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Federal Register documents tagged hematology-diagnostic-devices. Each entry is scored 1-5 for compliance materiality and dated for any comment or effective-date deadlines.
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§ 01 Agencies issuing on this topic
§ 02 Recent documents
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Medical Devices; Hematology and Pathology Devices; Classification of the Von Willebrand Factor Assay
Action: Ensure von Willebrand factor assays meet class II special controls as of 2026-06-01.
FDA classifies the von Willebrand factor assay as a class II medical device subject to special controls. The rule codifies device-specific requirements intended to provide reasonable assurance of safety and effectiveness and creates a regulated pathway for marketing these assays under class II controls.
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