21 CFR 886.5900
§ 886.5900 Electronic vision aid.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 886.5900, § 886.5900 Electronic vision aid, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91027
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.