topicfda-special-controls
Class II special-controls guidance sets the performance-testing and labeling required for 510(k) clearance.
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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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Medical Devices; Anesthesiology Devices; Classification of the Adjunctive Pain Measurement Device for Anesthesiology
Action: Ensure adjunctive pain measurement devices meet FDA class II special controls as of 2026-06-01.
FDA classifies adjunctive pain measurement devices for anesthesiology as class II medical devices subject to special controls. The rule codifies the device type and applicable controls, moving it into a regulated pathway intended to provide reasonable assurance of safety and effectiveness while facilitating market access.
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Medical Devices; Gastroenterology-Urology Devices; Classification of the Orally Ingested Transient Device for Constipation
Action: Ensure orally ingested transient constipation devices meet class II special controls as of 2026-06-01.
FDA classifies orally ingested transient devices for constipation as class II gastroenterology-urology devices subject to special controls. The rule codifies the device type and applicable controls, creating a 510(k)-type regulatory pathway rather than requiring the highest-risk classification.
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