Back to AI SaMD PlaybookTemplate · 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.

01 · Device overview

Device name*

Manufacturer*

Submission type*

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*

Automatic implementation?*

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

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?*

Markdown · 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.