CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New

October 13, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on October 9, 2020. To view listings for other dates, see CDRH New - News and Updates.

• New Emergency Use Authorizations
  • ePlex Respiratory Pathogen Panel 2 (GenMark Diagnostics, Inc.)
  • SDNA-1000 Saliva Collection Device (Spectrum Solutions LLC)
  • Access SARS-CoV-2 IgM (Beckman Coulter, Inc.)
  • Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2 (Genalyte, Inc.)
  • CareStart COVID-19 Antigen test (Access Bio, Inc.)
• Updated Emergency Use Authorizations
  • Appendix A: Authorized Surgical Masks
  • Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China
  • Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories
  • TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
  • UCLA SwabSeq COVID-19 Diagnostic Platform (University of California, Los Angeles (UCLA))
• EUA Authorized Serology Test Performance (Updated)
• Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - October 13, 2020
• FAQs on Testing for SARS-CoV-2 (Updated)
• November 9, 2020: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
• MedSun Newsletter, October 2020