CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New

September 10, 2020

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

• New Emergency Use Authorizations
  • Verily COVID-19 RT-PCR Test (Verily Life Sciences)
• Updated Emergency Use Authorizations
  • cobas SARS-CoV-2 & Influenza A/B (Roche Molecular Systems, Inc.) (IFU)
• FAQs on Testing for SARS-CoV-2 (Updated)
• FDA Reminds Users about the Importance of Following Instructions for the Cold-Therapy Mode of Water-Circulating Hot/Cold Therapy Devices: FDA Safety Communication