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February 24, 2023

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on February 23, 2023. To view listings for other dates, see CDRH New - News and Updates.

• Revised Emergency Use Authorizations
  • cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2) (Roche Molecular Systems)
  • cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System (Roche Molecular Systems)
• Consumer Information on: Guardant360 CDx - P200010/S010
• Evaluation of Airborne Chemicals from Neonatal Incubators – Letter to Health Care Providers
• Center for Devices and Radiological Health (CDRH) Compliance Programs (Updated)
  • Inspection and Field Testing of Radiation-Emitting Electronic Products (CPMG 7386.001)
  • Inspection of Domestic and Foreign Manufacturers of Diagnostic X Ray Equipment (CPMG 7386.003a)
• Update: Reduce the Risk for Medical Device Misconnections