The US Food and Drug Administration (FDA) has confirmed it will regulate all powered exoskeletons—a type of device intended to help paralyzed patients regain the ability to walk—as moderate-risk devices subject to a minimal level of premarket review.
FDA's announcement comes as little surprise to close industry watchers. In December 2014, FDA notified exoskeleton manufacturer Ekso Bionics that its "Ekso" bionic suit would be subject to premarket controls.
As Regulatory Focus reported at the time, the company had previously believed its product was a "low-risk" device (Class I) and would be exempt from FDA's premarket notification or premarket review procedures. According to the company, FDA said it wanted Ekso to submit a 510(k) (premarket notification) application prior to marketing the device. Most devices required to submit a 510(k) are classified as moderate-risk (Class II) devices by FDA.
That regulatory classification shouldn't have surprised the company, Focus noted at the time. FDA currently treats a similar technology, stair-climbing wheelchairs, as Class II devices, citing risks that mechanical failure could cause a patient to suffer a bad fall, such as down a flight of stairs. Users might also become trapped while using the device, suffer a bad reaction to the materials used in the manufacture of the device or be shocked by a battery failure.
New Regulatory Classification
FDA's latest announcement, made in a 23 February 2015 Federal Register announcement, confirms that Ekso Bionics' case was not unique.
FDA has issued a final order classifying all "powered exoskeletons" into Class II, requiring they meet "special controls." The hope is that the new regulatory controls will "provide a reasonable assurance of safety and effectiveness of the device," FDA said.
As FDA explains in its announcement, the change in regulatory status of the devices was triggered by Argo Medical Technologies, the manufacturer of the ReWalk exoskeleton. While the company's device was approved by FDA in June 2014 through the agency's De Novo classification procedure, a June 2013 request by the company to reclassify all powered exoskeletons was the driving force behind FDA's newest classification announcement.
FDA's Federal Register announcement explains:
"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."
As predicted by Focus, FDA's chief concerns for the device include mitigating the risks of "instability, falls and associated injuries," adverse reactions to device materials, battery failure, and device malfunction. Other potential risks include bruising and other use injuries, changes in the patient's heart rate and blood pressure, and use errors. FDA's Register announcement contains information intended to help manufacturers address and mitigate these risks.
FDA Federal Register announcement