ABSTRACT
The medical device industry in the United States and worldwide is immense
in its economic impact (sales in 1998 were $138 billion worldwide, and
$59 billion in the United States, $34 billion in the European Community, and
$23 billion in Japan; in 1998, the US medical equipment trade surplus was
$8.7 billion), scope (between 87 000 and 140 000 different devices are pro-
duced in the United States by approximately 8200 different manufacturers
employing some 311 000 people; it is believed that more than 1000 of these
manufacturers are development-stage companies without products yet on the
market), and importance to the health of the world’s citizens (Nugent, 1994;
the Wilkerson Group, 1999) (Table 3.1). Large companies dominate sales, but
(as in pharmaceuticals) not innovation. The assessment of the safety to
patients using the multitude of items produced by this industry is dependent
on schemes and methods that are largely peculiar to these kinds of products,
are not as rigorous as those employed for foods, drugs, and pesticides, and are
in a state of flux. Regulation of such devices is, in fact, relatively new. It is only
with the Medical Device Amendments (to the Food, Drug and Cosmetic Act)
of 1976 that devices have come to be explicitly regulated at all, and with the
Safe Medical Devices Act of 1990, the Medical Device Amendments of 1992,
and subsequent laws that the regulation of devices for biocompatibility
became rigorous (see Table 3.2). According to section 201(h) of the Food, Drug
and Cosmetic Act, a medical device is an instrument, apparatus, implement,
TABLE 3.1
The largest medical device markets (2001)
TABLE 3.2
FDA Classification of preamendment medical devices
machine, contrivance, implant, in vitro reagent, or other similar or related
article, including a component, part, or accessory that is
• Recognized in the official National Formulary, or the United States Phar-
macopoeia (USP, 2000), or any supplement to them.
