In vitro diagnostics (IVDs) meet the definition of a device under the Act. Section
201(h) of the Act defines a device as:
“an instrument, apparatus, implement, machine, contrivance, implant, in
vitro reagent, or other similar or related article, including any component,
part, or accessory, which is—
- recognized in the official National Formulary, or the United
States Pharmacopeia, or any supplement to them, - 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 - 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.” 21 U.S.C. 321(h)
