FDA Will No Longer Review EUA Submissions for SARS-CoV-2 LabFDA Will No Longer Review EUA Submissions for SARS-CoV-2 Lab-Developed Tests Oct 07, 2020 | Madeleine Johnson NEW YORK – The US Food and Drug Administration announced on Wednesday it will no longer review SARS-CoV-2 Emergency Use Authorization submissions for lab-developed tests.
We are currently in a different phase of the pandemic with respect to tests than we were previously," he said, noting that the FDA has authorized more than 250 tests to be run in labs, and more than 400 are offered under the agency's notification pathway.
FDA continues to prioritize review of EUA requests for point-of-care tests, home collection tests, at-home tests, tests that reduce reliance on certain types of test supplies, and high-throughput, widely distributed tests, Stenzel asserted.