# AI SaMD Playbook

> Working reference for regulating AI/ML Software as a Medical Device · FDA, EU AI Act, MHRA, Health Canada, PMDA, TGA and China NMPA. For RA, QA, security and product teams shipping AI-enabled devices.

Editorial site by Blue Goat Cyber. Covers premarket pathways, Predetermined Change Control Plans (PCCP), Good Machine Learning Practice (GMLP), AI medical device cybersecurity (SBOM / AI-BOM, model-layer threats), and post-market drift obligations. Pages are written for professionals preparing 510(k), De Novo, EU MDR + AI Act, MHRA, Health Canada, PMDA, TGA and NMPA submissions.

## Pages

- [Home](/): Index of the playbook, the seven regulators, and the tools below.
- [Cybersecurity](/cybersecurity): AI medical device cybersecurity · SBOM, AI-BOM, six model-layer threats, weekly auto-updated digest.
- [Crosswalk](/crosswalk): Side-by-side comparison of how the seven regulators position on AI in SaMD.
- [Glossary](/glossary): Searchable glossary of AI/SaMD regulatory terminology and acronyms.
- [GMLP self-assessment](/gmlp): Score an AI/ML medical-device program against the 10 GMLP principles.
- [Model Cards](/model-cards): Template, twelve-section checklist and worked examples for AI/ML SaMD model cards.
- [PCCP template generator](/pccp): Fill key fields and download a Predetermined Change Control Plan aligned to FDA 2024 final guidance.
- [PCCP Diff Checker](/pccp-diff): Side-by-side diff of two PCCP markdown drafts with section-level summary.
- [Risk Wizard](/risk-wizard): Nine questions estimate IMDRF SaMD category, FDA class, EU AI Act tier, MDR/IVDR, MHRA, HC and NMPA class.
- [Threat Model Builder](/threat-model): STRIDE AI threat register mapped to FDA Feb 2026 cyber guidance and EU AI Act Article 15.
- [Cost & timeline estimator](/cost-estimator): Planning numbers for AI/ML device submissions across all seven jurisdictions.
- [Submission checklists](/checklists): Step-by-step scaffolds for 510(k), De Novo and EU high-risk pathways, cited line-by-line.
- [Post-Market Drift Calendar](/post-market-calendar): Recurring post-market obligations by class and jurisdiction. ICS export.

## Regulators

- [FDA](/regulators/fda): U.S. premarket pathways, PCCP, GMLP, Feb 2026 cybersecurity guidance.
- [EU AI Act](/regulators/eu-ai-act): EU AI Act + MDR/IVDR double-classification for medical-device AI.
- [MHRA](/regulators/mhra): UK programme, AI Airlock sandbox, post-Brexit positioning.
- [Health Canada](/regulators/health-canada): Premarket guidance and FDA-aligned principles.
- [PMDA](/regulators/pmda): Japan · pre-approved change plans, IDATEN-style execution.
- [TGA](/regulators/tga): Australia · risk-based software rules with AI evidence overlay.
- [NMPA](/regulators/nmpa): China · specific AI medical-device framework on its own timeline.

## Optional

- [Colophon](/colophon): About the brief and methodology.