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Electronic Code of Federal Regulations

e-CFR data is current as of May 28, 2020

Title 21Chapter ISubchapter HPart 801Subpart A → §801.4


Title 21: Food and Drugs
PART 801—LABELING
Subpart A—General Labeling Provisions


§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.

This amendment delayed indefinitely at 83 FR 11639, Mar. 16, 2018.

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.

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