These skin-darkening devices clearly serve primarily a cosmetic purpose, but fall under the FDA’s “device” authority because it has the ability to affect the structure or function of the body while also being an instrument. Noah noted that while some might consider it a stretch to include firearms in this definition, the FDA is used to regular indoor tanning equipment and sunlamps. If regulated as a “device” through the FDA, this would mean that they’d have the ability to impose a national minimum age for purchasing, demand clearer storage instructions, and introduce performance safety standards. Using this definition, firearms and ammunition clearly are devices and accessories that can affect the structure or function of a body because of its ability to cause deliberate or accidental harm, Noah wrote. Presently, the FDA defines “devices as an instrument, apparatus, or a component intended to either diagnose, cure and treat - or “affect the structure or any function of the body of man or other animal.” Noah suggested it’s worth bringing up the idea since gun violence is already considered a public health challenge by many scholars and researchers. Gun manufacturers currently operate with “far too little oversight at present,” the paper maintained. While the device regulation authority is primarily used for instruments like hypodermic needles, syringes, and automated external defibrillators (AEDs), it provides a precedent for regulating potentially harmful products. Lars Noah, a law professor at the University of Florida, argues that the FDA’s oversight power over devices that can also inflict “accidental harms” offers an unconventional approach to the epidemic of gun violence in the U.S. Food and Drug Administration (FDA) regulatory authority over devices that “affect the structure or function of the body” can be used to limit the manufacture of firearms, according to a forthcoming paper in the Connecticut Law Review.
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