CDRH New - April 3, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on April 2, 2020. To view listings for other dates, see CDRH New - News and Updates.

Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) - Guidance for Industry and Food and Drug Administration Staff Emergency Use Authorizations - Added BioGX SARS-CoV-2 Reagents for BD MAX System (Becton, Dickinson & Company (BD)) FAQs on Diagnostic Testing for SARS-CoV-2 (Updated) Consumer Information on: Alto™ Abdominal Stent Graft System - P120006/S031 Class I Recall: LeMaitre Vascular Inc. Recalls LeMaitre Over the Wire Embolectomy Catheter Due to Balloon Deflation and Separation Issue Federal Register: Medical Device User Fee Amendments for Fiscal Years 2023 through 2027