SaMD PCCP checklist
AI/ML SaMD sponsors need a pre-specified modification envelope. FDA’s predetermined change control plan (PCCP) concept is guidance-heavy — this free 12-item SaMD PCCP checklist is a working list before counsel drafts the plan. A checked box is not authorization to skip a submission.
What a predetermined change control plan covers for SaMD / AI-ML
A SaMD PCCP typically frames the authorized intended use after a change, which modifications are in-scope vs out-of-scope, retraining and data-management practices, performance requirements, verification and validation methods, update triggers, user notification, rollback, impact assessment (labeling, cybersecurity, human factors), authorization roles, and aligned post-market monitoring. Use this list as a readiness agenda — not as a filing.
How to use this checklist (tick boxes → score)
Mark each of the 12 controls present or absent for your current plan draft. Treat the score as an agenda for RA/QA review with your team — not as authorization to ship a model update. Cross-check SaMD category and software safety class with our SaMD IMDRF category and IEC 62304 software safety class tools, then return to the free tools hub.
What your score means (gaps ≠ skip submission)
Checked boxes document intent that a control is addressed in your draft. Unchecked items belong in submission strategy, change protocol, or residual risk discussion. Explicitly: a checked box is not authorization to skip a submission.
Checklist items
0/12
0 of 12 PCCP controls marked present. Use open items as your RA/QA review agenda.
Need help turning gaps into a PCCP narrative?
Gaps on this list usually mean your PCCP narrative, V&V protocol, or post-market plan needs RA/QA depth — not another PDF. Book a Consultation with our clinical / regulatory engineering team (NexaMed RA-QA) to turn checklist gaps into a submission-ready change-control story.
Book a ConsultationFAQ
- What is a SaMD PCCP (predetermined change control plan)?
- A predetermined change control plan (PCCP) describes in advance which modifications a SaMD or AI/ML device may undergo after authorization, how those modifications are verified and validated, and how post-market performance will be monitored — so changes inside the authorized envelope can follow a defined protocol rather than an ad-hoc surprise.
- Does completing this checklist replace an FDA submission?
- No. This is an educational self-score. A checked box documents intent for RA/QA review; it is not authorization to skip a submission, supplement, or other regulatory action. Always confirm with qualified regulatory counsel against your product’s clearance or approval.
- Which modifications typically need to be pre-specified (retraining, performance, triggers)?
- Teams commonly pre-specify the modification envelope (what can and cannot change), retraining and data-management practices, performance metrics and acceptance criteria, update triggers (scheduled, drift, safety signal), V&V methods, user notification, and rollback or kill-switch behavior.
- How does PCCP relate to SaMD IMDRF category and IEC 62304 class?
- IMDRF SaMD category reflects significance of the information and healthcare situation; IEC 62304 software safety class reflects harm potential of software failure. A PCCP sits on top as the authorized change envelope for intended updates — classification and software class still shape risk controls, V&V depth, and documentation expectations.
- When should we book regulatory support vs self-score only?
- Self-score first to build an agenda. Book clinical / regulatory engineering support when gaps involve PCCP narrative drafting, V&V protocol design, labeling or cybersecurity impact, post-market monitoring commitments, or deciding what sits inside vs outside the authorized envelope.
Educational only. Not medical advice, not a regulatory determination, and not a substitute for qualified RA/QA, legal, clinical, or statistical counsel. SaMD PCCP checklist does not submit to FDA, Notified Bodies, or IRBs.
Related regulatory tools
Need help turning gaps into a PCCP narrative?
Gaps on this list usually mean your PCCP narrative, V&V protocol, or post-market plan needs RA/QA depth — not another PDF. Book a Consultation with our clinical / regulatory engineering team to turn checklist gaps into a submission-ready change-control story.
Book a Consultation