.png?width=50&height=50&name=Untitled%20design%20(33).png)
AI, PCCP, and the Upcoming FDA Requirements
A Field Guide for SaMD Teams Building with AI
FDA is finalizing its requirements for AI-enabled medical devices, and most quality systems were built for a different kind of product. Change control, design controls, and post-market surveillance were designed for fixed devices, not for models that retrain and drift after they ship. This guide shows you where the gaps are and what to do about them.
Written by Rook Quality Systems, it breaks down what a Predetermined Change Control Plan (PCCP) actually is, who needs one and when, and the practical steps SaMD teams can take now, even if AI is still in development.
-1.png?width=512&height=877&name=Untitled%20design%20(11)-1.png "Untitled design (11)-1")
A Practical Guide to Operationalizing the ML Lifecycle in Your QMS
Inside this 25-page resource, you'll find clear explanations, real regulatory context, and structured frameworks to help SaMD and digital health teams build quality systems that hold up to FDA's evolving AI/ML expectations. Each chapter focuses on recognizing where traditional quality systems fall short for AI, and how to close those gaps before they surface in an audit or a deficiency letter.
What's Inside?
Introduction
Why the requirements being finalized now apply to you whether you're shipping AI, building it, or planning for it, and why getting ahead of them is easier than retrofitting later.
Section 1 — PCCP Explained
A clear breakdown of what a Predetermined Change Control Plan is, its three core pillars, who needs one, and how it fits into the ML lifecycle.
Section 2 — FDA's Evolving Expectations
What's finalized, what's in active draft, and what's coming. How to build to draft guidance FDA reviewers are already applying today.
Section 3 — Where Current Quality Systems Fall Short
The structural mismatch between traditional QMS assumptions and what AI/ML actually requires, plus the five areas that most often catch SaMD teams off guard.
Section 4 — The PCCP Ecosystem
How PCCP, clinical evidence, and post-market surveillance connect, what a PCCP can and can't cover, and why post-market surveillance is not where modification decisions belong.
Section 5 — What to Do Now
A PCCP-ready development mindset, a six-procedure QMS gap map, and six practical steps you can take this quarter.
Section 6 — Closing the Gap
The continuous auditing and monitoring infrastructure PCCP and post-market obligations actually require, and how to build toward it.
FAQs from the Field
Real questions SaMD teams asked during a recent live session, answered directly, including the ones that don't have clean answers in the FDA guidance docs.
Six Reasons Your SaMD Team Needs This Guide
The AI Compliance Gap Won't Wait for Your Roadmap
The Requirements Are Being Written Now
FDA is finalizing its AI/ML expectations. The posture you build today shapes your regulatory position tomorrow.
Your QMS Has Gaps You Can't See Yet
Change control and post-market surveillance weren't built for data-driven changes. Most teams don't find out until an audit.
Written by a Team That Does This Daily
Rook supports SaMD and digital health teams through submissions, audits, and PCCP authoring across the full regulatory landscape.
PCCP and Post-Market Are One System
Your monitoring plan activates your PCCP pathway. This guide shows how to build them together, not as separate workstreams.
Practical, Not Theoretical
Clear frameworks and real steps, not a checklist or a wall of regulatory citations.
It Applies Whether AI Is Live or on the Roadmap
The steps inside work for teams shipping AI today and for teams that will be in two years.