Document Detail


Getting your medical device cleared for marketing in the U.S.
MedLine Citation:
PMID:  17271483     Owner:  NLM     Status:  PubMed-not-MEDLINE    
Abstract/OtherAbstract:
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. The discussion group leaders include Robert Munzner, a former branch chief for the Office of Device Evaluation at the FDA, and Grace Bartoo, a regulatory consultant with over 20 years in the imedical device industry. The format of this session is a discussion group, so please bring your questions and experiences to share.
Authors:
Grace Bartoo; Robert F Munzner
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Conference proceedings : ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual Conference     Volume:  7     ISSN:  1557-170X     ISO Abbreviation:  Conf Proc IEEE Eng Med Biol Soc     Publication Date:  2004  
Date Detail:
Created Date:  2007-02-02     Completed Date:  2007-06-12     Revised Date:  2014-08-21    
Medline Journal Info:
Nlm Unique ID:  101243413     Medline TA:  Conf Proc IEEE Eng Med Biol Soc     Country:  United States    
Other Details:
Languages:  eng     Pagination:  5136     Citation Subset:  -    
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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