The FDA and Devices

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. The chapter details the regulations involving medical devices for the designers of devices and systems. Regulation of medical devices is intended to protect consumer's health and safety by attempting to ensure that marketed products are effective and safe. The Cooper Committee concluded that the many inherent and important differences between drugs and devices necessitated a regulatory plan specifically adapted to devices. All devices were placed into classes based upon the degree of risk posed by each individual device and its use. The pre-market notification process and the Pre-market Approval Application (PMAA) became the regulatory pathways for device approval. Registration and listing provides the FDA with information about the identity of manufacturers and the products they make.