New rules from the U.S. Food and Drug Administration (FDA) require producers of SARS-CoV-2 tests that have received Emergency Use Authorization (EUA) to take additional steps to account for viral variants. Specifically, FDA is requiring test makers to update test labeling and evaluate the impact of variants on test performance. Here is a quick briefing on the new rules. FDA Authority to Revise EUA Conditions of Authorization The legislation giving FDA authority to issue EUA to clear diagnostic tests to detect SARS-CoV-2, Section 564 of the Federal Food, Drug, and Cosmetic Act, also allows the agency to establish additional Conditions of Authorization for those products. On Sept. 23, FDA issued a letter setting forth new Conditions of Authorization requiring test makers to account for new genetic variants of the virus to maintain the test’s EUA status. Which Tests the Revisions Affect The new Conditions of Authorization apply to certain molecular, antigen and serology tests that have already received EUA for SARS-CoV-2 diagnosis and detection. They do not apply to EUAs for authorized IL-6 assays, standalone specimen collection devices, or standalone home collection kits. Nor do they apply to EUAs that include substantially equivalent viral mutation Conditions of Authorization. Molecular Tests […]