The U.S. Department of Health and Human Services and the Food and Drug Administration are committed to helping ensure that COVID-19 tests are accurate, reliable, and available. As part of that commitment, HHS is withdrawing a policy established during the previous administration that limited FDA’s ability to address certain problematic COVID-19 tests.
The policy, first announced on August 19, 2020, related specifically to “laboratory developed tests” (LDTs). An LDT is a type of test that is generally designed, manufactured, and used in a single laboratory. The policy directed FDA not to require premarket review for LDTs, including premarket approval (PMA) or clearance (510(k)), and emergency use authorization (EUA), even in situations where they have poor performance.
By withdrawing the policy, HHS is helping to ensure that COVID-19 tests work as intended. Effective today, HHS no longer has a policy on LDTs that is separate from FDA’s longstanding approach in this area.
FDA also updated its policies for COVID-19 tests, including COVID-19 LDTs. These policies take into account the importance of test availability, reliability, and accuracy.
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.