Labeling

Labeling includes manuals and, in some cases, promotional literature and websites. Statements in labeling can change the intended use, so they are reviewed with regulatory eyes.

label, 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 [SOURCE: GHTF/SG1/N70:2011, Clause 4]

ISO 13485:2016, clause 3.8

The term “labeling” means all labels and other written, printed, or graphic matter (1) upon any article or its containers or wrappers, or (2) accompanying such article. This can include, among other things, any user or maintenance manuals and, in some instances, promotional literature.

FDA guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (October 2017), Appendix C, Significant Terminology