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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.

Medical device labeling is the essential information provided by manufacturers about a device's purpose, usage, risks, and maintenance. This labeling ensures safe and effective use, assisting healthcare professionals and patients while meeting regulatory compliance.

Background. The Food and Drug Administration (FDA) is responsible for assuring that foods sold in the United States are safe, wholesome and properly labeled. This applies to foods produced domestically, as well as foods from foreign countries.

Section 201(k) defines 'label' as a: 'display of written, printed, or graphic matter upon the immediate container of any article...' The term 'immediate container' does not include package liners.

Label compliance is the process of ensuring that a product label meets all pertinent regulatory requirements, but it extends beyond government regulation and into industry standards.

Subpart C: Labeling Requirements for Over-the-Counter devices. Subpart C of 21 CFR 801 provides guidelines for all over-the-counter devices, including how the principal display panel and statement of identity must be displayed.

Regulatory labels are primarily used to ensure consumer safety and that a given product was manufactured to meet industry standards. Most regulatory labels are born out of what are called ANSI standards which are developed by a group of industry professionals from key sectors.