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Scott Gottlieb: FDA Eyes Regulatory Framework for AI-Based Medical Devices

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Scott Gottlieb, commissioner of the Food and Drug Administration, announced the release of a discussion paper as the agency considers developing new regulatory framework to advance the development of artificial intelligence-based medical devices.

“We are exploring a framework that would allow for modifications to algorithms to be made from real-world learning and adaptation, while still ensuring safety and effectiveness of the software as a medical device is maintained,” Gottlieb said in a statement published Tuesday. 

He said the proposed framework intends to assure that algorithm changes use a validation process to ensure the effectiveness and safety of AI-based software and adhere to pre-specified performance goals and promote performance monitoring once the device enters the market. 

The FDA also plans to assess predetermined change control plan for software to offer detailed data on the types of anticipated changes based on the AI algorithm’s update and retraining strategy. Gottlieb noted the agency plans to issue draft guidance based on feedback it receives on the discussion paper. 

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