ABSTRACT
Since the technological advances of the 1950s and 1960s, the rate of innovation in the medical device industry has greatly accelerated. These innovations have led to very substantial therapeutic, monitoring, and diagnostic benefits in all areas of medicine. Often, these innovative devices were selected and used by healthcare professionals who received their basic sci-entific training before these technologies were developed. By the early 1970s, many medical devices were becoming so complex that medical professionals were no longer able to fully assess their attributes. Device developers and manufacturers were also encountering situations where devices interacted with the body in unanticipated ways or deficiencies in the production process led to patient injuries and deaths. This history was the driving force behind the 1976 Medical Device Amendments to the Food Drug and Cosmetic Act of 1938. By 1978, when the regulations required by this new law came into full effect, the production and clinical testing of medical devices were subject to FDA review. Many new devices entering the U.S. market had to undergo FDA review, either through the 510(k) PreMarket Notification process, or the PMA Premarket Approval process. The 1976 Amendments have been modified several times over the years and now also cover the device development process. This chapter provides an introduction to medical device classification, the preparation of premarket submissions, medical device clinical research, and manufacturing regulations.
