The highly diversified medical device industry manufactures
products ranging from tongue depressors to complex programmable
pacemakers. The Medical Device Amendments to the Federal
Food Drug & Cosmetic Act define a medical device as: "an
instrument, apparatus, implement, machine, contrivance, implant,
in vitro reagent, or other similar or related article… 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 any of its primary intended purposes.” Among other purposes,
the definition is intended to distinguish a device from a
drug.
