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Federal Register documents tagged class-ii-devices. Each entry is scored 1-5 for compliance materiality and dated for any comment or effective-date deadlines.
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Medical Devices; Anesthesiology Devices; Classification of the Real-Time Ultrasound Anatomy Visualization and Labeling Device for Ultrasound Guided Regional Anesthesia
Action: Assess whether covered devices meet the new FDA class II special controls.
FDA classifies real-time ultrasound anatomy visualization and labeling devices used for ultrasound-guided regional anesthesia as class II medical devices subject to special controls. The rule establishes the device type in the anesthesiology devices classification regulations, enabling regulation through class II controls rather than default higher-burden pathways.
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