Friday, March 26, 2021

In Vitro Diagnostics EUA Web Content Updated

Get Information on the IVD EUAs

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US Food and Drug Administration

COVID-19 Update: Updated In Vitro Diagnostics EUA Web Section

Today, the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) reorganized the In Vitro Diagnostics EUAs content on FDA.gov to help make it easier to find specific categories of EUAs and related information. 

With this update, new web pages have been created for these EUA types:

  • In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2
  • In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2
  • In Vitro Diagnostics EUAs - Serology and Other Adaptive Immune Response Tests for SARS-CoV-2
  • In Vitro Diagnostics EUAs - Individual EUAs for IVDs for Management of COVID-19 Patients

View Updated Web Section

Questions?

If you have questions about the templates, please email COVID19DX@fda.hhs.gov.


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