Yesterday, the U.S. Department of Health and Human Services (HHS) announced the agency is withdrawing a policy regarding laboratory developed tests (LDTs) established during the Trump Administration that limited FDA’s ability to address certain problematic Covid-19 tests.
The policy directed FDA not to enforce premarket review requirements for LDTs. In a statement announcing the move, HHS said this decision will help to ensure Covid tests are more safe and reliable.
The FDA said it 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.
The FDA now generally expects newly offered Covid tests, including LDTs, to have an EUA, or traditional marketing authorization, prior to clinical use.