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FDA Drops Draft Guidance For AI-Enabled Medical Device Developers

 
• By Brian Bossetta

The US FDA has published a draft guidance document for developers of AI-enabled medical devices describing the postmarket management of their products. The guidance offers a comprehensive approach to the management of risk throughout the total product life cycle of a device.

The Food and Drug Administration wants sponsors of AI-enabled medical devices to engage with the agency “early and often” and use the recommendations from its recently published draft guidance “Artificial Intelligence Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations” throughout the development process.

The document is intended to guide developers through the life cycle of their devices and provide recommendations pertaining to the contents of marketing submissions for devices that feature AI-enabled device software functions, including

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