CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New July 29, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on July 28, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay (Sandia National Laboratories) Lilly SARS-CoV-2 Assay (Eli Lilly and Company) Updated Emergency Use Authorizations Elecsys Anti-SARS-CoV-2 (Roche Diagnostics) (IFU, Amendment) Allplex 2019-nCoV Assay (Seegene, Inc.) (IFU, HCP, Patients, Amendment) Molecular Diagnostic Template for Commercial Manufacturers Molecular Diagnostic Template for Laboratories Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China Multiple Function Device Products: Policy and Considerations - Guidance for Industry and FDA Staff Webinar - Multiple Function Device Products: Policy and Considerations - September 10, 2020 FAQs on Testing for SARS-CoV-2 (Updated) Federal Register: Multiple Function Device Products: Policy and Considerations Federal Register: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee