Review of U.S. Medical Device Regulation

Abstract

Medical device regulation plays a significant role in the design, development, and commercialization of new medical technologies. A comprehensive understanding of the various regulatory requirements and their practical implementation is thus an essential cornerstone of successful medical device innovation. In this paper, we review the background, mission, and statutory requirements of medical device regulation in the United States. As opposed to pharmaceuticals, which have been regulated since the early 1900s, medical device regulation was not enacted before 1976, when Congress signed into law the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act of 1938. The U.S. Food and Drug Administration (FDA) has implemented a risk-based classification system, which is essential in determining the regulatory pathway for a given device. Our review of the different regulatory pathways discusses the specific steps and requirements associated with each pathway, and their implications for development and testing of different types of devices. The differences in these pathways are significant, and thus require careful consideration and analysis already at early stages of development. The FDA’s Quality Systems Regulation, which outlines specific requirements for development, testing, production, and postmarket surveillance, is another important aspect of device regulation. We present its elements and relationship to design controls and other operating procedures implemented by device manufacturers, and discuss their relevance in ensuring the safety and effectiveness of marketed devices. A summary of recent additions to device regulation, implemented by the FDA to allow for adequate regulation of products that combine drugs and devices or biologics and devices (so-called combination products), completes our review. Because of the significance of device regulation for medical device innovation, we strongly support increased efforts to educate the various stakeholders involved in the medical device development process, both at the academic and professional level.