The FDA announced that it took steps in an effort to support the development of COVID-19 tests for at-home self-collection.
Creating a voluntary emergency use authorization (EUA) template outlining the guidelines for at-home sample collection kits is among the steps the agency has taken, according to a news release. The template includes recommendations for laboratories and commercial manufacturers as they seek EUA.
Developers right now can offer a COVID-19 test for at-home self-collection under EUA and those tests can also be used as part of an institutional review board (IRB)-approved study.
Generally, developers are required to submit a request for EUA prior to the distribution and use of an at-home COVID-19 test. When they have not obtained EUA, the tests can be used as part of a research study that complies with the FDA’s requirements for device investigations.
The FDA has granted authorization to at-home COVID-19 tests that provide samples that can be sent to laboratories for processing and test reporting, but there are not currently tests authorized for use completely at home.
“During this pandemic, the FDA has remained supportive of making accurate and reliable tests widely available,” FDA Center for Devices & Radiological Health director Dr. Jeff Shuren said in the release. “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.
“An at-home test that returns false results could be harmful to an individual patient, and hinder broader public health efforts to mitigate the 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.”