The U.S. Food and Drug Administration (FDA) has announced plans to expand its use of artificial intelligence (AI) technologies in regulatory processes, signaling a significant shift in how the agency approaches oversight of medical devices and other products. The announcement highlights the FDA’s intention to leverage AI tools for tasks such as data analysis, decision-making, and product evaluation, aiming to enhance efficiency and accuracy in its operations.
According to the FDA, artificial intelligence will play a critical role in streamlining complex regulatory workflows. The agency plans to utilize AI for identifying trends in large datasets, automating routine tasks, and improving risk assessment models. Officials emphasized that these advancements could help address challenges posed by increasingly sophisticated medical devices that incorporate AI themselves. While details about specific implementation strategies remain limited, the FDA indicated it would prioritize transparency and stakeholder engagement throughout this process.
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