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.
As an indication of the industry’s importance to U.S. competitiveness, an estimated $77 billion
of medical devices and diagnostics products were manufactured in the
United States in
2002, and more than $20 billion per year in manufactured products were
exported. Furthermore, the level of innovation in this industry is escalating
rapidly largely due to the convergence of traditional medical device-related
technologies and bioengineering, biomaterials, computing and telecommunications.
