Title 21: Food and Drugs
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/ PART 886 - OPHTHALMIC DEVICES
/ Subpart F - Therapeutic Devices / § 886.5842 Spectacle frame.
§ 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.