CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New

September 22, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on September 21, 2020. To view listings for other dates, see CDRH New - News and Updates.

• Updated Emergency Use Authorizations
  • Appendix A: Authorized Surgical Masks
  • Bio-Rad SARS-CoV-2 ddPCR Test (Bio-Rad Laboratories, Inc.)
  • Infinity BiologiX TaqPath SARS-CoV-2 Assay (Infinity BiologiX LLC)
  • COVID-19 RT-PCR Test - Laboratory Corporation of America (LabCorp)
  • Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay (Ethos Laboratories)
  • SARS-CoV-2 IgG assay (Abbott Laboratories Inc.)
• New Emergency Use Authorizations
  • GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT (GK Pharmaceuticals Contract Manufacturing Operations)
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN190032, DEN190039, DEN200010 added)
• Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices
• FAQs on Testing for SARS-CoV-2 (Updated)