FDA Posts Guidance for COVID-19 Test Manufacturers

The U.S. Food and Drug Administration has posted new instructions for manufacturers to request emergency authorization for at-home and over-the-counter COVID-19 diagnostic tests.

The FDA’s new template is designed to help medical manufacturers and similar businesses navigate the emergency use authorization process for tests that can be administered at home, in schools, and offices, and be available without a prescription.

The agency’s intent is to make easy-to-use COVID-19 tests widely available as soon as possible.

“The recommendations are intended to help get tests to market that are simple enough to use at home, similar to a pregnancy test,” FDA Commissioner Stephen Hahn said.

“We hope that with the innovation we’ve seen in test development, we could see tests that you could buy at a drugstore, 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.”

Recommendations

The new template includes recommendations for validations 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.

It also provides recommendations for validation of tests intended to be sold over the counter.

The template outlines the recommended performance for this type of testing, including sensitivity and specificity, the FDA said in a statement.

“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 agency said.