In the United States, the FDA derives its authority from a law called the Food, Drug, and Cosmetic Act or FD&C. This law supplies the legal framework that gives the FDA its broad authority over consumer goods in the United States.

The Pure Food and Drug Act of 1906 was the first of more than 200 laws that constitute one of the world's most comprehensive and effective networks of public health and consumer protections at the time. This law was an early precursor to the FD&C. (For more information on significant amendments to the FD&C, see http://www.fdareview.org/01_history.php for a list and details.)

Learning Objectives:

- 1.1 - Describe the role of the FDA and other regulatory bodies in the manufacturing of medical devices.