On Jan. 16, 2015, the U.S. Food and Drug Administration promulgated a much-anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest attempt to provide some regulatory clarity in the wake of the explosion in popularity of wearable wellness devices and general fitness products. The draft guidance, which slightly loosens the FDA’s hold on general wellness products, comports with the agency's current policy of refocusing its resources on high-risk products and away from products that present a low risk to the end-user.
Background -
Historically, the FDA has not regulated devices intended to benefit a user’s overall health and wellness, unless those products made claims about disease prevention, treatment, mitigation or cure. In the FDA’s prior guidance of 1995, it stated it would regulate fitness equipment only if the equipment was “intended to be used for medical purposes[.]” On the other hand, if the equipment was to be used for “general physical conditioning,” the equipment was outside the FDA’s regulatory scheme.
Originally published in Law360, New York on January 27, 2015.
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