What is the purpose of an ‘intended use’ statement for medical devices?

An ‘intended use’ statement for medical devices plays a critical role in defining the specific purposes for which the device is intended and the target patient population. This statement provides key information that aids regulators, healthcare providers, and patients in understanding the device’s application in medical situations. By clearly articulating the intended use, manufacturers can also delineate the scope of the device's effectiveness and safety, ensuring that it is utilized appropriately within clinical settings.

This clarity is essential for regulatory submissions, as it helps regulatory agencies assess whether the device meets the necessary criteria for approval based on its intended applications. In addition, it ensures that marketing and labeling align with the defined intended use, preventing misuse or misrepresentation of the device in the healthcare environment.

Although competitive advantages, manufacturing processes, and risks associated with the device are important aspects of the overall context in which a medical device is evaluated, they do not directly address the primary purpose of the intended use statement. Hence, the focus remains on articulating who the device is for and what it is meant to accomplish in patient care.