Insights on Evidence and Communication with FDA in Device Submissions – FDA Watch
Wayne chats with Mark DuVal, CEO of DuVal & Associate; Bryan Feldhaus, President of DuVal & Associates; and Chris Lyle, Vice President of Evidence Strategy at DuVal & Associates. You’ll hear their thoughts on what’s happening right now at FDA and in the medical device industry; whether companies should engage FDA early in the pre-submission process or make their case in the actual submission; common breakdowns in the submission process; the importance of real-world evidence and where companies can still fall short; holding FDA to a consistent standard after initial feedback; and much more.
Headlines
Pharma: FDA reports progress after first year of roadmap to reduce animal testing in drug development
Devices: CDRH issues letter to combination product manufacturers with information on potential nitrosamine impurities
Food: FDA issues warning letters to food companies following serious violations
Cosmetics: FDA releases Grand Rounds presentation recording featuring experts from Office of Cosmetics and Colors
Resource Links
Food: FDA and Stop Foodborne Illness jointly hosting food safety culture series, with next event May 14
Cosmetics: Shelly Garg breaks down FDA’s PFAS in cosmetics report
About Our Guests
Mark DuVal
Mark DuVal, J.D., is CEO of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries.
His practice includes providing strategic regulatory advice, developing compliance programs, designing and implementing sophisticated marketing programs, counseling on reimbursement matters, conducting sales training and interfacing extensively on behalf of companies with the FDA with relation to product approvals and clearances, clinical trial negotiations, approvals, policy arguments, appeals, etc.
Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems working both domestically and internationally.
He was on assignment for 3M Health Care Systems, Ltd. In Europe based out of the United Kingdom. He then worked at Medtronic in Corporate Compliance for FDA, Anti-kickback, False Claims Act, HIPAA & HITECH, and other advice related to the FDA-regulated industry.
Mark earned his Juris Doctor from the William Mitchell College of Law where he served as executive editor on the law review, and his Bachelor of Arts in Public Administration from St. Cloud State University. Mark has served on various boards including the Minnesota BioBusiness Alliance, Minnesota Biosciences Council, The Food and Drug Law Institute and has been a former Chairman of the Minnesota State 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 Services program at St. Cloud State University.
Mark is a frequent national speaker and writer on issues relating to product approvals/clearances; combination products, product advertising and promotion, Anti-kickback and False Claims Act (reimbursement) matters.
Bryan Feldhaus
Bryan specializes in advising medical device, pharmaceutical and nutritional supplement companies on FDA law, regulations and guidance. His practice includes providing legal/regulatory advice in designing and implementing sophisticated marketing programs (considering FDA’s advertising and promotional regulations, the Anti-kickback Statute, False Claims Act and the Physician Payments Sunshine Act), conducting sales training, and interfacing extensively on behalf of companies with the FDA on promotional, inspectional and other enforcement matters. He also provides strategic advice and advocacy regarding clinical trials and regulatory submissions. Additionally, Bryan counsels companies on compliance matters, conducts compliance assessments, collaborates with clients to develop compliance programs, and provides compliance training to ensure clients understand and achieve their compliance goals in the context of their business objectives. Finally, Bryan advises medtech companies regarding their HIPAA and GDPR obligations as it relates to their relationship to patient data.
Prior to joining DuVal & Associates, Bryan enjoyed a fourteen-year career as a trial and litigation shareholder at a Minneapolis law firm. As a former litigation attorney, Bryan is experienced in trial and appellate matters, is admitted to practice in state and federal courts, and is experienced in commercial litigation and intellectual property matters, including patent and trademark litigation.
Bryan is a 2006 graduate from the University of St. Thomas School of Law. He obtained an LL.M. degree in Corporate Compliance and Organizational Ethics from the University of St. Thomas School of Law. He also obtained a Cybersecurity and Privacy Law Certificate from Mitchell Hamline School of Law in 2019.
Bryan has been recognized as an Up & Coming Attorney by Minnesota Lawyer, as a Rising Star by Minnesota Super Lawyers and is recognized in The Best Lawyers in America© for his work in the practice area of Litigation – Intellectual Property. Bryan also annually co-hosts a corporate compliance conference sponsored by Minnesota CLE. Finally, Bryan has served as a volunteer in the Federal Bar Associate Pro Se Project, was previously appointed to the City of Rosemount Parks and Recreation Department and has served as an Officer and Director on the University of St. Thomas School of Law Alumni Board, including as the Alumni Board President. He currently serves as a Director on the Rosemont Area Hockey Association Board of Directors.
Chris Lyle
Chris focuses his consulting practice on the intersection of clinical evidence, regulatory requirements, and payer coverage policies to support product approval requirements and demonstrate value to payers and providers. A biostatistician by training, Chris has successfully negotiated study designs with FDA and several OUS regulatory agencies.
Chris has over 25 years of experience in the medical device industry and has supported the development of medical devices, biologics, and pharmaceuticals. Prior to joining DuVal & Associates, Chris was a Partner at the JD Lymon Group, a Minneapolis-based reimbursement and market access consulting firm, where he focused on evidence development initiatives to support positive coverage arguments. He spent the prior 12 years at RCRI, a Minneapolis-based device CRO, where he held various executive positions including roles overseeing corporate operations, biostatistics, and market access. Before that Chris was a biostatistician at 3M Company working with 3M Pharmaceuticals and multiple medical device divisions.
Chris holds a B.A. in Mathematics from St. Olaf College, and an M.S. in Applied Statistics from Florida State University. He speaks routinely on evidence strategies and clinical study design to support pre- and post-approval requirements and has served on the community faculty of both Metropolitan State University and the St. Cloud State University Masters of Regulatory Affairs program. He is also a co-founder and Board member of JDL Access, LLC, a prior authorization and patient appeals firm based in Minneapolis.
FDA Watch Podcast 