topicmedical-device-classification
21 CFR device classifications set the regulatory pathway (Class I, II, III) and any special controls. A new classification reshapes the 510(k) burden for manufacturers in that category.
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Medical Devices; General Hospital and Personal Use Devices; Classification of the Rigid Sterilization Container With Electronic Monitoring
Action: Verify affected devices meet the new class II special controls by 2026-06-01.
FDA classifies rigid sterilization containers with electronic monitoring as class II medical devices subject to special controls. The rule codifies device-specific controls intended to provide reasonable assurance of safety and effectiveness and establishes the regulatory pathway for this device type.
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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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Medical Devices; Hematology and Pathology Devices; Classification of the Von Willebrand Factor Assay
Action: Ensure von Willebrand factor assays meet class II special controls as of 2026-06-01.
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.
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Medical Devices; Ear, Nose, and Throat Devices; Classification of the Oropharyngeal Electrical Stimulator
Action: Review class II special controls before marketing oropharyngeal electrical stimulators.
FDA classifies oropharyngeal electrical stimulators used in ear, nose, and throat applications as class II medical devices subject to special controls. The rule codifies the device type and applicable controls, creating a defined regulatory pathway for future marketing of these devices.
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