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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.
Articles / Publications
The Family Smoking Prevention and Tobacco Control Act: An Overview,
December 2009
Preemption of State Law Tort Suits against Medical Device and Drug Manufacturers,
June 2008
The Pathway to Market for Your Medical Device: A Primer on Obtaining Information from FDA,
May/June 2008
FDA's Regulatory Scheme for Human Tissue,
November/December 2007
Condition of Approval Studies: FDA Takes A New Look,
August 2005
Federal and State Requirements for HCT/Ps: An Overview,
May 2005
Comparative Claims: Legally Permissible, But Proceed with Care,
September 2004
FDA's Regulation of Combination Products: The Road Ahead,
November 2003
When All Else Fails: Understanding the Medical Devices Dispute Resolution Panel,
June 2003
FDA's Regulation of Analyte-Specific Reagents,
February 2003
Promoting Devices for Specific Indications Based Upon a General Clearance,
February 2003
Medical Device Reporting: A Risk-Management Approach,
January 2003
FDA's Regulation of Internet Promotion and Advertising,
July 2001
The Washington Legal Foundation Litigation and Its Aftermath,
February 2001
How to Transfer Ownership of a 510(k) Clearance,
April 2000
Displaying Investigational and Unapproved Medical Devices According to FDA Policy,
October 1997
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