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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.&nbsp;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. Even 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 protections requirements to mitigate impacts on the medical device supply chain and working through complex regulatory frameworks for combination products.In addition to his work with medical products, Tom has significant experience in tobacco-related regulatory matters. He has led teams in developing legal strategy for product standards and manufacturing regulations, contributed to litigation involving FDA’s premarket authorities, and developed enforcement strategies targeting youth-marketed e-cigarettes. He also represented the FDA in administrative hearings and supported complex premarket decisions, including heat-not-burn and modified risk tobacco product authorizations.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.

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Healthcare – Public Policy, Government Contracts Counseling & Compliance

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From Wearables to Supplements

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Thomas M. Sundlof

Thomas M. Sundlof

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