Medical Device Labeling

The Medical devices marketed in the United States, whether manufactured here or imported from abroad, must comply with the labeling requirements; if the labeling of a medical device does not comply with FDA regulations or requirements, it will be considered misbranded.

A "label" is a display of written, printed, or graphic matter upon the immediate container of any article.

"Labeling" includes all labels and other written, printed, or graphic matter upon any article or its containers or wrappers or accompanying such article.

LMG can help medical device companies review and modify their labeling to comply with FDA regulations.