USFDA

CDRH New - July 30, 2021

U.S. Food and Drug Administration sent this bulletin at 07/30/2021 09:16 AM EDT

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U.S. Food and Drug Administration - CDRH New

July 30, 2021

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on July 29, 2021. To view listings for other dates, see CDRH New - News and Updates.

  • Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - July 14, 2021
  • Quality and Compliance (Medical Devices) (Updated)
  • UDI Exceptions, Alternatives, and Time Extensions (Updated)
  • Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - August 4, 2021
  • False Positive Results with BD SARS-CoV-2 Reagents for the BD Max System - Letter to Clinical Laboratory Staff and Health Care Providers (Updated)
  • Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions
  • In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2 (Updated)
  • In Vitro Diagnostics EUAs - IVDs for Management of COVID-19 Patients (Updated)
  • In Vitro Diagnostics EUAs - Serology and Other Adaptive Immune Response Tests for SARS-CoV-2 (Updated)
  • In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2 (Updated)

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