Nilsa-Loyo-Berrios, PhD MSc

Nilsa Loyo-Berríos, PhD, MSc is a Deputy 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 epidemiology reviewer in the clinical areas of obstetrics-gynecology, cardiovascular, gastroenterology-urology, and respiratory medicine. She has extensive experience on the application of epidemiological principles, particularly on observational methodologies and analyses, to the evaluation and surveillance of medical devices throughout the total product life cycle. As Deputy Director, she is involved in activities related to the implementation of the National Evaluation System of health Technologies (NEST), developing national infrastructure, primarily focused on women’s health issues. Dr. Loyo-Berríos also oversees regulatory reviews for mandated studies (Post-Approval Studies (PAS) and Postmarket Surveillance (522 Section) Studies), and regulatory research. She has experience with research focused on the development of postmarket surveillance infrastructure and tools 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 Heath, Journal of Human Lactation, and Am J Epidemiology, among others.