Regulations last checked for updates: May 06, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025
§ 886.5850 - Sunglasses (nonprescription).

(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.

[52 FR 33355, Sept. 2, 1987, as amended at 65 FR 2321, 2000]
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 886.5850