Brandy Guarda, Regulatory Analyst in Washington, D.C., contributed to the drafting of this post.
The U.S. Food & Drug Administration (FDA) issued two new versions of guidance documents for COVID-19 tests on January 12, 2023: Policy for Coronavirus Disease-2019 Tests (the “COVID-19 Test Guidance”) and Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (the “Viral Mutations Guidance”). The COVID-19 Test Guidance supersedes its last version issued on September 27, 2022, and the Viral Mutations Guidance supersedes its first version issued on February 22, 2021. FDA issued these guidance documents the day after the U.S. Department of Health & Human Services (HHS) Secretary most recently renewed the section 319 Public Health Emergency declaration for COVID-19 (the “PHE declaration”) on January 11, 2023. The PHE declaration will expire in April 2023 unless the HHS Secretary terminates it earlier or renews it for another 90 days.
Both of the new versions of the guidance documents were updated so they will remain in effect for the duration of the section 564 Emergency Use Authorization declaration for COVID-19 In Vitro Diagnostics (the “EUA declaration”), regardless of the status of the PHE declaration. The updates are a departure from the previous versions, both of which were to last only for the duration of the PHE declaration and may be a signal that FDA is preparing for an earlier ending of the PHE declaration.
Other than the update to its duration, the COVID-19 Test Guidance was not significantly changed. The COVID-19 Test Guidance now states that FDA intends to review the Emergency Use Authorization (EUA) requests for a “small” subset of tests, which is technically an update from the reference to a “smaller” subset of tests in the previous version. However, the general review prioritization criteria including “likely to have a significant public health benefit” and “likely to fulfill an unmet need” remain the same.
Similarly, the Viral Mutations Guidance was not significantly updated. The Viral Mutations Guidance expressly notes that the “recommendations and policies” have not been revised from the previous version, while providing updated information on (i) the U.S. government’s designation of the omicron variant as a variant of concern on November 30, 2021 (section II); (ii) FDA’s efforts to evaluate the impact of new virus variants on tests authorized or cleared under the de novo or 510(k) pathway, as well as those under an EUA (section II); and (iii) FDA’s new web page SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (sections II and IV).
One notable change to the Viral Mutations Guidance, however, is that some of its recommendations now expressly apply to marketing submissions such as a de novo or 510(k) submission, as well as an EUA request, for a COVID-19 test. Section IV of the guidance provides that the following considerations will apply to both marketing and EUA submissions for COVID-19 tests: (i) performance validations across all known variants; (ii) developers’ plans for post-authorization monitoring; and (iii) inclusion of statements and limitations related to virus variants in the labeling.
Overall, the updates to the two guidance documents seem to further reflect FDA’s preparation for an end to the PHE declaration and transition into full marketing authorizations and clearances of COVID-19 tests.