|
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.
|
