The Biden Administration’s Swan Song on Digital Health: Two FDA Guidances on Artificial Intelligence and FDA’s Defense of its Clinical Decision Support Guidance

Lexology January 31, 2025
Ropes & Gray LLP

In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new draft guidance documents addressing artificial intelligence (“AI”). One is a long-awaited draft guidance addressing marketing submission and lifecycle management considerations for AI-enabled medical devices, titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations” (the “Device AI Draft Guidance”). The other is a draft guidance addressing the use of AI tools in the drug product lifecycle, titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products” (the “Drug AI Draft Guidance”). Although they address different...

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