(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.
(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]
Title 21 published on 2014-04-01
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