Email to dudd6 Oct 2021 19:39
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.