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. 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) (forthcoming 2011); "Chapter 17: Combination Products and Jurisdictional Issues." in Food and Drug Law and Regulation (David G. Adams et al. eds, FDLI 2008) pp. 557-70; 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.
Articles / Publications
FDA Appeals - Improving Your Odds of Success: Trends, Expectations, Strategies, March 21, 2012
Proper Reform Is Needed of the Appeals Process at the US Food and Drug Administration's Device Center, January 2012
What Happens to Medical Device Reports Once They Reach FDA?, January 2011
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
Blog Posts
FDA's Brief in Par: The Gift that Keeps on Giving, March 7, 2012
MDR Reporting - FDA Appears to Disavow The Two Year Presumption, February 14, 2012
FDA Issues Draft Guidance on Medical Device Appeals Processes, January 5, 2012
Examination of MDR Reporting Criteria Warranted in Light of Recent Warning Letter, November 29, 2011
Appealing Premarket Disputes in the Device Center: Reform Is Needed, October 9, 2011
FDA is Sued Over Product Designation Determination; Lawsuit Seeks Device Declaration and to Vacate FDA's Drug Findings, June 30, 2011
Nothing New: FDA Announces its Innovation Pathway Program for Breakthrough Technologies, February 14, 2011
FDA Releases Plan Intended to Improve the 510(k) Program; Plan Contains 25 Action Items to Implement During 2011, January 20, 2011
More Members of Congress Concerned About 510(k) Reform, January 4, 2011
Minnesota Lawmakers Send Letter to FDA with Concerns About the 510(k) Process, November 30, 2010
Reform of The De Novo Classification Process Needs To Be A Top Priority, September 27, 2010
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
Speaking Engagements
AdvaMed Medical Device Workshop on FDA Inspections, Warning Letters & CAPA, May 22 - 23, 2012
Interactive Session: How to Respond to 483s and Warning Letters
FDLI 55th Annual Conference, April 24 - 25, 2012
FDA Center Director's Roundtable Panel
FDA Appeals - Improving Your Odds of Success; Trends, Expectations, Strategies, March 21, 2012
RAPS Medical Device Submission & Compliance Strategies for the US Market Workshop, March 5 - 7, 2012
1) Premarket Notification Background, Substantial Equivalence and Techniques for Identifying Predicates for 510(ks)s
2) Advertising & Labeling
AdvaMed: Avoiding A Warning Letter, December 8 - 9, 2011
The Evolution of Expectations Over Time
AdvaMed Advertising and Promotion of Medical Devices in an Age of DTC and Social Media Marketing, November 2, 2011
Recent Update of Compliance Issues
Thompson Webinar, October 18, 2011
Combination Products: Classification, Regulations, and Guidances
RAPS Webcast: Advertising, Promotion and Labeling - Marketing in a Regulated Environment, September 8, 2011
Clinical and Regulatory Strategies for Combination Products Conference, July 11 - 12, 2011
Introduction to the Combination Product Sector
FX Conferences Audio Conference, June 21, 2011
When a 510(k) or PMA Goes Off Track - FDA's Appeals Process
RAPS Medical Device Submission & Compliance Strategies for the US Market Conference, June 7 - 9, 2011
Premarket Notification Background, Substantial Equivalence and Techniques for Identifying Predicates for 510(ks)
Advertising and Labeling
Association of Medical Diagnostics Manufacturers (AMDM) Annual Meeting, April 28, 2011
When a 510K or PMA Goes Off Track: What Are the Options for Appeal
ACI's Drug and Device Product Recalls Summit, March 21 - 22, 2011
Communicating Effectively with the FDA and collaborating with the Agency When Implementing a Recall
Physicians and Physician Organizations Law Institute, February 9 - 10, 2011
Legal Issues in Physician-Owned Device Companies
RAPS webinar and simulcast, December 2, 2010
Updates on the FDA 510(k) Clearance Process
ACI: FDA Enforcement Summit - Fortifying Regulatory and Compliance Practices in the New Era of Aggressive Enforcement, May 24, 2010
Effectively Responding to Warning Letters and Protecting Your Company's Interests
RAPS DC/Baltimore Chapter, April 8, 2010
Current Developments on the 510(k) Process
Virginia CLE Webcast on Enforcement Powers and Practices of the U.S. Food and Drug Administration, August 5, 2009
FDLI Audio Conference Moderator on Human Tissue Regulation, June 29, 2009
Clinical Device Group Webinar, March 18, 2009
FDA Inspections of Sponsors or Manufacturers
Moderator of ACI Forum Panel on TV, Radio, Print and "New Media": Identifying Legal and Business Parameters for DTC Marketing of Medical Devices, November 17 - 18, 2008