Unverified50% confidenceFactExact time
美国FDA在2021年发布的《AI/ML软件行动计划》中提出'预定变更控制计划'（Predetermined Change Control Plan）框架，要求AI辅助医疗决策工具提供完整证据链
1
Sources
50%
Confidence
Long-term
Relevance
8/29/2026
First Seen
Sources
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