- (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]