21 CFR 886.5850 - Sunglasses (nonprescription).

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§ 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]

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United States Code

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 886 after this date.

  • 2015-09-22; vol. 80 # 183 - Tuesday, September 22, 2015
    1. 80 FR 57090 - Medical Devices; Ophthalmic Devices; Classification of the Oral Electronic Vision Aid
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective September 22, 2015. The classification was applicable on June 18, 2015.
      21 CFR Part 886