Mark DuVal, JD


DuVal & Associates


Mark DuVal, JD, is President of DuVal & Associates, P.A. He works with extensively with FDA on behalf of companies on 510(k)s, de novos, PMAs and combination products, IDE negotiations, Pre-Submission meetings, inspections, warning letters, appeals, etc. His practice includes providing strategic regulatory advice for premarket submissions, designing and implementing sophisticated marketing programs (involving advertising and promotion under the FDCA, Anti-kickback, False Claims Act), counseling on reimbursement matters, developing compliance programs, interfacing with FDA inspectors and the Center, conducting sales training and interfacing extensively on behalf of companies with the FDA. Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and 3M Drug Delivery Systems and several 3M medical device divisions for almost 15 years, working both domestically and internationally. He was on assignment for almost one year with 3M Health Care Systems, Ltd. in Europe based out of the United Kingdom. He then worked at Medtronic in Corporate Compliance providing FDA, Anti-kickback, False Claims Act, HIPAA, and other advice related to the FDA-regulated industry. Mark co-founded the Minnesota Medical Device Alliance (MMDA) and has served on various boards including the Minnesota BioBusiness Alliance, Minnesota Biosciences Council (appointed by Governor Tim Pawlenty), and The Food and Drug Law Institute (FDLI) and was Chair of the Food, Drug and Medical Device Section of the Minnesota State Bar Association. He is also on the Board of Advisors of the Masters in Regulatory Affairs and Sciences program at St. Cloud State University.