CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New

September 9, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on September 8, 2020. To view listings for other dates, see CDRH New - News and Updates.

• New Emergency Use Authorizations
  • qSanger-COVID-19 Assay (BillionToOne, Inc.)
• Updated Emergency Use Authorizations
  • Everlywell COVID-19 Test Home Collection Kit (Everlywell, Inc.) (EUA Summary, Letter Granting EUA Revision(s))
• FAQs on Testing for SARS-CoV-2 (Updated)
• FAQs on Viral Transport Media During COVID-19 (Updated)
• Consumer Information on: SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) – P15003/S058
• Consumer Information on: ReActiv8 Implantable Neurostimulation System