Food and Drug Administration's Humanitarian Device Exemption Marketing Approval Pathway: Insights for Developing Devices for Rare Diseases

The Food and Drug Administration's (FDA) Humanitarian Device Exemption (HDE) is a unique marketing approval pathway for medical devices targeting diseases affecting small (rare) patient populations. In an effort to increase the utilization and success of this pathway, the FDA has analyzed data...

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Veröffentlicht in:	Journal of medical devices 2017-09, Vol.11 (3)
Hauptverfasser:	Liu, Gumei, Chen, Eric, Lewis, Debra, Rao, Gayatri
Format:	Artikel
Sprache:	eng
Online-Zugang:	Volltext
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