CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New July 30, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on July 29, 2020. To view listings for other dates, see CDRH New - News and Updates.

Updated Emergency Use Authorizations Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China Quest SARS-CoV-2 rRT-PCR (Quest Diagnostics Infectious Disease, Inc.) BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test (Xiamen Biotime Biotechnology Co., Ltd.) Meeting Notice: September 8-9, 2020 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Template for Manufacturers of Molecular and Antigen Diagnostic COVID-19 Tests for Non-Laboratory Use Accelerate Sustainable Capability (ASC) Pilot Study FDA News Release: Coronavirus (COVID-19) Update: FDA Posts New Template for At-Home and Over-the-Counter Diagnostic Tests for Use in Non-Lab Settings, Such as Homes, Offices or Schools Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers Federal Register: Medical Device User Fee Rates for Fiscal Year 2021