21 CFR 886.5925 - Soft (hydrophilic) contact lens.

§ 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]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code