Document Detail

The challenges of clinical validation of emerging technologies: computer-assisted devices for surgery.
MedLine Citation:
PMID:  19182016     Owner:  NLM     Status:  MEDLINE    
Over the last decade, the use of computers and robotics in medicine has increased commensurate with emergent advances in technology. This article largely focuses on the challenges that the U.S. Food and Drug Administration faces when evaluating new technologies for entry into the market. How different categories of devices are categorized and what types of data have been used for regulatory approval or clearance are described. These are compared with expectations that the clinical community may have for these devices. A brief discussion of current regulatory thinking about these types of devices is also included.
Michel Janda; Barbara Buch
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  The Journal of bone and joint surgery. American volume     Volume:  91 Suppl 1     ISSN:  1535-1386     ISO Abbreviation:  J Bone Joint Surg Am     Publication Date:  2009 Feb 
Date Detail:
Created Date:  2009-02-02     Completed Date:  2009-03-17     Revised Date:  2010-10-25    
Medline Journal Info:
Nlm Unique ID:  0014030     Medline TA:  J Bone Joint Surg Am     Country:  United States    
Other Details:
Languages:  eng     Pagination:  17-21     Citation Subset:  AIM; IM    
Division of General Restorative and Neurological Devices, Center for Devices and Radiologic Health, U.S. Food and Drug Administration, 9200 Corporate Boulevard, HFZ-410, Rockville, MD 20850, USA.
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MeSH Terms
Device Approval
Orthopedic Procedures / instrumentation*
Surgery, Computer-Assisted / instrumentation*
Validation Studies as Topic

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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