," FDA official Jeff Shuren said in a statement.

  • To date, more than 430 different COVID-19 tests have been issued EUAs.

  • FDA intends to focus its review on EUA and supplemental requests for tests that employ new technologies, new variants, or tests funded by a federal agency.

  • The World Health Organization (WHO) also warned that it struggles to identify and track new COVID variants as governments roll back the testing.

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