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  • 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 Articles/Publications • Draft Guidance on Medical Device Recalls: Improvements Are Needed, July / August 2013 • New Paper Argues 510(k) Program Has Strengths That Critics Have Overlooked, April 22, 2013 • The US FDA and its Draft Guidance on Medical Device Appeals, April 2013 • Real-World Implications of United States v. Caronia, January 31, 2013 • US FDA should be required to provide 510(k)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