Title :
Getting your medical device cleared for marketing in the US
Author :
Bartoo, Grace ; Munzner, Robert F.
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;
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
DOI :
10.1109/IEMBS.2004.1404426