New Developments in FDA Regulation of AI

New Developments in FDA Regulation of AI

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Medical Devices and Diagnostics Industry
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For the last several years, the U.S. FDA and its stakeholders have been calling for a new regulatory approach for artificial intelligence (AI) used in healthcare. Pretty much everyone seems to agree that AI is different from other medical devices, due in part to the fact that AI learns on the job. The fact that such learning changes performance over time and the fact that the company might make frequent updates both suggest the need for a new regulatory approach.