 |
Code of Federal Regulations (Last Updated: May 6, 2024) |
 |
Title 21 - Food and Drugs |
|
Chapter I - Food and Drug Administration, Department of Health and Human Services |
|
SubChapter H - Medical Devices |
|
Part 886 - Ophthalmic Devices |
|
Subpart F - Therapeutic Devices |
§ 886.5900 - Electronic vision aid.
Latest version.
-
§ 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.
[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38814, July 25, 2001]