USA – US FDA publishes EUA templates for COVID-19 IVD submission

The US Food and Drug Administration (FDA) issued new and updated templates for IVD emergency use authorization (EUA) submissions, adding to the range of documents available for support of both diagnostic and serology/antibody tests. These are intended to aid in the efforts to speed to market products used for the diagnosis and treatment of COVID-19.

Supplemental EUA request template released for COVID-19 diagnostic tests

The FDA published a supplemental Emergency Use Authorization (EUA) request template (download link) for molecular or antigen diagnostic COVID-19  tests used in serial testing programs, as well as at-home (self-testing) tests. This template ​supplements the recommendations found in the Molecular Diagnostic Template for Commercial Manufacturers, Antigen Template for Test Developers, and Template for Manufacturers of Molecular and Antigen Diagnostic COVID-19 Tests for Non-Laboratory Use, all of which are available to download on the FDA website