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FDA Announces Artificial Intelligence and Machine Learning in Software as a Medical Device

Yesterday, January 12, 2021, 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 plan outlines five actions that the FDA intends to take, including:

· Further developing the proposed regulatory framework, including through issuance of draft guidance on a predetermined change control plan (for software’s learning over time)

· Supporting the development of good machine learning practices to evaluate and improve machine learning algorithms

· Fostering a patient-centered approach, including device transparency to users

· Developing methods to evaluate and improve machine learning algorithms

· Advancing real-world performance monitoring pilots


You can download the plan here: https://www.fda.gov/media/145022/download



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