Regulatory

The Food, Drug, and Cosmetic Act governs the regulatory approval process for bringing a drug, biologic, medical device, food, or cosmetic to market. The class will discuss administrative procedures followed by the FDA. The course includes an overview of the drug, biologic, and medical device approval processes and the regulation of food and dietary supplements. Students then will be exposed to the enforcement activities of the FDA, including searches, seizure actions, injunctions, criminal prosecutions, and civil penalties authorized under the FD&C Act as well as other statutes, like the Public Health Service Act, which regulates the development and approval of biologics.

Software continually grows more complex and is becoming relied upon by health care professionals in the treatment of patients. This course describes how the U.S. government regulates software used in delivering health care, including the regulations utilized by the FDA and the Centers for Medicare and Medicaid Services. This course covers a wide range of topics, including FDA regulation of software as a medical device and software validation, medical imaging software regulation, electronic record keeping and software used in clinical trials, laboratory information management systems, and HIPAA privacy rules and security standards.

Medical products brought to market need to have a sound payment, coding, and coverage strategy.  Medicare covers over 100 million Americans and it leads the way in all United States insurance policies.  This course will provide insight into how medical product reimbursement works and allow students to understand how the Centers for Medicare & Medicaid Services (CMS) considers medical products for coverage, coding, and payment.  We’ll review the history of Medicare coverage and the regulations.  We’ll focus primarily on strategies used to get reimbursement for medical products—both at the national and local levels.

This course provides a comprehensive overview of in vitro diagnostic (IVD) devices and how they are regulated by the U.S. Food and Drug Administration (FDA) and by international organizations such as the European Union (E.U.). Topics that will be covered include: (1) a summary of the U.S. and international laws, regulations, and policies that govern IVD devices, (2) administrative and legal requirements and resources for IVD devices throughout the full product life-cycle, (3) types of IVD devices, (4) coverage and reimbursement of laboratory tests, and (5) current issues and developments. Upon completion of this course, the student will have a working knowledge of the requirements and policies of the regulation of IVD devices.