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Regulations/AI MedTech / SaMD/Updates & Assets
Updates & Assets · AI MedTech / SaMD

Updates & Assets for AI MedTech / SaMD.

This page is the living shelf for validated assets, weekly signals, revision notes, and future public tools. Nothing here should look published-ready until the source trail and boundary have been checked.

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
/ Asset shelf

Public assets attach only after source validation.

AI MedTech / SaMD
Asset 01

SaMD intended-use worksheet

Future asset for AI MedTech / SaMD; publish only after source check, date check, boundary review, and revision note.

Asset 02

AI/ML data summary

Future asset for AI MedTech / SaMD; publish only after source check, date check, boundary review, and revision note.

Asset 03

PCCP worksheet

Future asset for AI MedTech / SaMD; publish only after source check, date check, boundary review, and revision note.

Asset 04

transparency file

Future asset for AI MedTech / SaMD; publish only after source check, date check, boundary review, and revision note.

Asset 05

real-world performance review log

Future asset for AI MedTech / SaMD; publish only after source check, date check, boundary review, and revision note.

/ Watchlist

Updates must show what changed.

revision protocol
Protocol 01

Source revision

Record date, source URL, affected pages, and what interpretation changed.

Protocol 02

Weekly signal

Only promote signals that alter operating decisions, evidence expectations, market movement, or governance work.

Protocol 03

Checklist release

Each checklist needs version, source links, evidence fields, public-safe disclaimer, and review boundary.

Protocol 04

Retirement

Outdated pages should be marked, archived, or redirected without deleting the trace.

/ 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