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Regulations/AI MedTech / SaMD/AI Governance
AI Governance · AI MedTech / SaMD

AI Governance for AI MedTech / SaMD.

This page focuses on AI governance implications inside regulated work. It shows where AI changes evidence needs while keeping quality, regulatory, data, supplier, and human accountability controls in view.

Source basis: AI/ML-enabled device software, SaMD, and change-control guidanceUse: evidence-readinessBoundary: not legal advice
AI MedTech / SaM TRACE FDA AI/ML SAMD HUBFDA PCCP GUIDANCFDA LIFECYCLE-MAFDA AI-ENABLED D
/ AI governance

AI changes the evidence pattern, not the need for control.

AI MedTech / SaMD
Control 01

Training and validation data

Data provenance, representativeness, and clinical relevance are core evidence.

Control 02

Performance monitoring

Model drift and real-world performance need planned review.

Control 03

Transparency

Users need limits, intended use, updates, and performance information.

Control 04

Cybersecurity and software lifecycle

AI governance sits inside secure, controlled software lifecycle work.

/ Adjacent controls

AI governance must connect to existing regulated systems.

not isolated
Evidence 01

Intended-use and clinical workflow map

Connect this evidence to QMS, clinical, software, supplier, data, or lifecycle governance where applicable.

Evidence 02

Software function description

Connect this evidence to QMS, clinical, software, supplier, data, or lifecycle governance where applicable.

Evidence 03

Training/validation data summary

Connect this evidence to QMS, clinical, software, supplier, data, or lifecycle governance where applicable.

Evidence 04

Performance evaluation report

Connect this evidence to QMS, clinical, software, supplier, data, or lifecycle governance where applicable.

Evidence 05

Human factors/oversight rationale

Connect this evidence to QMS, clinical, software, supplier, data, or lifecycle governance where applicable.

Evidence 06

PCCP description

Connect this evidence to QMS, clinical, software, supplier, data, or lifecycle governance where applicable.

Source anchors

Current public sources for AI MedTech / SaMD.

official first

These links are the public source anchors for this workspace. Interpretation, checklists, and future assets should point back here before being reused outside iFeed.

Official FDA page

FDA AI Software as a Medical Device page

Current · FDA landing page for AI-enabled software as a medical device.

open
Official FDA guidance

FDA PCCP guidance for AI-enabled device software functions

2024-12-04 · Guidance on marketing submission recommendations for predetermined change control plans.

open
Official FDA draft guidance

FDA AI-enabled device lifecycle draft guidance

2025-01 · Draft lifecycle management and marketing submission guidance. Treat as draft/watch item.

open
Official regulator principles

FDA/Health Canada/MHRA GMLP principles

2021-10-27 · Ten guiding principles for machine-learning-enabled medical device development.

open