CDRH New - December 2, 2021

If your email program has trouble displaying this email, view as a webpage. December 2, 2021 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on December 1, 2021. To view listings for other dates, see CDRH New - News and Updates. New Emergency Use Authorizations HealthPulse@home (Audere) Re-Issued Emergency Use Authorizations LumiraDx SARS-CoV-2 RNA STAR Complete (LumiraDx UK Ltd.) Kwokman Diagnostics COVID-19 Home Collection Kit (Kwokman Diagnostics, LLC) Updated Emergency Use Authorizations Aptima SARS-CoV-2/Flu assay (Hologic, Inc.) MD Anderson High-throughput SARS-CoV-2 RT-PCR Assay (University of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory) CareStart COVID-19 Antigen Home Test (Access Bio, Inc.) UPDATE: Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics' Precice Devices - Letter to Health Care Providers List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated) Reclassification (Updated) MQSA National Statistics as of December 1, 2021 Federal Register: Anesthesiology Devices; Classification of the Isocapnic Ventilation Device Federal Register: Gastroenterology-Urology Devices; Classification of the Esophageal Tissue Characterization System Federal Register: Neurological Devices; Classification of the Conditioning Tool for Eating Disorders Federal Register: Neurological Devices; Classification of the Trunk and Limb Electrical Stimulator to Treat Headache Federal Register: Orthopedic Devices; Classification of the Intraoperative Orthopedic Strain Sensor

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