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e-CFR data is current as of February 23, 2021

Title 21Chapter ISubchapter HPart 886Subpart F → §886.5916


Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart F—Therapeutic Devices


§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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