JACLYN FONTEYNE is an associate in the Food, Drug, and Medical Device Regulatory group, where she advises clients on a range of matters related to Food and Drug Administration (FDA). Jaclyn advises clients across all FDA-regulated industries, and her work spans the product lifecycle, including clinical development programs, marketing authorization pathways, and postmarket compliance matters. She has experience advising clients on a variety of FDA topics, including establishment registration and listing, adverse event reporting, imports and exports, recalls, product promotion, and FDA enforcement authorities.
Jaclyn regularly supports clients regarding COVID-19 response efforts, particularly involving the emergency use authorization, marketing, and distribution of COVID-19 diagnostic tests and other personal protective equipment (PPE). Jaclyn has tracked FDA policies throughout the Coronavirus pandemic, and advises clients on their engagement with FDA and its Center for Devices and Radiological Health (CDRH) on these COVID-19-related topics.
Jaclyn also assists clients with Digital Health topics and Software as Medical Device initiatives in light of a rapidly evolving industry and FDA regulatory framework.
During law school, Jaclyn was a legal intern in FDA’s Office of Policy.
Prior to law school, Jaclyn worked as a social media specialist at an international pharmaceutical company.
Jaclyn is fluent in both French and German.