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Separate Ticket or Advanced Registration Required
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Repeat Solutions Circle
Evaluation Video ViewAttendees 31

Devices (includes Medical Devices & In Vitro Diagnostics)

Accelerating Regulatory Discussion on Digital Health Devices

Thursday, October 9, 2025
3:15 PM - 4:15 PM EST
Location/Room: 317
The MedTech industry is experiencing rapid innovation fueled by digital technologies. Digital health devices are becoming smarter, more connected, precise, and deeply integrated into patient care. These advancements introduce unique regulatory considerations, and keeping pace with technological evolution necessitates clear, effective communication with regulatory agencies. Fostering collaboration in this space is essential to bringing safe, innovative solutions to patients and end users more efficiently.

This session will explore how strategic communication with regulators can accelerate innovation in digital health devices, especially those incorporating AI/ML components. Attendees will gain:

  • Insights into the Digital Health Device Landscape: An understanding of the regulatory considerations specific to digital health technologies

  • Regulatory Frameworks & Challenges: An overview of the key dilemmas faced by regulatory affairs professionals in this evolving field

  • FDA Resources & Guidance: An introduction to the FDA’s Digital Health Center of Excellence (DHCoE) and Regulatory Accelerator, highlighting how these channels are shaping the future of digital health regulation to enable faster, more predictable development pathways

  • Best Practices for Early Engagement with the FDA: Strategies for leveraging early orientation meetings to de-risk development, clarify expectations, and accelerate timelines

  • Communication as a Strategic Asset:Real-world examples demonstrating how effective dialogue influences outcomes, navigates complexity, and drives innovation success