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April 25, 2023

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on April 24, 2023. To view listings for other dates, see CDRH New - News and Updates.

• New Emergency Use Authorization
  • MedArbor Diagnostics SARS-CoV-2 Assay (MedArbor, LLC dba MedArbor Diagnostics)
• Revised Emergency Use Authorizations
  • SalivaDirect (Yale School of Public Health, Department of Epidemiology of Microbial Diseases)
  • SalivaDirect for use with DTC Kits (Yale School of Public Health, Department of Epidemiology of Microbial Diseases)
  • LIAISON SARS-CoV-2 Ag (DiaSorin, Inc.) 
• Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication (Updated)
• Federal Register: Authorization of Emergency Use of a Medical Device During COVID-19