FDA releases first Artificial Intelligence (AI) regulatory plan to promote responsible digital health innovation

FDA Releases Artificial Intelligence/Machine Learning Action Plan (FDA press release): Today, the U.S. Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan describes a multi-pronged approach to advance the Agency’s oversight of AI/ML-based medical software … The AI/ML-Based Software as a Medical Device Action 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the FDA intends to take, including: Further developing the proposed regulatory framework, including through issuance of draft guidance on a predetermined change control plan (for software’s learning over time); Supporting the development of good machine learning practices to evaluate and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; and Advancing real-world performance monitoring pilots. Launched in September of 2020, the CDRH Digital Health Center of Excellence is committed to strategically advancing science and evidence for digital health technologies within the framework of the FDA’s regulatory and oversight role. The goal of the Center is to empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation. The Action Plan: Title: Artificial Intelligence and Machine Learning in Software as a Medical Device Descri...
Source: SharpBrains - Category: Neuroscience Authors: Tags: Brain/ Mental Health Technology & Innovation artificial intelligence digital health digital health innovation FDA Food and Drug Administration machine-learning regulatory framework software Source Type: blogs