Global clients in the medical device sector call on Suzanne Levy Friedman to help them navigate key legal and business issues. Suzanne's practice focuses primarily on matters related to the U.S. Food and Drug Administration's (FDA) regulation of medical devices.

Suzanne assists device companies in a wide range of activities across the life cycle of their products, including preparing regulatory submissions for clearance or approval of new devices, advising manufacturers on the lawful promotion and advertising of their devices, and addressing postmarket enforcement issues. 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 various products in this space and bring them to market. She also conducts regulatory due diligence in preparation for mergers and acquisitions.

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 FDA space to her work at the firm. During law school, she interned for FDA's Office of Chief Counsel, where she learned firsthand about the range of legal and regulatory issues addressed by the agency's Food, Drug, Device, Veterinary, and Tobacco centers. 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.