US FDA to Develop Regulatory Scheme for AI in Medical Products, Foster International Cooperation

Lexology April 3, 2024
Greenberg Traurig LLP

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The U.S. Food and Drug Administration (FDA) has outlined its plan to regulate artificial intelligence (AI) in medical products, including building its AI infrastructure and technical expertise, fostering international regulatory cooperation, and dialoguing with stakeholders to develop its regulatory framework.
FDA must comply with the Office of Management and Budget (OMB)’s March 28 Memorandum on Advancing Governance, Innovation, and Risk Management for Agency Use of AI when using AI to streamline its regulatory activities.
With AI regulation in its infancy and considerable regulatory activity planned, including guidance, demonstration projects, public meetings, and requests for information (RFIs), industry should engage with regulators now to inform and influence the development of regulatory...

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2024-04-04T14:14:05-04:00