CDRH New - April 13, 2021

If your email program has trouble displaying this email, view as a webpage. April 13, 2021 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on April 12, 2021. To view listings for other dates, see CDRH New - News and Updates. New Emergency Use Authorizations Lucira CHECK-IT COVID-19 Test Kit (Lucira Health, Inc.) Re-issued Emergency Use Authorizations SalivaDirect (Yale School of Public Health, Department of Epidemiology of Microbial Diseases) Updated Emergency Use Authorizations BD SARS-CoV-2/Flu for BD MAX System (Becton, Dickinson and Company (BD)) Verily COVID-19 RT-PCR Test (Verily Life Sciences) ASCA-Accredited Testing Laboratories Class I Recall: Medtronic Recalls Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy (CRT-Ds) Due to Risk of Shortened Battery Life Class I Recall: Smisson-Cartledge Biomedical, LLC Recalls ThermaCor 1200 Disposable Sets for Risk of Patient Contact to Aluminum Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - April 7, 2021 Problems Reported with Essure (Updated) Consumer Information on: ClearVisc Ophthalmic Viscosurgical Device – P200025 Consumer Information on: AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE) – P190013 Consumer Information on: Exablate Model 4000 System - Type 1.0 and 1.1 (Exablate Neuro) P150038/S006 Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated) Removal Lists of Tests that Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)

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