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SRC-186e8a7538fd7151 · Source record

Artificial Intelligence in Software as a Medical Device

US Food and Drug Administration · 1 connected claims

D04 · Health, Evidence, Supplements & PeptidesD09 · Legal, Compliance, Trust & RegTechD11 · AI Models, Agents & Human–AI InteractionD12 · Data, Knowledge, Search & EvidenceD14 · Cybersecurity, Identity, Privacy & ResilienceD18 · Operations, Governance & OrganizationD22 · Policy, Geopolitics & Societal Change

Canonical route

https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-software-medical-device

Claims connected to this source

  1. MWITA-WD-2026-007FDA's January 2025 draft guidance proposes lifecycle and marketing-submission recommendations for AI-enabled device software, while expressly remaining draft, non-binding and not for implementation.Evidence A

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