What this workspace makes usable.
AI MedTech / SaMDAI/ML-enabled device software, SaMD, and change-control guidance is mapped here for regulated life-sciences, health-tech, AI governance, and operational quality work. Regulatory evidence for AI/ML-enabled medical device software and Software as a Medical Device across development and lifecycle change.
iFeed maps public regulatory source themes into readiness questions. It does not determine device classification, market authorization, or submission strategy.
Device software function
Evidence depends on the clinical function, risk, and role of the software.
AI/ML model development
Training, testing, validation, and data representativeness need source-linked records.
Predetermined Change Control Plan
Planned model changes can be described and governed before implementation.
Transparency
Users need information about intended use, performance, limitations, and updates.
Human factors and oversight
Human interaction with AI output affects risk and evidence needs.
Real-world monitoring
Post-market performance and drift concerns need planned review.
Cybersecurity/data governance
Data and software controls influence safety and effectiveness evidence.
Regulatory submission strategy
Claims and changes need evidence suitable for the relevant regulatory pathway.
Primary references stay visible.
official firstFDA 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FDA AI-enabled device lifecycle draft guidance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.
IMDRF GMLP guiding principles
2025-01-29 · International GMLP source anchor for medical-device development.
Health Canada ML-enabled medical devices guidance
2026-04-01 · Machine-learning-enabled medical device pre-market evidence and change-control context.
The workspace can grow without breaking the source trail.
stable structureThe ten subchapters are fixed surfaces for future public assets.
Overview · Source Library · Articles & Clauses · Applicability · Interpretation · Evidence Readiness · AI Governance · Operational Flow · Actors & Services · Updates & Assets