The FDA is transitioning back to traditional regulatory processes to sign off on new COVID-19 tests after clearing more than 430 for emergency use during the pandemic, the agency said Sept. 27.
In its updated guidance, the agency said it would only review a "small subset" of new emergency use authorization requests for COVID-19 tests that would likely fill an unmet need or have a significant benefit to the public.
"Taking into account the current status of manufacturing capacity and consumer access given the administration's important investments in tests, for most new tests, shifting to traditional premarket review would best meet the public health needs at the current stage of the COVID-19 public health emergency," Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health, said in a news release.
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