Introduction

Robert Klepinski is an Officer with Fredrikson & Byron and practices in the Food, Drug & Medical Device Regulation, Health Care Fraud & Compliance and Intellectual Property Groups. Bob is also recognized as one of the leading FDA compliance attorneys. He counsels pharmaceutical, medical device, biotech, food and nutritional supplement companies on FDA policy. 

Bob retired from Medtronic, Inc., the world’s leading medical technology company. He served as general counsel for several of the Medtronic businesses, including Cardiac Rhythm Technology and Cardiac Surgery. While at Medtronic, he set the legal strategy for FDA compliance, including advertising and promotion, quality systems, regulatory and clinical. 

Bob frequently speaks at both local and national trade associations on FDA policy. He has been an adjunct professor at the University of Minnesota Law School and a guest lecturer at other law schools. He is currently an adjunct professor at St. Thomas University in the Masters in Regulatory program at its Graduate School of Engineering and its mini MBA program. 

Education

• William Mitchell College of Law, J.D., 1980, cum laude
• University of Minnesota, B.A., Mathematics, English

Bar Admissions

• Minnesota, 1980
• United States Patent Office

Practice Areas

• Bioscience and Chemical Technology
• Food, Drug & Medical Device Regulation
• Health Care Fraud & Compliance
• Intellectual Property
• Life Sciences
• Commercial Law

Selected Publications & Presentations

• “New MDDS Rules and Their Impact on Electronic Medical Records,” Health Law Webinar, February 8, 2012
• “Collecting Post-Market Device Data Without Running Afoul of FDA,” FX Conferences, January 19, 2012
• “Interpreting ‘Chemical Action’ – Can the Proposed FDA Guidelines Be Interpreted to Avoid Having Some Medical Devices Designated as Drugs?,” Regulatory Affairs SIG, January 18, 2012
• Quoted in Shawn M. Schmitt article, “GAO:  FDA Slow to Terminate Recalls; Is CDRH ‘Recall Project’ the Answer?” The Silver Sheet, July 2011
• “The Art and Science of Managing Serious Clinical Study Issues,” Association of Clinical Research Professionals, June 2011
• “Off Label Enforcement,” LifeScience Alley Ad Enforcement Program, June 2011
• “Promotion and Advertising,” The Food and Drug Institute, Introduction to Medical Device Law and Regulation: How the Government Regulates the Medical Device Industry, November 2010
• “Individuals Face Greater Risks in FDA Cases,” co-authored with Dulce Foster, FredALERT: Life Sciences, November 19, 2010
• Quoted in “Medical Device Industry Sounding Alarm,” Finance & Commerce, November 2, 2010
• “Medical Device Supply Relationships,” MichBio Expo & Conference, October 2010
• “New FDA Enforcement Activity: Hospital reporting of medical device events now resulting in Warning Letters,” Fredrikson & Byron Health Law Webinar Series, August 11, 2010
• “Off-label Marketing: Why hospitals and physicians should care about the FDA laws you thought were just for manufacturers,” Health Law Webinar, October 14, 2009
• “If a Movie Star Recommends it, it Must be Good, Right?,” co-authored with Ann Ladd, Update Magazine, Issue 5, September/October 2009 (with permission from FDLI)
• “FDA Medical Device Requirements,” Chapter in McGraw-Hill Engineering Handbook, 2009
• “Privacy Basics: A Quick HIPAA Check for Medical Device Companies,” MD&DI, August 2009
• Quoted in “Harbingers of Change for Med-Tech Industry,” Minneapolis/St. Paul Business Journal, July, 2009
• “FDA Releases Draft Guidance on Risk Information in Advertising,” FredALERT: Life Sciences, May 29, 2009
• “Negotiating Clinical Trials with For-Profit Companies,” and “FDA Regulatory Process,” Society of Research Administrators International (SRA) 2009 Midwest Section Meeting, Sioux Falls, South Dakota, May 5, 2009
• “Off-Label Use of Medical Devices in the USA,” Journal of Medical Device Regulation, May 2009
• Quoted in “FDA nearly doubles local staff, ready for regulation changes,” Minneapolis/St. Paul Business Journal, March 6, 2009
• “Combination Product Regulation - Now What?” and “The Changing World of Premarket Review,” LifeScience Alley Conference & Expo, December 10, 2008
• Quoted in The Gray Sheet article, “Endotec Case Sheds Light, But Not Enough, on Custom Devices, Says Attorney,” September 1, 2008
• Quoted in “Regulation of Investigational Medical Devices: Benefits and Obstacles,” Annals of Health Law Advance Directive, Vol. 18, , pgs. 29-37, Fall 2008
• “Good Reprint Practices: What the FDA Says Now,” ForeignExchange Translations, Inc. Teleconference, June 26, 2008
• “Clinical Agreements Why Do We Do Them?,” LifeScience Alley, Minneapolis, Minnesota, June 18, 2008
• “Fraud and Abuse Law - Have we Reached an Era of Self-Compliance?,” Regulatory Affairs Professional Society’s 2008 Advertising, Promotion & Labeling Conference, Baltimore, Maryland, May 12-13, 2008
• “Exploring the Medical Products and Devices Scenario” (Panel Discussion), Minnesota State Bar Association’s Advanced Trademark Law 2008: Trademarks in the Life Sciences, Minneapolis, Minnesota, March 6, 2008
• “Adapting to FDA Requirement Changes and Keeping Innovation Alive,” LifeScience Alley New Technology Showcase, St. Paul, Minnesota, December 6, 2007
• “Access to Clinical Devices through Nontraditional Routes,” Food And Drug Law Journal, Vol. 62, No. 4, 2007
• “The Effect of Fraud-and-Abuse Law on False Claims Act Prosecutions on Regulatory/Clinical Teams,” Regulatory Affairs in Medical Device Clinical Research Conference, Phoenix, Arizona, November 12-13, 2007
• “Getting the Word Out: What you can Say Publicly about your Trial,” LifeScience Alley Clinical SIG Seminar, Minneapolis, Minnesota, October 17, 2007
• “The Effect of Supreme Court Cases on Device Advertising,” ForeignExchange Translations, Inc. Teleconference, August 23, 2007
• “Best Practices for Managing Clinical Trial Contracts,” 2nd Annual Medical Device Clinical Trials Conference, Chicago, Illinois, July 23, 2007
• Speaker, RAPs Advertising, Promotion & Labeling Conference, Regulatory Affairs Professional Society, Minneapolis, Minnesota, May 10-11, 2007
• Quoted in MD&DI article, “Off-Label Promotion: The Game Is Up,” April 2007
• “Corrections and Removals: Recalls and Reporting to the FDA,” Reed Life Sciences PharmaMedDevice 2007 Conference, New York, New York, April 24-26, 2007
• “Lessons Learned from the Mistakes of Others” (Panel Discussion), The Second Annual Medical Device Regulatory, Reimbursement and Compliance Congress, Harvard University, Cambridge, Massachusetts, March 28-30, 2007
• “Clinical Trials Contracting,” Health Law Webinar Series, March 14, 2007
• “Post-Market Activity,” LifeScience Alley - Device Regulation 101, March 14, 2007
• “Indications: The Next Battleground in FDA Advertising Enforcement,” ForeignExchange Translations, Inc. Teleconference, January 18, 2007
• Quoted in MD&DI article, “Using FDA’s Guidelines Can Help Avoid Problems With Promotions,” January 2007
• “FDA Regulatory Matters,” St. Thomas University Mini MBA (4 times per year), St. Paul, Minnesota, 2006 and ongoing
• “Best Practices for Managing Clinical Trial Contracts,” 5th Annual LifeScience Alley Conference and Expo, St. Paul, Minnesota, December 6, 2006
• Quoted in The Gray Sheet article, “Endotec To Countersue FDA In Response To Injunction Attempt,” October 16, 2006
• Quoted in Clinical Trials Advisor article, “Device Trial Sponsors Must Be Careful In Wording Trial Agreements,” September 21, 2006
• “Developing a Legally Defensible Ad Campaign,” MD&M Minneapolis 2006 Conference, October 24-26, 2006
• “The Post-Market Transformation Initiative,” SMI's Medical Devices - Regulations, Clinical Evaluations & Post-Market Surveillance, October 23-24, 2006
• “Advertising and Promotion Regulations in Medical Devices,” Regulatory Affairs Professional Society (RAPS) 2006 Annual Conference, Baltimore, MD, October 15-18, 2006
• “Enforcement Update for DTC Medical Device Advertising,” Center for Business Intelligence (CBI) 3rd Annual Summit on DTC Strategies for Medical Devices, September 25-26, 2006
• “Legal Issues in Clinical Contracting,” MN Chapter of The Association of Clinical Research Professionals & Food & Drug Admin. FDA Clinical Trial Requirements, August 23-24, 2006
• “Device Design in Today's Environment,” ForeignExchange Translations, Inc., June 15, 2006
• “Old Customs, Ancient Lore: The Development of Custom Device Law Through Neglect,” Food and Drug Law Journal, Volume 61:2, June 2006 (with permission from FDLI)
• Quoted in MD&DI article, “Advertising SOPs Help Avoid Off-Label Troubles,” June 2006
• “FDA Control of Import and Export,” Regulatory Affairs Professional Society (RAPS) Ins & Outs of Import/Export, May 18, 2006
• Quoted in The Gray Sheet article, "FDA Official Separates Scientific Exchange From Off-Label Promotion," April 10, 2006
• “FDA Regulatory Matters,” St. Thomas University Mini MBA (4 times per year), 2006 and ongoing
• “Designing Devices in Today’s Regulatory Environment,” IP/Regulatory Affairs Session of the 2006 Design of Medical Devices Conference, University of Minnesota, April 20, 2006
• “Setting Promotional Strategy and Tactics After the Rebirth of the First Amendment,” Harvard University’s Medical Device Regulatory and Compliance Congress, March 2006
• “Stating Your Claim,” BioMedical Focus, March 20, 2006
• “Mock Trial,” co-presented with John Lundquist, BioMedical Focus, March 20, 2006
• “Device 101,” Medical Alley, March 8, 2006
• “Managing and Monitoring Adverse Events During Clinical Trials,” The Institute of Medical Technology’s Clinical Compliance and Good Clinical Practices for Medical Device and Diagnostic Manufacturers Seminar, November 15, 2005
• “MDUFMA and What it Means in 2005,” Regulatory Affairs Professional Society’s (RAPS) 2005 Annual Conference, October 2005

Professional Activities

• Minnesota State Bar Association, Founder, Food and Drug Law Section, and Section Council Member
• University of St. Thomas Adjunct Professor
• LifeScience Alley, Co-Chair, Regulatory Special Interest Group
• Regulatory Affairs Professional Society
• Food and Drug Law Institute, Editorial Board

Community Involvement

• AFDO Endowment Foundation, Board Member
• BioBusiness Alliance of Minnesota, Board of Directors