https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostics-testing-laboratories-certified-perform-high-complexity-testing-under-clia-prior?utm_campaign=2020-02-29%20Immediately%20in%20Effect%20Guidance%20on%20Coronavirus%20%28COVID-19%29%20Diagnostic%20Tests&utm_medium=email&utm_source=Eloqua

FDA Issues Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests

The U.S. Food and Drug Administration (FDA) issued the immediately in effect guidance titled, Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency.

Read the Guidance Upcoming webinar on this guidance On March 2, 2020, the FDA will host a webinar for laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments (CLIA), and others interested in learning more about this guidance. Questions? If you have questions, please contact the Division of Industry and Consumer Education.