21 CFR 886.5928 - Soft (hydrophilic) contact lens care products.

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§ 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.”

[ 62 FR 30988, June 6, 1997]

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United States Code

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 886 after this date.

  • 2016-09-22; vol. 81 # 184 - Thursday, September 22, 2016
    1. 81 FR 65279 - Medical Devices; Ophthalmic Devices; Classification of Strabismus Detection Device
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective September 22, 2016. The classification was applicable on June 8, 2016.
      21 CFR Part 886