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title: "PCCP Template Generator | AI SaMD Playbook"
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[Back to AI SaMD Playbook](/)Template · FDA Final Guidance, Dec 2024 (rev. Aug 2025) 

# PCCP _template_ generator

Answer a structured set of prompts covering the three required sections, Description of Modifications, Modification Protocol, and Impact Assessment, and download a ready-to-edit Predetermined Change Control Plan for your AI-enabled device submission.

Load worked exampleClear form

01 · Device overview

Device name\* 

Manufacturer\* 

Submission type\* 

510(k) De Novo PMA, original PMA Supplement Q-Submission (pre-sub)

Model architecture\* 

Intended use statement\* 

Anchor the entire PCCP. Every planned modification must stay inside the bounds of this statement. 

Model inputs\* 

Model outputs\* 

02 · Description of Modifications · §VI

Planned modifications\* 

Be specific. Vague modifications ("improve performance") will not survive FDA review. 

Expected frequency\* 

Ad hoc, as needed Annually Semi-annually Quarterly Monthly

Automatic implementation?\* 

Per §VI.B, automatic implementation is permitted but FDA expects a Q-Sub conversation first. 

No, manual release Yes, automatic (Q-Sub recommended)

03 · Modification Protocol · §VII

Data management & sequestration\* 

Reference standard / ground truth\* 

Required by §VII.B(1): the process for establishing ground truth and the protocol describing it. 

Re-training triggers\* 

Performance metrics\* 

Acceptance criteria\* 

These are the validation/performance requirements that gate every modification. 

Subgroup analysis approach\* 

Update mechanism & UDI\* 

User communication & training\* 

Roll-back plan\* 

Required content per Appendix A §(4)(d), describe how to bring devices back to a previous version. 

Real-world monitoring plan\* 

Required content per Appendix A §(4)(d), how, and at what frequency, real-world performance is monitored. 

04 · Impact Assessment · §VIII

Impact on benefits\* 

Impact on risks (ISO 14971)\* 

Cybersecurity impact\* 

Is this a combination product?\* 

No Yes, combination product

Download PCCP (.md)Show live previewMarkdown · open in Word, Google Docs, Notion, or any editor 

What you'll get

-   Three FDA-required sections, with §VI / §VII / §VIII headings. 
-   Built-in roll-back, monitoring, and labelling commitments. 
-   QMSR / ISO 13485 transition language baked in. 
-   Version-control table ready for §V.E revisions. 

**Source.** FDA, _Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions_, final guidance issued 4 December 2024, updated 18 August 2025. This template is an educational starting point; refine through your QMS and Q-Sub feedback before submission.

[

Pairs with

Model Cards starter

Document training data, performance, and limitations alongside this PCCP.

](/model-cards)

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