https://youtu.be/mFYrNmCS-so

FDA’s Center for Devices and Radiological Health (CDRH) recently established the Digital Health Center of Excellence to provide regulatory advice and support to the FDA’s regulatory review of device software functions (DSFs). A large number of early stage digital health products struggle to get to US market authorization due to the perception of difficulty in navigating the CDRH regulatory processes. This talk walks through the various pathways for bringing digital health devices to market in the US. It also highlights the guidance documents within the digital health and medical device portfolios that can be useful during the process of moving digital health technology from prototype to real-world deployment.

2023 BDSIL Mentor Vinay Pai, PhD, MS, MBA, is a Digital Health Specialist within the Digital Health Center of Excellence in FDA’s Center for Devices and Radiological Health (CDRH), Office of Strategic Partnerships and Technology Innovation (OST), Division of Digital Health (DDH), having joined the FDA in Sept. 2019. He is currently focused on horizon scanning for new digital health technologies, evaluating existing and emerging digital health technologies and helping develop strategies for such evaluations. Prior to that, Vinay was in the National Institutes of Health, first as a staff scientist in the National Heart, Lung, and Blood Institute (NHLBI) (working on MRI and CT technology development and image processing, and researched cardiac function in humans and mice models) and then as an program officer and division director for biomedical imaging informatics and health informatics in the National Institute of Biomedical Imaging and Bioengineering (NIBIB). Before NIH, Vinay was a faculty at New York University School of Medicine developing techniques using proton and hyperpolarized helium magnetic resonance imaging to study cardiac and lung function. Vinay has a PhD in mechanical engineering from Florida State University, and an MBA from Johns Hopkins University.