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Mr. Shapiro has represented health care companies on FDA-related matters since 1994. His practice focuses on medical device law. He works extensively with large, small, and startup manufacturers on a broad spectrum of U.S. Food and Drug Administration (FDA) matters. He assists companies in developing regulatory strategies and preparing product applications, including IDEs, 510(k)s, and PMAs; with compliance matters, including MDRs, recalls, and GMPs; with advertising and promotion compliance; with regulatory due diligence; and with combination product issues. 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.
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.
Blog Posts
It's Not A Section 518 Mandatory Recall, But The Baxter Infusion Pump Recall Comes Close,
May 5, 2010
Meet The New Transparency - Same as The Old Transparency,
April 7, 2010
The MDR Reporting System Badly Needs Reform: As A First Step, Malfunction MDRs Should Be Eliminated,
March 30, 2010
What is a Tobacco Product "Ingredient"? ,
November 3, 2009
FDA Issues Proposed Rule on cGMPs for Combination Products,
September 29, 2009
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