FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management
[in effect]United States · safety standard · safety standard
Jurisdiction
United States
Classification
safety standard
Status
in effect
Effective Date
Jan 6, 2025
Primary Sources
1 audited
Statutory Scope & Summary
FDA issued comprehensive draft guidance for AI-enabled medical devices covering total product lifecycle (TPLC) management, including design controls, data governance, transparency, bias mitigation,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).
Covered Sectors & Application Domains
Regulatory Analysis & Inquiries
6 entriesWhat does FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management cover?
FDA issued comprehensive draft guidance for AI-enabled medical devices covering total product lifecycle (TPLC) management, including design controls, data governance, transparency, bias mitigation,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Where does FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management apply?
FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management is recorded as a safety_standard applying in United States on the DEPLOY registry.
When did FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management take effect?
FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management is recorded as effective January 6, 2025 on the DEPLOY registry.
Is FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management still in effect?
FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management is currently in effect and applies to covered operators in the named jurisdiction.
What types of robots does FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management apply to?
FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management is recorded as applying to surgical, biometric, wearable on the DEPLOY registry.
Which robot models on the DEPLOY registry fall under FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management?
8 robot models on the DEPLOY registry match the form-factor scope of FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management: AI Pin, ANOVO, AirGo Vision, Amazfit (Balance / Active / T-Rex / Helio) and 4 others.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.
Primary Sources & Legal Instruments
1 document- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/artificial-intelligence-enabled-device-software-functions-lifecycle-management-and-marketingOfficial Source
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/artificial-intelligence-enabled-device-software-functions-lifecycle-management-and-marketing