Dr. Saha is a biomedical engineer by training with over 7 years of FDA experience and over +10 years of research experience in medical robotics and prosthetics. Dr. Saha 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, and early feasibility studies. While working at the FDA, Dr. Saha 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, and standards supporting exoskeleton pre-clinical testing.
Bachelors of Science and Engineering in Bioengineering: University of Pennsylvania
Masters of Science and Ph.D in Biomedical Engineering: Northwestern University
Prior to joining MCRA, Dr. Saha worked for 7 years at the FDA as a premarket lead reviewer in the Office of Neurology and Physical Medicine Devices and the Office of Cardiovascular Devices. Dr. Saha reviewed hundreds of regulatory submissions, including 510(k)s, PMA, De Novos, IDEs, 513(g)s, Breakthrough Designations, and pre-submissions. She specialized in the review of novel state of the art technologies in the early feasibility stages of review. In addition to these roles, Dr. Saha 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. She helped to launch the Safer Technologies Program (STeP) and provided programmatic expertise during the review of STeP submissions.
Before joining the FDA, Dr. Saha was a researcher in the field of prosthetics and robotic technologies for rehabilitation. Dr. Saha also worked at Mako Surgical where she helped train clinicians and company personnel on the use of a robotic application for orthopedic surgery.
At MCRA, Dr. Saha provides guidance on regulatory strategy and submission development with a focus on neurological and physical medicine devices.