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...

Full description

Saved in:
Bibliographic Details
Published in:Circulation (New York, N.Y.) N.Y.), 2005-11, Vol.112 (18), p.2883-2886
Main Authors: KAPLAN, Aaron V, HARVEY, Elisa D, KUNTZ, Richard E, SHIRAN, Hadas, ROBB, John F, FITZGERALD, Peter
Format: Article
Language:English
Subjects:
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
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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