Title 21: Food and Drugs
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/ PART 886 - OPHTHALMIC DEVICES
/ Subpart F - Therapeutic Devices / § 886.5540 Low-vision magnifier.
§ 886.5540 Low-vision magnifier.
(a) Identification. A low-vision magnifier is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device may be held in the hand or attached to spectacles.
(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. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.