21 CFR § 886.1415 - Ophthalmic trial lens frame.
---
identifier: "/us/cfr/t21/s886.1415"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 886.1415 - Ophthalmic trial lens frame."
title_number: 21
title_name: "Food and Drugs"
section_number: "886.1415"
section_name: "Ophthalmic trial lens frame."
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"
---
# 886.1415 Ophthalmic trial lens frame.
(a) *Identification.* An opthalmic trial lens frame is a mechanical device intended to hold trial lenses for vision testing.
(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 35604, Sept. 14, 1988; 66 FR 38811, July 25, 2001; 90 FR 55990, Dec. 4, 2025]