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FDA Drops Draft Guidance For AI-Enabled Medical Device Developers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The US FDA has published a draft guidance document for developers of AI-enabled medical devices describing the postmarket management of their products.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medical devices to engage with the agency “early and often” and use the recommendations from its recently published draft guidance “Artificial Intelligence Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations” throughout the development process.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...

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