21 CFR 801.116 - Medical devices having commonly known directions.

§ 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].

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 19-May-2018 03:57

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

  • 2018-03-16; vol. 83 # 52 - Friday, March 16, 2018
    1. 83 FR 11639 - Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Partial Delay of Effective Date
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; partial delay of effective date.
      Effective March 16, 2018, the amendments made to §§ 201.128 and 801.4, revised at 82 FR 2193 (January 9, 2017), delayed at 82 FR 9501 (February 7, 2017) until March 21, 2017, and further delayed at 82 FR 14319 (March 20, 2017) until March 19, 2018, are delayed indefinitely. Section 1100.5, added at 82 FR 2193 (January 9, 2017), delayed at 82 FR 9501 (February 7, 2017) until March 21, 2017, and further delayed at 82 FR 14319 (March 20, 2017) until March 19, 2018, is effective March 19, 2018.
      21 CFR Parts 201, 801, and 1100