Jeffrey K. Shapiro, JD

Jeff Shapiro is a partner in the law firm of Hyman, Phelps & McNamara (Washington, DC). He has represented healthcare companies on FDA-related matters since 1994. He advises companies on a wide variety of issues in the areas of medical devices, combination products, and human tissue products, including product approvals, marketing, clinical studies, jurisdictional issues, and enforcement. Mr. Shapiro has written and lectured extensively on a variety of FDA-related topics. He is the coeditor of Promotion of Biomedical Products, a textbook on FDA's regulation of promotion and advertising published in 2006 by the FDLI; he wrote two chapters of this textbook. Mr. Shapiro is also the coauthor of the book Combination Products: How to Develop the Optimal Strategic Path for Approval (FDA News 2005), available at He has written numerous articles on FDA regulatory topics in publications such as MD&DI, the Food and Drug Law Journal, Regulatory Affairs Focus, and the FDLI Update. Mr. Shapiro has served on the Editorial Advisory Board of MD&DI since 2007. Prior to joining the board, he was a long-time contributing editor to the magazine. He is also on the editorial advisory board of Update magazine and is a frequent speaker at medical device and diagnostic seminars and conferences. Prior to joining Hyman, Phelps & McNamara, he was a partner in the FDA practice group at Hogan & Hartson. Mr. Shapiro is a graduate of Brown University (1983, magna cum laude) and the Harvard Law School (1986, cum laude).