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INBLF Upcoming Events

—   INBLF Fourteenth Annual Meeting and Black Tie Event – San Francisco, California October 19th – 22nd, 2017 Are you ready to leave your heart in San Francisco?  We hope…

INBLF Supreme Court event featured in the National Law Journal

NLJ Article on INBLF’s Supreme Court dinner On October 10, 2014, about 200 INBLF members and guests convened in the Great Hall of the United States Supreme Court for the…

INBLF Annual Meetings and Black Tie Dinners

Thirteenth Annual Meeting and Black-Tie Dinner Chicago, Illinois September 15-18, 2016 Hosted by the Chicago Chapter   Twelfth Annual Meeting and Black-Tie Dinner Miami, Florida October 15-18, 2015 Hosted by…

INBLF European Summits

Ninth Annual INBLF European Summit Lisbon, Portugal May 25 – 28, 2017 Hosted by Coelho Ribeiro & Partners Associados                      …

INBLF Awards and Recognitions

The INBLF remembers the contributions of past leaders and recognizes the contributions of present members through its Memorial Awards. Alberto Lasheras Shine Memorial Award – Presented in loving memory of…

INBLF Asian Summits

Seventh Annual Asian-Pacific Summit Guangzhou, China – March 31st – April 2, 2017 Hosted by Robertsons                         Sixth Annual…

INBLF in the News

  INBLF press release – SelectUSA Summit June 2017   INBLF press release – SelectUSA Summit June 2016 INBLF in the New York Times INBLF in IP Law 360 INBLF…

INBLF Member Publications

James M. Mulcahy Mulcahy LLP Irvine, California Articles:  Ninth Circuit Dismisses Robinson-Patman and Sherman Act Claims, Stating: “We Must Return This Capitalist Rumble to The Forum Where it Belongs: The…

  • Jeffrey K. Shapiro

    Hyman, Phelps & McNamara, P.C.
    700 13th Street NW
    Suite 1200
    Washington, D.C. 20005, U.S.A.
  • Food and Drug Law


    Education • Brown University (magna cum laude) • Harvard Law School (cum laude) Affiliations • Editorial Advisory Board of MDDI and Update magazines • Frequent speaker at medical device and diagnostic seminars and conferences. Articles/Publications • Draft Guidance on Medical Device Recalls: Improvements Are Needed, July / August 2013 • New Paper Argues 510(k) Program Has Strengths That Critics Have Overlooked, April 22, 2013 • The US FDA and its Draft Guidance on Medical Device Appeals, April 2013 • Real-World Implications of United States v. Caronia, January 31, 2013 • US FDA should be required to provide 510(k)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 Recognition • DC Super Lawyers 2014, Food and Drug Practice Area • Who's Who Legal 2014: Life Sciences • LMG Life Science Star, FDA, Medical Devices, 2012-2014