For Immediate Release:

Today, the U.S. Food and Drug Administration posted a new template for commercial developers to help them develop and submit emergency use authorization (EUA) requests for COVID-19 diagnostic tests that can be performed entirely at home or in other settings besides a lab, such as offices or schools, and that could be available without a prescription.

“The FDA continues to help facilitate innovation in test development, thereby enhancing Americans’ access to COVID-19 tests,” said FDA Commissioner Stephen M. Hahn, M.D. “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.”

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.

This template outlines the recommended performance for this type of test, including sensitivity and specificity. While the recommended sensitivity for these non-lab tests is lower than lab-based tests, the tremendous benefits of broader access to simple and fast testing options generally outweighs this risk.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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