CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New

September 11, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on September 10, 2020. To view listings for other dates, see CDRH New - News and Updates.

• Presentation and Transcript added to Regulatory Overview for Developers and Sponsors of Neurological and Physical Medicine Devices: An Introduction to the De Novo Pathway Webinar
• Webinar Series - Gowns and Other Apparel for Use by Health Care Personnel in COVID-19 Pandemic - September 15, 2020
• New Emergency Use Authorizations
  • Wantai SARS-CoV-2 RT-PCR Kit (Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.)
  • BioCheck SARS-CoV-2 IgM Antibody Test Kit (BioCheck, Inc.)
  • BioCheck SARS-CoV-2 IgG Antibody Test Kit (BioCheck, Inc.)
• Re-issued Emergency Use Authorizations
  • KPMAS COVID-19 Test (Kaiser Permanente Mid-Atlantic States)
• Updated Emergency Use Authorizations
  • Verily COVID-19 RT-PCR Test (Verily Life Sciences) (EUA Summary)
• FAQs on Testing for SARS-CoV-2 (Updated)
• FAQs on Viral Transport Media During COVID-19 (Updated)