The US FDA1 currently regulates the manufacturing and marketing of medical devices in the United States under the Federal Food, Drug and Cosmetic Act2 (FDCA). It was not until 1938 FDCA that medical devices were subject to any type of federal regulation. However, it was nearly four decades later in 1976 that the device regulations took the next evolutionary step when substantive Medical Device Amendments3 to the FDCA were passed by Congress, which thereafter required the FDA to establish a comprehensive system of reviewing and approving the marketing of medical devices introduced into interstate commerce. The new law also prohibited, marketing a device until the FDA finds that the device is safe and effective. Despite the increased regulations resulting from the 1976 amendments, the statutory provisions were generally perceived as inadequate. The law was most significantly amended in 1990 by the Safe Medical Devices Act4 (sMdA); in 1992 by the Medical Device Amendments5 and yet again in 1997 by the Food and Drug Administration Modernization Act 6 (FDAMA) to further expand the FDA’s authority, increase its enforcement powers, and require device manufacturers and others to report adverse device experiences to the FDA (Table 22.1). These changes culminated to establish a comprehensive system of reviewing and approving the marketing of medical devices in the United States. The main changes introduced by these device regulations included the following:
(1) devices would now be classified into three distinct classes based on their perceived risk;
(2) a premarket notification system was introduced to enable the FDA to assess the safety and effectiveness of products prior to marketing; and
(3) a premarket approval system, distinct from the New Drug Premarket Approval requirements for drugs, was introduced for high-risk devices where FDA would review clinical evidence as to the safety and effectiveness of the device before granting approval to the manufacturer to market the item.7