To better advance the diagnosis of the new coronavirus COVID-19, the U.S. Food and Drug Administration (FDA) announced today that it will allow laboratories and medical institutions in the U.S. to directly develop and validate diagnostic tests without waiting for the FDA to complete a review of the “emergency use authorization.” The FDA says the move will allow the U.S. to diagnose the new coronavirus more quickly.
The new policy came as critics attacked the slow pace of the Administration’s response. Although the first case of the new corona virus was reported in early December, it has not been well prepared. And yesterday, a Washington state resident died of the new coronavirus, the first case of new coronavirus death.
“In line with this policy, we hope that some laboratories that have developed proven coronavirus tests will begin using them immediately before the FDA reviews,” Jeff Shuren, director of the FDA’s Center for Device and Radiological Health, said in a statement. “The FDA’s move means that the U.S. can test thousands of patients almost overnight, rather than the hundreds of patients they have today.
“We believe that this policy has struck the right balance in the public health emergency,” FDA Director Stephen Hahn said in a statement. Hahn also said the agency will continue to help ensure that the testing methods are well-founded before clinical testing is conducted, and that the FDA will use its critical independent review to follow up. At the same time rapidly expanding the testing capabilities of new coronaviruses in the United States.
CNN reported that the policy takes effect immediately: Once a laboratory verifies a diagnostic method, it must notify the FDA and submit an Emergency Use Authorization (EUA) request within 15 working days. The FDA stresses that the policy applies only to laboratories that can perform high-complexity tests. These labs can begin using proven diagnostic tests before the FDA completes the “Emergency Use Authorization” review.