Coronavirus (COVID-19) Update: FDA Updates Test Policies to Help to Ensure Accuracy and Reliability of Tests and Increase Access to At-Home Tests

The FDA today also updated its policies regarding tests, including LDTs, currently being offered prior to or without authorization, as well as policies regarding the types of tests on which the FDA intends to focus its review.

Moving forward, the FDA generally intends to focus its review on emergency use authorization (EUA) requests for the following types of tests: 

• At-home and point-of-care (POC) diagnostic tests for use with or without a prescription and that can be manufactured in high volumes;
• Certain high-volume, lab-based molecular diagnostic tests (and home collection kits for use with such tests) that expand testing capacity or accessibility such as through pooling of specimens to increase throughput, testing specimens collected at home and shipped to the lab, screening asymptomatic individuals or detecting multiple different respiratory viruses at once;
• Certain lab-based and POC high volume antibody tests that can measure the amount of antibodies (fully quantitative antibody tests) or the amount of neutralizing antibodies; and
• Tests for which the request is from, or supported by, a U.S. government stakeholder, such as the Biomedical Advanced Research and Development Authority or the National Institutes of Health’s Rapid Acceleration of Diagnostics.

Developers of other tests may consider pursuing marketing authorization through traditional device review pathways such as 510(k) notification or De Novo classification.

Source: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-updates-test-policies-help-ensure-accuracy-and-reliability-tests-and