Bakul is the Associate Director for Digital Health, at the Center for Devices and Radiological Health (CDRH), at the Food and Drug Administration (FDA). He leads regulatory policy and scientific efforts at the Center in areas related to emerging and converging areas of medical devices, wireless and information technology. This includes responsibilities for mobile health, health information technology, cyber security, medical device interoperability, and medical device software. He is also the FDA liaison between the Federal Communications Commission (FCC) and the Office of the National Coordinator (ONC). Since its inception in 2013, Bakul chairs the International Medical Device Regulators Forum (IMDRF) “software as a medical device” working group, a global harmonization effort.