FDA Moves Blood Test Device Into Class II
Published Date: 6/1/2026
Rule
Summary
The FDA is officially putting the von Willebrand factor assay into Class II, meaning it now has special safety rules but fewer red tape hurdles. This change helps labs and patients get access to this important blood test faster and safer, starting June 1, 2026. If you make or use these devices, expect smoother approvals and no big cost jumps.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Easier Approval Path for Test Makers
The FDA officially classified the von Willebrand factor assay as Class II with special controls effective June 1, 2026 (classification applicable September 29, 2022). That classification lets this device serve as a predicate for future devices so sponsors can use the less burdensome 510(k) premarket notification process instead of a De Novo request or premarket approval.
Faster, Safer Patient Access to Test
FDA says classifying the von Willebrand factor assay into Class II will provide a reasonable assurance of safety and effectiveness and will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens; the order is effective June 1, 2026 (classification applicable September 29, 2022). The device is a prescription test intended to aid diagnosis and management of von Willebrand factor disorders.
New Test Makers Must Meet Specific Study and Label Rules
Manufacturers marketing a von Willebrand factor assay must meet special controls that include detailed design verification and validation (analytical performance such as precision, linearity, detection capability, specimen/reagent stability, and hook effect), clinical comparison studies using representative clinical samples conducted at a minimum of three external sites, pediatric validation when applicable, and labeling that identifies known interferents and summarizes performance. The device remains prescription-only and is subject to premarket notification under section 510(k).
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