Define the "investigational device" under FDA regulations.

The term "investigational device" under FDA regulations refers specifically to a device that is intended for use in a clinical study aimed at gathering data to support the device's safety and effectiveness for a specific use. This designation is crucial because it allows for the controlled study of a device before it receives approval for general market use. Investigational devices are subject to strict regulatory control and must comply with regulations regarding clinical trials, including informed consent, reporting of adverse events, and maintaining the integrity of the study data.

The focus on clinical studies highlights the importance of investigating new technologies to ensure they meet necessary safety and efficacy standards prior to being introduced to the wider patient population. This regulatory pathway is essential for innovation in medical devices, allowing new products to be evaluated in a structured manner while protecting patient safety.

Devices that are already approved for market use, retired devices that are no longer in service, or devices without any regulatory oversight do not fit the definition of an investigational device, as they do not pertain to ongoing investigations or clinical evaluations for approval.