21 CFR 886.5928

§ 886.5928 Soft (hydrophilic) contact lens care products.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 886.5928, § 886.5928 Soft (hydrophilic) contact lens care products, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91035
Permanent ID: ys:prov:91035@1
SHA-256: 66da8512d2f52e8b3dd39704dc878d3bba2e85cd65339ef2de8a6952af7a6c0f

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Full text

(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.”

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.