An FDA Stamp on CES Gadgets Doesn’t Mean What You Think
AT CES LAST week, the health and wellness halls were overflowing with neuromodulators and laser-actuated balding remedies, Bluetooth breathalyzers and video-enabled ear infection probes, jet lag-busting headsets and Alzheimer’s-tracking apps. The poor publicists had quite a job to do. But you know what helps when you’re touting the next great health gadget? A big, shiny seal of approval from the Food and Drug Administration. Something about that stodgy blue art deco logo just tends to drown out the competition.
And it should! The FDA will never even get its hands on most of the products at CES, because they make squishy claims about wellness and fitness rather than tackle a distinct medical problem. “Frankly, there aren’t many real medical products here,” says Shai Gozani, CEO of NeuroMetrix, which is marketing a pain-relief wearable called Quell. Merely trying to fit into the agency’s rubrics means that a device is aspiring to something loftier than data tracking. But thanks to the arcane way the FDA deals—and doesn’t deal—with certain consumer and medical devices, those claims can mean wildly different things. And some of them don’t mean anything at all when it comes to safety or efficacy.
The top tier is what’s called “FDA-approved.” That’s mostly reserved for class III medical devices, the ones with the highest potential risk and highest potential benefit—stuff like body monitors, implantable pacemakers, and breast implants. Those devices need to submit a premarket approval application that includes safety and efficacy data. CES doesn’t display a ton of these devices, because they’re more likely to be used by doctors or require a prescription—and it is, after all, a consumer show. One of the few approved medical devices at the show was Dexcom’s wearable continuous monitor for glucose, which requires a doctor’s prescription.
But after “approved,” things get dicier. You might see “FDA-cleared,” which is reserved for products that get the thumbs-up because they’re similar to a device the agency knows is safe and effective. In FDA-speak, that clearance comes in the form of a document called a 510(k) that proves the thing is “substantially equivalent” to a previously OK’d device.
Take Gozani’s Quell pain relief device: It’s FDA-cleared via that 510(k) process, because it’s based on a different NeuroMetrix gizmo from a few years ago, called Sensus, that requires a prescription. (If you’re looking at that document like the good muckraker that you are and wondering why it says “Ascend,” that was Quell’s name before the company slapped a new IDEO-designed band on its wares and added an app to appeal to the tech crowd).
Now, even if a device is FDA-cleared or approved, it doesn’t mean the FDA initially OK’d it for exactly what the company is marketing. One of the cleared devices this year at CES was the ReliefBand, a wearable that claims to reduce VR motion sickness by stimulating the median nerve on the underside of your wrist. Cool, right? Sure. But the tech started out as an anti-nausea prescription for chemotherapy treatments, according to CMO Mark Goldstone, and got cleared for more general nausea and motion sickness indications later.