📄FDA Draft Guidance on AI-Enabled Device Software Functions
Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Artificial Intelligence Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations." This draft guidance, when finalized, will provide recommendations regarding the contents of marketing submissions for devices that include artificial intelligence (AI)-enabled device software functions including documentation and information that will support FDA's evaluation of safety and effectiveness. To support the development of appropriate documentation for FDA's assessment of the device, this draft guidance also proposes recommendations for the design, development, and implementation of AI- enabled devices that sponsors may wish to consider using throughout the total product lifecycle (TPLC). This draft guidance is not final nor is it for implementation at this time.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The draft guidance outlines compliance and regulatory requirements for AI-enabled medical devices, impacting businesses seeking FDA approval. Specifically, it includes recommendations for marketing submissions, lifecycle management, and performance monitoring of AI devices, indicating a need for businesses to adjust practices to ensure compliance.