FDA Official Clarifies: AI Tool Will Not Make Regulatory Decisions

A senior FDA official clarified that the agency’s artificial intelligence tool will not autonomously make regulatory decisions regarding medical products. Instead, the AI system is designed to assist officials in evaluating data, enhancing the efficiency of the review process. The tool will provide insights and analysis but will not replace human judgment. The FDA aims to incorporate AI to improve outcomes and streamline regulatory workflows while ensuring oversight remains with qualified professionals. The official emphasized that maintaining high safety and efficacy standards is paramount, and any decisions will ultimately rest in the hands of human regulators. This approach reflects a careful balance between leveraging technology and upholding rigorous evaluation standards in the medical field. Overall, the FDA’s use of AI is seen as a supportive mechanism rather than a substitute for traditional regulatory practices.

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