Medical Devices; Hematology and Pathology Devices; Classification of the Von Willebrand Factor Assay
Key claim: The FDA is classifying the von Willebrand factor assay as a Class II medical device subject to special controls to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) The Food and Drug Administration (FDA) is classifying the von Willebrand factor assay into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the von Willebrand factor assay. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
Why this matters
Class II classification with special controls establishes a defined regulatory pathway for von Willebrand factor assays, which are used to diagnose the most common inherited bleeding disorder. For manufacturers, this typically means 510(k) clearance rather than more burdensome premarket approval, potentially expanding patient access to these diagnostic tests. For clinicians and patients, the special controls set baseline performance expectations for a widely used coagulation diagnostic.