DocumentCode :
2749329
Title :
Getting your medical device cleared for marketing in the US
Author :
Bartoo, Grace ; Munzner, Robert F.
Volume :
2
fYear :
2004
fDate :
1-5 Sept. 2004
Firstpage :
5136
Abstract :
Summary form only given. This discussion group will explore the different requirements for getting a medical device cleared for marketing in the United States. Specifically, the discussion leaders will give an overview of the 510(k) and PMA, registration, and listing processes. The discussion will also include what is required for foreign companies who wish to import medical devices.
Keywords :
biomedical equipment; marketing; reviews; United States; marketing; medical device; overview; 510(k); FDA; Medical device; PMA; industry;
fLanguage :
English
Publisher :
ieee
Conference_Titel :
Engineering in Medicine and Biology Society, 2004. IEMBS '04. 26th Annual International Conference of the IEEE
Conference_Location :
San Francisco, CA
Print_ISBN :
0-7803-8439-3
Type :
conf
DOI :
10.1109/IEMBS.2004.1404426
Filename :
1404426
Link To Document :
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