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

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 framework for AI/ML SaMD