21 CFR Part 886, Subpart E - Surgical Devices

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There is 1 rule appearing in the Federal Register for 21 CFR 886. View below or at eCFR (GPOAccess)

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

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].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


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