Open AccessFDA requirements for clinical investigations of medical devices: A review for European manufacturers
Author(s) -
Ediger Autumn Dawn,
Limbach Birgit,
Dannhorn Dieter
Publication year - 2003
Publication title -
the quality assurance journal
Language(s) - English
Resource type - Journals
eISSN - 1099-1786
pISSN - 1087-8378
DOI - 10.1002/qaj.210
Subject(s) - food and drug administration , documentation , medical device , business , engineering , medicine , computer science , risk analysis (engineering) , biomedical engineering , programming language
The purpose of this article is to provide European manufacturers with a review of the USA's requirements for clinical investigations of medical devices. It is an introductory guide to what European manufacturers need to plan for and what is expected from them when conducting a clinical investigation in the USA. The Food and Drug Administration's (FDA) Investigational Device Exemption (IDE) process is outlined and specific FDA and other web pages are listed to enable the reader to obtain official documentation that provides more detailed information on the IDE process. Copyright © 2003 John Wiley & Sons, Ltd.