US FDA issues AI/ML Software as a Medical Device Action Plan

first_img Read Article By EH News Bureau on January 18, 2021 Based on stakeholder feedback, the Action Plan outlines five actions the US FDA intends to takeThe US Food and Drug Administration (FDA) recently 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 release states that 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the US FDA intends to take, which include:Further developing the proposed regulatory framework, including issuing draft guidance on a predetermined change control plan;Supporting the development of good machine learning practices to evaluate and improve machine learning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; andAdvancing real-world performance monitoring pilots.The US FDA anticipates this action plan will continue to evolve as AI/ML-based SaMD is a rapidly progressing field. The agency welcomed continued feedback in this area and will engage with stakeholders on these efforts. It will also continue to collaborate across the US FDA to build a coordinated approach in areas of common focus related to AI/ML. US FDA issues AI/ML Software as a Medical Device Action Plan Menopause to become the next game-changer in global femtech solutions industry by 2025 ML/AISoftware as a Medical DeviceUS FDA Phoenix Business Consulting invests in telehealth platform Healpha Healthcare IT MedTech News Comments (0) The missing informal workers in India’s vaccine story Adoption of AI/ML can disrupt healthcare services Indraprastha Apollo Hospitals releases first “Comprehensive Textbook of COVID-19” Related Posts MaxiVision Eye Hospitals launches “Mucormycosis Early Detection Centre” WHO tri-regional policy dialogue seeks solutions to challenges facing international mobility of health professionals Share Add Commentlast_img

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