21 C.F.R. § 886.5928
Soft (hydrophilic) contact lens care products
(a) Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.
(b) Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
Notes of Decisions
Cited in 4
cases (1 in the last 5 years), 1994–2021 · leading case: Scott v. CIBA Vision Corp.
Scott v. CIBA Vision Corp. (1995)
“( 21 C.F.R. § 886.5928 (1995).) The PMA process requires a manufacturer to submit a detailed application to the FDA, including information pertaining to product specifications, intended use, manufacturing methods, and proposed labeling.”
Genus Medical Technologies LLC v. FDA (2021)
“, 21 C.F.R. § 886.5928 (classifying “contact lens care products” for soft contact lenses, including solutions, as devices); see also Topical Drug Products for Over-the-Counter Human Use; Products for the Prevention of Swimmer’s Ear and for the Drying of Water-Clogged Ears; Final…”
Subby MARTELLO, Appellant, v. CIBA VISION CORPORATION, a Georgia Corporation, Appellee (1994)
“*1169 See 21 C.F.R. § 886.5928 (defining soft contact lens solution as a device intended to clean, disinfect, wet, or store a soft contact lens, and assigning Class III).”
Degelmann v. Advanced Medical Optics, Inc. (2011)
“21 C.F.R. § 886.5928 . “Use of Class II devices involves some risk of injury.”
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