The US Food and Drug Administration has published draft guidance suggesting it won't regulate products intended for general wellness — like fitness trackers — provided there aren't significant risks to their use. Low-risk devices aren't invasive; don't involve lasers or radiation exposure; and don't raise new usability or biocompatability issues. Devices that don't fall under this category include sunlamps meant for tanning, because of the cancer risks associated with UV; and implants for aesthetic purposes, because of the risks of rupture, according to the document.
New devices meant for general wellness may have an easier time getting to market, if current regulations holdFor the FDA's purposes, a general wellness device is something that encourages weight management, physical fitness, relaxation or stress management, self-esteem, and sleep management. As long as these don't make claims about specific diseases — for instance, as long as a fitness tracker doesn't say it can diagnose or fix obesity — the agency will use a light hand, particularly if there aren't serious side-effects to the device's use.
Most consumer devices fall into this category, as do many of the wellness products that we saw at CES: myBrain's Melomind, Healbe's GoBe, and Garmin's VivoFit, among others. And new devices meant to measure things like blood pressure may have an easier time getting to market, if the current recommendations hold. But the ruling also opens doors for devices of questionable accuracy and value, since the agency won't be closely tracking general wellness claims. So a device that claims to count steps or calories may not be held to high standards of accuracy, the way other kinds of medical devices are.
These guidance documents don't establish legally enforceable policy. Rather, they tend to describe the FDA's thinking on a certain subject. Now that the guidance has been posted, there is a 90-day comment period before the recommendations are finalized.