Essential Vaccine Policy Updates: ACIP, CDC’s COVID-19 Guidance, and What’s Next

ARIEL SEELEY is Of Counsel in the FDA practice group at Morgan Lewis. Ariel draws on her in depth knowledge of the U.S. Food and Drug Administration (FDA) to provide strategic counsel to clients on all aspects of FDA regulation, compliance, and enforcement issues related to the total product lifecycle for medical devices. Ariel specializes in the emerging legal issues related to cybersecurity and digital health technologies, including the use of artificial intelligence. With 14 years of FDA experience spanning multiple administrations and roles, Ariel leverages her deep familiarity with FDA’s laws and regulations to advise clients on regulatory pathway options, device classification, current good manufacturing practice and quality system compliance, FDA registration and listing, product recalls, and medical device reporting requirements. Most recently Ariel served as an Associate Director in the Office of Policy at the FDA’s Center for Devices and Radiological Health (CDRH) where she was responsible for the development of rules, orders, guidance, and petition responses, and served as CDRH’s legal authority on digital health, including artificial intelligence, and cybersecurity. Prior to joining CDRH, Ariel was an Associate Chief counsel in FDA’s Office of Chief Counsel, where she primarily counseled FDA on legal issues devices and food. Ariel is admitted in New York only, and her practice is supervised by DC Bar members.