COVID-19 Update: EUA Templates for Test Developers

U.S. Food and Drug Administration sent this bulletin at 10/06/2021 11:34 AM EDT

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COVID-19 Update: EUA Templates for Test Developers

Today, the U.S. Food and Drug Administration (FDA) posted updated templates intended to assist test developers and facilitate the Emergency Use Authorization (EUA) request and Pre-EUA submission processes for COVID-19 tests. The following templates include updated recommendations and additional clarity for test developers:

Diagnostic Templates (Molecular and Antigen)

  • Molecular Diagnostic EUA Cover Sheet Template
  • Molecular Diagnostic Template
  • Molecular Diagnostic Home Specimen Collection Template
  • Antigen Diagnostic Template
  • Molecular and Antigen Home Use Test Template
  • Supplemental Template for Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing

Serology/Antibody Templates

  • Serology Template
  • Template for Serology Tests that Detect or Correlate to Neutralizing Antibodies

These templates are intended to help test developers provide validation data and other information to the FDA. Developers can use alternative approaches and can discuss them with the FDA.

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Questions?

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