The FDA Probably Won’t Regulate Your Fitness Tracker
This is welcome news for my now four year old home health monitoring kit challenge.
The US Food and Drug Administration has published draft guidance suggesting it won’t regulate products intended for general wellness — like fitness trackers — provided there aren’t significant risks to their use.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 HOLD
For 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.
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