Bio Filter Option
Morgan Lewis
Maria Kalousi-Tatum

Maria Kalousi-Tatum

Associate

Washington, DC Phone +1.202.739.5140 Fax +1.202.373.3001

1111 Pennsylvania Ave. NW//Washington, DC 20004-2541//United States

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.

Awards and Affiliations

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

Admissions

  • District of Columbia
  • New York

Clerkships

  • Clerkship to Office of Special Masters of the US Court of Federal Claims (2018 - 2019)
  • Clerkship to Judge Nancy B. Firestone of the US Court of Federal Claims (2017 - 2018)

Education

  • Georgetown University Law Center, 2018, LL.M., Environmental & Energy Law, with Distinction, Dean’s List
  • Tulane University Law School, 2017, J.D.
  • Heriot-Watt University, Scotland, 2008, M.S., Translation & Conference Interpreting, with Overall Distinction
  • University of Glasgow, Scotland, 2006, M.A. (Hons), French & Hispanic Studies, Upper Second Class, Distinction in Spoken Spanish

Sectors

Services

Regions

Events

3/10/2021 - Impact of the Change in Administration on FDA’s Regulation of Devices and Digital Health

News

6/24/2021 - Purple Book Changes May Not Go Far Enough, Generics Bulletin
11/25/2020 - Getting Employees to Take a Vaccine, EHS Today

Publications

9/29/2022 - Eat Your Greens: FDA Proposes New Definition for ‘Healthy’ Packaged Food Claims
4/26/2022 - FDA Outlines Evaluation Approach to Non-Major Food Allergens in Draft Guidance
2/24/2022 - FDA Issues Long-Awaited Quality System Regulation Amendments
2/16/2022 - Dr. Robert Califf Confirmed to Fill FDA Commissioner Position
1/18/2022 - FDA Proposes Framework for Transitioning COVID-Related Medical Devices from EUA/Enforcement Discretion to Permanent Marketing Authorization
10/27/2021 - FDA’s Long-Awaited De Novo Classification Rule Is Finally Here
10/26/2021 - New US Department of Agriculture Initiative to Combat Salmonella in Poultry
10/11/2021 - FDA Signs Domestic Mutual Reliance Agreements with Four States to Protect Food Supply
9/14/2021 - Food Labeling Modernization Act Reintroduced in Congress
7/12/2021 - Patent Transparency for Biologics & Biosimilars: The Revamped Purple Book, BioProcess Online
6/22/2021 - USDA’s Proposal to Take Back Regulatory Oversight of GM Animals from FDA Remains Viable Despite Change in Administration
5/21/2021 - FDA’s Latest Initiatives Seek Input from Industry to Develop Food Traceability Tools
5/18/2021 - Revamped Purple Book Offers Greater Patent Transparency for Biologics
5/10/2021 - Sesame Becomes Newest Major Food Allergen
4/23/2021 - UPDATE: Trump Administration’s Midnight Rulemaking to Exempt Certain Class I and II Devices from 510(k) Requirement Rescinded
2/5/2021 - Biden Administration Halts Proposal to Exempt Some Class II Devices Currently Subject to Enforcement Discretion from 510(k) Requirement
2/3/2021 - FDA Issues More Guidance on Gene and Cell Therapy Products
1/12/2021 - Tele-Tuesday: Digital Health and the Incoming Biden Administration
1/7/2021 - How a Biden Administration Will Affect FDA’s Regulation of Medical Devices and Digital Health
12/30/2020 - LawFlash: FDA’s End-Of-Year Gifts: COVID-19 Diagnostic Tests and Collection Devices for Home Use
12/29/2020 - FDA’s End-of-Year Gifts: COVID-19 Diagnostic Tests and Collection Devices for Home Use
November 09, 2020 (Updated December 16, 2020) - COVID-19 Vaccines: Considerations for US Employers
9/15/2020 - LawFlash: HHS Limits FDA Oversight of LDTs Without Formal Rulemaking, Including During COVID-19 Pandemic
8/28/2020 - HHS Limits FDA Oversight of LDTs Without Formal Rulemaking, Including During COVID-19 Pandemic
8/18/2020 - Federal Agency Cooperation in Protecting the Domestic Food Supply Chain, Food Safety Magazine
7/27/2020 - We’re Not in Kansas Anymore – Harvard Law School Petitions FSIS on Cell-Based Meat and Poultry Labeling
June/July 2020 - Will FSIS Declare 31 Salmonella Serovars Adulterants in Meat and Poultry? Food Safety Magazine
5/21/2020 - FDA and USDA Clarify Cooperation in Protecting Domestic Food Supply Chain
4/7/2020 - Petition Asks FSIS to Declare 31 Salmonella Strains as Adulterants in Meat and Poultry, Food Safety Magazine
3/12/2020 - FDA Launches eSTAR Pilot Program to Further Simplify Medical Device 510(k) Submissions
1/23/2020 - Petition Asks FSIS to Declare 31 Salmonella Strains as Adulterants
1/16/2020 - Disclosure of WGS Data: What Might Inform and What Might Mislead
11/6/2019 - FDA Issues Final Rule on Calorie Labeling for Food Sold from Glass-Front Vending Machines