CDRH New - April 7, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on April 6, 2020. To view listings for other dates, see CDRH New - News and Updates.

Emergency Use Authorizations - Added Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators - Exhibit 1: Authorized Respirators, Viracor SARS-CoV-2 assay, and Gnomegen COVID-19 RT-Digital PCR Detection Kit Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff