21 CFR § 886.5928 - Soft (hydrophilic) contact lens care products.

---
identifier: "/us/cfr/t21/s886.5928"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 886.5928 - Soft (hydrophilic) contact lens care products."
title_number: 21
title_name: "Food and Drugs"
section_number: "886.5928"
section_name: "Soft (hydrophilic) contact lens care products."
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"
---


# 886.5928 Soft (hydrophilic) contact lens care products.

(a) *Identification.* A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.

(b) *Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

[62 FR 30988, June 6, 1997]