Skip to main content
RAPS Convergence 2025 Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Presentation Icons
Invitation Only
Invitation Only
Separate Ticket or Advanced Registration Required
Separate Ticket or Advanced Registration Required
Repeat Solutions Circle
Repeat Solutions Circle
Evaluation ViewAttendees 58

Devices (includes Medical Devices & In Vitro Diagnostics)

Navigating the New US Regulatory Landscape for the MedTech Industry: Trends and Changes, Including MDUFA

Thursday, October 9, 2025
9:15 AM - 10:30 AM EST
Location/Room: 301
This panel will examine the evolving dynamics of US medical device regulatory policy at the FDA's Center for Devices and Radiological Health (CDRH), focusing on the broader trends and emerging themes shaping the agency's approach in this new era of innovation. Experts will delve into the changing priorities and overall new direction of CDRH, including a specific focus on the Medical Device User Fee Amendments (MDUFA) program.

We will explore how shifts in the FDA environment—such as evolving landscapes, resource constraints, and policy changes—are not only shaping the upcoming MDUFA negotiations but also impacting the broader regulatory pathway for manufacturers striving to bring innovative technologies to patients. The discussion will also touch on the ripple effects of these US policies on global regulatory strategies, including those in the European Union.  

Learning Objectives:

  • Understand the evolving priorities and overall new direction of the FDA's Center for Devices and Radiological Health (CDRH) regarding US medical device regulatory policy.
  • Identify the broader trends and emerging themes that are shaping CDRH's approach to medical device innovation.
  • Analyze the implications of these regulatory changes for manufacturers seeking to navigate the regulatory pathway and bring innovative medical technologies to patients.