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

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


It’s sending some COVID-19 tests through the normal regulatory pathways, not the emergency ones.

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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 Radiological Health, in the statement.

The emergency use authorization system lets the FDA review and authorize tests quickly, which was key during the early stages of the COVID-19 pandemic when there weren’t nearly enough tests available to meet skyrocketing demand. It’s how we got the original tests that used deep nasal swabs to find the coronavirus, and it’s how all of the rapid at-home tests made it to drug store shelves. But now, there are plenty of COVID-19 tests available, the FDA said in its statement. There isn’t as much of a crush, so the agency can take more time reviewing new tests and give them full, formal approval.

The United States is still under a federal public health emergency, so the FDA can still use the emergency use authorization process if it feels it needs to. In the statement, the agency said it will still use that process in a few cases — like for tests that use new technologies, or for tests that diagnose a new variant.

But for other COVID-19 tests, the process will go back to normal. It’s another signal that federal agencies are shifting to make COVID-19 part of the normal public health backdrop, rather than an acute emergency.