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 atwww.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 MDDIand 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The US FDA and its Draft Guidance on Medical Device Appeals, April 2013

Real-World Implications of United States v. Caronia, January 31, 2013

US FDA should be required to provide 510(k) decision summaries for devices - a missed opportunity by lawmakers, July 2012

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

CDRH Working to Update Appeals Guidance for Consistency with FDASIA, April 17, 2013

Cytori Case Decision Upholds FDA's Not Substantially Equivalent Determination, March 24, 2013

Medical Device Recall or Product Enhancement? FDA's New Draft Guidance Should Be Recalled for Significant Repairs, February 28, 2013

First Fruits of FDASIA's New Device Reclassification Procedure, February 17, 2013

FDA Ramps Up Focus on Advertising of Restricted Devices to Consumers, January 7, 2013

A Difference of Opinion: CDRH's SOP for Internal Supervisory Appeals, October 8, 2012

FDA's Voluntary ISO Audit Submission Program, September 30, 2012

FDA Should Be Required To Provide 510(k) Decision Summaries, June 12, 2012

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

FXConferences, May 9, 2013
FxTrans Promotion Webinar

Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School's annual conference:, May 2 - 4, 2013
Why the 510(k) Pathway is the Right Approach for Most Medical Devices

RAPS Medical Device Submission & Compliance Strategies for the US Market Workshop, March 7 - 8, 2013
Premarket Notification Background, Substantial Equivalence and Techniques for Identifying Predicates for 510(ks)s
Advertising & Labeling

Real-World Implications of United States v. Caronia, January 31, 2013

Audioconference: When a 510(k) or PMA Goes Off Track - FDA's Appeals Process, January 10, 2013

AdvaMed/MTLI Advertising and Promotion Workshop, November 7, 2012
Review of Recent Compliance Issues

ACI: FDA Boot Camp Devices Edition, October 23 - 25, 2012
Fundamentals of FDA Regulatory Device Law
Overview of Device Regulation

Orthopedic Surgical Manufacturer's Association Fall Meeting on, October 18, 2012
Advertising and Promotion

Changes to the FDA's 510(k) Clearance Process Webinar, August 8, 2012

Elsevier Business Intelligence Webinar, June 19, 2012
Discovering the Impact of the FDA's Eagerly Awaited Final Risk-Benefit Guidance

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