CDRH New - March 2, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on February 29, 2020. To view listings for other dates, see CDRH New - News and Updates.

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 - Immediately in Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff Accelerated Emergency Use Authorization Template for SARS-COV-2 (covid-19) Molecular Testing of Respiratory Specimens in CLIA Certified High-Complexity Laboratories (Word - 128kb) Webinar - 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 - March 2, 2020 Emergency Use Authorizations - New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel (Wadsworth Center, NYSDOH)