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· Further developing the proposed regulatory framework, including through issuance of draft guidance on a predetermined change control plan (for software’s learning over time)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