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 knowl edge of the responsibilities and limits of the Food and Drug Administr ation (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 diff erence existed between regulatory control of drugs vs devices. The dru g-based approach for evaluation was rejected in favor of a new system based on device class and its degrees of risk. The premarket notificat ion process (510K), and the premarket approval application (PMAA) beca me the regulatory pathway for device approval. The investigational dev ice exemption (IDE) became the mechanism for established safety and ef ficacy. Occasionally conflicts exist between industry and the FDA. Sub mission of poorly planned studies wastes FDA resources whereas prolong ed approval times can be devastating to the small single product busin ess that creates the majority of our new devices. A compromise is obvi ously necessary if we are to maintain our premier identity as a new de vice entrepreneurial center and avoid industry's migration to countrie s where the regulatory standards might be less rigid.