21 CFR 886.5842 - Spectacle frame.

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§ 886.5842 Spectacle frame.

(a) Identification. A spectacle frame is a device made of metal or plastic intended to hold prescription spectacle lenses worn by a patient to correct refractive errors.

(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.

[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38814, July 25, 2001]

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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