在突破性设备计划下,FDA授权治疗设备
Kushal T Kadakia1, Sanket S Dhruva2,3, Joseph S Ross4,5,6
1Harvard Medical School, Boston, Massachusetts.
JAMA internal medicine
|June 30, 2025
概括
美国食品和药物管理局 (FDA) 的突破性设备计划 (BDP) 促进了新型治疗设备,其中大多数是按时审查的. 然而,由于设备有效性和安全性的不确定性,对持续的公共卫生益处仍然存在疑问.
科学领域:
- 医疗器械监管法规 医疗器械监管法规
- 卫生技术评估 卫生技术评估
- 临床创新 临床创新
背景情况:
- 美国食品和药物管理局 (FDA) 在2016年建立了突破性设备计划 (BDP),以加快创新医疗技术和改善患者的获取.
- 该计划的临床和监管特征在很大程度上尚未评估,需要对其有效性的评估.
研究的目的:
- 描述FDA指定的突破性设备的技术新性.
- 分析FDA审查时间和治疗突破性设备的市场前/市场后证据要求.
主要方法:
- 一项横截面研究分析了2016年1月1日至2024年9月30日期间经批准的治疗突破性设备的FDA公开数据.
- 评估设备新性,FDA审查时间与医疗设备用户费用授权 (MDUFA) 目标相比,关键研究设计,以及包括召回在内的市场后监管行动.
主要成果:
- 在获得突破性指标的1041种设备中,有127种被授权,其中包括75种治疗设备 (59.1%).
- 高风险的治疗设备 (34/75) 往往是新的 (第一种:67.6%;美国首次商业化:41.4%) 并在MDUFA目标时间内进行审查 (73.3%).
- 市场前研究 (89.3%) 显示了不同的终点测量 (49.4%的替代品,18.5%缺乏统计测试) 和短的后续持续时间. 40%的产品需要进行市场后研究,41.3%的产品需要延迟研究. 有12.0%的设备被召回.
结论:
- 大多数治疗突破指定的设备都是新的,并及时接受FDA审查.
- 对一些设备的好处和风险的证据的担忧要求进一步调查该计划对公共健康的持续影响.
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