CDRH New - April 2, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on April 1, 2020. To view listings for other dates, see CDRH New - News and Updates.

Emergency Use Authorizations - Added COV-19 IDx assay (Ipsum Diagnostics, LLC), qSARS-CoV-2 IgG/IgM Rapid Test (Cellex Inc.), and Letter Granting EUA Amendment(s) to Abbott RealTime SARS-CoV-2 assay and PerkinElmer New Coronavirus Nucleic Acid Detection Kit Meeting Notice: June 9, 2020 Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting Announcement FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data FAQs on Diagnostic Testing for SARS-CoV-2 (Updated) Medical Devices and the COVID-19 (Coronavirus) Pandemic MQSA National Statistics Device Advice: Comprehensive Regulatory Assistance (Updated) Federal Register: Medical Devices; Technical Amendment Federal Register: Medical Devices; Technical Amendment Federal Register: Reclassification of Certain Hepatitis C Virus Antibody Assays Devices, To Be Renamed Hepatitis C Virus Antibody Tests Federal Register: Reclassification of Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Assay Devices, To Be Renamed Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests