Hogan Lovells 2024 Election Impact and Congressional Outlook Report
Evelyn Tsisin
Associate Global Regulatory
Whether emerging start-ups or key industry players, Evelyn effectively collaborates with clients to develop regulatory strategies that get their cutting-edge medical technologies on the market and help them stay on the market.
Evelyn focuses on advising on a broad range of Food and Drug Administration (FDA) programs and regulations. Evelyn has experience drafting and filing 510(k) premarket notifications, De Novo requests, premarket approval applications (PMAs), investigational device exemptions (IDE), as well as attending pre-submission discussion meetings among clients and representatives of FDA.
Evelyn’s experience extends to addressing advertising and promotion issues related to medical devices, ensuring compliance with relevant regulations while also fostering innovative marketing strategies.
Evelyn has been with Hogan Lovells since 2018, first as a paralegal then summer associate and Leadership Council on Legal Diversity (LCLD) scholar all the while building practical insights as a member of the FDA Medical Device and Technology practice group.
Prior to rejoining the firm as an associate in 2024, Evelyn earned a dual J.D./Masters in Bioethics from University of Pennsylvania Carey Law School and University of Pennsylvania Perelman School of Medicine. At Penn, Evelyn was both on the Journal of Law and Social Change and a Board Member and Contributor to The Regulatory Review, where she published on healthcare regulation, policy, and equity issues.
Evelyn focused her pro bono efforts on research and advocacy as a member of the Health Law and Policy Project and as an instructor for the Youth Education Program, teaching local Philadelphia high school students about Constitutional law and legal writing in preparation for a yearly moot court competition.