21 CFR 886.5918 - Rigid gas permeable contact lens care products.

§ 886.5918 Rigid gas permeable contact lens care products.

(a)Identification. A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.

(b)Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

[ 62 FR 30987, June 6, 1997]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

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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