(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]
Notes of Decisions
Walker v. Johnson & Johnson Vision Prods., Inc, 552 N.W.2d 679 (Mich. Ct. App. 1996).
· cites it 2× “21 CFR 886.5925. Generally, Class III devices are subject to "premarket approval to provide reasonable assurance of [their] safety and effectiveness.”
Thomas v. Alcon Labs., 116 F. Supp. 3d 1361 (N.D. Ga. 2013).
“999 ; 21 C.F.R. § 886.5925 (b)(2) (specifying soft contact lenses intended for extended wear are Class III devices).”
Hernandez v. Coopervision, Inc., 691 So. 2d 639 (Fla. 2d DCA 1997).
“The attachments include copies of 21 C.F.R. § 886.5925 , which describes the extended wear contact lens as a Class III medical device subject to PMA and letters from the director of the Bureau of Medical Devices, FDA, approving the application and supplemental applications for…”
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