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FDA Publishes White Paper on AI and Medical Products

Recognizing the growing deployment and use of artificial intelligence (AI)-enabled technologies, the U.S. Food and Drug Administration (FDA) has published a white paper on the use of AI in medical products and devices.

Published in mid-March, the white paper “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” is an effort to map out a strategic plan for the “responsible deployment and use of AI and AI-enabled technologies in the health and human services sector.” The white paper sets forth a strategic plan with policies and frameworks for the regulation and oversight of AI-enabled technologies used in medical products.

The FDA’s AI and Medical Products white paper was jointly developed by various FDA Centers, including the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center of Devices and Radiological Health (CDRH), and the Office of Combination Products (OCP).

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Download the FDA’s white paper on AI and medical products.

Read an excellent summary of the white paper published on the JDSupra website.

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