ABSTRACT
The United States Food and Drug Administration (FDA) is an agency within the US Department of Health and Human Service. The FDA is a science-based, regulatory, and public health agency. The FDA regulates foods, drugs, biological products, cosmetics, and tobacco products. This chapter provides students and other interested individuals a concise overview of the US regulatory framework for medical devices. It focuses on the general regulatory requirements, pre- and post-market, necessary to legally market medical devices in the United States. In the United States, the FDA’s Center for Devices and Radiological Health is responsible for regulating medical devices and radiation-emitting electronic products. The Radiation Control for Health and Safety Act of 1968 required a radiation control program that included the development and administration of performance standards to control the emission of electronic product radiation from electronic products, such as microwave ovens, diagnostic x-ray equipment, and others.
