Robert J. Klepinski  portrait

Robert J. Klepinski

Adjunct Faculty
Phone
651-962-5750
Mail
Mail OSS100
2115 Summit Ave.
St. Paul, MN 55105

Career:

Robert Klepinski is an Officer with Fredrikson & Byron and practices in the Food, Drug & Medical Device, Health Care Fraud & Compliance and Intellectual Property service areas.  Robert is also recognized as one of the leading FDA compliance attorneys.  Robert counsels pharmaceutical, medical device, biotech, food and nutritional supplement companies on FDA policy.  Robert was a regulatory attorney for Medtronic, Inc., the world's leading medical technology company specializing in implantable and invasive therapies.  While at Medtronic, he set the legal strategy for FDA compliance, including advertising and promotion, quality systems, regulatory and clinical. 

Robert 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, including Northwestern University, Hamline University and William Mitchell College of Law.  He is currently an adjunct professor at St. Thomas University in 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

 

Professional Activities

  •  Minnesota State Bar Association, Founder, Food and Drug Law Section
  •  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

 

Selected Publications and Presentations

  • "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
  • 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

 

Service Areas

  • Bioscience and Chemical Technology
  • Food, Drug & Medical Device (Device, Drug & Food Regulation)
  • Health Care Fraud & Compliance
  • Intellectual Property

 

Fall 2014 Courses

Fall 2014 Courses
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J-Term 2015 Courses

J-Term 2015 Courses
Course - Section Title Days Time Location

Spring 2015 Courses

Spring 2015 Courses
Course - Section Title Days Time Location