Meaning of intended uses.
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... View More
Meaning of intended uses.
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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