A Primer of Drug/Device Law, or What’s the Law and How Do I Find It?

Working in a “regulated” environment has many connotations, but to those of us in medical products, the “regulators” always include the Food and Drug Administration (FDA) and the Food, Drug and Cosmetic Act. (FDCA). You cannot be “in compliance” with regulations you have never read or laws you cannot find. Hence, this chapter.