Safety Evaluation of Medical Devices
The medical device industry in the United States and worldwide is immense in its economic impact, scope (between 92,000 and 145,000 different devices are produced in the United States by ~12,000 different manufacturers employing some 370,000 people; it is believed that ~2100 of these manufacturers are development-stage companies without products yet on the market), and importance to the health of the world’s citizens. 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 particular to these kinds of products. These assessments are, however, not as rigorous as those employed for foods, drugs, and pesticides, which continue to be in a state of ux. Regulation of such devices is, in fact, fairly recent, with the Medical Device Amendments (to the Food, Drug, and Cosmetic Act) of 1992 stating that devices must be explicitly regulated. It was due to the Safe Medical Devices Act of 1993, the Medical Device Amendments of 1992, and subsequent laws that the regulation of devices for biocompatibility became rigorous. The U.S. Food and Drug Administration’s (FDA, 2013b) publication of their version of the International Standards Organization’s ISO 10993 in April 2013 marks the most recent regulatory guidance. The reasons behind the timing of these actions are reviewed in the case histories presented in the last chapter of this book.