WASHINGTON, July 1 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a final rule classifying SARS-CoV-2 serology tests as Class II medical devices subject to special controls, establishing a regulatory pathway intended to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens for manufacturers.

The rule, effective June 26, 2026, codifies a classification order that became applicable on May 5, 2023 . . .

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