Location: Ted & Marty Couch Auditorium

Location: Ted & Marty Couch Auditorium

Medical extended reality (Med XR) has arrived, with over 92 FDA-authorized devices already on the market. But many innovators still underestimate the regulatory foundations required for market adoption and regulatory success. This session introduces the fundamental strategies every Med XR team should know: how to determine if a product is a medical device, when wellness vs device claims apply, and which FDA pathways (510(k), De Novo, Breakthrough) may be relevant. We’ll begin by considering your intended use as a foundation to discuss how to frame claims and evidence decisions in ways that anticipate regulatory review, even in the absence of XR-specific guidance. Beyond covering the basics, we’ll spotlight the “unknown unknowns” or blind spots that often derail promising projects, so attendees leave with a regultory framing for their product and the right questions to guide both regulatory and business strategy.

Learning Objectives

- Understand your intended use as the foundation of your product and regulatory strategy

- Distinguish non-regulated vs. medical device claims and classify Med XR products with confidence.

- Recognize the primary FDA pathways available for MXR technologies.

- Frame claims and evidence decisions in ways that strengthen regulatory alignment.

- Identify common blind spots (“unknown unknowns”) and develop the right questions to guide cohesive regulatory and go-to-market strategy.

Format

90min interactive session, with worksheets, lecture and Q&A. Audience: XR product leaders, developers and regulatory professionals.