Upcoming FDA AI Draft Guidance Comment Deadline; Cancer Center Alliance Adds AI into Clinical Guidelines

There is still time for the public to submit comments to the FDA’s draft guidance for industry and FDA staff: “AI-Enabled Device Software Functions: Life Cycle Management and Marketing Submission Recommendations”. The deadline to submit comments is April 7, 2025. This draft guidance focuses on recommended content for marketing submissions for devices that include artificial intelligence (AI) enabled device software functions, including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. As there have been significant staff cuts at the FDA and its Center for Devices and Radiological Health (CDRH) that plays a large role in AI-related oversight, it seems unlikely that review times will shrink.

Against this backdrop, the use of AI in clinical decision support has gone “mainstream.” The National Cancer Care Network (NCCN), an alliance of the 33 leading cancer centers in the US that develops globally-respected guidelines for cancer care, integrated an AI tool into its guidelines for the first time in 2024 (for prostate and other cancers). The Plenary session at the upcoming NCCN 2025 annual conference at the end of March is entitled: Artificial Intelligence in Cancer Care: Opportunities, Challenges and Governance. One can anticipate that broader use of AI tools will redefine the standard of care, and raise important liability questions about the implications of use and non-use of AI.