21 CFR 886.5900 - Electronic vision aid.

Regulations last checked for updates: May 06, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

View all text of Subpart F [§ 886.5100 - § 886.5933]

§ 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]

authority: 21 U.S.C. 351,360,360c,360e,360j,360

source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.

cite as: 21 CFR 886.5900