Medical Device Labeling
The Medical devices marketed in the United States, whether they are manufactured here or are imported from abroad, must comply with the labeling requirements, if the labeling of a medical device is not comply with FDA regulations or requirements it will be considered as 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 any of its containers or wrappers, or accompanying such article.
At LMG we can help medical device companies to review and modify your labeling to comply with FDA regulations.