21 CFR 886.5916 - Rigid gas permeable contact lens.

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§ 886.5916 Rigid gas permeable contact lens.

(a) Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.

(b) Classification.

(1) Class II if the device is intended for daily wear only.

(2) Class III if the device is intended for extended wear.

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.

[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 10284, Mar. 4, 1994]

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United States Code

Title 21 published on 2015-04-01

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

  • 2015-09-22; vol. 80 # 183 - Tuesday, September 22, 2015
    1. 80 FR 57090 - Medical Devices; Ophthalmic Devices; Classification of the Oral Electronic Vision Aid
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective September 22, 2015. The classification was applicable on June 18, 2015.
      21 CFR Part 886