ABSTRACT
Working in a “regulated” environment has many connotations, but to those of us
in medical products, the “regulators” always include the Food, Drug, and Cos-
metic Act (FDCA), with its tangle of amendments, and the Food and Drug
Administration (FDA) itself, which issues innumerable regulations and guidances.
You can’t be “in compliance” with regulations you’ve never read or laws you
can’t find. Hence, this chapter.
