COVID-19 tests will no longer get emergency treatment at the FDA

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Illustration by Alex Castro / The Verge

Since the start of the pandemic, the Food and Drug Administration has signed off on 430 COVID-19 tests through its emergency use authorization powers — rules that let the agency push tests and drugs out the door more quickly during an emergency. Now, over two years later, the agency is backing off that system and will treat most COVID-19 tests just like other medical tests. In a statement Tuesday, the FDA said that most new COVID-19 tests will have to go through the normal, non-emergency test review process.

“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,” said Jeff Shuren, director of the FDA’s Center for Devices and...

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source https://www.theverge.com/2022/9/28/23376657/fda-covid-test-emergency-authorization-rules

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