Suzanne Levy Friedman

Suzanne Levy Friedman

Associate, Washington, D.C.

Email suzanne.friedman@​hoganlovells.com

Phone +1 202 637 5532

Fax +1 202 637 5910

LanguagesFrench, Spanish, Hebrew

Practice groupRegulatory

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 post-market enforcement issues. Suzanne is well-versed regarding the 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 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 the FDA space to her work at Hogan Lovells. During law school, she interned for the 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.

Education and admissions

Education

J.D., University of Pennsylvania Law School, 2014

M. Bioethics, University of Pennsylvania School of Medicine, 2014

B.A., Princeton University, cum laude, 2008

Bar admissions and qualifications

District of Columbia

New York

Representative experience

Advised companies selling various types of medical devices (aesthetics, wound care, etc.) on conforming their websites and other marketing materials to regulations on device promotion.

Drafted legal arguments for clearance of various innovative medical devices.

Conducted comprehensive audit of device and manufacturing process modifications for PMA-approved device and helped client properly notify FDA and obtain approval for same.

Advocated to obtain client's desired outcome to have its wound dressing classified solely as a medical device rather than a combination product.

Helped a woman (political dissident) from the Democratic Republic of Congo obtain asylum in the United States.

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