Director, Investigational Device Exemption Program, Center for Devices and Radiological Health
US Food and Drug Administration
Dr. Soma Kalb is the Director of the Investigational Device Exemption (IDE) Program in the Office of Device Evaluation’s (ODE) Clinical Trials Program 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 ODE, where she served as 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. She moved into her current role in 2013, where, as part of the Clinical Trials Program, she oversees the operations of the IDE Program and engages in analysis, development and implementation of regulatory policies and procedures for medical device clinical trials. 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.
Thursday, November 15
3:00 PM – 4:15 PM
Friday, November 16
3:30 PM – 4:45 PM