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Every article of foreign origin entering the United States must be legibly marked with the English name of the country of origin unless an exception from marking is provided for in the law.

The term 'labeling' is defined in the FFDCA as including all printed matter accompanying any article.

All labels must be designed and applied to devices and containers so that the labels will remain in place and legible during the customary conditions of distribution, storage, and use. Likewise, other labeling, such as user instructions, should remain legible during customary storage and use.

ISO 13416, the leading international standard for medical device quality systems, describes a label as the instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents.

The term ?labeling? includes all labels and other written, printed, or graphic matter on an article's immediate container or on, or in, any package or wrapper in which it is enclosed, except any outer shipping container. The term ?label? is that part of the labeling on the immediate container.

Medical device labeling refers to all of the information that is provided to the consumer with the device itself. This includes symbols, warnings, instructions, and control labels applied to the device or incorporated into the design by color coding, printing, machining, or molding.

Sec. 1.3 Definitions. (a) Labeling includes all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce.