C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 886—OPHTHALMIC DEVICES › Subpart F—Therapeutic Devices

21 C.F.R. § 886.5928

Soft (hydrophilic) contact lens care products

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(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.”

[62 FR 30988, June 6, 1997]
Notes of Decisions
Cited in 4 cases (1 in the last 5 years), 1994–2021 · leading case: Scott v. CIBA Vision Corp., 38 Cal. App. 4th 307 (Cal. Ct. App. 1995).
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Scott v. CIBA Vision Corp., 38 Cal. App. 4th 307 (Cal. Ct. App. 1995). · cites it 2× “( 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 Med. Tech. LLC v. FDA, 994 F.3d 631 (D.C. Cir. 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 Corp., a Georgia Corp., Appellee, 42 F.3d 1167 (8th Cir. 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 Med. Optics, Inc., 659 F.3d 835 (9th Cir. 2011). “21 C.F.R. § 886.5928 . “Use of Class II devices involves some risk of injury.”
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