Maria Kalousi-Tatum focuses her practice primarily on US Food and Drug Administration (FDA) approval, compliance, enforcement, and promotion matters related to medical devices and digital health technologies, such as software as a medical device (SaMD), clinical decision support software, wearable devices, artificial intelligence systems, and mobile medical apps. She also assists clients with approval, regulation, and promotion of drugs, dietary supplements, and conventional foods.
Prior to joining Morgan Lewis, Maria served as a clerk to Judge Nancy B. Firestone at the US Court of Federal Claims in Washington, DC, and the Office of Special Masters, where she worked on vaccine-related litigation. Maria has previously interned at the Center for Science in the Public Interest and has worked for the European Commission. She speaks fluent French, Greek, and Spanish and has a professional working proficiency in Portuguese and Catalan.
Georgetown University Law Center, 2018, LL.M., Environmental & Energy Law, with Distinction, Dean’s List