All topics · oropharyngeal-electrical-stimulators
topicoropharyngeal-electrical-stimulators
Federal Register documents tagged oropharyngeal-electrical-stimulators. Each entry is scored 1-5 for compliance materiality and dated for any comment or effective-date deadlines.
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§ 01 Agencies issuing on this topic
§ 02 Recent documents
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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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