Regulation of the Medical Device Industry – 6854

Spring 2023

This course will introduce students to the operation of the medical device industry, and to key state and federal laws regulating the industry, preparing them to tackle the complex legal issues that arise in a life sciences practice. We will start by exploring the origins of, and limits on, state and federal power to regulate the propagation of health care items and services. Next, we will focus on several examples of state regulation of devices. We will then consider how medical devices are paid for, the involvement of the federal government in that process, and the attendant regulatory scheme and the incentives it creates. We will also learn about the FDA and the ways it operates to assure safety and efficacy of medical devices and will explore how the promotion of medical devices is regulated by various federal agencies and the states. Finally, we will consider how HIPAA affects the flow of patient information between healthcare providers and medical device companies.