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FDA Announces New EUA Template for At-Home and Over-the-Counter SARS-CoV-2 Diagnostic Tests

FDA maze of regulations

FDA guidance provides pathway for developers and manufacturers to obtain EUAs for at-home and over-the-counter COVID-19 testing.

The US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) template for test developers attempting to create at-home and over-the-counter SARS-CoV-2 diagnostic tests. The FDA announced this new template in a press release July 29, 2020, providing a link to a new template and information about the intended uses of this template.

“The FDA continues to help facilitate innovation in test development, thereby enhancing Americans’ access to COVID-19 tests,” FDA Commissioner Stephen M. Hahn, MD, said as part of the announcement. “The recommendations provided today are intended to help get tests to market that are simple enough to use at home, similar to a pregnancy test. We hope that with the innovation we’ve seen in test development, we could see tests that you could buy at a drug store, swab your nose or collect saliva, run the test, and receive results within minutes at home, once these tests become available. These types of tests will be a game changer in our fight against COVID-19 and will be crucial as the nation looks toward reopening.”

According the FDA website, “The template includes recommendations for validation when a sample is to be collected and analyzed, and results are to be returned without the need to send a sample to a lab for analysis. The template also gives recommendations for validation of tests that are intended to be made available over-the-counter, that is, without a prescription.”

The new template provides details for test manufacturers and developers about recommended performance metrics, including sensitivity and specificity. The recommended sensitivity for these non-lab tests is lower than what is required for lab-based tests. The FDA indicates that the benefits of broad access to COVID-19 testing outweighs the risks of decreased sensitivity.

Related Resources:

FDA Press Release: FDA Posts New Template for At-Home and Over-the-Counter Diagnostic Tests for Use in Non-Lab Settings, Such as Homes, Offices or Schools