How does the FDA define a "medical device"?

The FDA defines a "medical device" as an instrument, apparatus, implement, machine, or similar article that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. This definition emphasizes the primary role of medical devices in patient care and treatment, highlighting their use in health-related applications rather than other purposes.

The focus on diagnosis and treatment establishes a clear boundary for what constitutes a medical device as opposed to other types of products. For example, a device intended solely for educational use does not fit this definition since its primary function is not related to medical diagnosis or treatment. Similarly, products used exclusively for cosmetic purposes or as medical office supplies lack the essential characteristics that delineate medical devices, which are fundamentally about addressing health conditions. Thus, the choice correctly aligns with the FDA’s criteria for categorizing medical devices.