Alert detail

Medical Devices; Hematology and Pathology Devices; Classification of the Von Willebrand Factor Assay

Policy ID: 2026-10898Specialty: Medicare AdvantageAdded: 6/2/2026Effective: June 1, 2026federal rule

Low

What changed

Final Rule published 2026-06-01. 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 pro

Who’s affected: Medicare Advantage billing teams · Effective: June 1, 2026

Primary source: View the official CMS/MAC document ↗

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