This Special Communication reviews the history of the FDA's regulation of AI in the industries it oversees and 10 concepts that deserve consideration as the regulatory system adapts to address this rapidly evolving technology.
10 concepts pertinent to regulation of AI by the FDA: AI Regulation Within the Broader US Government and Global Context, Keeping Up With the Pace of Change in AI, Flexible Approaches Across the Spectrum of AI Models, The Use of AI in Medical Product Development, Preparing for the Unknowns of Large Language Models and Generative AI, The Central Importance of AI Life Cycle Management, The Responsibilities of Regulated Industries, Maintaining Robust Supply Chains, Finding the Balance Between Big Tech, Start-Ups, and Academia, and The Tension Between Using AI to Optimize Financial Returns vs Improving Health Outcomes.
The FDA will continue to play a central role in ensuring safe, effective, and trustworthy AI tools to improve the lives of patients and clinicians alike. However, all involved entities will need to attend to AI with the rigor this transformative technology merits.
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