Predetermined Change Control Plans (PCCPs) for AI-Enabled IVDs

A DCN Dx Expert Insights conversation with Dan Simpson, RAC, Director of Regulatory Affairs at DCN Dx, and Emily Friedland, VP of Clinical Research at DCN Dx. FDA’s Predetermined Change Control Plan (PCCP) mechanism is designed to let manufacturers pre-specify certain post-clearance or post-approval changes, along with the protocol and acceptance criteria used to verify and validate those changes. For AI-enabled device software functions, PCCPs are now a core concept in FDA’s approach to iterative software updates. In this episode, we break down what belongs in a PCCP, how it shows up in a marketing submission, and how teams can connect PCCP planning to design controls, risk management, and quality system processes so the plan is executable after authorization, not just well written on paper. What we cover (bullets) • What FDA means by a PCCP and when it is relevant for AI-enabled IVDs • The three core components FDA expects to see (and why each one matters) • How PCCPs interact with marketing submissions (510(k), De Novo, PMA) and public-facing submission summaries • Where teams get tripped up: scope control, evidence expectations, and operationalizing the plan inside the QMS • What the broader “PCCPs for Medical Devices” draft guidance signals for non-AI device changes (hardware, materials, software) Dan Simpson, RAC is Director of Regulatory Affairs at DCN Dx, supporting regulatory strategy, pre-submission engagement, and U.S. and global submission planning for diagnostics teams. Emily Friedland is the VP of Clinical Research at DCN Dx, where she leads and fosters growth within the clinical operations teams. Questions about whether a PCCP makes sense for your device, or how to structure one so it holds up through review and post-market execution? DCN Dx’s Regulatory Affairs Services help IVD teams develop successful regulatory plans and submissions. We support FDA pathways including 510(k), De Novo, and PMA, with early Pre-Sub positioning and submission development, and we can advise on accelerated programs like Breakthrough Devices and STeP when they fit the product. Our team aligns verification and validation expectations across software and cybersecurity, biocompatibility, labeling, shelf life, analytical and clinical performance, usability and human factors, and CLIA waiver flex studies. We also support QMS readiness (ISO 13485, CLIA, CAP) and post-market obligations. Contact us at dcndx.com.