Definition
of Device
(201(h) of the Act)
The term "device" means an instrument, apparatus, implement,
machine, contrivance, implant, in vitro reagent, or other similar
or related article, including any component, part, or accessory,
which is—
(1) recognized in the official National Formulary, or the United
States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions,
or in the cure, mitigation, treatment, or prevention of disease,
in man or other animals, or
(3) intended to affect the structure or any function of the body
of man or other animals, and which does not achieve its primary
intended purposes through chemical action within or on the body
of man or other animals and which is not dependent upon being metabolized
for the achievement of its primary intended purposes.
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