CDRH New - January 22, 2021

If your email program has trouble displaying this email, view as a webpage. CDRH New January 22, 2021 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on January 21, 2021. To view listings for other dates, see CDRH New - News and Updates. New Emergency Use Authorizations KNH Surgical Face Mask (KNH Enterprise Co., Ltd.) Re-issued Emergency Use Authorization Cleveland Clinic SARS-CoV-2 Assay (Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute) Updated Emergency Use Authorizations EliA SARS-CoV-2-Sp1 IgG Test (Phadia AB) Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR) Recognized Consensus Standards Database (Updated) Post-Approval Studies Program (Updated) 522 Postmarket Surveillance Studies Program (Updated) Mammography Facility Adverse Event and Action Report - January 21, 2021: Ochiltree County Hospital District 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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