Medical exoskeleton devices, such as those intended for gait rehabilitation or patient ambulation, must adhere to stringent Regulatory Standards before they can be legally used in clinical environments. In the United States, the Food and Drug Administration (FDA) classifies powered lower-extremity exoskeletons as Class II prescription devices. These devices typically require a 510(k) premarket submission for clearance, which involves demonstrating substantial equivalence to an already legally available device.

Special controls are mandated to mitigate critical risks, which primarily include instability, falls, joint misalignment, and device malfunctions that could result in unintended movement. Manufacturers must provide robust evidence from clinical testing to demonstrate the device's accuracy, durability, and safety in the intended use environment with the target population. Rigorous testing of battery performance, software validation, and mechanical safeguards against electrical hazards are also compulsory components of the regulatory pathway.

Related Reports