Medical Devices; Hematology and Pathology Devices; Classification of the Von Willebrand Factor Assay
Ensure von Willebrand factor assays meet class II special controls as of 2026-06-01.
- Effective: June 1, 2026 — Rule effective on publication date.
§ 01 Summary
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.
§ 02 Why this matters
The rule adds codified special controls for von Willebrand factor assays, making manufacturers of this device type responsible for meeting class II requirements. It also reduces premarket burden relative to class III treatment by establishing a class II classification.
§ 03 Topics
§ 04 Affected entities
- agency: FDA
- agency: HHS
- industry: medical-device-manufacturers
- statute: FDCA
§ 05 Matching feeds
§ 06 Source document
Read the full Federal Register entry on federalregister.gov.
Show classifier input (what GPT-5.5 saw)
Type: Rule Agencies: Health and Human Services Department; Food and Drug Administration Citation: 91 FR 32336 Title: Medical Devices; Hematology and Pathology Devices; Classification of the Von Willebrand Factor Assay Abstract: 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 provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Classified Jun 3, 2026 by gpt-5.5. Fetched Jun 2, 2026.
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