Ariel Z. Seeley
Ariel Seeley focuses her practice on US Food and Drug Administration (FDA) regulatory compliance for medical devices, digital health technologies, foods, and dietary supplements. She draws on more than 14 years of experience at the FDA—including key roles at the Center for Devices and Radiological Health (CDRH) and the Office of Chief Counsel (OCC)—to guide clients through the agency's internal processes. Ariel helps clients navigate the complex maze of FDA’s regulatory and legal requirements throughout the total product life cycle—from premarket development and authorization through postmarket compliance and inspections.
While at FDA, Ariel was at the forefront of shaping FDA policy for the digital health revolution. She was instrumental in developing regulatory policies, frameworks, and guidance for artificial intelligence (AI), software as a medical device (SaMD), wearables, and other digital health technologies. She played an instrumental role in the development of pivotal guidance documents—including those for cybersecurity, clinical decision support software, general wellness products, and the AI product lifecycle—and the rule establishing the Quality Management System Regulation (QMSR). Ariel’s deep institutional knowledge also encompasses FDA’s policies for Laboratory Developed Tests (LDTs) and the evolution of predetermined change control plans (PCCPs) for AI-driven products.
Ariel brings experience in complex compliance and enforcement, having played a senior role in CDRH enforcement decisions and consent decree negotiations. At the FDA, she helped promote the use of innovative regulatory tools, including strategies for suspected data integrity issues and the application of FDA’s enforcement under FDCA Sections 518(a) and (b). Her tenure at the OCC involved high-level collaboration with the US Department of Justice to secure injunctions for Quality System Regulation violations. Beyond devices, Ariel managed critical legal issues in food and cosmetic safety, from navigating food additive petitions to leading investigations into foodborne illness outbreaks and administrative detentions.
Ariel leverages her deep institutional knowledge of the FDA and CDRH to guide medtech companies through every stage of the product life cycle. She provides expert counsel on premarket pathway strategies, clinical study compliance, and the evolving regulatory landscape for novel device and digital health technologies. From navigating Quality System Regulation (QSR) and facility inspections to managing complex product recalls, import alerts, and medical device reporting, Ariel supports clients’ efforts to stay compliant. Her background makes her an essential partner for high-stakes enforcement actions and critical crisis management.
Ariel actively participates in planning the Food and Drug Law Institute’s annual conference and is a frequent speaker at medical device and digital health industry conferences.
