What defines the intended use of a medical device?

The intended use of a medical device is fundamentally defined by its purpose for diagnosis or treatment of disease. This specification includes the functions and applications for which the device is designed and marketed. Understanding the intended use is essential for both regulatory approval and the effective operation of the device in clinical settings. It informs healthcare providers how to appropriately utilize the device and ensures that it addresses the specific health issues it was created to resolve.

In contrast, aspects such as market trends, profitability, or regulatory classification as a drug do not directly define the device's intended use. While these factors can certainly impact the development and distribution of medical devices, they do not encompass the primary reason for the device's existence in the healthcare environment, which is to aid in the diagnosis or treatment of patients. Therefore, focusing on the device’s specific medical purpose is crucial for understanding its role and ensuring its proper application in patient care.