Lexology December 9, 2024
Amid continued rapid development of novel software products that present new opportunities in the health care space, FDA has yet to grant marketing authorization to a medical device incorporating artificial intelligence (AI) that continuously learns in the field to create derived audiovisual content, otherwise known as generative AI (GenAI). However, the technology industry does not stand still, and manufacturers are eager to find ways to introduce continually learning algorithms to the medical device space in the U.S. Recognizing the simultaneous existence of significant risks and notable potential associated with GenAI, FDA dedicated the inaugural meeting of its Digital Health Advisory Committee on November 20-21, 2024, to discussing Total Product Lifecycle (TPLC) considerations for GenAI-enabled devices. Consistent with the TPLC approach...
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