Nilsa Loyo-Berrios, PhD, MSc

Nilsa-Loyo-BerriosFood and Drug Administration, Washington, D.C.
Publications Committee Member, MDEpiNet


Background

Dr. Loyo-Berríos is an Associate Director in the Division of Epidemiology, Office of Surveillance and Biometrics in the Center for Devices and Radiological Health. She joined the FDA in 2005 and worked as a regulatory reviewer in the clinical areas of cardiovascular, obstetrics-gynecology, gastroenterology-urology, and respiratory medicine. As an epidemiology reviewer, she applied her expertise on observational study methodologies and analyses, to the premarket and postmarket reviews and surveillance of medical devices. As Associate Director of the Division, she oversees regulatory epidemiology reviews for mandated studies (Post-Approval Studies (PAS) and Postmarket Surveillance (522 Section) Studies). She ensures scientific rigor for the design of studies, adherence to the Act and federal regulations, and high quality work products, while maintaining best practices and successful interactions with colleagues within the Center and with external stakeholders. Additionally, Dr. Loyo-Berríos is also involved with activities related to the development of national infrastructure for postmarket surveillance of medical devices. She is currently a member of the stakeholders working group for the development of the National Breast Implant Registry (NBIR), and provides oversight of FDA–internal related activities. Dr. Loyo-Berríos is also involved with regulatory research focused on the development of postmarket surveillance infrastructure for early detection of potential safety signals, as well as the development of methodologies using administrative databases for comparative effectiveness and/or safety of medical devices. She has authored and co-authored publications in prestigious peer reviewed journals such as JAMA, Journal of Bone Joint Surgery, Circulation Cardiovascular Quality Outcomes, Journal of Women’s Health, Journal of Human Lactation, and Am J Epidemiology, among others.