FDA issues draft guidance for AI-enabled devices

The FDA has released draft guidance for developers of AI-enabled medical devices, offering recommendations aimed at ensuring the safety and effectiveness of the devices. 

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The guidance, if finalized, would be the first to cover AI devices from design and development to post-market monitoring and risk management, according to a Jan. 6 news release from the agency. 

The guidance highlights key areas, including strategies to address transparency, bias and performance monitoring. 

The FDA has authorized more than 1,000 AI-enabled medical devices and the new guidance builds on previous efforts. 

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