Chief Medical Officer for Pediatrics and Special Populations
FDA
With nearly 3 decades of experience in healthcare, including clinical care as a triple board certified pediatric and adult congenital cardiologist, health system leadership, awarded research scientist, federal policy analysis, and technology regulation, I am a passionate and dedicated Chief Medical Officer at the U.S. Food and Drug Administration Center for Devices and Radiological Health (FDA CDRH). My core competencies include clinical and scientific leadership, innovation, policy development, and stakeholder engagement. My mission is to advance the health and well-being of pediatric and special populations through the development, assessment, and safe use of medical devices. I bring diverse perspectives and experiences to the FDA CDRH team, as a former academic clinician, researcher, educator, and advocate for children's health.
As the Center's senior expert on pediatric clinical science and practice, I oversee all efforts with respect to pediatric medical devices, from pre-market to post-market activities. I provide executive leadership in developing and implementing strategies, policies, and programs that promote pediatric device innovation and access, while ensuring safety and effectiveness. I lead and collaborate with multidisciplinary teams of experts, both within and outside the FDA, to address complex and emerging issues related to pediatric device development and regulation. I also leverage my skills in electronic health records (EHR), medical education, and public health to enhance the Center's data infrastructure, training, and outreach initiatives.
Thursday, September 19, 2024
3:15 PM – 4:15 PM PDT