The U.S. Food and Drug Administration said on Tuesday it will now review only a small number of emergency use authorization requests for COVID tests that are likely to have a significant benefit to public health, including fulfilling an unmet need. The agency is revising its COVID-19 test policy in light of the current manufacturing status and number of cases, it said, adding companies seeking EUA for their COVID tests will have to now apply for the agency’s traditional premarket review process.
“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. Last week, federal investigators found that the regulator’s decision to accept all EUA requests in the early months of the pandemic resulted in some ‘problematic tests on the market’ and recommended the FDA revise its EUA policies for the tests.
To date, more than 430 distinct COVID-19 tests have been issued EUAs. The FDA did not immediately respond to Reuters request for comment on the status of these tests after Tuesday’s policy revision. The FDA said on Tuesday it will also focus on supplemental requests for previously authorized tests, or those funded by a federal agency.
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