Promoting AI Use in Developing Medical Devices

The U.S. Food and Drug Administration (FDA) has issued a draft guidance intended to promote the development of safe and effective medical devices that use a type of artificial intelligence (AI) known as machine learning (ML). The draft guidance further develops FDA’s least burdensome regulatory approach for AI/ML-enabled device software functions (ML-DSFs), which aims to increase the pace of innovation while maintaining safety and effectiveness.

Read the full Alert on the Duane Morris website.

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