Ariel Z. Seeley
Ariel Seeley advises medical device, digital health, food, and dietary supplement companies on complex regulatory, compliance, and enforcement matters before the US Food and Drug Administration (FDA). Drawing on more than 14 years of experience at the FDA—including roles at the Center for Devices and Radiological Health (CDRH) and the Office of Chief Counsel (OCC)—Ariel guides clients through the agency’s legal, regulatory, and decision-making processes. She counsels clients across the total product life cycle, from product development and premarket authorization through postmarket compliance and inspections, recalls, and enforcement matters.
While at the FDA, Ariel was at the forefront of shaping FDA regulation of emerging technologies. During her FDA tenure, she served as lead counsel for the development of regulatory policies, frameworks, and guidance for AI, software as a medical device (SaMD), wearables, and other digital health technologies. Her work included pivotal guidance documents involving cybersecurity, clinical decision support software, general wellness products, AI-enabled devices, and predetermined change control plans (PCCPs). She also contributed to the development of FDA’s Quality Management System Regulation (QMSR) and advised on the agency’s approach to laboratory developed tests (LDTs). Ariel has a strong background in compliance and enforcement. At CDRH, she held a senior role participating in enforcement decisions and consent decree negotiations, and helped promote the use of innovative regulatory tools, including developing strategies for suspected data integrity issues and use of FDA’s authorities under Sections 518(a) and (b) of the Federal Food, Drug, and Cosmetic Act. While at OCC, she worked closely with the US Department of Justice on enforcement matters, including injunctions for Quality System Regulation violations.
Beyond medical devices, Ariel advised FDA on matters involving food, dietary supplements, and cosmetics. Her experience includes warning letters, administrative detentions, seizures and injunctions, food additive petitions, and investigations of foodborne illness outbreaks.
Ariel actively participates in planning the Food and Drug Law Institute’s annual conference and frequently speaks on medical device and digital health topics at industry conferences. She is certified in ISO 13485:2016 and is well-versed in its application to FDA’s QMSR.
