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FDA Issues 5-Point Action Plan For Artificial Intelligence/Machine Learning-Based SaMD

 
• By Shawn M. Schmitt

A new guidance document and a promise to hold a public workshop are just two commitments made by the US agency in a 12 January action plan aimed at AI/ML-based software as a medical device.

Old dart target with arrows.

A new guidance document and a promise to hold a public workshop are just two commitments made by the US Food and Drug Administration in a new five-point action plan aimed at artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD).

The FDA says its action plan, released on 12 January, was developed based on input from stakeholders who responded to the agency’s April 2019 discussion paper on a regulatory...

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