On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to enforce premarket review requirements for COVID-19 laboratory developed tests (LDTs). This prior policy, which waived premarket review requirements aimed at increasing broad public access to COVID-19 tests, was generally consistent with the FDA’s historical stance allowing laboratories to not seek approval of LDTs. With the policy announced by the Trump administration, laboratories again began offering their tests prior to or without an emergency use authorization (EUA) after the test was validated and a notification was provided to the FDA. While this policy expedited the availability of tests, the FDA contends that the policy also led to some poorly-performing tests being offered prior to FDA review. Notably, this prior policy did not apply to at-home or point of care collection tests, which have always required FDA review.

Now, given the number of authorized tests that are currently available, the FDA has expressed concerns about the rush to validation and whether there are accurate, reliable tests on the market. As such, the FDA maintains that repealing the waiver and reestablishing the requirement of premarket review will increase access to accurate and reliable COVID-19 tests, particularly diagnostic tests that can be performed at home or in places like doctor’s offices, hospitals, urgent care centers, and emergency rooms without having to be sent to a central lab for testing. As part of this new stance, the FDA has reissued and revised the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.

As a result of this policy update, the FDA “now 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 510(k), prior to clinical use.” The FDA intends to focus its review on EUA requests for the following types of tests:

  • At-home and point-of-care 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.

For tests currently being offered without the submission of an EUA request, the FDA expects laboratories to now submit an EUA. For such tests and notified tests with pending EUA requests, the FDA intends to review the EUA requests and, if the test is not subsequently authorized, expects laboratories to cease offering and marketing the test within fifteen calendar days of being notified.

Additionally, on November 15, 2021, the FDA issued an umbrella EUA for serial testing with certain molecular diagnostic tests developed by laboratories. These tests will be able to be used for testing at regular intervals as part of serial testing programs, such as those established at places like schools, workplaces, or community groups. The umbrella EUA is aimed at efficiently authorizing certain tests to help increase access to accurate and reliable molecular diagnostic tests.

The FDA announcement concludes by expressing the agency’s commitment to continue to offer support and expertise to help with the development of accurate and reliable tests, and to facilitate increased access to tests for all Americans. As the FDA continues to respond to the evolving needs of the nation amidst the COVID-19 pandemic, it is essential that laboratories offering COVID-19 LDTs understand the implications of these policy updates and adjust their processes accordingly in order to ensure compliance.

*This post was co-authored by Erin Howard, legal intern at Robinson+Cole. Erin is not yet admitted to practice law.