FDA Will No Longer Review EUA Submissions for SARS-CoV-2 Lab-Developed Tests

The US Food and Drug Administration announced it will no longer review SARS-CoV-2 Emergency Use Authorization submissions for lab-developed tests.

In the latest of its weekly virtual town hall sessions, the agency asserted that the change is consistent with the recent statement by the US Department of Health and Human Services and will also help FDA prioritize the review process during the pandemic.

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.

Source: https://www.genomeweb.com/regulatory-news-fda-approvals/fda-will-no-longer-review-eua-submissions-sars-cov-2-lab-developed#.X39rqWhKiUk