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Regulations/AI MedTech / SaMD/Source Library
Source Library · AI MedTech / SaMD

Source Library for AI MedTech / SaMD.

This source library keeps official references, implementation status, and public-use boundaries visible for the workspace. It supports evidence-readiness without turning protected standards, guidance, or legal material into loose checklist language.

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
/ Official shelf

Source library for AI MedTech / SaMD.

verified anchors
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Official FDA draft guidance

FDA AI-enabled device lifecycle draft guidance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
Official IMDRF document

IMDRF GMLP guiding principles

2025-01-29 · International GMLP source anchor for medical-device development.

open
Official Health Canada guidance

Health Canada ML-enabled medical devices guidance

2026-04-01 · Machine-learning-enabled medical device pre-market evidence and change-control context.

open
/ Source discipline

What can be used publicly and what must stay bounded.

public-safe
Rule 01

Official source first

Use regulator, source-owner, EUR-Lex, FDA, EMA, ICH, ISO/IEC, ISPE, IMDRF, Health Canada, MHRA or similar authority/source-owner pages before commentary.

Rule 02

Paid-source boundary

Where a standard or guide is protected, the page names the source and describes public-safe implications without reproducing protected clause text.

Rule 03

Status visible

Every source needs date/status language so draft, final, watch item, and effective/applicable dates are not mixed.

Rule 04

Interpretation separated

Source fact and iFeed interpretation must remain visibly separated before any checklist is published.

/ Source objects

Objects that deserve stable child pages.

future expansion
Object 01

FDA AI/ML SaMD hub

Primary FDA source for AI-enabled software medical-device ecosystem.

Object 02

FDA PCCP guidance

Final guidance for predetermined change control plans in AI-enabled device software functions.

Object 03

FDA lifecycle-management draft

Draft guidance; not for implementation until final.

Object 04

FDA AI-enabled device list

Marketing-authorised device list; not an endorsement beyond authorization status.

Object 05

IMDRF GMLP

International machine-learning practice principles for medical-device development.

Object 06

Health Canada MLMD guidance

Comparator for premarket ML-enabled device expectations.