Federal Register #FDA2026N5725

FDA Classifies von Willebrand Factor Assay as Class II Medical Device with Special Controls

This notice details the FDA's regulatory classification of the von Willebrand factor assay as a Class II medical device with special controls. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - Siemens Healthcare Diagnostics Products GmbH (device sponsor for INNOVANCE VWF Ac) - Products/Services Requested: - No procurement is being requested; the notice pertains to regulatory classification - Device: von Willebrand factor assay (used for measuring von Willebrand factor activity or size distribution in human plasma) - Unique or Notable Requirements: - Device is classified as Class II with special controls - Special controls include design verification, validation, analytical and clinical performance studies, labeling limitations, and identification of known interferents - Device is subject to premarket notification (510(k)) requirements - No procurement, contract, or award is being announced in this notice

Description

The Food and Drug Administration (FDA) is classifying the von Willebrand factor assay into class II with special controls. This device is intended for the measurement of von Willebrand factor activity or size distribution in human plasma and aids in the diagnosis and management of von Willebrand factor disorders. The classification aims to provide reasonable assurance of safety and effectiveness while enhancing patient access to innovative devices by reducing regulatory burdens. The device is prescription-only and subject to premarket notification requirements under section 510(k) of the FD&C Act.

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