ABSTRACT
The Food and Drug Administration (FDA) of the United States was first formed in 1906 in response to the then rampant interstate commerce in misbranded food, drink, and drugs. Of primary interest to designers of devices and systems will be the regulations involving medical devices, the subject of this chapter. The history of the FDA, a discussion of drug development and the role of the FDA in this, and the subject of combination devices (drug/device) will be the subject of Chapter 17.
