The FDA has added a method to streamline COVID-19 diagnostic test manufacturers’ efforts to apply for an emergency use authorization (EUA) for home sample collection.
The new template on the FDA website includes recommendations for laboratories and commercial manufacturers to use in preparing and submitting an EUA request. Currently, developers can offer a COVID-19 test for at-home self-collection under emergency use authorization (EUA), and COVID-19 tests for at-home self-collection may also be used as part of an (IRB)-approved study.
The FDA has authorized several COVID-19 tests for use with at-home collection of samples that can be sent to a lab for processing and test reporting. The agency said it is also aware of developers who are conducting Institutional Review Board-approved studies of COVID-19 tests that use at-home collection of test samples. No tests are authorized to be used completely at-home.
“During this pandemic, the FDA has remained supportive of making accurate and reliable tests widely available,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “Home collection raises unique concerns about safety and accuracy — for example, can the sample be collected safely and properly by a layperson, can the sample be shipped in a way that’s stable to ensure an accurate result once it reaches the lab, among other factors — which is why these tests require FDA review, to ensure they work as they should and are safe for all involved.”
The FDA maintains that an at-home test that returns false results could harm a patient, and possibly lead to further spread of COVID-19.
“We’ll continue to support ways of making our review processes as streamlined as possible, while continuing to protect patients and the public health,” Shuren said.
