21 CFR 801.116 - Medical devices having commonly known directions.

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There are 3 Updates appearing in the Federal Register for 21 CFR Part 801. View below or at eCFR (GPOAccess)
§ 801.116 Medical devices having commonly known directions.

A device shall be exempt from section 502(f)(1) of the act insofar as adequate directions for common uses thereof are known to the ordinary individual.

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].

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United States Code

Title 21 published on 2015-12-03

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 801 after this date.

  • 2017-01-09; vol. 82 # 5 - Monday, January 9, 2017
    1. 82 FR 2193 - Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective February 8, 2017.
      21 CFR Parts 201, 801, and 1100

Title 21 published on 2015-12-03.

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.

  • 2017-01-09; vol. 82 # 5 - Monday, January 9, 2017
    1. 82 FR 2193 - Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”
      GPO FDSys: XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective February 8, 2017.
      21 CFR Parts 201, 801, and 1100