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  1. Overview of Device Regulation

Device Labeling

Introduction to Medical Device Labeling

Label vs. Labeling

The U.S. Food and Drug Administration (FDA) develops and administers regulations under authority granted by laws passed by Congress that apply to food, drugs, cosmetics, biologics, radiation-emitting electronic products, and medical devices. Labeling regulations pertaining to medical devices are found in the following Parts of Title 21 of the Code of Federal Regulations (CFR).

The Federal Food, Drug and Cosmetic Act (FFDCA) is the law under which the FDA takes action against regulated products. Specifically:

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. Any word, statement, or other information appearing on the immediate container must also appear 'on the outside container or wrapper, if any there be, or the retail package of such article, or is easily legible through the outside container of wrapper.'

    Section 201(m) defines 'labeling' as:

  • 'all labels and other written, printed, or graphic matter

    (1) upon any article or any of its containers or wrappers, or

    (2) accompanying such article' at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.

    The term 'accompanying' is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc. 'Accompanying' also includes labeling that is brought together with the device after shipment or delivery for shipment in interstate commerce.


According to an appellate court decision: "Most, if not all advertising, is labeling. The term 'labeling' is defined in the FFDCA as including all printed matter accompanying any article. Congress did not, and we cannot, exclude from the definition printed matter which constitutes advertising."

Additional Labeling Topics

Device Advice Labeling Topics

General Labeling Guidance Documents

Natural Rubber (Latex) Labeling

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