All commercial medical technologies are subject to federal regulations to ensure safety, efficacy, and performance. These processes and their impact on go-to-market timelines may be unfamiliar to academic researchers and start-up companies.

This panel will enhance your Food and Drug Administration (FDA) medical device regulatory knowledge, summarizing the path to market for medical device products including standard hardware/software devices, Software as a Medical Device (SaMD) and Artificial Intelligence (AI) applications. A panel of regulatory affairs professionals will provide an overview of common medical device regulatory pathways as well as how and when to work with expert professionals.

This panel is designed for faculty, postdocs, graduate students and others interested in translating research into commercial healthcare products and those interested in exploring a career in regulatory affairs.