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- FDA Releases NEW Artificial Intelligence Draft Guidance
The Federal Drug Administration (FDA) has released a draft guidance entitled "Artificial Intelligence Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations." This draft guidance, when finalized, will provide recommendations regarding the contents of marketing submissions for devices that include artificial intelligence (AI)-enabled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 the 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To support the development of appropriate documentation for FDA's assessment of the device, this draft guidance also proposes recommendations for the design, development, and implementation of AI-enabled devices that sponsors may wish to consider using throughout the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). Comments may be submitted online until April 7, 2025.
The CAP previously advocated for transparency in AI and has advocated for the FDA to take the necessary steps to ensure regulatory burden is not transferred to pathologists.
The CAP is now analyzing how the proposed guidance will impact pathologists and will continue providing updates.