21 C.F.R. § 886.5540 Low-vision magnifier.
Title 21 - Food and Drugs
(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 regulations 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. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 66 FR 38814, July 25, 2001]
Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart F—Therapeutic Devices
§ 886.5540 Low-vision magnifier.
