21 CFR 886.5916
§ 886.5916 Rigid gas permeable contact lens.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 886.5916, § 886.5916 Rigid gas permeable contact lens, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91031
- Permanent ID
ys:prov:91031@1- SHA-256
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.