On November 15, 2021, the U.S. Department of Health and Human Services (HHS) announced the withdrawal of the policy established during the previous administration that limited U.S. Food and Drug Administration’s (FDA) ability to require that certain laboratory developed tests (LDTs), including COVID-19 tests, a type of test that is generally designed, manufactured, and used in a single laboratory, receive premarket approval (PMA) or clearance (510(k)), or emergency use authorization (EUA).

FDA has historically asserted that it has the authority to regulate LDTs as medical devices, but has generally exercised enforcement discretion over such tests except for certain test categories, e.g., pharmacogenomic (PGx) tests, direct-to-consumer tests (in vitro diagnostics that are marketed to consumers without the involvement of a healthcare provider), and tests that respond to emerging pandemics.

On August 19, 2020, HHS published a brief announcement on its website that FDA, an agency within HHS, shall not require premarket review of LDTs, absent notice-and-comment rulemaking. FDA responded by saying that it would no longer review such EUAs, and in December 2020, HHS ordered FDA to resume LDT EUA application review. Prior to HHS’ most recent announcement, FDA encouraged test developers to submit EUA requests for serology (antibody) tests, but stated, in relevant part, that it would not object to the development and use of serology tests to identify antibodies to SARS-CoV-2 by laboratories that are certified under CLIA to perform high-complexity testing. FDA, Guidance for Developers and Food and Drug Administration Staff, Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) (May 11, 2020).

On November 15, 2021, FDA issued the fifth edition of its guidance entitled Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)*. Importantly, FDA made clear that it generally expects COVID-19 tests to have been issued an EUA prior to the tests being distributed or offered, and that FDA’s decision to review and process an EUA request, and ultimately issue an EUA if the relevant statutory criteria are met, is based on a determination, on a case-by-case basis, that such action is necessary to protect the public health in an emergency. The policy outlined FDA’s enforcement policies regarding certain COVID-19 tests for the duration of the public health emergency. Currently, FDA intends to focus its review on EUA requests for the following types of tests: 

• Diagnostic tests (molecular and antigen) that can be used at the Point of Care (POC) or completely at home from developers who have indicated the ability to scale up manufacturing capacity shortly after authorization (e.g., a manufacturing capacity of ≥500,000 tests per week within 3 months of authorization;

• Laboratory-based molecular diagnostic tests that are: highly sensitive; high throughput; intended for pooling, home specimen collection, screening, or detection of multiple analytes; and from experienced developers who have indicated the ability to scale up manufacturing capacity shortly after authorization (e.g., a manufacturing capacity of ≥500,000 tests per week within 3 months of authorization);

• Home specimen collection kits intended for use with laboratory-based molecular diagnostic tests, where the manufacturer has indicated the ability to scale up to a manufacturing capacity shortly after authorization (e.g., ≥500,000 kits per week within 3 months of authorization);

• Laboratory-based and POC serology tests that are: high throughput, if laboratory-based; intended for the quantitative measurement of antibody titers; and from developers who have indicated the ability to scale up manufacturing capacity shortly after authorization (e.g., a manufacturing capacity of ≥500,000 tests per week within 3 months of authorization);

• Laboratory-based and POC serology tests that are: intended for the quantitative detection of neutralizing antibodies; and from developers who have indicated the ability to scale up manufacturing capacity shortly after authorization (e.g., a manufacturing capacity of ≥500,000 tests per week within 3 months of authorization); and

• Tests for which the EUA request is from (or supported by) a US government stakeholder, such as tests funded by the Biomedical Advanced Research and Development Authority (BARDA) or the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx).

Further, for tests intended for use on instruments not used for previously authorized tests, FDA intends to prioritize those tests where the developer indicates sufficient instrument and kit production capacity. For tests intended for use with home collection kits, FDA intends to prioritize those tests where there is sufficient assay and collection kit production capacity.

For tests not authorized and not being offered by November 15, 2021, FDA expects it will only review EUA requests for priority tests. FDA will notify test developers of such tests by email if FDA declines to review or otherwise decides not to authorize the test. Developers of other tests may consider pursuing marketing authorization through traditional device review pathways such as 510(k) notification or De Novo classification.