Publisher Summary The Food and Drug Administration (FDA) regulates medical products throughout their life cycle to help ensure the quality of the product, protection of human subjects in clinical trials, and safety and effectiveness of medical products that are marketed. The FDA regulates these products based on sound science, law, and public health. It is composed of scientists of many disciplines, including physicians, biologists, chemists, pharmacologists, microbiologists, statisticians, consumer safety officers, and epidemiologists. The FDA is further responsible for the review of regulatory submissions, the development and implementation of regulatory policy, research and scientific exchange, product surveillance, and compliance. As a science-based institution, the FDA strives to facilitate the development of new safe and effective medical products, while ensuring the safety of the products and their uses. Following the approval of a product, it performs biennial inspections to assess the firm's compliance with current good manufacturing practice. The FDA evaluates the observations and determines whether further regulatory action is needed. If the deficiencies are severe, it can issue an “intent to revoke” action, and if appropriate corrections are not made, it can revoke the license. The FDA can also fine the sponsor or seek an injunction to stop the marketing of a product.