The chapter holds the source skeleton.
articles · clauses · principlesThis page does not flatten AI MedTech / SaMD into a generic checklist. It identifies the specific source units that future interpretation, evidence objects, and public artifacts must trace back to.
FDA AI/ML SaMD hub
Primary FDA source for AI-enabled software medical-device ecosystem.
FDA PCCP guidance
Final guidance for predetermined change control plans in AI-enabled device software functions.
FDA lifecycle-management draft
Draft guidance; not for implementation until final.
FDA AI-enabled device list
Marketing-authorised device list; not an endorsement beyond authorization status.
IMDRF GMLP
International machine-learning practice principles for medical-device development.
Health Canada MLMD guidance
Comparator for premarket ML-enabled device expectations.
Protected material stays protected.
citation not copyingUse source-owner titles, status, and public summaries; do not reproduce protected standards or paid guide content.
cite · summarise · trace · do not copy
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FDA AI-enabled device lifecycle draft guidance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.