21 CFR 886.1500
§ 886.1500 Headband mirror.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 886.1500, § 886.1500 Headband mirror, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90928
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Full text
(a) Identification. A headband mirror is a device intended to be strapped to the head of the user to reflect light for use in examination of the eye.
(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. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.