HHS FDA Establishes Class II Classification for Von Willebrand Factor Assays
June 04, 2026
June 04, 2026
WASHINGTON, June 4 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a final order classifying the von Willebrand factor assay as a Class II medical device subject to special controls, creating a regulatory framework for diagnostic tests used in the evaluation and management of bleeding disorders. The action takes effect June 1, 2026, and codifies a classification that became applicable on Sept. 29, 2022. FDA said the classification provides reas . . .
