CDRH New - March 17, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on March 16, 2020. To view listings for other dates, see CDRH New - News and Updates.

Emergency Use Authorizations - Added COVID-19 RT-PCR Test (Laboratory Corporation of America) and Panther Fusion SARS-CoV-2 (Hologic, Inc.) Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff MQSA Facility Adverse Event and Action Report - March 13, 2020: The Breast Institute at JFK Medical Center North Campus