Federal Register #FDA-2026-N-5722

FDA Classifies von Willebrand Factor Assay and Real-Time Ultrasound Anatomy Visualization Devices as Class II (Special Controls)

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has issued a final order classifying two medical devices into Class II (special controls): - von Willebrand factor assay devices - Intended for measurement of von Willebrand factor activity or size distribution in human plasma - Used to aid in the diagnosis and management of von Willebrand factor disorders - Part number: 864.7293 - Real-time ultrasound anatomy visualization and labeling devices for ultrasound guided regional anesthesia - Provides real-time interpretation and enhanced visualization of live ultrasound images - Highlights anatomical landmarks to assist in regional anesthesia procedures - Part number: 868.1980 - Both device types require premarket notification under section 510(k) - Special controls for these devices include: - Clinical performance testing - Human factors testing - Software verification and validation - Specific labeling requirements - The classification aims to ensure safety and effectiveness, facilitate patient access, and reduce regulatory burdens - No specific OEMs or vendors are named in this regulatory action - No procurement, purchase quantities, or contract details are provided

Description

The Food and Drug Administration (FDA) is classifying the real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia into class II (special controls). This classification aims to ensure the safety and effectiveness of the device while improving patient access by reducing regulatory burdens. The device provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks to assist in regional anesthesia procedures. Special controls include clinical performance testing, human factors testing, software verification and validation, and specific labeling requirements.

View original listing