The Food and Drug Administration and the Hospital

Abstract

In Brief The US Food and Drug Administration (FDA) has authority over the medical device industry with respect to the design, testing, and marketing of medical devices. To a lesser extent, the FDA's authority reaches directly into the hospital or user setting. It is useful for hospital-based clinical/biomedical engineers to understand both aspects of the FDA to support the institution's compliance with FDA mandates, and to distinguish mandates from advisory communications. In addition, it can be useful for the clinical/biomedical engineer to be able to refute unsound claims that the FDA mandates or regulates hospital activities that it in fact does not. The U.S. Food and Drug Administration (FDA) has authority over the medical device industry with respect to the design, testing and marketing of medical devices. To a lesser extent the FDA's authority reaches directly into the hospital or user setting. It is useful for hospital based clinical/biomedical engineers to understand both aspects of the FDA in order to support the institutions compliance with FDA mandates, and to distinguish mandates from advisory communications. In addition, it can be useful for the clinical/biomedical engineer to be able to refute unsound claims that the FDA mandates or regulates hospital activities that it in fact does not.