Regulation of Digital Health Products: An Introduction
A session from FDLI’s Introduction to Medical Device Law and Regulation
Recorded April 8, 2025
Regulation of Digital Health Products: An Introduction
Define the different forms of medical health technology and understand how digital health products are regulated. Recognize the related policies that resulted from 21st Century Cures. Learn what requirements apply to FDA regulated digital health products.
Claire Dennis, Associate, Arnold & Porter LLP
Mahnu Davar, Partner, Arnold & Porter LLP
This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in April 2025.
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MAHNU DAVAR is a partner in the Washington, D.C. office of Arnold & Porter. His practice focuses on assisting FDA-regulated entities with complex regulatory and compliance matters. He has represented early stage medical technology companies, clinical labs, major academic research institutions, and some of the largest multinational drug and device companies in the oncology, ophthalmology, pain, and diabetes care spaces. Mr. Davar routinely counsels clients on the regulatory and compliance aspects of promotional launch campaigns, clinical research, educational grants and charitable giving, manufacturing and supply chain, deal diligence, and other mission-critical activities. He has conducted significant compliance investigations and audits for business operations in the US, Europe, and Asia, and has extensive experience defending companies in criminal and civil healthcare fraud investigations. He has also assisted clients to prepare for and navigate state and federal regulatory inspections. Mr. Davar is a lecturer at the University of Pennsylvania Law School, a Fellow of the Salzburg Global Seminar, and a former Fulbright Scholar to India.
































































































