David Giese's Presentation on FDA Regulation of Diagnostic Imaging AI

Описание: This is a presentation David Geese gave about FDA regulation of diagnostic imaging AI, sharing insights from over a decade of hands-on experience helping companies navigate the regulatory landscape.

Presentation Title
FDA Regulation of Diagnostic Imaging AI

Presentation Description
FDA regulation can seem like a black box, especially when it comes to diagnostic imaging AI. In this talk, David walks through the fundamentals of the US FDA regulatory process, with a particular focus on diagnostic imaging AI software.
Whether you’re early in development or approaching submission, this presentation will help you better understand regulatory expectations and avoid common pitfalls.
David shares lessons learned from helping clear 35+ medical devices, many in the diagnostic imaging AI space. He explains the classification process, 510(k) vs De Novo pathways, key documentation requirements, and how FDA assesses AI risk levels, from low-risk quantitative tools to high-risk CADx systems.
You’ll also get an overview of study design essentials:
When standalone performance studies vs reader studies are needed
Common mistakes around data provenance and US-data requirements
How FDA views transparency, bias disclosure, and post-market monitoring

This talk is especially valuable for engineers, founders, and regulatory professionals who want a clear, pragmatic look at what it takes to get diagnostic imaging AI FDA cleared today.