CDRH New

June 8, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on June 5-7, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations
Phosphorus Diagnostics LLC Phosphorus COVID-19 RT-qPCR Test
Hangzhou Biotest Biotech Co., Ltd. RightSign COVID-19 IgG/IgM Rapid Test Cassette
Updated Emergency Use Authorizations
Zymo Research Corporation Quick SARS-CoV-2rRT-PCR Kit (IFU, Amendment)
InBios International, Inc Smart Detect SARS-CoV-2 rRT-PCR Kit (IFU)
Abbott RealTime SARS-CoV-2 assay (Patients)
Abbott Laboratories Inc. SARS-CoV-2 IgG assay (Recipients)
Abbott Molecular Inc. Alinity m SARS-CoV-2 assay (Patients)
Simplexa COVID-19 Direct assay (IFU, HCP, Patients, Amendment)
ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit (IFU, HCP, Patients, Amendment)
Roche Diagnostics Elecsys Anti-SARS-CoV-2 (IFU, Amendment)
Advanced Sterilization Products (ASP) STERRAD Sterilization System
Battelle Decontamination System
Duke Decontamination System
Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China
Sterilucent, Inc. Sterilization System
STERIS Sterilization Systems for Decontamination of N95 Respirators
Stryker STERIZONE VP4 N95 Respirator Decontamination Cycle
Stryker Sustainability Solutions VHP Decontamination System
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised) - Guidance for Industry and Food and Drug Administration Staff
Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection - Letter to Health Care Providers (Updated)
N95 Respirators, Surgical Masks, and Face Masks (Updated)
FAQs on the EUAs for Non-NIOSH Approved Respirators During the COVID-19 Pandemic (Updated)
FAQs on Shortages of Surgical Masks and Gowns During the COVID-19 Pandemic (Updated)
FAQs on Testing for SARS-CoV-2 (Updated)
FDA News Release: Coronavirus (COVID-19) Update: FDA Reissues Emergency Use Authorizations Revising Which Types of Respirators Can Be Decontaminated for Reuse