Director, Division of Clinical Science and Quality, Center for Devices and Radiological Health
US Food and Drug Administration
Dr. Soma Kalb is the Director of the DCEA1: Division of Clinical Science and Quality at FDA's Center for Devices and Radiological Health. Dr. Kalb started her career at FDA in 2005, sharing her time between the Office of Science and Engineering Laboratories as a researcher and the Office of Surveillance and Biometrics as an analyst in the Division of Postmarket Surveillance in the area of cardiac rhythm devices. In 2007, she transitioned to Office of Device Evaluation, where she was a premarket reviewer in the Division of Cardiovascular Devices until December 2013. There, she gained experience leading reviews in several program areas (PMAs, IDEs, and Pre-submissions) for implantable electrophysiology devices. From 2013 through 2018, Dr. Kalb served as the Director of the Investigational Device Exemption Program, where, as part of the Clinical Trials Program, she oversaw the operations of the IDE Program and engaged in analysis, development and implementation of regulatory policies and procedures for medical device clinical trials. Currently, as Director of DCEA1, Dr. Kalb oversees activities related to clinical trials, bioresearch monitoring, epidemiology and real-world evidence methods, and outreach through FDA's MedSun program. Dr. Kalb received a Bachelor of Science degree in Electrical Engineering from the University of Maryland, a Master of Science degree in Biomedical Engineering from the Johns Hopkins University, and a Doctorate degree in Biomedical Engineering from Duke University.
Monday, November 18
2:45 PM – 4:00 PM
Tuesday, November 19
11:45 AM – 12:45 PM