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Regulations/AI MedTech / SaMD/Applicability
Applicability · AI MedTech / SaMD

Applicability for AI MedTech / SaMD.

This page turns scope and timing into a decision route. It separates who is in scope, what trigger applies, which date matters, and where teams should avoid premature compliance claims.

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
/ Applicability logic

Applicability begins with scope, not assumption.

AI MedTech / SaMD
Applicability 01

Medical intended use

Software must first meet device/SaMD intended-use reasoning.

Applicability 02

AI-enabled device software function

AI/ML model behaviour changes data, performance, update, and monitoring evidence needs.

Applicability 03

PCCP pathway

Predetermined changes can be planned but remain bounded by the reviewed plan.

Applicability 04

Non-device AI

Wellness/admin tools may be out of device scope depending on intended use and claims.

/ Dates and gates

Timing changes what can be responsibly claimed.

status gates
Gates

Track these before publishing a checklist or readiness claim.

2021 GMLP principles · 2024/2025 PCCP final guidance status · 2025 lifecycle draft watch · submission strategy gate · PCCP modification protocol · post-market monitoring review

06
/ Use cases

Regulated use cases need a decision record.

life sciences lens
Use case 01

Device software function

Use this as a trigger for AI MedTech / SaMD applicability review, not as an automatic compliance conclusion. Evidence depends on the clinical function, risk, and role of the software.

Use case 02

AI/ML model development

Use this as a trigger for AI MedTech / SaMD applicability review, not as an automatic compliance conclusion. Training, testing, validation, and data representativeness need source-linked records.

Use case 03

Predetermined Change Control Plan

Use this as a trigger for AI MedTech / SaMD applicability review, not as an automatic compliance conclusion. Planned model changes can be described and governed before implementation.

Use case 04

Transparency

Use this as a trigger for AI MedTech / SaMD applicability review, not as an automatic compliance conclusion. Users need information about intended use, performance, limitations, and updates.

Use case 05

Human factors and oversight

Use this as a trigger for AI MedTech / SaMD applicability review, not as an automatic compliance conclusion. Human interaction with AI output affects risk and evidence needs.

Use case 06

Real-world monitoring

Use this as a trigger for AI MedTech / SaMD applicability review, not as an automatic compliance conclusion. Post-market performance and drift concerns need planned review.

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