What is labeling?

What is labeling?

Labels and labeling are different. However, labels are a type of labeling.

The U.S. FDC Act (The Federal Food, Drug and Cosmetic Act) defines

Label

Written, printed, or graphic representation on the direct container of any article (The Federal Food, Drug and Cosmetic Act (FFDCA) Section 201(k))

Labeling

(1) on any article or its container or packaging material, or (2) accompanying such articles, including all labels and other written, printed, or graphic representations (The Federal Food, Drug and Cosmetic Act (FFDCA) Section 201(m))

In other words, a label is a label affixed to or stamped on a model nameplate (including UDI) and on primary packaging (primary package) The name plate is to be affixed or stamped on the primary packaging (primary package) or secondary packaging (packaging box).

Labeling means users …all printed materials that the patient sees.
For example, instruction manuals, attached documents, printed displays on packaging boxes, user training materials, catalogs, websites, exhibition videos, etc.
Not to mention instruction manuals, Even catalogs and websites can harm patients/users if their content is incorrect.

Labeling must be an output and must be design-reviewed and saved in the DHF (design and Development File) and must be saved in the DHF (Design and Development File).

However, in catalogs and websites, what is difficult to identify is the extent to which a product is an advertisement and the extent to which it is a labeling. Only a description of the model name and price would constitute an advertisement. However, if it describes indications, effects, functions, performance, diagnostic methods, etc., it could amount to labeling. A starter manual (simplified manual) that simplifies the instruction manual is also labeling. Simplified manuals are equivalent to labeling and should be stored in the DHF after design review as output from the design. In some cases, simplified manuals are prepared by the sales and marketing departments, but it is necessary to request a design review by the design department to ensure that the manuals are appropriately labeled. This is because ambiguous descriptions and omission of necessary information can lead to accidents.

Instruction manuals, simple manuals, etc., may in some cases be subject to design validation (or cumulative evaluation in usability engineering) must be performed.
An example of printed material that is visible to patients/users and is not equivalent to labeling is the “invoice”.

See:21 CFR 801 LABELING
labeling guide