topicclass-ii-special-controls
Specific 21 CFR Part 866-892 controls applied to a device classification — performance standards, labeling, and post-market requirements that gate 510(k) clearance.
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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; 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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