人道的用途の器具/心血管医学における人道的用途の器具の免除
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
まとめ
ヒューマニタリー・ユース・デバイス/ヒューマニタリー・デバイス・エグゼプション (HUD/HDE) 経路は,希少疾患のデバイスの開発を支援します. 専門家は,この迅速な規制経路を,市場への広範なアクセスではなく,真の孤児の指示のために予約することを推奨しています.
科学分野:
- 医療機器開発 医療機器の開発について
- 規制問題 規制問題
- 心血管器具は心臓血管器具として使われています.
背景:
- 第2回ダートマスデバイス開発シンポジウムは,医療機器開発における課題について議論するために専門家を招集した.
- ヒューマニタリー・ユース・デバイス/ヒューマニタリー・デバイス・エグゼメンション (HUD/HDE) 経路が心血管器具のイノベーションにおける役割は,重要なテーマでした.
- この経路は,米国で毎年4,000人未満の個人に影響を及ぼす稀な状態を標的としたデバイスへのアクセスを容易にします.
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