CDRH New - April 16, 2021

If your email program has trouble displaying this email, view as a webpage. April 16, 2021 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on April 15, 2021. To view listings for other dates, see CDRH New - News and Updates. New Emergency Use Authorizations SalivaDirect At-Home Collection Kit (Yale School of Public Health, Department of Epidemiology of Microbial Diseases) Color COVID-19 Self-Swab Collection Kit with Saline (Color Health, Inc.) Reissued Emergency Use Authorizations Color SARS-CoV-2 RT-LAMP Diagnostic Assay (Color Health, Inc.) BD Veritor System for Rapid Detection of SARS-CoV-2 (Becton, Dickinson and Company (BD)) Updated Emergency Use Authorizations Gravity Diagnostics SARS-CoV-2 RT-PCR Assay (Gravity Diagnostics, LLC) Fulgent COVID-19 by RT-PCR Test (Fulgent Therapeutics) BinaxNOW COVID-19 Ag Card (Abbott Diagnostics Scarborough, Inc.) COVID-19 Self-Collected Antibody Test System (Symbiotica, Inc) New CDRH Learn Module - MDSAP: Production and Service Controls Process: Part 3 Removal Lists of Tests that Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated) Class I Recall: Medtronic Recalls HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports Due to Risk of Damage to Controller Ports Federal Register: Medical Devices: Class I Surgeon's and Patient Examination Gloves Federal Register: Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices from Premarket Notification Requirements; Withdrawal of Proposed Exemptions

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