Hyman Phelps and McNamara Hyman Phelps and McNamara
Jeffrey K. Shapiro
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(202) 737-9633

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Danette L. Williams
(202) 737-9631

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Mr. Shapiro represents medical device companies before the Food and Drug Administration (FDA), assisting in developing regulatory strategy and preparing product applications, including IDE, 510(k), and PMA submissions or filings; with compliance matters, including MDRs, recalls, and QSRs (or GMPs); with labeling, advertising and promotion compliance; with the FDA aspects of regulatory due diligence, contracts and transactions; and with combination product issues. He has focused in this area since 1994, working with large, small, and startup manufacturers. He also has expertise in FDA's regulation of human tissue based products.

Mr. Shapiro has written and lectured extensively on a variety of FDA-related topics. He is the co-editor of Promotion of Biomedical Products, a textbook on the FDA's regulation of promotion and advertising published in 2006 by the Food and Drug Law Institute (FDLI); he authored two chapters of this textbook. Mr. Shapiro is also the co-author of the book, Combination Products: How to Develop the Optimal Strategic Path for Approval (FDA News 2005), available at www.fdanews.com. In addition, he has contributed chapters to several textbooks: "Chapter 4: Premarket Submissions," in the Medical Law Answer Book (Onel & Becker eds., Practicing Law Institute) (2011); "Chapter 17: Combination Products and Jurisdictional Issues." in Food and Drug Law and Regulation, 2d (David G. Adams et al. eds, FDLI 2011) pp. 495-512; and "Food and Drug Administration." in Emerging Spine Surgery Technologies: Evidence and Framework for Evaluating New Technology (Terry P. Corbin et al. eds., Quality Medical Publishing, Inc. 2006) pp. 6-11 (overview of FDA law and regulation of medical devices).

Mr. Shapiro has authored numerous articles on FDA regulatory topics in publications such as Medical Device and Diagnostic Industry (MDDI), the Food and Drug Law Journal, Regulatory Affairs Focus, and the Food and Drug Law Institute's (FDLI) Update. Mr. Shapiro is on the Editorial Advisory Board of MDDI and Update magazines. He is also a frequent speaker at medical device and diagnostic seminars and conferences.

Mr. Shapiro is a graduate of Brown University (1983 magna cum laude) and the Harvard Law School (1986 cum laude). He is admitted to practice law in the District of Columbia, California and Pennsylvania.