CDRH Promotes Experiential Learning ProgramMansour, Mark
>CDRH参与国际协调和融合工作，包括国际医疗器械监管论坛（IMDRF）发布的最终文件《机器学习医疗器械：关键术语和定义Machine Learning-enabled Medical Devices: Key Terms and Definitions》，并共同主持重启医疗器械 (SaMD)工作组。>2022年10月，CDRH发布“聚焦：数字健康监管科学机遇”重点介绍常见数字健康领域，如患者...
• Marketing Submission Recommendations for A Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions 关于人工智能/机器学习(AI/ML)设备软件功能变更控制计划的上市递交建议 • Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical ...
• Identify metrics and incorporate methods to better assess review process training satisfaction, learning, and staff behavior changes. • Promote informal training and knowledge sharing by seasoned staff for review staff and management to share division- or science-specific review processes, lessons...
AI and machine learning are powering new diagnostics, treatments, and patient monitoring systems. “Artificial intelligence is an algorithm that is trained on a particular data set and validated in a certain context,” she said. “But when it’s in real-world use, there can be challenges. And...
Draft guidance topics CDRH is hoping to address in FY 2021 includes: Peroxide-Based Contact Lens Care Products – Patient Labeling Recommendations; Pre-Determined Change Control Plan: Premarket Submission Considerations for Artificial Intelligence and Machine Learning software; List of Highest Priority Devic...
Responsible Deep Learning for Software as a Medical Device the Office of Science and Engineering Laboratories (OSEL) section III, and officials at the US FDA in Center for Devices & Radiological Health (CDRH) se... P Shah,J Lester,JG Deflino,... 被引量: 0发表: 2023年 ...
Purpose:Machine learning algorithms are best trained with large quantities of accurately annotated samples. While natural scene images can often be labeled... M Maynord,MM Farhangi,C Fermüller,... - 《Medical Physics》 被引量: 0发表: 2023年 A data‐efficient method for local noise power spe...
• Marketing Submission Recommendations for A Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions 关于人工智能/机器学习(AI/ML)设备软件功能变更控制计划的上市递交建议 • Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical...
CDRH Solicits Industry Participation in 2015 Experiential Learning ProgramAsebey, Edgar