title: Medical Devices; Ophthalmic Devices; Classification of the Oral   Electronic Vision Aid. Final order.
abstract: The Food and Drug Administration (FDA) is classifying the oral electronic vision aid into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the oral electronic vision aid's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D004581:Electronics / Q000145:classification; D004869:Equipment Safety / Q000145:classification; D006801:Humans; D009055:Mouth; D009885:Ophthalmology / Q000145:classification* / Q000295:instrumentation*; D012682:Sensory Aids / Q000145:classification*; D014481:United States; D014786:Vision Disorders / Q000534:rehabilitation; D014785:Vision, Ocular