Lauren Silvis has served as the Chief of Staff of FDA since 2017, overseeing the daily management of the Agency and leading the Agency’s activities on major initiatives. She provides strategic direction to senior leadership to advance FDA’s policy priorities, including efforts to promote medical product innovation, pursue a comprehensive plan for tobacco regulation, improve drug competition, fight the opioids crisis, and strengthen our food safety system. She also has extensive experience with medical device issues and has worked to advance policies on digital health, diagnostics modernization, and medical device safety.
Ms. Silvis works closely with the leadership of all FDA product centers and field operations to support their implementation of Agency policies. She also serves as the Commissioner’s direct liaison to other executive Agencies and organizations and engages across government on critical public health initiatives. In addition, she plays a key role in legislative engagement, communications, and stakeholder outreach.
Before being appointed Chief of Staff, Ms. Silvis served as Deputy Center Director for Policy in FDA’s Center for Devices and Radiological Health. At CDRH, Ms. Silvis led the development and implementation of all medical device policies, regulations, and guidance, and oversaw the Center’s communication and education functions. She regularly advised on regulatory, programmatic and legislative issues affecting medical devices and represented the Center on cross-cutting Agency issues.
Before joining FDA in 2015, Ms. Silvis was a partner practicing food and drug regulatory law at a large international law firm. She graduated cum laude from Duke University and earned her law degree cum laude from Georgetown University Law Center, after which she served as a law clerk to the Honorable James L. Ryan, U.S. Court of Appeals for the Sixth Circuit.