On May 29, 2020, the U.S. Food and Drug Administration (FDA) took steps to further support the development of COVID-19 tests for at-home self-collection by including a voluntary EUA template for at-home sample collection kits to its website. This template includes recommendations for use by laboratories and commercial manufacturers who may use it to facilitate the preparation and submission of 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 Institutional Review Board (IRB)-approved study.

For COVID-19 diagnostic tests that use at-home specimen collection kits and are intended for use in clinical decision making, developers are generally required to submit a request for an EUA prior to distribution and use of such test. In cases where the developer has not obtained an EUA, these tests may be used as part of a research study that complies with FDA’s regulatory requirements for device investigations, including applicable requirements for IRB review.

The FDA has authorized several COVID-19 tests for use with at-home collection of samples – such as from the nose or saliva – that can then be sent to a lab for processing and test reporting, and the agency is also aware of developers who are conducting IRB-approved studies of COVID-19 tests that use at-home collection of test samples. However, there are not currently any tests that are authorized to be used completely at-home. All tests that have received an EUA