CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New

September 16, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on September 15, 2020. To view listings for other dates, see CDRH New - News and Updates.

• New Emergency Use Authorizations
  • cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System (Roche Molecular Systems, Inc.)
• Updated Emergency Use Authorizations
  • TRIPLEX CII-SARS-CoV-2 rRT-PCR TEST (Columbia University Laboratory of Personalized Genomic Medicine) (EUA Summary, Letter Granting EUA Revision(s))
  • Aptima SARS-CoV-2 assay (Hologic, Inc.) (HCP, Patient, IFU, Letter Granting EUA Revision(s))
• Re-Issue Emergency Use Authorizations
  • Color COVID-19 Test Unmonitored Collection Kit (Color Genomics, Inc.)
• Problems Reported with Essure - New Variance Report
• FAQs on Testing for SARS-CoV-2 (Updated)
• SARS-CoV-2 Reference Panel Comparative Data
• Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Committee