21 CFR § 886.5925 - Soft (hydrophilic) contact lens.

---
identifier: "/us/cfr/t21/s886.5925"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 886.5925 - Soft (hydrophilic) contact lens."
title_number: 21
title_name: "Food and Drugs"
section_number: "886.5925"
section_name: "Soft (hydrophilic) contact lens."
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"
---


# 886.5925 Soft (hydrophilic) contact lens.

(a) *Identification.* A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.

(b) *Classification.* (1) Class II if the device is intended for daily wear only.

(2) Class III if the device is intended for extended wear.

(c) *Date PMA or notice of completion of a PDP is required.* As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.

[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 10284, Mar. 4, 1994]