Scope and Markets For Medical Implants

Abstract

Medical devices are used routinely in the practice of medicine not only in the United States but throughout the world. The use of polymers, metals, ceramics and composite materials in the formulation of medical devices dates back centuries to the use of plant and animal skins for the amelioration of pathological conditions that resulted from mechanical, chemical or pathogenic trauma to tissues and organs. The word ‘device’ as defined by the US Federal Drug and Food Administration (FDA) includes any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or a combination of these elements that is intended for diagnosis, prevention or treatment of a disease (Phelps and Dormer, 1986). Materials such as synthetic and natural polymers, metals, ceramics, and composites of these materials are by themselves not considered devices and are approved by the FDA when formulated into an end-use device. Prior to 1976, the use of medical devices was unregulated in the US. In 1976, the US Congress enacted the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act of 1938, which called for the regulation of three classes of devices. Class I devices are those that present little or no risk to the user. Class II devices present some risk and are subject to performance standards while class III devices are the most dangerous and require pre-market approval prior to their widespread distribution.