21 CFR § 886.1770 - Manual refractor.
---
identifier: "/us/cfr/t21/s886.1770"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 886.1770 - Manual refractor."
title_number: 21
title_name: "Food and Drugs"
section_number: "886.1770"
section_name: "Manual refractor."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "886"
part_name: "OPHTHALMIC DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 33355, Sept. 2, 1987, unless otherwise noted."
cfr_part: "886"
---
# 886.1770 Manual refractor.
(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]