21 CFR 886.5850
§ 886.5850 Sunglasses (nonprescription).
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 886.5850, § 886.5850 Sunglasses (nonprescription), United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91025
- Permanent ID
ys:prov:91025@1- SHA-256
3d1be0f271c71b772558f2d302f6d3fc9150afd0b7d4609e2c504955c294613f
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Full text
(a) Identification. Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.
(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 § 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.