预先确定的变化控制计划:推进安全,有效和高质量的AI-ML技术的指导原则
Eduardo Carvalho1, Miguel Mascarenhas2,3,4, Francisca Pinheiro5
1Institute of Science and Innovation in Mechanical and Industrial Engineering (INEGI), Campus da FEUP Rua Dr. Roberto Frias, 400, Porto, 4200-465, Portugal, +351 229578710.
JMIR AI
|October 31, 2025
概括
人工智能 (AI) 设备由于其自适应性而面临监管障碍. 预先确定的变更控制计划提供了一个解决方案,以简化对不断发展的人工智能技术的批准.
科学领域:
- 医疗器械监管法规 医疗器械监管法规
- 医疗保健中的人工智能
背景情况:
- 适应性人工智能 (AI) 提供了显著的好处,但挑战了当前的监管框架.
- 长时间的审批期限和反复提交的文件阻碍了采用支持人工智能的设备.
研究的目的:
- 探索美国食品和药物管理局 (FDA) 的预先确定的变化控制计划概念.
- 评估这些计划如何简化对不断发展的人工智能技术的监管监管.
主要方法:
- 审查FDA关于预先确定变更控制计划的指导方针.
- 分析这些计划对支持人工智能的设备审批流程的影响.
主要成果:
- 预先确定的变更控制计划可以减少对更新的人工智能软件功能的重复批准的需要.
- 这些计划旨在确保安全和合规性,同时加快监管决策.
结论:
- 实施预先确定的变化控制计划可以促进创新,并增加市场对AI和机器学习技术的采用.
- 简化监管监督通过减少负担和等待时间,使制造商和监管机构都受益.
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