What does the term "Device" refer to in the context of clinical research?

In the context of clinical research, the term "Device" specifically refers to a product that influences the structure or function of the body without relying on chemical action. This definition aligns with regulatory frameworks, such as those provided by the Food and Drug Administration (FDA), which classify devices based on their intended use and method of action. Devices can include a wide range of products, such as surgical instruments, diagnostic tools, and implants, all of which interact with the body mechanically or physically rather than chemically.

Understanding this definition is crucial for researchers and clinical trial professionals, as it helps delineate devices from drugs or biological products that achieve effects through biochemical mechanisms. This distinction ensures that the appropriate regulatory guidelines can be applied to the study and use of such products in clinical investigations.