Key Summary: "Health technology is advancing at a rapid clip, with many of these technologies appearing on consumer products like smartphones and tablets.""Federal regulators have responded to these changes with a flexible approach that allows firms to manufacture a ‘general wellness product’ (‘GWP’) without being subject to regulation typically applied to ‘devices’ that diagnose or treat a disease or condition.""Using currently available medical products and devices from across a spectrum of diseases, we describe how firms can use this existing regulatory framework to develop innovative products by ‘skating the line’ between mostly unregulat...
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