Carol Cave U.S. FDA

Carol Cave

Carol Cave U.S. FDA

Carol Cave is the Acting Associate Commissioner for Regulatory Affairs (ACRA) in the FDA’s Office of Regulatory Affairs (ORA). In this role, she oversees approximately 5,000 ORA staff stationed in the U.S. and around the world.

Before becoming Acting ACRA, Ms. Cave served as the Deputy Associate Commissioner for Regulatory Affairs (DACRA), overseeing inspections, compliance, enforcement, field laboratory operations, import operations, and strategic planning, among other areas.

Prior to serving as DACRA, she was Assistant Commissioner of Import Operations, leading the ORA’s Office of Enforcement and Import Operations (now the Office of Import Operations). In this role, she oversaw FDA-regulated imported products across all commodities, including investigations and compliance activities to ensure products entering the U.S. market complied with U.S. laws. Ms. Cave also served as the FDA lead for coordinating agency import activities with U.S. Customs and Border Protection, including developing and implementing joint regulations, policies, procedures, and operations, and coordinated with other federal agencies and foreign governments with border responsibilities.

Ms. Cave received a bachelor’s degree in Consumer Economics from the University of Maryland.