人道主义用途的设备/心血管医学中的人道主义设备豁免
Aaron V Kaplan1, Elisa D Harvey, Richard E Kuntz
1Dartmouth Medical School, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA. aaron.v.kaplan@hitchcock.org
Circulation
|November 4, 2005
概括
人道主义使用设备/人道主义设备豁免 (HUD/HDE) 途径有助于罕见疾病设备的开发. 专家建议将这种快速监管途径保留给真正的孤儿指示,而不是广泛进入市场.
科学领域:
- 医疗器械开发 医疗器械开发
- 监管事务 监管事务
- 心血管器械是指心血管器械.
背景情况:
- 第二届达特斯设备开发研讨会召开专家会议,讨论医疗设备开发的挑战.
- 人道主义使用设备/人道主义设备豁免 (HUD/HDE) 途径在心血管设备创新的作用是一个关键话题.
- 这一途径为针对美国每年影响不到4000人的罕见疾病的设备提供了更容易访问的途径.
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