Humanitarian use devices/humanitarian device exemptions in cardiovascular medicine

The Second Dartmouth Device Development Symposium held in October 2004 brought together leaders from the medical device community, including clinical investigators, senior representatives from the US Food and Drug Administration, large and small device manufacturers, and representatives from the fin...

Ausführliche Beschreibung

Gespeichert in:

Bibliographische Detailangaben
Veröffentlicht in:	Circulation (New York, N.Y.) N.Y.), 2005-11, Vol.112 (18), p.2883-2886
Hauptverfasser:	KAPLAN, Aaron V, HARVEY, Elisa D, KUNTZ, Richard E, SHIRAN, Hadas, ROBB, John F, FITZGERALD, Peter
Format:	Artikel
Sprache:	eng
Schlagworte:	Altruism Associated diseases and complications Atherosclerosis (general aspects, experimental research) Biological and medical sciences Blood and lymphatic vessels Cardiac Catheterization - standards Cardiology - standards Cardiology. Vascular system Cardiovascular Diseases - surgery Device Approval - standards Diabetes. Impaired glucose tolerance Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous Endocrine pancreas. Apud cells (diseases) Endocrinopathies Heart Diseases - surgery Humans Medical sciences United States United States Food and Drug Administration
Online-Zugang:	Volltext
Tags:	Tag hinzufügen Keine Tags, Fügen Sie den ersten Tag hinzu!

Beschreibung
Zusammenfassung:	The Second Dartmouth Device Development Symposium held in October 2004 brought together leaders from the medical device community, including clinical investigators, senior representatives from the US Food and Drug Administration, large and small device manufacturers, and representatives from the financial community to examine difficult issues confronting device development. The role of the Humanitarian Use Device/Humanitarian Device Exemption (HUD/HDE) pathway in the development of new cardiovascular devices was discussed in this forum. The HUD/HDE pathway was created by Congress to facilitate the availability of medical devices for "orphan" indications, ie, those affecting
ISSN:	0009-7322 1524-4539
DOI:	10.1161/CIRCULATIONAHA.105.553701