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 editable review draft for your AI-enabled device. This template does not establish FDA authorization or evidence adequacy.

Worked examples are fictional. Their numerical thresholds, sample sizes, notification periods and retention periods are not universal FDA requirements.

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?*

FDA will consider automatic modifications and recommends discussing automatic-update considerations through the Q-Submission Program (§VI.B). Describe guardrails; do not assume authorization or claim feedback you have not received.

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?*

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