The flow moves from source to reviewable work.
AI MedTech / SaMDRecommended operating sequence.
Define intended medical purpose · Map device software function · Assess risk and pathway · Build data/performance evidence · Plan PCCP if applicable · Prepare transparency material · Monitor post-market signals
Where teams usually lose traceability.
audit watchSource skipped
Using a blog summary instead of the official source creates weak claims.
Role unclear
Provider, deployer, sponsor, manufacturer, vendor, or owner responsibilities blur.
Evidence not owned
A document exists but nobody owns review, update, or closure.
Change not logged
Model, system, SOP, source, or guidance changes do not reach the evidence file.
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FDA AI-enabled device lifecycle draft guidance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.