Soma Kalb, PhD


Director, IDE Program

FDA/CDRH/ODE/Clinical Trials Program

Dr. Soma Kalb is the Director of the Investigational Device Exemption (IDE) Program in FDA/CDRH, a position she has held since 2013. In this role, she oversees the operations of the IDE and Q-submissions programs and engages in analysis, development and implementation of regulatory policies for medical device clinical trials.