2026年3月7日,一些团体敦促FDA平衡人工智能监督与放射学设备规则的创新. On March 7, 2026, groups urged the FDA to balance AI oversight with innovation in radiology device rules.

2026年3月7日,多个组织向FDA提交了关于放射学设备法规的建议变更的公开意见. On March 7, 2026, multiple organizations submitted public comments to the FDA regarding proposed changes to radiology device regulations. 医疗设备制造商协会敦促撤销拟议的民事处罚规则,指出对监管不确定性和创新的关切。 The Medical Device Manufacturers Association urged the withdrawal of a proposed civil penalty rule, citing concerns over regulatory uncertainty and innovation. 放射伙伴和国家卫生研究中心强调,需要严格监督医疗成像方面的AI,以确保病人的安全,而Subtle Medical则要求部分豁免某些AI动力成像工具,认为现行规则妨碍创新。 Radiology Partners and the National Center for Health Research stressed the need for strong oversight of AI in medical imaging to ensure patient safety, while Subtle Medical requested a partial exemption for certain AI-powered imaging tools, arguing that current rules hinder innovation. 所有评论都强调在监管严谨与诊断成像技术进步的需要之间取得平衡。 All comments emphasize balancing regulatory rigor with the need for technological advancement in diagnostic imaging.