Suzanne Levy Friedman

Suzanne assists device companies in a wide range of activities across the life cycle of their products, including preparing regulatory submissions for clearance/approval of new devices, advising manufacturers on the lawful promotion and advertising of their devices, and evaluating post-market product modifications. Suzanne is well-versed regarding FDA's evolving paradigm for software and digital health products, and she has helped clients determine the appropriate regulatory pathway for, and bring to market, various products in this space. She also works with clients on internal investigations into promotional, quality system, or other issues related to compliance with the Federal Food, Drug, and Cosmetic Act.

Suzanne frequently works on human tissue and combination products that combine a medical device element with a drug or a biologic. In conjunction, she helps advise clients on regenerative medicine and cell/gene therapies, which often raise questions that touch on multiple areas of FDA regulation.

Suzanne brings significant experience in the FDA space to her work at the firm. During law school, she interned for FDA's Office of Chief Counsel. Prior to law school, Suzanne spent two years with a health policy consulting firm in Washington, D.C., advising clients on the business impacts of FDA actions and related legislation. Suzanne also has a master's degree in bioethics.

In law school, Suzanne co-led Penn Law's health law and policy pro bono group, and she remains actively involved in pro bono service at Hogan Lovells.