An introduction to the Food and Drug Administration and how it evaluates new devices: establishing safety and efficacy.

Most physicians, and certainly the lay public, have only limited knowledge of the responsibilities and limits of the Food and Drug Administration (FDA) of the United States of America. Although laws as early as 1902 protected the public from unrestricted sale of unsafe drugs, it was not until 1976 that devices came under regulation. An obvious difference existed between regulatory control of drugs vs devices. The drug-based approach for evaluation was rejected in favor of a new system based on device class and its degrees of risk. The premarket notification process (510K), and the premarket approval application (PMAA) became the regulatory pathway for device approval. The investigational device exemption (IDE) became the mechanism for established safety and efficacy. Occasionally conflicts exist between industry and the FDA. Submission of poorly planned studies wastes FDA resources whereas prolonged approval times can be devastating to the small single product business that creates the majority of our new devices. A compromise is obviously necessary if we are to maintain our premier identity as a new device entrepreneurial center and avoid industry's migration to countries where the regulatory standards might be less rigid.