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52 FR 33355, Sept. 2, 1987, unless otherwise noted.
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Nomenclature changes to part 886 appear at 73 FR 35341, June 23, 2008.
(a) Identification. A manual refractor is a device that is a set of lenses of varous dioptric powers intended to measure the refractive error of the eye.
(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 management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 66 FR 38812, July 25, 2001; 90 FR 55991, Dec. 4, 2025]