The US Food and Drug Administration has published draft guidance suggesting it won't regulate products intended for general wellness — like fitness trackers — provided there aren't significant risks to their use.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...
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