US Food and Drug Administration
Silver Spring, MD
Dr. Soma Kalb is the Director of the DCEA1: Division of Clinical Policy and Quality at FDA's Center for Devices and Radiological Health. Dr. Kalb started her career at FDA in 2005 with a focus on cardiovascular devices, and has spent time conducting bench research in the Office of Science and Engineering Laboratories, conducting postmarket surveillance in the Office Surveillance and Biometrics, and preforming premarket reviews in the Office of Device Evaluation. 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, postmarket mandated studies and real-world evidence. 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, 2024
10:30 AM – 11:45 AM PT