21 CFR 801.4 - Meaning of intended uses.

§ 801.4 Meaning of intended uses.
Link to an amendment published at 82 FR 2217, Jan. 9, 2017.
This amendment was delayed until Mar. 21, 2017 at 82 FR 9501, Feb. 7, 2017.
This amendment was further delayed until Mar. 19, 2018 at 82 FR 14319, Mar. 20, 2017.

The words intended uses or words of similar import in §§ 801.5, 801.119, and 801.122 refer to the objective intent of the persons legally responsible for the labeling of devices. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he received the devices, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. But if a manufacturer knows, or has knowledge of facts that would give him notice that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a device which accords with such other uses to which the article is to be put.

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 10-May-2017 03:43

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

  • 2017-05-18; vol. 82 # 95 - Thursday, May 18, 2017
    1. 82 FR 22741 - Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Further Delayed Effective Date; Request for Comments; Extension of Comment Period
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; extension of comment period.
      FDA is extending the comment period on the document delaying the effective date and seeking comment on the final rule published March 20, 2017 (82 FR 14319). Submit either electronic or written comments by July 18, 2017. For additional information on the comment date, see ADDRESSES and SUPPLEMENTARY INFORMATION .
      21 CFR Parts 201, 801, and 1100