Before individuals in the U.S. can begin realizing these benefits, however, the new devices must be approved by the U.S. Food and Drug Administration (FDA).
Single-joint devices are currently considered to be Class I medical devices, so they are subject to the least amount of regulatory control. Currently, transfemoral prostheses are generally constructed by combining two, single-joint prostheses. As a result, they have also been considered Class I devices.
In robotic legs the knee and ankle joints are electronically linked. According to the FDA that makes them multi-joint devices, which are considered Class II medical devices. This means that they must meet a number of additional regulatory requirements, including the development of performance standards, post-market surveillance, establishing patient registries and special labeling requirements.
Another translational issue that must be resolved before robotic prostheses can become viable products is the need to provide additional training for the clinicians who prescribe prostheses. Because the new devices are substantially more complex than standard prostheses, the clinicians will need additional training in robotics, the authors point out.
In addition to the robotics leg, Goldfarb's Center for Intelligent Mechatronics has developed an advanced exoskeleton that allows paraplegics to
|Contact: David Salisbury|