Title: Translating FDA regulated Software as a Medical Device from Research to Practice
Presenter: David Vidal, Vice Chair, SaMD Regulatory, Center for Digital Health at Mayo Clinic
Abstract: Navigating FDA regulations for AI can be overwhelming. This talk will walk through AI functions that are likely regulated by the FDA and AI functions that are likely not. The talk will also provide an overview of the FDA quality systems regulations and design controls required for AI that qualifies as regulated Software as a Medical Device.
Bio: David Vidal, J.D. joined Mayo Clinic in 2020. He is an attorney and the Vice Chair for Software as a Medical Device (SaMD) Regulation in Mayo Clinic’s Center for Digital Health - Data & Analytics leadership. His team is leading the development of enterprise-wide infrastructure to enable safe, effective, and ethical realization of FDA regulated artificial intelligence (AI) and software solutions. David specializes in navigating product regulatory strategy and design controls for AI and software-based product teams. David also advises on SaMD compliance, federal regulations, and standards for AI and software frameworks. David previously held the position of General Counsel and Senior VP of Quality Assurance & Regulatory Affairs at IDx Technologies Inc., where he played an instrumental role in the FDA authorization and deployment of IDx-DR, the first autonomous AI diagnostic cleared by the FDA.