21 CFR 886.5900 - Electronic vision aid.
(a)Identification. An electronic vision aid is an AC-powered or battery-powered device that consists of an electronic sensor/transducer intended for use by a patient who has impaired vision or blindness to translate visual images of objects into tactile or auditory signals.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.