Thomas M. Sundlof

Tom Sundlof leverages more than two decades of government experience, including key leadership roles at the Food and Drug Administration (“FDA”), as well as legal roles at the U.S. House of Representatives, to provide clients with counsel on regulatory, compliance, and enforcement matters for medical devices, combination products, and other FDA-regulated industries. Tom previously served as Associate Chief Counsel and Assistant Deputy Chief Counsel (Acting) in the FDA’s Office of the Chief Counsel, where he advised on high-profile regulatory actions, enforcement, and policy development.

Tom draws on his government experience to help domestic and international clients successfully access the market by guiding them through the complex landscape of FDA regulations—from designing clinical trials and managing investigational uses to determining the right authorization pathways and crafting compelling applications. After securing market authorization, Tom advises clients on maintaining post-market compliance with evolving standards that affect everything from manufacturing processes to advertising practices. Leveraging his experience with federal agencies, Congress, and the White House, Tom also advocates for clients’ interests in regulatory and legislative matters, ensuring their voices are heard during rulemakings and policy development. Should clients face investigations or enforcement actions, Tom serves as a steadfast advocate, helping them minimize potential risks and navigate any resulting challenges with confidence.

During his tenure at the FDA, Tom advised on issues affecting a wide range of product categories. He led legal reviews of regulatory and enforcement actions, such as warning letters, enforcement of consent decrees, and recalls. He advised on complex premarket decisions such as premarket applications involving AI/machine learning technology, 510(k) withdrawals, and jurisdictional determinations of combination products via Requests for Designations. Tom also led legal review on rulemakings involving matters such as device classification and special controls, and guidances for emerging technologies. His work also includes navigating Environmental Protection Agency requirements to mitigate impacts on the medical device supply chain and working through complex regulatory frameworks for combination products.

Tom previously served as a litigator in the U.S. House of Representatives’ Office of General Counsel, where he gained extensive experience in litigation, appellate advocacy, and congressional investigations.

Since starting at Blank Rome, Tom has worked with a variety of companies in all spaces regulated by FDA, including food importers, dietary supplement manufacturers, clinical research organizations, veterinary medicine compounders, surgical implant designers, drug manufacturers, and AI powered medical device software developers. Tom has successfully steered companies through FDA investigations, inspections, and product recalls, and provides valued advice on premarket strategies. Tom is a frequent speaker on wearable health technology and AI device regulation, as well as issues impacting current good manufacturing practices.

• 2024, “Outstanding Service Award” for leadership and contributions to the mission of the Center for Tobacco Products by managing legal review of tobacco product standards, by Center for Tobacco Products, U.S. Food and Drug Administration
• 2024, “Director’s Special Citations (multiple)” for multidisciplinary collaboration and leadership in the development of the scientific and regulatory foundation of tobacco product standards, by Center for Tobacco Products, U.S. Food and Drug Administration
• 2020, “Outstanding Service Award” for legal services and dedication to FDA on significant and complex issues involving the regulation of tobacco products and cross-cutting issues, by U.S. Food and Drug Administration