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
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 ↗
Get the action steps and full analysis
The full analysis, the revision comparison and the as-of-date version of this policy are what a partner packet carries. The source document above is free and always will be.