RE:FDA Will No Longer Review EUA Submissions for SARS-CoV-2 LabWatcher2020 wrote: FDA 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.
Now that FDA has made such a decision and Health Canada seems to follow the lead of FDA it would be time for HC to adopt the same and lighten their load of the 94 applications that they are in the reviewing. The few that would remain would not take long to finally approve. Sona Nanotech lateral flow antigen test should be front and center. Go HC, you can do it!