21 CFR Part 820 Subpart K: Labeling and Packaging Control

Labeling may seem like a relatively simple topic, bit it is a very complicated topic with regards to medical devices. Before we go too far, let’s start with the basic definition of “label”. The term “label” means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.