If a medical device's labeling contains incorrect information, how should it be classified?

The classification of a medical device with incorrect labeling primarily falls under the category of a misbranded device. When a device's labeling does not accurately reflect its intended use, or if it contains false or misleading information, it is deemed misbranded according to regulatory standards. This classification is significant as it pertains specifically to issues of labeling and truthfulness in advertising rather than the safety or quality of the device itself.

An adulterated device typically refers to devices that are contaminated or fail to meet quality standards that could compromise safety. A misbranded device, on the other hand, specifically addresses the information provided on the label and how it may mislead consumers or health professionals.

Although a misbranded device may have implications for perceived safety or legality, the term itself is precise regarding the nature of the issue—focusing on incorrect labeling rather than the safety or quality of the device. Thus, if a medical device's labeling is incorrect, it is rightfully classified as misbranded.