21 CFR 886.1090
§ 886.1090 Haidinger brush.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 886.1090, § 886.1090 Haidinger brush, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90893
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Full text
(a) Identification. A Haidinger brush is an AC-powered device that provides two conical brushlike images with apexes touching which are viewed by the patient through a Nicol prism and intended to evaluate visual function. It may include a component for measuring macular integrity.
(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.