Suzanne Levy Friedman

Suzanne is a trusted advisor to companies navigating the complexities of medical device regulation by the U.S. Food and Drug Administration's (FDA).

Suzanne’s practice focuses on guiding clients in a wide range of activities across the life cycle of their products, including preparing regulatory submissions for new device clearance and approval, advising on the lawful promotion of devices and non-device software products, and evaluating post-market product modifications.  Before joining the firm, Suzanne spent over a decade in BigLaw helping medical device stakeholders anticipate, manage, and resolve regulatory risk and challenges.

Suzanne is highly adept at navigating the FDA's shifting landscape for software and digital health products, having advised clients through numerous shifts in the agency’s policies in this space. Known for her strategic insights and collaborative approach, she helps clients identify the appropriate regulatory pathway for their product and successfully bring them through FDA’s process and to market.  In addition, Suzanne assists clients with conducting internal investigations involving compliance matters under the Federal Food, Drug, and Cosmetic Act (FDCA), and executing on required remediation and/or training activities.

Practice Areas

Representative Matters

• Advised device companies on balancing FDA rules for device promotion with business needs in developing their websites and marketing materials.*
• Drafted legal arguments for premarket clearance/authorization of various innovative medical devices.*
• Prepared memoranda to justify companies’ legal positions that health-related software products do not constitute regulated devices.
• Conducted comprehensive internal investigation into whistleblower allegations of violations of several Food, Drug and Cosmetic Act requirements .*
• Advocated before FDA to obtain client's desired outcome to have its wound dressing classified solely as a medical device rather than a combination product.*
• Obtained a successful outcome in appealing an FDA determination on a client’s De Novo filing.
• Assisted an international client with drafting a PMA for its device and ensuring a successful pre-approval FDA inspection.*
• Represented a political dissident from the Democratic Republic of Congo in obtaining asylum and her green card, and then secured approval for her husband and daughter to join her in the U.S.*
• Served as guardian ad litem to advise the court on the best interests of two children whose parents were in custody disputes in DC Family Court.*

*matter handled prior to joining Honigman LLP

Prior Experience

• Hogan Lovells, Counsel
• Food and Drug Administration, Office of Chief Counsel, Legal Intern

Additional Languages

• French
• Spanish
• Hebrew

Education

Admissions

Press Releases