---
kind: "section"
citation: "21 C.F.R. § 886.5925"
title: "21"
number: "886.5925"
heading: "Soft (hydrophilic) contact lens."
url: "https://uscodex.org/cfr/21/886.5925"
---

# §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](/cfr/21/515.md) of the act is required before a device described in [paragraph (b)(2)](#b-2) of this section may be commercially distributed. See [§ 886.3](/cfr/21/886.3.md).

## Notes

### Amendments

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

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.

### Amendments

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