Maria Kalousi-Tatum advises clients on US Food and Drug Administration (FDA) approval, compliance, enforcement, and promotion matters related to medical devices and digital health technologies, including software as a medical device (SaMD), clinical decision support software, wearable devices, artificial intelligence systems, and mobile medical apps. She also counsels on US Drug Enforcement Administration (DEA) and state regulatory issues for controlled substances and medical products. Maria advises clients on FDA, Federal Trade Commission (FTC), and National Advertising Division (NAD) compliance and enforcement matters—as well as false advertising class action litigation—related to food and dietary supplements.
Prior to joining Morgan Lewis, Maria served as a clerk to Judge Nancy B. Firestone of the US Court of Federal Claims and the Office of Special Masters, where she worked on vaccine-related litigation. Maria previously interned at the Center for Science in the Public Interest and worked as translator for the European Commission and for multinational pharmaceutical and medical device companies. She speaks fluent French, Greek, and Spanish and has professional working proficiency in Catalan and Portuguese.
Member, Food & Drug Law Institute New to Food and Drug Law Planning Committee (2021)
Recipient, Thomas Bradbury Chetwood, S.J. Prize for the Most Distinguished Academic Record, Georgetown University Law Center