Ralph Hall has extensive experience in the areas of FDA, health care and corporate compliance, including the application of those regulatory systems to the medical device industry. He has expertise in the design and implementation of regulatory compliance programs and with FDA enforcement actions. Ralph also has experience in managing licensing matters and general corporate counseling.

Prior to rejoining FaegreBD Consulting, Ralph was with Guidant Corporation where he served as Senior Vice President and Deputy General Counsel – Litigation and Compliance. Also at Guidant, he was Special Counsel to the Board of Director's Compliance Committee and to the corporation's Compliance Office. Earlier, Ralph was General Counsel of Guidant's Cardiac Rhythm Management Group. Before joining Guidant, Ralph was with Eli Lilly and Company where he served in a number of legal roles, including chief environmental counsel.

Ralph also serves as a Professor of Practice at the University of Minnesota Law School where he teaches courses in FDA law, corporate compliance, negotiation and alternative dispute resolution. Ralph has spoken frequently at legal seminars on a variety of subjects.

Board Memberships

• Food and Drug Law Institute — National Board of Directors
• Cardiac Rhythm Management Research Foundation — Treasurer
• MR3 Medical, LLC — CEO

Faculty Positions

• University of Minnesota Law School — Professor of Practice, 2004-present, and Adjunct Professor, 2000-03
• Indiana University Robert H. McKinney School of Law, Indianapolis — Adjunct Professor, 1988-92, and Visiting Professor, 2009-present

Congressional Testimony

• House Energy and Commerce Committee — Subcommittee on Health, February 2012
• Senate Health, Education, Labor and Pension Committee — November 2011
• Senate Special Committee on Aging — April 2011
• House Energy and Commerce Committee — Subcommittee on Health, February 2011

Professional Associations

• American Bar Association
• Nanotechnology Consortium — Working group of consortium studying regulatory oversight models for nanotechnology in life sciences, environment, FDA, workplace exposure, agriculture and other areas pursuant to a National Science Foundation Grant
• Institute for Engineering in Medicine (IEM) — Interdisciplinary research organization strengthening collaborative efforts between the disciplines of engineering and biomedicine at the University of Minnesota and fostering collaborations with the medical device industry

Presentations

• Doing Business in Med Tech: FDA and CDRH in 2014
  BioBusiness Alliance of Minnesota, Minneapolis, February 2014
• Top Cases of 2012 and 2013: The Changing Legal Environment
  Panelist, Food and Drug Law Institute (FDLI) Advertising & Promotion Conference, Washington, D.C., September 2013
• The Sunshine Act Final Rule
  LifeScience Alley, Minneapolis, March 2013
• Update and Key Issues Involving 510(k) Reform Efforts
  Panelist, Food and Drug Law Institute (FDLI) Annual Conference, Washington, D.C., April 2011
• Improving the 510(k) Process: Lessons Learned From Recent Benchmarking Studies
  Panelist, OneMed Forum, San Francisco, January 2011
• 510(k) Under Assault
  Indiana University Emerging Technologies Center, Indianapolis, June 2010
• 510(k) Under Assault
  Co-presenter with Vincent Ventimiglia, LifeScience Alley, Washington, D.C., May 2010
• Ethical and Legal Issues in Nanotechnology
  Co-presenter, University of Notre Dame Symposium, March 2010
• Reducing Risk of Major Government Enforcement
  Co-presenter with Erin Reilly Lewis, ePharmaceuticals Webinar, August 2008
• Nanotechnology Law, Regulation & Policy Conference
  Co-chair, Food and Drug Law Institute, Washington, D.C., February 2008
• National Conference on Managing Legal Risks in Structuring & Conducting Clinical Trials
  Presenter, American Conference Institute, New York City, February 2008
• Understanding U.S. FDA Law
  Chinese FDA Delegation, University of Minnesota, November 2007
• Case Study: Incidental Findings in Clinical Trials Research — Legal Regulatory and Ethical Concerns
  National Conference on Managing Legal Risks in Structuring and Conducting Clinical Trials, Boston, September 2007
• The Three Faces of Post Market Surveillance
  Life Science Alley Trade Association, St. Louis Park, Minnesota, June 2007

Published Articles

• Bringing Your Pharmaceutical Drug to Market
  Co-publisher, FDLI, May 2015
• The New Regulator? The Rise of IMDRF
  BioFutures, official magazine of the Indiana Health Industry Forum and Indiana Medical Device Manufacturers Council, March 2014
• CDRH in 2014: Five Things to Watch
  Indiana Medical Device Manufacturers Council Update, 2014
• A Failure to Comply: An Initial Assessment of Gaps in IOM's Medical Device Study Committee
  Co-author with Eva Stensvad, Minnesota Journal of Law, Science & Technology, Vol. 12, Issue 2, 2011
• Matrixx Catches a Cold: Linking FDA and SEC Obligations
  Co-author with David Worrell, Financial Fraud Law Report, Vol. 3, Issue 6, June 2011
• Two Tracks, One Train? CMS and FDA Cooperation
  Co-author with Vincent Ventimiglia and Elizabeth Spurgin, Law360, Portfolio Media, Inc., Sept. 23, 2010
• When You Have a Hammer Everything Looks Like a Nail: Misapplication of the False Claims Act to Off-Label Promotion
  Co-author with Robert J. Berlin, Food and Drug Law Journal, Vol. 61, No. 4
• Inconsistent Government Policies: Why FDA Off-Label Regulation Cannot Survive First Amendment Review Under Greater New Orleans
  Co-author with Elizabeth S. Sobotka, Food and Drug Law Journal, Volume 62, No. 1
• Nanotechnology and FDA — Regulated Products: The Essential Guide
  Author of two chapters (Book published by Food and Drug Law Institute), 2009
• FDA Enforcement Heating Up
  Co-author with Erin Reilly Lewis, Law360, Nov. 20, 2009
• Punishing Corporate Crime: Legal Penalties for Criminal and Regulatory Violations
  Co-author with James T. O'Reilly, James Patrick Hanlon, Steven L. Jackson and Erin Reilly Lewis, Oxford University Press, August 2009
• Rethinking How to Respond to Government Investigations
  Co-author with J.P. Hanlon and Erin Reilly Lewis, Update Magazine, Food and Drug Law Institute, Issue 6, November/December 2008
• Developing Oversight Frameworks for Nanotechnology
  Co-author, Minnesota Journal of Law, Science and Technology, Volume 9, Issue 1, Winter 2008
• Does the Constitution Provide a Right of Access to Experimental Drugs?
  Journal of Nursing Law, Volume 11, No. 1
• Weaning FDA, Congress and Industry From Users Fees
  Co-author with Robert J. Berlin, Update Magazine, Food and Drug Law Institute, 2007
• The Next Enforcement Target: Your Company's Compliance Office
  Update Magazine, Food and Drug Law Institute, 2006
• Access to Experimental Drugs: A New Constitutional Right?
  Co-author with Colleen M. Roberts, Update Magazine, Food and Drug Law Institute, 2006