Manatt Health February 28, 2024
In January 2024, the U.S. Government Accountability Office (GAO) issued a report highlighting current obstacles to the U.S. Food and Drug Administration’s (FDA) timely and effective regulation of artificial intelligence (AI) and machine learning (ML) in medical devices and other emerging health care technologies (GAO Report). The GAO Report roughly coincided with remarks made by FDA Commissioner Robert Califf and increased media attention on the various challenges faced by federal agencies, such as FDA, in regulating AI/ML. As both Congress and the Executive Branch are mulling strategies to ensure safe, effective, equitable and efficient development and marketing of AI/ML solutions and tools, it is critical that each branch not only understand the limitations on FDA’s authority, but also further empower...
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