CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New

September 8, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on September 4, 2020. To view listings for other dates, see CDRH New - News and Updates.

• New Emergency Use Authorizations
  • cobas SARS-CoV-2 & Influenza A/B (Roche Molecular Systems, Inc.)
  • SGTi-flex COVID-19 IgG (Sugentech, Inc.)
• Updated Emergency Use Authorizations
  • VIDAS SARS-CoV-2 IgM (bioMérieux SA) (HCP)
  • VIDAS SARS-CoV-2 IgG (bioMérieux SA) (HCP)
  • Bio-Speedy Direct RT-qPCR SARS-CoV-2 (Bioeksen R&D Technologies Ltd.) (IFU)
  • Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China
• Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - Guidance for Industry and Food and Drug Administration Staff
• Meeting Materials for September 8-9, 2020 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
• Virtual Public Meeting - Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027 - October 27, 2020
• FAQs on Testing for SARS-CoV-2 (Updated)
• MedSun Newsletter, September 2020
• Federal Register: Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027