Readiness becomes visible through records.
AI MedTech / SaMDIntended-use and clinical workflow map
Keep this as a named evidence object for AI MedTech / SaMD: source basis, owner, status, review question, and update trigger should be visible before reuse.
Software function description
Keep this as a named evidence object for AI MedTech / SaMD: source basis, owner, status, review question, and update trigger should be visible before reuse.
Training/validation data summary
Keep this as a named evidence object for AI MedTech / SaMD: source basis, owner, status, review question, and update trigger should be visible before reuse.
Performance evaluation report
Keep this as a named evidence object for AI MedTech / SaMD: source basis, owner, status, review question, and update trigger should be visible before reuse.
Human factors/oversight rationale
Keep this as a named evidence object for AI MedTech / SaMD: source basis, owner, status, review question, and update trigger should be visible before reuse.
PCCP description
Keep this as a named evidence object for AI MedTech / SaMD: source basis, owner, status, review question, and update trigger should be visible before reuse.
Modification protocol
Keep this as a named evidence object for AI MedTech / SaMD: source basis, owner, status, review question, and update trigger should be visible before reuse.
Transparency/user information file
Keep this as a named evidence object for AI MedTech / SaMD: source basis, owner, status, review question, and update trigger should be visible before reuse.
Post-market monitoring plan
Keep this as a named evidence object for AI MedTech / SaMD: source basis, owner, status, review question, and update trigger should be visible before reuse.
Real-world performance review log
Keep this as a named evidence object for AI MedTech / SaMD: source basis, owner, status, review question, and update trigger should be visible before reuse.
Each object needs review before reuse.
question bankIntended-use and clinical workflow map
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Software function description
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Training/validation data summary
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Performance evaluation report
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Human factors/oversight rationale
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
PCCP description
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Modification protocol
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Transparency/user information file
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Current public sources for AI MedTech / SaMD.
official firstThese links are the public source anchors for this workspace. Interpretation, checklists, and future assets should point back here before being reused outside iFeed.
FDA AI Software as a Medical Device page
Current · FDA landing page for AI-enabled software as a medical device.
FDA PCCP guidance for AI-enabled device software functions
2024-12-04 · Guidance on marketing submission recommendations for predetermined change control plans.
FDA AI-enabled device lifecycle draft guidance
2025-01 · Draft lifecycle management and marketing submission guidance. Treat as draft/watch item.
FDA/Health Canada/MHRA GMLP principles
2021-10-27 · Ten guiding principles for machine-learning-enabled medical device development.