- 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 Read: No 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.
FDA To Review Smaller Number Of Emergency Use Requests For COVID-19 Tests
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