21 CFR 886.5925 - Soft (hydrophilic) contact lens.

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There is 1 rule appearing in the Federal Register for 21 CFR 886. View below or at eCFR (GPOAccess)
§ 886.5925 Soft (hydrophilic) contact lens.
(a) Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of 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]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-04-21; vol. 79 # 76 - Monday, April 21, 2014
    1. 79 FR 22012 - Medical Devices; Ophthalmic Devices; Classification of the Eyelid Weight
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      Effective Date: July 21, 2014. Compliance Dates: Premarket notification submissions (510(k)s) for eyelid weights filed on or after the effective date of this rule are expected to comply with the requirement of special controls at the time that the 510(k) is submitted. Premarket notification submissions (510(k)s) for eyelid weights filed before the effective date of this rule, but not yet cleared for marketing, are expected to comply with the requirement of special controls prior to receiving marketing clearance. External eyelid weights exempt from premarket notification under this rule and not currently marketed are expected to comply with the requirement of special controls prior to introducing devices into interstate commerce. Eyelid weights (both implantable and external) legally marketed before the effective date of this rule are expected to comply with the requirement of special controls by April 21, 2015. See section V of this document, “Compliance Dates,” for further information.
      21 CFR Part 886

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United States Code

Title 21 published on 2014-04-01

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

  • 2014-04-21; vol. 79 # 76 - Monday, April 21, 2014
    1. 79 FR 22012 - Medical Devices; Ophthalmic Devices; Classification of the Eyelid Weight
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      Effective Date: July 21, 2014. Compliance Dates: Premarket notification submissions (510(k)s) for eyelid weights filed on or after the effective date of this rule are expected to comply with the requirement of special controls at the time that the 510(k) is submitted. Premarket notification submissions (510(k)s) for eyelid weights filed before the effective date of this rule, but not yet cleared for marketing, are expected to comply with the requirement of special controls prior to receiving marketing clearance. External eyelid weights exempt from premarket notification under this rule and not currently marketed are expected to comply with the requirement of special controls prior to introducing devices into interstate commerce. Eyelid weights (both implantable and external) legally marketed before the effective date of this rule are expected to comply with the requirement of special controls by April 21, 2015. See section V of this document, “Compliance Dates,” for further information.
      21 CFR Part 886