Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device Action Plan

The U.S. Food and Drug Administration (FDA) issued the “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan” from the Center for Devices and Radiological Health’s Digital Health Center of Excellence.

The Action Plan is a direct response to stakeholder feedback to the April 2019 discussion paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device” and outlines five actions the FDA intends to take.

The Action Plan can be found here:

https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device