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Invitation Only
Invitation Only
Separate Ticket or Advanced Registration Required
Separate Ticket or Advanced Registration Required
Repeat Solutions Circle
Repeat Solutions Circle
Evaluation ViewAttendees 30

Devices (includes Medical Devices & In Vitro Diagnostics)

Accelerating Postmarket Innovation with Predetermined Change Control Plans (PCCPs): AI/ML and Beyond

Thursday, October 9, 2025
1:00 PM - 2:00 PM EST
Location/Room: 315
Predetermined Change Control Plans (PCCPs) provide device manufacturers a regulatory pathway for making predictable, efficient post market changes. While first championed for AI/ML software, PCCPs can just effectively cover hardware upgrades, shelf life extensions, labeling updates, and manufacturing improvements—when they are drafted, authorized, and executed with rigor.
In this panel discussion, seasoned regulatory and R&D leaders from a global device firm and an AI startup—joined by a former FDA official and a regulatory attorney—will share candid, field-tested advice on crafting PCCPs that withstand FDA scrutiny and drive business value.

Session Highlights:
  • Real-Life Experiences: Explore compelling real-life cases and proven methodologies that led to successful PCCP authorizations.

  • Common Challenges: Identify key pitfalls and challenges within the PCCP process, arming participants with practical insights to navigate potential obstacles. Shed light on time, resource commitment and ROI for the PCCP.

  • Implementation Post-Authorization: Explore how to incorporate an authorized PCCP into existing quality system and change control workflows for seamless, compliant execution.

    • Learning Objectives:

    • Understand the broader applications of PCCPs for postmarket changes, including and beyond design, labeling, and manufacturing modifications, while exploring their limitations and complementary regulatory pathways.
    • Learn practical tips and best practices for developing and submitting a high-quality PCCP, including key do’s and don’ts and leveraging the FDA pre-submission program effectively.
    • Develop strategies to balance business, regulatory, and quality system requirements to maximize the value of PCCPs and accelerate postmarket innovations.