FDA Oversees AI Integration in Medical Products Through Key Centers
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Artificial Intelligence (AI) is a machine system that makes predictions, recommendations, or decisions based on human-defined objectives to influence real or virtual environments.
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AI intersects with medical products because the FDA ensures the safety, efficacy, and security of drugs, biologics, devices, food, cosmetics, and radiation-emitting products.
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The FDA shapes healthcare's integration of AI through its centers like CBER, CDER, CDRH, and OCP.
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CDRH has a Digital Health Center of Excellence and an AI program for devices.
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CDER has an AI/ML program for drug development.