The future is here. The future will be regulated. Those are two possible conclusions from an announcement this week by Ekso Bionics, which said its robotic exoskeleton—intended to help paralyzed patients walk by augmenting their strength—must meet additional regulatory requirements put in place by the US Food and Drug Administration (FDA).
At issue is the method in which Ekso Bionics' "wearable bionic suit," Ekso, is supposed to be reviewed by regulators before it is allowed to be sold to consumers.
Ekso Bionics had apparently believed its product was a Class I (low-risk) medical device that, so long as it met basic standards established by the FDA, would be largely exempt from needing to provide FDA with evidence of its safety and efficacy.
FDA, however, has other ideas.
In a 2 December 2014 announcement, Ekso Bionics said FDA wants it to submit a 510(k) application before the regulator will allow the product to be sold. The 510(k) application, also known as a premarket notification, requires a company to either show how its product is substantially equivalent to an already-approved predicate device, or to adhere to "special controls" established by FDA.
Most (though not all) Class I medical devices are exempt from this requirement.
Why the New Requirements?
Why would FDA want to subject a robotic exoskeleton to greater regulatory controls? Consider the case of the stair-climbing wheelchair.
As Focus explained in April 2014, FDA recently classified stair-climbing wheelchairs as Class II (moderate-risk) medical devices after years of considering them Class III (high-risk) devices. Unlike hand-operated wheelchairs, which are considered Class I medical devices, the mechanical complexity and more advanced use of stair-climbing wheelchairs presents novel safety risks. For example, FDA expressed concern that a mechanical failure could cause a user to suffer a bad fall (such as down a flight of stairs), become trapped, have an allergic reaction to materials used in the device or be burned or shocked by a battery failure.
Regulators may well have similar concerns about the Ekso device, which is used in similar patient populations and situations.
Little Immediate Effect
In a statement, Ekso Bionics said it has already submitted a 510(k) application to FDA seeking marketing clearance for the product, and noted that FDA has allowed it "to continue marketing the product while the 510(k) filing is under review." The company must notify its customers of the regulatory change, however.
"Ekso Bionics is committed to full compliance with FDA's medical device regulations and is working with FDA to fully address the regulatory issues stemming from the recent change in classification for powered exoskeletons," it wrote.
The future—allowing the paralyzed to walk again—may be here, but it seems not even the future can avoid regulatory compliance issues.
More About the Ekso Device
h/t The Gray Sheet