Medical Devices; Hematology and Pathology Devices; Classification of the Von Willebrand Factor Assay
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.
Open the source record- Tags
- health IT, Rule, Health and Human Services Department, Food and Drug Administration
- Related exam domains
- CISM 3: Information Security Program
- Source record id
- 2026-10898
- First seen by InfoSec Signals
- 9/23/2026
Exam domain labels come from a keyword heuristic and are study hints, not an official mapping. The summary is the publisher's own text, shortened; the linked record is authoritative.