- 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.
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