Part 1: Background - What Are The Risks And What Is FDA's Role In Managing Risk?
At the turn of this century, healthcare was generally provided by a family practitioner who treated patients from cradle to grave. Today's healthcare products are developed and used within a complex system involving a number of key participants. As illustrated in the following figure, participants include (1) manufacturers who develop and test products and submit applications for their approval to the FDA; (2) the FDA, which has an extensive premarketing review and approval process and uses a series of postmarketing surveillance programs to gather data on and assess risks; (3) the healthcare delivery system, including its many elements; and (4) patients, who rely on the ability of this complex system to provide them with needed interventions while protecting them from injury. In many cases, the roles of the participants in this system evolved independently, and in some cases, the roles are not clearly defined.