The general labeling requirements for medical devices are contained in 21 CFR
Part 801. These regulations specify the minimum requirements for all devices.
Later sections in this chapter discuss any additional requirements needed for
specific categories of devices.
The label of a device shall contain the name and place of business of manufacturer,
packer, or distributor including the street address, city, state, and zip
code.
If the firm's street address is in the local telephone directory, the street
address can be omitted.
If the firm listed on the label is not the manufacturer, the firm information
must be qualified by an appropriate statement such as, "Manufactured
for..." or "Distributed by...."
If a packer, distributor, or seller intends a device for uses other than
those intended by the person from whom he received the device, these parties
must furnish adequate labeling in accordance with the new intended use.
If a manufacturer knows or has information indicating that this device is
to be used for conditions or purposes other than which it was intended, he
is required to provide adequate labeling in accordance with such other uses.
(An example of this might be a manufacturer of dental X-ray equipment who
is routinely selling his product to podiatrists.)
A word, statement or other required information may lack the required prominence and
conspicuousness for the following reasons:
If it fails to appear on the part or panel that is displayed under customary
conditions of purchase;
If the package contains sufficient space and the required information
fails to appear on two or more panels, each of which is designed to render
it to be displayed under customary conditions of purchase;
Failure to extend required labeling over package space provided;
Lack of sufficient label space for required labeling due to placement
of non-required labeling of the package; or
Smallness or style of type, insufficient contrast between labeling and
package background, designs which obscure labeling, or overcrowding of
labeling shich renders it unreadable.
Exemptions
Exemptions may be granted in those instances where device labeling lacks sufficient
space for required labeling provided that:
Existing label space is not taken up by including non-required information or by giving
prominence to a portion of the required labeling; and
Existing label space is not used for any representations in a foreign language.
All labeling shall be in English with the exception of products distributed solely within
Puerto Rico or a U.S. territory where the predominant language is other than English. In
these instances the predominant language may be substituted for English.
If any representation on the device label or labeling appears in a foreign language,
then all required labeling shall also appear in that foreign language.