21 C.F.R. § 886.5850 Sunglasses (nonprescription).
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart F—Therapeutic Devices
§ 886.5850 Sunglasses (nonprescription).
