SUZAN ONEL  is a partner at the Washington, D.C. law firm, Kleinfeld, Kaplan & Becker, LLP (KKB) and a recognized expert in FDA law. Ms. Onel has advised medical device, pharmaceutical, food, supplement, and cosmetic clients on FDA-related legal and regulatory issues since 1990. She has extensive experience counseling international and domestic manufacturers, distributors, and researchers on market entry strategies, premarket submissions (510(k)s, PMAs, IDEs, De Novo submissions), labeling and promotional activities, regulatory compliance, adverse event reporting, recalls and field corrections, and enforcement defense. Ms. Onel also advises on the development of corporate compliance programs and regulatory strategy. Her transactional work includes conducting regulatory due diligence for life science companies and investors, drafting supplier contracts and clinical research agreements, and conducting executive training sessions. Prior to joining KKB in 2016, Ms. Onel was Chair of the FDA Practice at a global law firm. She is a frequent and sought-after author and lecturer on FDA-related topics and was recently invited by the US State Department to be the keynote speaker at a government-sponsored conference in Honduras focused on trade facilitation and best practices to improve entry of food, drugs, and medical devices in Central America. Ms. Onel is a member of numerous professional organizations and is past Chair of the Medical Device Committee of FDLI; past co-Chair of the editorial board of FDLI’s Update Magazine; and past Chair of the ABA’s Food, Cosmetics and Nutraceuticals Committee within the Section of Science & Technology Law. She received her law degree from the University of Virginia School of Law, where she was an editor of the Virginia Environmental Law Journal, and she received her BA with honors from the University of Pennsylvania with a double major in Biological Basis of Behavior (neurobiology track) and European intellectual history.