The U.S. Food and Drug Administration (FDA) announced that it will regulate all powered exoskeletons as Class II (moderate to high risk) devices, meaning that they are subject to general and special controls prior to FDA approval, rather than Class I (low to moderate risk) devices that are subject only to general controls. The new regulatory controls will “provide a reasonable assurance of safety and effectiveness of the device,” according to the announcement, and help manufacturers address and mitigate risks associated with use of the device.
In December 2014, the FDA requested that Ekso Bionics, Richmond, California, submit a 510(k) premarket notification application prior to marketing its Ekso GT suit. Most devices required to submit a 510(k) are classified as Class II devices by the FDA, leading industry watchers to anticipate the regulation announcement, according to the Regulatory Affairs Professional Society’s publication Regulatory Focus.
“FDA classifies devices into Class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into Class II with the establishment of special controls,” said the announcement, published in the Federal Register on February 23.
After the final order becomes effective on March 26, any company filing a 510(k) for a powered exoskeleton must meet the special controls required by the order. These special controls include detailed testing, verification, and training processes to ensure that the device does not harm the person wearing the device. The FDA mentions several risks, including falls, unexpected movement, early battery failure, skin injuries and sores, burns, shocks, and interference with other electrical devices.
The change in regulatory status of exoskeletons was triggered by ReWalk Robotics (formerly Argo Medical Technologies), Yokneam Illit, Israel, and Marlborough, Massachusetts, which requested that its ReWalk exoskeleton be classified as a Class II medical device, reported Medical Device and Diagnostic Industry (MD+DI) magazine. The FDA approved the request, and issued the classification on June 26, 2014, the same day the ReWalk received FDA approval; the ReWalk Personal System followed the de novo classification regulatory pathway.