On November 15, 2021, the Department of Health and Human Services (HHS) issued a press release explaining the agency’s intent to withdraw a policy established during the Trump Administration that limited the Food and Drug Administration’s (FDA) ability to regulate COVID-19 laboratory-developed tests (LDTs). The new policy allows the FDA to require clinical labs to submit emergency use authorization (EUA) requests for such tests. On the same day, FDA published a revised Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency and an Umbrella EUA for serial testing using certain LDTs, as well as updated the majority of its FAQs on Testing for COVID-19.
In an FDA press release also published on November 15, the agency outlined its current areas of focus for EUA reviews:
- 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 Institute of Health’s Rapid Acceleration of Diagnostics.
The FDA’s revised policy guidance, linked above, indicates that the FDA generally expects newly offered COVID-19 tests, including LDTs, to have an EUA, or traditional marketing authorization such as a granted De Novo or cleared 501(k), prior to clinical use. For tests currently being offered without the submission of an EUA request, the FDA generally expects the submission of an EUA request, as described in the revised guidance. For such tests with pending EUA requests, FDA generally intends to review the EUA requests and, if the test is not subsequently authorized, expects developers to cease marketing the test within 15 calendar days of being notified.
HHS in August 2020 had directed that, absent rule and commenting and at least during the COVID-19 public health emergency, the FDA would not require premarket review and approval of LDTs. The sudden reversal in policy and reinstatement of regulatory restrictions and requirements will likely cause many clinical laboratories to scramble to reengage with the FDA and obtain authorization for their currently offered COVID-19 LDTs. However, the agency may tend to decline review or authorization of many currently unauthorized LDTs that are not within FDA’s current review priorities.
For over 35 years, Wachler & Associates has represented healthcare providers and suppliers nationwide in a variety of health law matters. If you or your healthcare entity has any questions pertaining to COVID-19 testing or healthcare compliance, please contact an experienced healthcare attorney at 248-544-0888 or wapc@wachler.com.