_Regulation · Safety standard_

# FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management

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

- **Jurisdiction:** [United States](/locations/united-states.md) (id: `aa8b9c05-c836-4021-801f-59801970401e`)
- **Kind:** `safety_standard`
- **Status (derived):** in_effect
- **Effective:** 2025-01-06

FDA issued comprehensive draft guidance for AI-enabled medical devices covering total product lifecycle (TPLC) management, including design controls, data governance, transparency, bias mitigation,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).

## 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### What does FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management cover?

FDA issued comprehensive draft guidance for AI-enabled medical devices covering total product lifecycle (TPLC) management, including design controls, data governance, transparency, bias mitigation,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### Where does FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management apply?

FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management is recorded as a safety_standard applying in United States on the DEPLOY registry.

### When did FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management take effect?

FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management is recorded as effective January 6, 2025 on the DEPLOY registry.

### Is FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management still in effect?

FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management is currently in effect and applies to covered operators in the named jurisdiction.

### What types of robots does FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management apply to?

FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management is recorded as applying to surgical, biometric, wearable on the DEPLOY registry.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.


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