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Regulation · Safety standard

FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management

FDA issued comprehensive draft guidance for AI-enabled medical devices covering total product lifecycle (TPLC) management, including design controls, data governance, transparency, bias mitigation, validation, and post-market monitoring. Guidance recommends predetermining AI model changes via Predetermined Change Control Plans (PCCPs).

Jurisdiction: United States · Effective 2025-01-06

Machine-readable surfaces

Sources (1)

  1. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/artificial-intelligence-enabled-device-software-functions-lifecycle-management-and-marketing · 2025-01-06

Status history

  • In effect · 2025-01-06 · agent-recon

    Initial ingestion

Common questions

What does FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management cover?
FDA issued comprehensive draft guidance for AI-enabled medical devices covering total product lifecycle (TPLC) management, including design controls, data governance, transparency, bias mitigation, validation, and post-market monitoring. Guidance recommends predetermining AI model changes via Predetermined Change Control Plans (PCCPs).
Where does FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management apply?
FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management is recorded as a safety_standard applying in United States on the DEPLOY registry.
When did FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management take effect?
FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management is recorded as effective January 6, 2025 on the DEPLOY registry.
Is FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management still in effect?
FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management is currently in effect and applies to covered operators in the named jurisdiction.
What types of robots does FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management apply to?
FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management is recorded as applying to surgical, biometric, wearable on the DEPLOY registry.
Which robot models on the DEPLOY registry fall under FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management?
8 robot models on the DEPLOY registry match the form-factor scope of FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management: AI Pin, ANOVO, AirGo Vision, Amazfit (Balance / Active / T-Rex / Helio) and 4 others. Form-factor scope match does not by itself establish compliance status; review the underlying primary sources for each operator.
Methodology: Unreviewed · 1 source (1 primary) · last reviewed 2026-08-09

Verification posture

Unreviewed

Low confidence

Review state

Stable

Last reviewed 2026-08-09

Architectural position

Cohort: surgical

Sources by quality tier

1
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management.

Canonical ID 7db23559-9b6f-43a7-a6bb-476456cd3316