21 CFR 886.5820
§ 886.5820 Closed-circuit television reading system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 886.5820, § 886.5820 Closed-circuit television reading system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91020
- Permanent ID
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Full text
(a) Identification. A closed-circuit television reading system is a device that consists of a lens, video camera, and video monitor that is intended for use by a patient who has subnormal vision to magnify reading material.
(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.