Dr. Saha is a biomedical engineer by training with over seven years of FDA experience and over 10 years of research experience in medical robotics and prosthetics. She has extensive knowledge of US regulatory processes associated with neurology and physical medicine devices. Her specialty is in the review of medical exoskeletons, brain computer interfaces, physical rehabilitation devices including wearable technology, neuromodulation devices, and early feasibility studies. While at FDA, she contributed to the development of the several policies and guidances, including the leapfrog guidance on brain computer interface, policies for the regulation of wearable devices for physical rehabilitation, standards supporting exoskeleton testing, and real-world evidence for marketing submissions.
Prior to joining MCRA four years ago, Dr. Saha worked for six years at the FDA as a premarket lead reviewer in the Office of Neurology and Physical Medicine Devices and the Office of Cardiovascular Devices. She reviewed hundreds of regulatory submissions, including 510(k)s, PMA, De Novos, IDEs, 513(g)s, Breakthrough Designations, and pre-submissions. Dr. Saha specialized in the review of novel state of the art technologies in the early feasibility stages of review. In addition to these roles, she also served as the Early Feasibility Program representative and as a policy analyst for the Office of Clinical Evidence and Analysis with a focus on the Safer Technologies Program and Real-World Evidence.
Before joining the FDA, Dr. Saha was a researcher in the field of prosthetics and robotic technologies for rehabilitation. She also worked at Mako Surgical where she helped train clinicians and company personnel on the use of a robotic application for orthopedic surgery.
Devjani holds a Bachelor of Science in Bioengineering from the University of Pennsylvania and a Master of Science and Ph.D. in Biomedical Engineering from Northwestern University.