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.
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Medical Devices; Ophthalmic Devices; Classification of the Oral Electronic Vision Aid
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 ide...
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80 FR 57090
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“Medical Devices; Ophthalmic Devices; Classification of the Oral Electronic Vision Aid,” thefederalregister.org (September 22, 2015), https://thefederalregister.org/documents/2015-24026/medical-devices-ophthalmic-devices-classification-of-the-oral-electronic-vision-aid.