FDA/CDRH – MDIC Co-Sponsored Public Meeting

Regulatory Science Innovations Catalyzing Medical Device Development

FDA/CDRH – MDIC Co-Sponsored Public Meeting
September 25, 2026 | FDA White Oak Campus, Silver Spring, MD and Virtual
8:30 AM – 4:30 PM ET

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Meeting Overview and Objectives

The U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) and the Medical Device Innovation Consortium (MDIC) are co-sponsoring a one-day stakeholder engagement meeting focused on advancing regulatory science for breakthrough and disruptive medical device technologies. In conjunction with this meeting, the FDA is opening a docket to receive comments from the public.

The purpose of the meeting is to advance regulatory science in support of breakthrough devices and disruptive medical device technologies by fostering meaningful, multi-stakeholder dialogue to help inform long-term research priorities and strategic planning for FDA’s Center for Devices and Radiological Health (CDRH). Through this collaborative effort, CDRH and MDIC seek to identify the regulatory science challenges anticipated to impact medical device development over the next decade.

Visit the FDA Meeting Page for more information.

Meeting Objectives

Gather Stakeholder Perspectives

Gather stakeholder perspectives on emerging device technologies, evolving clinical scenarios, and their anticipated regulatory science needs.

Identify Critical Regulatory Science Gaps

Identify critical regulatory science gaps that could potentially impede the development of safe and effective novel devices and disruptive medical device technologies.

Join us In-Person or Online this September!

FDA’s Center for Devices and Radiological Health (CDRH) and the Medical Device Innovation Consortium (MDIC) are pleased to convene this collaborative forum bringing together leaders from government, industry, academia, and patient advocacy to explore the future of medical device innovation. As the medical device landscape continues to evolve at a rapid pace, this discussion will engage in open, forward-looking dialogue on where regulatory science innovation can support the development of novel technologies. The program will explore topics such as unique clinical care paradigms, cybersecurity, digital health, non-animal methods, and in silico tools, with the goal of fostering collaboration, identifying critical regulatory science gaps, and advancing the development of regulatory science and medical device development tools that support safe and effective technologies.

 

Agenda and Panelists

  • Michelle Tarver, MD, PhD — Director, Center for Devices and Radiological Health (CDRH), FDA
  • Andrew Fish — President & CEO, Medical Device Innovation Consortium

  • Ed Margerrison, PhD – Director, Office of Science and Engineering Labs, CDRH

  • Brittany Caldwell, PhD, MBA – Director, Division of Partnerships and Innovation, CDRH

  • Josh Makower, The Yock Family Professor, Professor of Medicine and of Bioengineering, Stanford University Schools of Medicine and Engineering; The Byers Family Director and Co-Founder, Stanford Mussallem Center for Biodesign
  • Kolaleh Eskandanian, PhD, MBA – Senior Research Scientist, MedStar-Georgetown AI CoLab; Program Director, SPARK for Innovations in Pediatrics Hub

Break and Room Divide

  • Breakout 1: Emerging Device Technologies, Artificial Intelligence and Digital Health
    • Facilitator: Jennifer Goldsack, MChem, MA, MBA, OLY, Senior Vice President, Center for Digital Health and AI, American Medical Association
  • Breakout 2: Non-Clinical Evidence Generation and Testing Methods
    • Facilitator: Matthew Hillebrenner, MSE,  Director of Government Affairs, Fogarty Innovation
  • Breakout 3: Clinical Evidence Generation and Testing Methods
    • Facilitator: Morgan Hanger, Executive Director, Clinical Trials Transformation Initiative

Lunch Break

Breakout Session Report-Outs (10 minutes each)

Break

Speakers TBA

  • Suzanne Schwartz, MD, MBA Director, Office of Strategic Partnerships and Technology Innovation