According to the Food and Drug Administration (FDA), an investigational device is a device, including a transitional device, that is the object of a [clinical] investigation involving one or more subjects to determine the safety or effectiveness of the device (21 CFR 812.3). Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices.

• Also, see IDE Definitions and Acronyms for more definitions related to this term.
• The use of an investigational device in human subjects requires approval by the IRB and may also require approval from the FDA.