FDA Publishes New Artificial Intelligence & Medical Products White Paper

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On March 15, the United States Food & Drug Administration published a white paper entitled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” FDA announced the paper by sharing a short letter from Commissioner Califf, where he reaffirmed the Agency’s commitment to “promoting the responsible and ethical development, deployment, use, and maintenance of safe and effective medical products that incorporate or are developed with AI.” The white paper does not contain any new pronouncements of FDA position, but refers to existing guidance and serves as a reinforcement for existing FDA policy regarding AI.

Read the full alert on the Faegre Drinker website.

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About the Author: Jim Frederick

With a sophisticated background leading litigation, Jim Frederick defends innovative life sciences companies in pharmaceutical and medical device product liability, mass tort and consumer fraud lawsuits. Jim also represents clients in commercial litigation and appellate matters. A former Assistant U.S. Attorney in the District of Maryland, Jim wields his background investigating and prosecuting civil and criminal fraud cases to inform his defense strategy for clients.

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