Ariel Seeley

Ariel has more than 14 years of experience at FDA across two significant roles. As associate director for regulatory documents and special projects at FDA’s Center for Devices and Radiological Health (CDRH), Ariel provided strategic advice and guidance on a wide range of regulatory and policy issues impacting the total product lifecycle of medical devices, such as device classification, premarket pathways, investigational device exemptions (IDE), quality system requirements, postmarket reporting, recalls and withdrawals, and compliance actions. Ariel was also substantively involved in the drafting, development, and issuance of significant regulations and guidance documents issued during her tenure. 

While Ariel has familiarity with all product areas regulated by CDRH, she served as CDRH’s legal and policy authority on cybersecurity and digital health, including AI. Among many accomplishments in these areas, she assisted most recently with the development and execution of policies implementing new statutory provisions enacted through the Food and Drug Omnibus Reform Act of 2022 (FDORA): predetermined change control plans for devices and cybersecurity premarket submission requirements. Ariel has also engaged with Congress, and prepared FDA leadership for Congressional testimony, to advocate for the agency’s positions on various bills and to develop legislative proposals.

Prior to joining CDRH, Ariel served as an associate chief counsel in FDA’s Office of Chief Counsel (OCC). Ariel’s practice touched many aspects of FDA law and policy, including devices, food, and cosmetics. Her practice primarily involved counseling on the legal issues related to digital health technology and cybersecurity matters. This work included the development of FDA’s policies around medical mobile applications and other policies that helped stakeholders identify whether and how a software product was regulated by FDA. 

Additionally, Ariel counseled various components of FDA and HHS on a broad range of device, food, and cosmetic legal issues, including device classification; premarket authorization pathways; FDA’s work to investigate data integrity concerns and related actions, including 510(k) recissions; warning letters; IDE and clinical trial requirements; medical device reporting; quality system requirements; FDA’s implementation of the FDA Food Safety Modernization Act (FSMA), the Food and Drug Administration Safety and Innovation Act (FDASIA), and the 21st Century Cures Act; food additive petitions and food contact notifications; cosmetic oversight; FDA’s work investigating foodborne illness outbreaks and related actions, including administrative detention, recalls, and other enforcement activities; and consent decree negotiations in collaboration with the Department of Justice (DOJ).