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June 12, 2023

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on June 9, 2023. To view listings for other dates, see CDRH New - News and Updates.

• New Emergency Use Authorization
  • In-Dx SARS-CoV-2 RT-LAMP Assay (Michigan State University laboratories, Department of Medicine Olin Student Health Center)
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220028 added)
• Oxygenator Devices Used for Extracorporeal Circulation - Letter to Health Care Providers
• Voluntary eSTAR Program (Updated)
• Federal Register: Adverse Event Program for Medical Devices (Medical Product Safety Network)
• Federal Register: Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health
• Federal Register: Premarket Notification of Devices