March 22, 2021
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.
It is worth noting that the FDA is permitting authorization of such tests for use on asymptomatic individuals under certain circumstances. The template also includes recommendations on serial testing intervals and labeling.
Serology test templates also available for EUA submissions
The FDA updated the Serology Template for Test Developers (download link) to include additional validity studies and procedures addressing the impact of SARS-CoV-2 mutations on test performance. The recommendations on software validation, reagent stability study design, clinical agreement studies, and controls to be provided with the test kits have also been updated.
A new EUA request template for SARS-CoV-2 serology tests that detect or correlate to neutralizing antibodies was also published.
Related regulatory resources for US FDA and COVID-19:
- US FDA 510(k) registration consulting for medical device and IVD companies
- Webinar: Conducting safe in-person testing during COVID-19
- Webinar: Latest FDA expectations for human factors validation tests of combination products
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