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Expert Analysis

How AI Is Shaping FDA Medical Device Regulation

By Ben Haas and Elizabeth Richards (October 15, 2019, 5:08 PM EDT) -- The U.S. Food and Drug Administration is focusing its efforts on modernizing the regulatory pathway to market new medical device products to account for artificial intelligence and machine learning. In addition, the FDA is looking at real-world evidence and how it may be utilized for regulatory purposes. The FDA has acknowledged that both artificial intelligence and real-world evidence will have a major impact on the future of health care, and the agency wants to ensure its policies don't delay innovative new treatment options for patients....

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